BreastScreen Australia Evaluation Evaluation Final …...Breastscreen Australia Evaluation –...

BreastScreen Australia Evaluation

Evaluation Final Report

June 2009

Screening Monograph No.1/2009

Evaluation of the BreastScreen Australia Program – Evaluation Final Report – June 2009

The BreastScreen Australia Evaluation was supported by the BreastScreen Australia Evaluation Taskforce in the Commonwealth Department of Health and Ageing, comprising Julianne Quaine, Gillian Barber, Jessica Delaney, Karen Granton, Alex Lloyd, Sue Purtell, Kerry Watts and Andriana Koukari.

ISBN: 1-74186-968-4 Online ISBN: 1-74186-969-2 Publications Number: P3 -5587

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iBreastscreen Australia Evaluation – Evaluation Final Report June 2009

CONTENTS1 Preface 1

2 Executivesummary 4

2.1 Evaluation recommendations 4

2.2 Summary of Evaluation methodology 7

2.3 Summary of Evaluation findings and conclusions 8

3 BreastcancerinAustralia 14

3.1 Trends in breast cancer incidence 14

3.2 Trends in breast cancer screening 15

3.3 Trends in breast cancer treatment 15

3.4 Trends in breast cancer survival 16

3.5 Trends in breast cancer mortality 17

4 BreastScreenAustraliabackground 18

4.1 BreastScreen Australia 18

4.2 Governance and reporting arrangements 19

4.3 Program delivery 21

4.4 Recruitment strategies 23

4.5 Quality management and accreditation 23

4.6 Mammography outside the BreastScreen Australia Program 24

5 BackgroundandcontextoftheEvaluation 25

5.1 Purpose of the Evaluation 25

5.2 Scope of the Evaluation 25

5.3 Terms of reference for the Evaluation 27

5.4 Stakeholder input to the Evaluation 29

6 Healthoutcomes 32

6.1 Benefits associated with participating in BreastScreen Australia 34

6.2 Potential harms associated with participating in the BreastScreen AustralIa Program 52

6.3 Analysis 58

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7 Programparticipation,accessandequity 60

7.1 Program participation 63

7.2 Availability, accessibility and acceptability of the Program 75

7.3 Impact of Medicare Benefits Schedule (MBS) funded mammography on BreastScreen Australia 85

7.4 Analysis 101

8 Programperformance 106

8.1 Performance trends relating to performance indicators 108

8.2 Other trends in performance of BreastScreen Australia 126

8.3 Program performance by age group 140

8.4 Analysis 149

9 Programgovernanceandmanagement,andqualityassurance 152

9.1 Governance and management 153

9.2 Quality assurance 163

9.3 Program response to new research, evidence, and technologies 167

9.4 Analysis 169

10 Programinfrastructureandcapacity 173

10.1 Program workforce and infrastructure 174

10.2 Capacity issues 177

10.3 Program capacity into the future 179

10.4 Impact on Program demand and capacity of mammography outside the Program 187

10.5 Breast cancer screening technologies 187

10.6 Analysis 190

11 Economicoutcomes 192

11.1 Economic Evaluation and Modelling Study 192

11.2 Cost-effectiveness 196

11.3 Cost-utility 204

11.4 Marginal cost analysis 205

11.5 Financial implications analysis 205

11.6 Analysis 207

iiiBreastscreen Australia Evaluation – Evaluation Final Report June 2009

12 Policyissues 210

12.1 Age range 211

12.2 Screening interval 220

12.3 Screening of women at higher risk 222

12.4 Women with symptoms 229

12.5 Policy application 231

12.6 Analysis 238

13 StakeholderperceptionsoftheBreastScreenAustralia 244

13.1 Results of stakeholder consultations 244

14 AchievementofProgramaimsandobjectives 247

14.1 Achievement of BreastScreen Australia aims 247

14.2 Achievement of BreastScreen Australia objectives 254

15 Conclusionsandrecommendations 262

16 Appendices 280

16.1 Evaluation Advisory Committee membership 280

16.2 Outline of Evaluation projects 281

16.3 BreastScreen Australia Program aims and objectives 285

16.4 Questions linked to Evaluation projects 287

16.5 Levels of Evidence 289

16.6 Glossary 290

16.7 Abbreviations 294

16.8 List of Tables 297

16.9 List of Figures 302

16.10 References 305

1Breastscreen Australia Evaluation – Evaluation Final Report June 2009

1. PREFACEThis is the final report by the BreastScreen Australia Evaluation Advisory Committee (the EAC) to the Australian Health Ministers’ Advisory Council (AHMAC) on the Evaluation of the BreastScreen Australia Program (the Evaluation).

The Evaluation has been undertaken in accordance with the Evaluation plan, developed by the EAC and endorsed by AHMAC. This report synthesises Evaluation project activities and outcomes, identifies key findings and makes recommendations for the BreastScreen Australia Program.

1.1 ACKNOWLEDGEMENTS

The Evaluation was funded jointly by the Commonwealth and state and territory governments. This report was produced by the EAC with support from the Commonwealth Department of Health and Ageing’s BreastScreen Australia Evaluation Taskforce. Thanks are extended to the Australian Institute of Health and Welfare, BreastScreen Australia state and territory Program and data managers, state and territory cancer registries and the Department of Health and Ageing’s Medicare Analysis and Statistics Section for providing data and assistance to the Evaluation. Thanks are also extended to the consultants who undertook the individual Evaluation projects.

1.2 EVALUATIONADVISORYCOMMITTEE

The members of the EAC were:

Dr Helen Zorbas (Chair)

Dr Frida Cheok

Professor David Currow

Professor Dallas English

Professor Harry de Koning

Ms Valerie Lang AM

Mr David Learmonth

Ms Jennifer Muller PSM

Clinical Associate Professor Jonathan Osborne

Professor Julietta Patnick CBE

Professor David Roder

Ms Venessa Tripp

Dr Madeline Wall (observer)

Further details of the EAC membership are provided in Appendix 16.1.

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1.3 STRUCTUREOFTHEREPORT

The report is structured around the Evaluation objectives.1

• Evaluation objective 1: Outcomes delivered by the BreastScreen Australia Program is covered in Chapters 6–12.

• Evaluation objective 2: Achievement of the Program aims and objectives is addressed specifically in Chapter 14 as well as throughout the report, as individual aims and objectives are discussed in relation to the broader Program outcomes.

• Evaluation objective 3: Assessment of the appropriateness, efficiency and effectiveness of the Program is considered in Chapter 14 (appropriateness), and Chapters 6, 7, 8 and 11 (effectiveness and efficiency).

• Evaluation objective 4: Ongoing and unresolved issues impacting on the Program is addressed in Chapters 12 and 14.

• Evaluation objective 5: Opportunities to improve the Program is considered in Chapter 15 (conclusions and recommendations).

Each chapter presents findings from the Evaluation projects and other relevant sources in response to the Evaluation questions. Key findings are summarised at the beginning of the each chapter and the evidence to support these findings is discussed in an analysis section at the end of the chapter.

1.4 USEOFNATIONALACCREDITATIONSTANDARDS

Throughout the report, the performance of the BreastScreen Australia Program is analysed against both the agreed Program indicators2 and the national accreditation standards (NAS) (BreastScreen Australia, 2005a). The NAS are used to measure the performance of individual services as part of the BreastScreen Australia accreditation process. While these standards were not designed to assess the Program at a national level, in the absence of other benchmarks they have been used to assess the Program’s performance in this Evaluation.

1 See Chapter 5, section 5.3 for the terms of reference for the Evaluation2 See Figure 4.1 for list of Program performance indicators


1.5 NOTEONREFERENCING

This Evaluation report is based primarily on findings from the individual Evaluation projects and, as such, the individual reports are referenced throughout the report. Where specific or additional information is included from other sources, the original author is cited. A list of individual Evaluation projects is provided at Appendix 16.2

1.6 NOTEONDATAREPORTINGPERIODS

In this report, data reporting periods are presented, where possible, over a 2-year timeframe to correspond with the biennial screening interval of the BreastScreen Australia Program. However, in some instances, data were not available or not reported in a given time period. Moreover, comparison of trends over time was sometimes easier over a different interval, especially where comparisons involved long time periods. Therefore, in some parts of the report, reporting periods vary in length or have been averaged over a particular length of time. Regardless of length, the majority of reporting periods are based on a calendar year except where noted.

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2.1 EVALUATIONRECOMMENDATIONS

Recommendations

1. Continue BreastScreen Australia as a population-based screening program, providing biennial breast cancer screening using mammography for women in the target age group.

2. Use evidence of the greatest mortality benefit to determine a nationally agreed target age group for the Program. Based on the evidence, preference should be given in the following order to:

i. increasing the participation rate of women aged 50–69 years;

ii. extending the target age range to provide biennial screening for women aged 70–74 years;

iii. extending the target age range to provide annual screening for women aged 45–49 years;

iv. extending the target age range to provide biennial screening for women aged 45–49 years.

3. Women aged 40–44 years and women aged 75 years and over should no longer be eligible to attend the Program.

4. Develop clear national policies for BreastScreen Australia that address inconsistent policy application across jurisdictions to ensure equity for women.

Increasingparticipation

5. Focus on increasing the screening participation rate of the target age group to maximise mortality reduction through a range of social marketing, communication and service delivery strategies, while ensuring there is sufficient capacity to meet demand.

Sub-recommendations

– Increase the screening participation rate of Aboriginal and Torres Strait Islander women, women from culturally and linguistically diverse backgrounds, women living in very remote areas and women living in major cities.

– Increase rescreening rates in the target population, with a particular emphasis on increasing the rescreening rate between the first screening visit and subsequent rescreening.

– Promote the results of the Evaluation to women and health care providers to improve recognition of BreastScreen Australia and increase women’s understanding of breast cancer screening, including its benefits and potential harms.

2. EXECUTIVE SUMMARY


Governanceandmanagement

6. Improve national policy leadership and Program development to facilitate timely decision making, direction setting and capacity to deal with emerging issues and new technology.

7. Review jurisdictional governance and management to ensure optimal capacity to deliver an agreed service model and achieve policy consistency and operational efficiency.

Programcapacityandinfrastructure

8. Address capacity constraints on Program effectiveness through implementing enhanced workforce practices and service models and maximising the benefits of digital mammography.

9. Focus on minimising delays between screening and assessment of women with a screen-detected abnormality.

Screeningpolicyinrelationtobreastcancerrisk

10. Women at a potentially high risk of breast cancer (i.e. a relative risk greater than three times population risk) should not be screened within BreastScreen Australia due to their need for individualised assessment including more intensive surveillance and monitoring. National protocols should be implemented consistently for managing women at high risk of breast cancer who present to BreastScreen Australia services, including appropriate referral. This includes:

– women at potentially high risk due to a strong family history of breast cancer, as defined by National Breast and Ovarian Cancer Centre guidelines;

– women with identified high-risk genetic mutations, such as BRCA1 or BRCA2; and

– women with a recent (<5 years) diagnosis of invasive breast cancer or ductal carcinoma in situ.

11. Implement national policies to ensure women are screened at the appropriate interval according to their level of risk. Family history risk should be assessed using the National Breast and Ovarian Cancer Centre family history tool.

Sub-recommendations

– Womenwithaprevioushistoryofinvasivebreastcancerorductalcarcinomainsitu:BreastScreen Australia should provide access to annual screening to women from 5 years following diagnosis. Apart from mammography, ongoing surveillance of these women should be provided by their usual health care provider.

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– Womenwithahistoryofatypicalhyperplasia(atypicalductalhyperplasiaoratypicallobularhyperplasia)orlobularcarcinomainsitu:BreastScreen Australia should provide access to annual screening to women for at least 15 years following diagnosis. Apart from mammography, ongoing surveillance of these women should be provided by their usual health care provider.

– Womenatmoderateriskofbreastcancerduetofamilyhistory:BreastScreen Australia should provide access to biennial screening to women.

– Womenatorslightlyaboveaverageriskofbreastcancerduetofamilyhistory:BreastScreen Australia should provide access to biennial screening to women.

12. Womenwithsymptoms: BreastScreen Australia should not include women with symptoms in the Program. Women with symptoms require individualised assessment using the triple test approach in accordance with National Breast and Ovarian Cancer Centre guidelines. National protocols should be implemented consistently for managing women who present with symptoms to BreastScreen Australia services, including appropriate referral. Recommendation 19 also refers.

13. Develop a national policy based on a review of the available evidence in relation to identifying and managing women according to their breast density, following the implementation of digital mammography in BreastScreen Australia.

Researchanddata

14. Improve the quality, accessibility, consistency and timeliness of reporting of nationally agreed standard data items to address current inadequacies of data collection and provision.

15. Use Program data to:

– inform policy development;

– monitor and evaluate Program performance;

– review Program performance indicators;

– enable strategic research; and

– enhance opportunities for learning across the Program, including through sharing accreditation performance data.

Qualityimprovement

16. Strengthen the accreditation system, within a broader quality improvement framework, by modifying the role, membership and operation of the National Quality Management Committee. Consideration should be given to:

– separating the standard-setting responsibilities from the accreditation assessment processes;

– providing an independent chair;

– including more members who are independent of Program delivery; and

– ensuring greater transparency.


17. Refine the national accreditation process to reduce its overall burden on services and site visitors.

18. Refine both the number and structure of the national accreditation standards to focus on standards that align more closely with the objectives of the Program, and establish ongoing mechanisms for review of the standards.

Exploringalternativeservicemodels

19. Explore the potential benefits and feasibility of co-location or greater integration of screening and diagnostic services through pilot or demonstration studies. Possible areas for exploration are:

– diagnostic assessment of women with symptoms of breast cancer;

– individualised surveillance of women at potentially higher risk of breast cancer due to family history;

– individualised surveillance post-treatment of women with a recent (<5 years) invasive breast cancer or ductal carcinoma in situ; and

– individualised risk assessment of women of any age to assess their risk for breast cancer and recommend appropriate screening or surveillance to manage that risk, either within the Program or through referral to appropriate services.

2.2 SUMMARYOFEVALUATIONMETHODOLOGY

The Australian Health Ministers’ Advisory Council (AHMAC) agreed to an Evaluation of the BreastScreen Australia Program (the Evaluation) in October 2005. The Evaluation addresses the following objectives endorsed by AHMAC in June 2006:

• assess the outcomes delivered by the BreastScreen Australia Program (the Program);

• assess the extent to which the Program has achieved its aims and objectives;

• assess the appropriateness, efficiency and effectiveness of the Program;

• assess and address the ongoing and unresolved issues impacting on the Program; and

• identify opportunities to improve the Program overall.

To achieve these objectives, the Evaluation focused on three outcomes:

• health outcomes: the benefits and risks of the Program;

• process outcomes: the efficiency of implementation of the Program; and

• economic outcomes: the cost-utility, cost-benefit and cost-effectiveness of the Program.

AHMAC established an expert Evaluation Advisory Committee (EAC), comprising Australian and international experts and jurisdictional and consumer representatives, to direct and advise on the Evaluation. The EAC developed an Evaluation plan, which was endorsed by AHMAC in March 2007.

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Ten projects analysing different aspects of the Program were commissioned to assess Program outcomes. EAC members acted as sponsors to projects, providing expert advice to consultants and reviewing project findings. The Evaluation was also informed by consultation and communication with stakeholders. This report draws together and synthesises findings from the projects and stakeholder communication, and provides recommendations for consideration by AHMAC. Details of each of the projects are provided in Appendix 16.2.

2.3 SUMMARYOFEVALUATIONFINDINGSANDCONCLUSIONS

Keyfindings

1. BreastScreen Australia is broadly available, accessible and acceptable to many women.

2. The Program has been successful in reducing mortality from breast cancer at the current participation rate of 56% in the target age group (women aged 50–69 years) by approximately 21–28%.

3. The Program is cost-effective at an approximate cost of $38,000 per life year gained (LYG).3

4. The Program participation target of 70% of women in the target age group has not been met. Program participation for women aged 50–69 years has been steady at around 56% over the last few years. However, the absolute number of women in the target age group screened increased by 41% between 1996–1997 and 2004–2005. Rescreening rates are low, with only 60.5% of women returning to the Program within the recommended 2-year period following their first screen.

5. Evidence indicates that mammographic screening of women aged 50–69 years reduces mortality from breast cancer, and supports the continued biennial screening of women at population risk aged 50–69 years. There is limited new evidence from the literature with which to determine the appropriate policy for women aged 40–49 years and over 70 years of age.

6. Program performance data and results of the Mortality Ecological Study indicate that the greatest mortality benefit is achieved within the target age range of 50–69 years and that the greatest potential improvement in mortality benefit would be achieved with increased participation of women aged 50–69 years.

7. Participation in the Program reduces treatment-related morbidity. Breast cancers detected through BreastScreen Australia are significantly more likely to be smaller than those diagnosed outside the Program, and a higher proportion of breast cancers detected by BreastScreen Australia are treated by breast conserving surgery.4

3 Life years and costs were discounted using an annual rate of 5%, consistent with practice in Australia4 This finding derives from data obtained from the Victorian Cancer Registry 2005–2006. Data from the Royal Australasian College of

Surgeons (RACS) (NBOCC 2009) are also supportive of this finding.


8. For women aged 40–44 years, there is limited evidence of benefit for mammographic screening in relation to mortality reduction. There is also evidence of harms associated with screening in this age group, with a higher rate of invasive investigation without cancer present compared to women aged 45 years and over.

9. For women aged 45–49 years and women aged 70–74 years, there is some evidence of the benefit in relation to reduction in mortality from breast cancer assoiated with screening.

10. For women aged 75 years and over there is limited evidence of benefit in relation to mortality reduction associated with screening.

11. Where there is clear national policy direction, jurisdictional screening policies are consistent with and align with national policy. Where there is a lack of national policy direction, as in the screening of women at elevated risk of breast cancer, there is wide variation in screening practice at jurisdictional level, leading to inequity for women.

12. Claims have been made previously that mammography reimbursed through the Medicare Benefits Schedule (MBS) impacts on Program participation rate. It does not appear, however, that large numbers of women in the target age group are accessing non-diagnostic mammography outside the Program.

13. There are currently significant capacity issues in the Program, as evidenced by an increase in delays in recalling women to assessment, falling rescreening rates and plateauing of the participation rate for the target group, despite reduced attendance rates of eligible age groups.

14. Modelling of Program demand and capacity into the future indicates that, without intervention, demand for the Program, largely as a result of growth in the target cohort, will continue to exceed capacity. Although implementation of digital mammography will improve capacity, its introduction alone will not provide sufficient capacity to address the growing gap between capacity and demand. Radiography workforce issues are the greatest constraint to capacity.

15. Current governance and management arrangements at the national level have some strengths, notably clear and specific goals and objectives for the Program and robust structures for accreditation. However, there are significant areas requiring improvement including better collaborative decision making and strategic planning at a national level, evidence-based policy development and implementation, and timely response to address new and emerging issues.

16. The BreastScreen Australia accreditation system is highly accepted and respected. Some aspects of the accreditation system, however, are a burden for services. Program quality assurance would benefit from a greater focus on continuous quality improvement activities, including improved monitoring, in addition to accreditation.

17. The Program has a wealth of data that are currently underutilised. Despite significant efforts to standardise data collection, inconsistencies remain, limiting usability of data at a national level. There has been limited research regarding the use of Program data to inform policy.

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2.3.1 MORTALITY,MORBIDITYANDPERFORMANCE

The BreastScreen Australia Program has met its key objective of reducing morbidity and mortality from breast cancer among the target group of women aged 50–69 years. The Program is broadly available and well accepted by a majority of women with an average national participation rate of 56%. While positive health outcomes have been delivered for women, significant challenges exist that limit Program effectiveness. These include capacity constraints, which are apparent now and will deteriorate over the coming decade, impacting on participation rates, as well as deficiencies in current governance and management arrangements. The Program must address these challenges to remain successful, and needs to focus resources on screening policies aimed at achieving the best mortality and morbidity outcomes for women.

Biennial screening using mammography through the Program at the current participation rate of 56% is associated with a significant reduction in breast cancer mortality at the population level for women aged 50–69 years in the order of 21–28%. The Program is cost-effective at an approximate cost of $38,000 per life year gained (LYG).

The breast cancer detection rate is consistent with the national accreditation standard (NAS) and has improved significantly since the Program began, indicating improved performance in cancer detection and assessment of screen-detected abnormalities. More than half of the cancers detected by the Program are small (≤15mm), leading to less aggressive treatment and resulting in improved survival rates.

Screening has both benefits and harms, and all population screening programs aim to minimise harms and maximise benefits of participation. For women in the target age group, the Program is performing well in minimising false-positive and false-negative results, and the recall to assessment rate meets national standards. Sensitivity of mammography is significantly higher in women 70 years and over in the Program. For women aged 40–49 years, Program sensitivity is lower and the rate of false negatives is higher compared with that for older women. The rate of invasive investigation to identify cancers is higher for women aged 40–44 years compared with those aged 45–49 years.

2.3.2 PARTICIPATION

BreastScreen Australia is well accepted by women. National participation has increased for women in the target age group from 51.4% in 1996–1997 to 56.2% in 2004–2005. Participation is similar across socio-economic groups and rural, regional and metropolitan areas. However, for women living in very remote areas, Aboriginal and Torres Strait Islander women and women who speak a language other than English at home, participation rates are significantly lower than the national rate, despite improvements over time.

A high participation rate in the target age group is necessary to achieve substantial reductions in breast cancer mortality for Australian women and to ensure efficient use of resources. The Program objective of a 70% participation target for women in the target age group has not been met. Rescreening rates are also low, with only 60.5% of women returning to the Program within the recommended 2-year period following their first screen.


Failure to achieve the participation target is related to a range of factors, including women choosing not to attend or return, lack of awareness of the Program, as well as a decline in Program capacity. Other factors that may discourage participation include poor understanding among some women about the benefits of mammography screening and low awareness of the increasing risk of breast cancer with increasing age. A positive first-time screening experience, where pain, embarrassment and discomfort are well-managed, strongly influences a woman’s decision to return for a subsequent screen. Evidence suggests that mammography funded through the Medicare Benefits Schedule (MBS) has an insignificant impact on participation rates.

While the 70% participation target provides a level for the Program to strive towards, it should not be considered the ultimate or ‘gold’ standard. A higher participation rate for women in the target age range would result in even greater mortality reduction and cost-effectiveness.

2.3.3 CAPACITY

Demand for the BreastScreen Australia Program has increased over time, with 41% more women in the target group screened in the 2004–2005 screening period compared with 1996–1997. However, Program capacity is reaching its limit, with standards for timeliness of assessment, timeliness of screening appointments and rescreening rates not being met. Time to assessment is of particular concern, with 20% of women recalled for assessment not assessed within 28 days of a screen-detected abnormality.

Modelling to 2027 indicates that population growth will result in an ongoing increase in demand for services over the next 20 years. Digital mammography will provide additional capacity but not enough to fill the growing gap. Capacity has been channelled to women in the target age group of 50–69 years through protocols that give preference to this group. The proportion of women in the target age group participating in the Program has increased over time. However, close to one-quarter of Program capacity is taken up by women in the eligible age group (40–49 years and 70 years and over).

Workforce issues are the greatest constraint to capacity and there is wide variation in productivity across the Program. Small incremental improvements in the number of women who can be screened each year per radiographer can yield significant capacity increases, which could be used to minimise capacity gaps.

2.3.4 GOVERNANCEANDMANAGEMENT

Governance and management arrangements to date have supported the BreastScreen Australia Program with clear aims and objectives and an effective accreditation system. However, these arrangements have not provided strong enough leadership and direction. Program leadership must change to ensure the outcomes of this Evaluation inform future development. The focus must be on timely, collaborative decision-making in response to emerging issues, improved strategic planning and more effective use of Program data to inform Program policy.

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The Program accreditation system, while effective, is perceived as onerous and not fully transparent. A review of the accreditation system is required to minimise the burden on services and improve openness of decision making.

The Program has a wealth of data that are currently underutilised. While efforts have been made to standardise data collection, access to data and data analysis have been limited by data inconsistencies, which result in difficulties with national data aggregation. The Program would benefit from the availability of a national data set and a planned data analysis and research program to inform Program policy and future development effectively.

2.3.5 POLICY

There is high-quality evidence that screening women in the target age group of 50–69 years reduces mortality from breast cancer. Meta-analyses of randomised controlled trials (RCTs) undertaken in the 1970s and 1980s found that screening women aged 50–69 years resulted in a reduction in mortality from breast cancer in the order of 25% among those invited to screening and 35% among screening participants.

Limited new evidence is available to inform recommendations for screening younger and older women. Evidence from RCTs is consistent with a 15% reduction in mortality from breast cancer for annual screening of women aged 40–49 years. The risk reduction is less than that for women aged 50–69 years and has not reached statistical significance. Screening performance outcomes are poorer for women aged 40–44 years, meaning that the balance of benefit-to-harm for women in this age group is not as favourable as for women aged 45 years and over. No studies allow assessment of the effectiveness of screening in women 40–44 years compared with those aged 45–49 years. However, the mortality reduction associated with screening increases with age and it could be assumed that women aged 45–49 years would have a mortality benefit closer to that of women aged 50–55 years than women aged 40–44 years. Results from the Mortality Ecological Study undertaken as part of the Evaluation using BreastScreen Australia data support this assumption, although the results should be interpreted with some caution due to the small numbers in the study.

Evidence for the effectiveness of screening is also limited for women aged 70–74 years. Relative risk reduction in mortality from breast cancer has been demonstrated in women aged 65–74 years. Results from the Mortality Ecological Study support evidence of an effect in the order of a 12% reduction in mortality at a population level with a participation rate of 60%. However, the confidence intervals are wide due to small numbers in the study. Program performance data indicate that sensitivity of screening increases with age. A mortality benefit was not demonstrated for women aged 75 and over, although again the results should be interpreted with some caution due to the small numbers in the study.


Improving the participation rate for women in the current target age group of 50–69 years would produce the most improved outcomes in relation to mortality benefit and cost-effectiveness. There may be benefit in extending the target age range to include women aged 45–49 years and 70–74 years. There is some support for this approach from results of RCTs, evaluation of breast cancer screening services in Australia and internationally, and from Program performance data. These same sources provide support for ceasing access to the Program for women aged 40–44 years and women aged 75 years and over.

There is no evidence of benefit or harm from either extending the current screening interval from 2 years to 3 years or reducing the screening interval to 1 year for women aged 50–74 years. These findings support the continued biennial screening of women aged 50–74 years. For women aged 45–49 years, however, the greater likelihood of missing cancers, shorter sojourn time of breast cancer and subsequent higher interval cancer rate suggest that an annual screening interval may be appropriate for this age group, with the caveat that this will also lead to a higher recall rate and higher rate of false-positive results.

Program data indicate that around 17% of Program participants report a family history, past history of breast cancer or present with symptoms of breast cancer. Jurisdictional policy on approaches to screening or excluding these women varies greatly, with the potential for inequitable outcomes and the exclusion of some women from the Program. In some cases, a policy of annual screening has been used for women without discrimination regarding the level of risk. For some of these women, annual screening may not be necessary and this policy can impact on Program capacity. The Program would benefit from implementation of consistent and evidence-based screening policies for women at elevated risk of breast cancer. Strengthened governance and management arrangements would support the implementation of such policies.

While not examined in this Evaluation, there would be value in exploring other policy and service-delivery models for the Program aimed at improving efficiency and quality of services for women. This could include examining possible roles for the Program in risk assessment and management of women at very high risk of breast cancer, diagnostic assessment and greater co-operation or co-location with clinical breast cancer services.

2.3.6 SUMMARY

BreastScreen Australia is, and will continue to be, a cost-effective means of breast cancer control in Australia into the future. Mammography continues to be the most effective tool for breast cancer screening. No other technology has been demonstrated to reduce the breast cancer mortality of women in the population screening setting.

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3. BREAST CANCER IN AUSTRALIA5

3.1 TRENDSINBREASTCANCERINCIDENCE

The lifetime risk of breast cancer to age 75 years for Australian women is 1 in 11. Breast cancer is the most common cancer in women aged 34–75 years. In 2005, there were 12,170 new cases of invasive breast cancer diagnosed in Australia (AIHW and Australasian Association of Cancer Registries (AACR) 2008).

The incidence of breast cancer in the total female population increased from 109.1 new cases per 100,000 women in 1996 to 112.8 per 100,000 in 2004 (AIHW 2008). This increase was not statistically significant. The incidence of breast cancer is higher in older women. The breast cancer incidence rate for women aged 50–69 years increased significantly from 269.0 per 100,000 women in 1996 to 288.8 per 100,000 in 2004 (Figure 3.1).

The incidence of ductal carcinoma in situ (DCIS) across all ages increased from 10.2 new cases per 100,000 in 1996 to 14.4 per 100,000 in 2004. For women aged 50–69 years incidence of DCIS increased from 30.1 new cases per 100,000 women in 1996 to 45.1 per 100,000 in 2004.

Figure3.1 Incidence of breast cancer per 100,000 women, by age group, 1982–2004

0

50

100

150

200

250

300

350

70+

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004

50–69

<50

All ages

Num

ber

of n

ew c

ases

per

100

,000

wom

en

Approximate commencement of theBreastScreen Australia Program

Source: AIHW 2008

5 The AIHW collates national statistics on breast cancer and the performance of BreastScreen Australia in the annual BreastScreen Australia Monitoring Report. Copies of the report are available online at www.aihw.com.au. Chapter 3 presents a selection of data from the BreastScreen Australia Monitoring Report 2004–2005, released in May 2008.

http://www.aihw.com.au


3.2 TRENDSINBREASTCANCERSCREENING

The BreastScreen Australia Program commenced operation in 1991. In the 2-year period 2004–2005, over 1.6 million women were screened by the Program. Of these women, just over 1.2 million (74%) were in the target age group of 50–69 years. The national participation rate of women in the target age group in this period was 56.2%. The participation rate increased from 51.4% in 1996–1997 to 57.1% in 2001–2002 and decreased to 56.2% in 2002–2003, remaining unchanged in 2004–2005.

In 2005, the Program detected 3,680 invasive breast cancers, 2,823 of which were in women in the target age range. In 2005, for women aged 50–69 years:

• the age-standardised invasive breast cancer detection rate 73.8 per 10,000 women screened (first screening round) and 41.2 per 10,000 women screened (subsequent screening rounds);

• the age-standardised small-diameter (≤15mm) invasive cancer detection was 37.8 per 10,000 women screened (first screening round) and 26.7 per 10,000 women screened (subsequent screening rounds).

In 2002–2003, 45.7% of new invasive breast cancer cases diagnosed in women aged 50–69 years were detected through the Program, 17.1% were interval cancers detected in women participating in the Program and 37.1% were cancers detected in women not participating in the Program (Participation and Performance Trends Project).

3.3 TRENDSINBREASTCANCERTREATMENT

There are a range of treatments for breast cancer, including surgery (breast conservation or mastectomy), radiotherapy, chemotherapy and hormonal therapy. Treatment options depend on the type and extent of the cancer. Smaller cancers require less invasive surgery and less aggressive adjuvant treatments. Earlier detection of breast cancer, due in part to the BreastScreen Australia Program, has resulted in the detection of smaller cancers.

In 1995, clinical practice recommendations were produced in Australia, providing evidence-based guidance to clinicians about the treatment of breast cancer. Since this time, there have been significant changes in the management of breast cancer, consistent improvements in survival rates and many changes and improvements to treatment options, as outlined below.

• Surgical treatment

– Sentinel node biopsy, a less invasive approach to sampling axillary lymph nodes than axillary dissection, is now considered best practice in determining axillary spread, resulting in reduced arm morbidity, including reduced likelihood of lymphoedema.

• Adjuvant therapies

– Radiotherapy is now recommended as standard treatment in most cases after breast conserving surgery for DCIS to reduce the risk of subsequent invasive breast cancer and recurrence of DCIS.

– Use of multi-agent chemotherapy has increased significantly, reducing the risk of distant recurrence and improving survival.

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– As more evidence has emerged about the biology of breast cancer, therapies have become more targeted and effective based on individual tumour characteristics. A significant increase has been seen in the use of hormonal therapies, such as tamoxifen and more recently aromatase inhibitors, and biological therapies, such as trastuzumab (Herceptin®), resulting in reduced rates of recurrence and improved disease-free survival in women with specific tumour markers.

• Delivery of care

– Multidisciplinary care, in which individualised treatment plans are developed and implemented by a team of health professionals, including breast care nurses, is now regarded as best practice in the management of women with breast cancer. This approach ensures that all relevant treatment options are considered and that care is coordinated.

Provision of psychosocial care as a standard component alongside clinical care has also increased.

3.4 TRENDSINBREASTCANCERSURVIVAL

Cancer survival is defined as the length of time lived after the initial diagnosis of cancer. Relative survival analysis compares survival of people diagnosed with cancer (observed) with that experienced by the same age- and sex-matched population to which they belong (expected). The ratio of observed-to-expected survival is used to estimate the proportion of people whose risk of dying has been affected by their disease. This method of analysis does not require knowledge of the cause of death (AIHW & National Breast Cancer Centre (NBCC6) 2006).

Survival of women after diagnosis of breast cancer has increased significantly over time. One-year relative survival increased from 93.2% in 1982–1986 to 96.7% in 1998–2002, while 5-year relative survival increased from 70.9% to 86.6% over the same period (AIHW & NBCC 2006).

Five-year relative survival for women diagnosed between 1998–2002 was highest for women aged 40–49, 50–59 and 60–69 years, at around 90%, falling to 85% for women aged 70–79 years, 76% for women aged 80–89 years and 56% for those aged 90–99 years (AIHW & NBCC 2006).

6 In February 2008, National Breast Cancer Centre (NBCC) changed its name to National Breast and Ovarian Cancer Centre (NBOCC)


3.5 TRENDSINBREASTCANCERMORTALITY

In 2005, over 2,700 Australian women died from breast cancer. The death rate from breast cancer for women aged 50–69 years decreased significantly from 61.5 deaths per 100,000 women in 1996 to 51.8 deaths per 100,000 in 2005 (AIHW 2008). The early detection of breast cancer in women through the BreastScreen Australia Program has contributed to this decrease, along with advances in management and treatment. It is worth noting that mortality rates also decreased significantly for women of all ages, from 28.1 deaths per 100,000 in 1996 to 23.7 deaths per 100,000 women in 2005 (AIHW 2008) (Figure 3.2).

Breast cancer is the second most common cause of cancer-related death in women in Australia.

Figure3.2 Breast cancer mortality by age group, 1982–2005

0

20

40

60

80

100

120

140

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004

70+

50–69

<50

All ages

Num

ber

of d

eath

s pe

r 10

0,00

0 w

omen

Approximate commencement of theBreastScreen Australia Program

Source: AIHW 2008

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4. BREASTSCREEN AUSTRALIA BACKGROUND

4.1 BREASTSCREENAUSTRALIA

BreastScreen Australia is Australia’s national population-based breast cancer screening program using mammography. Screening is provided at no cost at 2-yearly intervals for women without symptoms of breast cancer. The target age group is women aged 50–69 years, although women aged 40–49 years and 70 years and over are also eligible to attend.

During the 1970s and 1980s results from a number of RCTs were published, demonstrating that breast cancer screening using mammography could reduce deaths from breast cancer among women aged 50–69 years. At this time, small-scale breast cancer screening services in the private and public sectors were being established across Australia.

In 1987, the National Breast Cancer Screening Evaluation was established as a joint initiative of the Commonwealth, state and territory governments under the auspices of AHMAC to evaluate the feasibility and cost effectiveness of a national screening program in Australia. Specifically the evaluation aimed to assess the possibility of providing a high-quality service that was acceptable and accessible to women, and represented value for money. The evaluation was piloted jointly with the states and territories in 11 sites over a 3-year period from 1987 to 1990. The evaluation report (AHMAC 1990) concluded that sufficient evidence existed to support the development of a national screening program, and in June 1990, AHMAC agreed to jointly fund a national breast cancer screening program with state and territory governments. The Program, known as the National Program for the Early Detection of Breast Cancer, was established in 1991 and became fully operational by 1995. Since 1996, the Program has been known as BreastScreen Australia.

The aims of BreastScreen Australia are to:

• ensure the Program is implemented so that significant reductions can be achieved in morbidity and mortality attributable to breast cancer;

• maximise the early detection of breast cancer in the target population;

• ensure that screening for breast cancer in Australia is provided in dedicated, accredited Screening and Assessment Services (SASs); and

• ensure equitable access to the Program for women aged 50–69 years.

The Program also aims to achieve high standards of Program management, service delivery, monitoring and evaluation and accountability. The aims and objectives of the Program are provided in detail at Appendix 16.3

The target age range for the Program is women aged 50–69 years. Women aged 40–49 years and 70 years and over are also eligible to attend the Program. Different protocols are applied at the jurisdictional level regarding attendance of women outside the target age range.


The number of women participating in the Program has increased over time, from 1.2 million women in 1996–1997 (AIHW 1998) to over 1.6 million in 2004–2005 (AIHW 2008). The proportion of women in the target age group has increased over time, from 858,303 women (68%) in the target age group in 1996–1997 to just over 1.2 million (74%) in 2004–2005.

4.2 GOVERNANCEANDREPORTINGARRANGEMENTS

BreastScreen Australia is funded jointly by the Commonwealth, state and territory governments under the Public Health Outcome Funding Agreements (PHOFAs).7 State and territory governments have responsibility for implementation of the Program within each jurisdiction while the Commonwealth government undertakes overall coordination of policy formulation, national data collection, quality control, monitoring and evaluation.

Overall leadership and direction is provided to the Program through the Screening Subcommittee (SSC), a subcommittee of AHMAC’s Australian Population Health Development Principal Committee (APHDPC). The SSC is a jurisdictional committee comprising Commonwealth, state and territory government representatives, replacing previous governance arrangements in 2006.

Within each state and territory, a state coordination unit (SCU) has responsibility for coordination and oversight of Program implementation within its jurisdiction. While arrangements vary by jurisdiction, state- and territory-level functions include Program management, funding, strategic planning, policy development, quality assurance, accreditation, data management, maintenance of registries, communication strategies (including social marketing), service development, workforce planning and jurisdictional Program performance monitoring and evaluation. Each jurisdiction has a Program governance structure in place to support these functions.

Program performance is monitored through various levels of reporting:

• SASs provide site visit reports and annual data reports as part of accreditation applications;8

• the AIHW and BreastScreen Australia produce annual monitoring reports, using de-identified data provided by the states and territories, reporting on eight agreed performance indicators (Figure 4.1);

• under the PHOFAs, states and territories report against a set of key performance indicators annually;

• annual reports on government services prepared by the Productivity Commission include high-level information on BreastScreen Australia; and

• states and territories provide performance monitoring reports to SASs and produce a jurisdictional statistical report.

Although the Program is monitored regularly, to date there has not been a comprehensive evaluation of health outcomes delivered by the Program.

7 The PHOFAs are due to expire at the end of June 2009; future funding arrangements will be incorporated into the National Healthcare Agreements8 These reports relate to achievements against the national accreditation standards; see Chapter 4 section 4.5

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Figure4.1 Agreed performance indicators for the BreastScreen Australia Program

1. Participation The proportion of the eligible population attending the screening Program within the recommended screening interval.

2. Detectionofinvasivecancers A measure of the rate of women with invasive breast cancers that are 15mm or less in size detected at a BreastScreen Australia service.

3. Sensitivity

3a. Intervalcancerrate – the rate of invasive breast cancers diagnosed after a screening episode that detected no cancer and before the next scheduled screening episode.

3b. Programsensitivity – the percentage of women with screen-detected invasive breast cancer among all Program-screened women diagnosed with invasive breast cancer during the screening interval (screen-detected and interval cancers).

4. DetectionofDCISThe rate of DCIS diagnosed in women attending a BreastScreen Australia service.

5. RecalltoassessmentThe rate of women who are recalled for assessment following attendance for a routine screening at a BreastScreen Australia service.

6. RescreeningThe proportion of all women screened in a given year whose screening outcome was a recommendation to return for screening in 2 years and who returned for a screen within 27 months.

7. Incidence

7a. Incidenceofbreastcancer– a measure of the number of new cases of breast cancer in the community each year.

7b. IncidenceofDCIS – a measure of the number of new cases of DCIS in the community each year.

8. Mortality A measure of the number of deaths caused by breast cancer in the community each year.

Source: AIHW 2008


4.3 PROGRAMDELIVERY

The BreastScreen Australia Program provides breast cancer screening services from the initial mammogram up to the point of histological diagnosis of breast cancer. The screening and assessment pathway is outlined in Figure 4.2. Screening uses two-view mammography, taking cranio-caudal and medio-lateral views of each breast, as these views have been shown to have optimal sensitivity, particularly for small cancers and cancers of low grade.

The state and territory Programs provide breast cancer screening and assessment services through a SAS or network of services. States and territories have established SASs in ways that best meet the needs of the different geographic and demographic characteristics of their populations. Each SAS is based on the same service model with a clearly defined geographical catchment, one or more designated assessment services and a range of satellite, mobile or relocatable screening service sites. In smaller services, SASs may be co-located. Each SAS must be accredited to provide breast cancer screening in the Program.

There are currently 33 accredited BreastScreen Australia services across Australia, operating in over 500 locations nationwide. Services vary in size: some cover vast geographical areas and involve relocatable and mobile screening units; others only cover part of a city. Services may be located wholly in the public sector or contracted to the private sector. Some services are a mix of both public and private arrangements.

The initial mammogram is performed in a screening unit. Every screen is read by two specially trained readers, one of whom must be a radiologist. Non-radiologist readers are medical officers trained in mammography reading. Women with screen-detected abnormalities are recalled to the assessment centre, where the abnormality is assessed by a multidisciplinary team consisting of a radiologist, surgeon, medical officer, nurse/counsellor and radiographer/sonographer. Assessment consists of a range of investigations, which may include a clinical examination, additional mammographic views, ultrasound, fine needle aspiration (FNA) and/or a core biopsy, depending on the clinical abnormality being assessed. Women with a diagnosis of breast cancer are referred outside the Program9 for management and treatment. Where a diagnosis is not ascertained, a small proportion of women will be referred for open biopsy, generally outside the Program.10 Follow-up information on primary treatment is collected for all women screened to enable collation of assessment and treatment outcomes for quality assurance.

Women who have a negative outcome from screening and assessment are re-invited for rescreening 2 years from their date of attendance.

9 Generally referral is to a breast surgeon in the private or public sector10 Only a few services are able to offer open biopsy within the Program

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Figure4.2 BreastScreen Australia screening and assessment pathway

Screening

Assessment

Diagnosis

Treatment

Recruitment of eligible womenie. aged 50–69 years

Mammography screeningFilm reading

Routine rescreenevery 2 years

Definitivetreatment

Breast Cancerdetected

Diagnostic openbiopsy recommended

Diagnostic open biopsy

Ongoing management

Breast cancer detected No breast cancer detected

No breast cancerdetected

Physical examination+/- Further mammography

+/- Ultrasound+/- Fine-needle aspiration biopsy

+/- Core biopsy

Surgery+/- Radiotherapy

+/- Chemotherapy

Recalled to assessment No breast cancer detected

Participation of women outside targetage group, ie. aged 40–49, 70+ years

Note: Activities above the dotted line are generally performed within the Program. Treatment is generally conducted outside the Program. Diagnostic open biopsy may or may not be performed within the Program.Source: Review of BreastScreen Australia Infrastructure and Capacity


4.4 RECRUITMENTSTRATEGIES

A range of strategies are used to encourage women in the target population to join the BreastScreen Australia Program. Direct mail strategies are used for women in the target age group, with women invited to participate through invitation letters usually based on the electoral roll.11 Follow-up letters are sent to women who do not respond to the invitation letters.

Recruitment strategies are supported at the SAS level by a range of community-based strategies and local activities, implemented by health promotion officers, and developed to respond to the characteristics of the women in that particular service catchment. Some services may have a high proportion of women from culturally and linguistically diverse backgrounds, while others will have differing socio-economic profiles or a higher proportion of women of Aboriginal and Torres Strait Islander origin. Strategies are tailored to ensure that women in the target age group and their health care providers are informed about the Program to encourage participation.

There have been a number of national and state and territory social marketing campaigns designed to recruit women in the target age group to join the Program or to remind lapsed participants to return to the Program. These campaigns have typically included mass media communication using television and radio in conjunction with print media advertising, for example the Sara Henderson campaign, which ran from 1995 to 1997.

Women aged 40–49 years and 70 years and over who are eligible to attend the Program are informed about the Program through communication activities, resource materials and public relations strategies. Different protocols exist at the jurisdictional level regarding routine invitation for rescreening of women and allocation of appointments for women outside the target age range.12 In most instances, these women do not receive a routine reminder for their 2-yearly rescreen.

4.5 QUALITYMANAGEMENTANDACCREDITATION

BreastScreen Australia aims to ensure quality is maintained across the screening and assessment pathway. The quality management framework for the Program is underpinned by a national accreditation system based on a set of evidence-based NAS, a risk assessment-based decision tool, electronic forms to support the use of the tool, and site visitor training. The accreditation process aims to ensure that the Program offers a high-quality service to women. This is achieved through periodic independent review, including service-level performance reviews, site visits, data audits and ongoing quality improvement strategies overseen by the state accreditation committees (SACs) and the National Quality Management Committee (NQMC). The NQMC is responsible for accreditation decision making and standard setting. It comprises 15 representatives from stakeholder groups both within and outside the Program. Services without accreditation cannot provide breast cancer screening and assessment under the Program.

11 The electoral roll is not used in all jurisdictions; see Chapter 12 for more detail on recruitment strategies used by each jurisdiction 12 See Chapter 12 for further information

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There are currently 173 NAS against which the performance of each service is measured. The NAS are set using Australian data to maintain a high-quality breast cancer screening program at a level that provides safe quality services within the Australian context. The NAS address all aspects of the screening pathway, including recruitment, management, technical quality assurance, education, counselling, screening, multidisciplinary assessment, clinical outcomes, data management and training. The NAS focus primarily on women in the target age group, but the principles of quality apply to all eligible women.

4.6 MAMMOGRAPHYOUTSIDETHEBREASTSCREENAUSTRALIAPROGRAM

The Medicare Benefits Schedule (MBS) provides a rebate for diagnostic mammography where there is a reason to suspect the presence of a malignancy, for example in women with breast symptoms and women with a personal or family history of breast cancer.

The MBS item description is:

MBS Item 59300: MAMMOGRAPHY OF BOTH BREASTS, if there is a reason to suspect the presence of malignancy because of:

(i) the past occurrence of breast malignancy in the patient or members of the patient’s family; or

(ii) symptoms or indications of malignancy found on an examination of the patient by a medical practitioner. Unless otherwise indicated, mammography includes both breasts (DoHA 2007).

The MBS specifically excludes rebates for mammography for screening purposes. However, it is apparent that some mammography services accessed through the MBS are for non- diagnostic purposes. Additional screening mammography may also occur in the private sector on a user-pays basis, for which a MBS rebate cannot be claimed.


5. BACKGROUND AND CONTEXT OF THE EVALUATION

5.1 PURPOSEOFTHEEVALUATION

Although the performance of the BreastScreen Australia Program against agreed indicators is monitored and reported regularly, there has not been a comprehensive evaluation of outcomes delivered by the Program to date. The purpose of the Evaluation was to provide a comprehensive assessment of the outcomes and performance of the Program for consideration by AHMAC.

5.2 SCOPEOFTHEEVALUATION

The Evaluation assessed the appropriateness, efficiency and effectiveness of the BreastScreen Australia Program. It also assessed and addressed ongoing and emerging issues that have an impact on the Program, and identified opportunities for overall improvement.

The Evaluation examined the benefits of the Program in terms of a reduction in breast cancer mortality rates, through a study of the association between mortality and participation, and also the potential harms associated with screening. It considered the appropriate target age range, screening interval, issues impacting on Program capacity, and Program performance to date. The Evaluation included an examination of participation rates and factors affecting participation.

The Evaluation also addressed issues that have emerged as the Program has matured, including:

• low participation rates in some areas, including small decreases in participation, despite overall increases in the number of women participating in the Program;

• workforce shortages;

• availability of new technologies, for example digital mammography;

• sustained community pressure to provide screening for women outside the current target age group;

• jurisdictional variations in Program policies, governance and recall protocols;

• variations in policy response to women with a personal or family history of breast cancer or symptoms of breast cancer;

• capacity for increases in the efficiency of the Program; and

• effectiveness of the Program in reducing mortality.

The Evaluation comprised ten projects analysing different aspects of the Program and was also informed by stakeholder consultation and communication. This report draws together and synthesises the findings from the projects and stakeholder communication. A summary of the projects is provided at Appendix 16.3. Details of stakeholder communication are included in Chapter 5.4.

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5.2.1 POPULATIONSCREENING

BreastScreen Australia is a population screening program, implemented in the context of the World Health Organization (WHO) screening principles. It is within this overarching framework that the performance of the Program is considered.

Screening for a disease involves performing tests on members of a population without symptoms of the disease. Screening is used to identify individuals who may have the disease and who require further investigation to determine the presence or absence of disease. An implicit assumption underlying the concept of screening is that early detection, before the development of symptoms, will lead to a more favourable prognosis, and that if treatment is started before the disease becomes clinically manifest, it will be more effective than treatment provided at a later date.

The aim of screening for breast cancer is to reduce the incidence of advanced disease and the rate of invasive disease in a population. The ultimate value of a cancer screening program is evaluated by its effect on mortality rates.

Screening has the potential to prevent the development of disease, prevent premature death and disability and to improve quality of life through the early detection of disease or its precursors. However, it also has costs and the potential to cause harm, for example through false-positive and false-negative results. Screening programs should be based on good quality evidence that the benefits are greater than the potential harms and that the program can be provided at reasonable cost. As screening has the potential to cause harm to individuals, screening programs should be delivered within the context of an effective quality assurance program.

Population screening is a complex process spanning a pathway that includes invitation and recruitment, information and education for consumers and health professionals, disease detection, recall, and follow-up diagnosis and management. In addition, monitoring and evaluation is required in the longer term to determine outcomes.

Decisions about screening require a consistent framework of principles that can be applied to any screening strategy. Australia adopted a Population-Based Screening Framework developed by the SSC of the APHDPC in 2008 to provide guidance for assessment of whether a potential screening program for a disease or condition should be introduced (AHMAC 2008). The framework has been adapted from the WHO principles developed by Wilson and Junger (1968) and takes into account:

• the need for a strong evidence base in making decisions about the introduction of a screening program, including evidence of the safety, reproducibility and accuracy of the screening test and the efficacy of treatment; and

• the requirement that a screening program offers more benefit than harm to the target population.

http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/pop-based-screening-fwork/$File/screening-framework.pdf


The decision to introduce a screening program needs also to consider whether outcomes obtained in the research setting can be reproduced in population screening settings.

The Australian Population-Based Screening Framework principles of early disease detection are outlined below.

• The condition should:

– be an important health problem;

– have a recognisable latent or early symptomatic stage.

• The test should:

– be highly sensitive;

– be highly specific;

– be validated;

– be safe;

– have a relatively high positive predictive value; and

– be acceptable to the target population including important sub-groups.

• Systems should be in place for evidence-based follow-up assessment of all people with a positive screening test regardless of place of residence, cultural beliefs, ethnicity, and socio-economic status.

• Treatment should be effective, available, easily accessible and acceptable to all people with the recognised disease or condition.

5.3 TERMSOFREFERENCEFORTHEEVALUATION

The Evaluation addressed the following objectives endorsed by AHMAC in June 2006:

1. assess the outcomes delivered by the BreastScreen Australia Program;

2. assess the extent to which the Program has achieved its aims and objectives;

3. assess the appropriateness, efficiency and effectiveness of the Program;

4. assess and address the ongoing and unresolved issues impacting on the Program; and

5. identify opportunities to improve the Program overall.

To achieve these objectives, and in particular, Evaluation objective 1, the Evaluation focused on three outcomes:

• health outcomes: the benefits and risks of the Program;

• process outcomes: the efficiency of the implementation of the Program; and

• economic outcomes: the cost-utility, cost-benefit and cost-effectiveness of the Program.

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5.3.1 EVALUATIONQUESTIONS

A series of key Evaluation questions were developed to assess Program outcomes and ongoing unresolved policy issues, and Evaluation projects were designed to address these questions.

1. What are benefits and harms in participating in the Program?

2. What impact has the Program had on breast cancer mortality?

3. To what extent is the Program an appropriate response to the incidence and prevalence of breast cancer?

4. What impact has the Program had on breast cancer morbidity?

5. What are the trends of participation in the Program?

6. To what extent is the Program available and accessible to all eligible women, in particular, to sub-populations of women where the participation is lower than the national average?

7. To what extent is the Program acceptable to women and other stakeholders?

8. What are the barriers to improving participation? What are the strategies to address these barriers?

9. What impact have BreastScreen Australia communication activities had on participation rates?

10. Do the current BreastScreen Australia communication mechanisms help women to make an informed choice about screening and rescreening?

11. What are the factors contributing to women choosing mammography outside the Program?

12. What are the trends in MBS-funded mammography over time and how do they relate to BreastScreen Australia participation rates?

13. What are the trends in MBS-funded breast cancer diagnostic procedures since the beginning of the BreastScreen Australia Program in 1991?

14. To what extent are women using MBS-funded mammography when they could be accessing BreastScreen Australia services?

15. What is the impact, on the Program, of mammography outside the Program?

16. How appropriate are the reporting mechanisms and key performance indicators for the Program?

17. How is the Program performing and what are the trends relating to performance indicators?

18. To what extent are women screened and rescreened in accordance with the Program’s recommended screening interval? (note also Q21)

19. What aspects of governance and management contribute to better outcomes?

20. Are the current Program management and governance arrangements delivering the best possible outcomes?

21. Are quality assurance mechanisms ensuring a high standard of quality within BreastScreen Australia?


22. How effective is the Program in responding to new evidence and research?

23. What are the impacts of infrastructure and workforce issues on Program capacity?

24. To what extent are women screened and rescreened in accordance with the Program’s recommended screening interval? To what extent is this related to capacity?

25. What is the impact on the Program of incorporating new technologies, in particular, digital mammography?

26. What is the net cost per woman screened?

27. What is the net cost per life year saved through the Program?

28. What are the factors influencing any variation in costs?

29. What is the cost per quality adjusted life year?

30. What are the marginal costs of the Program over marginal benefits?

31. Is the current Program policy on target age range and screening interval appropriate?

32. What is the best practice evidence for the management of women identified as being at higher risk?

33. What is the best practice evidence for the management of women with symptoms who present for screening?

34. What is the impact of inconsistent application of policy across jurisdictions?

35. Do the Program objectives continue to be appropriate?

A map of the Evaluation questions linked to Evaluation projects is provided at Appendix 16.4. Questions were answered in full or in part by one or more of the Evaluation projects.

5.4 STAKEHOLDERINPUTTOTHEEVALUATION

There is considerable community interest in issues relating to the BreastScreen Australia Program, in particular, the target age range, screening interval, and the benefits and potential harms associated with mammographic screening. At the inaugural meeting of the EAC, members discussed the need to engage with and seek the views of a range of stakeholders as part of the Evaluation and to ensure that effective communication strategies were in place to keep stakeholders informed about the Evaluation and its progress.

5.4.1 STAKEHOLDERCOMMUNICATIONSTRATEGIES

The EAC put in place a range of mechanisms to ensure that stakeholders were informed about the Evaluation and had an opportunity to provide input. Key strategies included:

• information letters sent to 29 peak medical and cancer organisations;

• regular posting of progress reports about the Evaluation on the Department of Health and Ageing website;

30

• regular progress reports about the Evaluation provided to:

– AHMAC

– APHDPC

– SSC

– BreastScreen Australia state and territory Program manager quarterly meetings; and

• EAC workshops with representatives from breast cancer organisations and BreastScreen Australia state and territory Program managers.

5.4.2 STAKEHOLDERCONSULTATION13

A variety of processes were employed to consult with a range of Program stakeholders.

IndividualEvaluationprojectconsultations

Numerous meetings and consultations with a broad range of stakeholders were conducted by individual project consultants during the course of each Evaluation project. Details of stakeholders consulted and the results of these consultations can be found in each of the individual Evaluation project reports. High-level results from these consultations have been included in the relevant chapters of the Evaluation final report.

Workshopwithbreastcancerandotherstakeholderorganisations

In March 2007, the EAC conducted a workshop with representatives from various breast cancer organisations and other relevant stakeholder groups. The objectives of the workshop were to provide stakeholders with an opportunity to receive information about the Evaluation and to raise and discuss with the EAC any issues for consideration in the Evaluation.

• Delegates from the following organisations participated in the workshop:

• Breast Cancer Network of Australia (BCNA);

• Cancer Council Australia;

• DES (diethylstilboestrol) Action Australia;

• National Breast and Ovarian Cancer Centre (NBOCC); and

• National Breast Cancer Foundation (NBCF).

13 See Chapter 13 for the results of stakeholder consultations


WorkshopwithandstateandterritoryBreastScreenAustraliaProgrammanagers

State and territory governments are responsible for implementation of the BreastScreen Australia Program at a jurisdictional level. Program managers are responsible for management of all Program functions at the jurisdictional level and ensure that service delivery is client-focused, efficient and of the highest standard. The role includes financial performance, statutory compliance of service delivery and management of human resources.

In March 2007, the EAC held a workshop with state and territory Program managers. The workshop provided an opportunity for Program managers to receive an update about the progress of the Evaluation and to seek information regarding specific aspects of the Evaluation projects. Importantly, the workshop was also an opportunity for Program managers to advise and discuss with the EAC relevant information about operational aspects of the Program and to highlight issues requiring consideration in the Evaluation.

Consumers

Several consumer organisations were represented in the stakeholder workshop outlined above. In addition, various consultations and focus groups were held with consumers by the individual project consultants in the course of conducting individual Evaluation projects.

Specific details of consumers consulted and the results of these consultations can be found in each of the individual Evaluation project reports. High-level results of these consultations are included in individual chapters of the Evaluation final report, and in particular Chapter 7.

SitevisitstoBreastScreenAustraliaservices

EAC members spent 2 days visiting BreastScreen Australia services in South Australia and Victoria. The site visits were to services with digital and analogue equipment located in both metropolitan and regional areas, including a mobile unit.

Visits to Melbourne and Bendigo provided an insight into operational differences in digital services in metropolitan and regional environments. EAC members also visited the SCU and an assessment centre in Adelaide and a mobile unit in Tanunda. During these visits, BreastScreen Australia staff demonstrated and explained the service delivery pathway. These visits provided EAC members with a valuable opportunity to develop a greater understanding of the day-to-day operation of the Program and to meet with and gain perspectives from Program staff first-hand.

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Keyfindings

1. BreastScreen Australia has achieved the Program aim of a significant reduction in mortality and morbidity attributed to breast cancer.

2. For the target age group of women aged 50–69 years, biennial screening through the Program at the current participation rate of 56% is associated with a significant reduction in breast cancer mortality of 21–28% (depending on the regression model used).

3. Analysis of the mortality reduction associated with participation in the Program indicates that increasing the participation rate will maximise the mortality reduction from breast cancer as a result of screening.

4. For women aged 45–49 years and 70–74 years, biennial screening through the Program is associated with a reduction in mortality. However, these results are not statistically significant, which may be due to the smaller numbers of women in these age groups participating in the Program.

5. Program performance data indicate that cancer detection rates meet the NAS and have improved significantly over time. More than half the cancers detected through the Program are small (≤15mm), which supports the role of the Program in detecting breast cancer early, when treatment and survival outcomes are better. During the period 2001–2005, 55.6% of all invasive cancers in the first screening round were small cancers; in subsequent screening rounds, 65.0% of all invasive cancers were small cancers.

6. National data from the Royal Australasian College of Surgeons (RACS) National Breast Audit suggest that participation in the Program reduces treatment-related morbidity. A higher proportion of breast cancers detected by the Program are treated by breast conserving surgery (74.8%) compared with cancers detected outside the Program (57.8%). Data from BreastScreen Victoria indicate that invasive cancers detected through the Program are more likely to be small cancers compared with invasive cancers detected outside the Program. The pre-operative diagnosis rate has improved significantly over time, from 64.2% in 1996 to 94.3% in 2005 (based on data from Victoria, Queensland, Western Australia and the Australian Capital Territory only). This means that more women are now likely to have a one-stage surgical procedure.

7. Potential harms associated with participation in a screening program include false-positive and false-negative results. The Program is performing well in relation to minimising false-negative results. In 2000–2003, Program sensitivity for the first screening round for women aged 50–69 years at 0–12 months following a negative screen was 90.5%.

6. HEALTH OUTCOMES


8. Other potential sources of harm include anxiety associated with screening, technical repeat status and recall to assessment. The recall to assessment rate meets the NAS. However, the Program is not meeting the NAS in relation to timeliness of assessing women who have a screen-detected abnormality, with 20.6% of women not assessed within 28 days of a screen-detected abnormality. Nor does the rate of technical repeat performed meet current standards, with 3.6% of women aged 50–69 years recalled.

9. Potential harms of screening identified as concerns by women include the impact of radiation from mammograms and trauma to the breast caused by the mammography process. However, evidence suggests that the level of harm due to radiation from screening in the eligible and target age groups is very low.

ThischapterexaminesEvaluationobjective1:AssessmentofhealthoutcomesachievedbyBreastScreenAustralia.

Evaluationquestion1: What are the benefits and harms associated with participating in the Program?

Health outcomes are evaluated by analysing the benefits and potential harms associated with participating in a program. The Evaluation considered the benefits of the Breast Screen Australia Program in relation to reduced mortality and morbidity through early detection of breast cancer. Potential harms were assessed in relation to morbidity caused to women as a result of participating in breast cancer screening. The Program aims to minimise morbidity caused to participants through a series of performance outcomes that minimise potential harms while maximising the number of cancers detected, particularly the number of small cancers (BreastScreen Australia 2005a). The Evaluation therefore examined both increased and decreased morbidity as a result of participation in the Program.

Findings are presented from a range of sources, including the Mortality Ecological Study, the Participation and Performance Trends Project and the Participation Qualitative Study. Information on variation in benefits and potential harms associated with screening by age group is included in Chapters 8 and 12.

34

6.1 BENEFITSASSOCIATEDWITHPARTICIPATINGINBREASTSCREENAUSTRALIA

The key benefit of participation in the BreastScreen Australia Program is reduced mortality from breast cancer. Other benefits include reduced morbidity due to the increased proportion of breast cancers treated by breast conserving surgery as opposed to mastectomy (as a result of early detection of breast cancer) and a high pre-operative diagnosis rate. Women also gain reassurance from true negative screens.

6.1.1 MORTALITYREDUCTION

BreastScreenAustraliaaim1: To ensure that the Program is implemented in such a way that significant reductions can be achieved in morbidity and mortality attributed to breast cancer.

Evaluationquestion2: What impact has the Program had on breast cancer mortality?

The effectiveness of a screening program is primarily assessed through its impact on mortality. The Evaluation measured the impact of screening on mortality through the Mortality Ecological Study.

BackgroundontheMortalityEcologicalStudy

The methodology for the Mortality Ecological Study was informed by a feasibility study conducted by the NBCC in 2006 on behalf of the Australian Government. The feasibility study reviewed, assessed and ranked design options for evaluating the effect of the BreastScreen Australia Program on breast cancer mortality. A small area ecological study design was selected by the EAC from the range of study design options proposed, on the basis that this would allow evaluation of Program outcomes at a population level rather than individual client level effects. Other factors favouring this approach included:

• relative ease of implementation;

• proof of concept, with similar studies implemented successfully in Australia and internationally;

• availability of data required for the study; and

• potential to complete the study within the relatively short timeframe of the Evaluation.

The feasibility study suggested that a case control study would be complementary to an ecological study and would provide additional robust information to inform recommendations on the future of the Program. Due to the complexity of implementing a case control study it was considered that such a study could not be completed within the agreed Evaluation timeframe.


The Mortality Ecological Study was a study, over time, of population groups, not individuals. Such studies are termed ‘ecological’ or ‘aggregate’. The aim of the Mortality Ecological Study was to determine the association, by small area of residence (local government area (LGA), statistical local area (SLA) or a combination of both), of Program participation with subsequent breast cancer mortality in women aged 40–79 years, and particularly in the target age group of 50–69 years.

The unit of analysis was the population of women resident in small areas in Australia: LGAs, SLAs or combinations of these. The study factor was biennial Program participation in these populations, and the outcome factor for investigation was subsequent breast cancer mortality in the same populations. Both factors were measured as counts of women in relation to the population. Thus, this was an aggregate cohort study using annual cohorts. In order to relate breast cancer mortality to screening coverage at time of diagnosis, deaths among women who had been diagnosed before the specified screening year were excluded from each annual cohort. This is described as ‘refined’ or ‘selective’ mortality analysis.

Factors considered as having the potential to affect the analysis included age group, use of MBS-funded mammography, region of residence, and area socio-economic indicators (all related to the area population). This information was obtained from Medicare Australia, AIHW (which sourced data from the Australian Bureau of Statistics (ABS)) and state and territory cancer registries, which added age, year and residential locality at time of diagnosis to the mortality data.

Regression models were constructed for 1990–2004 to relate biennial Program participation to subsequent breast cancer mortality. Two approaches were used:

• Poisson regression of cumulative mortality at 6 years following screening (since this was the lag with the strongest statistical association) using nine cohorts from screening years 1990–99 (with 6 years follow-up for each); and

• proportional hazard regression: a time-to-event analysis of deaths during the period 1990–2004, adjusted for follow-up time from diagnosis.

Biennial Program participation, subsequent breast cancer mortality, and MBS mammography were all stratified by 5-year age groups across 40–79 years for each small area in the various analyses. Unadjusted 95% confidence intervals (CIs) and corresponding intervals adjusted for repeated measures were provided for associations of Program participation with breast cancer mortality. These measures were calculated both for age-adjusted base models and for more complete models that were also adjusted for possible confounding factors, including MBS bilateral mammography coverage, region of residence, and socio-economic status.

36

Studylimitations

The Poisson regression analysis is the more conventional approach used to evaluate breast cancer screening and may be less vulnerable to lead time and related biases than proportional hazards regression. Lead time and related biases are likely to be small in this type of population-based mortality study. Deaths potentially would be expected to arise disproportionately from symptomatic cases, interval cancers, and high-grade and otherwise rapidly progressive screen-detected lesions.

A disadvantage of the Poisson regression approach is the exclusion of later screening years, from 2000 onwards, because of the need for 6 years of mortality follow-up. By comparison, all years could be included in the proportional hazards regression, since the analysis adjusts for duration of follow-up. Therefore, the collective results from both analytic approaches are considered to provide better evidence of the impact of participation in the Program on breast cancer mortality than results of either approach alone.

A positive aspect of the Mortality Ecological Study was that it was Australia-wide and addressed the Program effect at a population level, rather than at an individual person level. As with all observational studies (i.e. non-experimental epidemiological studies), the outcomes should not be interpreted as representing exact science.

Significant limitations were experienced in the data management phase of this study, particularly in the reconciliation of differences in geo-coding of small areas between the various jurisdictional data sets and over time. While effort was made to minimise these problems through data mapping and cleaning, it is inevitable that residual inconsistencies would have remained in addition to data loss for different aspects of the analysis. The influences of data loss on statistical associations of Program participation with breast cancer mortality may have been non-differential, but could still have affected estimates.

Other limitations of the Study were due to the variable quality and consistency for research purposes of data from multiple sources, collected over a long period primarily for other purposes. Unusable data had to be discarded, leading to appreciable data loss and potential for bias. Up to one-third of Program data was lost in the analysis due to data inconsistencies, mainly as a result of different conventions of SLA/LGA coding and changes in that coding across various agencies, including the ABS, AIHW, state and territory BreastScreen Australia Programs and jurisdictional cancer registries. In addition, data on many potential confounders that may have an influence on both breast cancer mortality and participation in BreastScreen Australia, such as treatment type or reproductive factors, were not available in these existing data sets.


Some of these data limitations may have inflated the measured Program effect. For example, the lack of a measure for treatment advances occurring independently of BreastScreen Australia may have inflated effect estimates to some extent, although for this to occur, these treatment advances would have had to co-vary with participation rates. Factors that may have had a reverse effect include residual confounding from ethnicity, with Australian data showing lower breast cancer mortality in women born in non-English speaking countries, and BreastScreen Australia data showing women who are generally non-English speaking at home have a lower Program participation rate.

It is not clear whether the net effect of these and other data limitations would have been an inflation or deflation of BreastScreen Australia effect estimates. Nonetheless, the similarity of results from this study with other similar studies based on data from New South Wales (NSW) and South Australia is notable and is considered to be highly indicative of a BreastScreen Australia effect and to give an indication of the scale of this effect.

Poissonregressionanalysis

Estimates from the Poisson regression analysis for the 50–69 year age range (Figure 6.1), adjusting for age group, MBS bilateral mammograms, region and socio-economic indices, indicate a statistically significant mortality reduction of 22% (95% CI: –31% to –12%) at a biennial Program participation rate of 60%. The equivalent mortality reduction based on the current 56% Program participation rate is also significant at 21% (95% CI: –29% to –11%), with significant mortality reductions of 25% (95% CI: –35% to –14%) for the 70% Program participation target, and 34% (95% CI: –45% to –19%) for 100% participation.

Since the small geographic areas used in this study had a wide range of participation rates, extending close to 100%, extrapolations were not required in the production of these mortality effect estimates. Similar statistically significant findings were obtained for each 5-year age group within the 50–69 year age range, with the largest effect evident for the 60–64 year age group. Reductions in mortality associated with Program participation were also evident for the 45–49 and 70–74 year age groups, but these did not reach statistical significance.

38

Figure6.1 Cumulative mortality (at 6 years) from breast cancer incidence in relation to BreastScreen Australia biennial mammography, 1990–2004; Poisson regression model including age group, biennial screening, MBS mammography, region and socio-economic index, ages 50–69 years

0 10 20 30 40 50 60 70 80 90 100

-80%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Biennial screening participation (%)

Mor

talit

y ch

ange

(%)

Point estimate

95% CIs unadjusted

Approx. 95% CIs adjusted for repeated measures analysis

Notes: Relative risk (RR) expressed as mortality change %, adjusted. Upper 95% confidence limits (UCL); lower 95% confidence limits (LCL)

Source: Mortality Ecological Study


Proportionalhazardsregressionanalysis

Estimates from the proportional hazards regression analysis for the 50–69 year age range (Figure 6.2), adjusting for age group, MBS bilateral mammograms, region and socio-economic indices, indicate a statistically significant mortality reduction of 30% (95% CI: –41% to –17%) at a biennial Program participation rate of 60%. The equivalent mortality reduction based on the current participation rate of 56% is 28% (95% CI: –38% to –17%), with a mortality reduction of 34% (95% CI: –46% to –20%) for the 70% Program participation target, and 45% (95% CI: –58% to –27%) for 100% participation.

Similar statistically significant findings were obtained for each 5-year age group within the 50–69 year age range, with the largest effect seen for the 60–64 year age group. Reductions in mortality associated with Program participation were also evident for the 45–49 and 70–74 year age groups, but these were not statistically significant.

Figure6.2 Mortality from breast cancer (adjusted for follow-up time from diagnosis) in relation to BreastScreen Australia biennial mammography, 1990–2004; proportional hazards regression model including age group, biennial screening, MBS mammography, region and socio-economic index, ages 50–69 years

-80%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Mor

talit

y ch

ange

(%)

0 10 20 30 40 50 60 70 80 90 100

Biennial screening participation (%)

Point estimate

95% CIs unadjusted

Approx. 95% CIs adjusted for repeated measures analysis

Notes: Relative risk (RR) expressed as mortality change %, adjusted. Upper 95% confidence limits (UCL); lower 95% confidence limits (LCL)Source: Mortality Ecological Study

40

Resultsbyage(Tables6.1and6.2)

Mortality reduction results for the 50–69 year age group were statistically significant, both for the Poisson and proportional hazards regression models, and for base models (age-adjusted only) and fully adjusted models (also adjusted for MBS-funded mammography, region of residence and socio-economic status). The estimates for mortality reduction from the fully adjusted model at 100% participation ranged from 34% (Poisson) to 45% (proportional hazards regression). Similar effect estimates applied for 5-year age groups within the 50–69 year target age range.

Mortality reduction results were not statistically significant for either analytical approaches for the 40–49 or 70–79 year age ranges. Interpretation is complicated by the smaller numbers of observations in these age groups. The potential for screening participation bias to have influenced results may also have been greater in these age groups than for 50–69 year age group, which was subject to active recruitment.

The strongest effect estimate outside the 50–69 year group from the fully adjusted models was for the 45–49 year age range, with a 40% (Poisson) to 46% (proportional hazards regression) mortality reduction calculated at 100% participation. Although these point estimates were relatively high, statistical significance was not achieved and the estimates were more vulnerable to random variation with the smaller numbers of strata available for analysis. By comparison, the fully adjusted models indicated a comparatively small effect of participation on mortality for 70–74 year olds, with an estimate of 20% arising from both the Poisson and proportional hazards regression models for 100% participation. Again, these results were not statistically significant.

Results from the fully adjusted models for the 40–44 year age range suggested little effect of Program participation on mortality, even at 100% participation, with a non-significant reduction of 8% seen with the Poisson analysis and a 6% increase seen with the proportional hazards regression model. Similarly, data for the 75–79 year age range pointed to a small non-significant 5% increase (Poisson) and non-significant 9% decrease (proportional hazards regression) for full 100% participation. The effects of small numbers and screening participation biases on these estimates are not known.


Table6.1 Summary of Poisson regression models for women aged 40 years and over by 5-year age groups – cumulative mortality (at 6 years) from breast cancer in relation to BreastScreen Australia biennial mammography, 1990–2004

Agegroup(years)–modelledbiennialscreeningadjustedforMBSmammography

+region+socio-economicstatus

indicatorBeta

estimatea

SEbofbetaunadjusted,

repeatedmeasuresadjusted

p-valueunadjusted

andrepeatedmeasuresadjusted

Mortalitychange(%)and95%CIs,c

unadjustedandadjustedforRMdatvariousscreeningrates

60% 70%

40–44 –0.0008 0.0021

0.0043

0.7024

0.8896

–4.7

(–25.5 to +22.0)

(–42.5 to +58.0)

–5.4

(–29.1 to +26.1)

(–47.6 to +70.6)

45–49 –0.0051 0.0015

0.0029

0.0004

0.0795

–26.4

(–38.3 to –12.2)

(–47.6 to +3.6)

–30.0

(–43.0 to –14.0)

(–53.0 to +4.2)

40–49 –0.0038 0.0012

0.0027

0.0013

0.1567

–20.4

(–30.7 to –8.3)

(–42.0 to +9.3)

–23.4

(–35.0 to –9.6)

(–47.1 to +11.0)

50–54 –0.0040 0.0009

0.0016

<0.0001

0.0108

–21.3

(–29.2 to –12.6)

(–34.8 to –5.1)

–24.4

(–33.2 to –14.5)

(–39.3 to –5.9)

55–59 –0.0041 0.0008

0.0016

<0.0001

0.0131

–21.8

(–28.8 to –14.1)

(–35.2 to –5.6)

–24.9

(–32.8 to –16.2)

(–39.7 to –6.5)

60–64 –0.0046 0.0008

0.0017

<0.0001

0.0078

–24.1

(–30.9 to –16.6) (–37.9

to –7.3)

–27.5

(–35.1 to –19.1)

(–42.6 to –8.5)

65–69 –0.0039 0.0008

0.0015

<0.0001

0.0111

–20.9

(–28.0 to –13.1)

(–33.7 to –5.6)

–23.9

(–31.8 to –15.1)

(–38.0 to –6.5)

50–69 –0.0041 0.0004

0.001

<0.0001

<0.0001

–21.8

(–25.4 to –18.0)

(–30.5 to –12.1)

–24.9

(–29.0 to –20.7)

(–34.6 to –13.9)

70–74 –0.0022 0.0011

0.0019

0.0466

0.2399

–12.4

(–23.0 to –0.3)

(–29.9 to +9.6)

–14.3

(–26.3 to –0.3)

(–33.9 to +11.3)

75–79 0.0005 0.0021

0.0036

0.0081

0.8625

+3.0

(–19.5 to +31.9)

(–32.5 to +57.4)

+3.6

(–22.4 to +38.1)

(–36.8 to +69.7)

70–79 –0.0016 0.0010

0.0018

0.1053

0.3731

–9.2

(–19.2 to +2.2)

(–26.5 to +12.3)

–10.6

(–22.1 to +2.6)

(–30.2 to +14.4)

Notesa change in log (mortality rate ratio) per 1% increase in participationb standard errorc confidence intervald repeated measuresSource: Mortality Ecological Study

42

Table6.2 Summary of proportional hazard regression estimates for women aged 40 years and over, by 5-year age groups – mortality from breast cancer (adjusted for follow–up time from diagnosis) in relation to BreastScreen Australia biennial mammography, 1990–2004

Agegroup(years)–modelledbiennialscreeningadjusted

forMedicaremammography

+region+socio-economicstatus

indicatorBeta

estimatea

SEbofbetaunadjusted,

repeatedmeasuresadjusted

p-valueunadjusted

andrepeatedmeasuresadjusted

Mortalitychange(%)and95%CIs,cunadjustedandadjustedforRMdatvarious

screeningrates

60% 70%

40–44 0.00062 0.00296

0.00696

0.83430

0.92916

+3.8

(–26.7 to +47.0)

(–49.1 to +112)

+4.4

(–30.4 to +56.7)

(–54.5 to +140)

45–49 –0.00607 0.00201

0.00512

0.00253

0.23547

–30.5

(–45.2 to –12.0)

(–56.0 to +9.7)

–34.6

(–50.4 to –13.9)

(–61.6 to +11.4)

40–49 –0.00384 0.00167

0.00464

0.02148

0.40779

–20.6

(–34.7 to –3.3)

(–48.9 to +23.6)

–23.6

(–39.2 to –3.9)

(–54.4 to +28.0)

50–54 –0.00523 0.00118

0.00295

0.00001

0.07625

–26.9

(–36.4 to –16.1)

(–42.9 to –6.5)

–30.7

(–41.0 to –18.5)

(–48.0 to –7.5)

55–59 –0.00564 0.00113

0.00283

0.00000

0.04588

–28.7

(–37.6 to –18.6)

(–45.3 to –7.0)

–32.6

(–42.3 to –21.3)

(–50.6 to –8.1)

60–64 –0.00776 0.00115

0.00288

0.00000

0.00695

–37.2

(–45.2 to –28.1)

(–52.9 to –16.3)

–41.9

(–50.4 to –32.0)

(–58.5 to –18.8)

65–69 –0.00522 0.00112

0.00261

0.00000

0.04578

–26.9

(–35.9 to –16.6)

(–42.9 to –6.4)

–30.6

(–40.5 to –19.1)

(–48.0 to –7.4)

50–69 –0.00596 0.00057

0.00129

0.00000

0.00000

–30.1

(–34.6 to –25.2)

(–40.9 to –17.2)

–34.1

(–39.1 to –28.7)

(–45.9 to –19.8)

70–74 –0.00227 0.00136

0.00291

0.09509

0.43603

–12.7

(–25.6 to +2.4)

(–33.8 to +15.0)

–14.7

(–29.2 to +2.8)

(–38.2 to +17.8)

75–79 –0.00093 0.00235

0.00485

0.69192

0.84765

–5.4

(–28.3 to +24.7)

(–41.1 to +51.9)

–6.3

(–32.1 to +29.3)

(–46.1 to +62.8)

70–79 –0.00197 0.00118

0.00236

0.09502

0.40386

–11.1

(–22.7 to +2.1)

(–30.8 to +14.7)

–12.9

(–25.9 to +2.4)

(–34.9 to +16.6)

Notesa change in log (mortality rate ratio) per 1% increase in participationb standard errorc confidence intervald repeated measuresSource: Mortality Ecological Study


ImpactofBreastScreenAustraliaonbreastcancermortality

The results of the Mortality Ecological Study indicate that, for the target age group of 50–69 years, participation in biennial screening through BreastScreen Australia is associated with an approximate 21–28% reduction in breast cancer mortality at the current national participation rate of 56%, or a 22–30% reduction at a national participation rate of 60% (derived from models using 1990–2004 data adjusted for various factors). The predicted breast cancer mortality reduction for the target participation rate of 70% is 25–34%, and the effect at 100% participation is a mortality reduction of approximately 34–45%.

The proportional hazard regression method produced larger effect estimates than the Poisson regression of cumulated breast cancer mortality at 6 years post-diagnosis. Age-specific analyses within the 50–69 year age group gave effects that were similar in direction and magnitude, with similar results seen for the 45–49 year age group and smaller reductions seen for the 70–74 year age group, irrespective of the regression model used. Results outside the 50–69 year age span were not statistically significant and more vulnerable to random variation due to smaller numbers of women participating.

Women aged 45–49 years and 70–74 years are not targeted or invited but self-select to attend the Program. Women who self-select to attend may be at a higher risk for breast cancer, for example, due to a family history of breast cancer, which may result in an underestimate of the mortality reduction from Program participation.

The preferred approach for interpreting study results was to consider results of the Poisson and proportional hazards regression models collectively and in the context of results from the earlier trials of mammography screening and other Australian service evaluations, especially BreastScreen Australia service evaluations in NSW (Taylor et al. 2004) and South Australia (Roder et al. 2008). Broadly consistent findings were presented from all sources, despite differences in study design and analytical methods. All results were broadly consistent with the conclusion drawn by the International Agency on Research in Cancer (IARC) expert panel, based on trial evidence, that breast cancer screening mammography reduces breast cancer mortality by approximately 35% among screened women aged 50–69 years (IARC 2002).

44

6.1.2 CANCERDETECTIONRATES

BreastScreenAustraliaaim2:To maximise the early detection of breast cancer in the target population.

Evaluationquestion3:To what extent is the Program an appropriate response to the incidence and prevalence of breast cancer?

The BreastScreen Australia Program aims to maximise the number of invasive breast cancers detected. These data are reported as the number of women with all-size invasive cancers per 10,000 women screened, as well as the number of women with small (≤15mm) invasive cancers per 10,000 women screened who are a subset of women with all-size invasive cancers (AIHW 2008). Interval cancer rates are also presented in this section.14

Cancer detection rates have increased over time (Figure 6.3). In 2001–2005, the all-size cancer detection rate per 10,000 women screened in the target age range of 50–69 years (first screening round) was 62.9 (95% CI: 60.4–65.5). This was a significant increase from the detection rate of 56.3 (95% CI: 54.3–58.3) seen for the 1996–2000 period. The all-size cancer detection rate also increased significantly over time for subsequent screening rounds.

Most of the cancers detected through the Program are small size cancers (≤15mm) (Figure 6.4). In 2001–2005, in the first screening round, 55.6% of all invasive cancers detected (small and all-size) were small size cancers. In subsequent screening rounds in the same period, 65.0% of invasive cancers detected were small size cancers. The proportion of cancers detected in the first screening round that were small did not change significantly between 1996–2000 and 2001–2005.

In 2001–2005, the small cancer (£15mm) detection rate per 10,000 women screened in the target age range of 50–69 years (first screening round) was 35.0 (95% CI: 33.1–36.9). This was a significant increase from the rate of 32.6 (95% CI: 31.1–34.1) seen in the 1996–2000 period. The proportion of invasive cancers detected that were small cancers (≤15mm) was higher in subsequent screening rounds than in the first screening rounds for the 2001–2005 period.

All cancer detection rates met the NAS (Figure 6.3).

14 See Chapter 8 for additional information on cancer detection rates and interval cancer rates


Figure6.3 All-size and small size cancer detection rate per 10,000 women screened, first and subsequent screening rounds, for women aged 50–69 years, compared with the national accreditation standard (NAS), 1996–2000 and 2001–2005

0

10

20

30

40

50

60

70

NAS2001–20051996–2000

SubsequentFirstSubsequent

All Size CancersScreening round

Canc

er d

etec

tion

rat

e

Small Cancers

First

a. National Accreditation Standard 2.1.1: ≥ 50 per 10,000 women aged 50–69 years who attend for their first screen are diagnosed with invasive breast cancer.

b. National Accreditation Standard 2.1.2: ≥ 35 per 10,000 women aged 50–69 years who attend for their second or subsequent screen are diagnosed with invasive breast cancer.

c. National Accreditation Standard 2.2.1: ≥ 25 per 10,000 women aged 50–69 years who attend for screening are diagnosed with small (≥15mm) invasive breast cancer (applies to both first and subsequent screening rounds).

Source: Prepared using data from the Participation and Performance Trends Project

46

Figure6.4 Small (≤15 mm) invasive breast cancers as a proportion of all-size invasive breast cancers, women aged 50–69 years, all screening rounds, 1996–2005

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Year

Num

ber

of c

ance

rs

0

500

1,000

1,500

2,000

2,500

3,000

>15mm

< or = 15mm

Source: Participation and Performance Trends Project

Interval cancer rates also conformed to the NAS. In 2000–2003, an estimated 6.9 (95% CI: 5.7–7.7) per 10,000 women aged 50–69 years screened for the first time were diagnosed with an invasive interval breast cancer 0–12 months following a negative screening episode. The interval cancer rate for 0–12 months for subsequent screening rounds was 7.4 (95% CI: 7.0–7.8) per 10,000 women. These rates met the NAS of <7.5 interval cancers at 0–12 months following a negative screen per 10,000 women screened.


6.1.3 PRE-OPERATIVEDIAGNOSISRATE

Evaluationquestion4:What impact has the Program had on breast cancer morbidity?

The pre-operative diagnosis rate is the proportion of women diagnosed with invasive cancer who received a definitive diagnosis of cancer before surgery. A definitive diagnosis of cancer means that women can actively participate in decisions about their treatment and usually are required to only undergo a one-stage surgical procedure for treatment of the invasive cancer. This reduces the morbidity associated with additional surgery and the potential anxiety from a longer wait time for a conclusive cancer diagnosis.

The pre-operative diagnosis rate in the BreastScreen Australia Program increased from 64.2% of women diagnosed with invasive cancer in 1996 to 94.3% in 2005 (Figure 6.5). This result is based on data from Victoria, Queensland, Western Australia and the Australian Capital Territory (ACT) only.15 The increase is likely to be due to improvements in diagnostic techniques used at assessment, in particular the increased use of core biopsy instead of FNA, with core biopsy more likely to give a definitive result.16

The rate of invasive procedures, such as FNA and core biopsy, when disease is not present could be considered a potential harm of screening.17 However, use of core biopsy to give a definitive result is associated with reduced morbidity and is therefore considered a benefit for women participating in the Program.

15 These data, reported in the Participation and Performance Trends Report, were not originally requested from jurisdictions. When requested, the data were readily available from some jurisdictions and only these data were reported.

16 See also Chapter 8, section 8.2.3 for more data on invasive assessment procedures17 See Chapter 6, section 6.2 for potential harms of screening

48

Figure6.5 Relationship between pre-operative diagnosis rate, fine needle aspiration (FNA) rate and core biopsy rate in Victoria, Queensland, Western Australia and Australian Capital Territory for women 40 years and over, 1996–2005

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Per 1,000 women Per cent

Year

0

2

4

6

8

10

12

0

20

40

60

80

100

Preoperative diagnosis

Core biopsy

Fine needle biopsy

Notes:a. FNA rate is the number of FNA biopsies performed per 1,000 women screened; core biopsy rate is the number of core biopsies

performed per 1,000 women screened (left axis)b. Pre-operative diagnosis rate is the number of women diagnosed with an invasive cancer who had a recommendation at assessment

of definitive treatment for cancer as a proportion of the total number of women diagnosed with invasive cancer who had a recommendation at assessment of definitive treatment for cancer or open biopsy (right axis)

c. Data presented include all women aged 40 years and over and all screening roundsd. Data are from Victoria, Queensland, Western Australia and the Australian Capital Territory onlySource: Participation and Performance Trends Project


6.1.4 LESSINVASIVESURGERY

Evaluationquestion4:What impact has the Program had on breast cancer morbidity?

Participation in the BreastScreen Australia Program is associated with an increase in the proportion of breast cancers treated by breast conserving surgery compared with mastectomy.

A study on the management of early breast cancer in Victoria before and after the introduction of the Australian clinical practice guidelines (White et al. 2004a) found that by 1999, only a short time after the Program had commenced, early breast cancers detected through BreastScreen Victoria were more likely to be treated using breast conserving surgery than breast cancers18 detected outside the Program (Table 6.3).

Table6.3 Proportion of patients with breast conserving surgery by cancer diagnosis source

Diagnosissource

Breastconservingsurgery,

%ofpatients Effect

ofyear

p-value

1995

multivariate

results

1999

multivariate

results

1995 1999 odds

ratio

95%CI odds

ratio

95%CI

Breast cancer

detected through

BreastScreen

Australia

61 78 <0.01 1 – 1 –

Breast cancer

detected outside

BreastScreen

Australia

52 63 <0.01 0.92 0.62–1.37 0.68 0.46–

1.01

Source: White et al. 2004a

Although the results show an increase in the proportion of patients having breast conserving surgery for cancers detected both within and outside the Program for the period 1995–1999, the increase is greater for cancers detected within the Program.

Data from RACS confirm that a higher proportion of breast cancers detected through BreastScreen Australia are treated with breast conserving surgery as opposed to mastectomy when compared with breast cancers detected outside the Program. Data from the RACS audit of 2,474 female patients treated by specialist breast surgeons in Australia in 2006 indicate that 74.8% of women referred from BreastScreen Australia had breast conserving surgery, whereas the corresponding percentage having breast conserving surgery after symptomatic referral was 57.8% (NBOCC & RACS 2009).

18 Early breast cancer is defined in this study as cases of early invasive breast carcinoma (UICC pathologic Stage 0, I, or II tumours) diagnosed between 1 April and 30 September in 1995 and 1999 and registered with the Victorian Cancer Registry

50

Similar data drawn from the Victorian Cancer Registry indicate that women aged 50–69 years screened in the BreastScreen Victoria Program were more likely to undergo breast conserving surgery as opposed to mastectomy when compared to women diagnosed with breast cancer in Victoria outside the Program (Table 6.4). Overall, 82% of women in BreastScreen Australia underwent breast conserving surgery for cancers of all sizes compared with 68% of women who were diagnosed outside the Program. This difference was statistically significant after adjusting for tumour size (p<0.001). As cancer size increased, breast conserving surgery was still higher for women diagnosed in the Program (Table 6.4). It should be noted that these results only apply to Victoria. However it is likely that the same or similar treatment patterns would exist in other parts of Australia.

Table6.4 Proportion of women aged 50–69 years undergoing breast conserving surgery as opposed to mastectomy for breast cancer detected by BreastScreen Victoria and outside the Program as reported to the Victorian Cancer Registry, 2005–2006

BreastcancercasesdetectedbyBreastScreenVictoria

Size Breast

conserving

surgery

% Mastectomy % Totalª

≤10 mm 384 86% 61 14% 445

11–19 mm 411 88% 58 12% 469

≥ 20mm 202 67% 101 33% 303

Total 997 82% 222 18% 1217

BreastcancercasesdetectedoutsideBreastScreenVictoria

Size Breast

conserving

surgery

% Mastectomy % Totala

≤10 mm 198 76% 62 24% 260

11–19 mm 382 82% 85 18% 467

≥ 20mm 397 56% 311 44% 708

Total 977 68% 458 32% 1418

Notes: a. Missing data: n=29, 2% (BreastScreen Victoria) n=39, 3% (other)Source: Data are breast cancer cases reported to the Victorian Cancer Registry, 2005 and 2006; data request submitted for the BreastScreen Australia Evaluation (2009)

Additional data from the Victorian Cancer Registry indicate that during the 2004–2006 period, more small cancers (≤15mm) were detected through BreastScreen Victoria than outside the Program. These results were significantly different for all 5-year age groups between 45 and 79 years (Table 6.5).


Table6.5 Size of invasive breast cancers notified by BreastScreen Victoria and other notifiers in Victoria, by age group, 2004–2006

Breastcancersize

≤15mm >15mm

Agegroup

(years)

Placeof

diagnosis

Total n % n % pvalue

(≤15mmvs>15mm)

40–44BSV 22 12 57 9 43

Other 657 228 38 373 62 p=0.08

45–49BSV 99 58 60 39 40

Other 931 340 39 524 60 p<0.001

50–69BSV 1881 1164 64 655 36

Other 2523 892 39 1372 60 p<0.001

70–74BSV 366 254 71 104 29

Other 426 136 37 226 62 p<0.001

75–79BSV 142 102 73 38 27

Other 511 113 27 313 73 p<0.001

Notes: missing data n=75 (3%) (BreastScreen Victoria) n=519 (10%) (other)BSV: BreastScreen VictoriaSource: Data are breast cancer cases reported to the Victorian Cancer Registry, 2005–2006. Data request submitted for the BreastScreen Australia Evaluation (2009)

For women aged 45–79 years there was less likelihood of nodal involvement when cancers were diagnosed in BreastScreen Victoria. This would result in less invasive forms of treatment (Table 6.6).

Table6.6 Nodal involvement of invasive breast cancers notified by BreastScreen Victoria and other notifiers in Victoria, by age group, 2004–2006

Nodalinvolvement

Agegroup

(years)

Placeof

diagnosis

Total n % pvalue

40–44BSV 22 10 45%

Other 657 287 44% p=0.9

45–49BSV 99 30 30%

Other 931 411 44% p=0.008

50–69BSV 1881 491 26%

Other 2523 989 39% p<0.001

70–74BSV 366 64 17%

Other 426 130 31% p<0.001

75–79BSV 142 27 19%

Other 511 151 30% p=0.01

Source: Data are breast cancer cases reported to the Victorian Cancer Registry, 2005 and 2006. Data request submitted for the BreastScreen Australia Evaluation (2009)

Although the data on nodal involvement were only available from BreastScreen Victoria, it is likely that similar results would be expected for other BreastScreen Australia services.

52

6.1.5 REASSURANCE

Women participating in screening gain reassurance from true negative results. Qualitative research undertaken as part of the Participation Qualitative Study conducted for the Evaluation found that women who participate regularly in breast cancer screening identify the benefits as early detection of breast cancer, improved chance of survival and the reassurance of an ‘all clear’ result.

6.2 POTENTIALHARMSASSOCIATEDWITHPARTICIPATINGINTHEBREASTSCREENAUSTRALIAPROGRAM

Although population screening results in a net health benefit to women participating in terms of reduced mortality and morbidity, screening also has the potential to result in harm for some individuals. Potential harms associated with participating in BreastScreen Australia include false-positive results, false-negative results, invasive investigations where cancer is not present and anxiety associated with all of these. Other potential sources of harm include anxiety associated with recall to assessment and technical repeat status. In addition, there is the potential for treatment of a disease that may not cause death in a woman’s lifetime. The Evaluation sought to examine the potential harms of participating in the Program. Data presented in this chapter are from the Participation and Performance Trends Project and other relevant sources, as cited.

To maximise the impact on breast cancer mortality and reduce the risk of any potential harms, the Program aims to minimise the number of recalls and the number of invasive procedures used to diagnose cancer, while at the same time maximising detection where cancer is present. To achieve this outcome, the Program needs strong standards to guide Program performance and effective quality control mechanisms to ensure a high standard of practice and ongoing quality improvement.19

6.2.1 FALSE-POSITIVEANDFALSE-NEGATIVESCREENINGRESULTS20

Mammography, like other screening tests, is not 100% accurate in determining whether a woman does or does not have cancer. Screening test results can be categorised as follows:

• true positive – when the screen correctly indicates that a woman has breast cancer;

• false positive – when a woman with a positive screening result does not have cancer;

• true negative – when a negative screen correctly indicates that a woman does not have cancer; and

• false negative – when a woman who has cancer has a negative screening result.

False-positive results can result in unnecessary procedures involving additional invasive investigations. They are also reported to cause distress and anxiety that can affect subsequent health behaviour.

False-negative results can delay a cancer diagnosis, allowing the cancer to progress to a more advanced stage before being detected. Women with a false-negative result on screening mammography may be falsely reassured and consequently may delay investigation of symptoms.

19 Program performance and quality assurance are examined in Chapters 8 and 9 of this report20 See also Chapter 8, section 8.2.3


To minimise harms associated with screening, the BreastScreen Australia Program aims to:

• maximise sensitivity (by minimising the number of women receiving false-positive results); and

• maximise specificity (by minimising the number of women who have false-negative results).

Program performance data indicate that Program sensitivity is high and that false-negative results are indeed minimised. The Program sensitivity rate for women aged 50–69 years in the 2000–2003 period was 90.5% (95% CI: 86.3–94.7) at 0–12 months after the first screening round.21

6.2.2 DIAGNOSISANDTREATMENTOFNON-PROGRESSIVEDISEASE

Breast cancer screening aims to diagnose cancer early to improve treatment outcomes. Early diagnosis through screening can result in diagnosis of progressive cancers, which untreated would cause death, and cancers that would not cause death (either because the woman died prematurely of another cause or because the cancer progressed so slowly that it would not have been diagnosed in the woman’s lifetime). Diagnosis of the latter group is referred to as ‘over-diagnosis’ and the subsequent treatment of such cancers is sometimes referred to as ‘over-treatment’. Screening cannot currently distinguish between progressive and non-progressive cancers, nor can premature deaths in screened women be predicted.

Estimates of ‘over-diagnosis’ of breast cancer from screening vary widely, depending on assumptions made in the estimation process. Evidence reviewed by the NBCC (2008) indicated a midpoint estimate of about 7–8% for combined DCIS and invasive cancer, with a plausible range of 5–13%.

The literature review undertaken in the Participation Qualitative Study found that participation in breast cancer screening can lead to unnecessary anxiety and treatment as a result of identifying cancer that may never have progressed. Although a few women in the Participation Qualitative Study were concerned that screening could lead to unnecessary anxiety, the majority of women viewed anxiety caused by recall as a necessary part of the process. Women did not appear to be aware of the potential for treatment of breast cancer that may not have progressed.

6.2.3 TECHNICALREPEATSTATUS22

Technical repeat status indicates whether or not additional film(s) were taken due to the technically unsatisfactory nature of a woman’s films as the screening visit. Technical repeats are associated with greater screening costs and higher levels of discomfort and radiation exposure experienced by women, but are performed to minimise morbidity associated with missed cancers. In the 2000–2005 period, the rate of technical repeat performed was 3.6% (95% CI: 3.6–3.6) for women aged 50–69 years.23

21 See also Chapter 8, section 8.1.322 See Chapter 8, section 8.2.1 for further discussion on technical repeat status23 Technical repeat status is calculated as the number of women who had a technical repeat performed at an initial or subsequent screening visit

as a proportion of all women screened. It does not include those women where a technical repeat was required, but refused by the woman.

54

The rate of technical repeat performed has, however, decreased over time for all age groups and for most jurisdictions. Victoria and Tasmania have very low rates (0.3% and 0.4%, respectively for women 40 years and over in 2001–2005). While the number of technical repeats performed is high for Aboriginal and Torres Strait Islander women aged 40 years and over when compared with the overall population, the rate has decreased over time, from 5.1% (95% CI: 4.8–5.4) in 1996–2000 to 4.5% (95% CI: 4.3–4.8) in 2001–2005. However, this is not a significant decrease.

6.2.4 RECALLTOASSESSMENT

The recall to assessment indicator measures the rate of women who are recalled for assessment following attendance for a routine screen at a BreastScreen Australia service. In most cases, the recall is made because the mammogram result indicates a suspicion of breast cancer. Assessment may include any or all tests, including additional mammography, physical examination, ultrasound and biopsy.24 Recall to assessment is considered a potential harm as it is likely to cause increased anxiety in women who are recalled.

While the Program recall to assessment rate met the NAS (Table 6.7), the rate has increased significantly over time, from 6.9% of women in 1996–2000 to 9.2% in 2001–2005 for the first screening round and from 3.8% in 1996–2000 to 4.0% in 2001–2005 for subsequent rounds.

Table6.7 Recall to assessment rate for mammographic reasons for women aged 50–69 years, 2001–2005

Nationalaccreditation

standard

Programrate

Firstscreeninground <10% of women aged 50–69

years are recalled for assessment

9.2 (95% CI: 9.1–9.3)

Subsequentscreeningrounds <5% of women aged 50–69 years

are recalled for assessment

4.0 (95% CI: 4.0–4.0)

Notes: Recall to assessment rate is the number of women recalled for assessment as a percentage of women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

6.2.5 TIMELINESS25

NAS 3.8.2 states that all women are to be notified of results of their screen in writing within 28 calendar days of the date of screening. The proportion of women screened who received their result within 28 days decreased significantly between 1996–2000 and 2001–2005 for all age groups. Overall, the proportion decreased from 98.5% of women screened in 1996–2000 to 95.3% of women screened in 2001–2005. Jurisdictional performance against this NAS is variable. All jurisdictions, with the exception of NSW, ACT and the Northern Territory (where performance was poorer), notified results to over 95% of women within 28 days of screening.

24 See Chapter 4, section 4.3 for more information on assessment25 See Chapters 8 and 10 for further information on timeliness


NAS 3.7.2 states that ≥90% of women requiring assessment are to attend an assessment visit within 28 calendar days of their screening visit. This standard has not been met nationally, and the proportion of women being assessed within the recommended 28 days has decreased over time (Figure 6.6). Between the 1996–2000 and 2001–2005 periods, the proportion of women aged 40 years and over attending an assessment visit within 28 calendar days of their screening visit decreased from 85.7% (95% CI: 85.5–85.9) to 79.2% (95% CI: 79.0–79.4).

All jurisdictions have experienced increasing difficulties in meeting the recall to assessment standard of 28 days. However, a marked difference between jurisdictions is apparent, with NSW, ACT and the Northern Territory falling significantly below the NAS (Figure 6.6).

Figure6.6 Proportion of women aged 40 years and over requiring assessment attending within 28 days of screening by state and territory, 1996–2000 and 2001–2005

Per cent

State or Territory

0

10

20

30

40

50

60

70

80

90

100

2001–20051996–2000

AustraliaNTACTTasSAWAQldVicNSW


6.2.6 INVASIVEPROCEDURESWHEREDISEASEISNOTPRESENT

Around 20% of women recalled for assessment will require an invasive procedure26 to confirm or exclude a diagnosis of breast cancer. During the 2001–2005 period, 22.5% of all women attending for assessment had a FNA or core biopsy performed. In 2005, the proportion of women having an invasive assessment procedure (FNA or core biopsy) in a screening round was 0.4% for FNA and 1.2% for core biopsy (Table 6.8).

26 Invasive procedures include FNA and core biopsy. Open biopsies have not been assessed in the Evaluation as these procedures are not performed in the Program in all jurisdictions. Not all open biopsies are performed for diagnostic purposes; some open biopsies are performed for both diagnosis and treatment.

56

The number of invasive procedures needs to be a balance between performing enough procedures to detect cancers present while minimising the use of invasive procedures where cancer is not present. A smaller proportion of women recalled for assessment by BreastScreen Australia in 2005 had FNA compared to a core biopsy. For every cancer detected, 0.8% of women had FNA and 1.9% of women had a core biopsy (Table 6.8).

Table6.8 Number of women aged 50–69 years who were screened, recalled, underwent an invasive diagnostic procedure and had invasive cancer detected in first and subsequent screening rounds, 2005

2005

Women

screened Womenrecalled FNA Corebiopsy

Cancer

detected

Number 631,730 23,948 2,362 5,407 2,823

Proportion per woman screened (%) 3.8 0.4 0.9 0.4

Proportion per women recalled (%) 9.8 22.6 11.8

FNA per cancer detected 0.8

Core biopsy per cancer detected 1.9

Source: Prepared with data from the Participation and Performance Trends Project

FNA and core biopsy are performed to provide a definitive diagnosis of an identified lesion as either malignant or benign. Procedures undertaken where a diagnosis is not provided (e.g. if the specimen is inadequate or equivocal) could be considered a potential harm associated with participation in the Program if these women progress to open biopsy for a definitive histological diagnosis. The proportion of FNAs and core biopsies that provided a definitive diagnosis was 72.6% and 90.3%, respectively in 2005 (Figure 6.7).

Figure6.7 Fine needle aspiration (FNA) and core biopsy results for women 40 years and over, 2005

0

10

20

30

40

50

60

70

80

90

100

Malignant

Suspicious

Atypical/equivocal

Benign

Inadequate

Core biopsyFine needle biopsy

Notesa. The number of FNA and core biopsy results recorded in each category as a proportion of the total number of fine needle and core

biopsy results for women screened in 2005b. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project


6.2.7 RADIATIONEXPOSURE

One of the concerns expressed by women in the Participation Qualitative Study was the potential impact of radiation from mammograms and trauma to the breast caused by the mammography process as a result of participating in the Program.

While exposure to ionising radiation is a known risk factor for development of breast cancer, the risk is greater in women aged 35 years and under. An analysis of cancers detected and predicted to be induced as a result of screening in the United Kingdom (UK) screening program concluded that for women aged 40 years and above, the benefit-to-harm ratio was favourable with annual screening, but that caution is required for women younger than 35 years (Law et al. 2001). Calculation of the ratio of cancers detected by mammography to cancers theoretically induced by radiation for different age groups has led to the conclusion that the benefit of screening mammography continues to exceed radiation risk for women over the age of 40 years (Policy Analysis Project).

6.2.8 WOMEN’SVIEWSONHARMSASSOCIATEDWITHPARTICIPATINGINTHEBREASTSCREENAUSTRALIAPROGRAM

The Participation Qualitative Study reported that women appeared to have low awareness of, or levels of concern about, the potential harms of screening. Anxiety caused by recall was not considered to be a potential harm by women but was rather viewed as a necessary part of the screening process. Some of the women who had been recalled for assessment and who had not subsequently been diagnosed with breast cancer saw the recall as evidence of the Program’s thoroughness. The Study noted that there is scope to minimise anxiety caused by recall to assessment by ensuring women are informed about the low rate of diagnosis amongst women recalled. There was little or no awareness among women of the potential morbidity caused by treatment of breast cancer that may not have progressed.

The main concerns raised by women in relation to Program participation were the impact of radiation from mammograms and trauma to the breast caused by the mammography process. Regular screening participants could not identify potential harms from screening other than pain or discomfort. Women who had previously attended screening or had never participated in screening were more likely to mention radiation and breast trauma as potential harms.

The potential for interval cancers to occur between screens was raised as a cause of concern by some women and health professionals. Those aware of this issue felt it is extremely important that women know of the potential for interval cancers.

58

6.3 ANALYSIS

Participation in the BreastScreen Australia Program provides significant benefits to women. The key benefit is reduced breast cancer mortality. Other benefits are reduced morbidity associated with an early diagnosis of breast cancer, improved pre-operative diagnosis and reassurance gained from true negative screens.

Results of the Mortality Ecological Study indicate a statistically significant mortality reduction at the population level as a result of participation in the Program of 22% for the Poisson regression model and 30% for the proportional hazards regression model (based on a participation rate of 60%) or 21% for the Poisson regression model and 28% for the proportional hazards regression model (based on the current BreastScreen Australia participation rate of 56%).

The Poisson regression analysis is the more conventional analytic approach for an evaluation of mammography screening and may be less vulnerable to lead time and related biases than the proportional hazard regression model. A disadvantage of the Poisson regression approach is the exclusion of later screening years (from 2000 onwards) because of the need for 6 years of mortality follow-up. By comparison, all years could be included in the proportional hazards regression model. Thus, collective results from both approaches provide better evidence of the impact of participation in the Program on breast cancer mortality than the results of either approach alone.

Some caution should be exercised in interpreting the study results of the Mortality Ecological Study as it provides information about Program effect at a population level rather than at an individual person level. In addition, as with all observational, non-experimental epidemiological studies, the results should not be interpreted as exact. In particular, a specific limitation for this study was the variable quality and consistency for research purposes of data from multiple sources collected over a long period primarily for other purposes.

The results of both analytic approaches in the Mortality Ecological Study are broadly consistent with results from international trials of mammography screening and evaluations of mammography screening service studies, including Australian research. Collective results from all these studies suggest that the Program has indeed reduced mortality from breast cancer in Australia.

Program performance data indicate that the Program has a high cancer detection rate and that this has improved over time. Most cancers detected through the Program are small size cancers, supporting the value of the Program in detecting breast cancer early when mortality and treatment outcomes are likely to be better. The Program’s high pre-operative diagnosis rate of invasive breast cancer is associated with the increased use of core biopsies, substantially reducing morbidity due to surgery and the waiting time for conclusive results.

Women participating in screening may gain reassurance from true negative results. The Program sensitivity rate and cancer detection rates suggest that such reassurance is largely justified. The Participation Qualitative Study found that women who participate regularly in screening through BreastScreen Australia appear to be aware of the benefits of screening for breast cancer, including early detection of breast cancer and reduced breast cancer morbidity.


Data from BreastScreen Victoria show that early breast cancers were more likely to be treated using breast conserving surgery than those detected outside the Program. This finding is supported by data from RACS and the Victorian Cancer Registry, suggesting that early detection of breast cancer through BreastScreen Australia has reduced breast cancer morbidity.

Potential sources of harm associated with participation in the Program include false-positive and false-negative results and anxiety and treatment as a result of diagnosing disease that may not have progressed. Other sources of harm include anxiety associated with technical repeat status and recall to assessment, and use of invasive investigations where cancer is not present.

Program performance data indicate that false-positive and false-negative results are minimised. Treatment of disease that may not have progressed to either high-grade or invasive disease is difficult to quantity, as cancers that fall into this category cannot be identified definitively. A review of the literature on evidence for ‘over-diagnosis’ conducted by the NBCC in 2007 indicated a midpoint estimate of about 7–8% for combined DCIS and invasive cancer with a plausible range of 5–13% in a well-organised screening program (NBCC 2008).

The rate of technical repeat performed has decreased over time. While recall to assessment rates do not meet the NAS, they have increased with time. This suggests that the Program is becoming more successful in minimising the potential harms of screening given that cancer detection and small cancer detection rates have increased over time.

The percentage of women having invasive assessment procedures in a screening round was 1.2% for core biopsy and 0.4% for FNA in 2005. While invasive procedures without a cancer being diagnosed could be considered a potential harm of the Program, FNA and core biopsy allow the Program to minimise morbidity. The proportion of core biopsies and FNAs that provided a definitive result (benign or malignant) was 90.3% and 72.6%, respectively in 2005. These proportions are reasonably high, indicating that most women who undergo an invasive procedure receive a definitive diagnosis. The high rate of pre-operative diagnosis of invasive cancer reduces morbidity for women.

Some of the performance data used in the Evaluation to assess the potential harm associated with participation in the Program are not routinely monitored or analysed at the national level. There is a need to monitor and report on the potential harms associated with participation in the Program, for example, rates of invasive procedures and timeliness standards, at a national level.

The Participation Qualitative Study found that women were not very aware or concerned about the potential harms of treatment of disease that may not have progressed or anxiety associated with recalls. In fact, some women saw recall as evidence of the thoroughness of the Program. Key concerns identified by women were the impact of radiation from the mammograms and trauma to the breast caused by the mammography process.

In summary, Program data show that the benefits associated with participation in the BreastScreen Australia Program outweigh the potential harms associated with participation. The effectiveness of the Program in detecting breast cancer early and the impact on the breast cancer mortality rate indicate that the Program is achieving its key goals.

60

Keyfindings

1. The BreastScreen Australia Program is broadly available, accessible and acceptable to a large number of Australian women.

2. The national participation rate for women in the target age group (50–69 years) increased from 51.4% in 1996–1997 to 56.2% in 2004–2005. While the Program participation target rate of 70% has not been achieved, the actual number of women aged 50–69 years participating in the Program has increased from 844,626 in1996–1997 to 1,188,720 in 2004–2005.

3. The participation rate for women in the target age has increased since 1996–2005 (55.4%) but has plateaued over the last few years, with a rate of 56.9% in 2000–2001 and 56.2% in both 2-year periods of 2002–2003 and 2004–2005.

4. The proportion of women in the target age group of 50–69 years has increased over time, from 68.1% in 1996–1997 to 73.6% in 2004–2005.

5. The rate of participation of women in the eligible age groups (women aged 40–49 years and 70+ years) peaked at 21.2% in 1998–1999 and has declined since then to 16.2% in 2004–2005. A number of jurisdictions have implemented policies to limit participation outside the target age range.

6. Little variation in participation by socio-economic status is apparent for women in the target age group. A small but statistically significant difference was seen in mean participation rate over the 10-year period 1996–2005 between women in the lowest socio-economic group (54.4%) and those in the highest socio-economic group (54.9%).

7. Participation varies by geographical area. In 1996–2005, mean participation by women in the target age group for was higher in inner regional (58.6%) and outer regional areas (58.6%) compared with the mean national participation rate of 55.4%. By contrast, the rate was lower than the national average for women living in major cities (53.7%) and very remote areas (44.8%).

8. Participation is significantly lower for women from Aboriginal and Torres Strait Islander and culturally and linguistically diverse backgrounds. Over 1996–2005, mean participation by women in the target age group was significantly lower for Aboriginal and Torres Strait Islander women (32.0%), and women who speak a language other than English at home (42.5%) compared with the mean national participation rate of 55.4%. While participation by these population sub-groups has increased over time, there is a need for additional communication strategies targeted to these specific groups.

7. PROGRAM PARTICIPATION, ACCESS AND EQUITY


9. Between 1996 and 2005, an estimated 16.8% of women aged 50–69 years attending BreastScreen Australia were at elevated risk of breast cancer, including women with a family history of breast cancer (12.7%), those with a personal history of invasive breast cancer or DCIS (0.9%) and those with symptoms of breast cancer (3.2%).

10. Qualitative research identified several factors acting as barriers to participation in the Program for some women, with impacts at different levels in the decision to participate in breast cancer screening. Barriers relate to: the process of having a mammogram and the associated pain, embarrassment and discomfort; limited understanding and appreciation of the benefits of screening, including low awareness of age as a risk factor for breast cancer; and factors related to the availability, accessibility and acceptability of the Program.

11. The experiences by women surveyed of the service provided by BreastScreen Australia were variable and it was clear that the experience could leave long-lasting and deep impressions. A positive first-time screening experience appeared to be an important influence on women choosing to return for rescreening.

12. The lack of awareness by women about key aspects of the Program indicates they may not read or retain the information provided in the consent form or general literature provided to them at BreastScreen Australia services.

13. Women generally considered a recall for assessment as evidence of the Program’s thoroughness. While recall to assessment did not appear to limit the acceptability of the Program for the women surveyed, anxiety caused by a recall for some women, who were not subsequently diagnosed with breast cancer acted as a future deterrent to participating in screening.

14. Mammograms are provided outside the Program through the MBS. In 2006, of the total number of women aged 50–69 years who had mammograms funded through the MBS, 36,364 women (28%) were estimated to have had the mammogram for non-diagnostic purposes. If these women had attended screening through BreastScreen Australia, the overall participation rate would have increased by 3.5%. Thus, the Program participation rate is not impacted on significantly by the availability of MBS-funded mammography, as has been suggested previously.

15. Women gave a range of reasons for choosing to have mammography outside the Program, including more timely notification of results, convenience and availability of ultrasound. Women who chose to have mammography outside the Program also tended to have a low awareness of the Program.

16. Awareness of the BreastScreen Australia brand is low amongst women who do not participate in screening and amongst women in some areas (e.g. metropolitan areas).

17. GPs can play a key role in encouraging women to participate in the Program and ways of using this resource should be better explored.

62

ThischapterconsidersEvaluationobjective1:AssessmentofoutcomesdeliveredbyBreastScreenAustralia. Specifically the chapter analyses participation in the Program and the extent to which the Program is available and accessible to eligible women, including sub-populations. The chapter considers the acceptability and appropriateness of the Program to women, the impact of communication strategies, and barriers to participation. The availability of MBS-funded mammography on BreastScreen Australia participation rates is also examined.

Findings are presented from the Participation and Performance Trends Project, the Participation Qualitative Study and the MBS Mammography Analysis Project.

Qualitative research was conducted to allow in-depth exploration of motivations, attitudes, feelings and behaviour. Group discussions were adopted as the primary methodology. Individual in-depth interviews were conducted in some situations, such as the location of respondents, or the need to explore views of people with specific roles, such as with breast physicians. The study dealt with relatively small numbers of subjects and provided findings that are not based on statistics: they are interpretive in nature, and are based on the experience and expertise of the researchers as they analysed the discussions. While broadly representative of the population at large, the outcomes cannot be assigned to a proportion of the population.

The research featured a comprehensive and inclusive sample of women aged 40–80 years. It included women from a mix of socio-economic and cultural backgrounds, including women from Chinese, Lebanese, Iraqi, Vietnamese, Greek and Aboriginal and Torres Strait Islander communities. Research was conducted in all jurisdictions to ensure national representation and covered metropolitan, regional and rural areas. The sample was also split by usage and experiences of BreastScreen Australia services, and included women who had been diagnosed with breast cancer through BreastScreen Australia and subsequently treated; and those who had been diagnosed with cancer in the interval between regular screening events. The sample of health professionals included GPs, breast physicians, nurse counsellors and Aboriginal health workers.


7.1 PROGRAMPARTICIPATION

7.1.1 PARTICIPATIONTRENDS

Evaluationquestion5: What are the trends of participation in the Program?

BreastScreenAustraliaobjective1:To achieve, after 5 years a 70% participation rate in the BreastScreen Australia Program by women in the target group (women aged 50–69 years) and access to the Program for women aged 40–49 years and 70–79 years.

BreastScreenAustraliaobjective8: To achieve patterns of participation in the Program which are representative of the socio-economic, ethnic and cultural profiles of the target population.

The BreastScreen Australia Program targets women aged 50–69 years, although women aged 40–49 years and 70 years and over are also eligible to attend. Women in the target age range are actively recruited to participate in the Program through a range of social marketing strategies and direct invitation letters. Reminder letters for rescreening are sent when women are due for their 2-yearly rescreen. Re-invitation letters are sent to women who do not respond to invitation or rescreen reminder letters.27

The participation rate measures the proportion of the target population attending BreastScreen Australia. A reporting interval of 2 years is used to reflect the recommended screening interval of 2 years for the Program.

BreastScreenAustraliaparticipationtarget

An objective of the BreastScreen Australia Program is to achieve a 70% participation rate for women in the target group (50–69 years). The participation target was set at Program implementation on the basis that a high participation rate among women aged 50–69 years was necessary to maximise the mortality benefits of population-based breast cancer screening in a cost-effective manner. While the 70% target provides a level of participation for the Program to strive towards, it is not considered a maximum target, as a higher participation rate in the target age group would be ideal in terms of mortality reduction and cost-effectiveness.

27 See Chapter 4 for further information on communication and recruitment practices

64

The 70% target was set based on studies which suggested that 30–35% of deaths from breast cancer would be prevented if all eligible women participated in breast cancer screening (AHMAC 1990). The Breast Cancer Screening Evaluation Steering Committee’s report to AHMAC in 1990 estimated that a participation rate of 70% would reduce the number of deaths from breast cancer among Australian women by 16% (Table 7.1).

Table7.1 Estimated annual reduction in deaths from breast cancer among Australian women aged 40–69 years due to a mammographic screening program, by participation rate (estimated in 1990)28

Participationrate% Mortalityreduction(%)

100 23

70 16

55 13

Notes: Using 1988 Australian mortality dataSource: AHMAC 1990

Participationbythetargetagegroup(50–69years)

The age-standardised national participation rate for women in the target age group increased significantly from 51.4% in 1996–1997 to 56.9% in 2000–2001 (Table 7.2). Participation was 56.2% in 2002–2003 and 2004–2005. Despite this increase, overall participation is significantly below the Program target of 70%.

While the participation rate has remained fairly steady since 2002, the actual number of women in the target group attending BreastScreen Australia has increased over the 10-year period 1996–2005 by 40.7% (from 844,626 in 1996–1997 to 1,188,720 in 2004–2005) (Table 7.2 and Figure 7.1). In 2004–2005, of the 1.615 million women attending the Program, 73.6% were in the target age range. Participation differs by region, with several BreastScreen Australia SASs, particularly those in regional and rural areas, achieving higher participation rates than the national rate.

Table7.2 BreastScreen Australia participation by women aged 50–69 years, 1996–2005

Yearsofscreening Number Rate(%) 95%CI

1996–1997 844,626 51.4 51.3–51.6

1998–1999 975,511 55.7 55.5–55.8

2000–2001 1,063,585 56.9 56.8–57.0

2002–2003 1,118,146 56.2 56.1–56.3

2004–2005 1,188,720 56.2 56.1–56.3

Notesa Years of screening periods cover calendar year (1 January to 31 December)b Rates are the number of women screened in the 2-year period as a percentage of the eligible female population calculated as the

average of the ABS Estimated Resident Population and age-standardised to the Australian population at 30 June 2001Source: Participation and Performance Trends Project

28 It should be noted that the estimates reported in the 1990 AHMAC report reproduced in Table 7.4 were based on screening women aged 40–69 years with the same participation rate across the age group and assumed a mortality reduction of 30% for all women aged 40–69 years. This produced a cost-effectiveness ratio of $10,435. A re-analysis of the data using a different model in 1993 and assuming a 33% mortality reduction in women aged 50–69 years and an 8% reduction in women aged 40–49 years obtained a cost-effectiveness ratio of $20,300 (Carter 1993). These cost-effectiveness results indicate the impact of the mortality reduction on the cost-effectiveness analysis. See Chapter 11 for further information on cost effectiveness.


Figure7.1 Number of women attending BreastScreen Australia by age group, 1996–2005

Num

ber

of w

omen

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

75+70–7450–6945–4940–44

2004–20052002–20032000–20011998–19991996–1997


Participation rates varied across jurisdictions for women aged 50–69 years over the 10-year period 1996–2005 (Figure 7.2):

• the mean participation rate ranged from 61.8% (95% CI: 61.4–62.2) for South Australia to 44.3% (95% CI: 43.1–45.5) for the Northern Territory;

• participation in the Northern Territory declined to a low of 41.1% in 2004–2005;

• participation in NSW was significantly lower than the national rate, with a 10-year mean of 52.4% (95% CI: 52.3–52.6); and

• participation increased steadily over the 10-year period in Queensland (42.9% in 1996–1997 to 58.7% in 2004–2005) and Western Australia (52.1% in 1996–1997 to 56.0% in 2004–2005).

Figure7.2 BreastScreen Australia participation by women aged 50–69 years, by state and territory, 1996–2005

1996–1997

Australia

NT

ACT

Tas

SA

WA

Qld

Vic

NSW

70

65

60

55

50

45

40

1998–1999 2000–2001 2002–2003 2004–2005

Part

icip

atio

n Ra

te (%

)

Notesa. Years of screening periods cover calendar year (1 January to 31 December)b. Rates are the number of women screened in the 2-year period as a percentage of the eligible female population calculated as the

average of the ABS Estimated Resident PopulationSource: Prepared using data from the Participation and Performance Trends Project

66

Attendanceofwomenoutsidethetargetage(40–49yearsand70yearsandover)

Women outside the target age group are eligible to attend the Program but are not specifically targeted or invited. Attendance for these women is therefore expected to be lower than for the target group. The age-standardised participation rate for women aged 40–49 years peaked in 1998–1999 at 21.2% before declining to 16.3% in 2004–2005 (Table 7.3 and Figure 7.3). In 2004–2005, of all the women attending BreastScreen Australia, 15.2% were aged 40–49 years.

Table7.3 BreastScreen Australia attendance by women aged 40–49 years, 1996–2005


1996–1997 250,635 18.9 18.8–19.0

1998–1999 290,127 21.2 21.1–21.3

2000–2001 287,904 20.3 20.3–20.4

2002–2003 281,080 19.1 19.1–19.2

2004–2005 245,492 16.3 16.2–16.3



The age-standardised participation rate for women aged 70 years and over peaked in 2000–2001 at 21.6% before declining to 17.1% in 2004–05, which was lower than any year since 1996–1997 (Table 7.4 and Figure 7.3). In 2004–2005, of all the women attending the Program, 11.8% were aged 70 years and over.

Table7.4 BreastScreen Australia attendance by women aged 70 years and over, 1996–2005


1996–1997 145,027 16.1 16.0–16.2

1998–1999 186,215 19.6 19.5–19.7

2000–2001 215,657 21.6 21.5–21.7

2002–2003 218,803 21.2 21.1–21.3

2004–2005 180,659 17.1 17.0–17.1




Figure7.3 BreastScreen Australia mean participation rate (95% CI) by 2-year interval for women aged 40–49, 50–69 and 70 years and over (age-standardised, Australia, 2001), 1996–2005

2004–52002–32000–11998–91996–7

Age: 70+ yrs.

2004–52002–32000–11998–91996–7

Age: 50–69 yrs.

2004–52002–32000–11998–91996–7

Age: 40–69 yrs.18.8 [18.8, 18.9]

21.2 [21.1, 21.2]20.3 [20.3, 20.4]

19.2 [19.1, 19.2]16.2 [16.1, 16.3]

51.4 [51.3, 51.6]55.7 [55.5, 55.8]

56.9 [56.8, 57.0]56.2 [56.1, 56.3]56.2 [56.1, 56.3]

16.3 [16.2, 16.4]20.2 [20.1, 20.3]

22.8 [22.7, 22.9]23.0 [22.9, 23.1]

19.1 [19.1, 19.2]


7.1.2 PARTICIPATIONOFSUB-POPULATIONS

BreastScreenAustraliaobjective8: To achieve patterns of participation in the Program which are representative of the socio-economic, ethnic and cultural profiles of the target population.

BreastScreen Australia participation trend data were examined by geographical region, Aboriginal and Torres Strait Islander status, socio-economic status and participation of women who speak a language other than English at home. In line with the Program objective, the data focused on women in the target age group of 50–69 years.

Participation rates are significantly lower than the national rate for some sub-population groups, particularly women living in very remote areas, Aboriginal and Torres Strait Islander women and women who speak a language other than English at home (Figure 7.4). Participation of women living in metropolitan areas is also lower than the national rate, although on a smaller scale. There is likely to be overlap in these population subgroups: many Aboriginal and Torres Strait Islander women live in remote areas and women who speak a language other than English at home may be more likely to reside in metropolitan areas.

Participation rates also vary significantly by socio-economic status, with lower rates of participation seen for women of higher and lowest socio-economic status compared with the national rate, although these differences are small (Figure 7.4).

68

The Participation Qualitative Study identified barriers relating to Program availability and accessibility for women in sub-populations where participation was lower. The Study also identified perceived barriers for women with disabilities and single women, although participation data are not available for women in these groups.

Lower Program participation and accessibility for certain sub-populations has long been recognised within the Program, with various strategies implemented to promote equitable participation. The need to maximise participation in rural and remote areas was recognised when the Program was established and is reflected by the provision of mobile screening services to extend geographical coverage of services. Other strategies include the provision of BreastScreen Australia communication materials in a number of languages, and development of links with Aboriginal and Torres Strait Islander health workers and Aboriginal and Torres Strait Islander well women’s services to improve Program awareness. There is evidence of improvement in participation for some sub-populations over time.

Figure7.4 BreastScreen Australia mean participation rates (95% CI) by 2-year interval and by population sub-group for women aged 50–69 years, 1996–2005

Indigenous

Non-English speaking

All

Indigenous & CALD

Very remote

Remote

Outer regional

Inner regional

Major city

5 (low)

1 (high)

SES IRSD:

2

3

4

ASGC:

53.7 [53.6, 53.9]

58.6 [58.4, 58.9]

58.6 [58.3, 59.0]

56.2 [55.3, 57.2]

44.8 [43.6, 46.1]

54.9 [54.7, 55.1]

54.5 [54.2, 54.7]

56.7 [56.4, 56.9]

56.5 [56.3, 56.8]

54.4 [54.1, 54.6]

55.4 [55.3, 55.5]

42.5 [42.3, 42.8]

32.0 [31.2, 32.8]

Notesa. The Australian Standard Geographic Classification (AGSC) was used to create regional categoriesb. The measure of socio-economic status (SES) is the 2001 ABS area-based Index of Relative Socio-economic disadvantage (IRSD)c. Culturally and linguistically diverse (CALD)Source: Prepared using data from the Participation and Performance Trends Project


Geographicalregion

The 10-year mean crude participation rate for the 1996–2005 period was significantly higher in inner regional (58.6%, 95% CI: 58.4–58.9), outer regional (58.6%, 95% CI: 58.3–59.0) and remote areas (56.2%, 95% CI: 55.3–57.2) compared with major cities (53.7%, 95% CI: 53.6–53.9) (Figure 7.5). The 10-year mean crude participation rate was lowest in very remote areas (44.8%, 95% CI: 43.6–46.1), although this rate has increased over time from 42.3% (95% CI: 41.0–43.6) in 1996–1997 to 45.8% (95% CI: 44.6–47.0) in 2004–2005 (Figure 7.5).

Figure7.5 Participation rate of women aged 50–69 years, by region, 1996–1997 to 2004–2005

0

10

20

30

40

50

60

70

Very remote

Remote

Outer regional

Inner regional

Major cities

2004–20052002–20032000–20011998–19991996–1997

Participation (per cent)


average of the ABS Estimated Resident Populationc. The Australian Standard Geographic Classification (ASGC) was used to create regional categoriesd. Women were placed in regional categories based on their postcode of residence, using a postcode to region concordanceSource: Participation and Performance Trends Project

70

AboriginalandTorresStraitIslanderwomen

The crude participation rate for Aboriginal and Torres Strait Islander women aged 50–69 years increased from 25.2% (95% CI: 24.5–26.0) in 1996–1997 to 35.3% (95% CI: 34.6–36.1) in 2004–2005 (Table 7.5). Overall, the mean crude 10-year participation rate (1996–2005) was 32.0%, which was significantly lower than the national rate of 55.4% (Figure 7.4).

Table7.5 BreastScreen Australia participation rate, Aboriginal and Torres Strait Islander women aged 50–69 years, 1996–1997 to 2004–2005

1996–1997 1998–1999 2000–2001 2002–2003 2004–2005

Mean

1996–2005

AboriginalandTorresStrait

Islander

Number 4,372 5,613 6,581 7,482 8,271 6,464

Crude rate 25.2 30.2 32.9 34.5 35.3 32.0

95% CI 24.5–26.0 29.5–31.1 32.1–33.7 33.7–35.3 34.6–36.1 31.2–32.8

Australia

Number 844,626 975,511 1,063,585 1,118,146 1,188,720 1,038,118

Crude rate 51.3 55.6 56.9 56.2 56.3 55.4

95% CI 51.2–51.4 55.5–55.7 56.8–57.0 56.1–56.3 56.2–56.4 55.3–55.5


average of the ABS Estimated Resident PopulationSource: Participation and Performance Trends Project

WomenwhospeakalanguageotherthanEnglishathome

The crude participation rate of women who reported speaking a language other than English at home increased significantly from 39.4% (95% CI: 39.2–39.6) in 1996–1997 to 43.2% (95% CI: 43.0–43.5) in 2004–2005 (Table 7.6). The 10-year mean crude participation rate for this group (1996–2005) was 42.5% (95% CI: 42.3–42.8), which was significantly lower than the crude national rate (Figure 7.4).


Table7.6 BreastScreen Australia participation by women aged 50–69 years who reported that they speak a language other than English at home, 1996–1997 to 2004–2005

1996–1997 1998–1999 2000–2001 2002–2003 2004–2005

Mean

1996–2005

Non-Englishspeakingwomen

Number 109,700 125,195 138,504 144,345 153,447 134,238

Crude rate 39.4 42.3 44.1 43.2 43.2 42.5

95% CI 39.2–39.6 42.1–42.6 43.8–44.3 43.0–43.4 43.0–43.5 42.3–42.8

Australia

Number 844,626 975,511 1,063,585 1,118,146 1,188,720 1,038,118

Crude rate 51.3 55.6 56.9 56.2 56.3 55.4

95% CI 51.2–51.4 55.5–55.7 56.8–57.0 56.1–56.3 56.2–56.4 55.3–55.5


average of the ABS Estimated Resident Populationc. Non-English speaking includes all women who self-reported that they speak a language other than English at homeSource: Participation and Performance Trends Project

Socio-economicstatus

Although differences in Program participation rates by socio-economic status over the 10-year period 1996–2005 were minor, a small but statistically significant difference was seen between quintiles, from 54.9% (95% CI: 54.7–55.1) in the first quintile to 54.4 (95% CI: 54.1–54.6) in the fifth quintile (Figure 7.4).

7.1.3 PARTICIPATIONBYWOMENATHIGHERRISKOFBREASTCANCERANDWOMENWITHSYMPTOMSOFBREASTCANCER

Women at higher risk of breast cancer include women with a family history of the disease or a previous history of breast cancer. Participation by women in these groups has been fairly steady over time (Figure 7.6). Combined, these groups of women represent 16.8% of women aged 50–69 years attending the Program. Results presented in this section should be interpreted with caution, as jurisdictional policies for screening higher risk women vary.29

29 See Chapter 12 for further information on jurisdictional policies

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Figure7.6 Proportion of screens where additional risk factors were reported for women aged 50–69 years, 1996–1997 to 2004–2005

Participation (per cent)

0

5

10

15

20

25

30

Symptoms

Previous history

Family history

2004–20052002–20032000–20011998–19991996–1997

Notesa. Year of screening periods cover 2 calendar years (1 January to 31 December)b. Per cent is the number of screens where a family history, previous, or breast symptoms were reported as a proportion of the total

number of screensc. Family history is self-reported and limited to first-degree relatives (mother, sister, or daughter) with a history of breast cancerd. Previous history is a self-reported history of breast cancer or DCISe. Symptoms are self-reported and include lump and nipple discharge (clear or blood-stained)Source: Participation and Performances Trends Project

Womenwithfamilyhistory

Within the BreastScreen Australia Program, family history is self-reported and limited to a first-degree relative (mother, sister or daughter) with a history of breast cancer.

Between 1996–1997 and 2004–2005, the proportion of women screened aged 50–69 years who reported a family history of breast cancer increased from 12.0% (95% CI: 12.0–12.1) to 13.1% (95% CI: 13.0–13.1) (Figure 7.6).

The proportion of women screened who reported a family history of breast cancer was highest in Western Australia and lowest in Victoria (Table 7.7). Results should be interpreted with caution as jurisdictions vary in their policies of obtaining family history from participants (Policy Analysis Project).30

30 See Chapter 12, section 12.5 for further information on jurisdictional policies


During the 10-year period 1996–2005, the proportion of BreastScreen Australia participants reporting a family history of breast cancer was highest for women aged 70 years and over (16.2%; 95% CI: 16.1–16.2), followed by those aged 40–49 years (14.2%; 95% CI: 14.1–14.3) and lowest for those aged 50–69 years (12.7%; 95% CI: 12.7–12.7) (Table 7.8).

Table7.7 Aggregate proportion of women screened aged 50–69 years who reported either a family history of breast cancer, previous history of breast cancer or DCIS or symptoms by state and territory, 1996–2005

Stateandterritory Familyhistory1996–2005

Previoushistory

1996–2005 Symptoms1996–2005

NSW (95% CI) 13.7 (13.6–13.7) 0.8 (0.8–0.8) 4.7 (4.7–4.8)

Vic (95% CI) 10.7 (10.6–10.7) 0.2 (0.2–0.2) 2.0 (2.0–2.1)

Qld (95% CI) 11.8 (11.7–11.8) 2.0 (2.0–2.0) 3.7 (3.6–3.7)

WA (95% CI) 15.4 (15.3–15.5) 1.6 (1.6–1.7) 0.5 (0.5–0.5)

SA (95% CI) 14.6 (14.5–14.7) 0.4 (0.3–0.4) 2.6 (2.5–2.6)

Tas (95% CI) 13.1 (12.9–13.3) 0.6 (0.5–0.6) 2.8 (2.7–2.9)

ACT (95% CI) 14.0 (13.7–14.2) 1.4 (1.4–1.5) 3.6 (3.4–3.7)

NT (95% CI) – – 3.0 (2.8–3.2)

Australia (95% CI) 12.7 (12.7–12.7) 0.9 (0.9–0.9) 3.2 (3.2–3.2)

Notesa. Per cent is the number of screens where a family history of breast cancer or a previous history of breast cancer or DCIS or breast

symptoms was reported as a proportion of the total number of screensb. Family history is self-reported and limited to first-degree relatives (mother, sister, or daughter) with a history of breast cancerc. Previous history is a self-reported history of breast cancer or DCISd. Symptoms are self-reported and include lump, nipple discharge (clear or blood-stained)e. Family history and previous history data were not able to be reported for the Northern TerritorySource: Prepared with data from the Participation and Performance Trends Project

WomenwithprevioushistoryofinvasivebreastcancerorDCIS

The BreastScreen Australia Program screens women at population risk. Women with a prior diagnosis are typically screened outside the Program. Within the Program, previous history of invasive breast cancer or DCIS is self-reported.

Between 1996–1997 and 2004–2005, the proportion of women aged 50–69 years reporting a past history of invasive breast cancer or DCIS increased by a small proportion from 0.8% (95% CI: 0.8–0.8) to 0.9% (95% CI: 0.9–0.9) (Figure 7.6).

During the 2004–2005 period, the proportion of screens where a history of breast cancer or DCIS was reported was highest in Queensland (2.2%) and lowest in Victoria (0.1%) (Table 7.7). Results should be interpreted with caution as jurisdictions vary in their policies of allowing women with a previous history of invasive breast cancer or DCIS to access the Program. Most jurisdictions allow women with a previous history to access the Program at 5 years post-diagnosis, although some will not screen women until 10 years post-diagnosis. Some jurisdictions also take into account the type of surgery (breast conserving surgery or mastectomy) to determine eligibility to access the Program.31


74

In the 10-year period 1996–2005, the proportion of Program participants reporting a previous history of breast cancer or DCIS was highest for women aged 70 years and over (2.5%; 95% CI: 2.5–2.6), followed by women aged 50–69 years (0.9%; 95% CI: 0.9–0.9) and lowest for those aged 40–49 years (0.3%; 95% CI: 0.3–0.3) (Table 7.8).

Table7.8 Aggregate proportion of women screened aged 50–69 years who reported either a family history of breast cancer, previous history of breast cancer or DCIS or symptoms, 1996–2005

Agegroup Familyhistory1996–2005

Previoushistory

1996–2005 Symptoms1996–2005

Ages 40–49 (95% CI) 14.2 (14.1–14.3) 0.3 (0.3–0.3) 6.3 (6.3–6.3)

Ages 50–69 (95% CI) 12.7 (12.7–12.7) 0.9 (0.9–0.9) 3.2 (3.2–3.2)

Ages 70 and over (95% CI) 16.2 (16.1–16.2) 2.5 (2.5–2.6) 2.9 (2.9–2.9)

Notesa. Periods cover 1 January 1996 to 31 December 1997, 1 January 1998 to 31 December 1999, 1 January 2000 to 31 December 2001,

1 January 2002 to 31 December 2003, 1 January 2004 to 31 December 2005b. Per cent is the number of screens where a family history of breast cancer or a previous history of breast cancer or DCIS or breast

symptoms was reported as a proportion of the total number of screensc. Family history is self-reported and limited to first-degree relatives (mother, sister, or daughter) with a history of breast cancerd. Previous history is a self-reported history of breast cancer or DCISe. Symptoms are self-reported and include lump, nipple discharge (clear or blood-stained)f. Family history and previous history data were not able to be reported for the Northern TerritorySource: Participation and Performance Trends Project

Womenwithsymptomsofbreastcancerwhopresentforscreening

The Breast Screen Australia Program provides screening to women without symptoms of breast cancer. Within the Program, symptoms are self-reported and include lump and nipple discharge (clear or blood-stained). Breast pain is excluded from this definition.

Between 1996–1997 and 2004–2005, the percentage of women aged 50–69 years reporting breast symptoms remained constant with an aggregate proportion of 3.2% (95% CI: 3.2–3.2) (Figure 7.6). For the 10-year period 1996–2005, the proportion of participants aged 50–69 years who reported breast symptoms was significantly higher in NSW than other jurisdictions at 4.7% (95% CI: 4.7–4.8) and significantly lower in Western Australia at 0.5% (95% CI: 0.5–0.5) (Table 7.7). Results should be interpreted with caution as jurisdictions vary in their policies of allowing women with symptoms to participate in the Program. There is also jurisdictional variation in the way in which symptoms are identified in women as they progress along the screening pathway as well as in symptom management.32

Over the 10-year period 1996–2005, the proportion of Program participants reporting breast symptoms was highest in the 40–49 year age group (6.3%; 95% CI: 6.3–6.4), followed by women aged 50–69 (3.2%; 95% CI: 3.2–3.2) and lowest in those aged 70 years and over (2.9%; 95% CI: 2.9–2.9) (Table 7.8).



7.2 AVAILABILITY,ACCESSIBILITYANDACCEPTABILITYOFTHEPROGRAM

The Evaluation explored the views of women and health professionals on the availability, accessibility and acceptability of BreastScreen Australia and the potential impact of these views on Program outcomes in terms of participation, access and equity. Findings are drawn from the Participation Qualitative Study.

7.2.1 AVAILABILITYANDACCESSIBILITYOFBREASTSCREENAUSTRALIA

Evaluationquestion6: To what extent is the Program available and accessible to all eligible women, in particular, sub-populations of women where the participation is lower than the national average?

BreastScreenAustraliaaim4: To ensure equitable access for women aged 50–69 years to the Program.

BreastScreenAustraliaobjective6: To recognise the real costs to women of participation in the Program, and to minimise those costs. This includes the provision of services at minimal or at no charge, and free to eligible women who would not attend if there were a charge.

BreastScreen Australia aims to ensure equitable access to the Program for women in the target age range (50–69 years). A number of strategies are employed to achieve this.

The Program has a wide geographical coverage to facilitate access for as many women as possible. There are currently 33 accredited BreastScreen Australia SASs, which provide services in over 500 locations nationwide. Some services cover vast geographical areas using relocatable and mobile screening units. Screening services are provided at no cost to participants.

Various national, state and territory communication campaigns and promotional activities have been undertaken with the aim of educating and informing women in the target age range of 50–69 years about the Program. Some communication materials are also available in a range of languages. Aboriginal and Torres Strait Islander Health Workers have been supported by the Program to facilitate access for Aboriginal and Torres Strait Islander women. In recent years, several states and territories have implemented jurisdictional social marketing campaigns. The last large-scale national communication campaign was implemented in 2000–2001.

76

The Participation Qualitative Study found that, overall, the Program was perceived by both women and health professionals to be available and accessible. Program participation data33 indicate that the participation rate is relatively high in regional areas and among lower socio-economic groups (with the exception of the lowest socio-economic group). However, some barriers to Program participation for certain sub-populations were identified in the literature, in particular, women from culturally and linguistically diverse backgrounds (especially new arrivals to Australia), Aboriginal and Torres Strait Islander women, and women with disabilities. In addition, the Participation Qualitative Study identified barriers to participation for women living in remote areas.

Issues highlighted for sub-populations included problems with accessing health services and a perceived lack of cultural sensitivity in the services provided by BreastScreen Australia. Ability to access or use transport was raised as a key difficulty for women from culturally and linguistically diverse backgrounds and Aboriginal and Torres Strait Islander women, while some women with disabilities chose not to access screening because they assumed they would be physically unable to undergo a mammogram.

Limited opening hours was cited as barrier by some women with inflexible jobs or ‘complex lives’, including women from lower socio-economic backgrounds. Difficulties accessing screening at a convenient time and accessing assessment services were reported by women in some remote and rural communities.

Results also suggest that some women may be deterred from attempting to participate because they are not aware that appropriate facilities are available. This view was most apparent amongst women with disabilities and those from culturally and linguistically diverse backgrounds, who expected that allowances would not be made to cater for women with disabilities or that access to interpreters would be limited. Some of the availability and access barriers reported apply to women who have never been screened and may not accurately reflect the availability of the Program.

General practitioners (GPs) and other health professionals who took part in the qualitative research were broadly very supportive of the Program and praised it for being free, available and accessible, with service distribution enabling most women to access the Program with relative ease. All health professionals surveyed stated that access is more of a problem for women from Aboriginal and Torres Strait Islander communities. Aboriginal and Torres Strait Islander health workers cited access as a key barrier for their clients, despite some services providing transport to assist women to attend screening.

33 See Chapter 7, section 7.1 for data on Program participation


7.2.2 ACCEPTABILITYOFBREASTSCREENAUSTRALIA

Evaluationquestion7: To what extent is the Program acceptable to women and other stakeholders?

BreastScreenAustraliaaim5: To ensure that services are acceptable and appropriate to the needs of the eligible population.

BreastScreenAustraliaobjective9:To provide services in accessible, non-threatening and comfortable environments by staff with appropriate expertise, experience and training.

BreastScreen Australia aims to ensure that the Program is acceptable to women.

The Participation Qualitative Study found that the Program has many perceived strengths with wide praise from many women and health professionals in relation to its availability, acceptability and accessibility for a large number of women in Australia. Most women and health professionals strongly supported the existence of the Program and reported a perception that the Program has improved over time. However, the research identified considerable variability in the way in which services are delivered across Australia, both between and within jurisdictions.

The Participation Qualitative Study identified that women’s experiences of Program services were variable and could leave extremely long-lasting and deep impressions. A key factor affecting perceptions of acceptability was the extent to which a woman felt the radiographer had made an effort to minimise her discomfort and embarrassment. The service environment also appeared highly influential on perceptions of acceptability, with details such as provision of baskets for women’s belongings having an exponential effect on satisfaction. These impressions can be particularly important at the first attendance.

The qualitative research suggests that the needs of women from culturally and linguistically diverse backgrounds and Aboriginal and Torres Strait Islander women are not currently met as effectively as those of the rest of the population. For example, concerns raised by Lebanese and Iraqi women included uncertainty about whether health workers would be female and whether mammography conflicted with their religious practices. These concerns contributed to a heightened sense of unease about the procedure. In particular, there was an expectation that staff would not be sensitive to the heightened embarrassment amongst women from very modest cultures and would be impatient in explaining processes to women with limited English skills.

78

Aboriginal and Torres Strait Islander women who had used BreastScreen Australia services, especially those who used the mobile unit in regional and remote communities, tended to not be very satisfied with their experiences. Aboriginal and Torres Strait Islander health workers surveyed suggested that providing screening within Aboriginal and Torres Strait Islander medical centres would be more acceptable to Aboriginal and Torres Strait Islander women, as this would enable the service to meet their cultural needs, while screening through mainstream health services was unlikely to be culturally appropriate. It should be noted that, given the limited sample size, comments from Aboriginal and Torres Strait Islander health workers may be difficult to generalise to the wider Aboriginal and Torres Strait Islander population.

Although most of the women and health professionals involved in the qualitative research were comfortable with the mode and timing of receiving results, time taken to receive results was a concern for a number of women and health professionals surveyed. While the women surveyed did not see being recalled for assessment as limiting the ‘acceptability’ of the Program, it was apparent that the anxiety caused by a recall for women who are not subsequently diagnosed with breast cancer could be viewed as a negative aspect of participation.

Women who had been diagnosed with breast cancer through BreastScreen Australia were strong supporters of the Program and felt the service provided was highly satisfactory. Indeed, some of these women were disappointed to have to leave the care of BreastScreen Australia upon diagnosis. Women who had experienced interval cancers tended to have retained their belief in the importance of regular screening but some had lost confidence in the quality of the screening mammography provided by BreastScreen Australia.

Overall, the GPs and breast physicians surveyed valued and endorsed the BreastScreen Australia Program. In common with the women surveyed, health professionals acknowledged the expertise of BreastScreen Australia staff in breast cancer screening, and were of the opinion that the Program responds well to feedback and had improved over the last decade.

7.2.3 FACTORSTHATINFLUENCEPARTICIPATIONINBREASTSCREENAUSTRALIA

Evaluationquestion8: What are the barriers to improving participation? What are the strategies to address the barriers?

The Participation Qualitative Study also explored barriers and facilitators to participation in the Program.

Factors that discouraged participation fell into three categories:

• factors related to having a mammogram;

• factors related to taking part in screening mammography; and

• factors related to the availability, accessibility and acceptability of the Program.


The literature review conducted as part of the Study identified that many key barriers to participation are not a direct function of the Program but relate to personal factors, such as embarrassment, desire to avoid pain, fear of results, concerns about the effects of radiation,34 and low awareness of risk factors for breast cancer.

Some women have strongly held reasons for not participating in screening, such as mistrust of procedures, concerns about the effect of radiation, trauma to breast and/or unwillingness to undergo medical interventions in the absence of symptoms. Although several studies identified in the literature review mentioned pain as a barrier to participation, the studies are contradictory in terms of the extent to which this is a significant barrier. The Participation Qualitative Study highlighted that the process of undergoing a mammogram and the associated pain and discomfort is a barrier to participation for some women and indicated that women’s perception of pain is often moderated by a positive first-time screening experience.

As mentioned in previous sections, other barriers identified by the Study for women from key sub-populations included perceptions by some women that there will be a lack of cultural sensitivity in services provided by BreastScreen Australia as well as real or perceived difficulties with accessing BreastScreen Australia services, including lack of, or difficulties using transport and limited opening hours.

Four key facilitators that positively influence women to participate in breast cancer screening were identified:

• an understanding of the benefits of breast cancer screening;

• exposure to communication from BreastScreen Australia;

• encouragement from family and friends; and

• recommendation from a doctor or Aboriginal and Torres Strait Islander health worker.

The importance of a doctor’s recommendation as a positive influence on screening participation is also supported by outcomes from the literature review, with one study suggesting it is particularly beneficial for women from culturally and linguistically diverse backgrounds.

The GPs surveyed acknowledged their role in encouraging women to participate in screening for breast cancer. It was apparent that GPs tended to adopt a proactive or reactive approach to this role. Reactive GPs, typically those working in larger practices with a high turn-around of patients, stated that they rarely discuss breast screening with patients. By contrast, proactive GPs saw their role as raising awareness of the Program among eligible women and encouraging those who are reluctant by clearly describing the benefits of screening. Despite feeling it is their responsibility to encourage women in the target age range to participate, proactive GPs reported not always being able to do so due to the competing demands of the consultation.

34 See Chapter 6, section 6.2.7 for information on radiation exposure in breast cancer screening

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7.2.4 BREASTSCREENAUSTRALIACOMMUNICATIONACTIVITIES

Evaluationquestion9: What impact has communication activities had on participation rates?

BreastScreenAustraliaobjective7: To make information about mammographic screening and the BreastScreen Australia Program available in easily comprehensible and appropriate forms in a variety of forums, and to women and health-care providers in particular.

The Participation Qualitative Study examined the impact of BreastScreen Australia communication activities on Program participation rates. The women surveyed reported satisfaction with the BreastScreen Australia communications they had been exposed to and reported that they were prompted to participate in the Program as a result of these. Invitation and reminder letters and phone calls appeared to be an effective means of encouraging participation in the Program for many women.

National advertising was also seen as important in promoting participation in the Program. Despite the fact that there has not been a national television campaign in recent years, women still mentioned the ‘Sara Henderson campaign’, including specific recall of her message ‘you bloody well should!’ and reported making their original appointment in response to a ‘Sara Henderson’ television commercial, rather than in response to an invitation letter.

Not all women in the qualitative research sample could recall receiving direct communications from BreastScreen Australia. Women who had never had a screening mammogram were least likely to recall seeing any BreastScreen Australia communication materials. Few Aboriginal or Torres Strait Islander women or women from culturally and linguistically diverse backgrounds remembered whether they had received an invitation or reminder letter.

Aboriginal and Torres Strait Islander women in remote communities indicated that they tend to receive verbal information from Aboriginal and Torres Strait Islander health workers rather than direct communications. However, they reported that the information provided was mostly about appointment times and travel arrangements rather than screening procedures, potential harms or benefits. Aboriginal and Torres Strait Islander health workers stated they would appreciate Aboriginal and Torres Strait Islander specific materials to explain the importance and process of breast cancer screening, particularly in the lead-up to a visit from the mobile service. The presence of the mobile unit was considered to be an effective advertisement for the Program in the Aboriginal and Torres Strait Islander communities it visited.


Women who participated in the Participation Qualitative Study reported that GPs are effective channels for communicating screening information because they are widely trusted, provide information about the relevance of breast cancer screening and can direct women to local services. GPs stated that more active communications from BreastScreen Australia could be useful in encouraging them to discuss breast screening with their female patients.

Although most Program participants reported feeling well informed about breast cancer screening, not all were fully aware of the process the first time they were screened and not all had been told about the potential for discomfort. Most women felt that explaining the purpose, process and expected experience of breast cancer screening before the procedure would encourage regular screening.

7.2.5 INFLUENCEOFTHEMEDIAANDCOMMUNICATIONACTIVITIESONMAMMOGRAPHYDEMAND

Media stories about health can precipitate significant and dramatic changes in behaviour (Chapman et al. 2005). The Evaluation examined the impact of media stories about breast cancer and high-profile celebrities on the number of MBS-funded mammograms (Figure 7.7). An increase in mammograms was seen at the beginning and end of the ‘Sara Henderson campaign’, which ran from 1995 to 1997. The increase was particularly apparent for women aged over 40 years.

An increase in the number of mammograms performed for younger women (0–39 and 40–49 years) was seen around the time of the breast cancer diagnosis of the high-profile celebrities Belinda Emmett and Kylie Minogue. Publicity of Belinda Emmett’s diagnosis in May 1998 saw bilateral mammogram services for the 40–49 year age group increase from 24,625 mammograms in the first quarter of 1998 to 35,000 mammograms in the following quarter. Over the same time period, the number of mammograms for women aged 0–39 years increased from 14,115 to 18,619 and with a further increase to 18,917 seen during the following quarter. Publicity around Kylie Minogue’s diagnosis in May 2005 saw the most marked increase in the 40–49 year age group with an increase from 20,937 mammograms recorded in the quarter prior to her diagnosis to 26,206 and 27,542 services in the following quarters, respectively. Services also increased in the 0–39 year age group.

News of Kylie Minogue’s diagnosis also increased the total number of women participating in BreastScreen Australia services, with an increase of 101% in bookings for initial mammograms in four jurisdictions in the 2 weeks following publicity (Chapman et al. 2005).

82

Figure7.7 Number of MBS-funded mammograms, by age group and dates of breast cancer-related media publicity, 1995–2007

Media Event

Num

ber

of m

amm

ogra

ms

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

80+

70–79

60–69

50–59

40–49

0–39

1995

1996

1999

2000

2001

2002

2003

2004

2005

2006

2007

Sara

H c

ampa

ign

begi

ns

1997

Sara

H c

ampa

ign

ends

1998

Belin

da E

mm

ett d

iagn

osis

1

Kylie

M d

iagn

osis

Belin

da E

mm

ett d

eath

Belin

da E

mm

ett d

iagn

osis

2


7.2.6 INFORMEDCHOICE

Evaluationquestion10:Do the current communication mechanisms help women to make an informed choice about screening and rescreening?

The Participation Qualitative Study examined the issue of informed choice, in particular whether current BreastScreen Australia communication materials provide enough information to women on the benefits and potential harms of participation to enable them to make an informed choice about participating in the Program.

The literature review indicated that many women are not well informed about risk factors for breast cancer. Additionally, the way in which information about breast cancer screening is framed was found to affect women’s support for breast cancer screening. These findings were supported by the outcomes from the qualitative research.

There was limited awareness among women of increasing age as a risk factor for breast cancer, irrespective of family history. A lack of understanding of the rationale for the Program target age range of 50–69 years of age was also apparent, particularly among women who had never participated or had ceased participating in breast cancer screening. This lack of awareness could impact negatively on a woman’s understanding of the individual relevance and appropriateness of screening. Erroneous perceptions about the level of risk for younger women are reinforced by media coverage focusing on cases of young celebrity women who diagnosed with breast cancer.

BreastScreen Australia produces communication materials at the jurisdictional level aimed at informing women about the Program and the screening process. Women surveyed in the Participation Qualitative Study reported feeling well-informed about screening mammography when they participate. However, some regular participants reported that they were not fully aware of the process the first time they participated in screening. The women surveyed were also generally unaware of the low rate of breast cancer diagnosis among women recalled for further investigation through BreastScreen Australia and the importance of reporting symptoms of breast cancer between regular screens to their GP because of the potential for interval cancers.

Women from Aboriginal and Torres Strait Islander communities and women who do not speak English at home tend to report feeling poorly informed about most medical procedures they undergo. The qualitative research indicated that breast cancer screening through BreastScreen Australia is no exception to this.

84

7.2.7 FACTORSCONTRIBUTINGTOWOMENCHOOSINGMAMMOGRAPHYOUTSIDEBREASTSCREENAUSTRALIA

Evaluationquestion11:What are the factors contributing to women choosing mammography outside the Program?

Although participation in BreastScreen Australia has increased over time, participation rates have remained fairly steady in recent years at around 56%, well below the target rate of 70%.

One factor that may contribute to the BreastScreen Australia participation rate is the availability of private mammography screening. Women can choose to be screened outside the Program by paying for screening through a private radiology service. Some private radiology services promote themselves as ’well women clinics’ and offer screening mammography for a fee. Rebates through the MBS are not available for these screening services.

Another factor that may contribute to the participation rate is the availability of MBS rebates for diagnostic mammography. MBS rebates, which can be bulk-billed, are available for diagnostic mammography where a doctor’s referral is provided. Doctors can refer for a mammogram on the basis of a suspicion of breast cancer due to personal or family history of breast cancer or presence of symptoms. Although MBS rebates are not available for screening, it is possible that some MBS-funded mammography is for non-diagnostic purposes.

The MBS item description is:

MBS Item 59300: MAMMOGRAPHY OF BOTH BREASTS, if there is a reason to suspect the presence of malignancy because of:

(i) the past occurrence of breast malignancy in the patient or members of the patient’s family; or

(ii) symptoms or indications of malignancy found on an examination of the patient by a medical practitioner. Unless otherwise indicated, mammography includes both breasts (DoHA 2007).

The Participation Qualitative Study examined why women choose to access mammography outside the Program, but did not distinguish between women who paid for screening through a private radiology service and those who accessed MBS-funded mammography.

The literature review found a key reason that some women choose to use private mammography services is the expectation that they will receive the results on the same day. This was of particular importance to women who considered themselves to be at high risk of breast cancer. However, a Victorian study found that the majority of women surveyed (98.7%) believed that BreastScreen Victoria services would be at least as good as that of private services (Market Access Consulting and Research 2005). This finding is supported at the national level by the qualitative research, in which most women surveyed expected BreastScreen Australia to be as accurate as private services, if not more accurate, since the Program is a specialist breast cancer screening service. However, some women surveyed expressed a belief that private services provide a better quality


service, either because they offer routine ultrasounds or because of an assumption that a paid-for service must be superior to a free service. These views tended to be expressed in particular by women who had experienced an interval cancer following screening.

Women surveyed who had used private services for screening reported doing so because they had previously undergone diagnostic mammography at a particular clinic and wanted to continue to use this familiar service. Other factors included faster results, convenience and the availability of ultrasound as a routine part of the process or the availability of ultrasound on the same day as the mammogram. In some cases, women aged 40–49 years reported using private services because they and/or their GP were not aware that they would be eligible for free screening through BreastScreen Australia.

The role of the woman’s GP in the decision to access private screening was also explored. The literature review identified two studies reporting that a small percentage of GPs preferred to refer women to private services over BreastScreen Australia. One study reported that 7% of GPs in Western Australia preferred private services over BreastScreen Australia due to the belief that service quality is superior (RACGP 2003). The second study in NSW suggested that some GPs may refer patients to private services if they have established links with private providers (Taylor et al. 2003). A small number of the GPs surveyed as part of the Participation Qualitative Study stated that they encourage women to use private services because of their links with private radiology clinics.

The literature review highlighted the potential for results about use of BreastScreen Australia or private radiology services to be influenced by some women’s confusion or recollection of which services they had accessed. The Participation Qualitative Study supported this suggestion. Awareness of the BreastScreen Australia ‘brand’ was low in some large metropolitan areas where there are a number of services and in jurisdictions where local marketing activity is less intense. Women from Aboriginal and Torres Strait Islander and culturally and linguistically diverse backgrounds had particularly low awareness of the brand.

7.3 IMPACTOFMEDICAREBENEFITSSCHEDULE(MBS)FUNDEDMAMMOGRAPHYONBREASTSCREENAUSTRALIA

Evaluationquestion12: What are the trends in MBS-funded mammography over time and how do they relate to BreastScreen Australia participation rates?

The Evaluation analysed trends in MBS-funded mammography and other breast-related diagnostic procedures to determine whether the availability of MBS-funded mammography is impacting on BreastScreen Australia participation rates. The MBS Mammography Analysis Project estimated the proportion of non-diagnostic mammography in order to determine the number of mammograms that could perhaps be undertaken through BreastScreen Australia.

86

7.3.1 TRENDSINMBS-FUNDEDMAMMOGRAPHY

Analysis of MBS-funded mammography over the period 1987–2007 for women aged

50–69 years indicates that the total number of MBS-funded bilateral mammograms peaked at 151,253 mammograms in 1993 but decreased sharply to a low of 114,280 in 1996, most likely due to the introduction of the BreastScreen Australia Program (Figure 7.8). Since 1996, there has been a gradual increase in the number of MBS-funded mammograms performed each year in this age group. The number of MBS-funded mammograms increased over the period 2003–2007, from 123,249 in 2003 to 133,493 in 2007, an increase of approximately 10,000 mammograms. This increase may reflect increasing capacity issues with the Program which is causing women to seek mammography elsewhere, such as through the MBS. Age-specific rates of MBS-funded bilateral mammograms were obtained for the years 2006 and 2007 for women aged 50–69 years. A small increase in the rate of mammograms per 100,000 occurred between 2006 and 2007 for women aged 60–64 years and 65–69 years (Figure 7.9).

Figure7.8 Annual number of MBS-funded bilateral, single and total mammograms for women aged 50–69 years, 1987–2007

Num

ber

of m

amm

ogra

ms

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

Total mammograms

One breast

Both breasts

1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007

Year

Source: MBS Mammography Analysis Project


Figure7.9 Annual age-specific rate of MBS-funded bilateral mammograms by age group, 2006–2007

Age Group

Mam

mog

ram

s (a

ge s

peci

�c r

ate)

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

85- 80-75-70-65-60-55- 50-45-40-35-30-25-20-

2006

2007


Age-specific rates were also obtained for women aged 50–69 years by jurisdiction. The rate of MBS-funded bilateral mammography peaked in the early 1990s and has since declined in all jurisdictions (Figure 7.10). The age-specific rate has been highest in NSW since 2002 and lowest in the Northern Territory since 1996. In South Australia, the rate has increased marginally over the period 2003–2007 and there has been a steady decline in the rate of MBS-funded bilateral mammography in Western Australia over time.

88

Figure7.10 Annual age-specific rate of MBS-funded bilateral mammograms for women aged 50–69 years, by state and territory, 1987–2007

Mam

mog

ram

s (a

ge s

peci

fic r

ate)

0

2000

4000

6000

8000

10000

12000

14000

16000ACT

NT

TAS

WA

SA

QLD

VIC

NSW

1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007

Year


Trends for MBS-funded mammography in women aged 20–85+ years over the period 1987–2007 are similar to those seen for the 50–69 year age group. A noticeable peak in mammography occurred in 1991, followed by an overall decline (Table 7.9). The number of MBS-funded mammograms for this age group decreased from a peak of 386,448 mammograms in 1991 to 287,319 mammograms in 2004.

Over the 20 years from 1987 to 2007, MBS-funded mammography numbers were consistently highest for women aged 45–49 years and 40–44 years (Figure 7.11). Over the 10-year period 1996–2005, attendance at BreastScreen Australia among women aged 40–49 years decreased (AIHW 2008).35 The number of MBS-funded mammograms performed for women aged 20–35 years and women aged 65 years and over remained fairly steady across the 20-year period, with no apparent impact from the introduction of BreastScreen Australia. Age-specific rates for MBS-funded mammograms of both breasts in 2006 and 2007 were highest for women aged 45–49 years (Figure 7.9). With the exception of the 45–49 year age group, age-specific rates for women aged 40–69 years are quite similar.

35 See Chapter 7, section 7.1 for further information on Program participation by age


Table7.9 Annual number and age-standardised rate of MBS-funded bilateral mammograms for women aged 20–85+ years, 1987–2007

Year Numberofservices

Agestandardisedrateper

100,000women

1987 144,295 2,545

1988 204,302 3,527

1989 273,335 4,616

1990 318,328 5,270

1991 386,448 6,273

1992 369,122 5,882

1993 375,241 5,891

1994 354,012 5,477

1995 346,251 5,274

1996 296,908 4,450

1997 304,145 4,488

1998 324,115 4,718

1999 300,300 4,310

2000 298,533 4,225

2001 302,464 4,214

2002 298,684 4,101

2003 288,571 3,901

2004 287,319 3,829

2005 317,566 4,166

2006 312,016 4,025

2007 312,564 3,965


90

Figure7.11 Annual number of MBS-funded bilateral mammograms by age group, 1987–2007

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,00085+

80-

75-

70-

65-

60-

55-

50-

45-

40-

35-

30-

25-

20-

1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007

Num

ber

of M

amm

ogra

ms



7.3.2 TRENDSINMBS-FUNDEDDIAGNOSTICSERVICESFORBREASTCANCER

Evaluationquestion13: What are the trends in MBS-funded breast cancer diagnostic procedures since the beginning of the BreastScreen Australia Program in 1991?

The Evaluation analysed trends in several MBS-funded breast-related diagnostic procedures over the period 1991–2007, including ultrasound,36 FNA,37 core biopsy38 and mammary ductogram39. The analysis shows a steady increase in the number of MBS-funded FNAs, core biopsies and mammary ductograms and a dramatic increase in the total number of ultrasounds40 claimed over this period (Figure 7.12). The number of MBS-funded mammograms is also included for comparison.

Figure7.12 Annual number of MBS-funded breast-related diagnostic services compared with annual number of MBS-funded bilateral mammograms for women aged 50–69 years, 1992–2007

Ultrasound

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

FNA (impalpable)

Core biopsy

Mamm ductograms

Total mammograms

1992 1994 1996 1998 2000 2002 2004 2006

Num

ber

of d

iagn

osti

c pr

oced

ures

/mam

mog

ram

s

Year

Note: Data begin at 1992 due to an incomplete data set for items in 1991–1992. Includes MBS-funded diagnostic items 55070, 55073, 55076, 55079, 31533, 31530, 31548 and 59306 and MBS-funded mammography items 59303 and 59300.Source: MBS Mammography Analysis Project

36 Ultrasound MBS items used in this analysis included referred and non-referred ultrasounds of both breasts (MBS items 55076 and 55079) and referred and non-referred ultrasounds of one breast (MBS items 55070 and 55076). Non-referred ultrasounds are most likely to occur when the radiologist taking the mammogram observes a sign and decides to follow up with an ultrasound.

37 FNA refers to MBS item number 31533 (impalpable breast lesions). FNA of palpable lesions (MBS item 73049 and 73051 was also reviewed in the analysis however these items do not refer specifically to breast lesions so are therefore not presented in this section of the report.

38 MBS items 31530 and 3154839 MBS item 5930640 Total number of ultrasounds includes ultrasounds for one and both breasts, referred and non-referred

92

Age-specific rates, obtained for 2007 only, indicate that women aged 45–49 years had the highest age-specific rate of referred bilateral ultrasounds (6,160 per 100,000 women) followed by women aged 40–44 years (5,604 per 100,000 women) (Figure 7.13). In some women, particularly younger women, ultrasound is preferred as the sole imaging technique due to breast density. In older women, usually those over 40 years, ultrasounds are commonly used in conjunction with mammography to undertake a breast examination (NBCC 2002). The overall increase in use over time of ultrasounds is likely to due to its recommended use as part of the ‘triple test’, the investigative pathway used to assess breast changes to confirm a diagnosis of breast cancer.

Similarly, the steady increase in use of FNA for impalpable breast lesions and core biopsy (Figure 7.12) is also likely to be because of the inclusion of these procedures in the ‘triple test’41 approach to diagnosis. In addition, Kricker and Clements (1999) attributed the increase in these procedures to increased experience with the procedures by health professionals, greater expertise in reporting results and improved reliability of test results.

Figure7.13 Annual age-specific rate of MBS-funded bilateral ultrasound (referred and non-referred) by age group, 2007

Ult

raso

unds

(age

spe

ci�c

rat

e)

Age Group

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Ultrasound 2 breast referred

Ultrasound 2 breast non-referred

85+80-75-70-65-60-55-50-45-40-35-30-25-20-


41 The triple test is made up of three diagnostic components: (1) clinical breast examination, including medical history; (2) imaging – mammography and/or ultrasound; (3) pathology via non-excisional biopsy – FNA cytology and/or core biopsy (NBCC 2002).


7.3.3 PARTICIPATIONINBREASTSCREENAUSTRALIAANDMBS-FUNDEDMAMMOGRAPHY

Evaluationquestion14: To what extent are women using MBS-funded mammography when they could be accessing BreastScreen Australia services?

The MBS Mammography Analysis Project compared participation rates in BreastScreen Australia to MBS-funded mammography by LGA, state and territory, geographic region and socio-economic status.

Overall, the number of women screened through BreastScreen Australia has gradually increased over time. By comparison the number of MBS-funded mammograms has remained relatively steady (Figure 7.14). In 2004–2005, 1,118,720 women aged 50–69 years were screened through BreastScreen Australia (AIHW 2008). The number of MBS-funded mammograms conducted in women in this age group over the same 2-year period totalled 255,350 services. These figures should be interpreted with caution, as the number of MBS-funded mammograms is likely to comprise mammograms for both diagnostic and non-diagnostic purposes.

Figure7.14 Number of mammograms conducted by BreastScreen Australia and mammograms funded through the MBS for women aged 50–69 years, 1996–2005

Num

ber

of w

omen

scr

eene

d/N

umbe

r of

mam

mog

ram

s

Year

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

Number of MBS funded mammograms (both breasts)

Number of women screened (BreastScreen Australia)

1996–1997 1998–1999 2000–2001 2002–2003 2004–2005

Note: A 2-year time period was used as BreastScreen Australia reports participation figures on a 2-yearly basis to correspond with the biennial screening intervalSource: Prepared using data from the Participation and Performance Trends Project and the MBS Mammography Analysis Project

94

Data on mammograms provided through BreastScreen Australia and the MBS were analysed to determine an attendance rate for both services. While women who have a mammogram through the BreastScreen Australia Program are essentially participating in the Program, this same distinction does not apply to MBS-funded mammography. It would be incorrect to assume women are ‘participating’ in the MBS, as the data presented in this section include MBS-funded mammograms for both diagnostic and non-diagnostic purposes. To address this issue, the term ‘attendance rate’ has been used instead of ‘participation rate’.

Attendance was presented by LGA, geographic region, socio-economic status and jurisdiction. The rate presented for each indicator was an annual attendance rate that had been averaged over the 5-year periods 1996–2000 and 2001–2005 to allow better comparison of trends. This rate in relation to BreastScreen Australia is lower than participation rates reported in other sections of this report, as the rate has not been presented in the usual Program 2-yearly screening interval.

BreastScreenAustraliaandMBS-fundedmammographybyLGA,allages

Analysis by LGA, in which the proportion of women participating in BreastScreen Australia was plotted against the proportion of women receiving MBS-funded mammograms, found no clear trends. Analysis by individual LGA may provide a clearer picture of any apparent trends.

BreastScreenAustraliaandMBS-fundedmammographyforwomenaged50–69years

BreastScreen Australia annual attendance rates remained relatively stable or increased slightly over time for women aged 50–69 years. In 2001–2005, the average annual participation rate in Australia was 28.9% (95% CI: 28.8–28.9), ranging from 32.2% (95% CI: 31.9–32.5) for South Australia to 21.8% (95% CI: 21.0–22.6) for the Northern Territory (Figure 7.15).

By comparison, MBS-funded mammography attendance decreased for most jurisdictions over the same time period. In 2001–2005, the national rate was 6.0% (95% CI: 6.0–6.1), ranging from 6.9% (95% CI: 6.6–6.9) for NSW to 2.8% (95% CI: 2.5–3.0) for the Northern Territory.

This trend is likely to be reflective of the availability of the BreastScreen Australia Program, which specifically targets women in this age group.


Figure7.15 Average annual attendance rates through BreastScreen Australia and MBS mammography for women aged 50–69 years, by state and territory, 2001–2005

NSW Vic Qld WA SA Tas ACT NT

50

45

40

35

30

25

20

15

10

5

0

Per cent

50–69 years MBS mammography

50–69 years BreastScreen Australia


No significant findings were seen across geographical regions (major cities, inner regional, outer regional, remote and very remote), as attendance at BreastScreen Australia dominated over MBS-funded mammography attendance in all areas. In 2001–2005, MBS-funded mammography attendance tended to be higher in major cities (6.5; 95% CI: 6.5–6.6) and inner regional areas (5.8; 95% CI: 5.7–5.8), while the rate was lowest in very remote areas (3.5; 95% CI: 3.1–3.9).

Little difference in BreastScreen Australia participation was seen between the second, third, fourth or fifth (lowest) quintiles of socio-economic status in 2001–2005. The first quintile (highest) had the lowest attendance at 25.2% (95% CI: 25.0–25.3). In contrast, MBS-funded mammography attendance was similar across the third, fourth and fifth (lowest) quintiles and was highest in the first quintile (highest) at 7.4% (95% CI: 7.3–7.5).

BreastScreenAustraliaandMBS-fundedmammographyforwomenaged40–49years

There was a substantial decrease in participation in BreastScreen Australia by women aged 40–49 years in most states and territories between 1996 and 2005. MBS-funded mammography rates also decreased in this age group over the same time period. Annual attendance at BreastScreen Australia in 2001–2005 for women 40–49 years was 9.4% (95% CI: 9.3–9.4), while MBS-funded mammography attendance was 6.1% (95% CI: 6.1–6.1).

Some variation is apparent by jurisdictions. NSW and Victoria had highest usage of MBS-funded mammography in 2001–2005 (Figure 7.16). Over this time period, the MBS-funded mammography rate was 6.7% (95% CI: 6.6–6.8) in NSW and 6.5% (95% CI: 6.4–6.6) in Victoria. Tasmania and the Northern Territory had the lowest MBS-funded mammography attendance rates at 4.4% (95% CI: 4.2–4.6) and 3.2% (95% CI: 2.9–3.5), respectively in 2001–2005.

96

Figure7.16 Average annual attendance rates through BreastScreen Australia and MBS-funded mammography for women aged 40–49 years, by state and territory, 2001–2005


50

45

40

35

30

25

20

15

10

5

0

Per cent

40+ years MBS mammography

40+ years BreastScreen Australia


BreastScreenAustraliaandMBS-fundedmammographyforwomenaged70+years

Participation by women aged 70+ years in the BreastScreen Australia Program has increased over time. Nationally, annual attendance at BreastScreen Australia in 2001–2005 for women aged 70+ years was 10.1% (95% CI: 11.1–11.2) compared with 2.9% (95% CI: 3.1–3.1) for MBS-funded mammography.

While annual attendance rates in women aged 70+ years were higher for BreastScreen Australia than for MBS-funded mammography for all jurisdictions, there were some exceptions. In 2001–2005, annual attendance in BreastScreen Australia for Western Australia and the ACT was only slightly above MBS-funded mammography attendance. In Western Australia, BreastScreen Australia attendance was 5.0% (95% CI: 5.2–5.6) compared with the MBS-funded mammography rate at 2.9% (95% CI: 2.9–3.2); in the ACT, the attendance rate was 4.4% (95% CI: 4.3–5.1) for BreastScreen Australia compared with 3.1% (95% CI: 2.9–3.6) for MBS-funded mammography attendance.


Figure7.17 Average annual attendance rates through BreastScreen Australia and MBS-funded mammography for women aged 70+ years by state and territory, 2001–2005

50

45

40

35

30

25

20

15

10

5

0

70+ years MBS mammography

70+ yearsBreastScreen Australia


Per cent


7.3.4 IMPACTOFMBS-FUNDEDMAMMOGRAPHYONBREASTSCREENAUSTRALIA

Evaluationquestion15: What is the impact, on the Program, of mammography outside the Program?

The MBS Mammography Analysis Project estimated the proportion of mammography undertaken through the MBS for diagnostic or surveillance purposes and for non-diagnostic purposes. It could be assumed that non-diagnostic mammography for women in BreastScreen Australia’s target age range could be undertaken through BreastScreen Australia.

The MBS data set provides information on the number of services provided and reimbursed but not the reason for the service or its outcome. In order to estimate MBS-funded diagnostic and non-diagnostic mammography, a set of assumptions was developed42 about patterns of mammography and use of breast-related diagnostic procedures that could allow classification of mammograms as either diagnostic or non-diagnostic.

The assumptions are detailed in Figure 7.18. Assumption 2, for example, is that bilateral mammograms that occurred on the same day as other breast-related diagnostic procedures (excluding bilateral ultrasounds) could be assumed to be diagnostic, as these procedures were probably requested at the same time by the same doctor. Bilateral ultrasounds were excluded from the other breast-related diagnostic procedures in assumption two because of the common clinical

42 Assumptions were developed by the MBS Mammography Analysis Project sponsors (EAC members) and endorsed by the EAC

98

practice of ordering mammograms and ultrasounds together, which may not always necessarily be for the purpose of investigating breast signs or symptoms. Mammograms and bilateral ultrasounds performed on the same day were therefore categorised as ‘unknown’ (assumption 7).

Assumptions were also developed to account for the number of women at high risk due to a personal history or family history of breast cancer, as these women are eligible to access diagnostic mammography under the MBS item description. Assumption 5 in relation to possible personal history is that these women will have claimed mammograms and invasive breast-related diagnostic services (FNA, core biopsy or ductogram) in the last 10 years. An assumption in relation to family history was not made due to the lack of a standard definition of ‘family history’; however, it was presumed that these women will have claimed repeat mammograms and ultrasounds occurring on the same day in the last 10 years, but not invasive diagnostic procedures such as FNA, core biopsy or ductogram.

Data and assumptions were used to form a flowchart separating mammography into three ‘streams’ – ‘diagnostic’, ‘non-diagnostic’ and ‘unknown’ (Figure 7.18). The ‘unknown’ category was included where there was insufficient information available to form a judgement as to whether a procedure was conducted for diagnostic or non-diagnostic purposes. The ‘non-diagnostic’ estimate is likely to be an underestimate, as it excluded women who had any other breast-related diagnostic services. It is likely that a proportion of women were classified in the ‘diagnostic’ category because another breast-related diagnostic service was performed as a result of the mammogram, when the original purpose of the mammogram was in fact for non-diagnostic purposes.

Within the ‘non-diagnostic’ classification, the category labelled ‘conservative non-diagnostic’ mammography (subset of box F; Figure 7.18), provides a likely estimate of women who regularly use MBS-funded mammography for non-diagnostic purposes.


Figure7.18 Estimate of the proportion of MBS-funded mammography used for diagnostic and non-diagnostic purposes in women aged 50–69 years, 2006

Assumptions1. Single breast mammograms are diagnostic.2. Bilateral mammogams and other breast-related diagnostic procedures occurring on the same day... are assumed to be diagnostic.3. Ultrasounds of one breast (referred and non-referred) are diagnostic.2

4. Non-referred ultrasounds of both breasts are diagnostic.2

5. Women at high risk due to a personal history of breast cancer will have had a previous breast related procedure in the last 10 years.6. Repeat mammograms with no diagnostic procedures completed over a period of 10 years are for non-diagnostic purposes.7. Referred bilateral ultrasounds without any other breast-related diagnostic service on the same day (excluding mammograms) cannot be assumed to be diagnostic.

Footnotes1. Estimation of women who would otherwise be likely to be eligible or targeted for BreastScreen Australia services.2. Assumptions 3 and 4 would be split across several boxes of the �ow chart.Source: MBS Mammography Analysis Project

A. Total MBS-funded mammograms

152,637

Est. Total diagnostic(G+J+K)

49,849 (38%)

Est. unknown44,822 (34%)

Est. Total non-diagnostic36,364 (28%)1

Total unknownH–J–K+E

44,822

D. Mammogram and diagnostic service/s, same day

87,053

E. Mammogram and diagnostic service/s, not on same day

7,618 (C–D–F)NON-DIAGNOSTIC

DIAGNOSTIC

C. Bilateral mammograms

131,035 (86%)

B. Single breast mammograms

21,602 (14%)(Diagnostic)

(Assumption 1)

G. Mammogram and diagnostic

service/s on the same day(excluding bilateral ultrasound)

15,334 (D–H)

(Assumption 2 & 7)

J. Mammogram, bilateral ultrasound

on same day and diagnosticprocedure/s in previous 10 years

28,687

(Assumption 5)

K. Repeat mammogram andbilateral ultrasound same day in previous 10 years, no otherdiagnostic service/s in 2006 or

previous 10 years5,828

H. Mammogram and bilateral

ultrasound on the same day, no other diagnostic service/s

on same day71,719

(Assumption 7) F. i Mammograms and no other diagnostic service/s in 2006

36,364

(Assumption 6)

Conservative estimate

Mammogram in 2006 and inthe previous 10 years, and noother diagnostic service/s in

2006 or in the previous 10 years6,833

100

Using the same assumptions, the proportion of MBS-funded diagnostic and non-diagnostic mammography was estimated for all women in the age groups 40 years and over, 40–49 years, 50–69 years and 70–74 years (Table 7.10).

Table7.10 Annual number of MBS-funded bilateral mammograms and estimated proportion of diagnostic, non-diagnostic and unknown mammography for selected age groups, 2006

Agegroup

Totalbilateral

mammograms

Mammograms

per100,000

women

Estimated

diagnostic

Estimated

non-diagnostic

Estimated

unknown

40+ years 276,716 6,812 45% 23% 32%

40–49 years 97,238 6,374 58% 15% 26%

50–69 years 131,035 5,931 38% 28% 34%

70–74 years 16,583 5,067 24% 34% 42%


Based on these estimates, the proportion of MBS-funded mammograms conducted for diagnostic purposes appears to decrease with age, while those undertaken for non-diagnostic and unknown purposes increase with age. It is difficult to identify possible reasons for the differences across age groups, as breast cancer incidence and risk factors vary by age and these estimates are only based on data for 1 year (2006). The increase in the ‘unknown’ category may be due to older women undergoing mammography and ultrasound for surveillance purposes following a breast cancer diagnosis, as this combination of procedures has been categorised according to assumptions for the ‘unknown’ group.

To determine the impact of MBS-funded mammography on the BreastScreen Australia Program, the non-diagnostic proportion of mammograms was used to calculate likely participation rates if these women were to join the Program (Table 7.11). Addition of the ‘non-diagnostic’ and ‘conservative non-diagnostic’ mammograms adds little to the current Program rate of 56.2%. At most, the addition of ‘non-diagnostic’ mammograms would increase participation by 3.5%, increasing participation to 59.7% nationally.

Table7.11 High, medium and low estimates of participation for BreastScreen Australia with the addition of MBS-funded non-diagnostic mammograms for women aged 50–69 years, based on 2006 data

Estimations Non-diagnostic

Conservative

non-diagnostic

Estimated number of biennial MBS-funded mammograms 73,380 13,104

Revised number of women screened (BreastScreen

Australia and MBS-funded mammograms)1,262,100 1,201,824

Current participation rate (BreastScreen Australia) (%) 56.2 56.2

Revised participation rate (BreastScreen Australia) (%)³ 59.7 56.8

Percentage change in participation rate (%) +3.5 +0.6

Notes:a. Annual number of mammograms is calculated as a percentage of the total number of bilateral mammograms estimated to be

non-diagnostic from Table 7.10b. Biennial mammograms calculated by doubling annual mammogramsc. Revised number of women screened calculated by adding the estimated number of biennial mammograms (from the Medicare system)

to the current number of women screened (AIHW 2008)d. Revised participation rate calculated by dividing the revised number of women screened by the Estimated Resident Population (ERP)

figure for women 50–69 yearsSource: Prepared using data from the MBS Mammography Analysis Project and the Participation and Performance Trends Project


7.4 ANALYSIS

The Evaluation showed an increase in BreastScreen Australia participation rates over time for women in the target age group (50–69 years) from 51.4% in 1996–1997 to 56.2% in 2004–2005. Participation has remained fairly steady over the last several years. While the target participation rate of 70% has not been achieved, the actual number of women attending the Program has increased over this 10-year period.

The 70% participation rate target was set on the basis that a high participation rate among women aged 50–69 years is necessary to maximise the reduction in mortality from breast cancer as a result of population-based breast cancer screening. The Breast Cancer Screening Evaluation Steering Committee’s report to AHMAC in 1990 estimated that a participation rate of 70% would reduce the number of deaths from breast cancer among Australian women by 16% (AHMAC 1990). Despite the lower Program participation rate, the results of the Poisson regression analysis and proportional hazards regression analysis, completed in the Mortality Ecological Study and discussed in Chapter 6, indicate that the Program has achieved a mortality reduction greater than 16%.43 This mortality reduction is likely to be due in part to improvements in treatment. Regardless of the mortality benefit seen, a participation rate that is lower than the 70% target is likely to result in a smaller-than-ideal mortality benefit and reduces the overall cost-effectiveness of the Program. A key finding of the Evaluation is that the overall BreastScreen Australia participation rate requires improvement in order to maximise the mortality benefit from the Program.

Evaluation findings based on analysis of participation data for different populations within the target age range are summarised below.

• Participation rates vary across jurisdictions, with data from 2004–2005 showing that participation by women aged 50–69 years was highest in South Australia (61.9%) and lowest in the Northern Territory (41.1%), where participation appears to be declining. Participation is also relatively low in NSW

• Participation is low among Aboriginal and Torres Strait Islander women, women who speak a language other than English at home and women living in very remote regions of Australia. However, there is evidence of improvement in participation for each of these groups.

• There is little variation in participation by socio-economic status, with a small but significant difference in participation rates of 0.5% between the highest and lowest quintiles seen over the 10-year period 1996–2005.

• Participation is lower for women living in major cities than for those living in inner and outer regional areas. There are many possible explanations as to why this occurring, including the possible effect of higher numbers of women in major cities who speak a language other than English at home. At this stage, the specific reasons for this trend are unclear and further research is required. One plausible explanation for the higher participation rate in remote and outer metropolitan areas could be the use of mobile screening units, which visit rural communities on a 2-yearly basis. Local publicity and women receiving their invitation or rescreen letters when the mobile unit is in their local region could contribute to higher participation rates. In addition, the participation rate decreased in metropolitan areas after

43 See Chapter 6, section 6.1 for findings from the Mortality Ecological Study

102

a peak in 2000–2001, despite an increase in the number of women aged 50–69 years attending the Program (in line with significant population growth in the target age group). This trend may be an indication that capacity is not keeping up with demand.

• The proportion of women at higher risk of breast cancer due to personal or family history or presence of symptoms44 among screening participants varies by jurisdiction. For women with a personal or family history of breast cancer, this proportion is tending to increase over time.

Participation has decreased over time in age groups outside the target age (40–49 years and 70 years and over). This could reflect capacity issues, given that higher numbers of women within the target age group are being screened. It may also be the result of policy changes in some jurisdictions.

Analysis of participation trends over time, particularly at the national level, highlights a number of areas of the Program that require improvement. This includes participation by Aboriginal and Torres Strait Islander women, women who speak a language other than English at home and women living in very remote geographic areas. The lower participation rates reported for these population sub-groups reflect the barriers to participation identified for sub-populations in the Participation Qualitative Study, which included problems with accessing health services and a perceived lack of cultural sensitivity in services provided by BreastScreen Australia. The qualitative research supports the need to improve the availability of breast screening for women living in rural and remote areas as well as addressing barriers to participation for Aboriginal and Torres Strait Islander women and women who speak a language other than English at home. Although some women in lower socio-economic groups cited limited opening hours as a barrier to participation, Program data show little difference in participation rates by socio-economic status, suggesting that this barrier may be a perception rather than reality.

Awareness of communication materials for Aboriginal and Torres Strait Islander women and women from specific culturally and linguistically diverse communities was low. Targeted communication strategies to raise awareness of the Program could enhance participation of these sub-populations. Communication aimed at women with disabilities may also reassure those who wish to attend that it is possible for them to do so.

Overall, levels of satisfaction with BreastScreen Australia services and communication activities were high amongst women and health professionals. However, the Participation Qualitative Study identified that there are opportunities to improve women’s understanding and appreciation of the benefits and reasons to participate in the Program, including raising awareness of age as a risk factor for breast cancer. It may also be beneficial to provide women outside the eligible age group with information in relation to age as a risk factor for breast cancer and the need to be breast aware. Eligibility for inclusion and exclusion in the Program should be clearly defined and consistent nationally to ensure women and health professionals have a clear understanding of options for participation in the Program.

44 Definitions (as defined in the Participation and Performance Trends Project report): PersonalHistory: a self-reported history of breast cancer or DCIS; FamilyHistory: self-reported and limited to a first degree relative (mother, sister or daughter) with a history of breast cancer; Symptoms:self-reported and includes a lump or nipple discharge (clear or blood-stained).


There is a need to explore and develop innovative ways to recruit lapsed participants and women who have not previously participated in response to initial invitations.

Although the research indicates that many women feel well informed in deciding whether to participate in breast cancer screening, the lack of awareness by women about key aspects of the Program indicates they may not read or retain the information provided in the consent form or general literature provided to them at BreastScreen Australia services. A review of materials, including communication and presentation style, will be important to ensure that key messages are communicated to and understood by women, especially in relation to the potential for interval cancer.

Some participants felt they were not adequately prepared for the screening process at their first visit. This finding was common across audiences but was particularly acute among Aboriginal and Torres Strait Islander women. There is a need to prepare women more effectively for their first screening attendance by providing information on the screening process, the low rate of diagnosis of breast cancer among women who are recalled for further investigation through BreastScreen Australia and the importance of prompt reporting of breast changes or symptoms of breast cancer appearing in the screening interval to their GP. There is scope to improve the first screening experience through the development of service protocols and appropriate training for BreastScreen Australia staff as well as by addressing pain as a barrier to participation.

GPs were broadly supportive of the Program but recognised there were gaps in their knowledge of the Program, including confusion about the age eligibility criteria, which they felt impaired their ability to promote the Program effectively. Some, especially male and younger female GPs, also wanted information on the process and procedure of screening to facilitate discussion with women who are concerned about using BreastScreen Australia for the first time. Ways to increase GPs’ awareness of the BreastScreen Australia operational and policy process should therefore be explored to facilitate discussion between GPs and their patients.

Findings from the Participation Qualitative Study indicated that some women choose to have a mammogram for screening outside BreastScreen Australia for a number of reasons, including faster results, convenience and the availability of ultrasounds. In some cases, women aged 40–49 years reported using private services because they and/or their GP were not aware that they would be eligible for free screening through BreastScreen Australia. The research also found that some GPs prefer to refer women to private services. Improving the time taken to receive results, extending opening hours and promoting the availability of services and adherence to quality standards adopted are possible options to improve participation rates in BreastScreen Australia.

Key issues identified in relation to participation, access and equity could be considered in a hierarchy of women’s attitudes towards screening, as presented in Figure 7.19.

104

Figure7.19 Key issues identified in qualitative study and ideal outcomes

Key issues to be addressed: Desired outcome:

Maximised understanding of key ‘risks’of screening mammography – appropriateresponses encouraged

Comfortable with screening process andprepared to re-screen

Attending the Program is perceived tobe achievable

Attending the Program is top-of-mind

Open to participating in screeningAppreciation of

relevance and benefits of screening mammography

1

Awareness of Program / brand2

Perceived availability andaccessibility of the Program

3

Service experience(acceptability of the Program)

4

Informed choice(acceptability)

5

Hie

rarc

hy o

f iss

ues

Source: Participation Qualitative Study

The hierarchy indicates the different stages involved in a woman’s decision to participate in breast cancer screening. Women firstly need to understand the relevance and potential benefits of breast cancer screening if they are to be open to participating in the Program. Once women are open to participating, they must be made aware of the Program and most must be reminded to attend at appropriate intervals. In order to actually take up the invitation to participate, women must perceive services to be available and accessible to them. Their experience of the service then has an influence on whether or not they will attend for rescreening. Finally, all women should understand the potential harms involved and be armed with appropriate information to help them make informed decisions about their participation. This hierarchy highlights the need to ensure not only that clear communication strategies and messages are targeted to a range of different audiences but that messages should take account of the issues that impact on a woman’s decision to participate in breast cancer screening.

The issues identified in the qualitative research would be best dealt with by developing a range of communication, market research and service delivery strategies. Strategies should include Program-wide and jurisdiction based marketing, including materials targeted at specific audiences, GPs and community health workers such as Aboriginal and Torres Strait Islander health workers.

The availability of mammography within the private sector has been considered a possible contributor to the lower than expected participation rate in BreastScreen Australia. Analysis of MBS-funded mammography demonstrates a significant decline in both the number and


age-specific rate of MBS-funded bilateral mammograms since the introduction of the BreastScreen Australia Program in 1991. The decline was most pronounced in younger age groups eligible to access BreastScreen Australia (40–44, 45–49 and 50–54 years).

Examination of data related to MBS-funded mammography indicates that a considerable proportion of MBS-funded mammography is undertaken for women who have had other breast-related diagnostic services such as FNA or core biopsy. This suggests that these women have accessed MBS-funded mammography appropriately through diagnostic services. Estimates of non-diagnostic bilateral mammography as a proportion of all MBS-funded bilateral mammography in 2006 ranged from 15% for women aged 40–49 years to 34% for women aged 70–74 years. For women in the target age group of 50–69 years, the estimated proportion of non-diagnostic MBS-funded bilateral mammography was 28%, which equates to 36,364 of the MBS-funded mammograms undertaken in 2006. Had these mammograms been undertaken through BreastScreen Australia, the Program participation rate would have increased by 3.5% to 59.7%. Results should be interpreted with caution, as the analysis of MBS data was based largely on assumptions about patterns of use. Thus, it appears that the availability of MBS-funded mammography is not impacting significantly on the ability of BreastScreen Australia to reach its 70% target participation rate as has been suggested previously.

Analysis of annual attendance rates for mammography through BreastScreen Australia or through the MBS also supports the finding that MBS-mammography is not impacting significantly on the Program. Over 2001–2005, in the target age group of 50–69 years, national annual attendance at BreastScreen Australia was 28.9% compared with 6% for MBS-funded mammography. These data, together with trend data examining MBS-funded bilateral mammography over time, suggest that the establishment of the BreastScreen Australia Program has impacted upon MBS-mammography rates. Rates of attendance over this period for MBS-funded mammography were highest in major cities and inner regional areas and were lowest in very remote areas. This is likely to be the result of availability of health services and medical professionals offering a mammography service. Analysis of participation by socio-economic status suggested that attendance for MBS-funded mammography is highest in the first (higher) quintile compared with the lower quintiles. Further analysis of this trend is required, as it is not possible to tell from the data why this may be occurring. Attendance at BreastScreen Australia was higher than MBS-funded mammography attendance for women 40–49 years and 70+ years; however, attendance at BreastScreen Australia for women in these age groups was significantly lower than for women aged 50–69 years. In the 70+ age group, there was little difference in attendance rates for either mammography service, particularly in Western Australia and the ACT. Again, it is not possible to tell from the data why this may be occurring.

106

8. PROGRAM PERFORMANCE

Keyfindings

1. BreastScreen Australia Program performance data showed that the all-size invasive cancer detection rate for women in the target age group of 50–69 years increased from 56.3 cancers per 10,000 women screened in 1996–2000 to 62.9 per 10,000 in 2001–2005 in the first screening round and from 39.2 to 43.4 cancers per 10,000 women screened in subsequent screening rounds. The cancer detection rate exceeded the NAS at both time points. The small cancer detection rate also met the NAS.

2. The all-size and small cancer detection rate for Aboriginal and Torres Strait Islander women aged 50–69 years increased over time but is still below the national rate.

3. Program sensitivity 0–24 months following subsequent screening rounds increased significantly from 66.9% in 1996–1999 to 71.0% in 2000–2003 for women aged 50–69 years.

4. The recall to assessment rate increased significantly between 1996–2000 and 2001–2005 from 6.9% to 9.2% in the first screening round and from 3.8% to 4.0% in subsequent rounds. These rates met the NAS.

5. The rescreening rate following first, second and subsequent screening rounds decreased significantly over time and does not meet the NAS. Data from 2003 showed that only 60.5% of women returned for rescreening within the recommended 2-year period after their first screen, while 80.1% returned after their third and subsequent screen.

6. The rate of technical repeat performed in 2001–2005 was 3.6% for women aged 50–69 years, with a decline seen since 1996–2000. The rate of technical repeat was higher in Aboriginal and Torres Strait Islander women at 4.5% in 2001–2005.

7. Timeliness of providing assessment to women with a screen-detected abnormality declined between 1996–2000 and 2001–2005. Of all women recalled for assessment, 79.2% were assessed within 28 days of their screening episode in 2001–2005, well below the NAS of >90%.

8. The use of FNA decreased from 14.0% of assessments in 1996–2000 to 10.0% in 2001–2005, whilst use of core biopsy increased over the same time period from 10.8% to 16.5% of assessments. The proportion of biopsies providing a definitive diagnosis increased between 1996–2000 and 2001–2005 from 67.8% to 73.2% for FNA and from 88.6% to 90.7% for core biopsy.

9. Program performance appears to vary by age group with higher age-standardised cancer detection rates seen for women aged 50–69 years and 70 years and over compared with women aged 40–49 years.

10. The Evaluation demonstrated the wealth of data collected at various levels within the Program, but highlighted the lack of coordination of data collection and the underutilisation of data at a national level. While there is value in using Program data to inform policy and research to improve the Program, current data inconsistencies inherent in multiple jurisdictional databases present challenges to data analysis and interpretation at the national level.


BreastScreenAustraliaaim3: To achieve high standards of Program management, service delivery, monitoring and evaluation, and accountability.

Evaluationquestion16: How appropriate are the reporting mechanisms and key performance indicators for the Program?

BreastScreenAustraliaobjective12: To collect and analyse data sufficient to monitor the implementation of the Program, to evaluate its effectiveness and efficiency, and to provide the basis for future policy and Program development decisions.

ThischapterconsidersEvaluationobjective1:AssessmentofoutcomesdeliveredbytheBreastScreenAustraliaProgram. Information is presented from the Participation and Performance Trends Project, which analysed trends in the performance of BreastScreen Australia against the eight agreed performance indicators45 with a particular focus on performance of the Program in screening population sub-groups. Program performance against the participation indicators is reported in Chapter 7.

The Participation and Performance Trends Project involved combining jurisdictional data for population sub-groups along the full length of the screening pathway. This type of analysis or combination of datasets had not been done previously for BreastScreen Australia data. In addition, Program performance in relation to potential harms of screening was examined. To assist with interpretation of results, the NAS are used in this chapter as benchmarks against which the results can be considered. While developed specifically for accreditation of individual services, the NAS were considered the most appropriate point of reference to benchmark the analysis as similar standards do not exist at a national level.46

The performance of the BreastScreen Australia Program is monitored through various levels of reporting. Services provide site visit reports and annual data reports as part of accreditation applications. The AIHW and BreastScreen Australia produce annual national monitoring reports based on de-identified data provided by jurisdictions. These reports are structured around the eight key performance indicators that were developed to measure Program activity, performance and outcomes. In addition, jurisdictions report against a key set of performance indicators annually under the PHOFAs,47 and the annual Report on Government Services prepared by the Productivity Commission includes high-level information on BreastScreen Australia.

45 See Chapter 4 for a list of Program performance indicators46 See Chapter 1, section 1.4 for a discussion on the use of the NAS as benchmarks for national performance47 The PHOFAs are due to expire at the end of June 2009. It is anticipated that future funding arrangements will be incorporated into the National

Health Care Agreements.

108

These many data reports vary considerably and, although they include some of the same items, they are produced separately for a range of purposes. For example, reports produced for accreditation are quite detailed and cover all areas of performance based on the 173 NAS. These data are not available for national purposes and are used only for accreditation decisions for each SAS.

8.1 PERFORMANCETRENDSRELATINGTOPERFORMANCEINDICATORS

Evaluationquestion17: How is the Program performing and what are the trends relating to performance indicators?

BreastScreenAustraliaaim2: To maximise the early detection of breast cancer in the target population.

BreastScreenAustraliaobjective3: To achieve agreed performance outcomes which minimise recall rates, retake films, invasive procedures, ‘false negatives’, and ‘false positives’, and maximise the number of cancers detected, particularly the number of small cancers.

The Evaluation analysed performance trends using relevant BreastScreen Australia performance indicators and the NAS. The performance indicators are used in annual performance monitoring reports produced for the Program by the AIHW. Data are presented primarily for the target age range of 50–69 years and results are compared to the relevant NAS where available.48

8.1.1 DETECTIONOFALL-SIZEANDSMALLINVASIVECANCERS

Detection of invasive cancer in BreastScreen Australia is reported as the number of women with all-size invasive cancers per 10,000 women screened, as well as the number of women with small (≤ 15mm) invasive cancers per 10,000 women screened. Small cancers are thus a subset of all-size invasive cancers. Detection of invasive cancer is reported by first and subsequent screening round and by population sub-group.

All-sizecancers,firstscreeninground,womenaged50–69years

Nationalaccreditationstandard2.1.1:

≥50 per 10,000 women aged 50–69 years who attend for their first screen are diagnosed with invasive breast cancer.

48 See Chapter 1, section 1.4 for a discussion on the use of the NAS as benchmarks for national performance


For the period 1996–2000, the all-size cancer detection rate per 10,000 women screened in the first screening round was 56.3 (95% CI: 54.3–58.3). In 2001–2005, the rate increased significantly to 62.9 (95% CI: 60.4–65.5). The rate in both time periods met the NAS.

Cancer detection rates increased during the first screening round in NSW, Queensland, Western Australia, Tasmania, ACT and the Northern Territory over 1996–2000, although not all increases were significant, particularly in smaller jurisdictions, due to small numbers. The rate for South Australia was higher than the national rate in 1996–2000 and remained high. The rate for Victoria remained constant over this period (Table 8.1).

Table8.1 All-size invasive breast cancer detection rate for women aged 50–69 years, by state and territory in first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005

Rate 95%CI Rate 95%CI

State/territory Firstscreeninground

NSW 54.2 51.0–57.5 60.6 56.4–65.1

Vic 59.4 55.4–63.6 58.6 53.9–63.7

Qld 55.5 51.4–59.9 67.8 61.8–74.2

WA 50.0 43.4–57.3 66.4 58.3–75.2

SA 67.1 59.4–75.6 67.5 58.0–78.1

Tas 51.5 38.9–66.9 76.2 57.4–99.1

ACT 66.8 49.1–88.9 72.8 50.7–101.3

NT 37.0 22.6–57.2 51.3 28.0–86.0

Australia 56.3 54.3–58.3 62.9 60.4–65.5

Subsequentscreeningrounds

NSW 37.7 36.2–39.3 44.0 42.6–45.5

Vic 40.5 38.7–42.3 39.0 37.5–40.6

Qld 39.4 37.2–41.8 44.9 43.0–46.7

WA 40.6 37.7–43.7 45.8 43.2–48.5

SA 41.5 38.6–44.6 46.3 43.6–49.1

Tas 33.0 28.4–38.1 46.5 41.7–51.8

ACT 39.1 32.4–46.8 41.6 35.6–48.3

NT 33.1 20.5–50.5 41.6 31.2–54.4

Australia 39.2 38.3–40.1 43.4 42.6–44.2

Notesa. Rates are the number of women with all-size invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in some jurisdictions, the reported rates should

be treated with caution and the confidence intervals around these rates consideredSource: Participation and Performance Trends Project

The all-size cancer detection rate by region increased between 1996–2000 and 2001–2005 for women living in all regions outside major cities (Table 8.2). The rate for women living in major cities was higher than for other regions in 1996–2000 and remained constant to 2001–2005. The all-size cancer detection rate was below the NAS for remote and very remote regions in 1996–2000 but reached the NAS in 2001–2005 for all regions except the remote region, where the rate was 44.7 (95% CI: 20.4–84.8) cancers detected per 10,000 women screened.

110

Table8.2 All-size invasive breast cancer detection rate for women aged 50–69 years, by region for first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005

Region Rate 95%CI Rate 95%CI

Majorcities

First screening round 60.4 57.8–63.1 60.3 57.2–63.4

Subsequent screening rounds 43.4 42.2–44.6 40.8 39.8–41.8

Innerregional



Outerregional



Remote



Veryremote



Australia

Firstscreeninground 56.3 54.3–58.3 62.9 60.4–65.5

Subsequentscreening

rounds

39.2 38.3–40.1 43.4 42.6–44.2

Notesa. Rates are the number of women with all-size invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in Remote and Very remote regions, the

reported rates should be treated with caution and the confidence intervals around these rates consideredc. The ASGC was used to create regional categoriesd. Women were placed in regional categories based on their postcode of residence, using a postcode-to-region concordanceSource: Participation and Performance Trends Project

Between 1996–2000 and 2001–2005, the all-size cancer detection rate for Aboriginal and Torres Strait Islander women attending their first screening round increased from 29.8 (95% CI: 16.3–50.1) cancers per 10,000 women screened to 38.1 (95% CI: 20.3–65.2). Despite this increase, the detection rate did not meet the NAS during either time period (Table 8.3).


Table8.3 All-size invasive breast cancer detection rate in Aboriginal and Torres Strait Islander women aged 50–69 years, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005


AboriginalandTorresStraitIslander

women



Allwomen



Notesa. Rates are the number of women with all-size invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in Aboriginal and Torres Strait Islander women,

the reported rates should be treated with caution and the confidence intervals around these rates consideredSource: Participation and Performance Trends Project

The all-size cancer detection rate for women who speak a language other than English at home attending their first screening round was similar in 1996–2000 (55.3; 95% CI: 50.2–60.7) and 2001–2005 (56.4; 95% CI: 50.4–62.9) (Table 8.4).

Table8.4 All-size invasive breast cancer in women who reported that they speak a language other than English at home aged 50–69 years, first and subsequent screening rounds, 1996–2000 and 2001–2005

Background 1996–2000 2001–2005


Non-Englishspeaking



Allwomen



Notesa. Rates are the number of women with all-size invasive breast cancers detected per 10,000 women screenedb. Non-English includes all women who reported that they speak a language other than English at homeSource: Participation and Performance Trends Project

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All-sizecancers,subsequentscreeningrounds,womenaged50–69years


≥35 per 10,000 women aged 50–69 years who attend for their second or subsequent screen are diagnosed with invasive breast cancer.

In 1996–2000, the cancer detection rate per 10,000 women aged 50–69 years attending for a subsequent screen was 39.2 (95% CI: 38.3–40.1). This rate increased in 2001–2005 to 43.4 (95% CI: 42.6–44.2). The rate over both time periods met the NAS.

The cancer detection rate increased across all jurisdictions over this time period, with the exception of Victoria, where the rate remained constant and in 2001–2005 was below the national rate (Table 8.1).

The cancer detection rate for subsequent screening rounds by region did not show a consistent trend over time. The rate in all regions met the NAS in 1996–2000 and 2001–2005, with the exception of the remote region in 2001–2005, where the rate was 33.5 (95% CI: 27.9–39.8) cancers detected per 10,000 women screened (Table 8.2).

The cancer detection rate for subsequent screens increased over time for Aboriginal and Torres Strait Islander women from 26.7 (95% CI: 17.6–38.8) per 10,000 women screened in 1996–2000 to 33.9 (95% CI: 26.0–43.6) in 2001–2005 (Table 8.3).

The cancer detection rate for subsequent screens for women who reported speaking a language other than English at home decreased from 39.0 (95% CI: 36.4–41.6) per 10,000 women screened in 1996–2000 to 33.7 (95% CI: 31.8–35.8) in 2001–2005 (Table 8.4).

Smallcancerdetectionrate(≥15mmsize),firstscreeninground,womenaged50–69years


≥25 per 10,000 women aged 50–69 years who attend for screening are diagnosed with small (≤15mm) invasive breast cancer.

The small49 cancer detection rate per 10,000 women screened increased from 32.6 (95% CI: 31.1–34.1) in 1996–2000 to 35.0 (95% CI: 33.1–36.9) in 2001–2005 (Table 8.5). These rates met the NAS (Figure 6.3). No significant difference in rates was seen between jurisdictions over time (Table 8.5).

49 Small refers to a cancer ≤15mm in diameter


Table8.5 Small (≤15 mm) invasive breast cancer in women aged 50–69 years, by state and territory, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005

State/territory Rate 95%CI Rate 95%CI

Firstscreeninground

NSW 31.3 28.9–33.8 34.5 31.3–37.9

Vic 32.3 29.3–35.4 31.4 28.0–35.1

Qld 33.4 30.2–36.8 38.9 34.4–43.8

WA 32.2 27.0–38.1 35.5 29.7–42.1

SA 39.4 33.5–46.0 34.3 27.6–42.1

Tas 29.4 20.1–41.6 47.1 32.6–65.8

ACT 34.1 21.9–50.8 43.7 27.0–66.8

NT 24.1 12.8–41.1 33.0 15.1–62.6

Australia 32.6 31.1–34.1 35.0 33.1–36.9


NSW 24.8 23.6–26.1 28.5 27.4–29.7

Vic 28.5 27.0–30.0 25.5 24.2–26.7

Qld 26.2 24.4–28.1 28.9 27.4–30.4

WA 28.3 25.9–30.9 29.0 26.9–31.2

SA 28.1 25.8–30.7 30.9 28.7–33.2

Tas 24.6 20.7–29.1 31.9 27.9–36.3

ACT 27.6 22.0–34.2 27.6 22.8–33.2

NT 22.0 12.0–37.0 25.9 17.8–36.4

Australia 26.7 26.0–27.5 28.2 27.5–28.8

Notesa. Rates are the number of women with small invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in some jurisdictions, the reported rates should

be treated with caution and the confidence intervals around these rates consideredSource: Participation and Performance Trends Project

The small cancer detection rate increased between 1996–2000 and 2001–2005 for all regions except major cities, where the rate remained similar over time (Table 8.6). The rate per 10,000 women screened in remote areas did not meet the NAS in 1996–2000 (17.3; 95% CI: 9.5–29.0) but did so in 2001– 2005. Despite an increase in the cancer detection rate in very remote regions over time (from 14.3 (95% CI: 3.9–36.5) in 1996–2000 to 19.9 (95% CI:5.4–50.9) in 2001–2005), the rate did not meet the NAS in either time period (Table 8.6). The small number of screens occurring in very remote regions is likely to have caused variation in the data, thus influencing the trend data quoted in Table 8.5.

114

Table8.6 Small (≤15 mm) invasive breast cancer in women aged 50–69 years, by region, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005

Region Rate 95%CI Rate 95%CI

Majorcities



Innerregional



Outerregional



Remote



Veryremote



Australia



Notesa. Rates are the number of women with small invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in Remote and Very remote regions, the

reported rates should be treated with caution and the confidence intervals around these rates consideredc. The ASGC was used to create regional categoriesd. Women were placed in regional categories based on their postcode of residence, using a postcode-to-region concordanceSource: Participation and Performance Trends Project

While the small cancer detection rate for Aboriginal and Torres Strait Islander women increased from 14.9 (95% CI: 6.0–30.7) per 10,000 women screened in 1996–2005 to 20.5 (95% CI: 8.3–42.3) in 2001–2005, it did not meet the NAS during either time period (Table 8.7).


Table8.7 Small (≤15 mm) invasive breast cancer in Aboriginal and Torres Strait Islander women aged 50–69 years, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005


AboriginalandTorresStrait

Islanderwomen



Allwomen



Notesa. Rates are the number of women with small invasive breast cancers detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of cancers detected in Aboriginal and Torres Strait Islander women,

the reported rates should be treated with caution and the confidence intervals around these rates consideredSource: Participation and Performance Trends Project

The small cancer detection rate for women who reported speaking a language other than English at home increased from 27.6 (95% CI: 24.0–31.5) per 10,000 women screened in 1996–2005 to 30.3 (95% CI: 25.9–35.2) in 2001–2005 and met the NAS during both time periods (Table 8.8).

Table8.8 Small (≤15 mm) invasive breast cancer in women aged 50–69 years who reported speaking a language other than English at home, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005


Non-Englishspeaking



Allwomen



Notesa. Rates are the number of women with all-size invasive breast cancers detected per 10,000 women screenedb. Non-English includes all women who reported that they speak a language other than English at homeSource: Participation and Performance Trends Project

Smallcancerdetectionrate(≤15mmsize),subsequentscreeningrounds,womenaged50–69years

The small cancer detection rate per 10,000 women screened for subsequent screening rounds increased from 26.7 (95% CI: 26.0–27.5) in 1996–2000 to 28.2 (95% CI: 27.5–28.8) in 2001–2005 (Table 8.5). A significant increase in the small cancer detection rate was seen in NSW and a significant decrease was seen in Victoria over this time period. In 2001–2005, all jurisdictions met the NAS for small cancer detection in subsequent screens.

116

The small cancer detection rate for subsequent screens by region was constant for major cities over time. An increase in the detection rate was seen for inner regional, outer regional and very remote areas and a decrease was seen for remote areas, although these changes were only significant for inner regions (Table 8.6). Apart from the remote region, all regions met the NAS.

While an increase was seen in the small cancer detection rate for subsequent screens for Aboriginal and Torres Strait Islander women (from 12.8 per 10,000 women screened (95% CI: 6.8–22.0 in 1996–2000 to 21.1 (95% CI: 15.0–29.0) in 2001–2005), the rate did not meet the NAS during either time period (Table 8.7). It should be noted that the confidence intervals for small cancer detection amongst Aboriginal and Torres Strait Islander women are very large.

The small cancer detection rate in subsequent screens remained similar over time for women who reported speaking a language other than English at home (Table 8.8). These rates were below the NAS in both 1996–2000 and 2001–2005.

8.1.2 INTERVALCANCERRATE

An interval cancer is an invasive breast cancer that is diagnosed after a screening episode that detected no cancer and before the next scheduled screening episode. A low interval cancer rate is desirable, as this would indicate the effectiveness of BreastScreen Australia in detecting the presence of breast cancer in well women (AIHW 2008).

Intervalcancerrate,firstscreeninground,womenaged50–69years


<7.5 per 10,000 women aged 50–69 years who attend for screening are diagnosed with an invasive interval breast cancer between 0 and less than 12 months following a negative screening episode.

The interval cancer rate per 10,000 women screened in the first screening round at 0–12 months was 7.0 (95% CI: 6.2–7.7) in 1996–1999 and 6.9 (95% CI: 5.7–7.7) in 2000–2003 (Table 8.9). This rate met the NAS over both time periods.

Table8.9 Interval cancers in women aged 50–69 years, first screening round, 0–12 months, 1996–1999 and 2000–2003

Rate 1996–1999 2000–2003

Number 333 206

Crude 7.0 6.9

ASR 6.9 6.7

95% CI 6.2–7.7 5.7–7.7

Note: Crude rates are the number of interval cancers detected per 10,000 women screenedASRs (age-standardised rates) are the number of interval cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project


Intervalcancerrate,subsequentscreeningrounds,womenaged50–69years

In subsequent screening rounds, the interval cancer rate per 10,000 women screened remained similar over time. The interval cancer rate was 7.6 (95% CI: 7.1–8.0) in 1996–1999 and 7.4 (95% CI: 7.0–7.8) in 2000–2003 (Table 8.10).

Table8.10 Interval cancers in women aged 50–69 years, subsequent screening rounds, 0–12 months, 1996–1999 and 2000–2003

Rates 1996–1999 2000–2003

Number 1,039 1,429

Crude 7.5 7.4

ASR 7.6 7.4

95% CI 7.1–8.0 7.0–7.8

Note: Crude rates are the number of interval cancers detected per 10,000 women screenedASRs (age-standardised rates) are the number of interval cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

The interval cancer rate at 13–24 months and 0–24 months in subsequent screening rounds has remained relatively constant over time (Figure 8.1).

Figure8.1 Interval cancers in women aged 50–69 years, subsequent screening rounds, 0–12 months, 13–24 months, and 0–24 months, 1996–2003

Rate

(per

10,

000

wom

en s

cree

ned)

0

2

4

6

8

10

12

14

16

18

20

0-24

13-24

0-12

1996 1997 1998 1999 2000 2001 2002 2003

Year

Note: Rates are the number of interval cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

118

8.1.3 PROGRAMSENSITIVITY

Program sensitivity measures the ability of the BreastScreen Australia Program to detect invasive breast cancers in women attending for screening. It is the proportion of invasive breast cancers that are detected within the Program out of all invasive breast cancers (interval cancers plus screen-detected cancers) diagnosed in Program-screened women in the 2-yearly screening interval (Participation and Performance Trends Project). There is no NAS for the Program sensitivity indicator.

Program sensitivity is high and there is evidence of improvement over time. For women aged 50–69 years, Program sensitivity in the first and subsequent screening rounds did not change significantly between 1996–1999 and 2000–2003 for either the 0–12 month or 0–24 month follow-up period (Table 8.11). However, Program sensitivity in the 0–24 month follow-up for subsequent screens increased significantly from 66.9% (95% CI: 64.3–67.9) in 1996–1999 to 71.0% (95% CI: 68.8–71.8) in 2000–2003 (Table 8.11 and Figure 8.2).

Table8.11 Program sensitivity for women aged 50–69 years, first and subsequent screening rounds, 1996–1999 and 2000–2003

Rate 1996–1999 2000–2003

Firstscreeninground

0–12months

Crude 89.0 90.0

ASR 89.0 90.5

95% CI 85.6–92.4 86.3–94.7

0–24months

Crude 75.1 77.4

ASR 75.3 78.5

95% CI 72.5–78.2 74.8–82.2


0–12months

Crude 83.5 85.6

ASR 82.7 85.1

95% CI 80.4–85.0 83.3–87.0

0–24months

Crude 66.9 71.0

ASR 66.1 70.3

95% CI 64.3–67.9 68.8–71.8

Note: Crude rates are the number of screen-detected cancers as a percentage of all cancers (screen-detected and interval cancers); ASRs (age-standardised rates) are the number of screen-detected cancers as a percentage of all cancers (screen-detected and interval cancers) and age-standardised to the population of women attending a BreastScreen Australia service in 1998.Source: Participation and Performance Trends Project


Figure8.2 Program sensitivity for women aged 50–69 years, subsequent screening rounds, at 0–12 months and 0–24 months follow-up, 1996–2003

Per cent

0

10

20

30

40

50

60

70

80

90

100

0-24

0-12

1996 1997 1998 1999 2000 2001 2002 2003

Year

Note: Rates are the number of screen-detected cancers as a percentage of all cancers (screen-detected and interval cancers) and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

8.1.4 DETECTIONOFDCIS

DCIS is a disease that involves changes in the cells in the lining of the ducts of the breast. Although the changes are like those seen in breast cancer, DCIS does not spread beyond the ducts and therefore is not an invasive cancer (NBCC 2003). Although the natural history of DCIS is not well understood, there is evidence that women with DCIS are at increased risk of subsequent development of invasive breast cancer (O’Shaughnessy 2000). BreastScreen Australia therefore aims to maximise the detection of DCIS.

DetectionofDCIS,firstscreeninground,womenaged50–69years


≥12 per 10,000 women aged 50–69 years who attend for their first screen are diagnosed with DCIS.

120

The DCIS detection rate per 10,000 women screened in the first screening round increased from 12.7 (95% CI: 11.8–13.7) in 1996–2000 to 17.0 (95% CI: 15.7–18.4) in 2001–2005. This rate met the NAS at both time periods. The DCIS detection rate increased significantly over time in Queensland and Western Australia (Table 8.12).

Table8.12 DCIS in women aged 50–69 years, by state and territory, first and subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005


Firstscreeninground

NSW 12.4 10.9–14.0 15.0 12.9–17.3

Vic 14.0 12.1–16.2 17.8 15.2–20.6

Qld 10.3 8.5–12.2 16.1 13.3–19.4

WA 15.1 11.6–19.4 26.3 21.3–32.1

SA 13.4 10.0–17.5 15.1 10.8–20.5

Tas 17.5 10.5–27.3 13.8 6.6–25.5

ACT 11.4 4.9–22.4 12.5 4.6–27.2

NT 13.0 5.2–26.7 14.6 4.0–37.5

Australia 12.7 11.8–13.7 17.0 15.7–18.4


NSW 7.9 7.2–8.6 9.4 8.7–10.1

Vic 8.0 7.2–8.8 9.8 9.1–10.6

Qld 8.0 7.0–9.1 10.3 9.5–11.3

WA 10.2 8.8–11.8 14.4 13.0–15.9

SA 11.9 10.3–13.5 9.9 8.7–11.2

Tas 13.0 10.2–16.4 11.6 9.2–14.4

ACT 9.5 6.4–13.7 13.2 9.9–17.2

NT 7.9 2.6–18.4 13.3 7.8–21.4

Australia 8.7 8.3–9.2 10.4 10.0–10.8

Notesa. Rates are the number of women with DCIS detected per 10,000 women screenedb. Due to the small populations and proportionately small numbers of DCIS detected in some jurisdictions, the reported rates should be

treated with caution and the confidence intervals around these rates consideredSource: Participation and Performance Trends Project

The DCIS detection rate increased in major cities, inner regional, outer regional and remote areas over time. In very remote areas, the rate decreased from 17.8 per 10,000 women screened (95% CI: 5.8–41.6) in 1996–2000 to 9.9 (CI: 1.2–35.9) in 2001–2005.

The DCIS detection rate for Aboriginal and Torres Strait Islander women increased from 10.7 per 10,000 women screened (95% CI: 3.5–24.9) in 1996–2000 to 20.5 (95% CI:8.3–42.3) in 2001–2005. The small number of DCIS detected and consequently large confidence intervals preclude meaningful comparisons.


The DCIS detection rate for women who reported speaking a language other than English at home was significantly higher than the national rate in 1996–2000 at 16.6 per 10,000 women screened (95% CI: 13.9–19.7). The rate remained constant over time and was 17.3 (95% CI: 14.0–21.0) in 2001–2005.

DetectionofDCIS,subsequentscreeningrounds,womenaged50–69years


>7 per 10,000 women aged 50–69 years who attend for their second or subsequent screen are diagnosed with DCIS.

The DCIS detection rate per 10,000 women screened in subsequent screening rounds increased significantly over time, from 8.7 (95% CI: 8.3–9.2) in 1996–2000 to 10.4 (95% CI: 10.0–10.8) in 2001–2005. The rate met the NAS at both time periods (Table 8.12). The DCIS detection rate increased significantly over time in NSW, Victoria, Queensland and Western Australia between 1996–2000 and 2001–2005 (Table 8.12).

The DCIS detection rate for subsequent screening rounds increased significantly, in line with the increase in the national rate, during the same time period for major cities and inner regional areas. Small but non-significant increases were seen in the other geographical areas.

The DCIS detection rate for subsequent screening rounds increased for Aboriginal and Torres Strait Islander women from 4.9 per 10,000 women screened (95% CI: 1.6–11.5) in 1996–2000 to 7.8 (95% CI: 4.3–13.1) in 2001–2005. The small number of DCIS detected and consequently large confidence intervals preclude any comparisons.

The DCIS detection rate for subsequent screening rounds in women who reported speaking a language other than English at home remained constant over time, with a rate of 8.5 per 10,000 women screened (95% CI: 7.3–9.8) in 1996–2000 and 8.1 (95% CI: 7.1–9.1) in 2001–2005. The rate in 2001–2005 was significantly below the national rate but still met the NAS.

8.1.5 RECALLTOASSESSMENT

The recall to assessment indicator is reported as the proportion of all women screened in a given calendar year who were recalled for assessment for mammographic reasons (Participation and Performance Trends Report). The recall to assessment indicator is an important measure for ensuring the number of investigations are minimised for women without comprising the number of cancers detected.

122

Recalltoassessment,firstscreeninground,womenaged50–69years


<10% of women aged 50–69 years who attend for their first screen are recalled for assessment

The recall to assessment rate following the first screening round increased from 6.9% (95% CI: 6.8–6.9) in 1996–2000 to 9.2% (95% CI: 9.1–9.3) in 2001–2005. The rate met the NAS during both time periods.

A significant increase in recall to assessment rates occurred in all jurisdictions during this time period (Table 8.13). South Australia had the lowest recall to assessment rate during both periods, while the highest rate in both periods was in Tasmania.

Table8.13 Recall to assessment, mammographic reasons, for women aged 50–69 years, by state and territory, first screening round, 1996–2000 and 2001–2005

1996–2000 2001–2005


NSW 6.5 6.3–6.6 8.8 8.6–9.0

Vic 7.5 7.3–7.6 9.7 9.5–10.0

Qld 7.3 7.1–7.4 10.0 9.7–10.2

WA 8.0 7.7–8.3 9.8 9.4–10.2

SA 4.2 4.0–4.5 6.0 5.6–6.5

Tas 8.6 8.0–9.2 10.9 10.1–11.8

ACT 5.1 4.5–5.7 8.1 7.1–9.2

NT 4.2 3.6–4.8 8.7 7.4–10.1

Australia 6.9 6.8–6.9 9.2 9.1–9.3

Note: Rates are the number of women recalled for assessment as the percentage of women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

Recalltoassessment,subsequentscreeningrounds,womenaged50–69years


<5% of women aged 50–69 years who attend for their second or subsequent screen are recalled for assessment.

The recall to assessment rate following subsequent screens increased from 3.8% (95% CI: 3.8–3.8) in 1996–2000 to 4.0% (95% 4.0–4.0) in 2001–2005. The rate met the NAS at both time periods. The recall to assessment rate increased over time in all jurisdictions with the exception of Western Australia, where the rate fell, and Queensland where the rate did not change (Table 8.14). South Australia had the lowest recall to assessment rate in both periods.


Table8.14 Recall to assessment, mammographic reasons for women aged 50–69 years, by state and territory, subsequent screening rounds, 1996–2000 and 2001–2005

1996–2000 2001–2005


NSW 3.6 3.6–3.7 4.1 4.1–4.2

Vic 4.1 4.0–4.1 4.2 4.2–4.3

Qld 4.4 4.3–4.5 4.4 4.3–4.5

WA 4.3 4.2–4.4 3.3 3.2–3.4

SA 2.1 2.0–2.2 2.4 2.3–2.5

Tas 4.6 4.4–4.8 5.5 5.3–5.7

ACT 3.4 3.2–3.6 4.4 4.2–4.6

NT 2.4 2.0–2.9 3.3 3.0–3.7

Australia 3.8 3.8–3.8 4.0 4.0–4.0


8.1.6 RESCREENING

Evaluationquestion18: To what extent are women rescreened in accordance with the Program’s recommended screening interval?

BreastScreenAustraliaobjective2: To rescreen all women in the Program at 2 yearly intervals.

The rescreening indicator measures the proportion of women who return for screening in the Program within the recommended 2-yearly screening interval. A high rescreen rate is important for maintaining the Program participation rate. The rescreening rate is reported as the proportion of all women screened in a given year whose screening outcome was a recommendation to return for screening in 2 years and who returned for a screen within 27 months. The screening interval of 27 months is used instead of the recommended screening interval of 24 months to allow for potential delays in screening availability and data transfer. While the indicator uses the target age group 50–69 years, only women 50–67 years are reported against the rescreen indicator.50

50 This is because women aged 68–69 years at one screen, are outside the 50–69 year age group 27 months after this screen

124

Rescreeningrate,firstscreeninground,womenaged50–69years


>75% of women aged 50–67 years who attend for their first screen within the Program are rescreened within 27 months.

The rescreening rate for women aged 50–67 years following the first screening round was 60.5% (95% CI: 59.8–61.2) in 2003, a decrease from 2000 when the rescreening rate was 66.3% (95% CI: 65.6–66.9). This rate did not meet the NAS at either time point.

The rescreening rate following the first screening round decreased in all jurisdictions over this time period (Table 8.15). All jurisdictions failed to meet the NAS in all years between 2000 and 2003, with only the ACT coming close to achieving the standard at 74.4% (95% CI: 67.5–81.9) in 2003.

Rescreeningrate,subsequentscreeningrounds,womenaged50–69years

NationalAccreditationStandard1.2.2:

> 90% of women aged 50–67 years participating in their second and subsequent rescreens within the Program are rescreened within 27 months of their previous screening episode.

Compared to the rescreening rate following the first screening round, the rescreening rate was higher in women following their second screen and increased further following third and subsequent screens. However the rescreening rate following second and subsequent screens decreased significantly over time (second screening round: 75.7% (95% CI: 75.2–76.3) in 2000 and 69.5% (95% CI: 68.8–70.1) in 2003; third and subsequent screening rounds: 84.2% (95% CI: 83.8–84.5) in 2000 and 80.1% (95% CI: 79.8–80.4) in 2003). These rates did not meet the NAS.

A decrease in the rescreening rate occurred over time in all states and territories with the exception of the ACT, where the rescreening rates following second and subsequent screening rounds increased between 2000 and 2003. In 2003, the second round rescreening rate was 82.4% (95% CI: 75.8–89.4) and the subsequent round rescreening rate was 90.0% (95% CI: 87.6–92.4), the latter meeting the NAS for subsequent rescreens (Table 8.15 and Figure 8.3).


Table8.15 Rescreen for women aged 50–67 years, by state and territory, following, first, second, and subsequent screening rounds, 2000–2003

NSW Vic Qld WA SA Tas ACT NT Australia

Firstscreeninground

2003 rate (%) 54.8 61.9 69.4 58.5 60.4 56.4 74.4 44.2 60.5

95% CI 53.7–

55.8

60.1–

63.7

67.8–

71.0

56.1–

61.0

57.2–

63.8

52.9–

60.1

67.5–

81.9

37.2–

51.8

59.8–61.2

2002 rate (%) 56.1 64.3 68.2 61.8 61.5 70.2 47.5 47.2 61.6

95% CI 55.1–57.1 62.9–

65.8

66.7–

69.7

59.6–

64.0

58.6–

64.4

65.1–

75.6

42.3–

53.1

39.2–

55.9

60.9–62.2

2001 rate (%) 55.3 65.4 72.7 62.2 64.7 72.6 47.7 40.5 62.9

95% CI 54.4–

56.3

64.3–

66.6

71.2–

74.2

60.0–

64.4

61.8–

67.6

67.8–

77.7

42.7–

53.1

34.6–

46.9

62.2–63.5

2000 rate (%) 62.7 67.7 71.1 60.3 66.4 68.5 56.1 49.6 66.3

95% CI 61.6–

63.8

66.3–

69.1

69.8–

72.5

57.9–

62.9

64.0–

68.9

64.1–

73.1

50.9–

61.6

42.9–

56.8

65.6–66.9

Secondscreeninground

2003 rate (%) 64.3 71.6 75.9 63.3 69.9 74.9 82.4 56.4 69.5

95% CI 63.3–

65.4

70.5–

72.9

74.4–

77.4

61.3–

65.4

67.2–

72.7

70.3–

79.8

75.8–

89.4

49.2–

64.3

68.8–70.1

2002 rate (%) 62.9 74.9 76.0 67.9 70.0 75.2 53.7 60.4 70.3

95% CI 61.8–

63.9

73.6–

76.3

74.7–

77.3

65.6–

70.2

67.8–

72.2

70.6–

80.0

49.1–

58.6

53.0–

68.4

69.7–71.0

2001 rate (%) 63.1 74.2 80.9 66.4 75.3 78.7 58.2 62.4 71.9

95% CI 62.1–

64.1

72.8–

75.6

79.7–

82.2

64.4–

68.5

73.2–

77.5

74.6–

83.1

53.3–

63.5

55.6–

69.7

71.3–72.5

2000 rate (%) 72.2 75.4 80.3 69.6 77.9 76.8 62.4 64.3 75.7

95% CI 71.3–

73.2

74.1–

76.7

79.2–

81.3

67.7–

71.6

75.8–

80.1

73.3–

80.3

57.6–

67.5

58.7–

70.2

75.2–76.3


2003 rate (%) 72.9 83.3 86.3 75.5 84.3 84.3 90.0 76.6 80.1

95% CI 72.4–

73.4

82.7–

84.0

85.6–

86.9

74.6–

76.4

83.3–

85.3

82.6–

86.0

87.6–

92.4

72.7–

80.6

79.8–80.4

2002 rate (%) 73.6 84.7 86.4 81.0 83.7 85.6 67.4 75.6 80.7

95% CI 73.1–

74.1

84.1–

85.4

85.7–

87.1

80.1–

82.0

82.8–

84.7

83.9–

87.3

65.4–

69.4

71.4–

80.1

80.4–81.0

2001 rate (%) 74.1 84.9 88.4 82.0 87.2 88.2 73.4 77.3 81.8

95% CI 73.6–

74.6

84.3–

85.6

87.7–

89.2

81.1–

83.0

86.2–

88.2

86.4–

90.0

71.3–

75.6

72.8–

81.9

81.5–82.1

2000 rate (%) 81.8 85.3 87.0 81.9 88.4 85.2 75.7 80.3 84.2

95% CI 81.3–

82.4

84.6–

86.0

86.2–

87.9

80.9–

82.9

87.3–

89.5

83.4–

86.9

73.4–

78.1

74.3–

86.5

83.8–84.5

Notesa. Rates are the number of women attending for rescreening as a percentage of women screened in each screening round and

age-standardised to the population of women attending a BreastScreen Australia service in 1998b. Women 50–67 are reported against the rescreen indicator, as after 27 months of their screen, a woman aged 68 or 69 years would

be outside the 50–69 year age groupSource: Participation and Performance Trends Project

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Figure8.3 Rescreen for women aged 50–67 years, by state and territory, first, second, and third and subsequent screening rounds, 2003

Per cent

0

10

20

30

40

50

60

70

80

90

100


First screening round Second screening round Subsequent rounds

Source: Participation and Performance Trends ProjectNote: Women aged 50–67 years are reported against the rescreen indicator, as after 27 months of their screen, a woman aged 68 or 69 years would be outside of 50–69 year age group

8.2 OTHERTRENDSINPERFORMANCEOFBREASTSCREENAUSTRALIA

8.2.1 TECHNICALREPEATSTATUS

Technical repeat status indicates whether or not additional film(s) were taken due to the technically unsatisfactory nature of a woman’s films at the screening visit. This is undertaken as part of the quality assurance process to ensure high-quality films. These additional films are called technical repeats, and may be taken at the initial screening visit, or at a subsequent screening visit. Technical repeats are associated with higher levels of discomfort and radiation experienced by women, but are performed to minimise morbidity associated with missed cancers.

The rate of technical repeat performed presented here is calculated as the number of women who have a technical repeat performed at an initial or subsequent screening visit as a proportion of all women screened. It does not include those women for whom a technical repeat was required but refused by the woman.

It should be noted that this is different to NAS 2.10.3 for technical repeat, which is calculated as the total number of technical repeat films as a proportion of the total number of films taken.

The rate of women aged 50–69 years who had a technical repeat performed decreased from 4.0% (95% CI: 4.0–4.0) in 1996–2000 to 3.6 (95% CI: 3.6–3.6) in 2001–2005 (Table 8.16).


The remaining data in this section are reported for women aged 40 years and over. It should be noted that there may be a variation in the measurement of technical repeat status across jurisdictions, given the much lower rate of technical repeat performed in Victoria and Tasmania. The proportion of women who had a technical repeat performed decreased in most jurisdictions, with the exception of Queensland, where rate was unchanged at 5.6% in 1996–2000 and 2001–2005 (Table 8.16). Victoria and Tasmania had the lowest rate of technical repeat performed. In 2001–2005, the rate was 0.3% in Victoria (95% CI: 0.3–0.3) and 0.4% in Tasmania (95% CI: 0.4–0.4). In 2001–2005 the highest rates of technical repeat performed were in South Australia (5.9%, 95% CI: 5.6–6.0) and the Northern Territory (6.4%, 95% CI: 6.0–6.7).

Table8.16 Technical repeat performed, women aged 40 years and over and women 50–69 years, by state and territory, 1996–2000 and 2001–2005

State/territory 1996–2000 2001–2005

Women40yearsand

over


NSW 4.7 4.7–4.8 4.0 4.0–4.0

Vic 0.3 0.3–0.3 0.3 0.3–0.3

Qld 5.6 5.6–5.7 5.6 5.5–5.6

WA 5.5 5.5–5.6 5.1 5.1–5.2

SA 8.0 7.9–8.1 5.9 5.8–6.0

Tas 0.1 0.0–0.1 0.4 0.4–0.4

ACT 6.9 6.7–7.1 5.7 5.5–5.9

NT 4.6 4.3–4.9 6.4 6.0–6.7

Australia

Women 40 years and over 4.1 4.1–4.1 3.7 3.7–3.7

Women 50 –69 years 4.0 4.0–4.0 3.6 3.6–3.6

Notesa. Rates are the number of women who had a technical repeat performed at initial or subsequent screening visit as a proportion of the

total number of screens.b. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

The proportion of women who had a technical repeat performed decreased in all regions (major cities, inner regional, outer regional, remote and very remote) between 1996–2000 and 2001–2005. The rate of technical repeat performed in very remote areas (4.1%, 95% CI: 3.9–4.4) and major cities (3.9%, 95% CI: 3.8–3.9) was higher than the national rate in 2001–2005.

Similarly, the proportion of women who had a technical repeat performed decreased between 1996–2000 and 2001–2005 for all socio-economic groups. In 2001–2005, rates were lowest in the first quintile, the highest socioeconomic group (3.4%, 95% CI: 3.4–3.5), and highest in the fourth quintile (4.0%, 95% CI: 4.0–4.0).

128

For Aboriginal and Torres Strait Islanders, the proportion of women who had a technical repeat performed remained high despite a non-significant decrease between 1996–2000 and 2001–2005 (Table 8.17). The rate of technical repeat performed decreased from 5.1% (95% CI: 4.8–5.4) in 1996–2000 to 4.5% (95% CI: 4.3–4.8) in 2001–2005.

Table8.17 Technical repeat performed in Aboriginal and Torres Strait Islander women aged 40 years and over, 1996–2000 and 2001–2005

1996–2000 2001–2005


Aboriginal and Torres Strait Islander 5.1 4.8–5.4 4.5 4.3–4.8

All women 4.1 4.1–4.1 3.7 3.7–3.7


total number of screensb. All women indicates all Australian women, including Aboriginal and Torres Strait Islander womenc. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

The rate of technical repeat performed in women who speak a language other than English at home decreased over time from 3.9% (95% CI: 3.8–3.9) in 1996–2000 to 3.6% (95% CI: 3.6–3.7) in 2001–2005 (table 8.18).

Table8.18 Technical repeat performed in women aged 40 years and over who reported speaking a language other than English at home, 1996–2000 and 2001–2005

1996–2000 2001–2005


Non-English speaking 3.9 3.8–3.9 3.6 3.6–3.7

All women 4.1 4.1–4.1 3.7 3.7–3.7


total number of screensb. Non-English indicates a person who reports that they speak a language other than English at home, and is based on BreastScreen

Australia Data Dictionary data element ‘B.4 Main language other than English spoken at home’c. All women indicates all Australian women, including women who report that they speak a language other than English at homed. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project


8.2.2 TIMELINESS

Timeliness is an important component in a screening program as it ensures that the results of screening are provided in a timely and appropriate manner for women, and if required, that further assessment is carried out promptly. Timely response assists with minimising any anxiety women may experience in relation to screening.

The Evaluation reports, for the first time, national data on the timeliness of BreastScreen Australia services.

Timebetweenscreeningandresult

Data presented for this indicator are the number of women aged 40 years and over with a time between date of screen and date of screening result of 28 days or less as a proportion of the total number of women screened with a date of screening result recorded.


All women are notified of results of their screening in writing, within 28 calendar days of the date of screening.

The proportion of women screened, aged 40 and over, who received their result within 28 calendar days decreased from 98.5% (95% CI: 98.5–98.5) in 1996–2000 to 95.3% (95% CI: 95.3–95.3) in 2001–2005. This did not meet the NAS at either time point. The median number of days between screening and result remained fairly constant over this same time period (7–8 days), indicating that the majority of women receive their results in a reasonable time frame. Data show that jurisdictions performed well overall in relation to time between screening and result (Table 8.19) with the exception of NSW, Victoria and the Northern Territory, where timeliness in providing results decreased between 1996–2000 and 2001–2005. In the Northern Territory the Program operations differ to accommodate the degree of remoteness and this in turn affects the time between screening and result.

Table8.19 Proportion of women aged 40 years and over who received their result within 28 days, by state and territory, 1996–2000 and 2001–2005

1996–2000 2001–2005


NSW 97.4 97.3–97.4 88.8 88.7–88.9

Vic 99.8 99.8–99.8 96.2 96.2–96.3

Qld 98.0 97.9–98.0 98.8 98.8–98.8

WA 99.8 99.8–99.8 99.9 99.9–99.9

SA 100.0 100.0–100.0 99.8 99.8–99.8

Tas 99.9 99.9–99.9 99.3 99.3–99.4

ACT . . . . . . . .

NT 93.4 93.1–93.8 85.2 84.7–85.7

Australia 98.5 98.5–98.5 95.3 95.3–95.3

Note: Data for the ACT were not available at the time of the data request for the Participation and Performance Trends ProjectSource: Participation and Performance Trends Project

130

Timebetweenscreeningandassessment

Data presented for this indicator are the number of women aged 40 years and over with a time between date of screen and date of first assessment of 28 days or less as a proportion of the total number of women recalled to assessment.


≥90% of women requiring assessment attend an assessment visit within 28 calendar days of their screening visit.

The proportion of women attending an assessment visit within 28 calendar days of their screening visit decreased from 85.7% (95% CI: 85.5–85.8) in 1996–2000 to 79.2% (95% CI: 79.0–79.4) in 2001–2005 (Table 8.20). These rates did not meet the NAS. For women aged 40 years and over, the median number of days to assessment increased over this time period from 15 to 20 days and the proportion of women not assessed within 28 days increased steadily from 2002 onwards (Figure 8.4).

Table8.20 Proportion of women aged 40 years and over with a time between screening and assessment of 28 days or less, by state and territory, 1996–2000 and 2001–2005

1996–2000 2001–2005


NSW 66.6 66.1–67.0 61.5 61.1–61.9

Vic 94.8 94.6–95.0 85.6 85.4–85.9

Qld 90.8 90.6–91.1 87.6 87.4–87.9

WA 96.2 95.9–96.5 92.4 92.0–92.8

SA 95.5 95.0–96.0 81.3 80.6–82.1

Tas 83.6 82.6–84.6 70.9 69.9–72.0

ACT 80.6 79.0–82.3 59.6 57.8–61.4

NT 61.4 57.5–65.4 40.7 37.7–43.7

Australia 85.7 85.5–85.8 79.2 79.0–79.4



Figure8.4 Median time between screening and assessment, and proportion of women aged 40 years and over, with a time between screening and assessment of 28 days or less, 1996 –2005

Median time (days) Per cent

0

5

10

15

20

25

30

35

40

45

50

0

10

20

30

40

50

60

70

80

90

100

Per cent

Median time (days)

2005200420032002200120001999199819971996

Notesa. Median time is the median number of days from date of screen to date of first assessmentb. The BreastScreen Australia National Accreditation Standard 3.7.2 requires that ≥90% of women requiring assessment attend an

assessment visit within 28 calendar days of their screening visitc. Data presented are the number of women with a time between date of screen and date of first assessment of 28 days or less as a

proportion of the total number of screens with an assessment visit recordedd. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

The median time in days, between screening and assessment for women aged 40 years and over increased for all jurisdictions, with the exception of NSW, where the median number of days between screening and assessment was 21 in 1996 and 2005, despite an increase in the intervening years. The increase in median number of days between screening and assessment was most marked for Victoria (from 14 days in 1996 to 24 days in 2005) and South Australia (from 15 days in 1996 to 27 days in 2005). In 2005, Queensland and Western Australia had the lowest median number of days between screening and assessment (both 15 days) and the Northern Territory and South Australia had the highest median number of days (32 and 27 days, respectively) (Figure 8.5).

132

Figure8.5 Median number of days between screening and assessment for women aged 40 years and over, by state and territory, 1996 and 2005

1996

Med

ian

Day

s

2005

0

10

20

30

40

50

60

70

80

90

100



The proportion of women with a time between screening and assessment of 28 days or less decreased between 1996–2000 and 2001–2005 for all jurisdictions (Figure 8.6), with the exception of Western Australia, which, despite a slight decrease, had the highest proportion of women with a time between screening and assessment of 28 days or less (92.4%; 95% CI: 92.0–92.8 in 2001–2005). The ACT, Northern Territory and NSW had the lowest proportion of women, with a time between screening and assessment of 28 days or less and decreases seen between 1996–2000 and 2001–2005 for each jurisdiction (ACT: from 80.6% (95% CI: 79.0–82.3) to 59.6% (95% CI: 57.8–61.4); Northern Territory: from 61.4% (95% CI: 57.5–65.4) to 40.7% (95% CI: 37.7–43.7); NSW: from 66.6% (95% CI: 66.1–67.0) to 61.5% (95% CI: 61.1–61.9)) (Table 8.20 and Figure 8.6).


Figure8.6 Proportion of women aged 40 years and over with a time between screening and assessment of 28 days or less, by state and territory, 1996–2000 and 2001–2005

100

90

80

70

60

50

40

30

20

10

0

NSW Vic Qld WA SA Tas ACT NT Australia

Per cent within 28 days

1996–2000

2001–2005


The median time between screening and assessment increased for all regions between 1996 and 2005. The increase was greatest in very remote areas, where the median time increased from 15 days in 1996 to 33 days in 2005. The proportion of women with a time between screening and assessment of 28 days or less decreased for all regions, with very remote regions again having the lowest proportion of women assessed within 28 days (58.4%; 95% CI: 55.7–61.2). Outer regional areas had the next lowest proportion of women with a time between screening and assessment of 28 days or less at 69.7% (95% CI: 69.1–70.3).

The median number of days between screening and assessment by socio-economic status did not vary significantly and was between 18 and 21 days in 2005. The proportion of women with a time between screening and assessment of 28 days or less was lowest for women in the lower socio-economic groups (76.3% (95% CI: 75.9–76.7) for women in the fourth quintile and 75.0% (95% CI: 74.6–75.5) for women in the fifth quintile).

For Aboriginal and Torres Strait Islander women, the median number of days between screening and assessment increased from 19 days in 1996 to 26 days in 2005. The proportion of women attending assessment within 28 days or less also decreased for this group from 75.1% (95% CI: 72.6–77.5) in 1996–2000 to 66.7% (95% CI: 64.4–69.0) in 2001–2005.

The proportion of women who reported speaking a language other than English at home with a time between screening and assessment of 28 days or less decreased from 83.6% (95% CI: 83.1–84.1) in 1996–2000 to 75.9% (75.4–76.4) in 2001–2005. The median number of days to assessment increased for this group from 16 days in 1996 to 21 days in 2005.

134

8.2.3 INVASIVEASSESSMENTPROCEDURES

FNA and core biopsy are the two primary invasive procedures performed at assessment within BreastScreen Australia.51 Data presented are the number of assessments with a FNA or core biopsy recorded as a proportion of the total number of assessments.

In the target age group of 50–69 years, the proportion of FNAs performed at assessment decreased from 14.0% (95% CI: 14.0–14.4) of assessments in 1996 to 10.0% (95% CI:9.9–10.2) of assessments in 2005. For women aged 40 years and over, the rate decreased from 13.9% (95% CI: 14.0–14.3) in 1996 to 9.9% (95% CI: 9.8–10.1) in 2005 (Figure 8.7). Conversely the proportion of core biopsies performed at assessment increased from 10.8% (95% CI: 10.8–11.2) in 1996 to 16.5% (95% CI: 16.5–16.9) in 2005 for women aged50–69 years. For women aged 40 years and over, the proportion of core biopsy assessments increased from 10.4% (95% CI: 10.5–10.8) in 1996 to 15.8% (95%CI: 15.9–16.3) in 2005 (Figure 8.7).

Figure8.7 Fine needle aspiration (FNA) and core biopsy conducted as a proportion of all assessments for women aged 40 years and over, 1996–2005

Per cent

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Year

0

5

10

15

20

25

30

Core biopsy

Fine needle biopsy

Notesa. Data presented are the number of assessments with FNA and core biopsy recorded as a proportion of the total number of

assessmentsb. All FNA and core biopsy results are counted in each assessment episodec. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

51 See Chapter 4 for discussion of the assessment process and procedures performed. Open biopsies have been excluded from this analysis as these procedures are not always performed for diagnosis alone and are not performed within BreastScreen Australia in a number of jurisdictions.


The rate of FNA at assessment decreased significantly in all jurisdictions between 1996–2000 and 2001–2005, with the exception of the ACT, where the decrease did not reach statistical significance (Table 8.21).

Over the same period, the rate of core biopsy increased significantly in all jurisdictions, with the exception of the ACT, where the rate of core biopsy was already higher than other jurisdictions in 1996–2000 and remained relatively similar at 2001–2005. Western Australia had the greatest increase in core biopsy rate, from 13.3% (95% CI: 12.8–13.9) in 1996–2000 to 28.4% (95% CI: 27.6–29.1) in 2001–2005 (Table 8.22).

The rate of use of FNA and core biopsy at assessment varied markedly between jurisdictions. In 2001–2005, the rate of FNA at assessment was highest in South Australia at 32.3% (95% CI: 31.2–33.4) and lowest in NSW at 4.7% (95% CI: 4.5–4.9) (Table 8.21). In 2001–2005 the use of core biopsy at assessment was lowest in Tasmania at 5.9% (95% CI: 5.3–6.4) and highest in Western Australia at 28.4% (Table 8.22).

Table8.21 Fine needle aspiration (FNA) in women aged 40 years and over, by state and territory, 1996– 2000 and 2001–2005

1996–2000 2001–2005


NSW 8.0 7.8–8.3 4.7 4.5–4.9

Vic 9.1 8.8–9.3 6.1 5.9–6.3

Qld 13.0 12.6–13.3 9.8 9.5–10.0

WA 28.3 27.5–29.1 18.3 17.7–18.9

SA 42.8 41.3–44.3 32.3 31.2–33.4

Tas 33.6 32.1–35.1 28.8 27.6–30.1

ACT 14.5 12.9–16.1 11.9 10.7–13.2

NT 27.2 23.2–31.6 7.6 6.1–9.4

Australia 13.9 13.8–14.1 9.9 9.7–10.0

Notesa. Data presented are the number of assessments with a FNA recorded as a proportion of the total number of assessmentsb. All fine needle biopsy results are counted in each assessment episodec. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

136

The rate of invasive procedures at assessment by region, socio-economic status and for Aboriginal and Torres Strait Islander women and women who reported speaking a language other than English at home reflected the national trend of decreasing use of FNA and increasing use of core biopsy between 1996–2000 and 2001–2005.

Table8.22 Core biopsy for women aged 40 years and over, by state and territory, 1996–2000 and 2001–2005

1996–2000 2001–2005


NSW 11.6 11.3–11.9 15.0 14.7–15.3

Vic 11.2 10.9–11.5 14.9 14.6–15.2

Qld 8.3 8.1–8.6 14.3 14.0–14.6

WA 13.3 12.8–13.9 28.4 27.6–29.1

SA 8.1 7.5–8.8 17.6 16.8–18.4

Tas 0.3 0.2–0.5 5.9 5.3–6.4

ACT 21.3 19.5–23.3 22.1 20.4–23.9

NT 2.6 1.5–4.3 14.0 11.9–16.4

Australia 10.4 10.2–10.5 15.8 15.6–16.0

Notesa. Data presented are the number of assessments with a core biopsy recorded as a proportion of the total number of assessmentsb. All core biopsy results are counted in each assessment episodec. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

Invasiveassessmentresults

The accuracy of invasive assessment procedures in providing a definitive diagnosis is important to minimise false-positive (a cancer diagnosis when none present) and false-negative (a benign diagnosis when cancer present) results and limit the number of women who require a more invasive procedure, such as a diagnostic open biopsy, to determine a diagnosis. This section presents the number of invasive cancer assessment results as a proportion of all FNA (Table 8.23) and core biopsies (Table 8.24) performed at assessment.

Inadequate results for FNAs decreased significantly from 15.5% (95% CI: 15.0–16.0) in 1996–2000 to 11.5% (95% CI: 11.0–11.9) in 2001–2005. Malignant results of FNAs also decreased over this time period from 25.1% (95% CI: 24.5–25.8) in 1996–2000 to 23.0% (95% CI: 22.4–23.7) in 2001–2005. However, benign results for FNAs increased significantly over this period from 41.7% (95% CI: 40.9–42.5) in 1996–2000 to 48.7% (95% CI: 47.8–49.6) in 2001–2005 (Table 8.23).


Table8.23 Fine needle aspiration (FNA) results and final cancer status results in women aged 40 years and over, 1996–2000 and 2001–2005

1996–2000 2001–2005

Result Rate 95%CI Rate 95%CI

Fineneedleresult

Inadequate (as per cent of procedures) 15.5 15.0–16.0 11.5 11.0–11.9

Final result was no cancer 12.0 11.6–12.5 9.0 8.6–9.4

Final result was invasive cancer/DCIS 3.1 2.9–3.3 2.2 2.0–2.4

Benign (as per cent of procedures) 41.7 40.9–42.5 48.7 47.8–49.6



Atypical (as per cent of procedures) 8.3 7.9–8.6 8.2 7.8–8.6



Suspicious (as per cent of procedures) 8.4 8.1–8.8 7.1 6.8–7.5



Malignant (as per cent of procedures) 25.1 24.5–25.8 23.0 22.4–23.7



Notesa. Rate is the number of FNA results in each category as a proportion of the total number of FNAs performedb. Data presented are the number of assessments with a FNA result recorded, and the number of these with a final cancer status result

of either no cancer or invasive cancer/DCIS as determined by the AIHW-derived data element screen detected cancer statusc. Final result was no cancer indicates no invasive cancer, DCIS or LCIS. Final result was invasive cancer/DCIS includes all cases of invasive

cancer and DCIS. LCIS and unknown results were included in the total FNA results, but not included in either final result categoryd. Only the first FNA result is counted in each assessment episodee. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

For core biopsies, inadequate results decreased significantly over time, while benign results decreased marginally from 51.8% (95% CI: 50.8–52.9) in 1996–2000 to 49.5% (95% CI: 48.8–50.3) in 2001–2005. There was a significant increase in a malignant results for core biopsies, from 35.9% (95% CI: 35.1–36.8) in 1996– 2000 to 40.3% (95% CI: 39.6–40.9) in 2001–2005 (Table 8.24).

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Table8.24 Core biopsy results and final cancer status results for women aged 40 years and over, 1996–2000 and 2001–2005

1996–2000 2001–2005

Result Rate 95%CI Rate 95%CI

Corebiopsyresult

Inadequate (as per cent of procedures) 3.8 3.5–4.0 2.2 2.1–2.4



Benign (as per cent of procedures) 51.8 50.8–52.9 49.5 48.8–50.3



Atypical (as per cent of procedures) 5.3 5.0–5.7 5.5 5.3–5.8



Suspicious (as per cent of procedures) 2.3 2.1–2.5 1.6 1.5–1.7



Malignant (as per cent of procedures) 35.9 35.1–36.8 40.3 39.6–40.9



Notesa. Rate is the number of core biopsies in each category as a proportion of the total number of core biopsiesb. Data presented are the number of assessments with a core biopsy result recorded, and the number of these with a final cancer status

result of either no cancer or invasive cancer/DCIS as determined by the AIHW-derived data element screen detected cancer statusc. Final result was no cancer indicates no invasive cancer, DCIS or LCIS. Final result was invasive cancer/DCIS includes all cases of

invasive cancer and DCIS. LCIS and unknown results were included in the total core biopsy results, but not included in either final result category

d. Only the first core biopsy result is counted in each assessment episodee. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

Accuracyinpredictingcancerstatus

FNA and core biopsy are performed to obtain a definitive diagnosis of a lesion as either cancer or benign with the aim of minimising false-positive and false-negative results. Accuracy in predicting cancer status is reported as a proportion of biopsies. FNA and core biopsy are not always performed to confirm a prediction of cancer, as they are also routinely performed to confirm that a lesion is benign (Participation and Performance Trends Project).

The proportion of FNA with a benign result when invasive cancer or DCIS was present increased significantly from 1.4% (95% CI: 1.2–1.5) in 1996–2000 to 1.8% (95% CI: 1.6–1.9) in 2001–2005. The proportion of FNA with a malignant result when cancer was not present decreased over time from 0.6% (95% CI: 0.5–0.7) in 1996–2000 to 0.4% (95% CI: 0.3–0.5) in 2001–2005 (Table 8.23).


The proportion of core biopsies with a benign result when invasive cancer or DCIS was present decreased from 1.6% (95% CI: 1.4–1.7) in 1996–2000 to 1.2% (95% CI: 1.0–1.3) in 2001–2005. The proportion of core biopsies with a malignant result when cancer was not present was stable over time at 0.6% (95% CI: 0.5–0.7) in 1996–2000 and 0.5% (95% CI: 0.4–0.6) in 2001–2005 (Table 8.24).

Compliancewithstandardsforfineneedleaspirationandcorebiopsy

The NAS define acceptable performance in the BreastScreen Australia Program for inadequate/miss rates, false-negative, false-positive, sensitivity and positive predictive values of both FNA and core biopsies. Tables 8.25 and 8.26 summarise the results for FNA and core biopsy against the relevant NAS in 1996–2000 and 2001–2005 for women 40 years and over.

Program performance with FNA had quite good compliance with the NAS. The NAS were met for the proportion of lesions classified as inadequate (NAS 2.18.1), false-negative results (NAS 2.19.5) and absolute and complete sensitivity (NAS 2.19.8 and 2.19.9). There was also a significant decrease in the proportion of lesions classified with an inadequate or insufficient result over time. However, the proportion of false-negative results with FNA increased from 1996 to 2005. Similarly, complete sensitivity decreased over time from 88.1 (95% CI: 86.3–90.0) in 1996–2000 to 87.1 (95% CI: 85.0–90.0) in 2001–2005. False-positive results (NAS 2.19.6 (a)) and positive predictive value (NAS 2.19.12) for FNA did not meet the NAS in either time period. False-positive results did, however, decrease slightly over this time period, from 1.7% (95% CI: 1.5–2.0) in 1996–2000 to 1.5% (95% CI: 1.3–1.8) in 2001–2005.

Similarly, quite good results were seen in Program performance for core biopsy. Results for three of the five NAS relating to core biopsy improved over time. The proportion of core biopsy procedures with a false-negative or inadequate result (NAS 2.18.2) decreased significantly and the absolute and complete sensitivity of core biopsy (NAS 2.19.10 and 2.19.11) increased in the time period 1996–2000 to 2001–2005 with the NAS met in both time periods. However, the false-positive rate for core biopsy did not meet the NAS, despite a small decrease over time from 1.5% (95% CI: 1.2–1.8) in 1996–2000 to 1.3% (95% CI: 1.1–1.5) in 2001–2005. The positive predictive value of a malignant core biopsy also did not meet the NAS, although a small increase did occur over time.

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Table8.25 Program performance against national accreditation standards (NAS) relating to fine needle aspiration (FNA), mean rates for women aged 40 years and over, 1996– 2000 and 2001–2005

NAS

Meanrate(95%CI)

1996–2000 2001–2005

2.18.1 <25% of all lesions assessed by FNA are classified with the result

inadequate/insufficient

15.5 (15.0–16.0) 11.5 (11.0–11.9)

2.19.5 <6% of malignant lesions assessed by FNA have a false-negative result 3.5 (3.1–3.9) 4.9 (4.4–5.4)

2.19.6 (a) <1% of lesions reported malignant by FNA have a false positive result 1.7 (1.5–2.0) 1.5 (1.3–1.8)

2.19.6 (b) The proportion of non-malignant lesions assessed by FNA with a

false-positive result

1.2 (1.0–1.4) 0.9 (0.7–1.1)

2.19.8 The absolute sensitivity of a diagnosis of breast cancer based on FNA

cytology is >60%

61.0 (59.5–62.6) 61.6 (59.9–63.4)

2.19.9 The complete sensitivity of FNA biopsy in the assessment of breast

lesions is >80%

88.1 (86.3–90.0) 87.1 (85.0–89.2)

2.19.12 The positive predictive value of a malignant FNA diagnosis is >98% 97.3 (94.9–99.8) 97.6 (94.9– 100.4)


Table8.26 Program performance against the national accreditation standards (NAS) relating to core biopsy mean rate for women aged 40 years and over, 1996–2000 and 2001–2005

NAS

Meanrate(95%CI)

1996–2000 2001–2005

2.18.2 The proportion of core biopsy procedures with a false-negative

or inadequate result

6.2 (5.7–6.8) 3.6 (3.3–4.0)

2.19.7 <0.5% of lesions sampled through core biopsy have a false-positive result 1.5 (1.2–1.8) 1.3 (1.1–1.5)

2.19.10 The absolute sensitivity of core biopsy in the assessment of breast lesions

is >70%

84.8 (82.7–86.9) 89.6 (88.1–91.2)

2.19.11 The complete sensitivity of core biopsy in the assessment of breast lesions

is >80%

92.8 (90.7–95.0) 95.2 (93.6–96.8)

2.19.13 The positive predictive value of a malignant core biopsy is >99% 98.3 (95.9–100.7) 98.6 (96.9–100.2)


8.3 PROGRAMPERFORMANCEBYAGEGROUP

8.3.1 TRENDSRELATINGTOPERFORMANCEINDICATORSBYAGE

This section reports on the performance of the Program by age group. Program performance in relation to women in the target age group of 50–69 years is presented earlier in this chapter. This section presents Program performance data for eligible women aged 40–49 years and 70 years and over, with comparison made to the Program performance for women aged 50–69 years.


All-sizecancer,firstandsubsequentscreeningrounds

The detection of all-size invasive cancer was higher in women aged 70 years and over for both first and subsequent screening rounds in 2001–2005 compared with younger age groups (Table 8.27).

Table8.27 All-size invasive breast cancer, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Firstscreeninground

Ages40–49

Crude 23.7 29.6

ASR 25.1 32.3

95% CI 23.4–26.9 30.1–34.7

Ages50–69

Crude 56.3 62.9

ASR 60.1 73.4

95% CI 58.0–62.3 70.1–76.9

Ages70andover

Crude 128.9 159.9

ASR 123.6 148.9

95% CI 116.1–131.4 134.7–164.1

Subsequentscreeninground

Ages40–49

Crude 18.4 20.3

ASR 17.4 19.3

95% CI 16.1–18.9 18.0–20.8

Ages50–69

Crude 39.2 43.4

ASR 38.5 42.5

95% CI 37.6–39.4 41.7–43.3

Ages70andover

Crude 57.9 64.4

ASR 58.0 64.0

95% CI 55.5–60.5 61.8–66.3

Note: Crude rates are the number of women with all-size invasive breast cancers detected per 10,000 women screened. ASRs (age-standardised rates) are the number of women with all-size invasive breast cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

By comparison, the all-size cancer detection rate was significantly lower in women aged 40–49 years. The all-size cancer detection rate for both age groups was significantly different from the rate for women aged 50–69 years. Detection rates increased over time for all age groups.

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Small(≤15mm)cancer,firstandsubsequentscreeningrounds

Similar to the all-size cancer detection rate, the detection of small invasive cancers was highest in women aged 70 years and over and lowest in women aged 40–49 years (Table 8.28). The small size cancer detection rate in younger and older women was significantly different from the rate for women aged 50–69 years.

Table8.28 Small (≤15mm) invasive breast cancer, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Firstscreeninground

Ages40–49

Crude 12.2 15.1

ASR 13.0 16.3

95% CI 11.8–14.4 14.7–17.9

Ages50–69

Crude 32.6 35.0

ASR 34.8 40.6

95% CI 33.2–36.5 38.1–43.2

Ages70andover

Crude 72.9 82.6

ASR 70.5 79.4

95% CI 64.8–76.5 69.0–90.8


Ages40–49

Crude 11.0 12.0

ASR 10.5 11.4

95% CI 9.4–11.6 10.3–12.5

Ages50–69

Crude 26.7 28.2

ASR 26.1 27.5

95% CI 25.4–26.9 26.9–28.2

Ages70andover

Crude 41.3 44.3

ASR 41.3 44.1

95% CI 39.2–43.4 42.3–46.0

Note: Crude rates are the number of women with small invasive breast cancers detected per 10,000 women screened. ASRs (age-standardised rates) are the number of women with small invasive breast cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project


Intervalcancerrate,firstandsubsequentscreeningrounds

There was no difference in interval cancer rate across age groups and over time between 1996–1999 and 2000–2003 at 0–24 months following the index screen, with the exception of the women aged 70 years and over, for whom the interval cancer rate was lower in subsequent screening rounds compared with women aged 50–69 years and women aged 40–49 years (Table 8.29).

Table8.29 Interval cancers, by age group, first and subsequent screening rounds, 1996–1999 and 2000–2003

Agegroup 1996–1999 2000–2003

Firstscreeninground

Ages40–49

Number 496 401

Crude 8.9 8.4

ASR 8.9 8.4

95% CI 8.1–9.7 7.6–9.3

Ages50–69

Number 950 569

Crude 10.0 9.7

ASR 9.9 9.5

95% CI 9.3–10.6 8.7–10.4

Ages70andover

Number 140 53

Crude 9.9 9.2

ASR 9.9 9.2

95% CI 8.3–11.6 6.9–12.0


Ages40–49

Number 510 651

Crude 9.8 10.0

ASR 9.8 10.0

95% CI 9.0–10.7 9.2–10.8

Ages50–69

Number 2,802 3,697

Crude 10.4 9.9

ASR 10.4 9.9

95% CI 10.0–10.8 9.6–10.3

Ages70andover

Number 420 690

Crude 8.1 8.7

ASR 8.1 8.7

95% CI 7.4–8.9 8.1–9.4

Note: Crude rates are the number of interval cancers detected per 10,000 women screened. ASRs (age-standardised rates) are the number of interval cancers detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

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Programsensitivity

Significant differences were seen in Program sensitivity by age group over the period 1996–2003. Program sensitivity was highest in women aged 70 years and over during 2000–2003 for both screening rounds (first and subsequent) at 90.2% (95% CI: 82.3–98.8) and 79.6% (95% CI: 79.0–80.2), respectively. By comparison, Program sensitivity was low for women aged 40–49 years. A Program sensitivity rate of 52.8% in 2000–2003 for this age group in subsequent screening rounds indicates that nearly half of all cancers detected in women in the in this age group were interval cancers (Table 8.30).

Table8.30 Program sensitivity, by age group, first and subsequent screening rounds, 1996–1999 and 2000–2003

Agegroup 1996–1999 2000–2003

Firstscreeninground

Ages40–49

Crude 60.0 64.4

ASR 60.0 64.4

95% CI 55.5–64.7 59.7–69.5

Ages50–69

Crude 75.1 77.4

ASR 75.3 78.5

95% CI 72.5–78.2 74.8–82.2

Ages70andover

Crude 87.5 90.2

ASR 87.5 90.2

95% CI 82.0–93.3 82.3–98.8


Ages40–49

Crude 50.8 52.8

ASR 50.8 52.8

95% CI 46.3–55.6 48.9–57.0

Ages50–69

Crude 66.9 71.0

ASR 66.1 70.3

95% CI 64.3–67.9 68.8–71.8

Ages70andover

Crude 78.9 79.6

ASR 78.9 79.6

95% CI 78.2–79.6 79.0–80.2

Note: Crude rates are the number of screen-detected cancers as a percentage of all cancers (screen-detected and interval cancers). ASRs (age-standardised rates) are the number of screen-detected cancers as a percentage of all cancers (screen-detected and interval cancers) and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project


DetectionofDCIS,firstandsubsequentscreeningrounds

DCIS detection increased with increasing age. In 2001–2005, the mean rate of DCIS detection per 10,000 women screened in the first screening round was highest for women aged 70 years and over and lowest for women aged 40–49 years (Table 8.31). While detection rates increased in women aged 50–69 years over time, rates did not increase for older and younger women.

As per the trend in the first screening round, DCIS detection was highest in women aged 70 years and over, while detection in the 40–49 year age group was significantly lower. DCIS detection rates in subsequent screening rounds increased over time in women aged 50 years and over.

Table8.31 DCIS, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Firstscreeninground

Ages40–49

Crude 7.4 8.9

ASR 7.4 8.9

95% CI 6.5–8.3 7.8–10.0

Ages50–69

Crude 12.7 17.0

ASR 12.9 18.5

95% CI 11.9–13.9 16.9–20.2

Ages70andover

Crude 19.8 25.5

ASR 19.8 25.5

95% CI 16.8–23.0 20.0–32.1


Ages40–49

Crude 5.8 6.2

ASR 5.8 6.2

95% CI 5.1–6.7 5.4–7.0

Ages50–69

Crude 8.7 10.4

ASR 8.7 10.3

95% CI 8.3–9.1 9.9–10.7

Ages70andover

Crude 10.1 13.0

ASR 10.1 13.0

95% CI 9.1–11.2 12.1–14.1

Note: Crude rates are the number of women with DCIS detected per 10,000 women screened. ASRs (age-standardised rates) are the number of women with DCIS detected per 10,000 women screened and age-standardised to the population of women attending a BreastScreen Australia service in 1998Source: Participation and Performance Trends Project

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Recalltoassessment,firstandsubsequentscreeningrounds

In the first screening round, the recall to assessment rate was similar for women aged 40–49 years, 50–69 years and 70 years and over. In subsequent screening rounds in 2001–2005, women 70 years and over had the lowest recall to assessment at 3.9% (95% CI: 3.8–3.9), while women aged 40–49 years had the highest recall to assessment rate at 4.9% (95% CI: 4.8–4.9).

Given the higher cancer detection rates in older women (Table 8.32), the number of women recalled to assessment who were subsequently found not to have cancer was higher for younger women, indicating a higher proportion of younger women are likely to experience harm associated with screening.

Table8.32 Recall to assessment, mammographic reasons, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Firstscreeninground

Ages40–49

Crude 6.9 8.8

ASR 7.0 9.0

95% CI 6.9–7.1 8.9–9.2

Ages50–69

Crude 7.0 9.5

ASR 6.9 9.2

95% CI 6.8–6.9 9.1–9.3

Ages70andover

Crude 6.8 8.5

ASR 6.7 8.4

95% CI 6.5–6.9 8.1–8.8


Ages40–49

Crude 4.3 4.9

ASR 4.3 4.8

95% CI 4.2–4.3 4.8–4.9

Ages50–69

Crude 3.8 4.0

ASR 3.8 4.0

95% CI 3.8–3.8 4.0–4.0

Ages70andover

Crude 3.5 3.9

ASR 3.5 3.9

95% CI 3.4–3.5 3.8–3.9



8.3.2 OTHERPROGRAMPERFORMANCETRENDSBYAGE

Technicalrepeatstatus

The highest rate of technical repeat performed was seen for women aged 40–49 years, although the rate decreased slightly between 1996–2000 and 2001–2005. In 2001–2005, the rate of technical repeat performed in this age group was 4.4% (95% CI: 4.4–4.5) compared with 3.4% (95% CI: 3.3–3.4) in women age 70 years and over (Table 8.33).52

Table8.33 Technical repeat performed, by age group, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Ages40–49

Crude 4.8 4.4

ASR 4.8 4.4

95% CI 4.7–4.8 4.4–4.5

Ages50–69

Crude 4.0 3.6

ASR 4.0 3.6

95% CI 4.0–4.0 3.6–3.6

Ages70andover

Crude 3.7 3.4

ASR 3.7 3.4

95% CI 3.7–3.8 3.3–3.4


total number of screens. ASRs (age-standardised rates) are the number of screens where a woman was recalled for technical reasons at initial or subsequent screening visit as a proportion of the total number of screens and age-standardised to the population of women attending a BreastScreen Australia service in 1998

b. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

Invasiveassessmentprocedures

As noted earlier in this chapter, trends in invasive assessment procedures indicate that use of FNA has decreased whilst use of core biopsies has increased over time. This trend was consistent for all three age groups of women (Table 8.34 and Table 8.35).

Overall, older women had the highest rates of FNA (11.0%) and core biopsy (19%) while younger women had the lowest rates (9.0% for FNA and 12.4% for core biopsy) as a proportion of women called for assessment. This difference occurred for both time periods (1996–2000 and 2001–2005) (Table 8.34 and 8.35), although the difference across age groups was more marked in the earlier time period of 1996–2000.

While the differences in invasive cancer procedures across age groups were small (in the order of 2% for FNA and 5% for core biopsy in 2001–2005), the differences in cancer detection rates suggest that more biopsies in younger age groups have a benign result.

52 These data only include women who underwent a technical repeat. They do not include women for whom a technical repeat was required, but refused by the woman

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Table8.34 Fine needle aspiration (FNA), as a proportion of assessments, by age group, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Ages40–49

Crude 12.4 9.0

ASR 12.4 9.0

95% CI 12.0–12.7 8.7–9.3

Ages50–69

Crude 14.0 10.0

ASR 14.2 10.1

95% CI 14.0–14.4 9.9–10.2

Ages70andover

Crude 17.0 11.1

ASR 16.8 11.0

95% CI 16.3–17.4 10.6–11.5

Notesa. Crude rates are the number of assessments with a FNA recorded as a proportion of the total number of assessments. ASRs

(age-standardised rates) are the number of assessments with a FNA recorded as a proportion of the total number of assessments and age-standardised to the population of women attending a BreastScreen Australia service in 1998

b. All FNA results are counted in each assessment episodec. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project

Table8.35 Core biopsy, as a proportion of assessments, by age, 1996–2000 and 2001–2005

Agegroup 1996–2000 2001–2005

Ages40–49

Crude 7.8 12.4

ASR 7.8 12.4

95% CI 7.5–8.0 12.1–12.7

Ages50–69

Crude 10.8 16.5

ASR 11.0 16.7

95% CI 10.8–11.2 16.5–16.9

Ages70andover

Crude 13.9 19.1

ASR 14.0 19.0

95% CI 13.4–14.5 18.5–19.6

Notesa. Crude rates are the number of assessments with a core biopsy recorded as a proportion of the total number of assessments.

ASRs (age-standardised rates) are the number of assessments with a core biopsy recorded as a proportion of the total number of assessments and age-standardised to the population of women attending a BreastScreen Australia service in 1998

b. All core biopsy results are counted in each assessment episodec. Data presented include all women aged 40 years and over and all screening roundsSource: Participation and Performance Trends Project


8.4 ANALYSIS

Trends in the performance of BreastScreen Australia were measured using the eight Program performance indicators. The indicator measuring participation was reported on in Chapter 7. Due to the lack of standards to measure trends in data at the national level, the NAS were used to benchmark Program performance.53

Data reported against each of the performance indicators revealed that the BreastScreen Australia Program is performing strongly and meets most of the NAS. However, there are areas where improvement is required, in particular in relation to rescreen rates, timeliness to assessment and performance on invasive procedures.

Cancer detection rates (all-size and small cancers) have increased over time and meet the NAS. Cancer detection rates by population sub-group have also improved over time. The low cancer detection rates evident for Aboriginal and Torres Strait Islander women and women who speak a language other than English at home may reflect lower breast cancer incidence rates in these sub-groups rather than poorer Program performance. Interval cancer rates decreased marginally between 1996–1999 and 2000–2003 for women in the target age group but continue to meet the appropriate NAS. Detection of DCIS in both first and subsequent screening rounds also increased significantly.

The recall to assessment indicator met the NAS for both first and subsequent screens. Recall to assessment increased between 1996–2000 and 2001–2005, with the most significant increase occurring for the first screening round (an increase from 6.9% of women screened in 1996–2000 to 9.2% in 2001–2005). The increased rate was only slightly below the NAS, which requires that fewer than 10% of women who attend for their first screen are recalled for assessment. This increase in recall to assessment rate, while likely contributing to favourable cancer detection rates, would have an impact on the capacity of the Program, with an increase in the number of women aged 50–69 years progressing to assessment from 17,072 in 1996 to 29,348 in 2005.54

The rescreen rate following first, second and subsequent screens did not meet NAS. Rescreen rates amongst women aged 50–69 years decreased significantly between 2000 and 2003. Possible explanations for the low rescreen rate include reduced promotion of breast cancer screening, capacity issues associated with the Program and women’s negative experience of the screening process. The Participation Qualitative Study conducted for this Evaluation uncovered the importance of a woman’s first screening experience on her likelihood to attend subsequent screens, with the experience leaving long-lasting impressions. If women felt they had not been adequately prepared for the screening process, particularly on their first visit, this could influence whether they would return in the future.55

The rate of technical repeat performed has decreased since 1996–2000. A higher rate of technical repeats was apparent for Aboriginal and Torres Strait Islander women compared with the national rate. This is likely to be due to the higher proportion of Aboriginal and Torres Strait Islander women residing in remote areas who are screened in mobile units with no on-site processing.

53 See Chapter 1, section 1.4 for a discussion on the use of national accreditation standards as benchmarks for national performance54 See Chapter 10 for discussion of Program capacity55 See Chapter 7 for discussion of the Participation Qualitative Study

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The NAS relating to time between screening and provision of results and the time between screening and assessment were not met. For the first time, this Evaluation has examined timeliness at a national level and has indicated growing capacity gaps within the Program.56

Performance relating to time between screening and provision of the result to women was close to the NAS in most jurisdictions. While the proportion of women not being advised of a result within the agreed time seems small (4.7% in 2001–2005), this equates to around 38,000 women across Australia who waited more than 28 days for a screening result. This trend may suggest an issue of capacity within the Program, particularly around the availability of screen readers in some jurisdictions.

Of greater concern is the delay for some women in assessment of a screen-detected abnormality, with the Evaluation showing that 20% of women recalled for assessment in 2001–2005 were not assessed within 28 days. The increase in the proportion of women not assessed within 28 days over time indicates this issue requires some attention. The differences across jurisdictions is noted, with the range of median number of days between screening and assessment varying from 15 days for both Queensland and Western Australia to 32 days in the Northern Territory and 27 days in South Australia in 2005.

In terms of invasive assessment procedures, use of FNA decreased significantly and use of core biopsy increased over time. This trend was seen across all population sub-groups and age groups. As a proportion of biopsies performed, the occurrence of a benign FNA result when invasive cancer or DCIS was present (false-negative result) increased, whilst for core biopsy, it decreased. The increased use of core biopsy has been attributed to several factors, including its superiority for the detection of some lesion types (particularly small lesions) and confirmation of benign lesions. This is reflected in the results of the Evaluation, with 90.3% of core biopsy results found to be definitive compared with 72.6% of FNA results in 2005. The change over time in the type of biopsy used is reflective of the Program’s ability to incorporate new technology and research to improve Program outcomes.

The Program is performing competently in meeting the NAS for FNA and core biopsy. However, with some NAS not being met (false-positive rate for core biopsy, positive predictive values of a malignant core biopsy, false-positive results for lesions reported malignant by FNA and positive predictive values for malignant FNA) there is a need for improvement.

Program performance across age groups indicates higher cancer detection rates for older women (50 years and over) compared with younger women (40–49 years), despite similar interval cancer rates and use of invasive procedures. The recall to assessment rate was also high for younger women, meaning that more women aged 40–49 years were recalled to assessment who were subsequently found not to have cancer. This suggests that a greater number of younger women compared to older women need to be screened, assessed and have a biopsy in order to detect one cancer. The data also suggest that the Program is only able to detect around half the cancers in younger women with close to half the cancers in women aged 40–49 years being interval cancers. The issue of Program performance by age group is considered further in Chapter 12.

56 See Chapter 10 for discussion about Program capacity


The NAS used to assess Program performance in this Evaluation are actually intended for use by individual SASs to measure performance for accreditation purposes, rather than for interpreting data at a national level. However, as the Participation and Performance Trends Project combined jurisdictional data sets, the NAS were considered an appropriate point of reference, given that standards do not exist at a national level. This deficiency highlights the need to develop appropriate standards that can be used to measure national performance. Additionally, some trends examined in this chapter, for example, data relating to invasive procedures, had no standards against which performance could be measured, highlighting the need for benchmarks for some key performance indicators. Development of and routine reporting against performance standards nationally could provide a more informative picture of Program performance.

In completing the data analysis for the Evaluation, significant inconsistencies were evident in data provided by jurisdictions, particularly in relation to data collected on sub-groups. While jurisdictions have systems in place to collect comprehensive data, the systems for collection of data for BreastScreen Australia vary by jurisdiction. These data inconsistencies have stemmed from the different ways in which each jurisdiction collects data and, to some extent, interpretation of BreastScreen Australia data dictionary terms. Program managers in their workshop with the EAC also raised concerns about inconsistencies in the data collected across jurisdictions, which may prevent or limit comparisons across jurisdictions.57

The data issues encountered during the completion of the Participation and Performance Trends Project and the Mortality Ecological Study58 indicate the need for more work to ensure consistent data collection across jurisdictions. A national dataset in a standard format is a key challenge for the Program to address for the future.

While a wealth of data is collected by the Program, at present the data are underutilised to inform Program evaluation and policy. Improving access to and analysis of Program data will allow data to be used to better inform the Program and its policies. Improvements in data collection must also be supported by enhanced rigour in data analysis. There are opportunities to develop partnerships between the BreastScreen Australia and the research community to ensure the data are best used to improve the Program.

57 See Chapter 13 for results of EAC discussions with state and territory Program managers58 See Chapter 6 for detailed findings from the Mortality Ecological Study

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9. PROGRAM GOVERNANCE AND MANAGEMENT, AND QUALITY ASSURANCE

Keyfindings

1. Identified strengths of the current BreastScreen Australia Program governance and management arrangements include clear and specific Program aims and objectives, and structures and processes for clinical and quality control. However, a number of governance and management issues at a national level have resulted in a lack of central policy directive; these issues need to be addressed as a priority.

2. The Program’s failure to achieve the stated goal of 70% participation and standards for rescreening, and specifically the failure to raise these issues with government for consideration and action, is strong evidence of the need for improved national leadership and strategic planning.

3. Areas of governance and management requiring improvement include national strategic planning, national policy development, use of Program data to inform Program policy and improvement, and the capacity to make timely decisions to address emerging issues.

4. The nature and extent of structural issues that may affect Program performance resulting from differing jurisdictional models of governance and management is unclear. Before implementing any governance and management reforms to the Program from this Evaluation it would be worthwhile to conduct a national review of jurisdictional operations. This would ensure that any agreed refinements or reforms from this Evaluation are implemented to best effect.

5. The BreastScreen Australia accreditation program is both respected and accepted, and all services have achieved accreditation. Strengths include strong stakeholder engagement and support, strong leadership from the NQMC and comprehensive NAS that underpin and unify the Program at a national level.

6. The current accreditation system is considered burdensome to services and state-level personnel who are required to prepare for accreditation against the 173 NAS, arrange site visits and perform as a site visitor.

7. The accreditation system, while considered robust, does not reflect industry best practice and requires improvement, with a need identified for increased openness, transparency, accountability and a greater degree of separation between development of standards and accreditation decision making.

8. Program quality assurance would benefit from a focus on a wider range of continuous quality improvement activities in addition to accreditation.

9. While the Program is evidence-based, the current governance and management arrangements limit the Program’s ability to realise the benefits of new research and technologies. Future Program governance mechanisms need to be better equipped to respond efficiently to emerging evidence


BreastScreenAustraliaobjective11:To achieve high levels of participation in the development and management of the Program by members of significant professional and client groups.

BreastScreenAustraliaobjective12:To collect and analyse data sufficient to monitor the implementation of the Program, to evaluate its effectiveness and efficiency, and provide the basis for future policy and program development decisions.

BreastScreenAustraliaaim6: To achieve high standards of Program management, service delivery, monitoring, evaluation and accountability

This chapter examines Program performance in terms of governance, management and quality assurance arrangements. Information is included from the Program Governance and Management Project and the Review of BreastScreen Australia Accreditation System.

9.1 GOVERNANCEANDMANAGEMENT

9.1.1 CURRENTBREASTSCREENAUSTRALIAGOVERNANCEANDMANAGEMENTARRANGEMENTS

Effective population screening programs depend heavily on governance and management arrangements to guide, support and deliver the program. BreastScreen Australia is no exception and requires sound governance and management to be successful. This was recognised when the Program was established, with the inclusion in the Program aims of achieving high standards of Program management.

The current governance and management arrangements of the Program have evolved since its establishment in 1991. As a national partnership between the Commonwealth, state and territory governments, the Program involves a complex range of contributors (Figure 9.1). In simple terms, these arrangements can be characterised as follows:

• a suite of national committees that are accountable to AHMAC; these committees are variously responsible for Program leadership and direction and are supported by the Department of Health and Ageing through provision of secretariat functions;

• operational responsibility held at a jurisdictional level; and

• analytical support provided by the AIHW.

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The current structure of BreastScreen Australia highlights the complex and multiple accountability arrangements within the Program. There are multiple forms of performance expectation within the Program, including:

• accountability to report on activity, output or outcomes;

• responsibility to share information on activity, output or outcomes; and

• responsibility to contribute as a member of a joint-jurisdictional committee within the scope of accountability for respective senior Commonwealth, state or territory government officer role.

There are up to eight layers in the structure from service delivery to Ministers. Generally, multiple layers dissipate the degree of accountability and result in the need for more formal processes and structures. The line connecting the performance management of the PHOFAs59 is not strong. This may be appropriate, however, given the implicit decision to devolve accountability to the states and territories.

The SSC of the APHDPC has a role to play in the governance and management machinery of the Program. However, findings from the Program Governance and Management Project indicate that the SSC considers its function as more advisory in nature rather than undertaking a national leadership and decision-making role.

59 See Chapter 4, section 4.2 for further information about the PHOFAs


Figure9.1 Diagrammatic representation of the BreastScreen Australia governance and management structure

Australian Health Ministers’ Conference

Australian Health Ministers’Advisory Council

Australian Population Health Development Principal Committee

Screening Subcommittee

Federal Health Minister

Department of Healthand Ageing

Australian Institute ofHealth and Welfare National Quality

Management Committee

State and Territory Health Ministers

State and Territory Health Departments

State / Territory Programs

ProfessionalColleges

State / Territoryand Quality bodies

Clinical staff –radiologists,

surgeons, medicalofficers

Radiographersand

sonographers

Healthpromotion;

administration

Datamanagement

staff

Counsellorsand nurses

Screening and Assessment Services

State / TerritoryCoordination Unit

information

contract

contract or employment

Public Health Outcome Funding Agreements

information

information

information

KEYreports toshares informationcontributors to

Source: Program Governance and Management Project

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9.1.2 ASPECTSOFGOVERNANCEANDMANAGEMENTTHATCONTRIBUTETOBETTEROUTCOMES

Evaluationquestion19:What aspects of governance and management contribute to better outcomes?

A review of international governance arrangements, including discussions with key people in breast screening programs in Canada, New Zealand, the Netherlands, Sweden and the UK, provided a number of useful insights for Australia in terms of aspects of governance and management that contribute to better outcomes.

Key themes included:

• the importance of strong and formalised relationships between national government and regionally based service providers to achieve effective evaluation and monitoring at the national level;

• the necessity of building consensus on policy and quality expectations across jurisdictions to achieve national goals and a coherent service for women;

• the importance of federal governments investing in building mechanisms for effective collaboration and building consensus across jurisdictions;

• the value of a national population register;

• the value of formal structures for key professionals to contribute to the direction of programs;

• the impact of policy differences across regions on consumers’ understanding and the potential to undermine public confidence;

• the importance of research and analysis to build understanding of the impact of different parts of the screening pathway on health outcomes; and

• the importance of planning ahead to ensure that key staff are secured in the face of international shortages, particularly in the case of radiologists.

9.1.3 EFFECTIVENESSOFCURRENTPROGRAMMANAGEMENTANDGOVERNANCEARRANGEMENTS

Evaluationquestion20: Are the current Program management and governance arrangements delivering the best possible outcomes?

The Program Governance and Management Project showed that there is significant strength in the operational performance of BreastScreen Australia. Data and insights gathered from discussions with Program managers, staff, consumers and clinicians during visits to every jurisdiction indicate that the Program delivers effectively to many women. In addition, it is apparent that the Program has attracted a highly committed and skilled workforce at all levels, including those involved in direct service to Australian women. This commitment is a key part of the successes that have been achieved through the Program.


This finding is supported by the relatively strong performance against the requirements of the NAS. The NAS are rigorous, extensive and provide relatively high levels of confidence in the workings of the Program. The reported ongoing commitment from jurisdictions is another important contributory factor, with examples provided by a number of services where performance has improved significantly following identification of service failures or weaknesses.

The Program’s operational performance is partly a result of the long-term impact of the national governance arrangements that have existed through the life of the Program. In this context, the work of the NQMC and the operation of the NAS are strong examples of robust governance and management.

The research also found that embedding operational responsibilities in jurisdictional administrations has, on balance, generated benefits. The operational framework of the Program determines some aspects of Program construction, and a level of practice inconsistency and policy flexibility is a necessary consequence of this operational devolution.

ContributionofgovernanceandmanagementarrangementstotheachievementofagreedProgramobjectives60

One of the fundamental obligations of the governance and management machinery of any public sector program is to strive to achieve the agreed program objectives.

The Program Governance and Management Project analysed Program performance against each of the 12 BreastScreen Australia Program objectives. In general terms, substantial achievements were evident for most Program objectives with a positive reflection on the operation of the Program overall.

A range of issues were identified with regard to objectives related to Program participation and rescreening. The failure of the Program to achieve these objectives is noted, in particular, the failure of the current governance and management structures to enable concerns about poor participation and rescreen rates to be brought to the attention of AHMAC or Ministers. A number of factors have been identified as diminishing the Program’s ability to meet participation and rescreening targets, including Program capacity, workforce availability and strategy issues. However, these factors do not justify the fact that the current governance and management structures have not sufficiently enabled these issues to be addressed. Notwithstanding the overall performance of the Program, the fact that critical issues relating to participation levels have not been adequately addressed indicates a failure of governance.

60 See Chapter 13 for further details on achievement of Program objectives

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Effectivenessoffunctionsatanationallevel

The Program Governance and Management Project assessed the level of performance achieved against a range of functions considered to be within governance and management responsibility. Many of the functions identified were reflected in the views and perspectives of various BreastScreen Australia staff and clinicians consulted during the Project. The overall conclusions were that for numerous functions, performance at a national level was less than desirable. The findings are presented in Table 9.1.

Table9.1 Assessment of Program performance against national Program functions from a governance and management perspective

Function Comment

Goals and objectives The Program has benefited from clear and specific goals and objectives.

Policy formulation and

maintenance

National mechanisms have demonstrated less than desirable effectiveness and capacity to make

timely policy decisions that inform consistency and quality of practice.

Strategic planning There was little evidence of national strategic planning in recent years.

Community education and

information

The decision to reduce effort in this area, while driven by loss of resources, was practical given the

constraints on Program capacity to deal with increasing demand.

Information and knowledge

sharing

Current arrangements do not contribute significantly to national sharing of evidence, although

Program manager meetings continue and those involved in the accreditation processes gain

benefits.

Workforce planning While a major issue for the Program, workforce planning has attracted little attention through

national governance and management structures.

Data and information

management

Considerable work has been done in the area of data and information management, although

more work on common data systems and timely information sharing to aid Program improvement is

desirable.

Quality and clinical risk

management

The structures and processes for clinical and quality control are sound and at the level required in a

Program of this kind.

Emerging issues The national governance and management structures are not strong in identifying and addressing

emerging issues in a timely way.

Research The Program has a large data resource that is being under-utilised for research purposes because

the structures are not designed to achieve this outcome.

Note: Assessment is based on consultation with BreastScreen Australia staff and clinicians, document review and analysisSource: Program Governance and Management Project

9.1.4 WEAKNESSESEVIDENTINNATIONALGOVERNANCEARRANGEMENTS

Several weaknesses in the national governance arrangements were identified. National governance mechanisms should ideally provide specific policy leadership, Program development and system capacities to support the high-quality and equitable service goals of the Program. They might also reasonably be expected to achieve efficiencies through consolidation or consistent action wherever it is in the interests of overall Program outcomes. Findings from the Program Governance and Management Project indicate that the current governance and management arrangements are not providing strong leadership and direction to the Program. This is reflected in deferred or delayed decision making and limited leadership, direction setting and capacity to deal with emerging issues, rather than in poor decision making or inappropriate actions.


Interestingly, the weaknesses outlined in the Program Governance and Management Project report are largely structural and do not derive inherently from Commonwealth/state and territory tensions or difficulties. These tensions are a common phenomenon in the Australian federal system and have undoubtedly played a role in shaping the Program. They are, however, less important than the structural issues that have been identified.

Many Program stakeholders have been involved in the Program for many years and there is a relatively high level of commitment to the Program as a national entity based upon cross-jurisdictional collaboration. However, it is clear that jurisdictions protect their interests strongly and can act somewhat capriciously if national policy or strategy is inconsistent with their view or priorities. The range of approaches taken to implementation of digital mammography across jurisdictions is one example in support of this. This tension would be better managed through a robust national governance structure rather than continuation of current arrangements.

Programrisksasaresultofgovernanceandmanagementweaknesses

The Program Governance and Management Project suggests that the identified structural weaknesses in governance and management are now beginning to diminish Program effectiveness and that this effect will increase over time in the absence of governance and management reform. The key risk areas identified are outlined below.

• In the absence of clear decisions regarding policy direction, workforce and resources, population coverage will be eroded over time. Erosion of population coverage will reduce Program performance and diminish outcomes.

• Consistent outcomes may decline as a result of local interpretation of policy and practice. The absence of timely policy decision-making and active linkage of standards issues to Program leadership is leading to diversification of Program operations. If this continues, it will be very difficult to re-establish consistency as stakeholders seek to preserve existing arrangements in particular jurisdictions.

• There is the potential for pressure to be placed on the NAS assessment process as staff become less willing to commit to the peer assessment process due to increased operational pressures.

• Growth in demand has not been managed adequately through the PHOFA. The generalised indexation arrangement within the PHOFA formula (allowing no provision for population growth) has embedded risks for a Program designed to achieve a specified level of population coverage. This has imposed an increasing cost burden on jurisdictions and has potentially eroded Program capacity.

There remain some important challenges to Program effectiveness and efficiency, particularly in the comprehensive achievement of some Program objectives, such as participation and rescreening. These challenges differ across jurisdictions, with some arising from structural choices made by individual jurisdictions and others from rising demand, supply and capacity pressures. Responses to these pressures are required, some urgently, if the robustness of the operational strength is to be maintained and enhanced.

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These findings strongly suggest that when post-Evaluation decisions regarding future Program development are made, a national review focused on jurisdictional performance would be justified. Such a review could:

• assist jurisdictions to address ‘local’ performance weaknesses;

• facilitate consistent approaches to policy-related operational reform; and

• assess options for improving national consistency in governance and operational processes within the service model where appropriate.

Much of the dissatisfaction expressed by stakeholders regarding current Program operation, and in particular the role of the Department of Health and Ageing, results from the weakness of the governance and management structures rather than jurisdictional competition or unwillingness to collaborate. These issues could be better managed in a robust national governance structure rather than continuation of current arrangements.

9.1.5 CONSIDERATIONSFORTHEFUTURE

The Program Governance and Management Project identified the following areas for consideration in future Program development:

1. clarifying the mandate for national leadership;

2. strengthening the capacity of the vehicle or mechanism chosen to provide national leadership;

3. developing cross-jurisdictional performance reporting mechanisms that refer to issues not covered by the NAS to improve the focus on efficiency and cross-jurisdictional sharing; and

4. reviewing jurisdictional governance and management to ensure optimal capacity to deliver the agreed service model, achieve policy consistency and operational efficiency.

Optionsforconsideration

The identified Program governance and management issues can be addressed directly or indirectly. Indirect resolutions may be achieved through wide-ranging change rather than reform of existing structures. The Program Governance and Management Project proposed four key options for future Program governance and management. These range from amendments to existing structures through to complete reform (Table 9.2). The four options are:

• Devolved, in which all functions would be devolved to the states and territories;

• Collaborative, which reflects the current arrangements;

• Enhanced, which aims to improve leadership and timely decision making by enhancing the capacity of existing governance and management structures; and

• Integrated, which would require the establishment a specific entity authorised by all governments to provide national leadership.


Numerous issues and potential trade-offs are required in each of the options presented in Table 9.2. The ‘Devolved’ option is substantially dependent upon a Commonwealth Government decision to step back from active involvement in this health domain. The ‘Collaborative’ model can be sustained provided that jurisdictions adjust expectations regarding what can be achieved through national infrastructure and take action to address current and future issues more autonomously.

Both the ‘Enhanced’ and ‘Integrated’ options represent approaches to improving the effectiveness of national governance. The ‘Integrated’ option would require the establishment of a new entity to lead national governance and in this context would entail a significant departure from current structural arrangements. The lack of an obvious entity to undertake this role also represents a challenge. In addition, further work would be required to understand the cost implications for this model. The costs are likely to reduce if synergies can be realised across cancer screening programs and/or through scale efficiencies by linkage with another entity.

The effectiveness of the ‘Enhanced’ option is dependent on a judgement about the extent to which existing structures can be enhanced and more adequately supported by a somewhat expanded Secretariat and decisions about whether further funding is required for its success.

The strengths of the ‘Enhanced’ option are that it maintains strong linkages with AHMAC structures and processes and retains both connection with and accountability to ministerial decision-making processes. It also enhances the capacity of the existing machinery to make strategic decisions and provide appropriate leadership to the Program. These gains are likely to be made at modest cost by utilising existing platforms and structures.

Specific aspects of the ‘Enhanced’ model are outlined below.

1. The SSC would be maintained as the primary point of policy formulation and leadership. It is also proposed that:

– the terms of reference would be refined to make clear that, while the SSC is advisory, it has a proactive mandate for Program leadership, including active attention to implementation issues;

– membership would be supplemented to include senior clinical advisers; and

– at least one ongoing working group would be established to undertake detailed work on policy and strategic priority development in order to support high-level deliberations of the SSC.

2. The operation of the NQMC and the infrastructure that supports it and implements the NAS would be continued, subject to any changes that may be agreed after completion of the Evaluation.

3. The capacity of the Secretariat to support an increased workload would be increased. The more proactive approach anticipated in the ‘Enhanced’ option will require increased administrative and analytical capacity if it is to achieve its goals.

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Table9.2 Options for future Program governance and management arrangements

Option Devolved Collaborative Enhanced Integrated

Description This approach would

involve all jurisdictions

agreeing to maintain

cancer screening

programs and to share

the cost (on some basis).

All other functions would

be devolved to states and

territories.

This approach would

involve the maintenance

of current arrangements

based on the current

AHMAC committee

structure.

This approach would

involve enhancing the

capacity of the existing

structure to provide

leadership and more

timely policy decisions

and support for

operational requirements.

This approach

would involve the

establishment of a

new entity, authorised

by all governments to

provide ongoing national

leadership.

It does not presume

transfer of operational

responsibility from states

and territories but does

require independent

and sustained national

leadership within or

across cancer screening

programs.

Strengths Enables states and

territories to get on

with their operational

responsibilities and to

adapt the Program as

required based on local

requirements.

Avoids the development

of unnecessary cost

overheads and would

enable states and

territories to make

ongoing adjustments to

their operations.

Provides a relatively

low cost way to address

key issues arising from

existing deficiencies.

A competent entity would

drive or facilitate national

agreements on key issues

and proactively support

ongoing Program reform,

and separation from

AHMAC and inner budget

sector agencies would

provide greater flexibility.

Weaknesses Erodes national

consistency and would

jeopardise quality through

the loss of the NAS.

Likely to provide ongoing

uncertainties and delays

given the continuation of

an expectation of national

consistency.

May not provide the level

of national leadership,

policy reform and

operational support

required to maintain a

strong national Program.

The costs for this model

are possibly quite high

– these would need to

be investigated further

and justified relative to

Program performance.

The greater flexibility

arising from separation

may also diminish

accountability.

Commentary High risk of quality

erosion and/or

diversification of Program

delivery.

Would require a strong

commitment to local

leadership across

the service delivery

network and more

effective informal/formal

cooperation.

While it will provide

a stronger national

direction, this option will

require both informal and

formal cooperation and

engagement with the

service delivery network

to be effective.

The viability of this

option would likely be

only justified if the entity

had carriage of multiple

screening programs.

Source: Program Governance and Management Project


9.2 QUALITYASSURANCE

The Review of BreastScreen Australia Accreditation System analysed BreastScreen Australia quality assurance mechanisms. In 2006, the Australian Commission for Safety and Quality in Health Care (the Commission) commenced a review of current accreditation arrangements within Australia and international directions in order to develop an alternative model for safety and quality accreditation. Aspects of the proposed model that have significance for BreastScreen Australia were taken into account in informing this Review.

9.2.1 BREASTSCREENAUSTRALIAQUALITYASSURANCEMECHANISMS

Evaluationquestion21:Are the Program’s quality assurance mechanisms ensuring a high standard of quality within BreastScreen Australia?

BreastScreen Australia aims to ensure quality is maintained throughout the screening and assessment pathway. The Program’s main form of quality assurance is accreditation, whereby service compliance with agreed standards is assessed by a detailed data report against the NAS and peer review via site visit. The accreditation system includes a set of nationally developed and recognised accreditation standards (the NAS), a risk-assessment based decision tool, electronic forms to support the use of the tool, and site visitor training. Services without accreditation cannot provide breast cancer screening and assessment under the Program.

BreastScreenAustraliaaim3: To ensure that screening for breast cancer in Australia is provided in dedicated and accredited Screening and Assessment Services as part of the BreastScreen Australia Program.

BreastScreenAustraliaobjective5: To fund through State Coordination Units only Screening and Assessment Services which are accredited according to agreed National Accreditation Standards, and to ensure that those standards are monitored and reviewed by appropriate State Accreditation Committees.

There are currently 173 NAS against which performance is measured. The NAS address all aspects of the screening pathway, including recruitment, management, technical quality assurance, education and counselling, assessment, data management and training. The NAS focus primarily on women in the target age group of 50–69 years, but the principles of quality apply to all women eligible for breast cancer screening (i.e. women aged 40 years and over).

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The NQMC is responsible for accreditation decision-making and standards setting. It comprises representation from Program managers, epidemiologists, radiologists, radiographers, consumers, the Commonwealth Government and professional groups, including the Royal Australian and New Zealand College of Radiologists, Royal Australasian College of Surgeons and Royal College of Pathologists of Australasia.

The accreditation system is underpinned by a quality improvement framework. For services to become accredited they must have a quality improvement framework in place and this is supported in documentation that provides guidance to services seeking accreditation. Self-assessment against the NAS and annual review of data reports supports ongoing monitoring and quality improvement.

9.2.2 EFFECTIVENESSOFBREASTSCREENAUSTRALIAQUALITYASSURANCEMECHANISMS

The Review of BreastScreen Australia Accreditation System found that the accreditation system through the NAS and the NQMC provides a critical role in supporting a national approach to Program quality assurance that is not evident elsewhere in the Program.

The literature review conducted for the Review of BreastScreen Australia Accreditation System found few studies exploring the effectiveness of accreditation in improving safety and quality. The end points or products of accreditation are often hard to define, making it difficult to evaluate or determine the benefits.

The literature suggests that, where a substantial focus on accreditation is a mechanism to ensure accountability for the standard of care, it is important that the accrediting organisation is separate from the standards-setting body. Furthermore, accrediting organisations should have a governance body that is representative of the stakeholders. The governance body should have appropriate organisational structures and processes in place, including strategic and operational plans, terms of reference and standard operating procedures. Independence between standards development and accreditation decision making is seen as a critical characteristic of an accreditation program, to ensure transparency and avoid conflict of interest.

The impact of accreditation was explored in detail through consultation with stakeholders, conducted for the Review of BreastScreen Australia Accreditation System. Consultation identified overwhelming stakeholder commitment and ownership of the accreditation system, with a strong consensus that accreditation and the NAS are central to Program effectiveness. Key findings in relation to the accreditation system are summarised below.

• There was strong consensus among all stakeholders consulted that the Program provides high-quality care that is safe and responsive to consumers. The Participation Qualitative Study also noted a perception amongst women and health professionals that the Program had improved over time. The accreditation system has evolved and strengthened since its inception, providing assurance to governments and the public that the system continues to be credible.


• Considerable variation was apparent in stakeholder perceptions regarding the openness and transparency in decision making in relation to accreditation. Stakeholders not involved with the NQMC expressed concern that the reasoning behind accreditation decisions was not always clear. In contrast, members of the NQMC were satisfied that decision making is open and transparent, although they acknowledged that jurisdictions and services may not have this view.

• The large proportion of BreastScreen Australia personnel on the Committee raises questions about the objectivity in decision making and independence of the Committee. Currently eleven of the fifteen members of the NQMC are employed by the Program in some operational capacity and the current Chair is a jurisdictional Program manager, who has been acting in an interim capacity for the past 3 years.

• The variable levels of achievement to meet the NAS create significant difficulty in applying the decision tool objectively. Some standards are aspirational targets, some are minimum standards, while others are somewhere in between. The lack of a process to accommodate ongoing revision of the NAS, and limited use of existing Australian data to set realistic targets that take account of statistical issues with smaller sample sizes, also weakens their use as a fair and objective measure.

• There is no formal open recruitment program and selection criterion for site visitors. Recruitment is on an ad hoc basis by the SCU. SCUs currently struggle to secure site visitors, particularly radiologists and surgeons. The performance of site visit teams is not formally assessed. Any feedback from services is handled through formal letters between the SCU and in some instances the NQMC.

• The lack of a central database and, with the exception of one state, the sharing of accreditation performance results across services, does not support systems learning. This is further compounded by the lack of formal opportunities at the national level for collaborative learning, research and development across service and jurisdictional quality improvement projects.

• The current accreditation system creates burdens that threaten the viability of the process and the Program. The burden on services to comply with the accreditation process detracts from service provision and quality improvement activities. Multidisciplinary involvement in accreditation activities, particularly in the current environment of escalating workforce shortages is not sustainable.

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9.2.3 STRATEGIESTOIMPROVEQUALITYASSURANCE

Overall, findings of the Review of BreastScreen Australia Accreditation System highlight a need to address the governance and operational management of the BreastScreen Australia accreditation system. The Review proposed three models for consideration, as outlined below.

1. Continuation of the status quo

Under this option, the current model and structure of the accreditation system would be maintained. The main risk associated with this model is the inability to sustain the status quo. Sustainability of the current system is threatened by the burden of accreditation detracting from service provision, and the difficulty in securing site visitors, particularly radiologists and surgeons. Unrecognised costs are currently absorbed with individuals committing their own time to accreditation activities. The small pool of expertise to draw on for site visitors also calls the objectiveness of the system into question and has the danger for decision making to be a somewhat isolated and insular process. This option also would represent a lost opportunity to improve the safety and quality of services.

2. Modification of the existing model

This option would maintain the existing model and structure with modifications made to the NAS, the quality improvement program and the accreditation assessment process. This option represents a minimalist but practical approach. Under this option, the number and structure of the NAS would be refined to focus on standards that align to the objectives of the Program, with mechanisms established for ongoing review of the NAS. This model also proposes the development of a national database that would allow performance data to be shared with services and the public. Development of a range of additional methods to support safety and quality improvement is also proposed, including forums to share learning, collaboration on research and development of professional development opportunities for all BreastScreen Australia personnel.

This option includes:

• re-alignment of NQMC membership to change the balance from internal BreastScreen Australia Program personnel to external members;

• appointment of an independent Chair of the NQMC;

• removal of site visitor selection from the function of the SCU through an adequately resourced NQMC Secretariat; and

• review of NQMC support to ensure participation is from a broad base of potential members.

Benefits of modifying the existing model include the retention of current strengths of the accreditation system with less risk to stakeholder engagement and ownership, and the potential for modifications to be readily implemented with minimal disruption to the current system. Potential efficiency gains would allow a focus on other quality improvement strategies.

The major risk of this option is failure to address concern amongst some stakeholder groups regarding the independence and objectivity of accreditation decision-making. It would also not address the lack of separation between standards setting and decision making, which is inconsistent with international and national directions in health care accreditation.


3. Change to the existing model

This option would separate the assessment, service delivery and policy development arms of the accreditation program. This could be achieved through outsourcing management of the accreditation process while maintaining multidisciplinary service team input into assessment of services against the NAS. While this model represents the ideal, there are two major risks in outsourcing management of the accreditation process. Firstly, outsourcing may lead to decreased ownership of the accreditation process by BreastScreen Australia personnel. Secondly, it will expose the real costs of running the accreditation program, which in its current form, is significantly greater than recognised due to the voluntary nature of much of the accreditation activity.

Changes to the NQMC as proposed in model 2 also apply to model 3. In addition, outsourcing management of the accreditation process will achieve separation of the various functions and allow the NQMC to focus on strategy and policy development. Separation of these components needs to be considered cautiously, as it is important to maintain a link between the development of policy and the practical experience of applying the NAS.

Significant changes to the BreastScreen Australia accreditation system may arise as a consequence of the current reform agenda through the Australian Commission for Safety and Quality in Health Care. Two major changes to the Program may risk destabilisation of the quality assurance and improvement systems putting at risk the ability of services to meet Program objectives.

9.3 PROGRAMRESPONSETONEWRESEARCH,EVIDENCE,ANDTECHNOLOGIES

9.3.1 PROGRAMGOVERNANCEANDMANAGEMENTSTRUCTURESINRELATIONTONEWRESEARCH,EVIDENCEANDTECHNOLOGIES

Evaluationquestion22: How effective is the Program in responding to new evidence and research?

There are two key government committees at the national level that consider research and evidence on new and emerging technologies across the entire health portfolio, including new technologies for screening for breast cancer:

• the Medical Services Advisory Committee (MSAC) provides advice to the Minister for Health and Ageing on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technologies and procedures in order to inform decisions about public funding for medical procedures

• the Health Policy Advisory Committee on Technology (HealthPACT) undertakes horizon scanning activities that provide advance notice and evaluation of significant new and/or emerging technologies and their potential impact on the health systems in Australia and New Zealand.

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HealthPACT is a sub-committee of MSAC and includes representatives from all state and territory government health departments, MSAC, the Department of Health and Ageing, the New Zealand Ministry of Health and New Zealand district health boards.

Papers produced by MSAC and HealthPACT in relation to new screening technologies are considered by the SSC. The SSC takes an evidence-based approach to the assessment of new technologies and can, if it wishes, refer new technologies to the MSAC for assessment, or seek advice on technologies on the horizon from HealthPACT. New research, evidence and technologies are also considered independently by states and territories, which may lead to variations across jurisdictions.

9.3.2 NEWTECHNOLOGYCASESTUDY:DIGITALMAMMOGRAPHY

An assessment of the effectiveness of the Program in response to new research, evidence and technology was undertaken in the Program Governance and Management Project using the case study of the Program response to the emergence of digital mammography. This was useful in understanding the strengths and weaknesses of the current governance and management machinery. The case study indicates that, although the Program did take an evidence-based approach to the assessment of digital mammography, there were significant delays in the decision-making process, reflecting deficiencies in Program governance and management arrangements.

All jurisdictions, with the exception of the Northern Territory, have implemented, are implementing, or have undertaken analysis on the costs and benefits of moving to a digital environment. Benefits for the Program in shifting to digital mammography include improved technology, more effective health outcomes and better service provision.

Co-ordinated trials of digital mammography commenced in the United States (US) in 2000, and the technology shift was identified around this time as an emerging issue for BreastScreen Australia. In December 2005, the former Australian Screening Advisory Committee (ASAC) determined that digital mammography was not best practice for screening at that stage. At that time, two states had already implemented digital mammography and another was at the business case stage, resulting in a potential conflict between these jurisdictions and the NAS. HealthPACT also considered evidence at this time and concluded that further review of the evidence as it became available was required to make an assessment of its effectiveness.

In May 2006, assessment of whether digital mammography is equivalent or better than film screen mammography, in terms of safety, effectiveness and cost-effectiveness for use in BreastScreen Australia, was referred by ASAC to MSAC. Also at this time, ASAC acknowledged that it needed to resolve the non-compliance of digital mammography with the NAS and agreed to establish the Digital Mammography Accreditation Standards (DMAS) Working Group to consider and develop accreditation standards for digital mammography. The commissioning of these two projects was important in establishing the evidence base and led to the endorsement of the issue by the APHDPC as one of the top priorities of the SSC in January 2007.


The DMAS Working Group first met in December 2006. The NAS review was completed 18 months later, and in May 2008, the Working Group was stood down. The parallel process of assessment of evidence for effectiveness of digital mammography, referred to MSAC in May 2006, took 23 months to complete and was endorsed by the Minister for Health and Ageing in April 2008.

The decision-making process to date has focused on amending the NAS. The case study identified a number of other issues that have not been considered to date at the national level:

• the need for consistency across jurisdictions;

• the expense involved in replacing analogue machines with digital equipment;

• the licensing costs involved in converting to digital mammography;

• workforce issues around the conversion; and

• strategic planning related to any developments in the national patient electronic medical record.

The Program Governance and Management Project report further speculated that there are likely to be a number of ongoing consequences from the lack of a united and proactive national effort to evaluate the impact of digital mammography and coordinate its implementation. These range from a delay in realisation of benefits to women and the workforce, missed opportunities regarding system compatibility and a lack of forward planning in integration with the national e-Health (electronic health) agenda.

9.4 ANALYSIS

Findings from the Program Governance and Management Project indicate that, while there is strength in Program operational performance, there are significant weaknesses in the Program governance and management arrangements at a national level and these need to be addressed as a priority.

Current arrangements do not provide sufficiently strong leadership to the Program, which has resulted in delayed decision making, limited direction setting and poor response and capacity to deal with emerging issues. In particular, improved national policy leadership and strategic planning is required. To this end, the role of the SSC of the APHDPC requires clarification and the lines of accountability for reporting from the SSC to Ministers should be strengthened.

The case study on digital mammography highlights the delayed decision-making processes in the Program in response to emerging issues and consideration of new research and technology as a result of poor governance and management arrangements. Although the Program takes an evidence-based approach to the assessment of new technology, there were considerable delays in decision-making. As a direct consequence, the Program is likely to experience delays in realising the full benefits of this new technology. This is of serious concern, as there are potential capacity benefits to the Program from the implementation of digital mammography.61

61 See Chapter 10, section 10.3 for results from modelling in relation to the benefits of digital mammography

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International comparators suggest that the delay in decision making around digital mammography was long. A number of reasons may account for the delay. Broadly speaking, no single entity took leadership of the issue, and the divided contributions of DMAS and MSAC (and associated committees) were focused on specific issues (quality and technology acceptability respectively). This process missed the wider sphere of policy and implementation issues. Furthermore, there was a lack of consistent national support and acknowledgment that the issue of digital mammography was of transformational importance and needed to be acted upon much earlier to bring it within the scope of the Program.

Although the findings suggest stark differences in Program governance and management at jurisdictional and national levels, the issues are complex. The governance and management issues identified at the national level do not solely reflect on the Commonwealth, but more on the weaknesses of the joint jurisdictional arrangements of the Program and expectations that national leadership can only emanate from the Commonwealth.

It should be noted that an analysis of governance and management arrangements at the jurisdictional level was not undertaken as part of this Evaluation. Research focused on the national governance and management arrangements with limited examination of the existing model at the national level and whether changes are warranted. As such, the question of structural issues that may affect Program performance resulting from differing jurisdictional models has not been fully addressed. Before implementing reforms to the Program it would be valuable to explore this area further through the implementation of a review of operations at the jurisdictional level. This would help to ensure that any agreed refinements are implemented to best effect.

In regard to the current structural arrangements, key issues to address are:

• clarification of the role and terms of reference of the SSC;

• assessment of the capacity of the SSC in terms of breadth of expertise, time and support provided to fulfil the a more proactive and strategic role;

• identification of appropriate SSC secretariat functions and resources;

• ensuring appropriate alignment between BreastScreen Australia with other cancer screening programs; and

• establishment of short-term mechanisms to implement outcomes of the current BreastScreen Australia Evaluation.

The Program Governance and Management Project put forward four options for future Program governance and management arrangements for consideration:

1. Devolved;

2. Collaborative;

3. Enhanced; and

4. Integrated.


The ‘Enhanced’ model is the preferred option for future governance arrangements. It actively addresses the weaknesses identified in the current arrangements and builds on existing structural strengths. Specifically the ‘Enhanced’ model:

• maintains the SSC as the primary point of policy formulation and leadership;

• continues the operation of the NQMC; and

• increases the capacity of the Secretariat to support an increased workload.

In relation to Program quality assurance, both the Review of BreastScreen Australia Accreditation System and the Program Governance and Management Project found that the overall accreditation process, supported by the NQMC and the NAS, is working well. The Program Governance and Management Project noted that the work of the NQMC and the operation of the NAS are strong examples of robust governance and management.

The BreastScreen Australia accreditation system has a number of strengths, including strong stakeholder engagement and support, and a process that challenges clinicians within the multidisciplinary team to review and critique performance. The NQMC provides leadership for the accreditation system and, together with the NAS and accreditation process, provides a critical unifying factor that underpins and unifies the Program at a national level. Program documentation and the NAS clearly outline the accreditation process and accreditation requirements and are a critical driver for services to achieve Program objectives. The relevance of many of the NAS in day-to-day operations means that the accreditation process is meaningful to services and is therefore seen to be more relevant than other health service accreditation programs.

However, there are several areas where the current accreditation system is not achieving best practice and requires improvement, including openness, transparency and accountability. Membership of the NQMC is balanced in favour of Program personnel. The NQMC Chair is presently held by a jurisdictional Program manager, acting in an interim capacity, in an arrangement that has been ongoing for over 3 years. In addition, there are a number of burdens associated with accreditation, such as scheduling and participating in accreditation site visits. The large number of NAS and the difficulty experienced by small screening volume services in meeting the standards are additional issues.

There is a tension between the need for independence of the accrediting body and the need for expert peer input into the accreditation process through site visits and assessment of service performance against the NAS. This is a particular challenge in achieving an appropriate balance between quality improvement activities and compliance with standards.

The current system involves a comprehensive rather than a perfunctory approach to accreditation. This is beneficial in allowing some leeway in decisions regarding the granting of accreditation status to services. However this, in turn, makes accreditation decisions more subjective and less transparent to those outside the NQMC.

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The Review of BreastScreen Australia Accreditation System proposed three models for consideration to address governance and operational management issues:

1. continuation of the status quo;

2. modification of the existing model by maintaining the existing model and structure with modification of the NAS, NQMC, quality improvement program and accreditation assessment processes; and

3. change to the existing model to separate the assessment and decision-making process from standards development and policy development aspects of the accreditation program.

A combination of models 2 and 3 could be developed. The NQMC could have an overarching role in quality assurance with a focus on policy development, ongoing- development and review of the NAS and high-level evaluation of Program performance to inform standard setting. An alternative body could be established with responsibility for the accreditation review of services against the NAS and decision making regarding accreditation. Members of the alternative body would have sufficient expertise, yet be independent of BreastScreen Australia and the NQMC.

There is a need to review the NAS and establish an ongoing mechanism for the review and update. There is also a need to establish a level for the NAS based on existing Australian data that is achievable and provides clear guidance on levels of achievement. Findings indicate that more consistent and improved data collection methods across jurisdictions for reporting against the NAS needs to be investigated.


10. PROGRAM INFRASTRUCTURE AND CAPACITY

Keyfindings

1. Current capacity issues for the BreastScreen Australia Program are impacting on participation rates, rescreening rates and timely recall to assessment.

2. Modelling indicates that further significant capacity issues will emerge in 2014 due to growth in the target population (assuming current participation rates and eligible and target age ranges remain constant).

3. Implementation of digital mammography within 5 years may address capacity constraints in the short term, particularly with the uptake of soft-copy reading. However, even with implementation of digital mammography, capacity constraints will only be delayed to 2015.

4. Workforce issues are the greatest constraint to capacity, with wide variation in productivity across the Program. Small incremental improvements in the number of women who can be screened each year per radiographer can yield significant capacity increases, which could be used to minimise capacity gaps.

5. There is scope to improve infrastructure capacity by exploring service delivery opportunities such as co-timing screening and assessment or co-locating SASs with diagnostic services.

6. Mammography is the most effective screening tool for breast cancer at this time. While digital mammography is increasingly replacing analogue mammography, no other new technology appears to be a realistic option for breast cancer screening in the near future.

ThischapterconsidersEvaluationObjective3:AssessmentoftheefficiencyoftheProgramintermsofinfrastructureandcapacity. Findings are presented from the Review of BreastScreen Australia Infrastructure and Capacity and from the results of a review of breast cancer screening technology conducted by HealthPACT for the Evaluation.

The Review of BreastScreen Australia Infrastructure and Capacity focused on identifying future capacity needs, potential gaps or spare capacity in the distribution of infrastructure and workforce and potential solutions to address shortfalls. The methodology included the construction of an economic model to project workforce and infrastructure needs through time, based on projections of the population of women aged 40 years and over in each SAS over the project horizon (2008–2027). It should be noted that the model base case assumes demand and supply are met in the base year (2008).

This chapter also draws on information from other Evaluation projects, particularly the Participation and Performance Trends Project,62 to determine the extent to which current Program capacity meets demand.

62 Discussed in Chapter 8

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10.1 PROGRAMWORKFORCEANDINFRASTRUCTURE

Evaluationquestion23: What are the impacts of infrastructure and workforce issues on Program capacity?

As part of the Review of BreastScreen Australia Infrastructure and Capacity, data on throughput (in terms of women screened), workforce and Program infrastructure (in terms of equipment) were collected directly from jurisdictions for each SAS. The Project also included a self-completed on-line survey of the BreastScreen Australia workforce.

As at June 2007,63 Program infrastructure included 168 fixed mammography units, 11 relocatable mammography units, 25 mammography units in mobile installations and 56 ultrasound units. Of the mammography units, 17 (8%) were digital. Since that time, at least six additional SASs have converted to digital systems.

As at 30 June 2008, there were 680 radiographers, sonographers, radiologist and non radiologist readers providing services to BreastScreen Australia – close to 330 full-time equivalent (FTE) staff (Table 10.1). Each SAS converted the headcount to FTE to provide an estimate of the number of hours of labour required to deliver screening and assessment services in Australia.

Table10.1 BreastScreen Australia workforce, full time equivalents (FTEs), June 2008

NSW VIC QLD SA WA TAS NT ACT Total

Radiographers only 63 61 52 18 22 6 2 7 231

Sonography only 2 0 2 0 0 0 0 0 4

Both radiography & sonography 7 0 18 4 0 0 0 1 30

Radiologist 19 12 8 6 5 1 0 2 53

Non-radiologist readers 1 1 9 0 0 0 0 0 11

TotalFTE 92 74 89 28 27 7 2 10 329

Note: ACT includes South East NSW (and NSW excludes South-East NSW). The FTEs also include those contractors that provide services to BreastScreen AustraliaSource: Review of BreastScreen Australia Infrastructure and Capacity

Evaluationquestion24: What are the impacts of infrastructure and workforce issues on Program capacity?

Table 10.2 details the number of vacancies for BreastScreen Australia by jurisdiction and by profession over the 2-year period prior to June 2008. The data collected represent vacant, fully-funded positions.

63 Excludes Gippsland, Victoria for which data were not available


Table10.2 BreastScreen Australia workforce, vacancies over 2 years prior to 30 June 2008

NSW VIC QLD SA WA TAS NT ACT Total

Radiographers only 8 12 21 3 4 2 0 4 54

Sonography only 0 0 0 0 0 0 0 0 0

Both radiography & sonography 4 0 0 3 0 0 0 0 7

Radiologist 2 8 0 0 0 0 0 2 12

Non-radiologist readers 0 0 1 0 0 0 0 0 1

TotalFTE 14 20 22 6 4 2 0 6 74

Note: ACT includes South East NSW (and NSW excludes South-East NSW)Source: Review of BreastScreen Australia Infrastructure and Capacity

Data were also collected on the number of weeks required to fill vacancies. Length of time varied by profession and jurisdiction, with the greatest difficulties reported in filling vacancies for radiographers. An average of 26 weeks was required to fill a radiographer position. Queensland, South Australia and Tasmania reported the greatest difficulties of all the jurisdictions in recruiting radiographers, with these positions going unfilled in some SASs. These results are consistent with comments received from the workforce survey responses discussed below. State and territory Program managers also reported long vacancy periods for staff who could provide both radiography and sonography. Positions for radiologist and non-radiologist readers took, on average, 7 weeks to fill.

A national workforce survey of all radiographers, sonographers, radiologist and non-radiologist readers providing professional services to BreastScreen Australia was conducted as part of the Review of BreastScreen Australia Infrastructure and Capacity. The workforce survey supplemented data from jurisdictions and provided commentary on the adequacy of the Program workforce in facing the demands placed on it both now and in the future. Responses were received from 242 respondents (a response rate of 35.5%) with representation from all states and territories. Of these, 67% (n=162) were radiographers and sonographers and 33% (n=80) were radiologist and non-radiologist readers; 15.6% were male and 84.4% female.

The hours of work per week provided by professionals to BreastScreen Australia varied greatly, with some professionals providing as little as 1 hour per week and others providing more than 50 hours per week. On average, radiographers and sonographers provided 22 hours per week and radiologist and non-radiologist readers provided 12 hours per week (Table 10.3). Permanent staff worked approximately twice the number of hours per week for BreastScreen Australia compared to the ‘casuals and all other’ category.

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Table10.3 Hours of work by employment status as reported in the survey

Totalhoursperweek TotalhoursperweekforBSA

Permanent Casual&allothers Total Permanent Casual&allothers Total

Min 3 1 1 3 1 1

Max 60 64 64 50 50 50

Mean 25 16 22 22 12 19

Median 25 10 22 22 8 18

Note: ‘casual and all other’ included casual workers, contractors, subcontractors and all other tenuresSource: Review of BreastScreen Australia Infrastructure and Capacity

Several themes emerged from comments provided by respondents on the BreastScreen Australia workforce.

• Overwhelmingly, comments focused on workforce shortages:

– 37% (n=90) of respondents referred to workforce shortages across all the key professions covered in the survey but mainly highlighted a shortage of radiographers;

– 20.7% (n=50) of respondents referred to the ageing of the workforce as a concern for BreastScreen Australia.

• A number of issues were identified that related to workforce:

– 27.6% (n=67) of respondents noted the stressful workload;

– 17.2% (n=42) mentioned that the workload, combined with the repetitive nature of the work, had caused injuries;

– 27.6% (n=67) highlighted poor rates of pay and the problems this caused with recruitment, retention and loss of workforce to the private sector or other career paths.

• A strong theme emerged around the lack of support for training opportunities and the limited career path (mentioned by 20.7% (n=50) of respondents).

• Other themes included:

– the profile of BreastScreen Australia and its reputation for excellence (4.6%, n=11 of comments received);

– the need for better scheduling (4.6% (n=11) of comments received); and

– widening the target population for screening (3.4% (n=8) of comments received).


10.2 CAPACITYISSUES

The following section examines whether the current capacity of BreastScreen Australia is meeting current demand, with much of this section drawn from data analysis undertaken for the Participation and Performance Trends Project.64

10.2.1PARTICIPATIONRATES65

The age-standardised national participation rate for women in the target age range of 50–69 years increased significantly from 51.4% in 1996–1997 to 56.9% in 2000–2001. While the participation rate has remained fairly steady over the last several years, the actual number of women aged 50–69 years attending the Program has increased over the 10-year period, with a growth of 40.7%.

In eligible age groups (40–49 years and 70 years and over), participation has decreased over time, presumably reflecting capacity issues as higher numbers of women within the target age group are screened.66

10.2.2RESCREENINGRATES67

BreastScreenAustraliaobjective2: To rescreen all women in the Program at 2-yearly intervals.

Evaluationquestion24:To what extent are women screened and rescreened in accordance with the Program’s recommended screening interval? To what extent is this related to capacity?

NAS 1.2.1 states that >75% of women aged 50–69 years who attend for their first screen within the Program are to be re-screened within 27 months.

NAS 1.2.2 states that > 90% of women aged 50–69 years participating in their second and subsequent rescreens within the Program are to be rescreened within 27 months of their previous screening episode.

The national rescreening rate does not meet the NAS, although there is variability between jurisdictions. In 2003, the national rescreening rate for women aged 50–67 years was 60.5% (95% CI: 59.8–61.2) following the first screening round and 69.5% (95% CI: 68.8–70.1) following the second screening round. Rescreen rates for first, second and subsequent screening rounds have all decreased since 2000. Overall, rescreen rates were highest in women aged 50–67 years,

64 See Chapter 8 for further detail on the findings from the Participation and Performance Trends Project65 See Chapter 7, section 7.1 for further information on Program participation66 See Chapter 7, Figure 7.1 for further information on Program participation67 See Chapter 8, section 8.1.6 for further information on rescreening in the Program

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followed by women aged 40–49 years, with the lowest rescreen rates in women aged 70 years and over. Again, this could reflect capacity issues due to the Program more effectively targeting and screening higher numbers of women aged 50–69 years.

It appears that the recommended rescreening interval is difficult to achieve given current Program capacity. The proportion of women rescreened at 28–36 month screening intervals has increased over time following first and subsequent screening rounds across all age groups (Table 10.4).

Table10.4 Participation 28–36 months after screening round, by screening round, 1996–2002

Screeninground 1996 1997 1998 1999 2000 2001 2002

First 5.7 5.9 6.3 5.8 6.1 6.6 8.3

Second 3.9 4.5 5.4 5.0 5.5 6.5 7.8

Third 3.0 3.0 3.6 3.6 4.7 5.7 7.2

Notesa. Year is the calendar year of the first screenb. Rates are the number of women who attended a second screen within each screening interval as a proportion of the total number of

women who attended a first screenSource: Participation and Performance Trends Project

The proportion of women aged 50–69 years who were rescreened within 28–36 months increased between 1996 and 2002 (the latest year with complete data for this screening interval), for all screening rounds. Participation increased from 5.7% to 8.3% between the first and second screening round, from 3.9% to 7.8% between the second and third screening round and from 3.0% to 7.2% between third and fourth screening rounds. These trends indicate that the capacity of the Program to rescreen women within 27 months is decreasing and is not meeting the NAS.

10.2.4TIMELINESS

The Review of BreastScreen Australia Infrastructure and Capacity collected data on the proportion of women in the eligible population who attend for a screening appointment within 28 calendar days of their booking date. The NAS of ≤90% was not met nationally, or in the majority of jurisdictions (South Australia, Victoria, Queensland, Northern Territory and NSW) (Table 10.5). The proportion of women with a time between screening and assessment of 28 days or less decreased significantly between 1996–2000 and 2001–2005 for all age groups.68

Capacity is likely to be a factor contributing to delays between screening and assessment, as is the travelling schedule for mobile units. Other contributing factors may include the willingness of women to attend available appointment times, frequency of assessment clinics or delays in organising interpreters for women who do not speak English.

68 See Chapter 8, section 8.1.4 for further information about the rates of recall to assessment in the Program


Table10.5 Percentage of women who attend for a screening appointment within 28 calendar days of their booking date (eligible population), 2007

%ofscreens Mean Median

NSW(a) 79.5% 94.7%

VIC 60.9% 57.0%

QLD 73.3% 80.8%

WA 92.5%

SA 38.1%

TAS 95.3%

ACT 92.0%

NT 86.8%

Total 73.3%

Max 97.4%

Min(b) 13.4%

Notes: (a) NSW data for Northern Sydney and Lower Central Coast were removed from the mean but not from the median.(b) Minimum was in Greater Western NSWSource: Review of BreastScreen Australia Infrastructure and Capacity

10.3 PROGRAMCAPACITYINTOTHEFUTURE

To assess the impact of infrastructure and workforce issues on Program capacity into the future, the Review of BreastScreen Australia Infrastructure and Capacity developed a model incorporating parameters drawn from the literature, a workforce survey, site visits to BreastScreen Australia services, data collected from jurisdictions for each SAS in Australia and data analysis undertaken for the Participation and Performance Trends Project.

The model conceptually consists of two modules:

• a ‘demand’ module, reflecting the need to screen women according to current BreastScreen Australia policies and practice; and

• a ‘supply’ module, reflecting the capacity of BreastScreen Australia to screen women.

Together the two modules provide a gap analysis between the demand for screening services due to population change and the supply of services based on the available workforce and infrastructure into the future.

A base case, representing the current Program and assuming constant screening policy in terms of eligible and target age ranges and participation rate, modelled demand for screening services due to changes in the eligible and target populations over a projection horizon of 20 years (2008–2027). The model assumed that supply meets demand in the base case (2008) (i.e. that there are no gaps in capacity).

In addition to the base case, six scenarios were modelled, consisting of ten options (Table 10.6). The six scenarios were divided between changes to policy and practice that could impact on either demand for, or supply of, BreastScreen Australia services.

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Scenarios relating to demand were:

• changes in age range (A);

• change in participation rate (B);

• change in screening policy for women at higher risk of breast cancer (D); and

• change in demand (F).

Scenarios relating to supply were:

• changes in workforce practice (C); and

• changes in technology (E).

The scenarios were modelled over 20 years (2008–2027).

Table 10.6 Scenarios modelled in infrastructure and capacity demand and supply modules

Scenario/

option Description

Basecase Current BreastScreen Australia Program

A1 Extension of the target age range to women aged 45–69 years (participation at 56.6%)

A2 Extension of the target age range to women aged 50–74 years (participation at 56%)

A3 Extension of the target age range to women aged 45–74 years (participation at 56%)

B4 Incremental increase in the participation rate in the target age group 50–69 years to 70% by 2027

C5 Replacing the shortfall in radiologists with non-radiologist readers

C6 Higher workforce productivity for radiographers

D7 Women with higher risk screened annually

E8 Digital mammography in 5 years with hard-copy reading

E9 Digital mammography in 5 years with soft-copy reading

F10 Phased reduction in MBS-funded mammography outside of Program

Source: Review of BreastScreen Australia Infrastructure and Capacity

Basecase

The base case assumes that participation rates of the eligible and target age groups will remain constant to 2027. At the aggregate level, this represents a continuing participation rate of 56% for the target group (women aged 50–69 years), with participation by women in the eligible age ranges 40–49 years and women aged 70 years and over continuing at current rates of 16.3% and 17.1%, respectively. Recall to assessment rates were also assumed to remain constant to 2027 at 4.8% for the target age group. Current participation rates and recall to assessment rates were also modelled individually for each SAS. Assumptions on the supply side were that workforce would remain stable and that equipment would be replaced as required. The national results are presented in Table 10.7.


Table10.7 BreastScreen Australia Program capacity, base case (current participation rates continue to 2027), per year

2008 2010 2015 2020 2027

Demand

Total number of women screened per year 899,108 939,062 1,039,196 1,122,000 1,219,254

Images demanded 3,922,353 4,095,430 4,529,796 4,888,261 5,307,413

Total women recalled to assessment 43,926 45,755 50,308 54,036 58,554

Supply

Number of screens (women) 899,108 959,232 1,037,290 1,051,499 1,045,925

Number of images 3,922,353 4,186,600 4,525,977 4,586,867 4,562,768

Number of assessments 43,926 45,755 48,582 49,100 48,921

Gap(excessdemand)

Screening images 0 –91,170 3,819 301,394 744,645

Assessments 0 –0 1,726 4,935 9,632

Number of women screened 0 –20,170 1906 70,501 173,329

Workforcegap–excessdemand(FTE)

Radiographers 0.0 10.6 39.1 64.0 93.7

Sonographers 0.0 0.5 1.4 2.4 3.6

Radiologist/Non-radiologist readers 0.0 2.6 9.7 16.0 23.8

Total 0.0 13.7 50.3 82.4 121.2

Workforcesupplied(FTE)

Radiographers 263.9 265.4 267.1 266.6 265.1

Sonographers 10.1 10.1 10.2 10.3 10.2

Radiologist/Non-radiologist readers 66.9 67.3 67.8 67.6 67.3

Total 340.9 342.8 345.2 344.5 342.6

Infrastructure

Number of machines, mammography 212.5 212.6 212.7 212.7 212.7

Number of machines, ultrasound 58.1 58.2 58.9 59.1 58.7

Gap, mammography 0.0 –4.6 0.1 13.9 34.5

Gap, ultrasound 0.0 2.3 7.3 11.7 17.1


The base case model results indicate that if current participation rates continue with the same eligible and target age ranges, there will be a shortage of staff and equipment in approximately 6 years. The demand for screening will outweigh Program capacity from 2014 onwards (Figure 10.1).

The results presented in Table 10.7 reflect the aggregation of information by SAS including:

• changes in population structure and growth in each SAS over time;

• workforce inflow and outflows: the workforce remains relatively constant over time at around 330–340 FTEs (i.e. inflow in the model was set to equal outflow, based on normal turnover rates, to keep the workforce constant); and

• replacement of analogue units with digital units in accordance with the amount of time to replacement for each machine indicated by each SAS (as shown in Table 10.6, the number of mammography units remains relatively constant over time at around 175; it is assumed that only digital imaging units will be used from 2019).

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In particular, the following observations were made based on base model results:

• the number of women wanting to be screened per year will rise from over 899,100 in 2008 to over 1.2 million in 2027, reflecting population growth and ageing;

• the excess of demand over supply will rise from around 1,900 women in 2015 to over 173,300 women in 2027;

• a shortage of radiologists will occur over time, equivalent to 24 FTE radiologists by 2027;

• a shortage of radiographers and sonographers will emerge and increase over time, equalling 93.7 FTE in 2027;

• the number of assessments required per annum will rise from around 43,900 in 2008 to close to 58,600 in 2027, reflecting the rise in the number of women screened and assuming a constant recall to assessment rate of 4.8% (this is a relatively conservative assumption, since current trends suggest recall to assessment rates have been rising);69

• the supply of assessments by 2027 will be 48,900 (a gap of 9,700 per year);

• while the number of Program mammography and ultrasound units remains relatively constant each year at around 213 and 58, respectively, by 2027 there will be a shortage of 35 mammography machines and 17 ultrasound machines.

Figure 10.1 shows the increasing gap over time between the annual number of screens required (assuming participation continues at the current rate) and the annual supply over time. The non-linear supply line reflects the replacement of analogue mammography machines with digital units. It is expected that by 2010 almost half of all mammography units will be digital.

Figure10.1 BreastScreen Australia Program demand and supply, base case – no change to the Program, number of women to be screened, 2008–2027

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69 See Chapter 8 for further data in relation to Program performance


Figure 10.2 illustrates the capacity gap by jurisdiction using current Program parameters (base case) over the period 2008–2027.

Figure10.2 Demand and supply growth and capacity gap by jurisdiction for base case (% in terms of women screened)

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Demandscenarios

In modelling the demand-related scenarios the capacity to screen (supply) remains the same as the base case. That is, only the need for screens (demand) is changed in the model as a result of population growth and scenario changes. The results for each scenario are outlined below and in Figures 10.3 and 10.4.

Changes to target age range (scenarios A1–A3)

• Extending the target age range above or below the current target age range will lead to short-term capacity gaps as soon as the target group is expanded.

• Extending the target age range to include women aged 45–49 years at an estimated participation rate of 56% (equivalent to the current participation rate of women aged 50–69 years), will increase the capacity gap in the number of women screened by 331,500 women over and above the base case capacity gap at 2027 (scenario A1).

• If women aged 70–74 years are included in the target age group at an estimated participation rate of 56% (equivalent to the current participation rate of women aged 50–69 years), the capacity gap will increase by 249,400 women over and above the base case capacity gap at 2027 (scenario A2).

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• Expanding the target age range from 50–69 years to include women aged 45–49 years (scenario A1) will result in a larger capacity gap than expanding the target age range from 50–69 years to include women aged 70–74 years (scenario A2).

• Including women aged 45–49 years and 70–74 years in the target age group at an estimated participation rate of 56% will result in the most significant capacity gap of all scenarios considered (a gap over and above the base case of 389,900 women screened by 2027) (scenario A3).

Change to participation rate (scenario B4)

• Incrementally increasing the participation rate from the current national rate of 56.3% to 70.0% by the end of the forecast horizon for women aged 50–69 years will result in the second highest demand for services and a capacity gap over and above the base case of 191,000 women screened at 2027.

Change to screening policy for women at higher risk of breast cancer (scenario D7)

• This is the only scenario considered on the demand side that lowers the need for screening and reduces the capacity gap created over the forecast horizon, as the scenario decreases overall the proportion of participants screened annually.70 Nevertheless, a capacity gap will remain throughout the forecast horizon, albeit less than the base case.

Figure10.3 BreastScreen Australia Program capacity gaps for demand-related scenarios (women screened)

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NotesScenarios:A1 Extension of the target age range to women aged 45– 69 yearsA2 Extension of the target age range to women aged 50–74 yearsA3 Extension of the target age range to women aged 45–74 yearsB4 Incremental increase in the participation rate for women in the target age group to 70% by 2027D7 Women with higher risk screened annuallyF10 Phased reduction in MBS-funded mammography outside of the ProgramSource: Review of BreastScreen Australia Infrastructure and Capacity

70 Based on data from the Participation and Performance Trends Project and the Policy Analysis Project, the current proportion of women with a family history attending BreastScreen Australia services for annual screens was estimated to be 10% for the purposes of this modelling


Phased reduction over the forecast horizon in MBS-funded mammography (scenario F10)

• The modelling indicated, as expected, that if more women choose to screen within BreastScreen Australia, there will be a shortage of 266,200 screens compared with a shortage of 188,300 screens in the base case. Further information is provided at section 10.4.

Supplyscenarios

In all scenarios, except for scenario C6, the demand, supply and resultant capacity gaps are estimated based on the scenario parameters and on current utilisation rates for infrastructure and workforce. Scenario C6 models the impact of improving workforce productivity by incrementally increasing productivity for radiographers from an average of two women screened per hour per radiographer to three women per hour over a 20-year time horizon. Evidence supporting this scenario is the range of productivity reported across the Program.

The impact of workforce changes on capacity was based on evidence for improving the available workforce. Findings related to supply scenarios are summarised below.

• Any shortage in radiologists could be addressed by increasing the number of available non-radiologist readers. In the base case, the shortage of radiologists rises to around 23.8 FTE in 2027. This shortage could be interpreted as a need for non-radiologist readers which rises to 23.8 FTE non-radiologist readers in 2027 (scenario C5).

• Radiographers are the main constraint of capacity shortages.

• Scenario C6 (incremental improvements to radiography workforce productivity) results in a substantial excess in capacity throughout the forecast horizon, and the potential to screen 522,200 women more than the base case by 2027. Increasing radiographer productivity by 3.3% per year (so that the number of mammographic screens supplied is 50% higher than the screens supplied in the base case by 2027) would create an oversupply of 103.6 FTE radiographers by 2027. Notably, there would still be a shortage of sonographers, radiologists and equipment by 2027. Increased radiographer productivity would create opportunity for implementation to any changes in screening policy that may occur.

Under all scenarios, except for scenario C6, BreastScreen Australia will face capacity constraints over the forecast horizon. The main capacity constraint on the Program in meeting the projected increases in demand for screening is workforce. While Scenario C6 does not specifically prescribe how productivity increase can be achieved, a review of the literature suggests that increased flexibility in working arrangements may yield significant productivity gains.

Scenarios E8 and E9 model the implementation of digital mammography, such that all mammography units would be digital within 5 years, with hard- (E8) and soft- (E9) copy reading. As can be seen in Figure 10.4, the change to digital mammography will provide some increase in capacity but this is insufficient to meet future demand.

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There is scope to improve infrastructure capacity utilisation in some SASs through changes in service delivery, such as by co-timing screening and assessment or co-locating screening and assessment or diagnostic centres where such does not already exist. Co-timing and co-location would enable efficiencies to be gained in the use of resources. Other innovative changes to screening and assessment, such as division of staff time between screening and assessment, appointment scheduling, more efficient utilisation of equipment, and facility layout, could also be implemented to increase productivity.

Figure 10.4 illustrates capacity gaps for the supply-related scenarios. Scenario C5 is not included in the figures, as it reflects replacing the shortfall in radiologists with non-radiologist readers. The capacity gap identified for radiologist FTEs in each scenario could potentially be filled with non-radiologist readers.

Figure10.4 BreastScreen Australia capacity gaps for supply-related scenarios (number of women screened)

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NotesScenarios:C6 Higher workforce productivity for radiographersE8 Digital mammography in 5 years with hard-copy readingE9 Digital mammography in 5 years with soft-copy readingSource: Review of BreastScreen Australia Infrastructure and Capacity


10.4 IMPACTONPROGRAMDEMANDANDCAPACITYOFMAMMOGRAPHYOUTSIDETHEPROGRAM

Modelling was undertaken in the Review of BreastScreen Australia Infrastructure and Capacity to determine the impact on Program capacity of including women currently utilising MBS-funded mammography outside BreastScreen Australia. The scenario utilised a phased reduction over the forecast horizon in MBS-funded mammography outside of Program from current rates to 50% of current rates or less. The modelling assumes that, currently, one-third of MBS-funded mammography is for non-diagnostic mammography. As expected, the results indicate that if women who currently choose to undertake mammography outside the Program elect to screen within the Program, there will be a further increase in predicted shortages, with demand outstripping supply by 2015 (Figure 10.3).

10.5 BREASTCANCERSCREENINGTECHNOLOGIES

10.5.1NEWTECHNOLOGY

Evaluationquestion25: What is the impact on the Program of incorporating new technologies, in particular, digital mammography?

Mammography is the most effective screening tool for breast cancer at this time. Any new technology would need to demonstrate a benefit at least equivalent to mammography in the screening context. A high level of evidence is essential to make decisions about screening programs, as screening is offered to healthy people and has the potential to cause harm that would not have occurred if they had not participated in screening.

New technologies for breast cancer screening must meet the Australian criteria for the assessment of population screening as outlined in the Population Based Screening Framework (APHDPC 2008). In particular, any new technology will need to meet the criteria for a screening test to ensure that it:

• is highly sensitive;

• is highly specific;

• is validated;

• is safe;

• has a relatively high positive predictive value;

• has a relatively high negative predictive value; and

• is acceptable to the target population, including important sub groups such as target participants who are from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander people, people form disadvantaged groups, and people with a disability.

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A number of papers on new technologies have been produced by MSAC and HealthPACT over the last few years that are relevant to breast cancer screening. These include:

• Breast Tomosynthesis: a breast cancer screening tool (HealthPACT August 2008);

• Digital mammography for breast cancer screening, surveillance and diagnosis (MSAC November 2007);

• Breast cancer diagnosis using ultrasound elasticity imaging (HealthPACT October 2007);

• Fermiscan: The detection of breast cancer by the analysis of diffraction patterns of hair (HealthPACT May 2007);

• Breast magnetic resonance imaging (MRI) (MSAC November 2006);

• Magnetic resonance spectroscopy for the diagnosis of breast cancer malignancies (HealthPACT September 2006); and

• MRI screening for breast cancer in genetically high-risk women (HealthPACT May 2004).

While the move to digital mammography is inevitable, no other new technology has been identified as an option for breast cancer screening in the near future. Tomosynthesis is now available for screening; however it is unlikely to be an effective or cost-effective alternative to digital mammography screening in Australia, and requires further investigation.

HealthPACT completed a Horizon Scan on new and emerging technologies for the screening of breast cancer in February 2009. The report identified seven technologies used for the detection of breast cancer: computed tomography (CT), positron emission tomography (PET); ultrasonography, thermography, electrical impedance, scintimammography and ductoscopy. In addition, three future technologies were reviewed: volatile organic compound breath tests, radar-based microwave imaging and optical coherence tomography; two of these technologies are being investigated by researchers in Western Australia (Australia and New Zealand Horizon Scanning Network 2009).

As these technologies are still in the early stages of clinical investigation, it would be premature to consider their use as part of a population screening program. HealthPACT concluded that in order to draw any meaningful conclusions regarding the potential of new breast cancer diagnostic technologies for the early detection of breast cancer, larger long-term studies of appropriate study design are needed in asymptomatic women.

Currently, thermography and electrical impedance are offered to Australian women on a ‘user-pays’ basis. These technologies are cause for concern, as regulatory control by the Therapeutic Goods Administration (TGA) is not required. Direct marketing to consumers may have social consequences, such as increasing burden on the health care system to cope with false-positive or false-negative test results. False-positive tests may result in an increase in the number of mammograms performed, especially in women younger than the target age group of 50–69 years.

While mammography is an imperfect tool for breast cancer screening, its use in population screening has contributed to the decline in mortality from breast cancer. The addition of MRI for women at higher risk of breast cancer and the transition to digital mammography has increased options available to women in Australia.


Digitalmammography

As at June 2008, 24% of BreastScreen Australia’s imaging units were digital, and this is expected to reach 50% by 2010.

Based on the literature review and stakeholder consultation, the Review of BreastScreen Australia Infrastructure and Capacity concluded that digital mammography will be implemented as analogue mammography becomes obsolete. Commentators have predicted that, within a decade, there will be no film-screen mammography machines or processors in major imaging facilities in Australia. Indeed, it is likely that BreastScreen Australia will need to be completely digital in 5 years.

Jurisdictional approaches to implementing digital systems have varied, in part, reflecting local considerations. The most appropriate type of digital equipment is likely to vary by region: some digital equipment is temperature- and motion-sensitive, and equipment for a given site may be dependent on throughput.

BreastScreen Programs in NSW, Victoria, Queensland and South Australia were of the view that digital systems would lead to productivity improvements. In particular, the use of Picture Archiving Systems (PACS) will address distribution differences of specialist readers across larger states, facilitate better workflows and benefit staff. Western Australia expressed an alternative view that the likely major impact of adopting digital mammography is that digital imaging will cost more, reading will be slower and it will have very high ongoing digital storage costs. The ACT, Northern Territory and Tasmania did not provide specific comment on these issues.

The impact on BreastScreen Australia of adopting digital systems is likely to include:

• a cleaner and quieter working environment;

• time savings due to film processing no longer being required;

• a reduced rate of technical repeat performed due to the ability to immediately see the image captured; this in turn reduces the need for women to return for repeat screens, and reduces their average dose of radiation;

• easier electronic image sharing and transfer, which has the potential to promote peer review, facilitate consultation and discussion, address localised shortages of radiologists, or improve the productivity of radiologists who may be currently under utilised; importantly it also has the potential to provide a more immediate response for women in rural and remote areas; and

• while the impact on reading time is uncertain, digital images can be displayed and examined more easily with computer software.

Modelling undertaken in the Review of BreastScreen Australia Infrastructure and Capacity to determine the impact on the Program of implementing digital mammography assumed a transition time of 2 years before productivity improvements associated with digital systems are realised. The modelling aimed to assess the impact of transitioning to digital mammography on the capacity to screen women. The results indicated that implementation of digital mammography within 5 years will delay the emergence of capacity shortages by 2 years (i.e. until 2015), particularly with the uptake of soft-copy reading (assuming current eligible and target groups and their participation rates are maintained).

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MSAC reviewed the safety, effectiveness and cost-effectiveness of digital mammography for screening purposes for BreastScreen Australia. The Report on digital mammography for breast cancer screening, surveillance and diagnosis (MSAC November 2007) concluded that digital mammography is as safe and effective as film mammography and recommended that public funding for this procedure be supported under the arrangements that currently apply to film mammography. MSAC also noted that film mammography is being superseded by digital mammography and will lose technical support. This recommendation was endorsed by the Minister for Health and Ageing in 2008.

10.6 ANALYSIS

The current capacity of BreastScreen Australia is failing to meet the growing population demand for screening and assessment services. Although increasing numbers of women have attended the Program over the last 10 years, the target age group participation rate remains static. A higher proportion of participants are now in the target age range as participation rates for eligible women have decreased.

Jurisdictions have implemented various policies71 to ensure capacity is used by the target age group and these policy changes appear to be having some effect. However there is sufficient evidence to suggest that, even with policies favouring the target age group, the Program is at a critical point. Accreditation standards for timeliness are not being met and have been declining over a number of years. Delays in assessing women with a screen-detected abnormality and the inability to provide screening in the 2-year interval for an increasing number of women are particular cause for concern.

Another possible reason for not achieving the rescreen standard is that women may choose not to return following their initial experience of mammography screening.72 Findings from the Program Governance and Management Project and the Participation Qualitative Study, however, indicate a view that the Program has been improving over time and that the recommended rescreening interval is difficult to achieve with current capacity.

While there is evidence of current capacity gaps from Program data, modelling results indicate that, if current participation rates continue with the same eligible and target age ranges, demand will exceed Program capacity from 2014 unless changes are implemented to workforce practice and service delivery.

Workforce appears to be a greater capacity constraint than infrastructure. Increasing the number of women who can be screened each year per radiographer can yield significant capacity increases, which could be used to close any capacity gaps in place of any additional infrastructure or workforce FTEs. The number of women who can be screened per radiographer each year is influenced by numerous factors, including average operating hours of mammography equipment, the opening hours of BreastScreen Services, facility layouts and scheduling arrangements for screening and assessment.

71 See Chapter 12, Section 12.5 and the Policy Analysis Project report72 See Chapter 7, Section 7.2.2 for further details on Program acceptability


Increasing radiographer productivity could be achieved with the introduction of more flexible working arrangements to meet the desire of approximately a quarter of the workforce to work fewer hours. It is possible that any associated reduction in average working hours resulting from increased flexibility may be more than offset by the increase in productivity. Flexible working arrangements have the potential to reduce fatigue and repetitive activities, and therefore reduce the risk of injury. Fewer hours worked at BreastScreen Australia would also provide an opportunity for radiographers to work in areas outside BreastScreen Services, resulting in a more varied workload.

Increased productivity may also be achieved through changes to service delivery and utilisation and scheduling of resources (such as co-timing screening and assessment or co-locating screening and assessment with diagnostic centres). Co-timing will require some business process changes and in some services, layout changes will be required to ensure separate waiting areas for screening and assessment clients. Increased flexibility in working arrangements may yield significant productivity gains. Increased productivity would also allow for implementation of any changes that may result in screening policy.

Currently no other technology is able to demonstrate a benefit that is at least equivalent to mammography in the screening context. Therefore mammography continues to be the recommended method of breast cancer screening for BreastScreen Australia. However, analogue mammography is becoming obsolete and will be superseded by digital mammography. It is likely that the Program will need to be completely digital in 5 years. The move to digital mammography may address short-term capacity constraints. However demand will reach supply in the medium term (2015) and will be exceeded in the long term (2019).

The introduction of digital mammography allows for the separation of image acquisition and reading. In a fully integrated digital environment, acquired images can be sent electronically to a reader anywhere within Australia, allowing the Program to address geographical distribution differences and to make more efficient use of the highly specialised but limited workforce.

Approaches to the transition to digital systems differ across jurisdictions, in part reflecting local considerations and differences in needs across different areas. An overarching coordination mechanism that facilitates efficient communication about the transition may be useful to ensure that information management and telecommunications systems protocols are compatible. Compatibility across state and territory BreastScreen Australia services (and potentially beyond BreastScreen with diagnosis and treatment services) would maximise the capacity to transfer images, improve the potential to address localised radiology staff shortages, facilitate flexible working hours and potentially improve access by diagnosis and treatment services to BreastScreen Australia expertise. Many jurisdictions are on the verge of committing to PACS, so there may be an immediate requirement for cross-jurisdictional coordination. As an additional benefit, greater coordination may increase communication across jurisdictions, facilitating broader transfer of learning.

Program capacity will need to be addressed as a matter of urgency, not only to ensure a national response to workforce constraints but also to ensure sufficient resources are available to support the effective implementation of digital technology and to increase the capacity of services to meet demand. Program capacity constraints should also be considered in relation to the Program age range. Potential changes to the Program target and eligible age range are discussed in Chapter 12.

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11. ECONOMIC OUTCOMES

Keyfindings

1. The cost of the BreastScreen Australia Program per woman screened in 2006–2007 was approximately $141.

2. The current Program policy of screening eligible women aged 40 years and over while specifically targeting women aged 50–69 years yielded a cost-effectiveness estimate of approximately $38,000/LYG gained over a 20-year timeframe.73 This estimate indicates the Program is delivering cost-effective outcomes.

3. Key factors influencing variation in costs are participation rates, screening interval and age groups included in the target age range.

4. The cost-effectiveness of expanding the target age group produced similar cost-effectiveness estimates for both older women (70–74 years) at $38,305/LYG and younger women (45–49 years) at $40,699/LYG.

5. Assuming capacity is expanded to meet Program demand, the cost of BreastScreen Australia will increase over the next decade as a result of growth in the population of the target age group.

ThischapteranalysesEvaluationObjective3:TheeconomicoutcomesachievedbyBreastScreenAustralia.Results are included from the Economic Evaluation and Modelling Study.74

11.1 ECONOMICEVALUATIONANDMODELLINGSTUDY

The Economic Evaluation and Modelling Study evaluated the effectiveness and cost of the current BreastScreen Australia Program to determine its impact on breast cancer mortality and to establish whether the Program was delivering cost-effective outcomes. The Program, and a range of policy alternatives, were compared against a hypothetical baseline of no screening program to determine the economic outcomes. These outcomes were expressed in terms of the cost-effectiveness, cost-utility and marginal benefit.

11.1.1 METHODOLOGY

The study comprised two key components: a systematic literature review of cost-effectiveness studies to inform the method used for the economic model; an economic analysis comprising the construction of a model to evaluate the cost-effectiveness of the BreastScreen Australia Program and various policy alternatives. A limited cost-utility analysis was also undertaken as part of the modelled economic evaluation.

73 Life years and costs were discounted using an annual rate of 5%, consistent with practice in Australia74 Further details on the BreastScreen Australia Evaluation projects are provided in Appendix 16.3


11.1.2SYSTEMATICLITERATUREREVIEW

A systematic literature review of cost-effectiveness studies of breast cancer screening strategies was undertaken to inform the methods for the economic model. In the majority of the studies, a breast cancer screening strategy was compared with another strategy or to a ‘no-screening’ scenario using a population of women of various age groups (40+ years) with an average risk of breast cancer. Most of the identified studies were conducted in Europe and the US, with only two studies completed in Australia.

Key findings from the literature review are summarised below.

• Markov modelling was the most commonly applied modelling approach identified.

• Most studies that incorporated the natural history of breast cancer in their modelling approach applied tumour size to define the relevant health states.

• The most commonly reported incremental cost-effectiveness ratio was cost per LYG.

• Few studies reported cost-utility results in terms of cost per quality adjusted life year (QALY) gained. Those studies reporting cost per QALY generally found breast cancer screening to be cost-effective when compared to a ‘no-screening’ scenario.

• Evidence on the cost-effectiveness of digital mammography screening compared to analogue mammography was limited.

11.1.3MODELLEDECONOMICMODELANALYSIS

The modelled economic analysis evaluated the cost-effectiveness of the BreastScreen Australia Program and various policy alternatives compared with a hypothetical no-screening scenario. The key aim of the economic model was to assess the breast cancer mortality benefits of screening, breast cancer screening costs and breast cancer treatment costs avoided due to increased cancer detection rates and the cancer stage shift associated with early detection through screening.

To fulfil this aim, a Markov model incorporating a Monte Carlo simulation was selected as the most appropriate modelling technique (based on the literature review outcomes). A Markov model is a model used in economic analyses in which the progression of a disease (in this case breast cancer) with and without interventions (screening/ no screening) is modelled over a number of time periods, each which are associated with a particular measure of health and each having a probability of moving from one health state to another (Culyer 2005). A Monte Carlo simulation is a form of simulation used frequently in economic analyses. In this model, the simulation randomly sampled hypothetical individual women from an age cohort representing the eligible age group for screening (various age groups of women aged 40 years and above). Costs (screening and treatment costs), were generated for each randomly sampled woman.

For each screening scenario analysed, a cohort of 800,000 women was simulated to determine average results. The model was simulated over a woman’s lifetime (in which women were assumed to survive to a maximum age of 100 years) using a cycle length of 3 months. At each

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cycle the model calculated whether a woman progressed from one health state to another based on predetermined transition probabilities. The average of the costs of screening and treatment per woman was then determined for both the screening and non-screening arms of the model.

Additionally, the model calculated the total number of cancers detected and divided these into three separate categories according to the mode of detection: screen-detected cancers, interval cancers and cancers detected outside the Program amongst women who did not participate in the Program. The base case used in the model was the current BreastScreen Australia Program (i.e. women in the target group aged 50–69 years, eligible age groups of 40–49 years and 70 years and over, and a screening interval of 2 years).

The cost-effectiveness of screening was reported as the incremental (or average) cost per LYG with the screening Program. Total costs and outcomes were reported per 100,000 women to standardise results. Life years and costs were discounted using an annual rate of 5%, consistent with practice in Australia, to account for the impact of differential timings of costs and benefits.

The model consisted of two separate components; the natural history of disease component and the BreastScreen Australia pathway. These are described in the next section.

Breastcancernaturalprogression

In this component of the Markov model, several health states were defined:

• no cancer;

• undiagnosed and diagnosed DCIS;

• undiagnosed and diagnosed cancer sizes of 0–10mm, 11–20mm, >20mm;

• breast cancer death; and

• other death.

Categorisation of breast cancer by tumour size was chosen to reflect BreastScreen Australia data collection. In each 3-month cycle, the likelihood that a woman progresses between health states was based on transition probabilities associated with each health state. The transition probabilities varied between model cycles and women depending on the woman’s age and disease history. In each model cycle, after determining whether the individual progresses to another health state, the woman would move through to the screening pathway.

BreastScreenAustraliascreeningpathway

This component of the model comprised a screening and non-screening arm.

In the screening arm, the probability of a woman participating in screening was determined by the duration of the screening interval between previous screening episodes (if any) and the next eligible screen (2 years). If the time period between screens was less than the screening interval, the woman transitioned through the natural history component of the model until the next cycle. If the screening interval had expired, participation rates determined the probability of attendance.


For a woman whose interval between screening episodes had not elapsed or who did not participate, that is, she was invited but did not attend screening, or who did not have cancer detected at screening (true-negative, false-positive, false-negative), the possibility of cancer detection between screens (i.e. an interval cancer) was determined using Program interval cancer data.75

If cancer was detected through screening, or between screens, the woman transited from the undiagnosed health state to the appropriate diagnosed DCIS or cancer health state. The woman remained in the diagnosed health state for 9 years after diagnosis and accumulated breast cancer treatment costs for the first 5 years after diagnosis. If a woman remained alive at 10 years after diagnosis, she was no longer assumed to be at increased risk of death. In addition, she was considered to be at higher risk of developing further breast cancer and was reinitiated with screening in the Program at a 1-year screening interval.

In addition to modelling detection rates associated with interval cancers, rates associated with cancers diagnosed outside BreastScreen Australia were also included in the model. In the non-screening arm of the model, diagnosis of breast cancer was assumed to occur in the clinical setting through diagnostic mammography in the public or in the private health system where most mammograms are reimbursed under the MBS. Not all mammograms reimbursed by the MBS would be for clinical purposes; a proportion would be indirectly used for non-diagnostic purposes, that is, women who could attend BreastScreen Australia but who are instead referred for mammography by their GP. For the purposes of modelling it was assumed that 30% of all MBS-funded bilateral mammograms would be for non-diagnostic purposes.76

Modelinputs

The economic model used data from the Program. Data inputs into the screening arm of the model included participation rates, DCIS and cancer detection rates (including screen-detected cancers, interval cancers and clinically diagnosed cancers outside the BreastScreen Australia Program), breast cancer and other mortality, cancer dwell times, and DCIS/invasive breast cancer incidence and prevalence rates.

Economic inputs into the model consisted largely of direct screening costs from the Program and annual treatment costs. Total direct screening costs associated with the Program included staff, materials and supplies, accommodation, capital, Program coordination and other recurrent costs. Data reported by the jurisdictions to the Productivity Commission formed the basis of the screening costs used. Annual breast cancer treatment costs by tumour size were based on published literature. The main modelling only considered direct costs of the screening Program. Indirect costs, in terms of productivity losses, were included in a sensitivity analysis.

75 Data provided by BreastScreen Queensland and BreastScreen Victoria76 See Chapter 7, Section 7.3 for further information on MBS-funded mammography. For women aged 50–69 years, the analysis determined that

28% of mammograms reimbursed under the MBS are non-diagnostic.

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Modelvalidation

The results generated by the current model fall within ranges reported from other international economic evaluations. Key findings in agreement with the literature included the cost-effectiveness of screening women 50–69 years biennially and the fact that screening women younger than 50 years of age and those aged over 70 years was less cost-effective when compared with screening women 50–69 years only.

Model validation comparing the numbers of cancers detected and breast cancer mortality per 100,000 women was completed on the outcomes generated by the economic model. Model results were found to be similar to estimates reported in the literature review for the study (Economic Evaluation and Modelling Study). For example, in relation to breast cancer mortality, the relative risk of death for women aged 50–69 years was calculated at 0.83 by the model. This was somewhat comparable with data from the IARC (IARC 2002), which estimated the relative risk of death from breast cancer at 0.75.77 The results were also consistent with the estimation of reduction in breast cancer mortality found in the Mortality Ecological Study.78

A limitation with most economic modelling, including Markov models, is their dependence on the quality of model inputs to accurately estimate desired model outputs. The model used BreastScreen Australia data, where available, for model inputs. It is also important to note that for such modelling, the possibility of random error cannot be excluded.

The model in the economic evaluation was created specifically for the Evaluation and was not trialled with other similar health conditions. Applying the same model to different diseases would further validate the robustness of the results.

11.2 COST-EFFECTIVENESS

Cost-effectiveness refers to a type of analysis used to compare the cost and effectiveness of an intervention to determine whether it will achieve the desired outcome, for example, a decrease in breast cancer mortality (Last 2005). The level at which estimates are considered ‘cost-effective’ are the estimates that provide the greatest effectiveness, measured as LYG for a given level of cost (Last 2005), rather than estimates of which intervention costs the least. In Australia, estimates below $50,000/LYG are generally considered cost-effective.

To determine the average costs of BreastScreen Australia, the base case in the model used the costs of the current BreastScreen Australia Program (i.e. screening the target age group of women 50–69 years and eligible women aged 40–49 years and 70+ years, at current Program participation rates of 56.2% using a screening interval of 2 years).

Time horizons of 40 and 20 years were chosen to illustrate long-term costs and expected outcomes, respectively. Results are reported here only for 20 years. Cost-effectiveness was modelled by comparing various screening program options (including the current mode of screening) with the ‘no-screening’ scenario where there is no BreastScreen Australia Program, but which includes a portion of ‘screening’ through the MBS.

77 See Chapter 12, Section 12.1.1 for further discussion about the reduction in breast cancer mortality estimated from RCTs78 See Chapter 6 for detailed findings from the Mortality Ecological Study


11.2.1NETCOSTPERWOMANSCREENEDTHROUGHBREASTSCREENAUSTRALIA

Evaluationquestion22: What is the net cost per woman screened?

The cost per woman screened in BreastScreen Australia was calculated at $141.00 for 2006–2007.The total cost of the BreastScreen Australia Program in 2006–2007 was estimated at $119.8 million. This figure was based on recent costing data from jurisdictions. The cost of the Program was comprised of staff costs, materials and supplies costs, accommodation costs, capital costs and other recurrent costs, such as purchase of specialised services and social marketing activities. Program co-ordination costs, including Commonwealth costs, were split amongst the previously mentioned cost categories.

11.2.2NETCOSTPERLIFEYEARSAVEDTHROUGHBREASTSCREENAUSTRALIA

Evaluationquestion23: What is the net cost per life year saved through the Program?

Over 20 years, the cost-effectiveness of the current Program was calculated to be $38,302/LYG. The model outcome indicated that, under this scenario, the average total cost per woman screened is $424. This estimate compares the current policy scenario of biennially screening the target age group of women 50-69 years and eligible age groups 40-49 years and 70+ years, at the current Program participation rate for these age groups, with the ‘no screening’ option.

11.2.3FACTORSTHATINFLUENCEVARIATIONSINCOSTS

Evaluationquestion24:What are the factors influencing any variation in cost?

Various screening scenarios were modelled against the ‘no-screening’ scenario. The cost-effectiveness results found that participation rates, age range and screening interval influenced cost.

In the models that included only the target age range of 50–69 years, increasing the participation rate from the current rate of 56.2% resulted in an increase in average costs relative to a hypothetical ‘no-screening’ scenario. This is due to the increasing number of cancers detected which would increase the cost of diagnosis and treatment.

In the models that extended the target age group, cost-effectiveness estimates increased when women aged 45–49 years and women aged 70+ years were added. Increasing the target age range would increase costs because of the greater numbers of women invited to participate in the Program. The higher cost/LYG for younger women is likely to be reflective of the lower rates of diagnosed and undiagnosed cancers amongst younger women than older women.

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Scenarios also increased participation by the 45–49 and 70–74 year age groups to 56.2% and 70%, respectively. Current participation rates for these age groups are 20.9% (45–49 years) and 36.6% (70–74 years). By increasing the participation rate for these groups of women, the proportional increase in the age groups making up the modelled 100,000 women cohort would be greater for younger women than older women. This makes it difficult to compare between screening scenarios in which the target age group varies.

Modelling of screening intervals found that more frequent screening generated higher cost-effectiveness estimates. While annual screening detected a greater number of cancers per 100,000 women and avoided a greater number of deaths per 100,000 women, this was at a significantly higher cost per woman screened in comparison to biennial and triennial screening. At a 70% participation rate, the cost per woman screened increased from $680 at 2-year intervals to $1,274 at annual intervals.

11.2.4MODELLEDSCENARIOS

A number of the modelled scenarios involved expanding the target age group, changing the screening interval and varying participation rates. These were all compared against a hypothetical scenario of a ‘no-screening’ scenario. The cost-effectiveness was modelled over a 20-year time horizon with all costs expressed in Australian dollars.

Expandingthetargetagerange

Current participation rate and maintaining an eligible age range

In this set of models, the target age range was expanded from the current Program target age group while maintaining current Program participation rates and a screening interval of 2 years. Eligibility of women was maintained. The participation rate was varied to increase participation in the target age group by women aged 45–49 years and 70–74 years as separate scenarios to determine the cost-effectiveness of an expanded target age range compared to no screening. Where an eligible age group was added to the target age group, the participation rate for this age group was inflated to 56%.

Using current Program participation rates, little difference was seen in cost-effectiveness estimates between scenarios (Figure 11.1). Expanding the age group to include women aged 70–74 years (Option 3A) resulted in a cost-effectiveness estimate of $38,305/LYG. Adding women aged 45–49 years (Option 2A) resulted in a cost-effectiveness estimate of $40,699/LYG. The average cost per woman screened did not differ greatly between Option 2A and 3A ($396 compared to $387). However, the average number of cancers detected per 100,000 women was greater for women aged 70–74 years (219 cancers detected per 100,000 women screened) compared with women aged 45–49 years (206 cancers detected per 100,000 women screened). Including women aged 45–49 and 70–74 years in the target age group resulted in a cost-effectiveness estimate of $37,612/LYG.


Increased participation rate for various target age ranges

Age-range scenarios were also modelled using as the base case a scenario of screening women 50–69 years only at a participation rate of 70% and a screening interval of 2 years. As with the scenarios above, the base case was varied to add the age groups of 45–49 years and 70–74 years in separate scenarios (also at a 70% participation rate) to determine the cost-effectiveness of expanding the target age range as well as the participation rate. In these scenarios, the eligible age group was not maintained.

The results for increasing the participation rate to 70% whilst also increasing the target age group are presented in Figure 11.2. Screening women 50–69 years only at a participation rate of 70% (Option B) generated a cost-effectiveness estimate of $45,576/LYG. Extending screening to women aged 70–74 years (Option 3B) resulted in a similar cost-effectiveness estimate of $42,492/LYG. The addition of women aged 45–49 years to the target age group (Option 2B) generated a cost-effectiveness estimate of $67,652/LYG. The cost-effectiveness of adding both women 45–49 years and 70–74 years at the higher participation rate was estimated to be $47,966/LYG.

Use of digital mammography

A scenario was modelled for the current screening Program assuming that digital mammography had replaced analogue mammography at all BreastScreen Australia sites. This scenario generated a cost-effectiveness estimate of $40,650/LYG.

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Figure11.1 Average cost-effectiveness ratios for extending the target age group using the current screening program compared with a ‘no-screening’ scenario

Aver

age

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/LYG

)

$0

$10,000

$20,000

$30,000

$40,000

$50,000

Digital Mammography

Option 4AOption 3AOption 2AOption A

Scenariooption Description $/LYG

A Current screening programa $38,302

2A +45–49 yrs to target age group at 56.2% participation $40,699

3A +70–74 yrs to target age group at 56.2% participation $38,305

4A +45–49 & 70–74 yrs to target age group at 56.2% participation $37,612

Digital Mammography Current screening program + all BreastScreen Australia use

digital mammography

$40,650

a. Participation rates used – 40–44 yrs (11.9%); 45–49 yrs (20.9%); 50–69 yrs (56.2%); 70+ yrs (17.1%) (AIHW 2008)Source: Economic Evaluation and Modelling Study


Figure11.2 Average cost-effectiveness ratios for extending the target age group using a 70% participation rate compared with a ‘no-screening’ scenario

Aver

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$40,000

$50,000

$60,000

$70,000

$80,000

Option 4BOption 3BOption 2BOption B


B Screening 50–69 year olds at 70% participation $45,576

2B +45–49 yrs to target age group at 70% participation $67,652

3B +70–74 yrs to target age group at 70% participation $42,492

4B +45–49 & 70–74 yrs to target age group at 70% participation $47,966

Source: Economic Evaluation and Modelling Study

Screening interval

Scenarios in which the screening interval was changed from biennial screening to annual or triennial screening used the current eligible and target groups and participation rates from the Program. The screening interval was also modelled for women in the target age group at 70% participation (Figure 11.3).

Using the current Program as the base, annual screening (Option 10A) produced a cost-effectiveness estimate of $55,411/LYG compared to $30,602/LYG for triennial screening (Option 11A). The cost-effectiveness estimate for biennial screening was $38,302/LYG.

Estimates of cost-effectiveness for different screening intervals and a 70% participation rate for the target group resulted in less variation than scenarios modelling the current Program. Biennial screening at a 70% participation rate (Option B) generated a cost-effectiveness estimate of $45,576/LYG compared with estimates of $47,520/LYG for annual screening and $39,589/LYG for triennial screening.

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Figure11.3 Average cost-effectiveness ratios for increasing and decreasing the screening interval, current program and women 50–69 years at 70% participation, compared with a ‘no-screening’ scenario

Aver

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$60,000

Option 11BOption 10BOption BOption 11AOption 10AOption A

Current 70% participation


A Current screening program $38,302

10A Current screening program + annual screening $55,411

11A Current screening program + triennial screening $30,602

B Screening 50–69 year olds at 70% participation $45,576

10B Screening 50–69 year olds at 70% participation + annual screening $47,520

11B Screening 50–69 year olds at 70% participation + triennial screening $39,589



Participation rate

Participation rate scenarios were modelled to examine the effects of low and high participation in the BreastScreen Australia Program (Figure 11.4). The base case for these scenarios used only the target population (women aged 50–69 years) at current Program participation rates of 56.2% and a screening interval of 2 years.

At the current participation rate, the cost-effectiveness estimate for the target age group (Option C) was $48,464/LYG. Reducing the participation rate to 45% (Option 2C) decreased cost-effectiveness to $57,656/LYG, while increasing participation to 70% (Option 3C) increased cost-effectiveness to $45,576/LYG. However, the possibility of random error cannot be excluded.

Figure11.4 Average cost-effectiveness ratios for varying the participation rate for women 50-69 years old compared with a ‘no-screening’ scenario

Aver

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Option 3COption 2COption C


C 50–69 yrs screening, 56.2% participation rate $45,576

2C 50–69 yrs screening, 45% participation rate $67,652

3C 50–69 yrs screening, 70% participation rate $42,492


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11.3 COST-UTILITY

Evaluationquestion25:What is the cost per quality adjusted life year (QALY)?

A cost-utility analysis adjusts life years gained as calculated in the outcomes for the cost-effectiveness analysis for quality of life and calculates the number of years lived in full health following a health intervention. This type of analysis uses utility weights to adjust life years, which are a quantitative measure of the strength of an individual’s preference for a particular health state or outcome. A widely used utility measure is the QALY. A QALY is a measure of quality of life that takes into account both the quantity and quality of life generated by an intervention (Culyer 2005). A QALY utility value is generally scaled between 1 and 0, where 1 is equal to perfect health and death is usually indicated by 0. Outcomes are expressed in terms of cost per QALY.

11.3.1COST-UTILITYANALYSIS

A comprehensive cost-utility analysis was not conducted for the Evaluation due to the limited time available and methodological issues relating largely to the collection of utility weights for the defined health states. There are two key methods of collecting utility values. The first is to determine utility weights using a population sample (either individuals experiencing the health state or individuals with knowledge of the health state who are not experiencing it, for example, clinicians, or a general population sample). This method is labour intensive and costly and therefore it is more common to use utility weights from existing literature.

To determine the range of pre-existing utility weights in relation to breast cancer, a literature review was conducted.79 The literature review, while extensive, was not an exhaustive review of all the relevant literature because, as more articles were sourced, health states and utility weights overlapped. The information was therefore considered sufficient for the purpose of informing the cost-utility analysis. A number of issues were encountered in relation to pre-existing utility weights. Few studies relating to screening have developed original weights. Instead, researchers have tended to use weights from other primary research studies. Variation exists in the description of similar health states as well as the methods and samples used to collect data. As a result, there was noticeable variation in utility weights for the same health state. Despite these issues, it was determined that some utility weights could be assigned to the health states in the current economic model to provide a limited cost-utility analysis.

The cost-utility model included utility weights for breast cancer treatment only, specifically for women undergoing mastectomy or breast conserving surgery. Although breast cancer treatment usually involves a combination of therapies, weights for other treatments were excluded as the original BreastScreen Australia data underpinning the model did not report on the proportion of women with possible treatment combinations. Utility weights relating to short-term therapies, such as radiation, were also excluded due to concerns with possible bias in the model and results.

79 This literature review was completed by Dr Frida Cheok, member of the EAC


The appropriate utility values for mastectomy or breast conserving surgery were assigned to pre-determined health states to adjust for quality of life after diagnosis and treatment for breast cancer. The average utility for mastectomy was 0.825 whilst the average for breast conserving surgery was 0.92. Using only these two utility values in the model, the QALY was calculated at $39,700/QALY for the current Program.

11.4 MARGINALCOSTANALYSIS

Evaluationquestion26: What are the marginal costs of the Program over marginal benefits?

In a marginal analysis, relevant costs and benefits of proposed alternative scenarios are compared systematically (Culyer 2005). The marginal cost-effectiveness ratio calculates the difference in total costs divided by the difference in total outcomes (life years) in moving from one scenario to the next.

It was not possible to perform the marginal analysis, or incremental analysis, of moving from one screening scenario to another using the type of model used in the economic evaluation. The whole model was an incremental analysis of moving from a ‘no-screening’ scenario to the various options modelled. For the current screening Program the marginal costs are $38,302/LYG and the marginal benefits are 200 deaths avoided per 100,000 women in the population. While marginal cost analysis of the various scenarios could not be calculated, adding women aged 45–49 years to the proposed target age group is likely to be less cost-effective than adding women aged 70–74 years.

11.5 FINANCIALIMPLICATIONSANALYSIS

The financial implications of implementing the Program for the next decade (2008–2017) were calculated. These results were not derived from the economic model results but were instead calculated by projecting the future population size for relevant age groups and applying participation rates and cost per screen derived from the current Program. Discounting was not applied to these figures, as it is conventional to present financial implications analysis using current prices. For this analysis, costs were determined for both the current target age group (women aged 50–69 years) and eligible age groups (women aged 40–49 years and 70+ years). The financial implications analysis modelled three policy alternatives (screening scenarios) as outlined below

• OptionA:Extendingthetargetagerangewhilemaintainingeligibleageranges Comprised women in both the target and eligible age groups at a screening interval of 2 years using current Program participation rates for the relevant age group. Option A was varied to include different age groups and screening intervals.

• OptionB:IncreasedparticipationforthecurrentandextendedtargetagerangeComprised women in the target age group only (50–69 years) using a 70% participation rate. Option B was varied to include additional age groups in the target age group at a participation rate of 70%, and different screening intervals.

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• OptionC:Increasingparticipationrateforcurrenttargetagerangeofwomen50–69yearsandremovalofeligibleagerange Comprised women in the target age group only (50–69 years) using a screening interval of 2 years at the current Program participation rate of 56.2%. Option C included variation in participation rates. The eligible population is not included in this option.

Resultsofthefinancialimplicationsanalysis

Results for Option A (the current BreastScreen Australia Program) indicate that costs will increase from $124 million in 2008 to $147 million in 2017. Expanding the target age range to include younger (45–49 years) or older (70+ years) age groups or both age groups, would result in a cost increase due to increased participant numbers (Table 11.1). Expansion of the target age range to include women aged 45–49 years would increase costs substantially to $144 million in 2008 and $168 million in 2017). Altering the screening interval also has a dramatic impact on cost with a change to annual screening resulting in a cost increase to $249 million in 2008 and $294 million by 2017. By comparison, triennial screening would significantly reduce costs.

Table11.1 Estimated screening costs ($millions) for 2008–2017 based on current participation rates

Option Optiondescription

2008

(Year1)

2017

(Year10)

Average

2008–2017

A Current screening Program $124 $147 $136

2A +45–49 years to target age group $144 $168 $156

3A +70–74 years to target age group $134 $161 $148

4A +45–49 & 70–74 years to target age group $153 $182 $168

Screening

interval

10A Current screening Program + annual screening $249 $294 $273

11A Current screening Program + triennial screening $84 $99 $92


Increasing Program participation to 70% for the target age group (Option B) would increase total costs to $115 million in 2008 and $137 million in 2017 (Table 11.2). Expanding the target age group at this participation rate of 70% would further increase Program costs. At this higher participation rate, by 2017, the cost of adding women aged 70–74 years to the target age would be significantly less than the cost if women aged 45–49 years were added ($162 million compared to $178 million). Adding women aged 45–49 and 70–74 years would increase costs substantially to $204 million in 2017. As with Option A, changing the screening interval also impacts upon costs, with annual screening adding significant cost to the Program (Table 11.2).


Table11.2 Estimated screening costs ($millions) for years 1–10 at a participation rate of 70%


2008

(Year1)

2017

(Year10)

Average

2008–2017

B Screening 50–69 year olds at 70% participation $115 $137 $128

2B +45–49 years to target age group at 70% participation $154 $178 $167

3B +70–74 years to target age group at 70% participation $133 $162 $148

4B +45–49 & 70–74 years to target age group at 70%

participation

$171 $204 $187

Screening

interval

10B Current screening Program + annual screening $231 $274 $256

11B Current screening Program + triennial screening $78 $92 $86


Varying the participation rate for the target age group only from 45% through to 70% participation (Option C) showed that, in general, increasing (or decreasing) the participation rate for women aged 50–69 years would result in increased (or decreased) total Program screening costs. By 2017, Program costs would range from a low of $88 million for a participation rate of 45% to $137 million for participation at 70% (Table 11.3).

Table11.3 Estimated screening costs ($millions) for years 1–10 for varying participation rates within the target age group


2008

(Year1)

2017

(Year10)

Average

2008–2017

C Screening 50–69 year olds at 56.2% participation $93 $110 $103

2C Screening 50–69 year olds at 45% participation $74 $88 $82

3C Screening 50–69 year olds at 70% participation $115 $137 $128


11.6 ANALYSIS

A Markov model was created to evaluate the effectiveness and cost of the current BreastScreen Australia Program. Outcomes were expressed in terms of cost-effectiveness, cost-utility and marginal benefit over a 20-year period. Cost-effectiveness results were compared with a ‘no-screening’ scenario where no formal screening program exists, but some women access mammography through the private health system with reimbursement through the MBS.

Cost-effectiveness of the current BreastScreen Australia Program was calculated at $38,302/LYG over a time horizon of 20 years. In Australia, estimates under $50,000/LYG are considered cost-effective. It could therefore be considered that the current Program is delivering cost-effective outcomes.

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The model was also used to calculate the cost of various policy alternatives (i.e. screening scenarios), including extending the target age range, changing the screening interval and varying participation rates. The base case used was the current Program, with a scenario of screening women aged 50–69 years at 70% used to examine variation in these policy alternatives.

Extending the target age range to include younger women (aged 45–49 years) lowered cost-effectiveness, particularly at a participation rate of 70%, where the cost-effectiveness estimate was $67,652/LYG. Addition of older women (aged 70–74 years) generated cost-effectiveness estimates similar to that of the base case. This is due to the higher incidence of breast cancers in older age women compared with younger women. Extending the target age range to include both the 45–49 and 70–74 year age groups was the most cost-effective option at $37,612/LYG at the current participation rate. Increasing the participation rate to 70% resulted in a cost-effectiveness estimate of $45,576/LYG for the base case and $47,966/LYG for the expanded target age range of 45–74 years.

With the future of BreastScreen Australia eventually moving towards digital mammography, a scenario modelling digital mammography was compared against the current Program. The cost-effectiveness estimate using digital mammography was higher than that of the base case ($40,650/LYG compared to $38,302/LYG). The increase in cost per LYG is likely due to the additional costs associated with the implementation of digital mammography, for example, capital costs, information technology costs and PACS.

Changing the screening interval from the current 2-year interval to annual or triennial screening indicated that more frequent screening was associated with a higher cost-effectiveness estimate. Annual screening was significantly more costly at $55,411/LYG when compared with the current Program estimate of $38,302/LYG. However, in scenarios using 70% participation rate, the cost-effectiveness estimates were fairly similar. With the screening interval scenarios, cost was the key determinant of cost-effectiveness (the total cost per woman screened) as opposed to LYG or cancer detection, which influenced costs associated with age range.

Participation rate scenarios were modelled using the target age group (50–69 years) and rates varying from the current Program participation rate (56.2%) to a lower (45%) and higher (70%) rate. Average costs increased with each increment in participation, which is likely due to the increasing number of cancers detected. This would therefore increase the costs of diagnosis and treatment. Overall, it was found that cost-effectiveness improved as participation increased.

A comprehensive cost-utility analysis was not conducted due to the limited time available. Despite issues around obtaining representative utility weights, a limited cost-utility analysis was undertaken by applying utility values specifically for women undergoing mastectomy or breast conserving surgery. The cost per QALY gained in the current Program was calculated at $39,700/QALY. This result indicates that the Program is cost-effective and compares with the unadjusted cost-effectiveness ratio of $38,302/LYG.


A financial implications analysis was also calculated as part of the economic evaluation to determine the costs of implementing the BreastScreen Australia Program over the next decade (2008–2017) using a range of options. Extending the target age range resulted in a cost increase over time, in particular if women aged 45–49 years were included in the target age range. This is the result of growth in population size over time. The increase in the target age range would also increase costs because of greater numbers of targeted women for the Program. A change to an annual screening interval also substantially increased costs compared with triennial screening. Similarly, an increase in the participation rate saw an increase in costs of implementing the Program.

Overall, the results of the Economic Evaluation and Modelling Study show that the current BreastScreen Australia Program is delivering cost-effective outcomes. Many of the estimates for different screening scenarios would also be cost-effective as these results are below the preferred $50,000/LYG threshold.

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12. POLICY ISSUES

Keyfindings

1. There is Level Ia evidence80 that biennial screening of women aged 50–69 years reduces the relative risk of mortality from breast cancer by 25% (95% CI: 33%–15%).

2. Evidence from RCTs is consistent with a 15% (95% CI: 26%–1%) reduction in mortality from breast cancer for annual screening of women aged 40–49 years. The risk reduction is less than that for women aged 50–69 years and has not reached statistical significance.

3. There is limited evidence available from RCTs about the benefits of screening in women over the age of 70 years. There is Level Ib evidence81 that screening does reduce mortality in this age group. Modelling indicates screening is probably still beneficial for women aged over 70 years who are in good health. Sensitivity of mammography is significantly higher in women aged 70 years and over in both first and subsequent screening rounds.

4. There is no new evidence to support changing the screening interval of the Program from the current policy of 2-yearly screening for women aged 50–69 years.

5. Factors that place a woman at a higher relative risk of developing breast cancer are increasing age, a strong family history of breast cancer or a previous history of invasive breast cancer or DCIS.

6. Women who were exposed to DES in utero may have a slightly increased risk of breast cancer. However, the level of risk is similar to exposure to a range of other risk factors that would not generally require more intensive screening or management protocols.

7. There is a high degree of consistency amongst jurisdictions in screening policy in relation to women in the target age range and women in the eligible age groups at average risk of breast cancer. Areas of consistency include recruitment of women, the provision of screening and assessment services and the screening interval.

8. There are differences among jurisdictions in relation to the proportion of women who have annual screening, and the management of women with a family history or personal history of breast cancer, women with symptoms and women with high breast density who present for screening.

9. Variation in policy application across jurisdictions is more likely to occur in those areas where national policy or guidelines are limited.

10. The absence of clear national policy guidance creates both considerable confusion for consumers and inequitable access for women.

80 Level Ia evidence is from a systematic review or meta-analysis of RCTs. See Appendix 16.5 for a description of the Oxford Centre for Evidence Based Medicine categories

81 Level Ib evidence is at least one RCT. See Appendix 16.5 for a description of the Oxford Centre for Evidence Based Medicine categories


ThischapterexaminestheevidenceforProgrampoliciesontheeligibleandtargetagerangesandscreeningintervalthroughliteraturereviewandexaminationofevidence-basedguidelinesandinternationalpractice.Also examined are screening policy issues that have emerged as the Program has matured, such as the appropriate management of women at higher risk of breast cancer and women with symptoms of breast cancer who present for screening. Policy application and consistency at jurisdiction level is also reviewed. Findings are presented from the Policy Analysis Project,82 which examined the literature on evidence for screening policy, evidence-based guidelines, international practice and policy application at jurisdictional level. In the analysis section, the results of three Evaluation projects: the Mortality Ecological Study, Policy Analysis Project and Participation and Performance Trends Project are drawn together to examine the evidence for appropriate screening policy for BreastScreen Australia.

12.1 AGERANGE83

Evaluationquestion31: Is the current Program policy on target age range and screening interval appropriate?

BreastScreen Australia has a target age range of 50–69 years and an eligible age range of 40–49 years and 70 years and over. Women in the target age range are actively targeted with invitation letters and communication activities, while women in the eligible age range are eligible to attend for screening but are not actively targeted. The policy distinction between the target and eligible age groups has been in place since the implementation of the Program and was based on evidence available at the time, which more strongly supported the effectiveness of breast cancer screening for women aged 50–69 years than for women outside this age range. There has been sustained public pressure to provide screening for women outside the current target age range of 50–69 years over the life of the Program.84 The Evaluation reviewed the evidence available on the effectiveness of breast cancer screening by age and considered the appropriateness of the current Program policy on age range.

82 See Appendix 16.2 for information on the BreastScreen Australia Evaluation projects83 See Chapters 6 and 8 for discussions on balance of benefit and harm in relation to age group84 See Senate Community Affairs Reference Committee report: The Cancer Journey: informing choice (June 2005). Recommendation 30 is to review

the target age range of BreastScreen Australia

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12.1.1EVIDENCEOFEFFECTIVENESSOFBREASTCANCERSCREENINGBYAGE:WOMEN50–69YEARS

The Policy Analysis Project literature review examined the evidence base for best practice in relation to age range for screening women at average risk of breast cancer and the relative benefits and potential harms of screening women in different age cohorts.

Evidencefromrandomisedcontrolledtrials

The literature review confirmed that screening women aged 50–69 years reduces mortality from breast cancer (Level Ia evidence).85

Eight large RCTs86 on breast cancer screening using mammography were undertaken in the 1970s and 1980s. The trials differed in terms of age group recruited, screening interval and details of screening protocols. The results of these trials have been published at various years of follow-up, and several meta-analyses have been produced on trial results. Results of the meta-analyses (Table 12.1) suggest that, for women of average risk aged 50–69 years, regular breast cancer screening with mammography reduces breast cancer mortality by up to 25% in screened women.

The United States Preventative Services Taskforce Review (USPSTF) included seven trials of mammographic screening in women aged 39–74 years at trial entry in its meta-analysis. The trials included were the Canadian and New York trials and the five Swedish trials. The meta-analysis found that screening with mammography gave a relative risk (RR) of death from breast cancer of 0.78 (95% Credible Interval (CrI):87 0.70–0.87) in women aged 50 years or above (Humphrey et al. 2002).

The IARC conducted a meta-analysis including the Finnish and five Swedish trials for women aged 50–69 years and concluded that the relative risk of mortality from breast cancer for screening participants aged 50–69 years was 0.75 (95% CI: 0.67–0.85) (IARC 2002).

The Cochrane Collaboration conducted a meta-analysis in 2001 (Olsen & Gøtzsche 2001), which was updated in 2006. The 2006 revision included the Canadian and New York trials and the five Swedish trials for women aged at least 50 years of age. The Cochrane meta-analysis found that the relative risk for deaths ascribed to breast cancer in women over 50 years was 0.77 (95% CI: 0.69–0.86) (Gøtzsche & Nielsen 2006).

Table12.1 Summary of outcomes from key meta-analyses on the effectiveness of breast cancer screening

RR(95%CrI)n=trialsincluded

Age(years) IARC(2002) USPSTF(2002) Cochrane(2006)

40–49 0.81 (0.65–1.01) n=6 0.85 (0.73–0.99) n=7

30–74 0.84 (0.77–0.91) n=7 0.80 (0.73–0.88) n=7

50+ 0.78 (0.70–0.87) n=7 0.77 (0.69–0.86) n=7

50–69 0.75 (0.67–0.85) n=6

65–74 0.78 (0.62–0.99) n=2

Notes: Credible interval (CrI); Relative risk (RR)Source: Policy Analysis Project

85 See Appendix 16.5 for details on Oxford levels of evidence86 Trials were New York Health Insurance Plan (HIP); Canada National Breast Screening Study (CNBSS1 and 2); Stockholm; Göteborg; Malmõ I and II;

Swedish two county: Kopparberg and Östergötland; Finland and Edinburgh 87 CrI is the Bayesian equivalent of confidence intervals (Glossary of Terms in The Cochrane Collaboration Version 4.2.5, May 2005 (cited in Policy

Analysis Project))


Datafromevaluationofscreeningprograms

The mortality reduction estimated as a result of population-based breast screening programs implemented has been broadly consistent with the effect found in the RCTs. Results from a Swedish study comparing breast cancer mortality rates in geographic areas where mammography programs had been introduced in different years found that biennial screening was associated with a relative risk of mortality from breast cancer in the 50–69 year old age group of 0.70 (95% CI: 0.57–0.86) after 11 years of follow-up (Jonsson et al. 2007). A combined analysis of cohort studies conducted in screening programs found the relative risk of mortality from breast cancer was 0.72 (95% CI: 0.63–0.82) (Gabe & Duffy 2005), although the studies included varied considerably in quality, design and age groups. Non-RCT comparative studies are even more diverse, but again the results are consistent with the mortality reduction found in trials (Gabe & Duffy 2005).

In Australia, the effect of the BreastScreen Australia Program on breast cancer mortality at a jurisdictional level has been found to be consistent with the effect reported by other countries. A case-control study of breast cancer deaths in South Australia found that participation in screening resulted in a relative risk of mortality of 0.59–0.70 (Roder et al. 2008). An ecological study conducted in NSW reported a statistically significant reduction in breast cancer mortality associated with breast cancer screening, with the reduction in risk of mortality from breast cancer of 30% at a participation rate of 70% consistent with the earlier RCTs (Taylor et al. 2004).

12.1.2EVIDENCEONEFFECTIVENESSOFBREASTCANCERSCREENINGBYAGE:WOMEN40–49YEARS


RCT results indicate a lower level of reduction of mortality from breast cancer for women in their 40s compared with those aged 50–69 years. Most of the RCTs of breast cancer screening included some women in their 40s, and there have been several meta-analyses of the results of screening for these women. These results show that the risk of mortality from breast cancer in women aged 40–49 years is reduced by about 15% by breast cancer screening (Table 12.1).

The IARC review (IARC 2002) included the five Swedish trials. Women were enrolled between the ages of 40–49 years in three of these trials and were aged 43–49 years and 45–49 years in the remaining two trials. The meta-analysis included just over 100,000 women. There were small numbers of deaths in these trials with 166 and 173 deaths amongst cases and controls respectively. Overall, the relative risk of mortality from breast cancer was 0.81 (95% CI: 0.65–1.01).

In 2002, the USPSTF meta-analysis of seven RCTs included the two trials that used clinical breast examination plus mammography, the New York Health Insurance Plan (HIP) and the Canadian trials (Humphrey et al. 2002). This meta-analysis included nearly double the number of subjects randomised compared with the IARC meta-analysis and reported that for women younger than 50 years participating in breast cancer screening the relative risk of breast cancer mortality was 0.85 (95% CI: 0.73–0.99) at a mean of 14 years follow-up.

214

The Cochrane Collaboration’s meta-analysis included data from eight trials88 (Gøtzsche & Nielsen 2006). The overall finding was of a relative risk of 0.84 (95% CI: 0.72–0.99) for breast cancer mortality at 13 years of follow-up for women under 50 years of age.

Few of the early RCTs were designed to examine mortality reduction specifically in women aged 40–49 years or were conducted in a way to enable the data on this age group to be drawn out. Women were aged 40 years and over at enrolment, and it is likely that some of the benefit of screening occurred when these women were aged over 50. The time until mortality benefits begin to be observed in these trials is longer in women younger than 50 years of age than in older women (8 years versus 4–6 years) and some of the observed benefits could be due to screening after age 50 (USPSTF 2002). A re-analysis of the five Swedish trials estimated that up to 70% of the 10% benefit in mortality reduction in women aged 40–49 years at trial entry was due to women screening in the years after turning 50 years of age (de Koning et al. 1995).

The UK Age Trial (Moss 2006) was designed to overcome issues in the design of the earlier trials to determine the mortality benefit of screening women from 40 years of age. Nearly 161,000 women aged 39–41 years were randomised in the ratio of 1:2 to annual mammography or usual medical care to 48 years of age. The trial population was followed up for 10 years by flagging at the National Health Service (NHS) central register to determine breast cancer incidence, breast cancer, all-cause mortality and emigration. At an average follow-up of 10.7 years, the intervention group had a decreased relative risk of breast cancer mortality of 0.83 (95% CI: 0.66–1.01). The absolute risk reduction was 0.4 per 1,000 women invited to screening (95% CI: –0.07–0.87). Two factors limited the ability of the Age trial to fully meet its proposed objectives (Moss 2006; Elmore 2007). Firstly, because of cost and logistic issues, the sample size was smaller than originally planned (161,000 women instead of 190,000). Secondly, because treatment of breast cancer had improved over the time of the study, mortality was 2.35 per 1,000 instead of 3.3 per 1,000 as predicted, which reduced the difference between screened and non-screened arms and therefore reduced the study power.

Based on the meta-analyses of RCTs that included women aged 40–49 years, and the one RCT specifically designed to study the benefit of screening women aged 40–49 years, it appears that the mortality effects, and therefore the benefits of screening are smaller than for the 50–69 year cohort. In addition, the confidence intervals suggest there may be no statistically significant mortality benefit of screening for this age group. It is difficult to present conclusive evidence, as few trials included younger women and the benefits achieved for younger women participating in the trials cannot be distinguished from the benefits for older women.

88 Trials included in the Cochrane review were New York Health Insurance Plan (HIP); Canada National Breast Screening Study (CNBSS1 and 2); Stockholm; Göteborg; Malmõ I and II; and Swedish two county: Kopparberg and Östergötland.


Mammographyperformancecharacteristicsinwomenaged40–49years89

The performance characteristics of mammography programs tend to be poorer for women in their 40s than for women in the target age group. The lower sensitivity and specificity of mammography in younger women results in more false-positive and false-negative results. The balance of benefits to risks for this age group is therefore not as favourable as for women in the 50–69 year age group.

12.1.3EVIDENCEONEFFECTIVENESSOFBREASTCANCERSCREENINGBYAGE:WOMEN70YEARSANDOVER


There is little evidence available from RCTs of breast cancer screening for women over the age of 70 years. Only two RCTs have examined the effectiveness of starting screening in women over 70 and these have been based on small numbers. Many previous trials designed to measure mortality reductions both from screening and treatment tended to exclude older women (Law et al. 1996).

A combined analysis reported a summary relative risk among women aged 65–74 years of 0.78 (95% CI: 0.62 – 0.99) (Humphrey et al. 2002). Nystrom (2002) conducted a re-analysis of two Swedish trials, which included women aged 65 years and over at recruitment, and estimated the relative risk of mortality from breast cancer in women aged 70–74 years was 1.12 (95% CI: 0.73–1.72). The IARC review (2002) did not present a meta-analysis for the older age group due to the lack of available trials.

Evidencefromevaluationofscreeningprograms

The Dutch screening program extended its target age range of 50–69 years to include women aged 70–74 years in 1998. Since 2001, breast cancer mortality in women aged 65–74 years has shown a marked decline of 2.8% per annum, attributed in part to the screening program (Otten et al. 2008).

Evidencefrommodelling

An Australian study reviewed models of the life-expectancy benefit of screening in older women as a percentage of the benefit in younger women (Barratt et al. 2002). Although the models were based on different assumptions and different data, all of them showed a decrease in relative benefit as women aged. In women aged 70–74 years, the benefit was 33–83%, in women aged 75–79 years the benefit was 48–61%, while in women older than 80 years of age the relative benefit was less than half that for younger women.

A later study by Barratt et al. (2005) modelled the impact of continuing screening compared with ceasing participation in the Program for women aged over 70 years who had self-rated their health status as good, excellent or poor (Table 12.2). The data suggested that for all three groups, approximately two additional deaths from breast cancer would occur for every 1,000 women who discontinued screening at age 69 years. The rate of diagnosis of invasive breast cancers was

89 See Chapter 8, section 8.3 for further information about Program performance in relation to different age groups

216

significantly lower for women who discontinued screening in all groups. For the group of women self-rated as being in excellent health, invasive cancers were observed at a rate of 36.8 per 1,000 for women who continued screening compared with

25.9 per 1,000 for the unscreened group. The biggest difference between the three groups was the number of women who died from other causes with 117 women in ‘excellent’ health and 410.6 women in ‘poor’ health predicted to die from other causes. The results of this modelling represent lower level evidence, but the information does suggest that the impact of co-morbidities may be sufficiently significant to be considered when giving advice on screening participation to women aged over 70 years.

Table12.2 Modelled mortality outcomes for 1,000 Australian women >70 years old with self-rated health status who started screening at age 50 years according to self-rated health and whether they continued screening or not

Eventover10years

Goodorfairself-rated

health(basecase) Excellentself-ratedhealth Poorself-ratedhealth

Screening Stop

screening

Screening Stop

screening

Screening Stop

screening

Die from breast cancer 6.2 8.4 6.4 8.8 5.6 7.6

Die from other causes

than breast cancer

199.5 199.3 117.1 117.0 410.6 410.2

Total who die 205.7 207.8 123.5 125.8 416.2 417.8

Source: Barratt et al. 2005 (only partial table has been reproduced) as cited in Policy Analysis Project

The NHS Breast Screening Programme (NHSBSP) similarly suggests that mammography screening remains beneficial for women aged over 70 years who are in good health and have a life expectancy of about 10 years and that increasing life expectancy rates should be considered as part of decision making (NHSBSP 2006).

It may be more useful to measure the benefit of screening in terms of improved life expectancy rather than in terms of relative or absolute reductions in mortality (Barratt et al. 2002). The effectiveness of screening is probably continuous and it may be difficult to specify an exact age at which screening should stop. It has therefore been argued that this is a decision for women to make in consultation with their healthcare providers (Barratt et al. 2002; NHSBSP 2006).

The average life expectancy for Australian women has increased since the beginning of the Program (Table 12.3) and this may impact on considerations about screening of women over the age of 70 years.

Table12.3 Life expectancy (years) for females in Australia, 1980–1982 to 2004–2006

1980–1982 1990 1994–1996 1998–2000 2004–2006

At birth 78.3 80.1 81.1 82 83.5

At age 65 years 18.0 19.0 19.6 20.40 21.5

Note: Data covers 3-year periods except for 1990Source: Policy Analysis Project


In 2004–2005, around 180,000 women aged 70 years and over attended the BreastScreen Australia Program, representing approximately 11% of the women screened in the Program. Of these, 65% were aged 70–74 years. The majority of these were residents of Victoria and Queensland, where women in this age group continue to be invited to participate in screening up to the age of 74 years, although this practice recently ceased in Victoria.

Summary

Table 12.4 provides a summary of the data on mortality reduction from a range of studies presented in this section and from the Mortality Ecological Study.

Table12.4 Summary of evidence on the effect of breast cancer screening on breast cancer mortality in 5-year age groups

Source

AGEGROUPS(years)

40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–79

Relative risk (95% CI)

of breast cancer mortality

from meta-analysis

of RCTs

Womenwithage

inrangeof40–49

atenrolment

0.81 (0.65–1.01) IARC a

0.85 (0.73–0.99) USPSTF b

0.96 (0.78–1.18) Cochrane c

0.84 (0.72–0.99) Cochrane d

Womenwithageinrangeof50–69

yearsatenrolment

0.75 (0.67–0.85) IARC e

0.78 (0.70–0.87) USPSTF f

0.72 (0.62–0.85) Cochrane g

0.77 (0.69–0.86) Cochrane h

Womenwithage

inrangeof70–74

yearsatenrolment

1.12

(0.73–1.72)

Nystrom 2002 i

Mortality reduction (%)

(95% CIs) from screening

in BreastScreen Australia

at 60% participation rate,

1990–2004 (Poisson

regression – cumulative

mortality at 6 years) j

–4.7

(–42.5

to +58.0)

–26.4

(–47.6

to +3.6)

–21.3

(–34.8

to –5.1)

–21.8

(–35.2

to–5.6)

–24.1

(–37.9

to–7.3)

–20.9

(–33.7

to–5.6)

–12.4

(–29.9

to +9.6)

+3.0

(–32.5

to +57.4)

40–49years

–20.4 (–42.0 to +9.3%)

50–69years

–21.8 (–30.5 to –12.1)

70–79years

–9.2 (–26.5 to +12.3)

Mortality reduction

from screening in

BreastScreen Australia at

60% participation rate

(Proportional hazards

regression) j

+3.8

(–49.1

to+112)

–30.5

(–56.0

to +9.7)

–26.9

(–42.9

to –6.5)

–28.7

(–45.3

to –7.0)

–37.2

(–52.9

to–16.3)

–26.9

(–42.9

to –6.4)

–12.7

(–33.8

to +15.0)

–5.4

(–41.1

to +51.9)

–20.4 (–42.0 to +9.3%) –30.1 (–40.9 to –17.2) –11.1 (–30.8 to +14.7)

a IARC 2002. Meta-analysis included Swedish trials only. b Humphrey et al, 2002. Meta-analysis included Swedish, Canadian and HIP (New York) trials c Gotzsche & Nielsen 2006. At 7 years of follow-up, women below 50 years of age d Gotzsche & Nielsen 2006. At 13 years of follow-up, women below 50 years of agee IARC 2002. Meta-analysis included Swedish trials and one Finnish trial onlyf Humphrey et al. 2002 Meta-analysis included Swedish, Canadian and HIP (New York) trialsg Gotzsche & Nielsen 2006. At 7 years of follow-up, women at least 50 years of ageh Gotzsche & Nielsen 2006. At 13 years of follow-up, women at least 50 years of agei Nystrom et al. 2002, quoted in Humphrey et al. 2002. Based on re-analysis of two Swedish trials that included women older than

65 years of age at enrolmentj See also Chapter 6 for further details of findings from the Mortality Ecological Study

218

12.1.4COMPARATIVEDATAONSCREENINGACROSSAGECOHORTSUSINGAUSTRALIANDATA

There are a number of differences between age cohorts with regard to the biology of breast cancer and the performance of a mammographic screening program in different age groups. These are summarised in Table 12.5 using Australian data.

Breastcancerincidence90

The incidence of breast cancer increases with age from 118 per 100,000 women per year in women aged 40–44 years to 337 per 100,000 in women aged 65–70 years (Table 12.5). The incidence rates level off in women in their 70s, although this may be an effect of the targeted screening age group (Mandelblatt et al. 2003; Humphrey et al. 2002; Harris & Leininger 1995). In most countries with established mammographic screening programs, the increase in incidence of breast cancer in women aged 50–69 years has been greater than that in women over 70 years of age (Héry et al. 2008). This is likely to be due to the increase in screen-related detection of cancers of low malignant potential.

For women, age remains the biggest risk factor in the development of breast cancer. The risk of being diagnosed increases significantly along the continuum of age, with over 70% of cases found in women aged 50 years and older and the risk increasing with age, although it levels off around the age of 70 years.

Table12.5 Comparative data on breast cancer across age cohorts in Australia

40–49years 50–59years 60–69years 70–79years

Incidence of breast cancer per 100,000

Australian population 2000–2004

40–44 118

45–49 186

50–54 246

55–59 300

60–64 334

65–69 337

70–74 314

75–79 307

Risk of developing breast cancer 1 in 70 if aged 40 1 in 40 if aged 50 1in 30 if aged 60 1 in 30 if aged 70

Source: Policy Analysis Project

Outcomesandperformanceofbreastcancerscreening91

The various outcomes and performance characteristics of a mammographic screening program vary with age. Screening is more effective in detecting cancer in older age cohorts due to increasing incidence and increasing sensitivity of mammography as women age (Table 12.6).

As breast cancer incidence increases with age, the cancer detection rate in the BreastScreen Australia Program increases with age. The rate of cancers detected per 10,000 women screened in women aged 40–49 years is half that of women aged 50–69 years, whether in first or subsequent screening rounds. For women aged 70 years and over the cancer detection rate is around 50% greater than that of women aged 50–69 years (Table 12.6).

Despite different cancer detection rates, the recall to assessment rate across different age cohorts is fairly constant, indicating that for each cancer detected, more women in the younger age cohorts will be recalled for assessment compared to older ages.

90 See Chapter 3 for further data in relation to breast cancer incidence91 See Chapter 8 for further details in relation to Program performance


The interval cancer rate across age cohorts is similar in the Program. However, the sensitivity of mammography increases across increasing age cohorts. This indicates that for each cancer detected in women in the younger age cohort, more will be interval cancers compared to the older age cohort. In women aged 40–49 years in subsequent screening rounds, almost half of the cancers detected are interval cancers. In the period 2001–2003, the 0–24 month interval cancer rate in subsequent screening rounds for women aged 40–49 years was 10.0 (95% CI: 9.2–10.8) per 10,000 women screened. In the period 2001–2005, the all-size cancer detection rate in subsequent screening rounds for women aged 40–49 years was 19.3 (95% CI: 18.0–19.8). The sensitivity of mammography in 2000–2003 in this age group in subsequent screening rounds was 52.8 (95% CI: 48.9–57.0). By contrast, for women aged 50–69 years, the sensitivity of mammography in subsequent screening rounds was significantly higher at 70.3 in 2000–2003, while for women aged 70 years and over, sensitivity was 79.6 (95% CI: 79.0–80.2) per 10,000 women screened.

Program data were used to determine the number of women needed to be screened, recalled or have a biopsy to detect one cancer. As can be seen from Table 12.6, many younger women need to be screened and assessed to detect one cancer, and many younger women will have more biopsies for each cancer detected. For women aged 40–44 years, six women will have a biopsy for one cancer detected compared to less than half that number in the 50–69 year age group.

Table12.6 Comparison of breast cancer screening: program performance by age group

Parameter

Agegroup(years)

40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–79

Age-standardised cancer detection rate/10,000 women screened (95% CI), 2001–2005

Small (≤15mm), first round 40–49years

16.3 (14.7–17.9)

50–69years

40.6 (38.1–43.2)

70yearsandover

82.6 (69.0–90.8)

Small (≤15mm), subsequent rounds 11.4 (10.3–12.5) 27.5 (26.9–28.2) 44.1 (42.3–46.0)

All – first round 32.3 (30.1–34.7) 62.9 (70.1–76.9) 148.9 (134.7–164.1)

All – subsequent rounds 19.3 (18.0–20.8) 42.5 (41.7–43.3) 64.0 (61.8–66.3)

Age-standardised DCIS detection rate/10,000 women screened (95% CI), 2001–2005

First round 8.9 (7.8–10.0) 18.5 (16.9–20.2) 25.5 (20.0–32.1)

Subsequent rounds 6.2 (5.4–7.0) 10.3 (9.9–10.7) 13.0 (12.1–14.1)

Age-standardised interval cancers rate/10,000 women screened (95% CI), 0–24 months, 2001–2003

First round 8.4 (7.6–9.3) 9.5 (8.7–10.4) 9.2 (6.9–12.0)


Sensitivity (screen-detected cancers as proportion of screen-detected and interval cancers), 0–24 months,

age-standardised (95% CI), 2000–2003

First round 64.4 (59.7–69.5) 78.5 (74.8–82.2) 90.2 (82.3–98.8)


Recall to assessment rate – proportion of women recalled of all women screened (2005)

First round 8.5 10.3 10.6 9.4 10.0 9.1 8.7 11.3

Subsequent rounds 4.9 4.9 4.3 3.7 3.9 3.7 3.8 4.3

Age-standardised invasive procedure rate, number of procedures as a total of all assessments, (95% CI), 2001–2005

FNA 9.0 (8.7–9.3) 10.1 (9.9–10.2) 11.0 (10.6–11.5)

Core biopsy 12.4 (12.1–12.7) 16.7 (16.5–16.9) 19.0 (18.5–19.6)

220

Parameter

Agegroup(years)

40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–79

Number needed a (NN) to screen / to recall and to biopsy to detect one cancer (2005) and cancer yield b (2005)

NN screen first round 437 252 195 136 106 112 106 33

NN screen subsequent rounds 774 397 340 270 197 180 163 125

NN recall first and

subsequent rounds

37 22 17 10 8 7 7 5

NN FNA 3.5 3.0 1.3 1.2 0.7 0.6 0.6 0.6

NN core biopsy 6.1 3.8 2.8 1.9 1.6 1.4 1.6 1.3

Yield c 1.97 3.01 3.48 4.00 5.32 5.70 6.20 9.04

a Calculations based on 2005 data as presented in the Participation and Performance Trends Project b Number of all-size cancers detected first and subsequent rounds/1,000 women screened in 2005 c Number of all-size cancers detected first and subsequent rounds/1,000 women screened in 2005Source: Participation and Performance Trends Project

12.2 SCREENINGINTERVAL

Determining the appropriate screening interval for a cancer screening program is important in the resulting effectiveness of the program. The screening interval needs to be short enough to detect cancers before they are clinically apparent so they can be treated earlier, providing improved survival. The interval needs to be long enough so that any harms of the screening program are minimised for participants.

Sojourn time is an important concept in interpreting evidence related to the appropriate screening interval. Sojourn time is the time from when the cancer would have become detectable by screening and when it becomes symptomatic. Ideally, the screening interval should allow detection of cancer within the sojourn time. The probability of a cancer being detected by screening mammography depends on the sojourn time and the screening interval. Cancers with a longer sojourn time are more likely to be detected at screening, but are also more likely to have a good prognosis (IARC 2002). Thus, screening tends to pick up slow-growing, good-prognosis tumours. This bias in the type of cancers detected at screening is known as length bias.

12.2.1EVIDENCEONMAMMOGRAPHICSCREENINGINTERVAL

The literature review undertaken in the Policy Analysis Project examined the evidence base in relation to recommended screening intervals for screening of women at average risk. Findings indicate that there are little data available from RCTs that directly compared screening intervals.

A trial in Finland (Klemi et al. 1997) of 36,000 women aged 40–49 years found little difference in the proportion of interval cancers if women were screened annually (27%) versus 3-yearly (39%) (p=0.22 for difference). Only 100 interval cancers were detected during the trial, and different screening intervals were used for different ages.

Table12.6 Comparison of breast cancer screening: program performance by age group (continued)


A trial in the UK, based on data from screening units in Nottingham, Cardiff, Epping, Gateshead and Newcastle, predicted that shortening the screening interval in women aged 50–62 years would have a relatively small effect on breast cancer mortality. The relative risk of predicted mortality from breast cancer was 0.95 (95% CI: 0.83–1.07) for annual screening compared with every 3 years (United Kingdom Coordinating Committee for Cancer Research (UKCCCR) 2002).

The USPSTF meta-analysis reported no difference in overall efficacy for annual mammography compared with biennial mammography, although it suggested that more research was needed to investigate whether this conclusion also held for women in their 40s (Humphrey et al. 2002).

The IARC meta-analysis (2002) concluded that there is little evidence on which to base recommendations on the frequency of screening mammography since most RCTs included in the IARC review invited women to be screened at intervals of about 24 months.

A review of the results of UKCCCR and Swedish studies concluded that, based on current evidence, the appropriate screening interval for women aged 50–60 years is likely to be between 2 and 3 years, while screening for women under 50 years of age may need to be more frequent (Blamey et al. 2000).

Evidenceformorefrequentscreeningofwomenagedlessthan50yearsofage

There is limited comparative information about screening intervals of 1, 2 or 3 years for women younger than 50 years, and most studies have not found great differences between the performance of programs using different intervals.

It is possible that annual screening may improve outcomes for younger women (younger than 50 years) if sojourn times are shorter and interval cancer rates are higher for this age cohort, while less frequent screening may be appropriate for older women (>70 years of age).

Breast cancers in women aged 40–49 years are thought to grow faster than breast cancers in older women. A re-analysis of results from the Swedish Two County trial indicated that the reduced effect on mortality for women aged 40–49 years compared to older women is due to the faster progression of a substantial proportion of tumours in this age group and the rapid increase in incidence during this decade of life (Tabar et al. 1995). The mean sojourn times in the age groups 40–49 years, 50–59 years, 60–69 years, and 70–74 years were 1.7, 3.3, 3.8, and 2.6 years, respectively. Tabar concluded that the interval between screenings should be shortened to achieve a greater benefit in the younger age group, and estimated that a 19% reduction in mortality would result from an annual screening regime.

A review of performance measures from seven US mammographic registries found that sensitivity, recall rate and cancer detection rate increased with time since previous mammography (Yankaskas et al. 2005). Specificity decreased with increasing time and there was a slight decrease in positive predictive value from 5.1% (95% CI 4.8–5.4%) for screening intervals of 21–27 months to 4.6% (95% CI 4.4–4.8%) for intervals of 9–15 months.

222

An observational study of data from the same seven registries in the US compared breast cancer outcomes (stage, tumour size, grade and oestrogen receptor status) of women diagnosed with breast cancer who were screened at 1-year intervals (n=5400) and 2-year intervals (n=2440). The study found that women in their 40s were more likely to present with a late-stage breast cancer than an early-stage cancer if they had a 2-year screening interval compared with a 1-year interval (28% versus 21%; OR = 1.37; 95% CI: 1.00–1.86). This difference was not seen for older women. There was no difference in the number of tumours that were larger than 20mm in size, grade III or IV or ER-negative for the women aged 40–49 years who were screened 2-yearly compared to those screened annually. Furthermore, this study reported there was no evidence that annual screening provided more benefit than biennial screening for women with high mammographic breast density compared to women with predominantly fatty breasts (White et al. 2004b).

The evidence for shorter screening intervals should be balanced against that fact that the estimated cumulative risk of ever having a false-positive result has been calculated to be significantly higher for women participating in a screening program with a screening interval of 1 year than for programs with an interval of 2 or 3 years (IARC 2002).

Annual screening could increase radiation exposure. The UK Age trial used single-view mammography after the first screen to reduce the radiation exposure. An analysis of cancers detected and induced as a result of screening in the UK screening program concluded that, for women aged 40–49 years, the benefit-to-risk ratio was favourable with annual screening, but that caution is required for women younger than 35 years (Law et al. 2001).

Available evidence about screening intervals is somewhat inconclusive. Where mortality benefits have been demonstrated for shorter screening intervals, these have only been small. Based on current evidence, a screening interval of 2 years for women aged 50–69 years seems to be appropriate and is in line with most international screening mammography programs. There may be benefit in considering different screening intervals for younger and older women.

12.3 SCREENINGOFWOMENATHIGHERRISK

Evaluationquestion32: What is the best practice evidence for the management of women identified as being at higher risk?

The literature review conducted for the Policy Analysis Project examined the evidence base for best practice in relation to screening women at higher risk.

12.3.1RISKFACTORSFORDEVELOPINGBREASTCANCER

Within a population-based breast cancer screening program, it may be appropriate to apply different screen policies or to use different screening technologies for some sub-groups of women. All women face some risk of breast cancer over their lifetime. However, a woman’s personal risk of developing breast cancer is dependent on the cumulative impact for her of the different factors that increase or reduce her individual levels of risk.


A wide range of factors have been examined in relation to risk of breast cancer. Meta-analyses of existing clinical trials and research reveal inconsistent findings on many factors posited as breast cancer risk factors. Table 12.7 details the findings from different sources on estimated relative risk across various factors. Concurrence is not always evident. Risk differentiation is commonly ascribed as average, moderate or high. While this categorisation is usually used for family history, it could also be used to place other risk factors into context.

Apart from increasing age, the following factors increase the relative risk of developing breast cancer of greater than two times the population risk:

• high breast density;

• a family history of breast cancer in a first degree relative; and

• previous history of breast cancer.

Table12.7 Relative risk factors for developing breast cancer from two different reviews

Riskfactorsforbreastcancer

Relativeriskofdevelopingbreastcancer

Source1 Source2

Advanced age >10 >4 with increasing age

BRCA1 or BRCA2 mutation Not reported >4

High breast density for age on mammogram 5 >4

Previous atypical hyperplasia 4–5 2–3.99

Previous breast cancer >4 >4

High exposure to ionising radiation 3 1.25–1.99

First child after 40 years of age 3 Not reported

First child after 29 years of age Not reported 1.25–1.99

Menarche before 11 years of age 3 *

Menopause after 54 years of age 2 1.25–1.99

Breast cancer in one first–degree relative >2 1.25–1.99

High BMI post–menopausal 2 1.25–1.99

Current use of HRT 1.3–1.6 1.25–1.99

Oral contraceptive (current use) 1.2 1.25–1.99

DES exposure in utero 2 1.25–1.99

One alcoholic drink daily 1.07 Not reported

Three standard drinks daily Not reported 1.25–1.99

High BMI pre–menopausal (protective factor) <1 <0.8

Breastfeeding for 12 months (protective factor) 0.96 <0.8

One birth (protective factor) 0.93 <0.8

Nulliparous (no births) Not reported 1.25–1.99

Note: * a risk reduction of 10–20% has been estimated for each year of delay of menarche after the age of 12 years.Body Mass Index (BMI) ; Hormone Replacement Therapy (HRT).Source: Source 1 – Veronesi et al. 2005 ; Source 2 – NBOCC 2008

224

Womenexposedtodiethylstilboestrol(DES)

Two studies identified in the literature review examined the relative risk for developing breast cancer for women exposed to DES in utero. One study reported a relative risk of 2 (Veronesi et al. 2005), while the second found that the relative risk ranges from 1.25–1.99 (NBOCC 2008). These findings indicate that women who were exposed to DES in utero may have a slightly increased risk of breast cancer, but the level of risk is similar to exposure to a range of other risk factors (Table 12.7) that would not generally require more intensive screening protocols.

12.3.2BESTPRACTICEMANAGEMENTFORWOMENWITHHIGHERPERSONALRISK92

Womenwithafamilyhistory

Women with a family history of breast cancer can have varying levels of risk of breast cancer ranging between a true increased risk to an average risk level. While the majority of women who develop breast cancer do not have a family history of the disease, the risk of developing breast cancer increases for women with inherited genetic susceptibility and/or first–degree family history. A strong family history of breast cancer is a recognised risk factor for developing breast cancer, though a strong family history does not necessarily imply a specific inherited gene fault (Anderson et al. 2008).

Family history becomes increasingly relevant as a risk factor with the number of blood relatives with a history of breast cancer, the number who were younger when first diagnosed, and with proximity of the relationship. From a collaborative analysis of 52 case-control studies, the relative risk of developing breast cancer for women with one affected first-degree relative is 1.80 (99% CI: 1.69–1.91); for women with two affected first-degree relatives this rises to 2.93 (99% CI: 2.36–3.64), while the relative risk for women with three or more affected relatives is 3.90 (99% CI: 2.03–7.49) (NBOCC 2008). As breast cancer incidence in the general population increases with age, breast cancer in older relatives is more likely to be due to chance, whereas breast cancer in younger relatives is more likely to be due to familial factors. An elderly relative with breast cancer usually does not imply elevated family-linked risk for breast cancer in their relatives. Estimates of absolute risk are provided for factors by age, dependent on the number of affected first-degree relatives (Table 12.8).

Table12.8 Absolute risk (%) of developing breast cancer over the next 10 years by age cohort and number of affected first-degree relatives

Ifthewomanisnowaged:

Absoluteriskattributabletonumberofaffectedfirst-degreerelatives(%)

Two One None

20 years 0.2 0.1 0.04

30 years 2.0 1.0 0.4

40 years 5.2 2.5 1.4

50 years 5.3 3.2 1.9

60 years 5.6 3.5 2.3

70 years 5.7 4.2 2.5


92 In this Evaluation, the term ‘higher personal risk’ is used to refer to women with increased risk due to family history of breast cancer, previous personal history of breast cancer and women with high breast density


Based on studies that examined the relative and absolute risk of developing breast cancer as a result of family history, the NBCC (2006) developed risk categories for women with a family history of breast cancer (Table 12.9).

Table12.9 Categories of risk for women with a family history of breast cancer

Category Lifetimerisk Criteria

Atorslightlyaboveaverage

risk

(>95% of female population)

Between 1 in 11 and 1 in 8

No more than 1.5 times the

population average

• No confirmed family history of breast cancer

• One 1˚ relative diagnosed with breast cancer at age

50 years or older

• One 2˚ relative diagnosed with breast cancer at any age

• Two 2˚ relative on the same side of the family diagnosed

with breast cancer at age 50 years or older

• Two 1˚ or 2˚ relatives diagnosed with breast cancer at age

50 years or older, on different sides of the family

Moderatelyincreasedrisk

(<4% of female population)


1.5–3 times the population

average

• One 1˚ relative diagnosed with breast cancer before the

age of 50 years

• Two 1˚ relatives on the same side of the family diagnosed

with breast cancer

• Two 2˚ relatives on the same side of the family diagnosed

with breast cancer, at least one before the age of fifty

Note: does not apply to women with the additional features

of the potentially high-risk group

Potentiallyhighrisk

(much less than 1% of female

population)


May be 3 times the population

average but individual risk

may be higher or lower as

determined through genetic

testing

• Women who are potentially high risk of ovarian cancer

• Two 1˚ or 2˚ relatives on one side of the family diagnosed

with breast or ovarian cancer plus one or more of the

following features on the same side of the family:

– additional relative(s) with breast or ovarian cancer

– breast cancer diagnosed before the age of 40 years

– bilateral breast cancer

– breast and ovarian cancer in the same woman

– Ashkenazi Jewish ancestry

– breast cancer in a male relative

• One 1˚ or 2˚ relatives diagnosed with breast cancer

at age 45 years or younger plus another 1˚ or 2˚ relatives

on the same side of the family with sarcoma at age

45 years or younger

• Member of a family in which the presence of a high risk

breast cancer gene mutation has been established.

Source: Adapted from NBCC 2006 as cited in the Policy Analysis Project

There is no clear evidence for best practice management of women with a family history of breast cancer in a population-based screening program. Models of practice are therefore usually generally based on expert consensus opinion. Comparisons between models of practice need to be treated with caution, as the definitions of increased risk or high risk may vary. Models generally distinguish between management of those women at potentially high risk as compared to those at moderate risk (Table 12.10).

226

Table12.10 Models of practice for women with family history of breast cancer or known genetic mutation

Source Guidelines

NBOCC(Australia)a Moderatelyincreasedrisk

• At the very least attend for screening mammograms as per the general

population

• Additional surveillance, such as mammography from a younger age, or more

frequently, should be considered on an individual basis

• Discuss possible participation in a relevant approved clinical trial for the

prevention of breast cancer

Potentiallyhighrisk

• Refer to a family cancer clinic for risk assessment and management

• It is recommended that, in consultation with a cancer specialist, an individual

surveillance program be developed which may include:

– attending for regular clinical breast examination

– annual mammography with or without other imaging techniques

– surveillance for ovarian cancer

• The age at which screening commences should be determined on an individual

basis, but it is generally accepted practice to begin screening at least 5 years prior

to the age of diagnosis of the closest relative

• Discuss possible participation in a relevant approved clinical trial for the

prevention of breast cancer

NationalInstituteforClinical

Excellence(NICE)(UK)b

• Women aged 40–49 years satisfying referral criteria (at raised or greater risk)

should be offered annual mammography

• Women known to have a genetic mutation should be offered annual MRI

surveillance if they are BRCA1 and BRCA2 mutation carriers aged 30–49 years,

or Tp53 mutation carriers aged 20 years or older

• Annual MRI surveillance should be offered to women 30–39 years at a 10-year

risk of greater than 8%

• Annual MRI surveillance should be offered to women aged 40–49 years at a

10-year risk of greater than 20%; or a 10-year risk of greater than 12% where

mammography has shown a dense breast pattern

UnitedStatesPreventiveServices

Taskforce(USPSTF)(US)

• Women whose family history is associated with an increased risk for deleterious

mutations in BRCA1 or BRCA2 genes be referred for genetic counselling and

evaluation for BRCA testing

• Against routine referral for genetic counselling or routine breast cancer

susceptibility gene (BRCA) testing for women whose family history is not

associated with an increased risk for deleterious mutations in breast cancer

susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)

Notesa. NBOCC Guidelines are currently under reviewb. In the UK (NICE Guidelines), some family cancer clinics exist which are ‘one-stop-shop’ multidisciplinary clinics specialised in the

counselling and genetic testing of families that are at increased risk of developing breast cancerSource: Original sources as cited in the Policy Analysis Project


The literature review findings suggest that women with a family history should be evaluated as to their level of risk due to family history using an established tool (Level IV evidence).93 Those at high risk should be managed in a similar way to those with a genetic mutation (Level V evidence)94 and such management may not be appropriate to be provided in a population screening program. Women with a known genetic mutation are at high risk of developing breast cancer and should be managed through a specialised clinic with different protocols, including MRI as the screening tool (Level III evidence).95

Those at moderate risk may need review and specific management protocols including possible annual screening (Level V evidence).96 Those at lower or average risk should be screened according to screening protocols for the general population (level V evidence).

Womenwithaprevioushistoryofbreastcancer

Women previously diagnosed with breast cancer face a higher risk of developing a new and different breast cancer than women who have never been diagnosed. Women with a history of breast cancer face a 2–5-fold increased relative risk of developing a second primary breast cancer with an absolute risk of 64/10,000 patients/year (Soerjomataram 2005). The risk of a contralateral breast cancer is similarly raised in women whose first tumour was DCIS (Claus 2003). Half of these newly detected cancers occur in the contralateral breast (NBCC 2001). The risk also varies depending on the treatment for the original breast cancer. If a breast has been removed, the risk is negligible for that side.

Women who have had a breast cancer are also at risk of recurrence of the same cancer. This rate differs according to the stage of the cancer, the initial surgical treatment and the adjuvant therapy used. Australian clinical guidelines state that, with current treatment protocols, the in-breast recurrence rate is 1–2% per annum and 1% after mastectomy (NBCC 2001). A review of recurrence in patients enrolled in RCTs found that the 10-year incidence of local regional recurrence after mastectomy was about 13% (interquartile range (IQR) 9–26%) and about 12% (IQR 7–15%) after breast conserving surgery and radiotherapy (Clemons et al. 2001). This also applies to DCIS, with about 8% of women developing invasive cancer in the same breast within 5 years of a diagnosis of DCIS (NHSBSP 2006). The hazard is highest in the first 1–2 years after the primary diagnosis (Saphner et al. 1996).

There is little evidence to suggest the appropriate screening interval for women with a previous history of breast cancer. A Dutch retrospective analysis of 275 patients who developed contralateral breast cancer during follow-up compared groups of patients who had annual mammography with those who had biennial mammography and found that the rates of impalpable breast cancer were comparable (30% for annual and 27% for biennial mammography) and that a similar number of tumours were at similarly favourable stages (60% versus 58%) (Kaas et al. 2000). The study also found that the 5-year survival rates were the same (75%) for the two groups.

93 Evidence from case series or poor quality case control studies94 Evidence from expert committee reports, opinions and/or clinical experience of respected authorities95 Evidence from case-control studies96 Evidence from case series or poor quality case-control studies

228

As a result of the significantly heightened risk of cancer recurrence in women with a previous history of breast cancer, clinical guidelines tend to recommend more frequent screening intervals and/or follow-up for these women. However, few evidence-based options exist. International and national models of practice for management of women with a previous history of cancer are summarised in Table 12.11.

Table12.11 Models of practice for women with personal history of invasive breast cancer

Agency Guidelines

NBOCC(Aust) Recommended follow-up schedule:

• 1–2 years after diagnosis: history and clinical examination every 3 months and mammography

(and ultrasound if indicated) at 6–12 months after radiotherapy, then annually thereafter

• 3–5 years after diagnosis: history and clinical examination every 6 months and mammography

(and ultrasound if indicated) every 12 months

• 5+ years after diagnosis: history, clinical examination, mammography (and ultrasound if indicated)

every 12 months

USPSTF(US) No statement of recommendation on women with a personal history

AmericanSocietyof

ClinicalOncology

(ASCO)(US) a

Women treated with breast conserving therapy should have their first post-treatment mammogram

no earlier than 6 months after definitive radiation therapy. Subsequent mammograms should be

obtained every 6–12 months for surveillance of abnormalities. Mammography should be performed

yearly if stability of mammographic findings is achieved after completion of locoregional therapy

HealthCanada Women should be followed up annually including an annual mammogram

NHSBSP(UK) Most breast screening units provide follow-up mammography for women who have previously been

treated for breast cancer. Women who have had a bilateral mastectomy are excluded.

NICE(UK) Routine long-term intensive follow-up has not been shown to be effective and should cease.

Networks should agree on evidence-based policy on the frequency of mammography for women who

have been treated for breast cancer. Intensive follow-up of women who have been treated for primary

breast cancer should not be offered by the breast unit as a matter of routine. Women and their GPs

should be reassured that routine tests to detect metastatic cancer are not necessary because they do

not improve quality of life or survival.

a. 2006 recommendation; these are the guidelines referred to in National Cancer Institute documentationSource: Original sources as cited in the Policy Analysis Project

For other breast conditions, DCIS, lobular carcinoma in situ (LCIS) and atypical hyperplasia, the NBOCC has developed follow-up guidelines and recommends:97

• follow-up schedule for women diagnosed with DCIS: regular long-term follow-up, including annual clinical examination and mammography

• follow-up schedule for women diagnosed with atypical ductal hyperplasia (ADH), LCIS or atypical lobular hyperplasia (ALH): annual clinical examination and annual bilateral mammography for at least 15 years following diagnosis.

97 NBCC 2003


Womenwithhighbreastdensity

The literature review findings indicate that women with high breast density are at an increased risk of breast cancer (Level IIb evidence)98 and that mammography is less sensitive in these women. Clear evidence of best practice for screening is lacking and, in particular, a practical method to accurately measure breast density in a screening setting is not yet available. However, digital mammography appears to offer promising results for women with high breast density (Level Ib evidence).99

Limited evidence exists on best practice models for screening women with dense breasts (Table 12.12). This is in part because breast density measurement is not routinely used in clinical care (Kerlikowske et al. 2007). An RCT comparing mammography with mammography plus ultrasound in women with heterogeneously dense breast tissue in at least one quadrant (Berg et al. 2008) found that diagnostic accuracy improved from 0.78 (95% CI: 0.67–0.87) to 0.91 (95% CI: 0.84–0.96) when ultrasound was added. The combination test resulted in an additional 1.1–7.2 cancers being diagnosed per 1,000 screens, but also increased the number of false-positive results.

Table12.12 Models of practice for women with high breast density

Guidelines

NHSBSP(UK) Annual MRI surveillance is recommended for women aged 40–49 years at a 10-year absolute risk of greater

than 12% where mammography has shown a dense breast pattern

USPSTF(US) No statement of recommendation on women with dense breasts

General recommendation of annual screening for women aged 40–49 years, in part due to pre-disposition to

denser breasts and in part due to the increased aggressiveness of breast cancer in younger women

Source: Original sources as cited in the Policy Analysis Project

12.4 WOMENWITHSYMPTOMS

The literature review examined the evidence base for best practice in relation to women with symptoms that may be associated with breast cancer.

12.4.1PREVALENCEANDIMPLICATIONSOFBREASTSYMPTOMS

Evaluationquestion33: What is the best practice evidence for the management of women with symptoms who present for screening?

BreastScreen Australia currently targets asymptomatic women. However, on presentation, a small number of women have a symptom that may be associated with breast cancer.

There are a range of breast symptoms and the risk of breast cancer differs according to the symptom. Table 12.13 outlines the approximate risk of a woman having breast cancer if she presents with a particular symptom. Data are not always easy to compare, but the risk of breast cancer is about 3–5% in women presenting with a lump or a blood-stained nipple discharge, and

98 Evidence based on at least one well-designed cohort study or low-quality RCT99 Evidence based on at least one RCT

230

may be even higher in women presenting with a nipple change, particularly fixed acute nipple inversion or ulceration. The risk of cancer is probably no higher than average risk for women presenting with clear nipple discharge, cyclic mastalgia, non-cyclic mastalgia without palpable mass or non-mammary pain, or for women who have had long-standing nipple inversion.

Table12.13 Prevalence of breast symptoms amongst symptomatic women and absolute risk of breast cancer

Symptom

Approximateproportionofsymptomatic

womenwhopresentwithsymptom(%)

Estimatedabsoluteriskofbreastcancer

inwomanpresentingwithsymptom

(reference,country)(%)

Breastlump 76% ~3% (Kavanagh 2000, Australia)

Nippledischarge 2%

bloody ~3% (NBCC 2006a)

non-bloody <1% (NBCC 2006a)

Nipplechanges 8% ~5% (Neville 1982, UK)

Breastchanges 4% Unknown

Painalone 10%

cyclic Unknown, probably very low

non-cyclic ~1% (Duijm 1998, Netherlands)

extra-mammary <1%


In the UK, the NHS provides virtually all mammography screening and diagnostic services through a coordinated publicly funded program. Women reporting breast cancer symptoms are referred, within this program, to symptomatic clinics for diagnostic assessment (Smith-Bindman et al. 2003).

Newcastle-upon-Tyne Breast Screening and Assessment Unit conducted a retrospective study of 4327 women who had presented with breast complaints and had a negative screening mammogram (Hide et al. 1999). The study reviewed the outcomes of the service’s policy for selective recall of women whose symptoms were defined as most likely to indicate malignancy (recent breast lump, breast or nipple distortion, or a blood-stained nipple discharge). Of 448 women recalled for assessment with these symptoms, eight malignancies were detected (1.8%). Of the 3,879 women with other symptoms, 4 developed interval cancers in the same breast as the symptoms (0.1%). The review concluded that the service’s policy of recalling only women with symptoms suggesting malignancy was justified.

The European Union Guidelines (2006) state that screening and diagnostic mammograms should be conducted separately due to the different protocols required. However, there does not appear to be any guidance on whether it is appropriate to combine these as two different protocols within one service.

12.4.2MANAGEMENTOFWOMENWITHSYMPTOMSWHOPRESENTFORSCREENING

The management of women with significant symptoms (lump, blood-stained discharge, nipple change), as opposed to asymptomatic women, is fundamentally different from a screening program point of view. Mammography will miss some cancers in both groups. The mammography result alone cannot be used to determine management of women who present with significant


symptoms. Screening services make a decision on investigation and follow-up based primarily on the result of a mammogram. Women with significant symptoms require investigation and follow-up irrespective of the result of their mammogram.100

In a symptomatic clinic, there is a particular duty of care on clinicians faced with clinical signs to interpret negative mammograms cautiously, and to call for prompt additional investigation, additional views or early recall (Murphy et al. 2007).

This poses questions for screening services, which have been addressed in two different ways:

1. provide a population screening service for asymptomatic women only and refer all symptomatic women to their own doctor (BreastScreen Australia, USA); or

2. provide two streams of service – a screening service for asymptomatic women and a diagnostic service for symptomatic women (UK); symptoms in this system are defined as recent breast lump, breast or nipple distortion, or a bloody nipple discharge.

Literature review findings indicate that there is some international evidence to suggest there may be advantages in developing a separate symptomatic stream that encourages women to identify symptoms and ensures that negative mammograms are followed up appropriately.

12.5 POLICYAPPLICATION

12.5.1REVIEWOFPOLICYANDPRACTICEATTHEJURISDICTIONALLEVEL

Evaluationquestion34: What is the impact of inconsistent application of policy across jurisdictions?

The Policy Analysis Project reviewed current policy and practice in BreastScreen Australia services by examining current written policies and procedures and interviewing BreastScreen Australia services staff and consultant clinicians. The review focused on identifying policy consistency and variations in policy and practice between the individual jurisdictions and the impact of these variations.

Key findings in relation to variations in practice across jurisdictions are outlined below.

• National policies in relation to screening women at average risk in the target age range (50–69 years) are applied with a high degree of consistency and reflect the national policies where they exist.

• All jurisdictions provide screening for women in the eligible age range (40–49 years and 70 years and over), but do not actively recruit this group.

• With the exception of one jurisdiction, reminders for rescreening are not sent to women over the age of 70 years.

100 In accordance with guidelines from the NBOCC the recommended management of a breast symptom is the triple test

232

• Three jurisdictions, including the two largest jurisdictions, do not currently send reminders for rescreening to women aged 40–49 years once they have attended an initial screening session. In the past, the practice of sending reminders to this age group was more widespread.

• Practices in relation to the management of women who present with symptoms, or women with a strong family history of breast cancer, vary between jurisdictions.

• Criteria for accepting women with a personal history of breast cancer into the Program vary significantly and practices in one jurisdiction may be contradictory to those implemented in other jurisdictions.

• Few jurisdictions have a policy on the management of women with dense breasts. No jurisdictions have a policy on identification or measurement of dense breasts.

• There are no specific policies in relation to screening women exposed to DES in utero.

The review findings suggest that variations in practice are greater in those areas where there is no national policy or where guidelines do not exist. Variation in practice was apparent in the screening of women at higher risk of breast cancer, such as women with a family history or a past history of breast cancer, and in the management of women with symptoms. In the absence of a stated national policy position, jurisdictions have made individual policy decisions. When the evidence for any given practice in an area is inconclusive, or where national policy is open to interpretation there was further variation.

The review suggested that it is possible that some jurisdictions may be implementing policies that are not aligned with available evidence and/or the expert opinion. Some Program managers felt the lack of national policies made it difficult to justify particular practices in their jurisdiction and expressed the view that clearer policy positions would be welcomed. For consumers, policy variations are likely to lead to confusion and inequity of access to services across jurisdictions. Particularly for an increasingly mobile population, it is confusing for women if a national Program cannot provide consistent advice on Program eligibility.

Table 12.14 provides a summary of current practice across jurisdictions and highlights variations.


Table12.14 Summary of jurisdictional variation in current policy practice

Policyarea Currentnationalpolicy Summaryofpractice

Variancein

practice*

Screening of

women in the

target age range

Asymptomatic women aged

50–69 are targeted to attend

BreastScreen Australia

Invitations: All jurisdictions send letters

of invitation to screening to women

turning 50 years of age if they have

access to the electoral roll. A range of

comprehensive recruitment strategies are

also aimed at the target age group.

Some variance with

use of electoral roll

Bookings: All jurisdictions use the

national BreastScreen number and most

have a centralised booking system.

Practices relating to information requested

at booking regarding symptoms, previous

history and family history vary.

Some variance

Rescreening: Practices in relation to the

screening interval for women at higher

risk vary.

Some variance

Follow-up: All jurisdictions have detailed

protocols for ensuring that there is follow-

up if women do not attend a screening

appointment; follow-up is more intense if

women fail to attend an assessment.

No significant

variance

Screening of

women aged

40–49 years

BreastScreen Australia national policy

states that asymptomatic women

aged 40–49 years are eligible to

attend BreastScreen Australia for

mammographic screening, should they

request it. However, women in this

age group are not actively recruited or

targeted to attend the Program.

Invitations: No jurisdictions currently

actively recruit women in this age group

but women are able to attend if they wish.

No variance

Rescreening: Three jurisdictions,

including the largest two, do not send

reminder letters for 2-yearly rescreening

appointments.

Some variance

Screening of

women aged

70+ years


states that asymptomatic women aged

70 years and over are eligible to attend

BreastScreen Australia for

mammographic screening, should they

request it. However, women in this

age group are not actively recruited or

targeted to attend the Program.

Invitations: No jurisdictions currently

actively recruit women in this age group

but women are able to attend if they wish.

No variance

Rescreening: Only one jurisdiction sends

reminder letters for 2-yearly rescreening

appointments for women to the age of

74 years.

One exception

234

Policyarea Currentnationalpolicy Summaryofpractice

Variancein

practice*

Screening women

with symptoms


states that:

• BreastScreen Australia selects

women on the basis of age alone

• decisions on eligibility based on the

presence or absence of symptoms

would be impractical

• it is Program policy that women

with symptoms are actively

discouraged from attending the

program

• BreastScreen Australia has a

responsibility to those women who

attend for screening and who have

symptoms and requires protocols to

be in place for this situation

• BreastScreen Australia screens such

women, and recommends further

investigation (either within the

Program or through the woman’s

GPs) regardless of the outcome of

the mammogram.

Identification: Four jurisdictions do not

ask any questions relating to symptoms

at booking.

Some variance

Management: Management of women

with symptoms, regardless of when and

how they are identified, varies. Most

jurisdictions will accept women with

symptoms into the Program but encourage

them to seek care from their GP. Two

jurisdictions will only give a screening

appointment to women with symptoms if

they specifically request and if the medical

officer is in agreement.

Some variance

Screening

women with a

family history

National BreastScreen Australia policy

does not provide specific details for the

management of women with a family

history of breast cancer.

Identification: Only one jurisdiction asks

clients about family history at booking.

No significant

variance

Definition: Definitions of a strong family

history vary between jurisdictions.

Significant variance

Management: If a woman is identified

as having a strong family history, most

jurisdictions recommend annual screening

but the two largest jurisdictions do

not. However some practices have only

changed in recent years.

Some variance

Screening women

with a personal

history

There is no national policy on the

eligibility for entry or re-entry into the

Program for women with a personal

history of breast cancer. There is no

national policy on the management

of women with a personal history of

breast cancer.

Jurisdictions apply a wide range of criteria

for accepting women with a personal

history of breast cancer into the Program.

Once admitted into the Program, women in

this group are generally screened annually.

Significant variance

Screening women

with dense breasts


identification and management of

women with dense breasts.

Three jurisdictions have a very basic

stated policy relating to women with

dense breasts.

Significant variance**

Screening women

exposed to DES


identification and management of

women exposed to DES.

None of the jurisdictions have specific

policies relating to women exposed to DES.

No variance

Notes:a. *relates to application of national policies (where applicable)b. ** there is limited variance in that most jurisdictions do not have this as a major policy area but there is significant variance in that

some have no policy and the others have somewhat different policies.Source: Policy Analysis Project

Table12.14 Summary of jurisdictional variation in current policy practice (continued)


Areasofconsistency

The review of current practice found there was consistency among jurisdictions in the following areas:

• recruitment of women, with established processes for actively recruiting women in the target age group and detailed guidelines to follow-up women who have failed to respond to an invitation to screening or a scheduled assessment appointment;

• provision of screening of women in the eligible (40–49 years and 70 years and over) age groups with the same screening and assessment services provided for these groups as for the target age group of 50–69 years (other than the process of sending reminders for rescreening appointments); and

• screening interval, with women in the target age group of 50–69 years invited and sent reminder invitations when due to be rescreened every 2 years and rescreening offered at 2-yearly intervals to women who have been assessed as being of average risk during the previous screening session.

Areasofdifference

The review of current practice found there were significant differences among jurisdictions in the following areas:

• criteria for providing annual screening;

• management of women with a family history;

• management of women with a personal history of breast cancer;

• management of women with symptoms; and

• management of women with high breast density.

These areas of difference are outlined in further detail below.

Annualscreening

There is no national policy on criteria for annual screening. The BreastScreen Australia NAS specify that annual screening should only be offered to women at substantially increased risk of breast cancer and states that fewer than 10% of women aged 50–69 years should be screened annually.

The review of current practice found that women assessed as being at higher risk of developing breast cancer may be offered annual rescreening. The decision to recommend annual rescreening in each jurisdiction is generally based on specific criteria. Although these criteria do vary across jurisdictions, a strong family history and personal history of breast cancer are common eligibility criteria for annual screening in seven out of eight jurisdictions. However, the review also found that there are significant differences in the way that criteria for annual screening are defined and managed in each jurisdiction (Table 12.15).

236

Table12.15 Summary of definitions of criteria for annual screening

Standardcriteriaforrecommendationforannualscreening

NSW Qld SA Tas Vic WA NT ACT

LCIS ✔ ✔ ✔ ✔ ✔ ✔

ADH, ALH ✔ ✔ ✔ ✔ ✔ ✔

Strong family history of breast cancer ✔ ✔ ✔ ✔ ✔ ✔ ✔

Personal history of breast cancer ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Ovarian cancer ✔ ✔ ✔

Genetic ✔ ✔ ✔

Notes: ± refers to a family history of both breast and ovarian cancer.Source: Policy Analysis Project

Womenwithafamilyhistoryofbreastcancer

Current national BreastScreen Australia policy does not provide specific details for the management of women with a family history of breast cancer. The review of current practice focused on women with a ‘strong’ family history and found that the criteria for a strong family history are defined differently across jurisdictions. The most consistently applied criterion is a female first-degree family member diagnosed with breast cancer under the age of 50 years.

The method for identifying a strong family history varies between jurisdictions as does the response to management of women with a strong family history. All jurisdictions except one have a policy of annual screening for women with a strong family history.

The Family History Tool, developed by the NBOCC specifically for use in the BreastScreen Australia Program, is used by very few BreastScreen services to assess the level of risk for women who identify that they may have a family history.

Womenwithaprevioushistoryofbreastcancer

Current national Program policy does not specify eligibility for entry or re-entry into the Program for women with a previous history of breast cancer. Similarly, there are no national policies specified with regard to the management of this group.

The review of current practice found that jurisdictional policies and practices relating to the participation and management of women with a personal history of breast cancer vary significantly across jurisdictions and reflect the greatest degree of variability of any of the policies considered in the evaluation. In addition, jurisdictions apply specific criteria to determine whether women with a previous history of breast cancer can enter or re-enter the Program. However, there is a high degree of variability in the criteria used and the way in which they are applied. The most consistent criterion for accepting women with a previous history is for women with a unilateral mastectomy.

Variations in the way in which eligibility is determined for this group of women appear potentially contradictory and appear to be determined primarily by whether a woman finds herself in one jurisdiction rather than another. A woman in one jurisdiction would be ineligible if she has had breast conserving surgery, whereas in another jurisdiction she is eligible to be screened annually.


Womenwithsymptoms

In relation to women with symptoms, national Program policy states that:

• BreastScreen Australia selects women on the basis of age alone;

• decisions on eligibility based on the presence or absence of symptoms would be impractical;

• it is Program policy that women with symptoms are actively discouraged from attending the Program;

• BreastScreen Australia has a responsibility to those women who attend for screening and who have symptoms and requires protocols to be in place for this situation; and

• BreastScreen Australia screens such women, and recommends further investigation (either within the Program or through the woman’s GP) regardless of the outcome of the mammogram.

Although it is national policy to actively discourage women with symptoms from attending BreastScreen Australia, each service has a protocol governing procedures for the screening of women with symptoms designed to act as a safety net for women with symptoms. Existence of these protocols is an acknowledgment of the dilemma the Program faces in relation to duty-of-care for women with symptoms who present for screening.

In an effort to provide guidance for jurisdictions in the development of policy for women with symptoms, a draft national policy framework was developed in 2001. In addition, the NAS require that all women in whom symptoms are identified be recommended for further assessment, regardless of the result of the mammogram.

The review of current practice found that half of the jurisdictions ask women specific questions at the booking stage about the presence of symptoms. All jurisdictions however, have procedures in place for recording the presence of symptoms either at booking or at the time of screening.

Most jurisdictions will screen a woman who presents for screening with a symptom and all jurisdictions will refer women with symptoms to their GP for further investigation. Five jurisdictions also send a letter to the woman’s GP advising of the need for further investigation. In two jurisdictions, women with symptoms have a clinical examination performed at the time of screening. Two other jurisdictions refer women with symptoms to their assessment clinic for further investigation.

There is wide variability in the way in which symptoms are identified and managed by both jurisdictions and individual services across jurisdictions. The key factors contributing to variances include: differing views about the role of BreastScreen Australia; the size of the screening service; and access to publicly-funded diagnostic services, including mammography, within a jurisdiction.

Womenwithhighbreastdensity

There is no agreed method of measuring and identifying breast density and as such, a national policy for the identification and management of women with high breast density does not exist. There are very few established policies for the management of women with high breast density across jurisdictions. Three jurisdictions and one regional service have specific policies to guide the management of women with high breast density.

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12.6 ANALYSIS

Agerangeandinterval

Research identified in the literature review indicates that there is Level Ia evidence that screening of women aged 50–69 years reduces mortality for breast cancer. This finding supports the continued screening of women at average risk aged 50–69 years. However, there is limited new evidence available from the literature review to inform the policy direction for changing the target age range for BreastScreen Australia.

In terms of the Program screening interval, overall, for women aged 50–69 years there is no new evidence from the literature review to support either extending the screening interval from 2 years to 3 years or to reduce the screening interval to 1 year.

In determining the policy on age range for the Program, evidence has been drawn from a range of Evaluation projects as well as the results of the Policy Analysis Project to provide a series of options for consideration.

Optionsforthetargetagerange

A number of options are proposed in relation to target age range and screening interval for screening women of average population risk.

Increasing participation of women aged 50–69 years

RCTs of breast cancer screening in women aged 50–69 years report a statistically significant mortality reduction from breast cancer. Meta-analyses of these trials indicate a mortality reduction in the order of 25% (Table 12.5). The results of the Mortality Ecological Study, as well as other service evaluation studies in Australia, support the mortality benefit of screening in this age group. The Mortality Ecological Study estimates the benefit to be in the order of 22–30% at a participation rate of 60% (Table 12.5).

The current Program participation rate is 56.2%. The participation rate increased steadily in the early years after Program commencement, reaching 51.4% in 1996–1997. The participation rate has plateaued in more recent years.

In establishing BreastScreen Australia, AHMAC agreed a participation target of 70% with the assumption this would lead to a reduction of breast cancer mortality of 16%. Results from the Mortality Ecological Study indicate that the estimated reduction in mortality has been achieved to a level higher than expected and that increasing the participation rate could result in a further reduction in breast cancer mortality. Increasing the participation rate from its current level to 70% would lead to an additional reduction in the relative risk of mortality from breast cancer of over 5%.

Increased effort needs to be made to achieve higher participation rates in women aged 50–69 years as this is the age group where there will be the greatest mortality benefit. Currently, 73.6% of participants in the Program are in the target age range. Increasing participation to 70% for women for whom benefit is greatest will result in a greater benefit for more Australian women.


Extending the target age range to include women aged 70–74 years

There is limited evidence from RCTs of the benefit of screening women aged 70 and over, as many of the large RCTs did not include women in their 70s in the trial population. However, two trials that did include women aged 65–74 years of age have reported relative risk reductions in this age group in the order of 22% (Humphrey et al. 2002).

The Dutch screening program extended its target age range of 50–69 years to include women aged 70–74 years in 1998. Since 2001, breast cancer mortality in women aged 65–74 years has shown a marked decline of 2.8% per annum, attributed in part to the screening program (Otten et al. 2008).

The results of the Mortality Ecological Study also indicate a reduction in mortality from breast cancer for women aged 70–74 years, although these results were not statistically significant due to the small numbers in the study.

Other evidence to support screening of the 70–74 year age group include: increasing life expectancy for women; the high incidence of breast cancer in this age group; and the similar or better Program performance for women aged 70–74 years compared to women aged 50–69 years in terms of sensitivity, recall and cancer detection rates (Table 12.6).

Extending the target age range to include women aged 45–49 years, with annual screening for the younger age group (45–49 years)

Meta-analyses of RCTs report a mortality reduction in women aged 40–49 years in the order of 15–19%. The mortality effect of screening in this age group is lower than that for women aged 50–69 years.

It is plausible that the mortality reduction effect increases across the decade, such that women 45–49 years would have a mortality benefit from screening closer to that of women aged 50–55 years than to women aged 40–44 years. The Mortality Ecological Study supports this assumption. The estimated mortality reduction, based on the Poisson regression analysis, of screening women aged 45–49 years is 26.4% (95% CI: –47.6 to +3.6) which is similar to that for women aged 50–54 years (–21.3; 95% CI: –34.8 to –5.1), but quite different to that for women aged 40–44 years (–4.7; 95% CI: –42.5 to +58.0). The comparison is similar for the proportional hazards regression model. It should be noted that data for women aged 40–49 years in this study should be treated with caution due to the small numbers in the study and the potential for bias due to low participation rates.

Given the evidence of mortality benefit in women aged 45–49 years, some consideration should be given to the frequency of screening as there is some evidence that breast screening outcomes would be better if screening for women aged 45–49 years was more frequent than biennial.

While the RCTs generally used screening intervals of 24 months, three Swedish trials used shorter screening intervals. The Gothenburg trial, with an 18-month screening interval for women aged 39–49 years at entry showed a relative risk of breast cancer mortality of 0.56 (95% CI of 0.34–0.91) at 13 years of follow-up (Bjurstam et al. 2003).

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Breast cancers in women aged 40–49 years are thought to grow faster than breast cancers in older women. A re-analysis of results from the Swedish Two County trial (Tabar et al. 1995) concluded that the interval between screenings should be shortened to achieve a greater benefit in this age group. There is some evidence of improved outcomes for women aged 40–49 years who have annual screening as compared to biennial screening (White et al. 2004b).

The UK Age trial was designed to definitively determine the mortality benefit of screening women aged 40–49 years. Unlike earlier RCTs, this trial enrolled women from the age of 40 years (Moss et al. 2006). The trial offered annual screening to this age group. Results to date at 10.7 years follow-up have not demonstrated a statistically significant reduction in mortality. The estimated level of effect has been similar to that demonstrated in the earlier RCTs with a relative risk of 0.83 (95% CI 0.66–1.04). Further follow-up at 14 years from this trial is anticipated.

BreastScreen Australia performance data indicate that interval cancer rates per 10,000 women screened at 0–24 months after their index screen are similar in the 40–49 year age group compared to the 50–69 year age group. However, the proportion of interval cancers detected as a total of all cancers detected in younger women is high, with close to half the cancers detected in women screened at age 40–49 years being interval cancers, as can be seen from the sensitivity of screening in this age group.

One concern about this option is the potential for increased radiation exposure with annual screening. However, it has been proposed that annual screening of women aged 40–49 years has a favourable ratio of potential benefits to risks (Law et al. 2001).

Screening women aged 40–44 years of age

RCTs report a mortality reduction in women aged 40–49 years, but with a lower mortality effect than that seen for women aged 50–69 years. The mortality reduction is in the order of 15–19% (Table 12.4). Part of this mortality benefit is likely to be due to screening occurring when women were aged 50 years, as women in these trials were aged between 40–49 years at trial entry. Comparison of the results of the Cochrane Review (Gøtzsche & Nielsen 2006) of mortality benefits at 7 years and 13 years of follow-up support this view (Table 12.4). A re-analysis of the five Swedish trials indicates that up to 70% of the 10% benefit in terms of reduction in mortality in women aged 40–49 years at trial entry is due to women screened in the years after turning 50 years of age (de Koning et al. 1995). Any mortality benefit in screening women aged 40–49 years is likely to occur later in the decade rather than at the younger age of 40–44 years.

Program performance data (Table 12.6) indicate that screening women aged 40–44 years results in lower cancer detection rates (yield 1.97 cancers detected/1,000 women screened) with higher rates of recall and invasive procedures for every cancer detected in this age group compared to the 50–69 year age group (yield 4.46 cancers detected/1,000 women screened, data not shown). This means that more than three times as many women need to be screened, and of these, three times as many recalled to assessment in the 40–44 year age group for one cancer to be detected, compared to the 50–69 year age group.


The population benefits of screening would increase if more women aged 50–69 years were screened compared to women aged 40–44 years of age. In 2008–2009, an estimated 90,000 women aged 40–44 years (11.2% of the age cohort) will attend for screening. Not screening women in the 40–44 year age group would provide the capacity to increase the participation rate of women aged 50–69 from 56.2% to 60.1%.

Screening women aged 75 and over

No RCTs have included women aged 75 and over as study participants and therefore the mortality benefit for this age group is unknown. Results from the Mortality Ecological Study indicate that there may be no mortality benefit in this age group, although the small size of the study population would account for the wide confidence intervals around these results (Table 12.4).

Program performance data indicate that cancer detection rates are high for women in this age group; however, it is probable that this group of women are less likely to benefit from screening given other health issues. Models of life-expectancy benefit from screening in women aged 75 years and over indicate the benefit is at least half, or less than that of women aged 50–69 years.

Population benefits and mortality benefits are therefore more likely to be achieved from screening women aged 70–74 years. In 2004–2005, 119,180 women aged 70–74 years and 61,479 women aged 75 and over attended the Program. The participation rates within this age group were 36.6% for women aged 70–74 years, 15.7% for those aged 75–79 years, 5.2% for women aged 80–84 years and 1.2% for those aged 85 years and over. Not screening women aged 75 and over would provide the capacity to increase the participation rate of women aged 70–74 from 36.6% to 55.0%.

Screeningwomenatelevatedriskofbreastcancer

While screening policy for women of average risk in the target and eligible age ranges was consistent across BreastScreen Australia, the variations in policy application amongst women at higher risk of breast cancer have the potential to create inequities for women. Not surprisingly, policy variation was greatest in the absence of a national policy.

In the absence of a stated national policy position, many jurisdictions have made decisions about a preferred approach. When the evidence in an area is also inconclusive, there was evidence of further variation. The resulting differences in practice could result in the use of Program capacity for population subgroups or an individual where the evidence of benefit is limited and in some cases could be detrimental to Program participants.

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Findings indicate that there are three distinct areas where a clear policy position is required:

• development of a clearly defined target age group, rather than an eligible and target age range, as is currently the case;

• a clear definition of what is meant by ‘higher risk’; and

• clear policy statements and definitions on eligibility to attend BreastScreen Australia and the appropriate management of women with:

– a family history of breast cancer;

– personal history of breast cancer;

– higher risk of breast cancer; and

– women who present with symptoms.

In determining a definition of ‘high risk of breast cancer’, the relative risk of breast cancers due to a range of lifestyle choices, environmental and genetic factors need to be considered. While there is some evidence on the relative risk of breast cancer related to a range of risk factors, evidence is less compelling on the appropriate screening policies for a given level of risk.

There is limited evidence available to clearly inform policy direction in the areas of women at higher risk of breast cancer and women with symptoms. The Program has had limited policy guidance in relation to these areas and this has resulted in disparity of policy across jurisdictions. Results from the Policy Analysis Project and the Program Governance and Management Project101 suggest that the development of clear and consistent national policies on identification, eligibility and management of women at increased risk of developing breast cancer and women with symptoms would be beneficial.

The following risk factors place women at an increased risk for breast cancer:

• women with BRCA 1 or 2 genes identified through genetic testing;

• high breast density for age;

• women with previous breast cancer or DCIS;

• women with previous LCIS or atypical hyperplasia (ADH or ALH);

• women with a family history of breast cancer; and

• women with a high exposure to ionising radiation.

BRCA 1 or BRCA 2

These women require more intensive surveillance and monitoring than is or can be provided through the Program. Women in this category would be best managed outside the Program.

High breast density for age

Currently there is little evidence available on measuring breast density or best practice for the management of women with dense breasts. A watching brief should be maintained on this area with a view to developing a clearer policy position once the Program has fully implemented

101 See Chapter 9 for further details on findings from the Program Governance and Management Project


digital mammography. In the absence of a consistent definition and method for measuring breast density, it would be useful to undertake research to inform the development of policy in this area. Development of information for women about changes in breast density (and natural variation on density) over time and the relationship between high breast density and breast cancer would also be beneficial.

Previous history of breast cancer

A number of current guidelines (Australian and international) suggest the need for more frequent screening of women in the 5-year period following diagnosis. However, there is little strong evidence to suggest that this actually leads to better health outcomes. Approaches to screening women with a past history of breast cancer in the Program vary widely. A consistent policy specifying eligibility and management of women with a previous history of breast cancer is required. Women with a previous diagnosis of breast cancer should be eligible to enter the Program after a period of 5 years from diagnosis. Following this period of time, women with a previous history of breast cancer should have their risk level assessed on a case-by-case basis to determine suitability to access the Program.

Women with atypical hyperplasia

Very little evidence is available on the best practice management of women with atypical hyperplasia. These women could be screened within the Program and, as such, a clear policy would need to be developed for the screening interval.

Women with a family history of breast cancer

There is variation within the Program regarding the management of women with a family history of breast cancer. It is probable that some women are being screened more frequently than is necessary based on their family history.

Standardised methods for determining family history are not routinely used in the Program. A standardised policy for family history is required, incorporating the use of a standardised tool and implementation of the appropriate screening policy. The NBOCC Family History Tool to assess level of risk has been developed for the BreastScreen Australia Program.

A national policy on identification, eligibility and management of women with a family history of breast cancer should be developed and implemented by BreastScreen Australia.

Womenwithsymptoms

The issue of whether to include women with symptoms in the Program, how to define symptoms and how women with symptoms should be best managed continues to present a number of difficulties for the Program. A different approach for the management of women with symptoms is required by BreastScreen Australia. The feasibility of implementing a clearly defined symptomatic and diagnostic pathway, co-located with BreastScreen Australia services, should be examined through the implementation of a demonstration or pilot site study.

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13. STAKEHOLDER PERCEPTIONS OF THE BREASTSCREEN AUSTRALIAThis chapter discusses the results of the EAC workshop with key stakeholder groups. An overview of the different strategies utilised throughout the Evaluation to ascertain the views of stakeholders in relation to the Program is provided in Chapter 5.4.

The Evaluation also conducted qualitative research with women to identify their experience, knowledge and perceptions of the Program. More detailed information on the findings from this Evaluation project can be found in Chapter 7 of this report or in the Participation Qualitative Study report.

13.1 RESULTSOFSTAKEHOLDERCONSULTATIONS

WorkshopwithBreastcancerandotherstakeholderorganisations:102

Stakeholders raised the following issues as important for consideration in the Evaluation:

• workforce issues, including workforce training and the impact of the current shortage of radiographers, particularly in rural communities;

• the appropriateness of the Program age range and consideration of inviting and encouraging eligible age groups, particularly women aged 70 years and over, to attend;

• consideration of new and emerging technologies to provide better services to different age groups;

• the appropriateness and accessibility of the Program for population sub-groups, including women from culturally and linguistically diverse backgrounds and Aboriginal and Torres Strait Islander women;

• the use of mammography in Australia outside the BreastScreen Program and the overall participation of Australian women in breast cancer screening;

• the introduction of digital mammography and its performance in screening younger women, particularly those with high breast density;

• accessibility of the Program for women in rural and remote areas;

• consideration of the issue of harms from screening related to both false-negative and false-positive results and the need to gain women’s views about the importance of potential harms;

• the appropriateness of policies in relation to the eligibility of women diagnosed with previous breast cancer to rejoin the Program; and

• the use of appropriate screening intervals for women at higher risk of breast cancer.

102 See Chapter 5, section 5.4 for a list of organisations participating in this workshop


WorkshopwithstateandterritoryBreastScreenAustraliaProgrammanagers:103

State and territory Program managers raised a number of issues for consideration in the Evaluation.

• Service delivery issues with transfer to digital mammography: access to the Program could be limited for women living in remote areas once analogue technology is no longer available.

• Inconsistencies in data collected across jurisdictions may prevent or limit comparisons across jurisdictions.

• Lack of public knowledge and understanding about population-based screening can lead to unrealistic expectations around what a screening mammogram will detect.

• Workforce issues – in particular the national shortage of radiographers and radiologists.

• Accreditation issues – accreditation and continuous quality improvement are critically important to BreastScreen Australia. Program managers expressed concern that if there was a move to each jurisdiction managing the accreditation of its services there would be a reduction in quality and consistency. The large number of NAS is also an issue for some Program managers.

• Program managers would like the Evaluation to consider and address the confusion arising from eligible versus target age groups, as well as differences in policy and practice across jurisdictions. In particular, Program managers would like to see clear, nationally consistent policy decisions from the Evaluation on the eligibility of age groups and the eligibility and management of women at high risk (including women with previous breast cancer and family history).

• The role of BreastScreen Australia in relation to management of symptomatic women and the co-location of Program services with breast diagnostic services. In some geographical areas, the only equipment available for diagnostic breast work for symptomatic women is at BreastScreen Australia services. Some BreastScreen Australia services are under pressure to use screening equipment and staff to assess symptomatic women not eligible to access the Program. This is occurring mainly in regional and provincial areas and will become an increasing issue with the Program upgrade to digital technology. Linked to this issue is the broader question of the role of BreastScreen Australia in relation to the assessment and management of symptomatic women who are outside the Program age range or not able to access appropriate services or facilities due to geographical location.

• Governance and management issues, particularly in regard to stronger national leadership for the Program, including clearer governance and management arrangements and a stronger role for the Department of Health and Ageing.

103 See Chapter 5, Section 5.4 for further details on this workshop

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Consumers

Several consumer organisations were represented in the stakeholder workshop with the EAC. Various consultations and focus groups were also held with consumers by project consultants during the course of conducting individual Evaluation projects. Specific findings from these consultations are provided in the Evaluation project reports. High-level findings from consumer consultations have been included in relevant chapters of this report.

Consumer feedback is particularly relevant to the Participation Qualitative Study, which specifically conducted qualitative research with women. The Study involved qualitative research with women to identify their experience, knowledge and perceptions of the Program. More information on the results of this Study can be found in Chapter 7.


14. ACHIEVEMENT OF PROGRAM AIMS AND OBJECTIVES

Evaluationquestion35: Do the Program objectives continue to be appropriate?

The BreastScreen Australia Program aims and objectives are listed below with the evidence of achievement in relation to the aim or objective summarised along with a proposed rating. References to relevant parts of this report are provided to support the summary assessment. The rating scale used is as follows:

• achieved – evidence that all aspects of the aim/objective have been achieved across the majority of services/jurisdictions to the desired level

• partly achieved – the aim/objective has been achieved to some degree but not in all jurisdictions/population groups or not to the desired level.

14.1 ACHIEVEMENTOFBREASTSCREENAUSTRALIAAIMS

Aim1 To ensure the Program is implemented in such a way that significant reductions can be achieved in morbidity and mortality attributed to breast cancer.

Performance Achieved

Evidencetosupportperformancerating

Mortality

• The Program has achieved significant reductions in mortality attributed to breast cancer.

• Results from the Mortality Ecological Study indicate that, at a population level, based on small geographic area analysis, a participation rate of 60% in the Program by women aged 50–69 years is associated with a statistically significant reduction in breast cancer mortality of 22–30%.

Morbidity

• The Program has been successful at reducing the morbidity associated with a breast cancer diagnosis for women with breast cancers diagnosed through the Program.

• Morbidity related to a breast cancer diagnosis can be measured by the extent of resection required to remove the cancer, the number of diagnostic procedures and the degree of accuracy and invasiveness required to make a definitive diagnosis. Morbidity would be considered to be reduced with higher rates of breast conserving surgery and with a minimal number of diagnostic procedures required for a definitive diagnosis.

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• In 1999, women whose breast cancer was detected through BreastScreen Victoria were almost 50% more likely to have breast conserving surgery than women whose cancer was diagnosed outside the Program. The proportion of women having breast conserving surgery following diagnosis in BreastScreen Victoria increased significantly over time, from 61% in 1995 to 78% in 1999. Although these results are not national, given the similarity of small-size cancer detection rates across the Program they are likely to be reflective of the BreastScreen Australia Program as a whole.

• Over time, the proportion of women with a breast cancer diagnosed in the Program who required an open biopsy (a more invasive procedure compared to FNA or core biopsy) for definitive diagnosis has decreased.

Aim2 To maximise the early detection of breast cancer in the target population.



• The Program has maximised the early detection of breast cancer.

• Early detection of breast cancer can be measured by the small (≤15mm) breast c ancer detection rate, the proportion of all cancers diagnosed that are small in size and Program sensitivity.

• The NAS for small cancer detection is that >25 per 10,000 women screened will be diagnosed with a small invasive breast cancer. In the BreastScreen Program in 2001–2005, the small cancer detection rate was 35 (95% CI: 33.1–36.9) per 10,000 women screened in the first screening round and 28.2 (95% CI: 27.5–28.8) in subsequent rounds for women aged 50–69 years.

• The small cancer detection rates in women from culturally and linguistically diverse backgrounds, and the rates by jurisdiction and geographic area were similar to the national rate in 2001–2005 for both first and subsequent rounds in most instances. Exceptions were seen for Victoria (subsequent rounds), regional areas (subsequent rounds) and the rate for Aboriginal and Torres Strait Islander women (first and subsequent rounds). Rates for women from culturally and linguistically diverse backgrounds, and by jurisdiction and geographic area all met the NAS.

• Most cancers diagnosed in the Program are small. In 2001–2005, the rate of small cancer detection was 55.6% of the all-size cancer detection rate in the first round, and 64.5% in subsequent rounds.

• Program sensitivity has increased over time. Sensitivity was 70.3% (95% CI: 68.8–71.8) in subsequent rounds at 0–24 months in the period 2000–2003.

• Increasing the participation rate would further maximise the early detection of breast cancer in the target population.


Aim3 To ensure that screening for breast cancer is provided in dedicated and accredited Screening and Assessment Services as part of the BreastScreen Australia Program.



• BreastScreen Australia services are provided in dedicated and accredited SASs in all jurisdictions.

• There are currently 33 SASs across Australia. All services are accredited through the Program accreditation process. The current accreditation status of each service is outlined in Table 14.1.

Table14.1 Accreditation status of BreastScreen Australia Services, 2008

Jurisdiction

ScreeningandAssessment

Service Accreditationstatus Accreditationexpires

NSW Hunter New England 4 year November 2012

Sydney South West Provisional May 2010

Sydney West Provisional November 2009

Northern Sydney Central Coast 4 year May 2012

North Coast NSW 2 year with high-priority

recommendations

November 2009

Greater Southern NSW 4 year accreditation November 2011

Southern Sydney Illawarra 2 year with high-priority

recommendations

May 2009

Greater Western NSW 2 year with high-priority

recommendations

August 2009

Victoria North Western 2 year with high-priority

recommendations

August 2009

Monash 4 year February 2013

Geelong and South West 4 year August 2009

St Vincent’s 2 year with high-priority

recommendations

May 2010

Maroondah 2 year with high-priority

recommendations

April 2010

Central Highlands/Wimmera 2 year with high-priority

recommendations

September 2010

Gippsland 4 year February 2011

Bendigo Regional 2 year with high-priority

recommendations

November 2010

Mobile Service 4 year November 2008

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Jurisdiction

ScreeningandAssessment

Service Accreditationstatus Accreditationexpires

Queensland Brisbane Northside 4 year November 2010

Gold Coast 4 year November 2011

Townsville 2 year with high-priority

recommendations

September 2010

Rockhampton 2 year with high-priority

recommendations

February 2010

Toowoomba 4 year May 2009

Nambour 4 year September 2010

Brisbane Southside 2 year with high-priority

recommendations

August 2010

Cairns 2 year with high-priority

recommendations

August 2009

Ipswich 4 year with extension May 2009

Bundaberg 4 year November 2012

Mackay 2 year with high-priority

recommendations

November 2009

SouthAustralia South Australia 4 year March 2011

Western

Australia

Western Australia 4 year with commendation February 2012

Tasmania Tasmania 4 year November 2009

Northern

Territory

Northern Territory 2 year with high-priority

recommendations

May 2009

Australian

CapitalTerritory

Australian Capital Territory 4 year February 2010

Aim4 To ensure equitable access for women aged 50–69 years to the Program.

Performance Partly achieved


• Equity of access to the Program can be measured by comparing participation rates by jurisdiction, geographic area, socio-economic status and sub-population group to the national participation rate. Equity of access would be achieved if these participation rates were similar to the national participation rate.

• The mean national participation rate was 55.4% (95% CI: 55.3 – 55.5) in the period 1996–2005.

Table14.1 Accreditation status of BreastScreen Australia Services, 2008 (continued)


• Over the same period, participation rates were significantly lower in the Northern Territory (44.3%, 95% CI: 43.1–45.5), NSW (52.4%, 95% CI: 52.3–52.6) and Western Australia (54.7%, 95% CI: 54.3–55.0). Rates have tended to decrease in the Northern Territory, remain steady in NSW and increase in Western Australia over this period.104

• Participation rates for the 10-year period were lower amongst women living in major cities (53.7%, 95% CI: 53.6–53.9) and very remote areas (44.8, 95% CI: 43.6–46.1).

• Participation rates by socio-economic status were lower than the national rate for women in the two highest (54.9, 95% CI: 54.7–55.1 and 54.5, 95% CI: 54.2–54.7) and lowest (54.4, 95% CI 54.1–54.6) socio-economic groups, although variation by socio-economic status was quite small across all socio-economic groups.

• While participation rates were lower among Aboriginal and Torres Strait Islander women (32%, 95% CI: 31.2–32.8) and women from culturally and linguistically diverse backgrounds (42.5, 95% CI: 42.3–42.8) over the 10-year period, the rates of participation for these two groups, in particular participation by Aboriginal and Torres Strait Islander women has improved over time.

• Equity of access can also be determined by assessing where BreastScreen services are delivered and efforts made to provide a readily accessible service to women in the target group.

• BreastScreen Australia services are provided in rural areas across Australia through the use of mobile and relocatable services. Program participation by women living in outer regional (58.6, 95% CI: 58.4–58.9) and remote areas (56.2%, 95% CI: 55.3–57.2) was higher than the national participation rate, indicating that the use of mobile and relocatable services to ensure equity of access has been successful.

• While the Program has been quite successful in ensuring equitable access for the majority of the population, the lower participation rates of Aboriginal and Torres Strait Islander women, women from culturally and linguistically diverse backgrounds and women living in remote areas, indicates that the Program has partly achieved this aim.

Aim5 To ensure the services are acceptable and appropriate to the needs of the eligible population.



• Whether services are acceptable and appropriate to the needs of the eligible population can be assessed through participation and rescreening rates and the views of women obtained via qualitative research for this Evaluation.

• High rescreening rates would indicate the service is acceptable and appropriate to the target group.

104 See Chapter 7.1 for further data on Program participation rates

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• Participation rates of Aboriginal and Torres Strait Islander women and women from culturally and linguistically diverse backgrounds similar to the national rate would indicate the service is appropriate to the needs of these populations.

• The views of women currently attending BreastScreen Australia and of women who had previously attended BreastScreen Australia can also provide insight to the acceptability and appropriateness of the service.

• There are two NAS related to rescreen: >75% of women aged 50–67 years who attend for their first screen are rescreened within 27 months; and >90% of women aged 50–67 years who attend for their second and subsequent screens are rescreened within 27 months.

• In 2000, the rescreening rate for women aged 50–67 years who attended for their first screen was 66.3% (95% CI: 65.6–66.9); this had decreased significantly to 60.5% (95% CI: 59.8–61.2) by 2003.

• In 2000, the rescreening rates for women aged 50–67 years who attended for their second, third and subsequent screens were 75.7% (95% CI: 75.2–76.3) and 84.2 (95% CI: 83.8–84.5), respectively and these had decreased significantly to 69.5% (95% CI: 68.8–70.1) and 80.1 (95% CI: 79.8–80.4) by 2003.

• The rescreen rates have not met the NAS for some time, indicating that many women do not return for a subsequent screen within the recommended screening period of 27 months.

• Focus groups conducted with women who had attended BreastScreen Australia services, conducted as part of the Participation Qualitative Study found that, overall, women were broadly supportive of the Program and considered it to be available, accessible and acceptable. However, some women’s experiences of BreastScreen Australia, such as the extent to which they perceived efforts were made to minimise their discomfort or embarrassment, emerged as key factors influencing their perception of acceptability of the Program. These qualitative results provide some insight into the rescreening rates, at least for some women.

• As noted above, participation rates were lower among Aboriginal and Torres Strait Islander women and women from culturally and linguistically diverse backgrounds over the 10-year period. The gradual improvement in participation rates for these two groups, in particular participation by Aboriginal and Torres Strait Islander women over time, indicates that the Program is becoming more acceptable to these population sub-groups. The qualitative research conducted for the Evaluation indicated that some Aboriginal and Torres Strait Islander women and some women from culturally and linguistically diverse backgrounds felt the service provided did not meet their needs.

• In summary, while BreastScreen Australia is broadly acceptable to its target group, there are some women who do not find the service acceptable and appropriate to their needs.


Aim6 To achieve high standards of Program management, service delivery, monitoring and evaluation and accountability.



• The Program has high standards of service delivery and some aspects of governance and management and monitoring and evaluation. However, there are a number of areas where the governance and management of the Program requires improvement.

• Evidence of the standard of Program management, service delivery, monitoring and evaluation and accountability can be drawn from the results of the Program Governance and Management Project, the Policy Analysis Project and the Review of BreastScreen Australia Accreditation System.

• There are significant strengths in the Program’s governance and management arrangements, including clear and specific goals and objectives and robust structures for quality and clinical risk management. However, there are also areas requiring improvement.

• The governance and management structures in place do not allow for effective and timely decision-making in the development of new policy and in responding to emerging issues and new technology. This is illustrated by the inconsistent application of policy in relation to screening women at potentially higher risk of breast cancer across the Program and the implementation of digital mammography.

• Significant work has been undertaken on the development of a data dictionary and production of an annual BreastScreen Australia Monitoring and Evaluation Report. However, access to Program data at a national level for the purposes of informing policy development and responding to legitimate research questions for the Program has been limited. Where national data do exist (for example the Monitoring and Evaluation reports produced by AIHW), policy response has been limited (for example in relation to the participation rate). These findings indicate there are areas for improvement in the current governance and management arrangements.

• The achievement of accreditation status in services across the Program and the support of the Program by women and health care providers indicate the Program has high standards of service delivery at the SAS level.

• Accreditation of individual services is a fundamental and effective management tool. The authority of the NAS and accreditation process derives from the widespread respect and acceptance of the standards, NQMC and SAC as adjudicatory bodies.

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14.2 ACHIEVEMENTOFBREASTSCREENAUSTRALIAOBJECTIVES

Objective1 To achieve, after 5 years, a 70 per cent participation rate in the BreastScreen Australia Program by women in the target group (women aged 50−69 years) and access to the Program for women aged 40−49 years and 70−79 years.



• While some individual services may have a participation rate close to or exceeding 70% at various times, at a national level the Program as a whole has never reached a 70% participation rate.

• In recent years, the participation rate has remained steady despite increases in the number of women screened. As the number of women in the target population increases, Program capacity and delivery appears to have been unable to keep pace with demand.

• Participation peaked in 2001–2002 at 56.9% (95% CI 56.8–57.0) and has since decreased to 56.2% (95% CI 56.1–56.3).

• Access to the Program for women aged 40–49 years and 70–79 years has been maintained across all jurisdictions, with some exceptions, since the Program commenced. The attendance rate of women aged 40–49 years peaked in 1998–1999 at 21.2% (95% CI: 21.1–21.3) and fell to 16.3% (95% CI: 16.2–16.3) in 2004–2005. The attendance rate of women aged 70 years and over peaked in 2000–2001 at 21.6% (95% CI: 21.5–21.7) and fell to 17.1% (95% CI: 17.0–17.1) in 2004–2005

• The proportion of women attending the Program who in the eligible age group has fallen from 31.9% in 1996–1997 to 26.4% in 2004–2005.

Objective2 To rescreen all women in the Program at 2-yearly intervals.

Performance Partly achieved.


• The Program is failing to achieve this objective for many women.

• There are two NAS related to rescreening:

– >75% of women aged 50–67 years who attend for their first screen are rescreened within 27 months; and

– >90% of women aged 50–67 years who attend for their second and subsequent screens are rescreened within 27 months.

• In 2000, the rescreening rate for women aged 50–67 years who attended for their first screen was 66.3% (95% CI 65.6–66.9) and this decreased significantly to 60.5% (95% CI 59.8–61.2) by 2003.


• In 2000, the rescreening rates for women aged 50–67 years who attended for their second and third and subsequent screens were 75.7% (95% CI: 75.2–76.3) and 84.2 (95% CI 83.8–84.5), respectively and these decreased significantly to 69.5% (95% CI: 68.8–70.1) and 80.1 (95% CI: 79.8–80.4) by 2003.

• At a national level, the rescreening rates have not met the NAS for some time. Many women do not return for a subsequent screen within the recommended screening period of 27 months.

• The rescreening rates could be a result of women not choosing to return, and if so, this is supported by the results of the Participation Qualitative Study, or due to limited capacity, or more probably a combination of both.

Objective3 To achieve agreed performance outcomes which minimise recall rates, retake films, invasive procedures, ‘false negatives’, and ‘false positives’, and maximise the number of cancers detected, particularly the number of small cancers.



• The Program has generally performed well against this objective.

• The NAS for the recall to assessment rate are:

– <10% of women aged 50–69 years who attend for their first screening round are recalled for assessment

– <5% of women aged 50–69 years who attend for their second or subsequent screening round are recalled for assessment

• In 1996–2000, the recall to assessment rate for women attending their first round was 6.9% (95% CI: 6.8–6.9). This increased significantly to 9.2 (95% CI: 9.1–9.3) in 2001–2005. Recall to assessment rates have met the NAS at a national level and in all jurisdictions, apart from Tasmania, where the first-round recall to assessment rate for 2001–2005 was above the NAS and significantly higher than the national rate.

• In 1996–2000, the recall to assessment rate for women attending subsequent rounds was 3.8% (95% CI: 3.8–3.8). This increased to 4.0 (95% CI: 4.0–4.0) in 2001–2005. Recall to assessment rates met the NAS at a national level and in all jurisdictions, apart from Tasmania, where the recall to assessment rate for subsequent rounds in 2001–2005 was above the NAS and significantly higher than the national rate.

• While recall to assessment rates have increased over time, all-size cancer detection rates, at both first and subsequent rounds, meet the NAS and have improved over time.

• The rate of technical repeat performed has improved significantly over time, from 4.0% (95% CI: 4.0–4.0) in 1996–2000 to 3.6% (95% CI: 3.6–3.6) in 2001–2005,

• The decreased use over time of open biopsy to obtain a definitive diagnosis is evidence of performance in minimising invasive procedures.

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• Program performance against a number of NAS related to FNA and core biopsy indicates overall improvement in use of these procedures against the standards over time. This is particularly the case for improved sensitivity of these procedures.

• The false-positive rate of core biopsy decreased from 1.5% in 1996–2000 to 1.3% in 2001–2005. This does not meet the NAS (<0.5% of lesions sampled through core biopsy have a false-positive result).

• The false-positive rate of FNA decreased from 1.7% in 1996–2000 to 1.5% in 2001–2005. This does not meet the NAS (<1% of malignant lesions assessed by FNA have a false-positive result).

• The false-negative or inadequate result of core biopsy decreased from 6.2% in 1996–2000 to 3.6% in 2001–2005. There is no NAS for core biopsy false-negative result.

• The false-negative rate of FNA increased from 3.5% in 1996–2000 to 4.9% in 2001–2005. This does meet the NAS (<6% of malignant lesions assessed by FNA have a false-negative result).

• As a proportion of all cancers detected, more than half of the cancers detected in the Program are small in size, ≤15mm. In 2001–2005, the rate of small cancer detection was 55.6% of the all-size cancer detection rate in the first round, and 64.5% in subsequent rounds.

Objective4 To refer to appropriate treatment services and collect information about the outcome of treatment.



• While the scope of BreastScreen Australia only extends to the point of diagnosis, facilitation of a successful pathway to treatment services is critical if ultimate health outcomes are to be achieved.

• The Program has partly achieved this objective. Referral to appropriate treatment services operates at service level. However, there are no Program data at a national level to describe the treatment outcome for women who have a cancer diagnosed in the Program.

• The Program Governance and Management Project results indicate that services have good relationships with professionals within the treatment pathway. This includes appropriate referral to GPs or breast surgeons and engagement of breast surgeons in the assessment stage of the pathway. It appears that services that have strong links with breast surgeons are more confident that women entering the treatment pathway will have appropriate care.


Objective5 To fund through State Coordination Units only Screening and Assessment Services which are accredited according to agreed National Accreditation Standards, and to ensure that those standards are monitored and reviewed by appropriate State Accreditation Committees.



• As noted above under Aim 3, all BreastScreen Australia SASs have achieved accreditation against the NAS.

• With the exception of the Northern Territory, all jurisdictions with a single SAS have achieved 4-year accreditation. There is evidence to suggest that the larger states with more devolved management responsibilities have struggled to fully achieve the NAS.

• The Review of BreastScreen Australia Accreditation System indicates that the system is performing but is quite burdensome to services and therefore unsustainable.

Objective6 To recognise the real costs to the women of participation in the Program, and to minimise those costs. This includes the provision of services at minimal or no charge, and free to eligible women who would not attend if there were a charge.



• The ability of the Program to meet this objective is dependent on jurisdictional decisions on service location and on the development of effective strategies to decrease indirect costs to women.

• Efforts made by jurisdictions to minimise costs to women include:

– locating services so that most women living in metropolitan or regional centres will travel less than 30 minutes to reach a screening service;

– utilising mobile vans to visit large regional centres; and

– hiring buses to bring women in remote communities into regional centres for screening.

• The main challenge has been setting up assessment centres outside metropolitan centres. The Northern Territory and Tasmania have decided to maintain single capital city assessment centres due to funding and radiologist availability constraints, creating a significant inconvenience to some women.

• Travel assistance schemes operate in some jurisdictions. However, women attending for screening as opposed to assessment may not be able to access these in all jurisdictions.

• All services are provided free of charge to women.

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Objective7 To make information about mammographic screening and the BreastScreen Australia Program available in easily comprehensible and appropriate forms in a variety of forums, and to women and health-care providers in particular.



• Effective promotion of the Program is central to encouraging and maintaining participation. Given that participation rates have not reached the agreed target of 70%, it could be argued that the Program has not been effective in its provision of information to women. However, Program promotion needs to be balanced with capacity.

• The Program has employed a variety of means to communicate information to women and their health care providers about BreastScreen Australia. However there is evidence that communication has been less effective to some population groups and this has impacted on their participation rates.

• While there are clear efficiencies to be gained from central design and production of communication materials for local distribution, services have a better understanding of the needs of local communities and how to best reach their target group. BreastScreen Australia has produced a wide range of communication materials at jurisdictional and national levels.

• Focus groups conducted with women through the Participation Qualitative Study provided information about women’s views on Program communication strategies.

• National advertising of the Program (the ‘Sara Henderson campaign’) was recalled by many women despite this campaign being some years earlier. In fact, the peak participation rate in the Program was achieved in the time period of this campaign.

• Women reported that invitation and reminder letters and phone calls are also effective communication activities.

• Aboriginal and Torres Strait Islander women, women from culturally and linguistically diverse backgrounds, and women who had not previously attended screening were generally less aware of BreastScreen Australia communication materials.

• Both the literature review and qualitative research findings indicate that women generally have a limited understanding of risk factors for breast cancer (in particular the risk associated with increasing age), and the benefits and potential harms of screening. Women who attended for the first time reported not being aware of the level of discomfort they were likely to experience.

• While regular Program participants felt informed about the screening process, some women reported being unaware of the low rate of diagnosis of women recalled to assessment and the need to be aware of interval cancers.

• Awareness of the BreastScreen brand varied across Australia. Women in some areas were less aware of the BreastScreen Australia services and whether they had attended the Program or a private mammography service.

• Health care providers indicated they would like more resources available to assist them in providing accurate information to women about the Program.


Objective8 To achieve patterns of participation in the Program which are representative of the socio-economic, ethnic and cultural profiles of the target population.



• As with the overall participation objective, creating equitable access and delivery of services across population subgroups is a core function of Program performance.

• Participation rates for women of different socio-economic status show significant differences from the overall national rate. However the range of participation rates across socio-economic groups in 2004–2005 was quite small (<3%). The Program has been quite successful in achieving patterns of participation representative of socio-economic profile of the target population.

• In contrast, there is a clear need to enhance strategies to target Aboriginal and Torres Strait Islander women and women from culturally and linguistically diverse backgrounds. While the participation rates for these groups have improved over time, participation is still well below the national rate. In 2004–2005, participation rates were more than 20% and 10% below the national rate, respectively, for women in these groups.

Objective9 To provide services in accessible, non-threatening and comfortable environments by staff with appropriate expertise, experience and training.



• Creating a welcoming and appropriate environment for women is central to achieving participation and rescreening objectives. While the Program has not achieved expectation in participation rates and rescreening rates, there is sufficient evidence to indicate the Program has substantially achieved this objective.

• Results from the Participation Qualitative Study indicate that many women who attend the Program found BreastScreen Australia services to be broadly available, acceptable and accessible. Women who were regular attendees perceived that the service had improved over time.

• Some women in the qualitative study reported a range of problems in accessing BreastScreen Australia. Issues included access to transport, perceived lack of cultural sensitivity, availability of interpreters and opening hours. Some of these issues were reported by women who had never been screened and may not accurately reflect the accessibility of the Program.

• However the below-standard rescreen rates indicate that, at least for some women, the service provided by BreastScreen Australia was such that they chose not to return. The results of the Participation Qualitative Study indicate that the first screening experience is important in determining whether women choose to return for subsequent screens.

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• A number of NAS measure performance relevant to this objective. These include the physical environment of the service and the qualifications and skills of staff. Achievement of accreditation status by services would seem to indicate that generally BreastScreen Australia services are provided in appropriate environments with suitably qualified and skilled staff.

Objective10 To provide appropriate services in that: the provision of counselling, education and information is an integral part of the Program; sensitive procedures for the notification of recall to assessment are in place; and the time between the initial screen and assessment is minimised.



• Providing services that minimise distress to women is a component of implementing an effective screening pathway. While there is evidence that BreastScreen Australia provides appropriate services in the provision of counselling and sensitive communication to women recalled to assessment and those subsequently diagnosed with cancer, timeliness standards for reporting results and the period between screening and assessment are not being met.

• The Program has developed standards for timeliness of provision of results and recall for assessment. Achievement of these timeliness standards has been decreasing over time and does not meet the relevant NAS.

• The proportion of women who received their results within 28 days decreased from 98.5% (95% CI: 98.5–98.5) in 1996–2000 to 95.3 (95% CI: 95.3–95.3) in 2001–2005. The NAS is that 100% are women notified of their screening result within 28 days.

• The proportion of women requiring an assessment who attended that assessment within 28 days of their screening visit decreased from 85.7% (95% CI: 85.5–85.8) in 1996–2000 to 79.2 (95% CI 79.0–79.4) in 2001–2005. The NAS was not met at either time point (≥90% of women requiring assessment attend an assessment visit within 28 days of their screening visit).

• In the Participation Qualitative Study, women who had been diagnosed with breast cancer through the Program were highly satisfied with the services provided by BreastScreen Australia, indicating that the Program has the appropriate expertise and services in place for providing counselling to women.

• Women who had been diagnosed with an interval cancer and women recalled to assessment with no diagnosis of cancer were satisfied with the services provided by BreastScreen Australia.


Objective11 To achieve high levels of participation in the development and management of the Program by members of significant professional and client groups.



• While there is evidence of a range of structures at the jurisdictional level that involve relevant professional groups, clinicians and consumers in the development and management of the Program, this is less common at the national level.

• Ensuring high-level participation of relevant stakeholders at a national level involves creating forums for robust input and discussion on issues appropriate for discussion by those groups (including level of detail). Participation by relevant stakeholders should have a dual purpose of informing the Program as well as providing relevant information to individuals so that they can make informed contributions.

• The main formal Program structure involving professional groups and consumers is the NQMC. These groups are less involved at a national level in formal structures responsible for the development and management of the Program.

Objective12 To collect and analyse data sufficient to monitor the implementation of the Program, to evaluate its effectiveness and efficiency, and to provide the basis for future policy and Program development decisions.



• A wealth of data are collected about women who attend the Program and there have been significant efforts to ensure data collection is consistent across the country through the development of a data dictionary. However, there are many areas where data could be used to evaluate the Program, inform policy decisions and support evidence-based decisions about the Program.

• There have been many unrealised opportunities in data collection and analysis that have resulted from a lack of national commitment and attention.

• Data collection systems are not compatible across jurisdictions, which causes significant problems in national consolidation and data analysis. This was certainly found when compiling data for this Evaluation and in some cases meant that records could not be used, for example in the Mortality Ecological Study.

• While the availability of the Monitoring and Evaluation Reports produced by the AIHW are an achievement, the indicators reported on by the AIHW align incompletely to the objectives of the Program and the 3-year delay to publication means information is not readily available with which to inform policy and decisions.

• In addition there are currently no formal mechanisms for data and knowledge sharing across jurisdictions and therefore lost opportunities to learn about best practice and innovative practices.

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15. CONCLUSIONS AND RECOMMENDATIONS

Keyfindings

1. BreastScreen Australia is broadly available, accessible and acceptable to many women.

2. The Program has been successful in reducing mortality from breast cancer at the current participation rate of 56% in the target age group (women aged 50–69 years) by approximately 21–28%.

3. The Program is cost-effective at an approximate cost of $38,000 per life year gained (LYG).105

4. The Program participation target of 70% of women in the target age group has not been met. Program participation for women aged 50–69 years has been steady at around 56% over the last few years. However, the absolute number of women in the target age group screened increased by 41% between 1996–1997 and 2004–2005. Rescreening rates are low, with only 60.5% of women returning to the Program within the recommended 2-year period following their first screen.

5. Evidence indicates that mammographic screening of women aged 50–69 years reduces mortality from breast cancer, and supports the continued biennial screening of women at population risk aged 50–69 years. There is limited new evidence from the literature with which to determine the appropriate policy for women aged 40–49 years and over 70 years of age.

6. Program performance data and results of the Mortality Ecological Study indicate that the greatest mortality benefit is achieved within the target age range of 50–69 years and that the greatest potential improvement in mortality benefit would be achieved with increased participation of women aged 50–69 years.

7. Participation in the Program reduces treatment-related morbidity. Breast cancers detected through BreastScreen Australia are significantly more likely to be smaller than those diagnosed outside the Program, and a higher proportion of breast cancers detected by BreastScreen Australia are treated by breast conserving surgery.106

8. For women aged 40–44 years, there is limited evidence of benefit for mammographic screening in relation to mortality reduction. There is also evidence of harms associated with screening in this age group, with a higher rate of invasive investigation without cancer present compared to women aged 45 years and over.

9. For women aged 45–49 years and women aged 70–74 years, there is some evidence of benefit in relation to reduction in mortality from breast cancer associated with screening.

10. For women aged 75 years and over there is limited evidence of benefit in relation to mortality reduction associated with screening.

105 Life years and costs were discounted using an annual rate of 5%, consistent with practice in Australia106 This finding derives from data obtained from the Victorian Cancer Registry 2005–2006. Data from the Royal Australasian College of Surgeons

(RACS) (NBOCC 2009) are also supportive of this finding.


11. Where there is clear national policy direction, jurisdictional screening policies are consistent with and align with national policy. Where there is a lack of national policy direction, as in the screening of women at elevated risk of breast cancer, there is wide variation in screening practice at jurisdictional level, leading to inequity for women.

12. Claims have been made previously that mammography reimbursed through the Medicare Benefits Schedule (MBS) impacts on Program participation rate. It does not appear, however, that large numbers of women in the target age group are accessing non-diagnostic mammography outside the Program.

13. There are currently significant capacity issues in the Program, as evidenced by an increase in delays in recalling women to assessment, falling rescreening rates and plateauing of the participation rate for the target group, despite reduced attendance rates of eligible age groups.

14. Modelling of Program demand and capacity into the future indicates that, without intervention, demand for the Program, largely as a result of growth in the target cohort, will continue to exceed capacity. Although implementation of digital mammography will improve capacity, its introduction alone will not provide sufficient capacity to address the growing gap between capacity and demand. Radiography workforce issues are the greatest constraint to capacity.

15. Current governance and management arrangements at the national level have some strengths, notably clear and specific goals and objectives for the Program and robust structures for accreditation. However, there are significant areas requiring improvement including better collaborative decision making and strategic planning at a national level, evidence-based policy development and implementation, and timely response to address new and emerging issues.

16. The BreastScreen Australia accreditation system is highly accepted and respected. Some aspects of the accreditation system, however, are a burden for services. Program quality assurance would benefit from a greater focus on continuous quality improvement activities, including improved monitoring, in addition to accreditation.

17. The Program has a wealth of data that are currently underutilised. Despite significant efforts to standardise data collection, inconsistencies remain, limiting usability of data at a national level. There has been limited research regarding the use of Program data to inform policy.

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Based on the Evaluation outcomes, the EAC has developed a number of recommendations for consideration by AHMAC.

ContinuetheProgram

The Evaluation has shown that BreastScreen Australia is widely available, acceptable and accessible to women. The Program has been effective in reducing mortality and morbidity experienced by Australian women in relation to breast cancer and, with the exception of achieving the targeted participation rate, has substantially achieved its aims and objectives. Failure to achieve the targeted participation rate is probably related to diminishing Program capacity and the subsequent response of limiting Program promotion, rather than an intrinsic failure of the Program.

Participation in the Program, at a population level, has reduced mortality related to breast cancer in the target age group of 50–69 years in the order of 21–28%. The Program is cost-effective at an estimated cost of $38,000 per LYG. Mammography continues to be the technology of choice for breast cancer screening.

Recommendation1

Continue BreastScreen Australia as a population-based screening Program, providing biennial breast cancer screening using mammography for women in the target age group.

Extendthetargetagerange

Meta-analyses of RCTs of breast cancer screening in women aged 50–69 years using mammography report a statistically significant mortality reduction from breast cancer in the order of 25%. Results from the Mortality Ecological Study support the mortality benefit of screening in this age group.

In establishing BreastScreen Australia, AHMAC agreed a participation target of 70% with the assumption this would lead to a reduction of breast cancer mortality of 16%. The average participation rate of women aged 50–69 years in the Program was 55% over the decade 1996–2005. Despite the fact that the target participation rate has not been achieved, it is estimated that the reduction in mortality achieved has been higher than expected. Increasing the participation rate would result in a further reduction in breast cancer mortality with reduction greatest in women aged 50–69 years.

Three-quarters of the participants in the BreastScreen Australia are in the target age range of 50–69 years. Without increased Program capacity, further gains in mortality reduction would most effectively be realised by limiting the Program to women in this age group only.

Two RCTs that included women aged 65–74 years have reported a reduction in relative risk of breast cancer mortality in the order of 22%. There is evidence from the Netherlands of a reduction in breast cancer mortality in women aged 65–74 years of 2.8% per annum attributed in part to the screening Program. Results from the Mortality Ecological Study indicate a reduction in


mortality from breast cancer for women aged 70–74 years who participate in biennial screening in the order of 12%, although these results were not statistically significant due to the small numbers in the study.

Increasing life expectancy for women, the higher incidence of breast cancer with increasing age and the similar or better Program performance for women aged 70–74 years compared to women aged 50–69 years (in terms of sensitivity, recall and cancer detection rates) add further support to adding this age group to the target age range.

While the mortality benefit of screening women aged 45–49 years is less than that for women aged 50–69 years, meta-analyses of RCTs have reported a mortality reduction in women aged 40–49 years in the order of 15–19%. The mortality reduction effect increases with age and it could thus be assumed that women aged 45–49 years would experience a mortality benefit from screening closer to that for women aged 50–55 years than those aged 40–44 years. The Mortality Ecological Study undertaken as part of the Evaluation supports this benefit in women aged 45–49 years with some caveats.

There is evidence from the Swedish RCTs of younger women with an 18-month screening interval that screening outcomes in younger women would be improved if screening was more frequent than biennial. Breast cancers in women aged 40–49 years appear to grow faster than breast cancers in older women. The low sensitivity of biennial screening in women aged 40–49 years in BreastScreen Australia results in almost half the number of cancers detected in screened women in this age group being interval cancers. While this suggests a need for annual screening of women aged 45–49 years, Program capacity would be further stretched were this recommendation implemented and additional resources would be required. If Program capacity cannot provide for annual screening of women aged 45–49 years, biennial screening could be offered for women in this age group. It should be recognised that while there is some evidence of benefit for screening women in this age group, this would also lead to higher recall rates and false-positive results.

Recommendation2

Use evidence of the greatest mortality benefit to determine a nationally agreed target age group. Based on the evidence, preference should be given in the following order to:

(i) increasing participation of women aged 50–69 years;

(ii) extending the target age range to provide biennial screening for women aged 70–74 years;

(iii) extending the target age range to provide annual screening for women aged 45–49 years;

(iv) extending the target age range to provide biennial screening for women aged 45–49 years.

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Removetheeligibleagerange

The mortality benefit of screening women aged 40–49 years is lower than that for women aged 50–69 years, with a large part of the mortality benefit likely to occur later in the decade rather than at a younger age. Screening women aged 40–44 years results in lower rates of cancer detection with higher rates of recall and invasive procedures compared to the 50–69 year age group. Detection of one cancer in this age group requires more than three times as many women to be screened, with three times as many recalled to assessment, and more than twice as many core biopsies performed compared to the 50–69 year age group.

There is limited evidence to support a mortality benefit of screening women aged 75 years and over. While cancer detection rates are high, women in this age group are less likely to benefit from screening given competing health issues. Models of benefit from screening in women aged 75 and over indicate the benefit is at least half or less than that of women aged 50–69 years. Ceasing eligibility to screening for women aged 40–44 and women aged 75 and over would free up capacity to increase the participation rate of women in the target age group and increase the mortality reduction from breast cancer as a result of BreastScreen Australia.

Recommendation3

Women aged 40–44 years and women aged 75 years and over should no longer be eligible to attend the Program.

Developclearnationalpolicies

Program data indicate that almost 17% of the women screened by BreastScreen Australia have either a family history of breast cancer, a previous history of invasive breast cancer or DCIS, or present for screening with symptoms of breast cancer. There are no consistent national policies on eligibility or screening of women in these groups. This has resulted in variations in practice across jurisdictions and also raises questions in relation to equity of access and outcomes for women.

Women, BreastScreen Australia services, staff and clinicians would all welcome the development of clear and consistent national policies within BreastScreen Australia on the identification, eligibility and management of women at increased risk for developing breast cancer.

Evidence should be used to inform screening policies, both from BreastScreen Australia data and from critical reviews of current literature. In Australia, the NBOCC is the primary source of evidence-based clinical guidelines to inform practice in the area of breast cancer detection and management. A number of NBOCC guidelines are currently available and these should be used to inform the development of best practice policy in BreastScreen Australia services

Recommendation4

Develop clear national policies for BreastScreen Australia that address inconsistent policy application across jurisdictions to ensure equity for women.


Increaseparticipation

While BreastScreen Australia is broadly available, accessible and acceptable to a large number of Australian women, the national participation rate, at an average of 55% over the 10-year period 1996–2005, has not reached the 70% target rate. Nor does the availability of MBS-funded mammography appear to be impacting on the participation rate. While the Program has been effective in reducing mortality from breast cancer, the participation rate requires improvement to maximise cost-effectiveness and achieve further reductions in mortality. A range of communication and service delivery strategies should be explored to improve Program participation, taking account of Program capacity.

Participation rates for Aboriginal and Torres Strait Islander women, women who speak a language other than English at home, women living in major cities and women living in very remote geographic areas require improvement. Strategies to improve participation in these groups should address service availability and barriers to participation and seek to improve knowledge of the benefits of breast cancer screening.

Awareness of Program communication materials and the BreastScreen Australia brand amongst Aboriginal and Torres Strait Islander women and women from specific culturally and linguistically diverse communities is low. Targeted communication strategies to raise awareness of the Program could enhance participation of these sub-populations.

The rescreening rate first, second and subsequent rounds has decreased significantly over time and has not met the NAS for rescreening, although variability does exist between jurisdictions. Many women are choosing not to return for screening. As a women’s first screening experience can leave a long-lasting and deep impression, service delivery strategies need to address the importance of a positive first-time screening experience to encourage women to return for rescreening.

Many women are not well informed about risk factors for breast cancer and appear to have a limited understanding and appreciation of the potential harms and benefits associated with breast cancer screening and the potential for interval cancers to occur. Awareness is also limited about the importance of increasing age as a risk factor for breast cancer, irrespective of family history. This is associated with a lack of understanding of the rationale for the Program target age range of 50–69 years of age, particularly among women who have never participated or have ceased participating in screening. This lack of awareness can impact negatively on a woman’s personal understanding of the relevance and appropriateness of screening. Media coverage tends to focus on cases of young celebrity women who have had breast cancer, which reinforces erroneous perceptions about the level of risk for younger women. Targeted communication strategies are required to address women’s misconceptions and enhance understanding of the relevance and benefits of participating in breast cancer screening.

Awareness of the brand BreastScreen Australia was low amongst some women. The results of the Evaluation could be used to promote the Program, raise awareness of risk factors for breast cancer and provide opportunity to promote the benefits of breast cancer screening.

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Recommendation5:

Focus on increasing the screening participation rate of the target age group to maximise mortality reduction through a range of social marketing, communication and service delivery strategies while ensuring there is sufficient capacity to meet demand.

Sub-recommendations

• Increase the screening participation rate of Aboriginal and Torres Strait Islander women, women from culturally and linguistically diverse backgrounds, women living in very remote areas and women living in major cities.

• Increase rescreening rates in the target population, with a particular emphasis on increasing the rescreening rate between the first screening visit and subsequent rescreening.

• Promote the results of the Evaluation to women and health care providers to improve recognition of BreastScreen Australia and increase women’s understanding of breast cancer screening, including its benefits and potential harms.

Governanceandmanagement

The Program has demonstrated significant operational performance, evidenced through the effective services that it provides to women as well as the highly committed and skilled workforce that it attracts. The strong operational performance can, in part, be credited to the long-term impact of the Program’s governance and management arrangements. Strong examples of effective governance and management can be seen in the work of the NQMC and the operation of the NAS.

However, a number of governance and management issues at a national level have resulted from a lack of Program leadership. These issues are now beginning to affect Program performance and must be addressed urgently. Particular areas of governance and management requiring improvement include national strategic planning, national policy development, use of Program data for research to inform Program policy and improvement, and the capacity to make timely collaborative decisions to address emerging issues

Two major consequences of the limited national leadership and direction have been the necessary development of individual jurisdictional governance and management arrangements and the development of jurisdictional policy to inform practice. Development of these arrangements at a jurisdictional level may be appropriate in terms of responding to local need. However, variation in policy and practice between services in the same Program raises questions in relation to equity of access and outcomes for women.


Future governance and management demands will be substantial, in particular in relation to implementation of recommendations from this Evaluation. Program governance mechanisms need to be better equipped to deal with emerging issues in a nationally consistent manner. Any model selected to address governance and management issues should focus on strengthening the capacity of existing structures to provide more effective national leadership and Program development.

Recommendation6:

Improve national policy leadership and Program development to facilitate timely decision making, direction setting and capacity to deal with emerging issues and new technology.

The existing Program has operational strength, which should be sustained and reinforced through the next phase of Program development. The Evaluation did not specifically examine the different jurisdictional governance and management arrangements in detail and it is unclear how these different models may be affecting larger structural issues in the Program and ultimately the effect on overall Program performance. Before implementing any governance and management reforms to the Program, it would therefore be worthwhile conducting a review of jurisdictional operations. This would ensure that any agreed refinements or reforms from this Evaluation are implemented to best effect.

Recommendation7:

Review jurisdictional governance and management to ensure optimal capacity to deliver the agreed service model and achieve policy consistency and operational efficiency.

Programcapacityandinfrastructure

Current Program capacity is failing to meet population demand for screening and assessment services. Modelling indicates that demand for screening will increase into the future due to growth in the target age group, placing greater strain on capacity. Implementation of digital mammography, particularly the uptake of soft-copy reading, will provide limited additional capacity, which will be insufficient to meet growing demand.

The radiography workforce is a major constraint to capacity in meeting demand for screening and there is wide variation in productivity across the Program. Small incremental improvements in the number of women who can be screened each year per radiographer can yield significant capacity increases, which could be used to minimise capacity gaps. However, current workforce shortages need to be taken into account. Even with improvements in workforce productivity, capacity constraints will still exist unless there are changes to service delivery and an increase in available workforce. Consideration should be given to exploring innovative ways to increase workforce productivity and attract skilled professionals to the workforce.

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Digital mammography is being implemented across jurisdictions. However, approaches differ across states and territories, in part reflecting local considerations and differences in need. Compatibility across state and territory Program services, and potentially with diagnosis and treatment services, would facilitate image transfer, help to address localised radiology staff shortages, facilitate flexible working hours and potentially improve access by diagnosis and treatment services to BreastScreen Australia expertise. An overarching coordination mechanism that facilitates efficient communication about the transition from analogue to digital imaging may be useful to ensure that compatible information management and telecommunications systems protocols are introduced. Many jurisdictions are on the verge of committing to PACS, so there may be an immediate requirement for cross-jurisdictional coordination and national leadership to facilitate timely decision making and direction setting.

Recommendation8:

Address capacity constraints on Program effectiveness by implementing enhanced workforce practices and service models and maximising the benefits of digital mammography.

Accreditation standards for timeliness are not being met and have been declining over a number of years. Of particular concern are delays in assessing women with a screen-detected abnormality and an inability to provide screening within the 2-year interval for an increasing number of women. Strategies to address capacity issues for the Program will need to focus on this these issues. Service delivery opportunities, such as co-timing screening and assessment, or co-locating SASs with diagnostic services, need to be explored.

Recommendation9:

Focus on minimising delays between screening and assessment for women with a screen-detected abnormality.


Managementofwomenatelevatedriskofbreastcancer

Factors that place women at an increased risk of breast cancer are strong family history, previous breast cancer, high risk breast conditions and high breast density.

Women at high familial risk (i.e. risk greater than three times the population risk) require more intensive surveillance and monitoring than is currently provided through BreastScreen Australia which was established to provide population screening. Women in the high-risk category would therefore be best managed outside the Program and should be deemed ineligible to access BreastScreen Australia services. This includes:

i) women at potentially high risk due to a strong family history of breast cancer, as defined using the NBOCC Family History Tool; and

ii) women with identified genetic mutations such as BRCA1 or BRCA 2.

Women with a previous history of breast cancer or DCIS are at increased risk of a cancer recurrence. There is currently little evidence to suggest the appropriate screening interval for these women and national policy to inform eligibility and management of women in this group is limited. This has resulted in wide variations in practice across jurisdictions. The NBOCC clinical practice guidelines recommend intensive surveillance for 5 years for women following diagnosis of an invasive breast cancer or DCIS. From 5 years post-diagnosis, annual mammography, plus ultrasound if indicated and annual history and clinical examination are recommended. BreastScreen Australia is not well placed to provide the intensive surveillance required in the first 5 years following a diagnosis of invasive breast cancer or DCIS.

Recommendation10:

Women at potentially high risk of breast cancer (i.e. a relative risk greater than three times population risk), should not be screened within BreastScreen Australia due to their need for individualised assessment including more intensive surveillance and monitoring. National protocols should be implemented consistently for managing women at high risk of breast cancer who present to BreastScreen Australia services, including appropriate referral. This includes:

• women at potentially high risk due to a strong family history of breast cancer, as defined by NBOCC guidelines;

• women with identified high-risk genetic mutations, such as BRCA1 or BRCA 2; and

• women with a recent (<5 years) diagnosis of invasive breast cancer or DCIS.

NBOCC has developed a Family History Tool for use by BreastScreen Australia to assess a woman’s risk level based on family history. Use of this tool varies across jurisdictions, as does the definition and the management of women with a family history. Use of the NBOCC Family History Tool in all Program services to assess familial risk would provide consistency of access and health outcomes for all women using attending the Program.

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Women at moderate or slightly above average risk should continue to be eligible to attend BreastScreen Australia, and should be screened at biennial intervals as per the NBOCC guidelines.

NBOCC clinical guidelines for women following diagnosis of invasive breast cancer or DCIS recommend that, from 5 years post-diagnosis, women should have annual screening and clinical examination. For women with a history of ADH, ALH or LCIS, annual screening and clinical examination is recommended for 15 years following diagnosis. BreastScreen Australia should provide annual mammography for these groups of women with ongoing surveillance provided by their usual health care provider.

Recommendation11:

Implement national policies to ensure women are screened at the appropriate interval according to their level of risk. Familial risk should be assessed using the National Breast and Ovarian Cancer Centre family history tool.

Sub-recommendations

• Women with a previous history of invasive breast cancer or ductal carcinoma in situ: BreastScreen Australia should provide access to annual screening to women from 5 years following diagnosis. Apart from mammography, ongoing surveillance of these women should be provided by their usual health care provider.

• Women with a history of atypical hyperplasia (atypical ductal hyperplasia or atypical lobular hyperplasia) or lobular carcinoma in situ: BreastScreen Australia should provide access to annual screening to women for at least 15 years following diagnosis. Apart from mammography, ongoing surveillance of these women should be provided by their usual health care provider.

• Women at moderate risk of breast cancer due to family history: BreastScreen Australia should provide access to biennial screening to women.

• Women at slightly above average risk of breast cancer due to family history: BreastScreen Australia should provide access to biennial screening to women.


Womenwithsymptoms

Consistent with the definition of a population screening program, BreastScreen Australia was established to provide screening for women within a defined age range who are asymptomatic of breast cancer.

Management of women with symptoms differs significantly from that for asymptomatic women. Symptomatic women require prompt examination and should not be assessed using screening mammography alone. BreastScreen Australia is primarily structured to provide mammographic screening and some BreastScreen Australia Services, particularly mobile units, are not resourced to provide diagnostic services in the timeframes that may be required. Although all BreastScreen Australia services have mechanisms in place to respond appropriately to women who present for screening with symptoms, approaches are inconsistent. The potential for a delayed response remains, and this may occur for a variety of reasons. Women may not disclose the presence of a symptom in the belief that they will be turned away if they do or women in rural communities may delay having their symptom investigated by waiting for the mobile BreastScreen unit to return to their region.

Recommendation12:

BreastScreen Australia should not include women with symptoms in the Program. Women with symptoms require individualised assessment using the triple test approach in accordance with NBOCC guidelines. National protocols should be implemented consistently for managing women who present with symptoms to BreastScreen Australia services, including appropriate referral. Recommendation 19 also refers.

Highbreastdensity

Limited evidence exists on best practice for screening women with high breast density. In particular, a practical method to measure breast density accurately in a screening setting is not yet available. Following implementation of digital mammography in BreastScreen Australia, a national policy based on a review of the available evidence in relation to identifying and managing women according to their breast density should be developed.

Recommendation13:

Develop a national policy based on a review of the available evidence in relation to identifying and managing women according to their breast density, following the implementation of digital mammography in BreastScreen Australia.

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Researchanddata

Objective 12 of the BreastScreen Australia Program is to collect and analyse data sufficient to monitor the implementation of the Program, evaluate its effectiveness and efficiency, and provide the basis for future policy and Program development decisions.

Each jurisdiction has its own data system in place to collect service data. These systems were established differently in each jurisdiction, creating issues around consistency. Implementation of the BreastScreen Australia data dictionary aimed to reduce these inconsistencies. However, it appears that most jurisdictions have applied individual interpretations of the dictionary to their systems. During the Evaluation, two projects relied on data from jurisdictional BreastScreen datasets – the Participation and Performance Trends Project and the Mortality Ecological Study. Obtaining the data was a protracted process with almost 6 months between the initial request and provision of data. The Mortality Ecological Study experienced a loss of one-third of Program data due to inconsistencies. There is a strong need for the Program to address issues of data quality, data consistence and data availability.

Timeliness was also another key issue identified in relation to data collection and reporting. This refers to both the time taken to collect and clean the data into a useable dataset as well as the time lag of 3 years between the collection and publication of Program data in the Annual Monitoring Report produced by the AIHW. Improving accessibility to Program data at a national level is also required. Due to the different data systems used by jurisdictions, a central repository of data to address issues of quality and timeliness is required. A nationally agreed data set, in a standard format, is a key challenge for the Program to address for the future.

Recommendation14:

Improve the quality, accessibility, consistency and timeliness of reporting of nationally agreed standard data items to address current inadequacies of data collection and provision.

There are numerous areas in which data can be used to benefit the Program.

Inform policy development

Despite the wealth of data currently collected on the Program, data are underutilised in the development of Program policy. Application of screening policies is inconsistent across jurisdictions, creating confusion for women. A strategy to develop robust policies that are informed by the Program data could assist with reducing this inconsistency.


Monitor and evaluate Program performance

There is a gap between data collected for the eight Program performance indicators and a feedback process for Program response at a national level. Evaluating Program performance is challenging as no benchmarks exist to assess national performance meaningfully. In the absence of any other standards, the NAS were used as benchmarks in the Evaluation despite being developed for use at a service level. The lack of any standard for some datasets, for example in relation to invasive assessment procedures, morbidity and timeliness, indicates the need for standards to be developed in unmet areas. The Annual Monitoring Report, while helpful in monitoring and evaluating Program performance, is not timely, as the report is based on data from 3 years previously.

Review Program performance indicators

Eight key performance indicators are currently available to measure Program activity, performance and outcomes. These have remained constant since the Program commenced. Regular review is required to ensure that the indicators remain relevant and reflective of current practices.

The Evaluation revealed that Program’s response to new research and/or technologies is inadequate. Regular review of indicators could, in part, address this issue, as could implementation of a process for monitoring new research and/or technologies in relation to breast cancer screening. These are tasks that could potentially be allocated within the revised arrangements for governance and management of the Program.

Enable strategic research

There is an opportunity for the Program to undertake strategic research by drawing on Program data that are collected but are currently underutilised. A research agenda could identify research gaps by engaging with Program stakeholders to identify research priorities. Access to a national dataset is also required. Opportunities to develop research partnerships between BreastScreen Australia and the research community should be explored to ensure the wealth of data can be used for Program improvement.

Enhance opportunities for learning across the Program, including through sharing accreditation performance data

Despite the considerable amount of data collected at a jurisdictional level and the analysis of data by individual services through the accreditation process, information sharing between jurisdictions is limited. At present, the Annual Monitoring Report is the only means of sharing information at a national level. Facilitating opportunities for states and territories to share information, including accreditation data, will enhance learning for services at a local and jurisdictional level.

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Recommendation15:

Use Program data to:

• inform policy development;

• monitor and evaluate Program performance;

• review Program performance indicators;

• enable strategic research; and

• enhance opportunities for learning across the Program, including through sharing accreditation performance data.

Qualityimprovement

The BreastScreen Australia accreditation program has a number of strengths, including strong stakeholder engagement and support, and a process that challenges clinicians within the multidisciplinary team to review and critique performance. The NQMC provides leadership for the accreditation system and, together with the NAS and accreditation process, provides a critical unifying factor that underpins and unifies the Program at a national level. Program documentation and the NAS clearly outline the accreditation process and accreditation requirements and are a critical driver for services to achieve Program objectives.

However, there are several areas for improvement. Accreditation decision-making should be predicated on openness, transparency and accountability. There is a need for a separation between standards development and accreditation decision-making. The current accreditation system raises questions of objectivity in decision-making. The fact that eleven of the fifteen members of the NQMC, including a jurisdictional Program manager as the current Chair, are employed by the Program in some operational capacity highlights a lack of independence of the Committee membership.

The current accreditation system, including the 173 NAS, also imposes burdens that impact on the viability of the accreditation system and place a considerable burden on services. The workload required for services to comply with the accreditation process detracts from service provision and limits the range of quality improvement activities that can be undertaken at a service level. Multidisciplinary involvement of site visitors in accreditation activities, particularly in the current environment of escalating workforce shortages is not sustainable.

There are efficiency gains that would be realised by streamlining the accreditation process with the potential reallocation of capacity to service delivery and other quality improvement strategies.


Recommendation16:

Strengthen the Program accreditation system, within a broader quality improvement framework, by modifying the role, membership and operation of the NQMC. Consideration should be given to:

• separating the standard setting responsibilities from the accreditation assessment processes;

• providing an independent Chair;

• including more members who are independent of Program delivery; and

• ensuring greater transparency.

Recommendation17:

Refine the national accreditation process to reduce its overall burden on services and site visitors.

Recommendation18:

Refine both the number and structure of the NAS to focus on standards that align most closely with the objectives of the Program and establish ongoing mechanisms for NAS review.

Exploringalternativeservicemodels

Fundamental to the Evaluation is the consideration of the role of the BreastScreen Australia Program in the control of breast cancer in Australia. The Program was established to provide screening for women within a defined age range who are asymptomatic of breast cancer. In practice, the policy approach for women at elevated risk of breast cancer through a personal or family history of the disease is variable across the Program.

Symptomatic women do attend the Program, and anecdotal information indicates that women on occasion do not reveal the presence of symptoms to facilitate screening through the Program rather than seeking referral elsewhere. This is not an ideal situation for a screening program that relies primarily on mammographic results alone to indicate the need for further investigation.

The Program has extensive expertise and technology available for the diagnosis of breast cancer in many services across Australia. Program services are required to attain a high level of performance and are reviewed regularly on that performance through the accreditation process. This raises the question of whether the highly skilled and effective BreastScreen Australia Program has a role in the control of breast cancer in Australia more broadly.

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An important issue is that women who are unable to access BreastScreen Australia and are at potentially increased risk of breast cancer may be accessing poorer quality services. Clinical guidelines recommend that women at very high risk of breast cancer should have an individualised surveillance program formulated on the basis of their risk assessment. An examination of the access and availability of such services for women at very high risk for breast cancer was outside the terms of reference for this Evaluation and was not examined. This issue merits investigation with broader clinical cancer services to ensure these women receive the best possible advice and care.

With the wealth of experience in BreastScreen Australia and newer modes of diagnostic technology such as MRI now available, consideration needs to be given to expanding the role of BreastScreen Australia. This could encompass a risk assessment of women, without age restriction, and ensuring appropriate referral, where the required service exists elsewhere, and/or provision of appropriate diagnostic services where they exist within, or could be developed within, the Program.

There is the potential to increase capacity in the Program through changes to service delivery and restructuring the utilisation and scheduling of resources such as co-locating screening and assessment or diagnostic centres. Increased flexibility in working arrangements may also yield significant productivity gains.

It is therefore proposed that the feasibility of integrating screening and diagnostic services, co-located under the umbrella of BreastScreen Australia, should be examined through the implementation of a demonstration or pilot site study.

A number of potential advantages have been identified through the establishment of an integrated pathway in the Program. These include:

• potentially better quality of services for all women as a result of staff sharing knowledge and resources across the different service provision pathways;

• likely efficiencies through shared use of resources and workforce;

• alleviation of an enormous amount of difficulty for women who do not always understand the difference between screening and diagnostic mammograms;

• provision of appropriate services for women at high risk including risk assessment, counselling and information, and management including genetic testing


Recommendation19:

Explore the potential benefits and feasibility of co-location or greater integration of screening and diagnostic services through pilot or demonstration studies.

Possible areas for exploration are:

• diagnostic assessment of women with symptoms of breast cancer;

• individualised surveillance of women at potentially higher risk of breast cancer due to family history;

• individualised surveillance post-treatment of women with a recent (<5 years) invasive breast cancer or DCIS; and

• individualised risk assessment of women of any age to assess their risk for breast cancer and recommend appropriate screening or surveillance to manage that risk, either within the Program or through referral to appropriate services.

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16. APPENDICES

16.1 EVALUATIONADVISORYCOMMITTEEMEMBERSHIP

Member Category Expertise

Dr Helen ZorbasDirectorNational Breast and Ovarian Cancer Centre

Chair and Australian expert

Practicing breast physician; population health expert; evidence-based practice; clinical guidelines; monitoring; service improvement; psychosocial support to improve breast cancer care

Dr Frida CheokConsultant Health Economist

Australian expert Health economist and epidemiologist; experience in health services research; monitoring and evaluation of BreastScreen Australia Program

Professor David CurrowChief Executive OfficerCancer Australia

Cancer Australia representative

Cancer care and cancer research

Professor Dallas EnglishDirectorCentre for Molecular, Environmental, Genetic and Analytical EpidemiologyThe University of Melbourne

Australian expert Cancer epidemiology; environmental and genetic determinants of breast, colon, prostate and skin cancer

Professor Harry de KoningProfessor of Screening Evaluation, Department of Public HealthErasmus Medical CentreThe Netherlands

International expert Monitoring and evaluation, such as the evaluation of the national breast cancer screening program in the Netherlands; screening women at high risk using alternative screening technologies

Ms Valerie Lang AM Consumer Representative Consumer Health Forum representative

Mr David LearmonthDeputy SecretaryDepartment of Health and Ageing

Department of Health and Ageing representative

Policy expertise

Ms Jennifer Muller PSMSenior DirectorCancer Screening ServicesQueensland Health

Jurisdictional member (large jurisdictions)

Population health and quality improvement policy and practice. Management of screening programs in Australia; monitoring and evaluation

Clinical A/Professor Jonathan OsborneState RadiologistBreastScreen Queensland

Australian expert Diagnostic radiologist sub-specialising in breast disease

Professor Julietta Patnick CBEDirectorThe National Health System (NHS) Cancer Screening Programmes, United Kingdom

International expert Management of cancer screening programs and evaluations, such as the review of the NHS Breast Screening Programme and economic evaluations

Professor David RoderHead of Centre for Cancer Control Research; andAssociate Director of the Cancer Epidemiology CentreCancer Council of South Australia

Jurisdictional member (small jurisdictions)

Epidemiology of breast cancer; health services research

Ms Venessa Tripp Consumer representative Formerly a Senior Executive Service Officer in social policy areas of the Australian Public Service

Dr Madeleine WallClinical LeaderBreastScreen Aotearoa

Observer Diagnostic radiologist with expertise in breast screening in New Zealand


16.2 OUTLINEOFEVALUATIONPROJECTS

EconomicEvaluationandModellingStudy

Conducted by: IMS Health

Lead sponsor: Dr Frida Cheok

Supporting sponsors: Professor Harry de Koning and Ms Jennifer Muller

The Economic Evaluation and Modelling Study justified and implemented a suitable modelling technique to determine the effectiveness and cost-effectiveness of the current BreastScreen Australia Program against a baseline of no screening program and a range of policy alternatives. The model was calibrated with Australian data to estimate the impact of the Program on breast cancer mortality across different age groups; determine whether the Program is delivering cost-effective outcomes by conducting a cost-utility analysis; and to provide cost-effectiveness data to inform future policy decisions. The Study utilised Australian data, including BreastScreen Australia performance and costing data.

MedicareBenefitsSchedule(MBS)MammographyAnalysisProject

Conducted by: Department of Health and Ageing with data provided from Medicare and the AIHW, and advice from EAC project sponsors

Lead sponsor: Professor David Currow

Supporting sponsors: Dr Frida Cheok, Professor Dallas English and Clinical Associate Professor Jonathan Osborne

The Medicare Benefits Schedule (MBS) Mammography Analysis Project aimed to quantify the amount of non-diagnostic MBS-funded mammography, particularly among women aged 50–69 years who are eligible to access the services of BreastScreen Australia. The Project also analysed trends in MBS mammography and other diagnostic procedures associated with breast cancer diagnosis over the last 20 years.

MortalityEcologicalStudy

Conducted by: National Breast and Ovarian Cancer Centre (NBOCC)

Lead sponsor: Professor Dallas English

Supporting sponsors: Professor David Currow and Professor Harry de Koning

The Mortality Ecological Study examined the association by residential Statistical Local Area (SLA), or SLA aggregation, of BreastScreen Australia participation with time-lagged (subsequent) breast cancer mortality for women in the target age group of 50–69 years as well as women aged 40–49 and over 70 years, who are eligible for screening. The methodology was informed by the results of the Mortality Methodological Study and involved an ecological study with adjustment for mammograms provided outside of BreastScreen Australia and socio-economic differences at the SLA level. The study utilised data from BreastScreen Australia, state and territory cancer registries, Australian Bureau of Statistics (ABS) and Medicare mammography data.

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MortalityMethodologyStudy

Conducted by: National Breast and Ovarian Cancer Centre (NBOCC)

The Mortality Methodology Study reviewed and ranked the design options for evaluating the impact of the BreastScreen Australia Program on breast cancer mortality in the population, with regard to feasibility and quality of evidence. The methodology involved an extensive literature review and ranking of studies against an agreed set of criteria by an expert panel. The findings were used to inform the Mortality Ecological Study.

ParticipationandPerformanceTrendsProject

Conducted by: Australian Institute of Health and Welfare (AIHW)

Lead sponsor: Professor David Roder

Supporting sponsors: Dr Frida Cheok, Professor Dallas English and Ms Valerie Lang

The Participation and Performance Trends Project analysed BreastScreen Australia Program data to determine the performance of the Program across population sub-groups and jurisdictions and to identify trends in participation and performance within sub-groups and geographic areas over time. Population sub-groups included: women in rural areas; Aboriginal and Torres Strait Islander women; women from culturally and linguistically diverse backgrounds; women in the eligible and target age groups; women with symptoms who present for screening and women with a family history or a past history of breast cancer. The Project used BreastScreen Australia performance indicators and other routinely collected Program data from 1996 to 2005.

ParticipationQualitativeStudy

Conducted by: Blue Moon Research

Lead sponsors: Ms Valerie Lang and Ms Venessa Tripp

Supporting sponsor: Dr Helen Zorbas

The Participation Qualitative Study explored the views of health practitioners and BreastScreen Australia participants and non-participants within the target and eligible population to determine BreastScreen Australia’s availability and acceptance, and barriers to participation. The Study involved a literature review and qualitative research.

The qualitative research built on the literature review results to fill in information gaps and provide detailed findings on each of the Evaluation question topics. The research featured a comprehensive and inclusive sample of women aged 40–80 years, and women from a mix of socio-economic and cultural backgrounds. Research was conducted in all jurisdictions to ensure representation across Australia and included metropolitan, regional and rural areas. The sample was also split by usage and experiences of BreastScreen Australia services, and included women who had been diagnosed with breast cancer through BreastScreen Australia and subsequently treated; and women who had been diagnosed with cancer in the interval between regular screening events. The sample among health professionals included GPs, breast physicians, nurse counsellors and Aboriginal health workers.


PolicyAnalysisProject

Conducted by: HDG Consulting Group

Lead sponsor: Mr David Learmonth

Supporting sponsors: Professor Harry de Koning and Ms Jennifer Muller

The Policy Analysis Project reviewed the current BreastScreen Australia policy on age range and screening interval and the appropriate management of women with increased risk of breast cancer. The Project investigated best-practice evidence for managing women considered to be at higher risk of breast cancer such as women presenting for screening with symptoms, women with dense breasts, women with a family history, women exposed to diethylstilboestrol (DES), and women with a past history of breast cancer. In addition, the Project reviewed the existence and impact of inconsistency in the application of national policy across jurisdictions. The methodology included a literature review; analysis of current policy practice across jurisdictions and consultation with key stakeholders, including state and territory BreastScreen Australia Programs.

ProgramGovernanceandManagementProject

Conducted by: The NOUS Group

Lead sponsor: Ms Venessa Tripp

Supporting sponsors: Mr David Learmonth and Ms Jennifer Muller

The Program Governance and Management Project reviewed and analysed the current Program management and governance structures in place for BreastScreen Australia, including an examination of strategic direction and leadership, decision-making processes, performance monitoring, reporting, accountability and funding arrangements as they relate to achieving the aims and objectives of BreastScreen Australia. The Project also identified strategies and practices that contribute to best practice, equitable client outcomes, ongoing Program improvement and accountability through appropriate governance and management arrangements and Program delivery model. The Project methodology included a literature review; collation and analysis of information related to Program governance and management at national and jurisdictional level; and consultation with key stakeholders including state and territory BreastScreen Australia Programs.

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ReviewofBreastScreenAustraliaAccreditationSystem

Conducted by: KPMG

Lead sponsor: Clinical Associate Professor Jonathan Osborne

Supporting sponsor: Professor Julietta Patnick

The Review of BreastScreen Australia Accreditation System benchmarked the current BreastScreen Australia accreditation system against Australian and international best practices for accrediting healthcare services and identified options to ensure system sustainability and its ability to deliver ongoing quality improvements. This Project considered whether the current accreditation system continues to be appropriate, and whether the system meets or exceeds benchmarks for healthcare service accreditation and core criteria for a robust accreditation system. The methodology for this Project included a literature review; an assessment and review of the current accreditation system; and extensive consultation with key stakeholders including state and territory BreastScreen Australia Programs and the National Quality Management Committee (NQMC).

ReviewofBreastScreenAustraliaInfrastructureandCapacity

Conducted by: Access Economics

Lead sponsor: Ms Jennifer Muller

Supporting sponsors: Dr Frida Cheok, Clinical Associate Professor Jonathan Osborne and Professor Julietta Patnick

The Review of BreastScreen Australia Infrastructure and Capacity reviewed the capacity of BreastScreen Australia in meeting current and future demand, in the context of the availability and distribution of infrastructure and workforce. The Review assessed current demand and identified future demands for screening and assessment services due to population growth and/or policy changes, and best practice management of infrastructure and workforce to meet identified future demands. The Review also identified the potential benefits from the introduction of digital mammography to the BreastScreen Australia Program. The methodology included a review of current capacity, services and workforce; identified service demands; literature review; data analysis; modelling of current and future demand and capacity; and consultation with key stakeholders, including state and territory Programs. BreastScreen Australia Program data and Medicare data were included in the data analysis.


16.3 BREASTSCREENAUSTRALIAPROGRAMAIMSANDOBJECTIVES

Aims

1. To ensure that the Program is implemented in such a way that significant reductions can be achieved in morbidity and mortality attributed to breast cancer.

2. To maximise the early detection of breast cancer in the target population.

3. To ensure that screening for breast cancer in Australia is provided in dedicated and accredited Screening and Assessment Services as part of the BreastScreen Australia Program.

4. To ensure equitable access for women aged 50–69 years to the Program.

5. To ensure that services are acceptable and appropriate to the needs of the eligible population.

6. To achieve high standards of Program management, service delivery, monitoring and evaluation, and accountability.

Objectives

1. To achieve, after 5 years, a 70% participation rate in the BreastScreen Australia Program by women in the target group (women aged 50–69 years) and access to the Program for women aged 40–49 years and 70–79 years

2. To rescreen all women in the Program at 2-yearly intervals.

3. To achieve agreed performance outcomes which minimise recall rates, retake films, invasive procedures, ‘false negatives’, and ‘false positives’, and maximise the number or cancers detected, particularly the number of small cancers.

4. To refer to appropriate treatment services and collect information about the outcome of treatment.

5. To fund through State Coordination Units only Screening and Assessment Services which are accredited according to agreed National Accreditation Standards, and to ensure that those standards are monitored and reviewed by appropriate State Accreditation Committees.

6. To recognise the real costs to the women of participation in the Program, and to minimise those costs. This includes the provision of services at minimal or no charge, and free to eligible women who would not attend if there were a charge.

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7. To make information about mammographic screening and the BreastScreen Australia Program available in easily comprehensible and appropriate forms in a variety of forums, and to women and health-care providers in particular.

8. To achieve patterns of participation in the Program which are representative of the socio-economic, ethnic and cultural profiles of the target population.

9. To provide services in accessible, non-threatening and comfortable environments by staff with appropriate expertise, experience and training.

10. To provide appropriate service in that; the provision of counselling, education and information is an integral part of the Program; sensitive procedures for the notification of recall are in place; and the time between the initial screen and assessment is minimised.

11. To achieve high levels of participation in the development and management of the Program by members of significant professional and client groups.

12. To collect and analyse data sufficient to monitor the implementation of the Program, to evaluate its effectiveness and efficiency, and to provide the basis for future policy and Program development decisions.

Source: BreastScreen Australia, National Quality Management Committee 2005


16.4 QUESTIONSLINKEDTOEVALUATIONPROJECTS

Projecttitle Outcomes Evaluationquestions

Mortality Methodology Study Health 2. What impact has the Program had on breast cancer mortality?

Mortality Ecological Study Health 1. What are the benefits and harms of participating in the Program?

2. What impact has the Program had on breast cancer mortality?

3. To what extent is the Program an appropriate response to the incidence

and prevalence of breast cancer?

Participation and

Performance Trends Project

Process Participation,

access and equity

5. What are the trends of participation in the Program?

Process Program

performance

15. How appropriate are the reporting mechanisms and key performance

indicators for the Program?

16 How is the Program performing and what are the trends relating to

performance indicators?

17. To what extent are women rescreened in accordance with the

Program’s recommended screening interval?

Health 1. What are benefits and harms in participating in the Program?

4. What impact has the Program had on breast

cancer morbidity?

Review of BreastScreen

Australia Infrastructure

and Capacity

Process Infrastructure

and capacity

21. How effective is the Program in responding to new evidence

and research?

22. What are the impacts of infrastructure and workforce issues on

Program capacity?

23. To what extent are women screened and rescreened in accordance

with the Program’s recommended screening interval? To what extent

is this related to capacity?

25. What is the impact on the Program of incorporating new

technologies, in particular, digital mammography?

Policy Analysis Project Policy Issues 31. Is the current Program policy on target age range and screening

interval appropriate?

32. What is the best practice evidence for the management of women

identified as being at higher risk?

33. What is the best practice evidence for the management of women

with symptoms who present for screening?

34. What is the impact of inconsistent application of policy

across jurisdictions?

Review of BreastScreen

Australia Accreditation

System

Process Program

performance

20. Are quality assurance mechanisms ensuring a high standard of quality

within BreastScreen Australia?

288

Projecttitle Outcomes Evaluationquestions

Participation Qualitative

Study

Process Participation,

access and equity

6. To what extent is the Program available and accessible to all eligible

women, in particular, to sub-populations of women where the

participation is lower than the national average?

7. To what extent is the Program acceptable to women and other

stakeholders?

8. What are the barriers to improving participation? What are the

strategies to address these barriers?

9. What impact have BreastScreen Australia communication activities had

on participation rates?

10. Do the current BreastScreen Australia communication mechanisms

help women to make an informed choice about screening and

rescreening?

Health 4. What impact has the Program had on breast cancer morbidity?

Policy Issues 11. What are the factors contributing to women choosing mammography

outside the Program?

Economic Evaluation and

Modelling Study

Economic Cost-

effectiveness

26. What is the net cost per woman screened?

27. What is the net cost per life year saved through the Program?

28. What are the factors influencing any variation in costs?

Cost-utility 29. What is the cost per quality adjusted life year (QALY)?

Cost-benefit 30. What are the marginal costs of the Program over marginal benefits?

Program Governance and

Management Project

Process Program

performance

18. What aspects of governance and management contribute to

better outcomes?

19. Are the current Program management and governance arrangements

delivering the best possible outcomes?

MBS Mammography Analysis

Project

Process and economic 12. What are the trends in MBS funded mammography over time and how

do they relate to BreastScreen Australia participation rates?

13. What are the trends in MBS funded breast cancer diagnostic

procedures since the beginning of the BreastScreen Australia Program

in 1991?

14. To what extent are women using MBS funded mammography when

they could be accessing BreastScreen Australia services?

24. What is the impact, on the Program, of mammography outside

the Program?


16.5 LEVELSOFEVIDENCE

Rating Description

Ia Systematic review or meta-analysis of randomised controlled trials

Ib At least one randomised controlled trial

IIa Systematic review of cohort studies

IIb At least one well-designed cohort study or low quality controlled study

IIc Ecological studies or outcomes research

IIIa Systematic review of case-control studies

IIIb Individual case-control study

IV Case series or poor quality case-control studies

V Expert committee reports, opinions and/or clinical experience of respected authorities

Source: Oxford Centre for Evidence Based Medicine categories (2001) cited in Policy Analysis Project

290

16.6 GLOSSARY

AboriginalandTorresStraitIslander:Refers to a person who identifies as an Aboriginal and/or Torres Strait Islander and is accepted as such by the community with which he or she lives (BreastScreen Australia Data Dictionary, 2005).

Atypicalhyperplasia(AH):An increase of atypical cells in the breast epithelium. Atypical hyperplasia (AH) is further sub-classified into atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) in which the increase of abnormal cells occurs within the milk ducts of the breast. This condition is associated with a significant risk of developing subsequent carcinoma in either breast (NBCC 2001).

BRCA1/BRCA2: Breast cancer susceptibility gene 1 and 2 refers to an inherited gene mutation in a woman which is associated with a higher risk of breast cancer (NBCC 2001).

Breastconservingsurgery:Surgery where the breast cancer is excised (removed) together with a margin of normal breast tissue. The whole breast is not removed (NBCC 2001).

Corebiopsy:Sampling of breast tissue with a cutting needle to provide a tiny cylinder of tissue for histological examination (NBCC 2001).

Culturallyandlinguisticallydiverse(CALD):In this report, culturally and linguistically diverse individuals are those born overseas in countries where English is not the primary language spoken and/or individuals born in Australia whose preferred language spoken is not English.

Diethylstilbestrol(DES):A synthetic form of oestrogen prescribed for women between the 1938 and 1971 to help women with complications of pregnancy.

Ductalcarcinomainsitu(DCIS):An abnormal proliferative condition of epithelial cells in the mammary ducts. These cells display cytological (cellular) features of invasive carcinoma but, unlike invasive carcinoma, DCIS is contained within the ducts (NBCC 2002).

Fineneedleaspiration(FNA): Sampling of cells from breast tissue for cytological (cellular) examination. When suction is applied during the sampling, this is referred to a FNA or FNA biopsy (NBCC 2001).

False-negative:The test result has incorrectly observed that the disease is not present (AIHW 2008). The number of examinations with cancer present that were incorrectly called normal, expressed as a percentage of the total number of examinations (NBCC 2001)

False-positive:The test result has incorrectly observed that the disease is present (AIHW 2008). A test result that is falsely identified as positive, that is, the individual is given a malignant result that subsequently turns out to be benign (NBCC 2001).

High-riskwomen: A collective term used to refer to women at a higher risk of breast cancer – women with family history, women with a past history of breast cancer or DCIS or women with symptoms.

Hormonaltherapy:The use of drugs or hormones that specifically inhibit the growth of hormone-responsive cancer cells (NBCC 2001).


Intervalcancer: An invasive breast cancer that is diagnosed after a screening episode that detected no cancer and before the next scheduled screening episode.

Jurisdiction:Collective term used to refer to the states and territories of Australia.

Lapsedscreeners:Women who have screened through BreastScreen Australia in the past but have not re-attended the service in the recommended screening interval of 2 years or have never re-attended BreastScreen Australia since their initial screen (Participation Qualitative Study).

Leadtime:The time gained in treating or controlling a disease when detection is earlier than usual (e.g. in the pre-symptomatic stage), when screening procedures are used for detection. (Last 1995)

Leadtimebias:Over-estimation of survival time, due to the backward shift in the starting point for measuring survival that arises when diseases such as cancer are detected early, as by screening procedures. More generally, a systematic error arising when follow-up of groups does not begin at comparable stages in the natural history of a condition. For example, interventions for women whose breast cancer is detected by screening cannot be compared validly with interventions for women whose disease is first detected by clinical examination at a later stage of the disease (Last 1995).

Lobularcarcinomainsitu(LCIS):A benign (non-cancerous) proliferative process in the lobular units of the breast. It does not have specific mammographic features and is usually detected by chance in the course of a breast biopsy for another lesion (NBCC 2001).

Mastectomy:Surgical removal of the breast, which may be total (all of the breast) or partial (NBCC 2001).

MedicareBenefitsSchedule(MBS):A listing of Medicare services subsidised by the Australian Government as part of Medicare, Australia’s universal health insurance scheme.

Mobileunit:A mobile unit provides screening, or screening and assessment, as part of a particular SAS in a variety of locations. A mobile unit can take the form of a truck, bus or van, and is fully self-contained in that all screening occurs on the vehicle (BreastScreen Australia – National Quality Management Committee 2005a).

Morbidity:The departure from a state of physical or psychological well-being.

Mortalityrate:An estimate of the proportion of a population that dies during a specified time period of a specified illness or disease (Last 1995).

Nationalaccreditationstandards(NAS):The 173 standards used in accreditation decision-making of BreastScreen Australia services. The standards are comprised of data and non-data items and are grouped into ten categories to reflect the key performance objectives of BreastScreen Australia.

NationalQualityManagementCommittee(NQMC): The committee responsible for accreditation decision-making of BreastScreen Australia services and development and revision of the national accreditation standards. It is comprised of representatives including state and territory Program managers, epidemiologists, radiologists, radiographers, consumers, the Commonwealth Government and professional groups such as the Royal Australasian College of Surgeons and Royal College of Pathologists of Australia.

292

‘Never’screeners:Women in the target age range who have never attended a BreastScreen Australia service for a mammogram (Participation Qualitative Study).

Poissonregressionmodel:A statistical model for count data (data that refers to the number of occurrences of an event that have been counted) based on the Poisson distribution (a distribution having the characteristic that the mean is equal to the variance) (Culyer 2005).

Populationrisk:Refers to an individual’s risk of developing a disease, such as breast cancer. At population risk, the risk is equivalent to that of the general population.

Programsensitivity:The ability of the Program to detect invasive breast cancers in women attending for screening. It is measured as the proportion of invasive breast cancers that are detected within the BreastScreen Australia Program out of all invasive breast cancers (interval cancers plus screen-detected cancers) diagnosed in Program-screened women in the 2-yearly screening interval (AIHW 2008).

Proportionalhazardsregressionmodel:A model that is a form of multiple regression used in exploring the simultaneous effects of multiple variables on survival (Culyer 2005).

PublicHealthOutcomeFundingAgreement(PHOFA):An agreement in which the Australian Government makes payments to state and territory governments to support their public health programs, such as BreastScreen Australia.

Recalltoassessment:The rate of women who are recalled for assessment following attendance for a routine screen at a BreastScreen Australia service. In most cases, the recall is made because the mammogram result indicates a suspicion of breast cancer (AIHW 2008).

Relocatableunit:A relocatable unit provides screening as part of a Screening and Assessment Service (SAS) in a variety of fixed sites through the use of relocatable mammography machine and other equipment transported between facilities. Screening does not occur on the vehicle ((BreastScreen Australia – National Quality Management Committee 2005a).

Rescreening:The proportion of women who return for screening in the Program within the recommended screening interval (AIHW 2008). BreastScreen Australia’s recommended screening interval is 2 yearly.

ScreeningandAssessmentService(SAS):The managing entity that provides comprehensive screening and assessment services for BreastScreen Australia in a defined catchment area within a state or territory (BreastScreen Australia – National Quality Management Committee 2005a).

Stateaccreditationcommittee(SAC):The committee that oversees accreditation activities within its state or territory. The SAC also works alongside the state coordination unit (SCU) and the Service providers to support the provision of quality services.

Statecoordinationunits(SCU):The unit responsible for the planning and overall co-ordination of the BreastScreen Australia Program in each state and territory. The SCU, in conjunction with the state accreditation committee (SAC), is also responsible for the planning and coordination of accreditation of services within the state or territory.


Technicalrepeat(s):Refers to the additional films taken at either the initial or subsequent screening visit. See also Technical repeat status.

Technicalrepeatstatus:Indicates whether or not additional film(s) were taken due to the technically unsatisfactory nature of a woman’s films at the screening visit.

TripleTest:The recommended approach of the investigative pathway used to assess breast changes. The full test is made up of three diagnostic components: (1) clinical breast examination, including medical history; (2) imaging – mammography and/or ultrasound; (3) pathology via non-excisional biopsy – FNA cytology and/or core biopsy (NBCC 2002).

294

16.7 ABBREVIATIONS

AACR Australasian Association of Cancer Registries

ABS Australian Bureau of Statistics

ACT Australian Capital Territory

ADH atypical ductal hyperplasia

AGSC Australian Standard Geographic Classification

AHMAC Australian Health Ministers’ Advisory Council

AIHW Australian Institute of Health and Welfare

ALH atypical lobular hyperplasia

APHDPC Australian Population Health Development Principal Committee

ASAC Australian Screening Advisory Committee

ASCO American Society of Clinical Oncology

ASR age-standardised rate

BCNA Breast Cancer Network Australia

BMI body mass index

BRCA1 breast cancer susceptibility gene 1

BRCA2 breast cancer susceptibility gene 2

BSV BreastScreen Victoria

CALD culturally and linguistically diverse

CI confidence interval

CrI credible interval

CT computed tomography

DCIS ductal carcinoma in situ

DES diethylstilboestrol

DMAS Digital Mammography Accreditation Standards (Working Group) (subcommittee of Screening Subcommittee)

EAC Evaluation Advisory Committee

ERP estimated resident population

FNA fine needle aspiration

FTE full-time equivalent

GP general practitioner

HealthPACT Health Policy Advisory Committee on Technology

HIP Health Insurance Plan of Greater New York

HRT hormone replacement therapy

IARC International Agency for Research against Cancer

IQR interquartile range

IRSD Index of Relative Socio-economic disadvantage

LCIS lobular carcinoma in situ


LGA local government area

LYG life year gained

MBS Medicare Benefits Schedule

MRI magnetic resonance imaging

MSAC Medical Services Advisory Committee

NAS national accreditation standards (BreastScreen Australia)

NBCC National Breast Cancer Centre (now NBOCC)

NBCF National Breast Cancer Foundation

NBOCC National Breast and Ovarian Cancer Centre

NHS National Health Service (United Kingdom)

NHSBSP National Health Service Breast Screening Program (United Kingdom)

NICE National Institute for Clinical Excellence (United Kingdom)

NN number needed

NQMC National Quality Management Committee (BreastScreen Australia)

NSW New South Wales

NT Northern Territory

OR odds ratio

PACS Picture Archive and Communication System

PET positron emission tomography

PHOFA Public Health Outcome Funding Agreement

QALY quality-adjusted life year

Qld Queensland

RACS Royal Australasian College of Surgeons

RCT randomised controlled trial

RM repeated measures

RR relative risk

SAC State Accreditation Committee

SAS Screening and Assessment Service

SA South Australia

SCU State Coordination Unit

SES socio-economic status

SLA statistical local area

SSC Screening Subcommittee

Tas Tasmania

TGA Therapeutic Goods Administration

theEvaluation BreastScreen Australia Evaluation

theProgram BreastScreen Australia

UK United Kingdom

296

UKCCCR United Kingdom Coordinating Committee for Cancer Research

US(A) United States (of America)

USPSTF United States Preventative Services Task Force

Vic Victoria

WA Western Australia

WHO World Health Organization


16.8 LISTOFTABLES

Table 6.1 Summary of Poisson regression models for women aged 40 years and over by 5-year age groups – cumulative mortality (at 6 years) from breast cancer in relation to BreastScreen Australia biennial mammography 1990-2004

41

Table 6.2 Summary of proportional hazard regression estimates for women aged 40 years and over by 5 year age groups – mortality from breast cancer (adjusted for follow-up time from diagnosis) in relation to BreastScreen Australia biennial mammography 1990-2004

42

Table 6.3 Proportion of patients with breast conserving surgery by cancer diagnosis source

47

Table 6.4 Proportion of women aged 50–69 years undergoing breast conserving surgery as opposed to mastectomy for breast cancer detected by BreastScreen Victoria and outside the Program as reported to the Victorian Cancer Registry, 2005–2006

48

Table 6.5 Size of invasive breast cancers notified by BreastScreen Victoria and other notifiers in Victoria, by age group, 2004–2006

48

Table 6.6 Nodal involvement of invasive breast cancers notified by BreastScreen Victoria and other notifiers in Victoria, by age group, 2004–2006

49

Table 6.7 Recall to assessment rate for mammographic reasons for women aged 50–69 years, 2001–2005

52

Table 6.8 Number of women aged 50–69 years who were screened, recalled, underwent an invasive diagnostic procedure and had invasive cancer detected in first and subsequent screening rounds, 2005

54

Table 7.1 Estimated annual reduction in deaths from breast cancer among Australian women aged 40–69 years due to a mammographic screening program, by participation rate (estimated in 1990)

61

Table 7.2 BreastScreen Australia participation by women aged 50–69 years, 1996–2005

62

Table 7.3 BreastScreen Australia attendance by women aged 40–49 years, 1996–2005

64

Table 7.4 BreastScreen Australia attendance by women aged 70 years and over, 1996–2005

64

Table 7.5 BreastScreen Australia participation rate, Aboriginal and Torres Strait Islander women aged 50-69 years, 1996-1997 to 2004-2005

68

Table 7.6 BreastScreen Australia participation by women aged 50–69 years who reported that they speak a language other than English at home, 1996–1997 to 2004–2005

68

298

Table 7.7 Aggregate proportion of women screened aged 50–69 years who reported either a family history of breast cancer, previous history of breast cancer or DCIS or symptoms by state and territory, 1996–2005

70

Table 7.8 Aggregate proportion of women screened aged 50–69 years who reported either a family history of breast cancer, previous history of breast cancer or DCIS or symptoms, 1996–2005

71

Table 7.9 Annual number and age-standardised rate of MBS-funded bilateral mammograms for women aged 20–85+ years, 1987–2007

84

Table 7.10 Annual number of MBS-funded bilateral mammograms and estimated proportion of diagnostic, non-diagnostic and unknown mammography for selected age groups, 2006

94

Table 7.11 High, medium and low estimates of participation for BreastScreen Australia with the addition of MBS-funded non-diagnostic mammograms for women aged 50–69 years, based on 2006 data

94

Table 8.1 All-size invasive breast cancer detection rate for women aged 50–69 years, by state and territory, first and subsequent screening rounds, 1996-2000 and 2001-2005

103

Table 8.2 All-size invasive breast cancer detection rate for women aged 50–69 years, by region for first and subsequent screening rounds, 1996–2000 and 2001–2005

104

Table 8.3 All-size invasive breast cancer detection rate in Aboriginal and Torres Strait Islander women aged 50-69 years, first and subsequent screening rounds, 1996-2000 and 2001-2005

105

Table 8.4 All-size invasive breast cancer in women who reported that they speak a language other than English at home aged 50–69 years, first and subsequent screening rounds, 1996–2000 and 2001–2005

105

Table 8.5 Small (≤15 mm) invasive breast cancer in women aged 50–69 years, by state and territory, first and subsequent screening rounds, 1996–2000 and 2001–2005

107

Table 8.6 Small (≤15 mm) invasive breast cancer in women aged 50–69 years, by region, first and subsequent screening rounds, 1996-2000 and 2001-2005

108

Table 8.7 Small (≤15 mm) invasive breast cancer in Aboriginal and Torres Strait Islander women aged 50–69 years, first and subsequent screening rounds, 1996–2000 and 2001–2005

109

Table 8.8 Small (≤15 mm) invasive breast cancer in women aged 50–69 years who reported speaking a language other than English at home, first and subsequent screening rounds, 1996–2000 and 2001–2005

109

Table 8.9 Interval cancers in women aged 50–69 years, first screening round, 0–12 months, 1996–1999 and 2000–2003

110


Table 8.10 Interval cancers in women aged 50–69 years, subsequent screening rounds, 0–12 months, 1996–1999 and 2000–2003

111

Table 8.11 Program sensitivity for women aged 50–69 years, first and subsequent screening rounds, 1996–1999 and 2000–2003

112

Table 8.12 DCIS in women aged 50–69 years, by state and territory, first and subsequent screening rounds, 1996–2000 and 2001–2005

114

Table 8.13 Recall to assessment, mammographic reasons, for women aged 50–69 years, by state and territory, first screening round, 1996–2000 and 2001–2005

116

Table 8.14 Recall to assessment, mammographic reasons for women aged 50–69 years, by state and territory, subsequent screening rounds, 1996–2000 and 2001–2005

116

Table 8.15 Rescreen for women aged 50–67 years, by state and territory, following, first, second, and subsequent screening rounds, 2000–2003

118

Table 8.16 Technical repeat performed, women aged 40 years and over and women 50–69 years, by state and territory, 1996–2000 and 2001–2005

120

Table 8.17 Technical repeat performed in Aboriginal and Torres Strait Islander women aged 40 years and over, 1996–2000 and 2001–2005

121

Table 8.18 Technical repeat performed in women aged 40 years and over who reported speaking a language other than English at home, 1996–2000 and 2001–2005

121

Table 8.19 Proportion of women aged 40 years and over who received their result within 28 days, by state and territory, 1996–2000 and 2001–2005

122

Table 8.20 Proportion of women aged 40 years and over with a time between screening and assessment of 28 days or less, by state and territory, 1996–2000 and 2001–2005

123

Table 8.21 Fine needle aspiration (FNA) in women aged 40 years and over, by state and territory, 1996– 2000 and 2001–2005

127

Table 8.22 Core biopsy for women aged 40 years and over, by state and territory, 1996–2000 and 2001–2005

128

Table 8.23 Fine needle aspiration (FNA) results and final cancer status results in women aged 40 years and over, 1996–2000 and 2001–2005

129

Table 8.24 Core biopsy results and final cancer status results for women aged 40 years and over, 1996–2000 and 2001–2005

130

Table 8.25 Program performance against national accreditation standards (NAS) relating to fine needle aspiration (FNA), mean rates for women aged 40 years and over, 1996– 2000 and 2001–2005

132

300

Table 8.26 Program performance against the national accreditation standards (NAS) relating to core biopsy mean rate for women aged 40 years and over, 1996–2000 and 2001–2005

132

Table 8.27 All-size invasive breast cancer, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

133

Table 8.28 Small (≤15mm) invasive breast cancer, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

134

Table 8.29 Interval cancers, by age group, first and subsequent screening rounds, 1996–1999 and 2000–2003

135

Table 8.30 Program sensitivity, by age group, first and subsequent screening rounds, 1996–1999 and 2000–2003

136

Table 8.31 DCIS, by age group, first and subsequent screening rounds, 1996–2000 and 2001–2005

137

Table 8.32 Recall to assessment, mammographic reasons, by age group, first and subsequent

138

Table 8.33 Technical repeat performed, by age group, 1996–2000 and 2001–2005 139

Table 8.34 Fine needle aspiration (FNA), as a proportion of assessments, by age group, 1996–2000 and 2001–2005

140

Table 8.35 Core biopsy, as a proportion of assessments, by age, 1996–2000 and 2001– 2005

140

Table 9.1 Assessment of Program performance against national Program functions from a governance and management perspective

149

Table 9.2 Options for future Program governance and management arrangements 153

Table 10.1 BreastScreen Australia workforce, full time equivalents (FTEs), June 2008 164

Table 10.2 BreastScreen Australia workforce, vacancies over 2 years prior to 30 June 2008

164

Table 10.3 Hours of work by employment status as reported in the survey 165

Table 10.4 Participation 28–36 months after screening round, by screening round, 1996–2002

167

Table 10.5 Percentage of women who attend for a screening appointment within 28 calendar days of their booking date (eligible population), 2007

168

Table 10.6 Scenarios modelled in infrastructure and capacity demand and supply modules

169

Table 10.7 BreastScreen Australia Program capacity, base case (current participation rates continue to 2027), per year

170

Table 11.1 Estimated screening costs ($millions) for 2008–2017 based on current participation rates

194


Table 11.2 Estimated screening costs ($millions) for years 1–10 at a participation rate of 70%

194

Table 11.3 Estimated screening costs ($millions) for years 1–10 for varying participation rates within the target age group

195

Table 12.1 Summary of outcomes from key meta-analyses on the effectiveness of breast cancer screening

199

Table 12.2 Modelled mortality outcomes for 1,000 Australian women >70 years old with self-rated health status who started screening at age 50 years according to self-rated health and whether they continued screening or not

202

Table 12.3 Life expectancy (years) for females in Australia, 1980–1982 to 2004–2006 203

Table 12.4 Summary of evidence on the effect of breast cancer screening on breast cancer

204

Table 12.5 Comparative data on breast cancer across age cohorts in Australia 205

Table 12.6 Comparison of breast cancer screening: program performance by age group

207

Table 12.7 Relative risk factors for developing breast cancer from two different reviews

212

Table 12.8 Absolute risk (%) of developing breast cancer over the next 10 years by age cohort and number of affected first-degree relatives

213

Table 12.9 Categories of risk for women with a family history of breast cancer 214

Table 12.10 Models of practice for women with family history of breast cancer or known genetic

215

Table 12.11 Models of practice for women with personal history of invasive breast cancer

217

Table 12.12 Models of practice for women with high breast density 218

Table 12.13 Prevalence of breast symptoms amongst symptomatic women and absolute risk of breast cancer

219

Table 12.14 Summary of jurisdictional variation in current policy practice 222

Table 12.15 Summary of definitions of criteria for annual screening 225

Table 14.1 Accreditation status of BreastScreen Australia Services, 2008 237

302

16.9 LISTOFFIGURES

Figure 3.1 Incidence of breast cancer per 100,000 women, by age group, 1982–2004 16

Figure 3.2 Breast cancer mortality by age group, 1982–2005 19

Figure 4.1 Agreed performance indicators for the BreastScreen Australia Program 22

Figure 4.2 BreastScreen Australia screening and assessment pathway 24

Figure 6.1 Cumulative mortality (at 6 years) from breast cancer incidence in relation to BreastScreen Australia biennial mammography 1990-2004, Poisson regression model including age group, biennial screening, MBS mammography, region and socio-economic index, ages 50-69 years

38

Figure 6.2 Mortality from breast cancer (adjusted for follow-up time from diagnosis) in relation to BreastScreen Australia biennial mammography 1990-2004, proportional hazards regression model including age group, biennial screening, MBS mammography, region and socio-economic index, ages 50-69 years

39

Figure 6.3 All-size and small size cancer detection rate per 10,000 women screened, first and subsequent screening rounds, for women aged 50–69 years, compared with the national accreditation standard (NAS), 1996–2000 and 2001–2005

44

Figure 6.4 Small (≤15 mm) invasive breast cancers as a proportion of all-size invasive breast cancers, women 50-69 years, all screening rounds, 1996-2005

45

Figure 6.5 Relationship between pre-operative diagnosis rate, fine needle aspiration (FNA) rate and core biopsy rate in Victoria, Queensland, Western Australia and Australian Capital Territory for women 40 years and over, 1996–2005

46

Figure 6.6 Proportion of women aged 40 years and over requiring assessment attending within 28 days of screening by state and territory, 1996–2000 and 2001–2005

53

Figure 6.7 Fine needle aspiration (FNA) and core biopsy results for women 40 years and over, 2005

54

Figure 7.1 Number of women attending BreastScreen Australia by age group, 1996–2005

62

Figure 7.2 BreastScreen Australia participation by women aged 50–69 years, by state and territory, 1996–2005

63

Figure 7.3 BreastScreen Australia mean participation rate (95% CI) by 2-year interval for women

65

Figure 7.4 BreastScreen Australia mean participation rates (95% CI) by 2-year interval and by population sub-group for women aged 50–69 years, 1996–2005

66

Figure 7.5 Participation rate of women aged 50–69 years, by region, 1996–1997 to 2004–2005

67


Figure 7.6 Proportion of screens where additional risk factors were reported for women aged 50–69 years, 1996–1997 to 2004–2005

69

Figure 7.7 Number of MBS-funded mammograms, by age group and dates of breast cancer-related media publicity, 1995–2007

78

Figure 7.8 Annual number of MBS-funded bilateral, single and total mammograms for women 50-69 years, 1987-2007

82

Figure 7.9 Annual age-specific rate of MBS-funded bilateral mammograms by age group, 2006–2007

82

Figure 7.10 Annual age-specific rate of MBS-funded bilateral mammograms for women aged 50–69 years, by state and territory, 1987–2007

83

Figure 7.11 Annual number of MBS-funded bilateral mammograms by age group, 1987–2007

85

Figure 7.12 Annual number of MBS-funded breast-related diagnostic services compared with annual number of MBS-funded bilateral mammograms for women aged 50–69 years, 1992–2007

86

Figure 7.13 Annual age-specific rate of MBS-funded bilateral ultrasound (referred and non-referred ) by age group, 2007

87

Figure 7.14 Number of mammograms conducted by BreastScreen Australia and mammograms funded through the MBS for women aged 50–69 years, 1996–2005

88

Figure 7.15 Average annual attendance rates through BreastScreen Australia and MBS mammography for women aged 50–69 years, by state and territory, 2001–2005

89

Figure 7.16 Average annual attendance rates through BreastScreen Australia and MBS-funded mammography for women aged 40–49 years, by state and territory, 2001–2005

90

Figure 7.17 Average annual attendance rates through BreastScreen Australia and MBS-funded mammography for women aged 70+ years by state and territory, 2001–2005

91

Figure 7.18 Estimate of the proportion of MBS-funded mammography used for diagnostic and non-diagnostic purposes in women aged 50–69 years, 2006

93

Figure 7.19 Key issues identified in qualitative study and ideal outcomes 98

Figure 8.1 Interval cancers in women aged 50–69 years, subsequent screening rounds, 0–12 months, 13–24 months, and 0–24 months, 1996–2003

111

Figure 8.2 Program sensitivity for women aged 50–69 years, subsequent screening rounds, at 0–12 months and 0–24 months follow-up, 1996–2003

113

304

Figure 8.3 Rescreen for women aged 50–67 years, by state and territory, first, second, and third and subsequent screening rounds, 2003

119

Figure 8.4 Median time between screening and assessment, and proportion of women aged 40 years and over, with a time between screening and assessment of 28 days or less, 1996 –2005

123

Figure 8.5 Median number of days between screening and assessment for women aged 40 years and over, by state and territory, 1996 and 2005

124

Figure 8.6 Proportion of women aged 40 years and over with a time between screening and assessment of 28 days or less, by state and territory, 1996–2000 and 2001–2005

125

Figure 8.7 Fine needle aspiration (FNA) and core biopsy conducted as a proportion of all assessments for women aged 40 years and over, 1996–2005

126

Figure 9.1 Diagrammatic representation of the BreastScreen Australia governance and management structure

146

Figure 10.1 BreastScreen Australia Program demand and supply, base case – no change to the Program, number of women to be screened, 2008–2027

171

Figure 10.2 Demand and supply growth and capacity gap by jurisdiction for base case (% in terms of women screened)

172

Figure 10.3 BreastScreen Australia Program capacity gaps for demand-related scenarios (women screened)

173

Figure 10.4 BreastScreen Australia capacity gaps for supply-related scenarios (number of women screened)

175

Figure 11.1 Average cost-effectiveness ratios for extending the target age group using the current screening Program compared with a ‘no screening scenario’

188

Figure 11.2 Average cost-effectiveness ratios for extending the target age group using a 70% participation rate compared with a ‘no-screening’ scenario

189

Figure 11.3 Average cost-effectiveness ratios for increasing and decreasing the screening interval, current Program and women 50–69 years at 70% participation, compared with a ‘no screening’ scenario

190

Figure 11.4 Average cost-effectiveness ratios for varying the participation rate for women 50–69 years old compared with a ‘no screening’ scenario

191


16.10REFERENCES

Anderson E, Berg J, Black, R, Bradshaw N, Campbell J, Carnaghans H et al. 2008. Prospective surveillance of women with a family history of breast cancer: Auditing the risk threshold. Br J Cancer; 98: 840–844.

Australia and New Zealand Horizon Scanning Network, 2009. National Horizon Scanning Unit Emerging Technology Bulletin: New and emerging technologies for breast cancer detection. Canberra: AGPS.

Australian Health Ministers’ Advisory Council. Breast Cancer Screening Evaluation Committee. 1990. Breast cancer screening in Australia: Future directions. Australian Institute of Health: Prevention Program Evaluation Series No. 1, Canberra: AGPS.

Australian Institute of Health and Welfare (AIHW). 2008. BreastScreen Australia monitoring report 2004–2005. Canberra: AIHW.

Australian Institute of Health and Welfare (AIHW) & Australasian Association of Cancer Registries (AACR). 2008. Cancer in Australia: An overview, 2008. Canberra: AIHW.

Australian Institute of Health and Welfare (AIHW) & National Breast Cancer Centre (NBCC). 2006. Breast Cancer in Australia: An overview, 2006. Canberra: AIHW.

Australian Institute of Health and Welfare. 1998. Breast and cervical cancer screening in Australia 1996–1997. Canberra: AIHW.

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