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Datum

Corporate presentatie Maastricht UMC+ (titel presentatie)

Naam spreker (optioneel)

Functie spreker (optioneel)

Titel van de presentatie

Onderwerpregel

Presentatie Prof. Dr. Jan Jansen

Patient-reported outcome measures (PROMs) in onderzoek: ontwikkeling en validatie.

Prof. dr. Carmen Dirksen

Head dept. Clinical

Epidemiology and Medical

Technology Assessment

(KEMTA)

Dr. Merel Kimman,

postdoc/senior researcher

KEMTA

Content

• What are PROMs

• Toolbox PROMs

• Relation with VBHC – Maastricht UMC+

• ICHOM and COMET – standard outcome sets/measures

• Practical examples:

- PESaM questionnaire

- PROM-HISS

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What are PROMs?

PROs: patient reported outcomes

PROMs: patient-reported outcome measures

Patients’ experiences of health (outcomes)

PREMs: patient-reported experience measures

Patients’ experiences of health care (structure/process)

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Why patient experiences of health (outcomes)?

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Types of PROMs

Generic: physical, mental and social aspects of health

• Examples: SF-36, EuroQol-5D, HUI-3, WHO-QoL

Domain specific: physical OR mental OR social

• Examples: Anxiety (STAI), Depression (BDI, HADS),

Population-specific

• Examples: Children (TACQOL, KidScreen, EQ-5D-Y), Elderly (ICECAP-O, ASCOT)

Condition/disease or function specific

• Examples: Asthma (AQLQ), Knee / Hip (Oxford Knee Score), High Blood pressure (Bulpitt), cancer (EORTC)

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Some examples PROMs

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EQ-5D-3L

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Toolbox PROMs (2017)

PROM cyclus

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Can also be used for

PREMS (e.g. CQ-

index)

Aim can also be

research

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1. Determine the objective: why, for whom, what setting

• Individual patient: to obtain insight in patient’s functioning/experienced health, to support in diagnostic process, choice for treatment, improve communication between patient and healthcare professional

• Internal quality: PROM data at aggregated level to get insight in quality of care, compare between HC professionals, organisations for quality improvement, info NOT available for patients or HC insurers

• External quality: PROM data at aggregated level, made publicly available to HC insurers (contracts) and patients (choose HC provider). Possibly also for HC Inspectorate.

• Research into effectiveness of treatments, HTA and policymaking

• Combination of the above; may be complex, conflicting goals

determine most important goal

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2. Selection of PROs

• Which PROs?

- Health is broad concept, can be measured on different levels (e.g. symptoms, functioning, health state, quality of life)

- Decision regarding at what level(s) to measure

• Identify relevant PROs

- Literature review (identification)

- Interviews/focus-groups (confirmation)

• Prioritise and select most relevant PROs

- Together with relevant stakeholders (depending on objective)

- PROs should fit objective, e.g.:

* individual patient: PRO should change through treatment

* internal quality: PRO should be influenced by health care (better care, better PROs)

* research: PRO should distinguish between comparative treatments

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3. Selection of PROMs (1)

• First explore which PROMs are already administered in patient group!! (especially in multidisciplinary treatment; reduce burden patient & HC provider)

• Determine requirements of PROM

- generic, disease-specific, etc.

- paper-pencil, interview, web-based, proxy

- psychometric properties

- feasibility/acceptance by stakeholders

• Identify existing PROMs

- literature review

- databases with PROMs

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3. Selection of PROMS (2)

• Selection of PROMs based on content

- does it measure the selected PROs?

face validity

• Determine psychometric properties of the PROMs

- Validity: does the PROM measure what it intends to measure?

- Reliability: does the PROM return the same results under the same conditions?

- COSMIN checklist (appraisal of articles investigating psychometric properties of PROMs)

• Determine feasibility, interpretability and acceptability of PROMs

- Feasibility: easy to use? (understandable, low burden, costs of usage, interpretability for HC professional)

- Interpretability: outcome meaningful? (score is low/high, minimally important change, etc.)

- Acceptability: support of PROM (e.g. already widely used)

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3. Selection of PROMS (3)

• Select most appropriate PROM

- involve relevant stakeholders in choice

e.g. through formal consensus method

• Determine trajectory:

- Testing selected PROM (step 4)

- Further development PROM (e.g. does not measure all selected PROs, not tested in target group, no Dutch version available)

- If not available/fit for purpose: develop new tool (part II Masterclass Merel Kimman)

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4. Testing PROM

• How depends on objective of PROM

• Always check if feasibility, validity and reliability (literature, other sources) also applies in target group

mix qualitative & quantitative research

practical and scientific value PROM

• Also applies in case of new PROM or further development existing PROM

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5. Define indicator

• An indicator gives meaning to results of a PROM

- e.g. average pain in adults in leg after hernia operation at 6 weeks FU (scale 0-10)

- proportion of patients that scores 10 or higher on PROM for anxiety

• Comparison with ‘norm score’

• Internal or external quality indicator: doing better or worse than norm score?

• Research: basis for sample size calculation (e.g. difference in proportions of patients above or below norm score/cut-off value)

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5. Define indicator (2)

Three steps in indicator definition:

1.Which outcome/indicator?

2.Comparability of measurement of indicator

- registration: procedures and analysis

- population characteristics: age, gender, education level, etc.

- representativeness respondents/sample

3.Define the (concept) norm of indicator, based on

- research, experts, average value

- can also be relative norm (deviation from mean)

- discriminative ability of norm more informative

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6. Testing indicator

Testing indicator in practice

• Do the requirements for comparability and discriminative ability hold?

• Are differences statistically different?

• Are statistically different scores relevant (for conclusions regarding e.g. quality)?

• Ongoing testing important to gain knowledge regarding value of indicator in relation to objective

• Adapt norm/ accept concept norm

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7. Actual use of PROM (in daily practice*)

• Define implementation strategy

- barriers and facilitators: HC professional, patient, organisation, culture, regulations

- tailored implementation strategy: educative meetings, educative materials, reminders, feedback on PROM use, adaptations in organisation, managerial support

• Helpful to integrate PROM within existing processes

• Beware of patient privacy and data anonymity

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* Step not relevant in research

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8. Maintenance and evaluation

• Evaluation of PROM and/or outcome indicator based on results (possibly return to PROM cycle)

• Structural financing necessary

• Questions:

- are chosen PROMs relevant for objective?

- does it measure intended outcomes?

- is the PROM being sufficiently used?

- does the outcome indicator still suffice?

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Many links to

relevant tools in

document!!

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PROMS and value-based health care (VBHC)

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Includes

PROMs!

Strategy conference November 2, 2017

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Strategy conference November 2, 2017

International Consortium for Health

Outcomes Measurement (ICHOM)

Identify Select

Including PROMs Including PROs

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International Consortium for Health Outcomes Measurement (ICHOM)

• ICHOM connected with Harvard Business School, de Boston Consulting Group and Karolinska Institute (2012)

• Work ICHOM based on VBHC: care with best patient-relevant outcome per euro invested

• The Netherlands well represented in international ICHOM expert teams

• ICHOM sets used as starting point for development outcome indicators and PROMs

• Current registrations: clinical outcome indicators of ICHOM fairly well represented, PROMs much less represented

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PROM(s)

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