How to investigate levels of Adherence to antiretroviral...

How to Investigate Adherence to Antiretroviral Treatment

WHO/EMP/MIE/2011.1

An Indicator-Based Approach

WHO/EMP/MIE/2011.1

How to Investigate

Adherence to

Antiretroviral

Treatment


How to Investigate Adherence to Antiretroviral Treatment:


ii

This manual was made possible through support provided by the Swedish International

Development Cooperation Agency (Sida), under the terms of Sida contribution 72300310 and the

World Health Organization, under an Agreement for Performance of Work, OD-AP-07-00516. The

opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the

Swedish International Development Cooperation Agency or the World Health Organization.

© World Health Organization and Management Sciences for Health 2011

All rights reserved.

The designations employed and the presentation of the material in this publication do not imply

the expression of any opinion whatsoever on the part of the World Health Organization or

Management Sciences for Health concerning the legal status of any country, territory, city or area

or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on

maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they

are endorsed or recommended by the World Health Organization or Management Sciences for

Health in preference to others of a similar nature that are not mentioned. Errors and omissions

excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization and Management

Sciences for Health to verify the information contained in this publication. However, the

published material is being distributed without warranty of any kind, either expressed or

implied. The responsibility for the interpretation and use of the material lies with the reader. In

no event shall the World Health Organization or Management Sciences for Health be liable for

damages arising from its use.

Recommended Citation

This document may be reproduced if credit is given to WHO and MSH. Please use the

following citation.

World Health Organization and Management Sciences for Health. 2011. How to

Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach.

iii

Acknowledgements

This manual has been completed with the help of many people who have taken part in the

International Network for the Rational Use of Drugs Initiative on Adherence to

Antiretrovirals (INRUD-IAA)

Ethiopia

Drug Administration and Control Authority: Planning and Drug Information

Abraham Gebre Giorgis

Federal HIV/AIDS Prevention Control Office (FHAPCO)

Workalemahu Mulugeta, Assefa Yibeltal

INRUD Ethiopia

Tenaw Andualem (also MSH)

Management Sciences for Health (MSH)

Gabriel Daniel, Negussu Mekonnen, Hailu Tadeg

Kenya

INRUD Kenya

Edwine Barasa, Lillian Gitau (also MSH)


Patrick Boruett, Josephine Maundu, Peter Nguhiu, Michael Thuo, Mary Wangai

National AIDS/STIs Control Program (NASCOP)

Christine Awuor, Dorine Kagai, Ibrahim Mohamed, Irene Mukui, Susan Njogo,

Namibia

International Training & Education Centre for Health (I-TECH)

Miriam Kasanda

Ministry of Health and Social Service

Francina Kaindjee, Victor Muthiani, Joseph Rushubiza


Jacob Kawonga, David Mabrizi, Jude Nwokike

Rwanda

Center for Treatment and Research on AIDS, Malaria, Tuberculosis and Other Epidemics

(TRACPlus)

Ruton Hinda, Corine Karema, Vincent Mutabazi, Francois Ndamage (deceased),

Sabin Nsanzimana, Jose Nyamusore,


Gege Buki, Antoine Gatera, Patrick Gaparayi, Max Kabalisa, Mark Morris, Aline

Mukerabirori, Denise Murekatete, Georges Ntumba

Ministry of Health

Dr. Agnes Binagwaho

National University of Rwanda, School of Public Health

Joseph Ntaganira

Sweden

Swedish International Development and Cooperation Agency (Sida)

Peter Iveroth, Christina Larsson

Division of International Health, Karolinska Institute, Stockholm

Stefan Peterson, Goran Tomson, Rolf Wahlstrom



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Switzerland

World Health Organization, Department of Essential Medicines and Pharmaceutical Policies

Kathy Holloway, Richard Laing, Kris Weerasuriya

Tanzania

INRUD Tanzania and Muhimbili University of Health and Allied Sciences

Soni Rainalds Malele, Amos Massele, Candida Moshiro


Romuald Mbwasi. Salama Mwakisu

National AIDS Control Program

David Sando, Bernard Senyael, Geofrey Somi, Roland Swai

Uganda

INRUD Uganda and Department of Pharmacology and Therapeutics, Makerere University

Celestino Obua, Paul Waako

Joint Clinical Research Centre

Joshua Kayiwa


Saul Kidde


Hudson Balidawa

UK


John Chalker, Larysa Szalapaj (IT consultant)

USA


Julie Frye, Keith Johnson, Lewis Parish, Amber Thomson

Harvard Medical School Drug Policy Research Group

Dennis Ross-Degnan, Catherine Vialle-Valentin, Anita Wagner

Zambia


Oliver Hazemba


Abel Mwalele, Harold Witola

University of Zambia, Department of Community Medicine

Seter Siziya

v

Acronyms

AIDS acquired immune deficiency syndrome

ART antiretroviral therapy

ARV antiretroviral

HIV human immunodeficiency virus

IAA Initiative on Adherence to Antiretrovirals

IHCAR Division of International Health of the Karolinska Institute

INRUD International Network for the Rational Use of Drugs

MPS WHO Medicine Policy and Standards

MSH Management Sciences for Health

NACP National AIDS Control Programme

Sida Swedish International Development Cooperation Agency

Susp Suspension

WHO World Health Organization

vi

CONTENTS

Acknowledgements ........................................................................................................................... iii

Acronyms .............................................................................................................................................. v

Introduction .......................................................................................................................................... 1

CHAPTER 1 --- Overview of the manual ......................................................................................... 5

Field-testing methods .......................................................................................................................... 6

Results .................................................................................................................................................... 6

Conclusion from feasibility tests ........................................................................................................ 8

CHAPTER 2 --- Core indicators of adherence .................................................................................. 9

Self report-based adherence measures from exit interviews ......................................................... 9

Dispensing-based adherence equals measures ................................................................................ 9

Patient attendance and defaulting ..................................................................................................... 9

Alternate attendance indicators ......................................................................................................... 9

Self report-based adherence measures from exit interviews ......................................................... 9

CHAPTER 3 --- Indicators for possible determinants of adherence ........................................... 15

Facility indicators determinants ...................................................................................................... 16

Patient care indicator determinants ................................................................................................ 22

Demographic indicator determinants ............................................................................................. 24

CHAPTER 4 --- Survey design ......................................................................................................... 25

Sampling facilities .............................................................................................................................. 25

Sampling retrospective patient records .......................................................................................... 25

Conclusion .......................................................................................................................................... 28

Sampling for exit interviews ............................................................................................................ 29

CHAPTER 5 --- Data collection tools and how to modify, print and fill them in ..................... 31

Overview ............................................................................................................................................. 31

Customization .................................................................................................................................... 32

Accessing the data entry forms ........................................................................................................ 37

Printing data entry sheets for data collection ................................................................................ 41

Filling in the forms ............................................................................................................................. 42

Filling in the facility questionnaire form ........................................................................................ 42

Filling in the retrospective dispensing data ................................................................................... 49

Filling in the forms ............................................................................................................................. 49

Filling in the exit interview forms ................................................................................................... 52

Some comments about workflow .................................................................................................... 59

CHAPTER 6 --- Planning and field methods ................................................................................. 60

Preparations for survey ..................................................................................................................... 60

Permissions and approval ................................................................................................................ 60

Select and prepare sample sites ....................................................................................................... 60

Recruit survey coordinator, team leaders, and data collectors ................................................... 61

vii

Plan data collection visits schedule ................................................................................................. 62

Create the medicines lists.................................................................................................................. 62

Train personnel .................................................................................................................................. 63

Pilot-test the data collection methods ............................................................................................. 63

Ethics for data collectors ................................................................................................................... 63

Collecting data .................................................................................................................................... 63

Sampling and retrospective data extraction ................................................................................... 64

Exit interview ...................................................................................................................................... 64

Facility interview ................................................................................................................................ 64

Computer entry .................................................................................................................................. 64

Completed forms review .................................................................................................................. 65

Team leader communication with survey coordinator ................................................................ 65

CHAPTER 7 --- Training of data collectors and team leaders ..................................................... 69

Training team leaders before data collectors ................................................................................. 69

Sample training syllabus ................................................................................................................... 70

CHAPTER 8 --- Data entry and data processing ........................................................................... 73

Data entry general points .................................................................................................................. 73

Data entry procedures ....................................................................................................................... 73

Data consolidation for all facilities .................................................................................................. 83

Data processing .................................................................................................................................. 88

Data summarization and report creation ....................................................................................... 88

CHAPTER 9 --- Interpretation of data and follow-on questions ................................................. 89

Dissemination of results to key stakeholders ................................................................................. 91

CHAPTER 10 --- Guidance notes on survey report template ...................................................... 93

Process description ............................................................................................................................ 93

Review summaries - Consolidate summary data .......................................................................... 94

Report document ................................................................................................................................ 95

Resources ........................................................................................................................................... 100

APPENDIX 1 --- Frequently asked questions .............................................................................. 101

APPENDIX 2 --- Data collection forms ......................................................................................... 103

2A. Retrospective dispensing form ............................................................................................... 103

2B. Patient identifier forms ............................................................................................................. 105

2C. Patient exit interviews .............................................................................................................. 106

2D. Facility interview questionnaire ............................................................................................. 108

2E. Questionnaire template form list ............................................................................................. 111

2F. Consolidation template form list ............................................................................................. 111

APPENDIX 3 --- Training slides .................................................................................................... 112

APPENDIX 4 --- Report template .................................................................................................. 126

CONTENTS ...................................................................................................................................... 128

ACRONYMS ..................................................................................................................................... 129



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BACKGROUND ............................................................................................................................... 130

RESULTS ........................................................................................................................................... 134

CONCLUSION ................................................................................................................................. 136

ANNEX 1: Facility interview results in detail .............................................................................. 137

ANNEX 3: Retrospective record review results in detail ........................................................... 140

APPENDIX 5 --- Complementary indicators of adherence ........................................................ 141

APPENDIX 6 --- Complementary indicators of determinants of adherence ........................... 143

1

Introduction

Collecting data on adherence is vitally important because of the ever present threats of

treatment failure and resistance. This is a manual for standardizing methods of collecting

data on levels of adherence to antiretroviral medicine in health facilities. Standardization is

needed so that rates can be compared over time and between facilities. It is critical to

monitor adherence to improve patient outcomes, and data exist in facilities to do so.

This manual will enable programme managers giving antiretroviral medicines to patients to

assess the performance of facilities under their responsibility with respect to levels of

adherence to antiretrovirals (ARVs). It is a step by step guide on how to design and carry

out a national or facility survey or a programme survey.

With these methods, managers can identify facilities where they need to intervene to

improve adherence levels. Managers can examine the causes of poor performance and work

with the facilities to make improvements and then use the survey methods to assess whether

improvement has occurred.

Managers can also examine facilities that are doing well, to share lessons on how to achieve

exceptional performance.

The main purpose therefore is to define a limited list of standardized adherence indicators

and methods of measurement, enabling an assessment of:

How a facility is doing at that moment.

How it is doing over time.

How it compares to other facilities.

The effectiveness of interventions to improve adherence levels.

All of these indicators will, in turn, give a yardstick for managers to concentrate energies

and resources on poorer performing facilities for maximal system strengthening. In addition,

indicators for likely determinants of good and poor adherence are also presented to help

explain facility results and suggest interventions where needed.

The problem with measuring adherence to ARVs is that it is a behaviour that takes place in

the privacy of the patient’s home. Therefore, all measures are indirect and subject to

different biases and inaccuracies. However, the goal of developing these core indicators is

that they correlate with clinical outcome. They must also be easy to collect in any facility

giving antiretroviral treatment.

The first chapter provides an overview of why adherence is important. It also includes a

stepwise summary of the work that the International Network for the Rational Use of Drugs

(INRUD) Initiative on Adherence to Antiretrovirals (IAA) has undertaken to develop this

manual, together with results of the early feasibility studies to see what could be done.



2

Chapter 2 describes the core indicators of adherence and how to collect them. These core

indicators are designed to be collectable almost anywhere. The three main areas are based

on:

Self-reported doses of ARV medicines missed over a recent period of time.

The number of days that ARV medicines were dispensed over the last six months.

The regularity of patient attendance at appointments.

Appendix 5 contains further complementary adherence indicators that may be collected

where the information sources exist.

Chapter 3 describes a number of indicators of possible determinants of good and poor

adherence. These include both facility-level indicators, such as drug supply, workload,

opening hours, patient waiting time, dispensing rates for ARV and non-ARV medicine and

quality of medicine labelling, and patient care indicators, such as patient travelling time,

travelling costs, and patient knowledge on dosage. Again, these are designed so that they

may be collected almost anywhere. In Appendix 6, further complementary determinants

indicators are described that may be collected where the information sources exist.

Chapter 4 goes into survey design and discusses how to sample facilities, retrospective

records and patients for interviewing.

Chapter 5 explains the data collection tools and how to fill them in, column by column.

Three main data collection tools are attached in Appendix 2:

1. A form for filling in details of patients' attendance and days of pills dispensed for 100

patients sampled randomly over the last six months.

2. An exit interview form for interviewing 30 patients as they leave the facility.

3. A facility interview sheet.

Chapter 6 explains how to plan for a survey and provides a checklist for the survey

coordinator. Chapter 7 gives sample training for data collectors, including a set of

PowerPoint slides in Appendix 3. Chapter 8 explains how to enter the data into the

computer and how the given spreadsheets do the analysis automatically. Chapter 9 helps to

interpret the data and gives examples of different adherence results, interprets possible

reasons and interventions, and Chapter 10 includes instructions on how to complete the

survey report template file, which is included on the accompanying CD-Rom and is outlined

in Appendix 4.

The basic premise of this document is that it is possible to narrow down the factors needed

to improve adherence. This manual describes how to measure adherence. We know that it

works with routine data and we encourage you to use this information in creating your own

programmes to improve ART adherence.

Introduction

3

The accompanying CD-Rom contains:

1. This manual: ‚Adherence Indicator Survey Manual.doc”.

2. The data collection forms for country-level customization (password ‚INRUD‛);

printing for data collection; and for double data entry: ‘Questionnaires.xlt’.

3. The form which will automatically consolidate the data: ‘Consolidated.xlt’.

4. The training slides to train the data collectors: ‘Team Leader Role.ppt’; ‘Dispensing

Records.ppt’; ‘Exit Interviews.ppt’; and ‘Facility Form.ppt’.

5. The report template: ‘Adherence Survey Report Template.docx’.



4

1

5

CHAPTER 1 --- Overview of the manual

The 2004 International Conference on Improving Use of Medicines highlighted the urgent

need to develop strategies to improve adherence to antiretroviral therapy (ART)

(www.icium.org). Accepted wisdom is that if the ART adherence rate is less than 901–95%,2

treatment can fail, and the virus may become resistant. A review of adherence studies for

chronic illnesses found that achieving adherence rates above 80% is difficult, even in

resource-rich countries.3 Therefore, the ability to accurately monitor adherence rates for ART

and immediately address problems is crucial.

Although many countries are scaling-up ART programmes, few have developed any

practical approaches to monitor treatment adherence. The INRUD-IAA is taking on the

challenge.

A survey conducted in early 2006 in five East African countries—Ethiopia, Kenya, Rwanda,

Uganda and the United Republic of Tanzania—looked at the current programme practices in

measuring and calculating adherence and defaulting behaviours by patients receiving ARV

medicines. It showed that definitions of both adherence and defaulters or dropouts varied

considerably, if they existed at all. Measurement at the individual or facility level was

haphazard, using various data sources and methods of calculation. But nevertheless, much

useful information was recorded at both the clinic and pharmacy locations. At a follow-up

regional meeting held in Entebbe, Uganda, from 27–29 April 2006, it was agreed that

definitions and methods should be harmonized and candidate indicators were suggested for

the following methods: self-reporting from patient interviews or clinical records; non-

adherence, based on missed days from pharmacy records; and defaulting, based on

information from attendance registers.

1 Arnsten JH et al. Antiretroviral therapy adherence and viral suppression in HIV-infected drug

users: comparison of self report and electronic monitoring. Clinical Infectious Disease, 2001,

33:1417–1423.

2 Paterson DL et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV

infection. Annals of Internal Medicine, 2000, 133:21–30.

3 DiMatteo MR. Variations in patients’ adherence to medical recommendations. A quantitative

review of 50 years of research. Medical Care, 2004, 42(3):200–209.



6

The Swedish International Development Cooperation Agency (Sida) awarded a five-year

grant to Management Sciences for Health (MSH) and the INRUD on 1 September 2006, for

enhancing adherence to ARVs in East Africa. Partners and collaborators include INRUD

groups in the five East African countries of Ethiopia, Kenya, Rwanda, Uganda and the

United Republic of Tanzania; the National AIDS Control Programmes of these five

countries; the Division of International Health of the Karolinska Institute, Harvard Medical

School Drug Policy Research Group, and the World Health Organization’s (WHO)

Departments of Medicines Policy and Standards and Technical Cooperation for Essential

Drugs and Traditional Medicine (later merged to become the Department of Essential

Medicines and Pharmaceutical Policies).

Four national surveys were undertaken with the suggested indicators to field-test the

feasibility of collecting the data in a wide variety of facilities. In a separate study, these were

followed by a validation study where the five selected indicators of adherence were

validated as predictors of improvement in clinical outcomes

Field-testing methods

Four national surveys were undertaken in Kenya, Rwanda, Uganda, and Ethiopia between

October 2006 and June 2007 to investigate the feasibility and reliability of the methods for

collecting the adherence indicators.

The sampling strategy included 20 randomly chosen health facilities in each country with at

least 100 patients on ARVs six months before the survey. Data collectors were practicing

pharmacists, doctors, or senior-level medical or pharmacy students. Teams of three, four or

five data collectors surveyed a single facility in one day and entered the day’s data in the

evening.

In each facility, data collectors randomly sampled medical and pharmacy records and

interviewed 30 patients who were leaving the clinic. Data collectors examined the pharmacy

records to see how many days of medicine had been dispensed over the period and to track

patients from the previous months to see when and if they showed up for their next

appointment. Pill count and self-reported adherence data were included if mentioned in the

records.

Results

More than 6500 records showed that across facilities, the median percentage of days that

patients received medicines was high—91 to 95% (Table 1). On a facility level though, this

measure varied from 53 to 100%. The median percentage of patients with gaps in treatment

of 30 days or more across countries was between 2 and 18% but on a facility level, the figure

ranged from 0 to 60%.

The median percentage of patients who attended their next appointment on or before the

day scheduled ranged from 72 to 92% (Table 1). However, variability across facilities was

large, with the best facility achieving 100% on-time attendance versus only 15% at the worst

facility.

Chapter 1

Overview of manual

7

Interviewers carried out 1631 interviews in the four countries, averaging 20 per facility. All

self-reported adherence rates from current patients were very high across the four countries;

for full self-reported adherence across health facilities, no median percentage was less than

96.6 (Table 1).

Table 1. Adherence values across countries and facilities

Median percentage across all facilities (Minimum facility percentage - Maximum facility

percentage)

Country Ethiopia Uganda Rwanda Kenya

Indicator

Attendance, dispensing, and gap (N = 1,989) (N =1,695) (N =1,602) (N = 1,265)

Exit interviews (N = 565) (N = 408) (N = 285) (N = 373)

Full self-reported adherence in last 3 days from exit interview

96.6 (90–100)

96.7 (63–100)

100 (60–100)

96.6 (80–100)

Average percentage of days covered by medicine dispensed

95 (89–99)

91 (77–97)

97 (88–100)

95 (53–100)

Percentage of patients with ≥ 30 days gap in medicines dispensed

9 (0–33)

18 (0–42)

2 (0–12)

16 (0–60)

Percentage of patients attending

clinic appointment as scheduled

72

(58–99)

78

(15–100)

92

(38–100)

77

(46–96)

Percentage of patients attending clinic within three days of appointment

87 (72–99)

80 (20–100)

96 (67–100)

N/A

N/A = Data not collected

Usefulness of pill counts and self-report in clinic notes

Overall, only 15% of 6551 patient records included a pill count (Table 2). Therefore,

calculating adherence measures based on pill counts in medical and pharmacy records does

not appear to be widely applicable.

More records included a self-report adherence measure (45% overall), although this measure

was infrequently recorded in Rwanda (10%). However, the methods used to derive these

self-report measures varied, which makes comparisons problematic. In Ethiopia, for

example, the method of recording self-reported adherence was to use a ‚G‛ (good) to

indicate better than 95% adherence, an ‚F‛ (fair) for 85–95% or a ‚P‛ (poor) for less than

85%. Of the 83% of records that included a self-report measure, 96% were rated ‚good.‛



8

Table 2. Number of records with pill counts and self reports

Ethiopia Uganda Rwanda Kenya Total

Number of records examined 1989 1695 1602 1265 6551

Percentage of records with

pill counts 0 9 44 12 15

Percentage of records with self-reports 83 33 10 4 45

Conclusion from feasibility tests

The INRUD-IAA field tests examined four categories of indicators for adherence to ARV

medicines and treatment defaulting:

1. Self-reported adherence from exit interviews.

2. Days supplied by medicine.

3. Patient attendance.

4. Pill counts and self-reports in clinic records.

The first three methods offer feasible approaches to standardizing measures of adherence

and defaulting in low-resource settings. Pill counts are used too infrequently; whereas, self-

reports in clinic records appear more promising. However, the consistency of the data-

gathering methods needs to be assessed.

The four field tests provide strong evidence that adherence targets can be met in resource-

poor settings. However, in all countries, some facilities had low values, particularly for

dispensing-based adherence and patient attendance. Managers should examine the causes of

poor performance in these facilities and work with them to make improvements. Facilities

that are doing well can also share lessons on how to achieve exceptional performance. Only

by monitoring adherence and defaulting can we know where, and what kind of.

interventions are needed.

2

9

CHAPTER 2 --- Core indicators of adherence

The five core indicators of adherence with the alternate attendance indicators are:

Self report-based adherence measures from exit interviews

1. Percentage of patients with full adherence to ART (i.e., no doses missed in the recall

period, which is three days in the INRUD-IAA methodology).

Dispensing-based adherence equals measures

2. Average percentage of days covered by ARVs dispensed for a sample of patients for

a defined period (180 days).

3. Percentage of patients who experienced a gap in ARV availability of more than 30

days in a row during the same defined period.

Patient attendance and defaulting

4. Percentage of patients who attend on or before the day of their appointment.

5. Percentage of patients who come within three days of their appointment.

Alternate attendance indicators

6. Percentage of all visits in the last six months made before the days of medicine supplied at the

previous visit have been consumed.

7. Percentage of all visits in the last six months made within three days of when the medicine

supplied at the previous visit have been consumed.

Self report-based adherence measures from exit interviews

A clinician or pharmacist can easily collect data for this indicator by asking patients whether

they have missed any doses of pills in the last three days, and if so, how many. For valid

answers to this question the interviewer must appear non-judgmental. The recommended

way of asking this is ‚Many patients have troubles in taking their ARV doses as prescribed,

how many of the ARV doses did you miss in the last three days?‛



10

Using clinical records to measure this indicator is possible only if the question has been asked consistently and recorded routinely. Because of this, self report written in clinical notes is a complementary adherence indicator. In practice, clinicians or pharmacists may have asked patients about their adherence but not recorded the answer. Also, the recall period they may have asked about could vary between their adherence yesterday to their adherence since the

last clinic visit.

The indicator chosen here using self-reporting is indicator 1 below.

Indicator 1. Percentage of patients with full adherence to ART

Rationale Perfect (or > 95%) adherence is the primary treatment goal.

Source of data Patient self-report: ―In the last 3 days, have you missed any of the ARV doses you were supposed to take?‖ [Response: yes/no].

Data collection Patient interview: Based on sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day).

Computation (Number of patients responding ―no‖/number of patients asked) × 100.

Comments The question is standardized to 3 days. In practice this question could be asked for last 1, 2, 3, 4, or 7 days. For any of these periods, missing one dose is equivalent to less than 95% adherence (missing 1 dose in 7 days is 7.1% of doses on a twice daily regimen). Calculation can be the same if the question is asked for 30 days or for the period since the last clinic visit, but

interpretation would differ.

Pitfalls The only hope of getting an honest answer is if the interviewer is friendly and non-officious. Interviewers need to be trained to ask the question in a uniform way.

An example of use may be that, of 30 patients asked this question, four said that they had

missed one or more doses in the last three days. This means that for this facility the self-

reported full adherence rate would be 26/30 which is 86.7%. In practice the percentage is

high and inflated (95% on average in the four field tests) but does correspond to clinical

outcomes where it has been checked. The lowest percentage for a single facility in the four

feasibility studies was 60%. So managers would know to concentrate their attention on that

facility.

Dispensing-based adherence measures

Pharmacy dispensing records are useful to measure longer-term adherence patterns. By

counting the number of days that medication is dispensed over a period, two important

adherence indicators can be calculated—long-term adherence to ARVs and the rate of

patients with significant gaps in treatment.

The dispensing-based adherence measures are defined as follows:

1. Average percentage of days covered by ARVs dispensed for a sample of patients for

a defined period (180 days).

2. Percentage of patients who experienced a gap in ARV availability of more than 30

days in a row during the same defined period.

Chapter 2

Core indicators of adherence

11

Although by using dispensing data, we cannot reliably measure whether drugs are actually

used, we can detect any gaps where the patient has no dispensed drugs. As such, this may

overestimate true adherence—the patient may have received the medicine, but did not

consume it correctly. However, if the patient never received the medicine, then s/he cannot

adhere to treatment. For example, if the patient was dispensed medicine for 145 out of 180

treatment days, then the patient’s maximum adherence rate could only be 81%. In the four

feasibility trials, the median number of days covered in each country was above 90%.

However, when looking at facilities the lowest was 53%. If on average patients only had 53%

of their days covered by medicines, then good adherence levels are impossible and an

intervention is greatly needed.

With the data collection forms to generate the indicators, it is necessary to write down each

attendance over the last six months and the numbers of days of ARVs dispensed.

Indicator 2. Average percentage of days covered by ARVs dispensed for a sample of patients for a defined period (180 days)

Rationale Adherence measures from pharmacy refill rates have been shown to

correspond to clinical outcomes. If there are too few days of medicine dispensed, then we infer that the patient has missed doses.

Source of data Pharmacy records.

Data collection Based on the sample of 100 patients who visited the pharmacy during the

seventh month before data collection (the index visit) and using historical dispensing data in pharmacy records, identify the date and days’ supply of

all ARVs dispensed during the index visit and during all subsequent visits for this patient during the follow-up period chosen. If the number of days’ supply provided in the last dispensing during the follow-up period is greater than the number of days left in the period, count only the days’ supply equal to the number of days left in the period. This is done automatically if the data entry sheet is used.

Computation For individual patient: Long-term adherence—(Total number of days’ ARV supply dispensed/number of days in period) × 100

Note: If any long-term adherence rate is >100%, then change it to 100%

For facility: Average percentage long-term adherence—Sum of sampled patient long-term adherence rates/number of sampled patients

If the patient has more than one ARV in the treatment regimen, this indicator should be calculated for the least supplied medication, as any

part of a dose missed counts as a missed dose.

Note: The computation is automatic on the spreadsheet analysis tool. The tool is an MS Excel spreadsheet supplied with the manual where the data

entry forms look like the hand written data entry forms. Data need double entry for each facility onto the spreadsheets. There is a separate consolidation file in which the summary data for each facility are imported and the indicators automatically generated.

Comments Pharmacy dispensing records are useful for measuring long-term adherence, but this method makes assumptions about completeness of the dispensing data and about how the medicines were consumed.

Pitfalls Identifying reliable patient-specific longitudinal records may be a problem in some systems; the records are usually easily retrievable (e.g., dispensings recorded on a single page or in a consistent place in the clinical record). However some data may be inconsistently recorded, so a

low measure on the indicator may reflect poor record keeping.



12

There is a difference between having a series of small gaps and one long gap in terms of

adherence. For this reason the other indicator measures the rate of patients with gaps in

treatment of 30 days or more. Between the four countries in the feasibility trial, this varied

from 2 to 18% of patients, but in the worst facility 60% of patients had such a gap. This may

be because people dropped out permanently through defaulting or death, or that they

remained in treatment. This would be an important follow-up question.

Indicator 3. Percentage of patients who experienced a gap in ARV availability of more than 30 days in a row during a defined period

Rationale A gap in medicine supply of more than 30 days has serious implications for resistance and treatment failure.


Data collection Based on the same sample of 100 patients and the same data on dates of dispensing and number of days dispensed since the index visit.

Computation For individual patient: Discontinuation—If patient ever experiences a gap of > 30 days between the end of days’ supply in one dispensing (or end of total days’

supply available if ARVs remain from previous dispensings) and date of the next dispensing

For facility: Percentage discontinuation (number of patients experiencing a gap in ARV treatment > 30 days/number of patients) × 100.

Comments This can be calculated automatically using the spreadsheet analysis tool.

Pitfalls As with the previous indicator, identifying reliable patient-specific longitudinal records may be a problem in some systems, if one visit is not recorded then the

patient will appear to have a gap of 30 days, so a low measure on the indicator may reflect poor record keeping.

Patient attendance and defaulting measure

A missed appointment should trigger programme action to reach out to patients at risk of

defaulting on their treatment. However, because the patient may have had extra days of

medicine, attendance failure within three days of an appointment can also be a trigger point.

The two core performance indicators related to attendance are:

4. Percentage of patients who attend on or before the day of their appointment.

5. Percentage of patients who attend within three days of their appointment.

The purpose is to look at a visit the patient made, note when the next appointment was

made for, and then see if the patient kept the appointment. Because some programmes give

certain patients three months of medicine, it is necessary to review the records to see the

patient’s attendance four months before, see the date of the next appointment, and then note

whether the patient’s next visit was on or before that date (indicator 4), or within three days

of that date (indicator 5).

Chapter 2

Core indicators of adherence

13

When filling in the dispensing data collection form, alternate attendance indicators can be

calculated easily. This means that we have two alternative attendance indicator:

6. Percentage of all visits in the last six months made before the medicine supplied at

the previous visit have been consumed.

7. Percentage of all visits in the last six months made within three days of when the

medicines supplied at the previous visit have been consumed.

Indicator 4. Percentage of patients who attend on or before the day of their appointment

Rationale Rate of missed appointments is one measure of programme success in actively

engaging patients.

Source of data Clinic or pharmacy records (if available).

Data collection Based on the systematic sample of 100 patients, look at all scheduled appointments after the attendance four months prior to the date of data collection.

Note: Only include those patients who attended during the month four months

before data collection.

Computation (Number of patients appearing for appointment on or before day scheduled/number of patients in sample) × 100.

Comments

Many programmes use different definitions of defaulting. The intention of this indicator is to identify a trigger point for programme action to reach out to patients at risk of defaulting.

Pitfalls Some systems may not record the date of the next appointment. If this is the

case, you can take the number of days of medicine dispensed and assume the last day is the day of the next appointment.

Indicator 5. Percentage of patients who attend within three days of their appointment

Rationale Some patients are given an extra two or three days of medicine. Therefore if they have missed their appointment by less than three days they may still be in treatment. This may serve to explain indicator 4.

Source of data Same as 4—Clinic or pharmacy records (if available).

Data collection Based on the systematic sample of 100 patients, look at all scheduled appointments after the attendance four months prior to the date of data collection.

Note: Only include those patients who attended during the month four months

before data collection.

Computation (Number of patients appearing within three days of their appointment/number of sampled patients) × 100.

Comments

If programme routinely gives extra two or three days treatment, then this may

be the appropriate trigger point rather than indicator 7. The intention of this indicator is to identify an alternative trigger point for programme action to reach out to patients at risk of defaulting.

The different rates in different facilities are striking. Where a facility has a high percentage of

patients attending on or before the day of their appointment, the likelihood of high

adherence levels is increased. In the feasibility studies, the national medians varied from 72



14

to 96%, but in terms of facilities the lowest was 15%, meaning that only 15% of patients came

on the day of their appointment.

Sometimes the appointment dates are not available in the pharmacy notes making the two

indicators above impossible to collect. Alternative attendance indicators are:

6. Percentage of all visits in the last six months made before the medicine supplied at

the previous visit have been consumed.

7. Percentage of all visits in the last six months made within three days of when the

medicine supplied at the previous visit have been consumed.

With the method of filling in the dispensing form and recording all dates of visits in the last

six months and numbers of days of pills dispensed, it is easy to automatically generate

another two indicators which are approximate to indicators 4 and 5 above and take into

account all the visits over the last six months rather than only looking at one. Alternative

attendance indicator 6 is:

Indicators 6 & 7. Percentage of all visits in the last six months made before the days of medicine supplied at the previous visit have been

consumed and within three days of the drugs being consumed

Rationale Rate of attendance before medicine is finished and within three days of the medicines being finished are measures of treatment adherence and one

measure of programme success in actively engaging patients.


Data collection Based on exactly the same data as collected for indicators 2 and 3 above which was based on the sample of 100 patients and used historical dispensing data in pharmacy records. The date and days’ supply of all ARVs dispensed during the index visit and during all subsequent visits for this patient during the follow-up period chosen should be recorded.

Computation Using the spreadsheet analysis tool the computation can be made for the sample of patients.

(Number of appointments attended on or before pills ran out/total number of appointments sampled) × 100.

(Number of appointments attended within three days of pills running out /total number of appointments sampled) × 100.

Comments

To calculate this indicator, the spreadsheet analysis tool is needed.

3

15

CHAPTER 3 --- Indicators for possible

determinants of adherence

Determinants are defined here as those factors which may be the cause of good or poor

adherence. Adherence indicators’ determinants help to identify why patients may have

problems adhering to treatment; for example, staff with high average workloads may not

have the time to adequately counsel patients. Data for these indicators can be collected at the

same time as data for the core adherence indicators. The determinants and their data sources

follow.

The data collection forms can be seen in Appendix 2.

Table 3. Facility indicators

Availability of ARVs and other key medicines

1. The percentage of a selected list of first-line adult ARVs currently in stock.

2. The percentage of a selected list of first-line paediatric ARVs currently in stock.

3. The percentage of key medicines for HIV-associated illness currently in stock.

4. The percentage of days each medicine on a list of adult ARVs has been in stock in the last 90 days

5. The percentage of days each medicine on a list of child ARVs has been in stock in the last 90 days.

6. The percentage of days that each medicine on a list of key medicines for HIV-associated illness has been in stock in the last 90 days.

Health facility accessibility and infrastructure

7. Extent of clinic hours—Number of hours clinic is open per week for routine AIDS care.

8. Convenience of clinic hours—Whether clinic is open at least one evening or one weekend day for routine AIDS care.

9. Clinician patient load—Average number of AIDS patients seen per clinician hour.

10. Support staff patient load—Average number AIDS patients per week per support staff.

11. Presence of private space for counselling—Whether facility has a private space available for adherence counselling.

12. Presence of laboratory—Whether facility has access to a laboratory that is actively measuring CD4 counts or viral loads within the programme.

13. Frequency of CD4 and viral load testing.

14. ARV dispensing rate—Percentage of patients who had all prescribed ARVs dispensed at the health facility.

15. Non-ARV medicines dispensing rate—Percentage of patients who had all prescribed medicines dispensed at the health facility.

16. Proper medicines labelling—Percentage of patients for whom all medicines dispensed are adequately labelled.

Record keeping

17. The percentage of facilities with a functioning clinic attendance register showing all patients who visited each day.

18. The percentage of facilities with an appointment book or other system showing all patients due for clinic attendance each day.



16

Table 4. Patient care indicators

1. Patient knowledge of ARV regimen—Percentage of patients who know when to take each of their ARV medicines and how much to take each time.

2. Patient waiting time—Average amount of time patients spend in the facility during a visit.

3. Patient travel time to care—Average amount of time spent travelling to health facility to receive care.

4. Patient travel cost to care—Average cost for travelling to health facility to receive care.

Table 5. Demographic indicators

1. Average age of patients.

2. Gender—Percentage of patients who are female.

Facility indicators determinants

ARV availability on day of data collection

1. The percentage of a selected list of first-line adult ARVs currently in stock.

2. The percentage of a selected list of first-line paediatric ARVs currently in stock.

Rationale Lack of availability of ARVs can be a key system-related barrier to adherence.

Source of data Observation in health facility pharmacies on day of data collection.

Data collection Check which medicines on a list of ARVs intended to be in stock are actually

in stock (any amount will do as long as it is in stock and in date).

Computation (Number of ARVs in stock/number of ARVs intended to be in stock) × 100.

Comments Before the survey, it is necessary to agree a list of up to 10 key first-line ARVs for adults and children which should always be in stock.

Key medicine availability

3. The percentage of key medicines for HIV-associated illness currently in stock.

Rationale Lack of availability of key medicines needed to treat or prevent ARV side effects, opportunistic infections, or other HIV-associated illnesses can be a barrier to ARV adherence.

Source of data Observation in health facility pharmacies on day of data collection.

Data collection Check which medicines on a tracer list of key medicines needed to treat or prevent HIV-associated opportunistic infections and other illness are actually in stock (any amount will do as long as it is in stock and in date).

Computation (Number of medicines on tracer list in stock /number of medicines on tracer list) × 100.

Comments Need to prepare tracer list of up to 10 key medicines.

Chapter 3

Indicators for possible determinants of adherence

17

Without medicines, no successful treatment is possible. Even if there are no stock cards or

records, it is always possible to see the medicines that are present on the day of the data

collection. Because some facilities do not treat children and some do not treat adults, there

are two separate lists of key ARVs that need to be decided on. It is also vital to treat

opportunistic infections as they occur, so a third list of medicines for the most frequent

opportunistic infections needs to be developed.

On the day of data collection, if there is any amount of each of the specified drugs present

and in date, then the drug will be recorded as present.

ARV availability over the last 90 days

4. The percentage of days each medicine on a list of adult ARVs has been in stock in the

last 90 days.

5. The percentage of days each medicine on a list of child ARVs has been in stock in the

last 90 days.

Rationale Failure to maintain continuous availability of ARVs can be a barrier to patient confidence and long-term adherence.

Source of data Pharmacy stock records.

Data collection Check stock records for each medicine on adult and paediatric ARV list to determine the number of days in stock in the previous 90 days (any amount will do as long as it is in stock and in date).

Computation (Number of days that medicine was in stock in last 90 days/90) × 100.

Calculated separately for each listed medicine.

Comments Need to prepare tracer list of up to 10 first line adult and paediatric ARVs.

By looking back over the last 90 days for each medicine on each of the three lists, one gets a

longer term perspective on drug availability than just looking on the day of data collection.

However, it means that a good system of record keeping or stock cards is needed and so the

information may not be as reliable.

6. Key medicine availability over the last 90 days—The percentage of days each

medicine on a list of key medicines for HIV-associated illnesses has been in stock in

the last 90 days.

Rationale Failure to maintain continuous availability of key medicines needed to treat HIV-associated illnesses can be a barrier to patient confidence and long-term adherence.

Source of data Pharmacy stock records.

Data collection Check stock records for each medicine on a tracer list of key medicines to determine the number of days in stock in the previous 90 days (any amount will do as long as it is in stock and in date).

Computation (Number of days that medicine was in stock in last 90 days/90) × 100.

Calculated separately for each listed medicine.

Comments Need to prepare tracer list of up to 10 key medicines.



18

Health facility accessibility and infrastructure

7. Extent of clinic hours—Number of hours clinic is open per week for routine AIDS

care.

8. Convenience of clinic hours—Whether clinic is open at least one evening or weekend

day for routine AIDS care.

Rationale If the facility opening hours correspond to the patient’s life or work schedule, then adherence to appointments is easier.

Source of data Facility manager and patient interview.

Data collection On the day of data collection, ask the facility manager which days and times the clinic is open for routine AIDS care (including clinical treatment of AIDS patients and dispensing of ARVs). Verify with patients during patient interviews.

Computation Extent of hours—Total number of hours clinic is routinely open for AIDS care.

Convenience—If clinic is open at least one evening or weekend day.

Comments The manager may claim longer opening hours than are actually so in routine practice. Patient interviews can help to verify the information provided.

The more the clinic is open the greater the convenience for the patient. This is particularly

true if the patient is working on week days where a clinic time in the evenings or weekends

would make attendance much easier. If the clinic is only open one day a week and if the

patient misses that day, they have to wait seven days until the next opportunity.

9. Clinician patient load—Average number of AIDS patients seen per clinician hour.

Rationale Heavy patient volume can be a barrier to communication and adherence.

Source of data Attendance records and interview with health facility administrator.

Data collection Determine how many patients were seen for consultative clinical visits during

the previous month; also, determine the number of hours spent in clinic during the month by all the clinicians who provided these consultative services.

Computation Number of patients seen for AIDS consultative services in last month (both on ART and not on ART)/total number of hours worked by clinicians who provided

these consultative services.

Comments It may be hard to distinguish which visits are for AIDS consultative care and to determine which clinicians actually worked which hours; if necessary, compute the indicator based on the last week although this may be less representative.

In practice, the clinic may be open much less than it is in theory. For example, many clinics

may theoretically be open all day, but in practice they may start late and finish by lunchtime.

This means that during actual working the clinic is very busy and that only a little time can

be given to each patient whereas if the patients were really able to attend during the

theoretical working time, there would be much more clinician time per patient.

In each of the four feasibility surveys, the number of patients per clinician hour was around

two. This is much lower than expected because in practice all the work was crammed into a

few hours. However, in the busiest clinic the number was as high as 17 and in the least busy

Chapter 3


19

clinic as low as one patient every five hours. This therefore becomes a useful discussion

point for interventions in conjunction with the work load of the support staff and the

following patient care indicators of waiting time.

10. Support staff patient load—Average number of AIDS patients per week per support

staff.

Rationale The more staff that are present to provide social and emotional support, the more likely the patient is to receive personal care and adherence support.

Source of data Facility manager and observation.

Data collection At the time of the visit ask about the number and type of staff routinely present

for support services (adherence counselling, social and emotional counselling). Count the number of staff present during data collection to verify. The number

of AIDS patients seen for consultative care per week is determined by looking in the attendance register (if there is a register present) for the last four weeks and dividing by four.

Computation Number of patients seen for AIDS consultative services in last week (both on ART and not on ART)/number of support staff.

Comments It may be more accurate to ask to see a roster of all staff and their hours for a week if this is available.

It is important to only count each staff person once. For example, if a nurse does counselling and dispensing as well as nursing, this only counts as one staff member.

11. Presence of private space for counselling—Whether facility has a private space

available for adherence counselling.

Rationale A private space for counselling makes it more likely that patients can

communicate openly and honestly with the counsellor. Private space does not necessarily mean a separate sound proof room. In practice, privacy means that the conversation cannot be overheard.

Source of data Facility interview and observation.

Data collection At the time of data collection, ask whether the facility has any private space for counselling and observe whether or not it is actually in use.

Computation Presence of actively used private space for counselling (Yes/No).

Comments Need to agree on a definition of what constitutes adequate privacy in a given setting.

Private space does not necessarily mean a separate sound proof room. In practice, privacy

means that the conversation cannot be overheard. In many crowded clinics this may be a

quiet corridor or the far side of a room, but these spaces may not be available. In the four

feasibility studies, the results of the number of facilities which provided access to private

space varied between 13 and 19 out of 20 facilities sampled.



20

12. Presence of laboratory— Does the facility have access to a functioning laboratory

system for measuring CD4 counts or viral loads so that results can be ready for the

patient's next routine visit?

Rationale A functioning laboratory that can measure CD4 counts or viral loads in or near the facility or within the programme makes it more likely that these clinical markers will be monitored on a regular basis, which can promote discussion about adherence.

Source of data Facility interview and observation.

Data collection At the time of data collection, ask whether the facility has a functioning

laboratory on-site, within the programme or within a five-minute walk that can produce CD4 or viral load results in time for the patient's next routine visit and

whether the test or transport would cost the patient anything.

Computation If the laboratory is functioning and provides the test and transportation for free,

then record Yes. Otherwise, record No.

Comments Laboratory needs to be functioning on the day of data collection

Some facilities have access to a laboratory in a central facility within their programme and

may either take blood to send to the facility or send the patient to the central facility for

testing. From the patient’s point of view, the first option is much easier and less time

consuming. If patients have to pay for their own transport, many may not be able to afford

it. This then would not be defined as access.

13. CD4 and viral load testing rate.

Rationale Increase in CD4 count over time is an indirect measure of success in controlling HIV; routine testing for CD4 can assist in adherence monitoring.

Source of data Facility interview.

Data collection While doing the facility interview, ask about the intended frequency for CD4 and viral load tests and whether the intended frequency is met.

Computation CD4 testing rate—The stated number of months between routine CD4 tests for each patient.

Viral load testing rate—The stated number of months between routine viral load tests for each patient.

Comments Not all facilities do routine CD4 counts or viral loads for all patients. Many facilities may claim to do them routinely but in fact do not. This method does not allow for checking this.

Chapter 3


21

14. ARV dispensing rate—Percentage of patients who had all prescribed ARVs dispensed

at the health facility.

Rationale Failure to dispense, during the patient visit, all ARVs that were prescribed is a primary barrier to adherence.

Source of data Patient exit interviews.

Data collection For sample of 30 patients attending on day of data collection (or all patients if

< 30 attend that day), check to see if all ARVs prescribed were dispensed.

Computation (Number of patients dispensed all ARVs prescribed/number of patients surveyed) × 100.

Comments Need to ask if patients were told to fill prescription outside of health facility or

to return earlier than usual to pick up additional ARVs.

15. Non-ARV medicines dispensing rate—Percentage of patients who had all prescribed

medicines dispensed at the health facility.

Rationale Failure to dispense during the patient visit all non-ARV medicines prescribed can

contribute to overall low adherence.


Data collection For sample of 30 patients attending on day of data collection (or all patients if <

30 attend that day), check to see if all non-ARV medicines prescribed were dispensed.

Computation (Number of patients dispensed all non-ARV medicines prescribed/number of patients surveyed) × 100.

Comments Need to ask if patients were told to fill prescription outside of health facility or to return earlier than usual to pick up additional non-ARV medicines.

16. Proper medicines labelling—Percentage of patients for whom all medicines dispensed

are adequately labelled.

Rationale Proper labelling of all medicines promotes better knowledge about their use and is essential for patient safety.


Data collection Based on a sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day—For each medicine, the labelling on the container in which they were dispensed must contain name of medicine, how many times a day to take medicine, and how much to take each time.

Computation (Number of patients with all dispensed medicines labelled correctly/number of patients assessed) × 100.

Comments Medicines must each be dispensed in a separate container (pill bottle or envelope), and each container must contain at a minimum the three items of

labelling assessed.

These items all are important for whether the patient can take the medicine regularly as

prescribed.



22

Record keeping

17. The percentage of facilities with a functioning clinic attendance register showing all

patients who visited each day.

18. The percentage of facilities with an appointment book or other appointment system

showing all patients due for clinic attendance each day.

Rationale Without a system to know who is expected and who has already kept their appointment, it is impossible to monitor whether patients have come when

they were scheduled, and therefore not possible to contact them and remind them of their missed appointment.


Data collection While doing the facility interview ask to look at the appointment and

attendance and appointment systems and check for whether it is being used successfully on the day of the interview.

Computation Clinic attendance register—The presence of a functioning clinic attendance register.

Appointment book—The presence of a functioning appointment book system.

Comments It is important to check whether the system is functioning. It would help to ask who is expected at the next clinic day, who came yesterday, and how many failed to turn up yesterday? If these questions can be answered easily, the system is working.

Patient care indicator determinants

Information and communication

17. Patient knowledge of ARV regimen—Percentage of patients who know when to take

each of their ARV medicines and how much to take each time.

Rationale Detailed knowledge of the correct ARV regimen is essential to adherence.

Source of data Patient exit interviews

Data collection Based on a sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day)—For each ARV in treatment regimen, ask

―Could you please tell me how many times a day you take this medicine, how much you take each time, and whether you take it before or after eating or with your meal?‖

Computation Number of patients knowing all three aspects of all ARVs/number of patients asked) × 100

Comments Need to determine correct treatment regimen for all ARVs used.

This is asked during the exit interview leading up to the self report on missed doses over the

last three days. So for each ARV in turn the interviewer asks the patient "when are you

meant to take this medicine?" and then asks ‚and in the last three days have you missed any

of your doses?‛

Chapter 3


23

Cost to patient in time and money

18. Patient waiting time—Average amount of time patients spend in the facility during a

visit.

Rationale If patients have to spend a long time at the facility each time they have an appointment, they are less likely to be motivated or able to continue to attend

appointments.

Source of data Patient exit interview

Data collection Based on a sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day)—Ask when they arrived at the facility today

and calculate the number of minutes between then and the time of leaving. In addition, record which services the patient received (clinical examination, laboratory test, adherence counselling, social service counselling, pharmacy dispensing)

Computation Sum across patients of number of minutes from entering the facility to leaving/number patients asked

Comments The arrival time may be approximate as people may not know. It can be asked

in relation to the clinic opening time. An alternate would be following a number of patients through from arriving to leaving.

19. Patient travel time to care—Average amount of time spent travelling to health facility

to receive care.

Rationale Length of time spent travelling to receive care can be a barrier to adherence.

Source of data Patient exit interviews

Data collection Based on a sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day)—Ask how many minutes it took for the patient to travel to the health facility for this visit

Computation Sum across patients of number of minutes travelled for this visit/number of patients assessed

Comments The departure time and arrival time may be approximate as people may not know. It can be asked in relation to dawn or a cultural event such as an early prayers ceremony and the clinic opening time. The time should be recorded in minutes.

In some cases, patients may travel the day before to get near the clinic, perhaps to stay with

a relative. They may take the opportunity to do a little business such as selling produce. In

this case the travelling time should be included, but not the time spent in the vicinity.



24

20. Patient travel cost for care—Average cost spent travelling to health facility to receive

care.

Rationale Cost of travelling to receive care can be a barrier to adherence.


Data collection Based on a sample of 30 patients attending on day of data collection (or all patients if < 30 attend that day)—Ask how much it cost (in local currency) for

the patient to travel to the health facility for this visit.

Computation Sum across patients of cost of travelling to care for this visit /number of patients assessed.

Demographic indicator determinants

1. Average age of the patients.

2. Gender—The percentage of patients who are female.

Rationale Age and gender may both affect adherence.

Source of data Pharmacy notes.

Data collection These can be noted while checking the 100 sampled patient records for the adherence and defaulting indicators.

Computation Age: Sum all ages in years divided by number of patients.

Gender: (Sum all female patients divided by sum all patients) ×100.

4

25

CHAPTER 4 --- Survey design

Sampling facilities

Carrying out a survey of these indicators could be done in a single facility or in a sample of

facilities. A survey to examine adherence in a large programme or system of care, such as

the National AIDS Programme, should include a minimum of 20 health facilities. If a system

of care includes fewer facilities, then all of them should be included in a survey to measure

system performance. A survey in a single facility only reflects the performance in that

facility so it cannot be used to represent the performance in the country (unless it is the only

facility providing treatment).

Facilities are best selected randomly within specific strata defined by key characteristics

such as geographic location, facility type and facility management. The sample of facilities

should be as randomly chosen as is feasible, taking into account the logistics of travel and

the days the clinics are open.

The retrospective sample of patients is 100, so that it is preferable to only choose facilities

that had at least 100 patients on ARVs six months ago. However, if one wants to look at

smaller facilities, this can be done but instead of sampling, all patients’ records should be

looked at.

The data to calculate each indicator should be collected at each facility. The sample sizes

suggested are sufficient for a moderately reliable set of adherence measures at each facility

(such as when monitoring performance over time) and a very reliable cross-sectional or

longitudinal estimates of these measures in the system as a whole.

Sampling retrospective patient records

The purpose of this exercise is to give us all the adherence indicators except the self report of

the exit interview. As such it is the single most important exercise of the survey.

Retrospective data from attendance records and pharmacy records are useful because they

allow computation of indicators related to success of short-term and long-term adherence,

defaulting, and clinical outcomes. It is necessary to take a sample of 100 patients who

attended the clinic during the month seven months before. To end up with information on

100 patients, it is advisable to sample 120 patients from the list of those who attended during

that month as some records may be unavailable.



26

This means that if the data collection is taking place in June, you need the patients who

attended in November the year before. This is because you need to follow the patient for six

whole months and if the patient attended on the last day of November, then six months

from then would be the last day of May. Depending on the month of data collection, the

months to sample patient attendance from is documented in Table 6.

Table 6. Attendance months to retrospectively sample and the month to

look at for judging the attendance of the next appointment

Survey data collection

month

Retrospective sample for

those patients attending 7 months before, during the

previous month of:

For looking at attending next

appointment start with visit 4 months before in the

previous month of:

January 2008 June 2007 September 2007

February 2008 July 2007 October 2007

March 2008 August 2007 November 2007

April 2008 September 2007 December 2007

May 2008 October 2007 January 2008

June 2008 November 2007 February 2008

July 2008 December 2007 March 2008

August 2008 January 2008 April 2008

September 2008 February 2008 May 2008

October 2008 March 2008 June 2008

November 2008 April 2008 July 2008

December 2008 May 2008 August 2008

Retrospective sampling methods

If present, the pharmacy or clinic attendance register is the primary source of data for

identifying patients in treatment who attended in the required month.

Situation 1.

Functioning attendance register and patient identification numbers

If there is an attendance register that distinguishes between those on ART and those not on

ART, and if a patient identification number is recorded there that can be used to find the

relevant clinical and pharmacy records, the following method can be adopted. If there is a

register in the pharmacy, then this is preferable as it will be the pharmacy records that are

being examined.

The sample of visits should be spread evenly across the month. Simple or systematic

random sampling is acceptable. For example, if there were 300 patient attendances of

patients on ART during that month and you want to choose 120, then to find the sampling

interval you can divide 300 by 120 to get 2.5. Then randomly take the first or second patient

on the list and alternately take every second and third patient. Take the Patient Selection

Chapter 4

Survey design

27

Sheet (Appendix 2) and fill in each patient identification number and the date of the visit for

a hundred and twenty patients.

Alternatively, if for example there are 30 pages of patients, then it is quite acceptable to

choose randomly four patients per page (120/30) taking one near the top, two near the

middle, and one near the bottom.

Figure 1. Flow chart of decision making for how to sample retrospective

patient records



28

Situation 2.

There is an attendance register, but it does not distinguish between those on ART and those not on ART; however, there is an ART initiation register

In this situation, another method has to be found. As a last resort, this may include sampling

many more than 120 from the attendance register to end up with 100 patients on ART. In

many facilities, most patients are seen every month. If this is the case, then one can use the

register of ART initiation. Count all the patients who have initiated ART from when the

clinic started to up to the end of the month you are sampling. The sample of patients should

be spread evenly across the time of initiation.

Situation 3. There is no attendance register and no ART initiation register, but patient identifier number is in order of initiation

You need to check how the pharmacy and clinical notes are stored. It may be that they are

stored by patient identifier numbers and that the numbers correspond to the order of ART

initiation (the first patient to receive ART is number one, the second number two, etc.). If

this is the case, then you need to determine the identification number given to the last

patient starting ART at the end of the month for which you are interested, and sample all

patients who had started before then.

Situation 4. There is no attendance register, and no ART initiation register. The patient

identification numbers are not allocated in order of ART initiation

You need to check the total number of patients on ART now and the total number that were

on ART seven months before and then sample from all patients. The number sampled

should correspond to the proportion that had started before the end of the month you are

interested in. For example: if now there are 750 patients on ART and seven months ago there

were 500. To find a hundred patients who had initiated before seven months ago, you will

need to sample at least [(750/500) * 100] patients which is 150. It would be safer to sample

200.

Conclusion

Any set of circumstances may be met in practice. Based on experience to date (after

80 facilities in 4 countries), it has been possible to devise a sensible system for sampling

records. You may need to be creative. The key is to understand the recording and storage

systems for both the pharmacy records as well as the attendance register information.

Chapter 4

Survey design

29

Sampling for exit interviews

At each facility it will be necessary to interview patients as they leave. The last point of call

for the patient is usually the dispensary. It is challenging to find a suitable place for the

interviews because it should be:

Close to the dispensary.

Afford adequate privacy.

Allow interviewer and interviewee space to sit down.

Have enough space so that more than one interview at a time can be conducted.

Therefore one of the first activities is to find a suitable space for these interviews.

The sample of patients is a convenience sample. The aim is to interview 30 patients who are

on ART (except those who started on the day of data collection). If there are less than

30 patients that day then all should be interviewed. If there is a rush of patients, more than

one data collector should be assigned to interview them to avoid unnecessary delay to the

patient.

In order to know which patient is on ART and should therefore be interviewed, it is useful

to ask the dispenser to request relevant patients to go for the interview.



30

5

31

CHAPTER 5 --- Data collection tools and how to

modify, print and fill them in

The information in this chapter is organized according to this structure:

NB: In this chapter, words in italics represent text that is shown on screen.

Overview

The data entry suite consists of three main forms, each storing information about the

following elements:

Facility

Retrospective dispensing data

Exit Interviews

It is recommended that the facility questionnaire is entered first because the system relies

upon being able to identify the facility by a facility ID.

Data Collection

Overview

Customization

Printing data entry sheets for data collection

Filling in the Forms

Facility Questionnaire Retrospective Dispensing Data Exit Interviews

Second Data Entry

Consolidation

Some comments about workflow

Accessing the data entry forms



32

It is a requirement that data entry is completed twice for each form; as the user enters data a

second time, it is verified against the first entry and discrepancies are highlighted and can be

amended by the user.

Before data are collected it is possible to customize the suite to suit the facilities relevant to

your work.

Before data are collected you may print the relevant empty forms to use in the data capture

exercise.

At the end of the data entry the records entered are consolidated and summarized for

reporting purposes.

Customization

The first thing you will need to do is to customize the forms you are about to use. This

includes:

a) Formulating and entering the three medicine lists of up to 10 each of your country’s

first line adult and paediatric ARVs and key medicines used for opportunistic

infections.

b) Adding the list of types of health facilities and hospitals relevant to your survey.

c) Adding the names of regions of your country or area from which you sampled.

d) The types of facility management in your area, such as government, NGO, faith-

based, etc.

e) The different sources of supplies of ARVs, such as government, PEPFAR, the Global

Fund, etc.

f) Location names. The default values are urban and rural, but could be whatever is

suitable for your area or country.

To customize your form, find the file named: ‘Questionnaires.xlt’ in your list of objects and

using your mouse right click on the file; select the option to open it.

Chapter 5

Data collection tools and how to modify, print and fill them in

33

When you open the file you will see the following display:

This is the Macro Warning Sheet and it appears each time you enter the application. Its

purpose is to ensure that you enable those macros and other components necessary, but

without violating the security of your PC. There are instructions on this sheet that you can

read to guide you.



34

Follow the instructions on the Macro Warning sheet; that is, select the button Options (circled

in the image above) in the ribbon panel. You will be presented with a display that looks like

this:

Select the option to Enable this content:

Chapter 5


35

The INRUD Control form will be shown.

Enter your password here into the field provided and select Open.

The password is ‚INRUD‛.

A message will be displayed. When you have read it, select OK.



36

You will be taken to the Country Customization sheet. It looks like this:

Regions Location Name ADULTS ARV First Line Abbreviation CHILDREN ARV First Line Abbreviation Drugs for Opportunistic Infections

Teaching Hospital TH Northern Government Gov Government Gov Urban 1 Lamivudine 150mg tab 3TC 1 Efavirenz 50 mg or 100mg tab EFV 1 Cotrimoxazole 480 mg or 960 mg tab

Referral hospital RH Southern Private Priv Global Fund GF Rural 2 Stavudine 40 mg tab D4T 2 Efavirenz 30mg/ml syrup EFV 2 Cotrimoxazole 240mg/5ml susp

Zonal Hospital ZH Eastern Mission FBO PEPFAR PEP 3 Stavudine 30 mg tab D4T 3 Nevirapine 10mg/ml syrup NVP 3 Fluconazole 150 mg or 200 mg tab

District Hospital DH Western Other NGO NGO NGO NGO 4 Nevirapine 200 mg tab NVP 4 Lamivudine 10mg/ml syrup 3TC 4 Miconazole Gel

Other Hospital OH Central Other Other Other Other 5 Efavirenz 200 mg tab EFV 5 Zidovudine 100 mg tab ZDV 5 Erythromycin 250 mg or 500 mg tab

Health Center or Clinic HC 6 Efavirenz 600 mg tab EFV 6 Zidovudine 10 mg/ml syrup ZDV 6 Nystatin 10,000 IU/ml oral drops

7 ZDV 300 mg tab +3TC 450 mg tab ZDV,3TC 7 Stavudine 15mg tab D4T 7 Acyclovir 200 mg tab

8 8 Stavudine 20 mg tab D4T 8 Acyclovir 5% Cream

9 9 Stavudine 1mg/ml syrup D4T 9 Folic Acid 5mg tab

10 10 10

7 9 9

Facility Types Facility Management Supply Sources

Make changes to the columns as you wish to make it most appropriate for your location. In

particular, the medicine lists may need to be compiled according to local standard treatment

guidelines.

When maintaining the data in this sheet, please ensure that you only modify data within the

designated boundaries.

Adapting other forms

There are a number of forms that you may wish to consider for customization. The full list is

available in Appendix 2E. The forms may need adapting for the particular circumstances

being surveyed. The exit interview questions will need to be translated into the appropriate

local languages. This can be done during data collection training. Exit interview forms are

listed separately in the appendix.

Saving and exiting

When you have completed customizing the data, save your changes to the template. Do this

by clicking on the save icon in the banner:

Chapter 5


37

Lastly close the template document. Select the Office Button with a left click.

You will see the following list of options. Select the option to Close.

Accessing the data entry forms

The techniques for opening a document for printing data entry sheets and opening the

document for data entry are the same. For either of these tasks, right click on

Questionnaire.xlt file name in Windows Explorer and select the New option or using your

cursor double click on the file name as it appears in the list of items in your folder:



38

You will see this display:

This is the Macro Warning Sheet and it appears each time you enter the application. Its

purpose is to ensure that you enable those macros and other components necessary, but

without violating the security of your PC. (The security warning here is different from that

displayed when customizing the questionnaire.)

The next step is to select the Options button (circled in the image above) from the security

warning message. This will cause the following window to be shown:

Chapter 5


39

Select the option to Enable this content and press OK.



40

Control form

The INRUD Control form will be shown.

This form is used for a variety of purposes, one of which is to control the data entry and to

give you a quick view as to what remains to be entered for this facility.

Form printing section

Save & close

options

Main control section for entry of collected data

Reminder: how to access

customization

Form name

First Entry access & control

Second Entry

access & control

Tick boxes indicating

completion of data entry

Chapter 5


41

Printing data entry sheets for data collection

A number of different forms may be printed in preparation for collecting the data. From the

INRUD Control form, enter the number of copies you want to print and select the form you

require. To select the printer to use and to set up the document properties, select the Print

options button.

Enter the number of copies to print and then click onto the form you would like to print.

You will then see the Print dialog form. This is a standard Microsoft Excel dialog box and

you may make changes as required



42

After printing, photocopy the number of forms you need, ensuring back-to-back copying

where relevant:

1. Facility questionnaire: sides 1 and 2 should be photocopied back-to-back and side 3

on a separate sheet of paper.

2. Exit interviews: this should be on one piece of paper; sides 1 and 2 back-to-back.

3. Retro dispensing data: for this form there are eight sheets altogether. You are

requested to complete 100 records, if possible. Data for patients 1-25 should be back-

to-back and will take up two pages. Similarly for the two forms with patients 26-50,

51-75, and 76-100.

Quantities of forms needed:

You will require forms for the following purposes:

For training data collectors:

You will need at least two of each form for each participant while training.

For data collection:

For data collection it is helpful to have enough forms for everyone to work on and

one spare set for the facility manager in case they would like them.

Types of forms:

For the facility interview:

You should only need two per facility: one for the team leader to do the interviews

and one for the facility manager if needed.

For the exit and retrospective forms:

It is helpful to have one per data collector per facility and one more for the facility

manager.

Filling in the forms

Filling in the facility questionnaire form

Several questions gather data about the infrastructure at each health facility. These include

the presence or absence of a private space for counselling and a laboratory for CD4 or viral

load testing. In addition, since consistent availability of medicines is a key determinant of

adherence, several indicators measure the current and recent availability of ARVs and other

key medicines to treat or prevent HIV-associated illnesses. The way to do this is to interview

the facility manager and pharmacist, visit the pharmacy and look at the attendance register,

if available, and fill in the facility data collection form.

Chapter 5


43

Preparing for the facility interview

Before carrying out the interview, it is necessary to compile three lists of medicines and

doses, each with up to 10 medicines and formulations:

Key ARV medicine for adults with dose and formulation.

Key ARV medicine for children with dose and formulation.

Key non-ARV medicines that should be present in every facility.

For the ARV medicines, decisions have to be made on which medicines should be present in

all clinics. Therefore, first-line treatments should be included. Second-line medicines should

only be included if all facilities are expected to stock them. The paediatric list should only be

filled in if the clinic treats children with ARVs.

Sample lists are included in the document ‚Questionnaires.xlt‛ and can be

modified/adapted to local conditions via the customization section see Customization earlier

in this chapter.

Table 7. Sample list of needed adult ARVs

Adults ARV first-line drug Abbreviation

1 Lamivudine 150 mg tab 3TC

2 Stavudine 40 mg tab D4T


4 Nevirapine 200 mg tab NVP

5 Efavirenz 200 mg tab EFV

6 Efavirenz 600 mg tab EFV

7 ZDV 300 mg + 3TC 150 mg tab ZDV, 3TC

8

9

10



44

Table 8. Sample list of needed paediatric ARVs

Paediatric ARV first-line drug Abbreviation

1 Efavirenz 50 mg or 100 mg tab EFV

2 Efavirenz 30 mg/ml syrup EFV

3 Nevirapine 10 mg/ml syrup NVP

4 Lamivudine 10 mg/ml syrup 3TC

5 Zidovudine 100 mg tab ZDV

6 Zidovudine 10 mg/ml syrup ZDV



9 Stavudine 1 mg/ml syrup D4T

10

The list of expected non-ARV medicines will depend on the system. That list would also

depend on the most common opportunistic infections and co-morbidities. If the non-ARV

medicines present in a hospital pharmacy are different than for the ART clinic, those

medicines would not be counted as being present.

If the stock records are incomplete, it may be difficult or impossible to know the number of

days that each medicine has been in or out of stock in the last 90 days. The pharmacist,

however, may know if there have been any stock outs, in which case you can just ask

whether there have been any stock outs in the last three months for each medicine.

Table 9. Sample list of key non-ARV medicines

Key non-ARV drugs

1 Co-trimoxazole 480 or 960 mg tab

2 Co-trimoxazole 240 mg/5ml susp

3 Fluconazole 150 mg or 200 mg tab

4 Miconazole 20 mg/g oral gel

5 Erythromycin 250 mg or 500 mg tab

6 Nystatin 10,000 IU/ml oral drops

7 Aciclovir 200 mg tab

8 Aciclovir 5% cream

9 Folic acid 5 mg tab

10

Chapter 5


45

For a view of the Facility questionnaire see Appendix 2D.

Type in the shaded boxes only.

Questionnaire side one

As for the other forms, fill in the facility identifier, the date of data collection, the data

collector’s name, and the facility name.

Facility identifier

Date

Data collector

Region

Name facility

Q1 Facility type

Q2 Facility management

Q3 Supply source ARVs

Q4 Clinic location

Q1. Fill in the type of facility from the drop-down list. These options were defined on the

Country Customization sheet.

Q2. Fill in the type of facility management from the drop-down list. These options were

defined on the Country Customization sheet.

Q3. Fill in the source of ARVs for the facility from the drop-down list. These options were

defined on the Country Customization sheet. You may enter two sources.

Q4. Fill in the facility setting from the drop-down list. These options were defined on the

Country Customization sheet.

Q5. Fill in the number of hours the clinic and ARV pharmacy is open each day. The

opening hours of the clinic and pharmacy may be different, if so, fill in both;

otherwise just fill in the clinic hours.

Opening hours CLINIC

Days Number of hours

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

Total hours =



46

Opening hours PHARMACY

Days Number of hours

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

Total hours =

Q5b. Check whether these hours have changed in the last six months because we are

looking at retrospective records over the last six months (for example, the clinic may

have only been open one day a week and is now open five). Answer Y/N.

Q5c. If the hours have changed, explain the difference.

Q6. Is the clinic open at a convenient time? Answer Y/N.

A weekend or evening clinic would be easier to attend for those in regular employment. We

define open as at least a two-hour session. This must be on Saturday or Sunday or in the

evening after 5 p.m.

Q7. You must see the attendance register. Check on how well it was filled in for the last

clinic day. If well filled in, answer yes, otherwise no.

Q8. You must see the appointment book. Check for who is expected on the day of data

collection. Check whether you can see if everyone who was due on the last clinic day

attended or not. If well filled in, answer yes, otherwise no.

Q9. Fill in the number of patients seen in a week.

The number of patients with HIV/AIDS seen in a week should include all AIDS patients, not

just those on ARVs.

The number should be found from records, not just from what the manager estimates. Check

the register for the number in the last 4 weeks (28 days) and divide by 4 to get average

number per week. If numbering is a problem, count for last complete week only.

Q10. Write down the number of clinicians present at a typical clinic.

Calculating the number of doctors or clinical officers in a normal clinic presents some

complications:

They should only be counted if they are seeing HIV/AIDS patients (not general

patients).

One difficulty is to decide who to include as a doctor or clinical officer. If

nurses are doing triage or prescribing, then they should be included.

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47

If a different number attend on different days or parts of days, add up the

number for each clinic and divide by the number of clinics.

o Example 1—If there are four days when there are two doctors or clinical

officers, and on the fifth day, two extra specialists attend, then we would

add up each day and divide by five. This would be (2 + 2 + 2 + 2 + 4)/5 =

12/5 = 2.4.

o Example 2—There are three mornings when there are three doctors or

clinical officers, two mornings with two doctors, and every afternoon

there is one doctor. Then this would be 10 sessions (5 morning sessions

and 5 afternoon sessions) with (3 + 3 + 3 + 2 + 2 + 1 + 1 + 1 + 1 + 1 + 1)/10 =

19/10 = 1.9.

o Example 3—If there are four doctors or clinical officers present for two

days, and one for three days the number would be (4 + 4 + 1 + 1 +

1)/5=11/5 = 2.2.

Then the calculation for the number of patients per clinician per hour is (number of

patients seen in a week) divided by (number of clinicians in an average clinic x the

number of hours the clinic is open in a week). (This will be calculated automatically

when the data are entered).

Q11. The purpose here is to find the number of non-clinicians who work in an average

clinic. If one person does more than one job, it is important to only count them once.

So, if a nurse also does counselling, then s/he should only be counted once. If the

person works in the community and not in the clinic, s/he should not be counted but

should be mentioned below. Only paid professional staff based in the facility should

be counted, so this does not include cleaners, for example.

How many of the following staff working directly with HIV/AIDS patients

do you have during a normal clinic?

(count one staff only once)

(Check while in the clinic)

Number working

nurses

social workers

nutritionist

counsellors

pharmacists

pharmaceutical technologist

other (specify)

Total

Then the calculation for the number of HIV/AIDS patients per week per support staff is

calculated by dividing the number of patients in a week by the number of support staff.

(This will be calculated automatically when the data are entered).

Questionnaire Side Two

Q12-14 For each question, enter Y/N—You must be able to see a copy of each of the guidelines

asked for to mark a yes—it is not enough to be told there is one.



48

Q15. If the manager says a guideline is followed to start a patient on ART, then write Y

and name the guideline in the next square. Otherwise write N.

Q16. Ask how many days supply of ARVs are usually given to patients during their first

month of treatment.

Q17 Ask how many days supply of ARVs are usually given to patients after their first

month of treatment.

Q18. Mark Y for all that apply.

Q19. Mark Y for all that apply.

Q20. Answer Y/N—The definition of a private space is where a conversation can be had without

being overheard.

Q21-22 Ask whether the programme provides child care, food for patients on ART, and has a

formal system for linking patients with support of another person on ART. Answer

each Y/N or S (sometimes).

Q 23 Ask whether the programme has formal links with the community such as churches

or other organizations. Answer Y/N.

Q24-25 Because there are so many different laboratory systems the two questions to ask are:

Do you have a functioning laboratory system for measuring CD4 counts, so that

results can be ready for the patient's next routine visit? Answer Y/N.

Is both the test and transport for the test free for patients? Answer Y/N.

The laboratory must be working and active that day. If it is not functioning then it does not

count.

If both Q24 and Q25 are Y, then the indicator of whether there is access to a laboratory for a

CD4 count will also be Y. Otherwise the indicator will be N.

Q26–28 Remember that the lists of medicines need preparing in advance. The ones given here are

only suggestions.

There are three columns for each of the three lists of drugs. The principles for filling in the

three tables are the same.

The present Y/N column

For the present column, the drugs must be available and in date. It does not matter how

many of them there are.

For the number (#) of days in stock in last 90 days column

Chapter 5


49

For each formulation of each medicine mentioned it is necessary to look at the stock cards

for the last 90 days and see how many of these days the drug has been in stock and mark

that in the appropriate column.

Any stock outs in the last 90 days

If the stock records are incomplete, it may be difficult or impossible to know the number of

days each medicine has been in or out of stock in the last 90 days. However, the pharmacist

may know if there have been any stock outs. Therefore if the number of days in the last 90

days is impossible to find for each medicine, ask the pharmacist or dispenser whether there

have been any stock outs in the last three months and answer Y/N.

The calculations will be done automatically when the data are entered into the spreadsheet.

Filling in the retrospective dispensing data

The data for filling in this form will normally have to be taken from pharmacy records. The

clinical records may have the number of days prescribed, but will usually not include actual

dispensing. However, if there are no coherent pharmacy records the prescribed data may

suffice. It is necessary to find the date and the number of days of ARVs dispensed. If the

patient is on more than one ARV and they are given for a different number of days, take the

one with the least number of days dispensed.

Filling in the forms

Take the Retrospective Dispensing Data form. Each page has space for 25 patients, one

patient to each row. To fill in information on 100 patients, 4 forms will be needed. The

retrospective data collection form can be seen in Appendix 2A.

On the written form, first, fill in the top of the form with the most important information:

The date of data collection.

Facility name and number.

The data collector’s name.

Each column of the form has a letter above it, and directions for each column will be given in

turn.

A B C D E

Seq. No. Patient identifier Age in years at index visit

Gender M/F

Date initiation ARVs

1



50

Column B

For each patient always start by writing the patient identification number down. If it is

necessary to turn the sheet over make sure to again write the patient identification

number down on the relevant row. This helps avoid getting rows confused.

Column C

Find the age of the patient in years at the index visit. If the patient is a child, make sure

the age is in years and NOT months. If the child is younger than two years old, take the

age to the nearest six months (0.5, 1, 1.5, 2). Otherwise, take the age in years.

Column D

Write the gender of the patient as M for Male or F for Female.

Column E

Find the date ARVs were initiated and write down the date in (dd/mm/yy) format. It is

important to write down a date here because many calculations depend upon it. If you

cannot find an exact date, write down a date that is approximately correct.

G H J K N O

Index visit dispensing Visit 2 dispensing Visit 3 dispensing

Index visit Date any ARV

drugs dispensed

(dd/mm/yy)

# days of ART

dispensed on that day

Date any ARV drugs

dispensed (dd/mm/yy)

# days of ART dispensed on

that day

Date any ARV drugs

dispensed (dd/mm/yy)

# days of ART dispensed on

that day

Column G

The index visit date is the date the patient had medicine dispensed in the month seven

months ago, which was the date the patient was selected for (as in Table 2). Write down

the date in dd/mm/yy format (for example, 12 March 2004 would be 12/03/04).

Column H

Write down the number of days of ARVs dispensed. (Note: Do not write down the

number of pills. Write the number of days of pills dispensed.)

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51

Columns J and K

Write the date of the next visit and the number of days of pills dispensed.

Columns N and O

Write the date of the next visit and the number of days of pills dispensed.

Continue to write down these details for each visit up to the present day. Normally it will be

7 visits or fewer but there are spaces for 12 visits in case it is necessary. When you turn over

the form, do not forget to write the patient identification number on the second side.

Now look at the patient attendance four months ago as shown in Table 6 and look at the

appointment the patient was given at that time at that attendance. If the data collection is in

April 2008, look to see if the patient attended in December 2007. If so, what was the date of

the next appointment given at the December visit? Then look and see if the patient attended

that next appointment.

BX BY BZ CA

If yes If missed If missed

Did patient attend 3 months ago

Attended next appt after visit 3 months

ago

Attended in next 3 days after missed

appt

Attended in next 30 days after missed visit

Column BX

Did the patient attend around 3 months ago (e.g., December 2007)? Answer Yes or No. If

the answer was No, you have finished. Leave all other columns (BY, BZ, and CA) blank.

If the answer was Yes, then look for the date the patient was given for their next

appointment after that and go on to the next columns.

Column BY

Did the patient attend on or before the date of the given next appointment (Yes/No)?

(For example, did the patient attend the appointment given during the December 2007

visit?)

Note: If there was no appointment given, you can see how many days of ARVs were given and

calculate whether the patient attended on or before the last day that the pills would run out.

Column BZ

If the patient missed their appointment did they attend within the next three days of the

missed appointment? (Yes/No).



52

Note: If the appointment was on the 11th and they came on the 14th, the answer would be Yes. If

they attended on the 15th, the answer would be No.

The system will validate that the data in columns BX, BY, BZ and CA to ensure that it is

consistent.

Filling in the exit interview forms

The purposes of this form are to ask for self-report on adherence, as well as check how long

patients spent at the clinic, how long it took to travel to the clinic, how many of their

prescribed ARVs and other drugs were actually dispensed, whether the medicines are

correctly labelled, whether the patient has experienced any adverse drug events in the last

month, and whether they know how to take their medicine correctly.

All questions will need to be asked in appropriate local languages. The uniform way of

asking each question in the appropriate language needs to be agreed upon and written

down. This can be done at the time of data collection training.

The proposed patient indicators can also be used to assess adherence among paediatric

patients. If the patient is a child who has been brought to the clinic by a caregiver, then there

are two screening questions to ask the caregiver to see whether the child would be eligible

for the survey. If the caregiver is not the one who usually gives the child medicine, then that

child should not be included. (Patient exit interview form).

It is desirable to conduct at least 30 exit interviews at each facility. If there are not 30

patients, then try to interview all the patients that visited that day. It is important to visit on

a day when patients are expected. The patients you want to interview are those on ART, but

not those who started ART the same day of data collection.

The interview should be done sitting down in a comfortable spot. It will be most helpful to

find a good place and ask the pharmacy dispenser to ask the relevant patients to go there for

interview. The place should be near the pharmacy as this is the last place the patient usually

visits before leaving the clinic.

It is important to be pleasant and polite. You should speak in a language well known to the

patient, and not be officious, or dress in a white coat, or speak with technical words. You

must put the patient at their ease if you wish to get real information. The main point is to

build a trust so that when you get to the final questions on whether they have missed any

doses in the last three days they will give you an honest answer.

The patient is under no obligation to speak to you, so you should introduce yourself with

the important points:

You are working with the Ministry of Health to try and help to improve services for

people taking ARVs.

It will only take a few minutes.

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53

It is confidential; no harm or change will happen to the patient as a result of

partaking.

The patient may withdraw at any time.

A typical introduction may be:

‚Good morning. My name is<<< and I’m working with the Ministry of Health to

try and help to improve services for ARVs in the country. I would like to speak to

you for a few minutes about your experience in the clinic today and the medicines

you are taking. All the information you give me will be entirely confidential, so no

one will know identities. It shouldn’t take more than ten minutes. Would you mind

speaking with me?‛

If the patient is a child with a caregiver

If the patient is a child with a caregiver, it is necessary to ask pre-qualifying questions:

Is the child personally responsible for taking the medicine? If the answer is yes,

continue with the interview with the child. However, if the answer is no, ask the

caregiver:

o Are you the one who usually gives this child his/her medicine?

o Was it you who brought the child to the clinic originally and was told how the

child should take the medicine?

If the answer to either question is negative, then do not continue the interview and exclude

the child from the survey.

The exit interview form

The exit interview form can be seen in Appendix 2C. The form is large enough to write

down the information for 30 patients, with one patient for each row.

Fill in the top of the form first with:

The date of data collection.

Facility name and number.

The data collector’s name.



54

Each column has a letter above it. We will give directions for each column in turn. Fill in the

form for one patient for each row. Words to be spoken are written in bold italics. They will

need to be translated into local languages. However all data collectors should agree the

language and words so that they can ask the questions in the same way.

A B C D E F

Pt # Age in Yrs

Gender, M/F

Occupation Normal activity

Months on trt.

1

2

Column B Can I please ask your age?

Write age in years. If the patient is a child, make sure the age is in years and not months.

If the child is less than two years old, take the age to the nearest six months (0.5, 1, 1.5, 2).

Otherwise, write the age in years.

Column C

Note gender (write male or female).

Column D What is your occupation?

The main point of this question is to get an answer to the next question. If the patient is a

child who does not attend school yet, his or her occupation can be preschool, if the child is

in school, the occupation can be pupil. Housewife may be an occupation depending on

culture.

Column E With your illness, are you now able to actively continue with

your normal activities?

Write Y for yes or N for no. If the person is a child, a mother or caregiver knows the

appropriate level of activity of a child that age.

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55

Column F When did you start on the medicine for HIV/AIDS?

Ask when they started ART and write how many months on ARV treatment.

H I J

Cost home to clinic Time home to clinic (in mins) Time in clinic today (in mins)

Column H Did it cost you anything to get to the clinic today? If so, how much?

Ask how much it cost to come to the clinic today from their house or place of work and

write in local currency.

Column I How long did it take you to travel to the clinic today?

Ask how long it took to come to the clinic today from their house or place of work and

write in minutes (not hours and minutes). If they don’t know the answer, try and find

when they left. You may be able to relate it to some other event like dawn or prayers.

Then try and find when they arrived perhaps in relation to clinic opening time. Then you

can work it out.

In some cases the patient may have travelled from a remote area the day before to stay

with a relative overnight and come to the clinic in the morning, or even arrived earlier

before the appointment to do other things, such as sell produce. In these cases take into

account the travel time from the remote area as well as the travel time from the place

stayed in locally, but do not take into account the rest of the time. Calculate total travel

time in minutes.

Column J What time did you arrive at the clinic today?

Calculate total time in clinic during this visit in minutes based on the time it is when

asking the question. It is useful before the interview to work out how long it is now since

the beginning of the clinic, so that it is quicker to calculate how long the patient has been

there. Write in minutes.

If patient doesn't know the time, try and relate it to something else such as the

beginning of clinic, and calculate the time.

(For information only) May I see all the medicines you were given today and any

prescriptions you may have been given?

Ask to see all the ARVS and non-ARVS dispensed and the prescriptions for all drugs

prescribed. If the patient has no prescription, just look at the medicines given.



56

K L M N

All ARVS dispensed All non-ARVS

dispensed All ARVs well

labelled All other medicines well

labelled

Column K Were you asked to come back sooner than usual because they didn’t have all the medicine you needed?

The patient may not know the word ARV, so it may help by picking up the relevant

medicines and asking whether all medicines like these were dispensed. Write Yes or No.

Column L Were you asked to go and buy any other medicine?

Again the patient may not understand the word non-ARV. However, if not all

prescribed medicines have been dispensed, the patient would normally know as they

would have been asked to go and buy the missing medicine or to come back soon to pick

up the missing supply. Write Yes or No.

Column M

For labelling and packaging, first look at each of the dispensed ARV medicines and

judge whether it is:

o In a separate container or envelope

o Does each container or envelope contain:

Drug name

Dose per time

Number of times per day

To write Yes, all ARV medicine must comply, otherwise write No.

For dose per time, and number of times per day, you need to decide what is acceptable. A

question that comes up is —is 2TDS or 2BD acceptable? Most teams felt that this is adequate

for communicating with a professional but is not sufficient for communicating with a

patient.

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57

Column N

1. For labelling and packaging of the non-ARV medicine, first look at each of the dispensed

drugs. Look to see if each non-ARV medicine was dispensed in a separate container or envelope?

Does each container or envelope contain the drug name, dose per time, number of times per day?

If all comply, write Yes; if not, write No.

The next part of the interview is the most important part. It is essential to put the patient as

much at ease as possible. Say in the local language, "Some patients find it difficult to take all

the medicines every day in exactly the way they are supposed to."

O P Q R

Name of first ARV in patient regimen # times per day Patient knows # times per day

Y/N

# Doses missed in last 3 days

Column O

2. Take the first antiretroviral and write the name (in agreed abbreviation).

Column P

3. Write the correct number of times per day this medicine should be taken (if you don’t

know, look at the packet).

Column Q How many times a day do you take this medicine?

4. Does the patient know the correct number of times they are meant to take the medicine

each day? Write Yes or No.

Column R In the last three days have you missed any doses? If so, in the last three days how many times have you missed?

5. Write the number of missed doses (0, 1, 2, etc.)

Do the same for each separate ARV.

Columns S–V

6. If there are a total of two ARVs, write in columns S–V.



58

Columns W–Z

7. If there are three ARVs, also write in columns W–Z.

AF AG

Reason for missing doses

(Code 1-15)

If "Other," then specify reason for missing doses

Column AF

8. If they have missed any doses you can ask the reason and classify it according to the

code in column AH (last column).

Table 10. Codes to explain missing doses (column AH)

1 = Toxicity-side effect 9 = Travel problems

2 = Shared with others 10 = Inability to pay

3 = Forgot 11 = Alcohol

4 = Felt better 12 = Depression

5 = Too ill 13 = Took holy waters

6 = Stigma 14 = Fasting

7 = Drug out of stock 15 = Changed regimen

8 = Patient ran out of pills or lost pills 16 = Other (specify in column AG)

Column AG

9. If the reason is ‚other‛ (code 16), specify the reason in column AG.

End the interview by thanking the patient and wishing him or her good luck and a nice

day.

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59

Some comments about workflow

The system will support the entry of data using a variety of different sequences. The aim of

the exercise is to complete the double-entry of three different forms. Here are some

examples to illustrate this.

Sequence number

Step

Example 1: 1 First Entry Facility Questionnaire

2 First Entry Retrospective Dispensing Data

3 First Entry Exit Interviews

4 Second Entry Facility Questionnaire

5 Second Entry Retrospective Dispensing Data

6 Second Entry Exit Interviews



3 First Entry Retrospective Dispensing Data


5 First Entry Exit Interviews



2 First Entry Exit Interviews – commencement of

3 First Entry Retrospective Dispensing Data – commencement

of


5 First Entry Retrospective Dispensing Data – completion of


7 First Entry Exit Interviews – completion of


Second data entry

The data entered for the first and second data entry are the same. There are some minor

differences between the two sets of functions. This includes the comparison of data entered

into the second data set being compared to the first data set entered. There are also some

differences relating to summary fields. These are discussed in more detail in Chapter 8.

Consolidation

Description of the procedures to consolidate the entered data into a summary report are

included in the Data Consolidation Section, Chapter 8.

6

60

CHAPTER 6 --- Planning and field methods

Preparations for survey

Surveys are most useful when they are designed to meet specific objectives. Managers and

policy-makers responsible for administering an HIV/AIDS programme, or health providers

responsible for supervising the quality of medical care in public sector ART facilities would

be interested in the results of an adherence indicator survey.

If the initiative for carrying out an adherence survey does not originate with such people,

they should be involved in its design at an early stage.

Adequate planning and preparation for the survey will increase the likelihood that data will

be collected and recorded in a reliable way.

Persons planning and carrying out an adherence indicators survey need a basic knowledge

of pharmaceuticals, some understanding of the principles of sample surveys, and an

appreciation of the logistical requirements for carrying out field studies. The indicators and

methods recommended in this manual have been designed to minimize as far as possible the

need for a high level of sophistication in these areas. Carrying out more in-depth follow-up

activities, or designing and mounting an intervention, will in many cases require a higher

level of technical expertise.

Permissions and approval

Often this work will be carried out by or for the National AIDS Control Programme. If this is

the case, they may not need any outside permission. If such a survey is being carried out by

any other group, they will need letter of permission from the National Aids Control

Programme documenting their approval. In addition, the survey group may need approval

from an ethical review board. This will depend on the country.

Select and prepare sample sites

Issues involved in the selection of an appropriate sample of facilities have been addressed in

Chapter 4. Once facilities have been selected and staff trained, the field work can begin. One

key to the success of a study is adequate preparation of sample sites.

Preparation includes adequate notification to relevant authorities of the study’s purposes

and methods. This increases the likelihood that the study results will be accepted and

Chapter 6

Planning and field methods

61

utilized. If possible, it is also helpful to visit each sample site beforehand. These visits can be

used to promote the active cooperation of clinical and pharmacy staff.

The logistical preparation can also be done during such preparatory visits. Study planners

can identify the required sources of data at each facility, prepare them for use by the data

collectors, and determine how the retrospective sample may be drawn and where the exit

interviews can take place.

Recruit survey coordinator, team leaders, and data collectors

The survey should have one overall coordinator to oversee all stages of the survey including

design, recruitment of team leaders and data collectors, training, data collection, data

processing, data analysis, report writing, and dissemination. During data collection, the

coordinator should be in constant touch by phone with all teams to resolve difficult issues

and to communicate changes to the other teams.

The data collection method is designed in such a way that one facility can be surveyed in

one day by a team of four data collectors. Therefore each team needs one team leader and

three or four data collectors.

The decision as to how many teams are needed is a local decision. In the feasibility surveys,

we surveyed 20 facilities in a five-day week using four teams. This worked well but could be

adapted to local needs and resources. To ensure consistency in results, all data collectors

should be trained together, and then be allowed to practise together at one or two pilot sites.

The team leader needs to have the capacity to assess the record-keeping system and

efficiently decide how to sample for the retrospective records. They also need to know how

to communicate with the facility managers and manage the work of the team so that all

people are busy at all times. If the appearance of patients for interview slows down they

should make sure data collectors are concentrating on the retrospective records. It is the

team leader’s job to make sure everyone is busy and that there are no bottlenecks, such as

people not working because more sampling and record extraction is needed.

The team leader and at least two other team members should be comfortable with using

Excel on computers.

Data collectors should be familiar with pharmaceutical terms to be able to reliably extract

information from records, and to record it accurately during observations. The most

effective data collectors are people with clinical experience, such as physicians, nurses,

pharmacists, paramedical staff, or senior medical or pharmacy students.

Data collection can be tedious, and requires an aptitude for concentration and attention to

detail. The best data collectors combine the discipline to collect data in a standardized way

with the flexibility to adapt procedures to the requirements of unusual situations. People

who have these traits but lack technical knowledge can be trained to perform effectively and

will improve with experience; people without them will never perform effectively,

regardless of their technical qualifications.



62

It is also helpful if at least two members of the team have the ability to enter data onto a

computer quickly and reliably.

Plan data collection visits schedule

As stated above, the team of three or four data collectors with a team leader can manage one

facility in one day and double-enter the data on the laptop (if available) the same day.

However, they need to arrive at the facility at or before opening time, so that they can begin

to draw the retrospective sample and the corresponding notes before the clinic becomes very

busy. This means that the team needs to sleep near the facility.

If the required sample is 20 facilities then four teams of data collectors can manage that in

five working days (or two teams in 10 days), provided that the facilities are reasonably close

together and they can spend the night near the next day’s facility. So logistically, the 20

facilities need to be divided into four groups and one team assigned to each group. At the

end of the day of data collection, the team needs to travel towards the next facility and sleep

there. This requires careful planning and a dedicated vehicle for each team for the duration.

The teams should stay together at night so that they can easily assemble and go to the

facility as a group. If the team does not arrive early, the whole day can easily be off schedule

because the staff members are too busy to collaborate.

It is important that the survey day is also the day patients are expected. This means that

apart from geographic proximity, each facility’s clinic schedule needs to be taken into

account. To find this out, it will be necessary to call the facility’s ARV clinic to find which

days they expect enough patients to do the exit interviews. Without careful preparation, it is

all too common that some facilities have no patients on the day of data collection.

Every facility should be told in advance when to expect data collectors' visits. When funds

permit, it can be useful to "hire" one or more staff at each facility to assist the data collectors

in finding records and deciphering handwriting.

For each facility chosen, the survey team should contact the head of the facility to explain

the purpose of the work, provide a letter from the National AIDS Control Programme, and

ask the facility for consent and assistance.

Create the medicines lists

The coordinators will need to create lists for essential adult ARVs, paediatric ARVs, and

non-ARV key medicines. These lists should all be prepared in conjunction with the team

leaders before the field work begins. First-line ART treatment medicines for adults and for

children are recommended for the two ART lists; and treatment guidelines for the common

opportunistic infections should be used to construct the key medicines list. Staff from the

NACP may assist with this task. See the previous chapter for how to modify the forms.

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63

Train personnel

A key step in preparing for field work is to train the team leaders and data collectors to

collect and code the data in a correct and consistent way. Training is addressed in the next

chapter.

Pilot-test the data collection methods

During the training of the team leaders’ and data collectors’ trainings, the data collection

methods should be piloted at separate facilities to make sure the methods work and that

they are understood. This is an important step which will provide an opportunity to identify

and solve unforeseen problems. It will also identify "natural leaders" who can assist the

other data collectors in case of difficulty.

Experience shows that during the pilot testing the rate of data collection is always very slow.

Data collectors should be reassured that with practice their rate will increase dramatically.

So study planners should not make calculations of the time required at each site based on

this exercise.

Ethics for data collectors

All data collectors should understand that any patient information they receive is

completely confidential. They should not under any circumstances divulge any of

that information to anyone else outside the survey. Depending on where the

survey is carried out, it may be necessary for the data collectors to sign a

confidentiality agreement.

It also needs to be understood that patients have no obligation to give exit interviews. Before

the interview begins the interviewer should communicate the purpose of the interview and

give an assurance of confidentiality. At that point, the patient needs to be asked for their

consent to continue with the interview. If the patient agrees, only at that point should the

interview begin.

To select the sample of patients for the retrospective sample from the attendance register, the

patient identifier form is used. For this only the patient identification number is recorded,

not the name. This will enable the pharmacy records to be found in the most anonymous

way possible.

Collecting data

Remember to arrive at the same time as the clinic opens to set up before the main rush of the

day starts. After introducing the team members to the facility manager, the team needs to

quickly decide:

How can they sample the retrospective records?

Where they can sit to extract the data from the records?



64

Where they can sit to do the exit interviews?

How can they have the patients directed to that spot?

Sampling and retrospective data extraction

The methods of retrospective sampling have been discussed before in Chapter 4 and Table 3,

but these need to be established and started immediately so that if selected records need to

be pulled, this can be done promptly so that the data extractors can start. It is important to

minimize any waiting time. The first step is therefore to work out how the sampling is

possible in that record-keeping system and start the process. This needs imagination and

skill on the part of the team leader.

Space is needed for data collectors to sit down with the pile of records and extract the

relevant data. A separate room with one or two tables is ideal. All data collectors not

interviewing should be engaged in this. In all, 100 sets of patient records are needed. It may

be quicker to select 25 (or less) at a time so that data extractors do not have to wait while

records are being found.

Exit interview

A location needs to be found and made comfortable and the dispenser needs to be briefed to

direct the relevant patients to the place for interviews. The exit interviews take about 10

minutes each, so depending on patient flow the appropriate number of interviewers will be

chosen. This will vary through the day. It may be that the pharmacist comes in late so there

is a queue of patients and a sudden rush when the pharmacist starts work. Careful

adjustment to this patient flow is needed. When no patients are available for interviewing,

the data collectors should concentrate on the retrospective data extraction.

Facility interview

Once the sampling and record extraction process is working, the place and manner of exit

interviews have been established and the data collectors know and are settled in their

different roles, the team leader can start on the facility interview. It should only take one or

two hours at most, so that the team leader should also do a fair share of retrospective data

extraction.

Computer entry

Once the process is underway and at least 70 retrospective records have been extracted, one

or two team members can start to enter the data on a computer. If this is the team leader, it

becomes a chance to make sure the data are entered sensibly and gives the opportunity to

ensure quality control and handling any problems that are encountered.

Check to make sure the dating systems of the collected data and the data entry

software are the same (i.e., dd/mm/yy)

Chapter 6


65

There are two approaches to processing the data from an indicators’ study—manual

tabulation and computerized analysis. These adherence indicators have been designed so

that if the data are entered into spreadsheets that look exactly like the manual data collection

sheets, then the indicators will be automatically calculated.

For accuracy, each form needs to be double-entered by two different people. The software

will highlight any disagreements, which should be checked by the supervisor or team

leader. It is best to enter the data as soon as possible after collecting the data. If possible,

include two people in each team to enter the data at the time of data collection or in the

evening of the day of the data collection.

Completed forms review

Once the data is double entered the team leader should review the entry and decide on the

correct answers when the double entry disagrees.

Team leader communication with survey coordinator

Once data collection is underway, it is important that the coordinator regularly

communicates with the team leaders and data collectors and goes out into the field with

them to ensure that the agreed procedures are being followed. The team leader can phone

the study coordinator if the team has any unresolved issues or if there is a new finding

which should be communicated to the other teams.

Following is a copy of a checklist for coordinator activity as a guide.



66

Table 11. Coordinator checklist

Coordinator checklist

Task Completed

Organize the survey process

Permissions and approval

If needed, seek approval for the survey from National AIDS Control Programme

Select and prepare sample sites

Select likely sites Find days clinic are open and work out travelling logistics Notify the head of the facilities and the heads of the HIV clinic of

the purposes and methods of the study. If possible do this in person, otherwise by letter and phone.

Recruit team

leaders

Recruit 4 suitable team leaders and agree on terms and conditions

Recruit data collectors

Recruit 12-16 suitable data collectors and agree terms and conditions

Organize transport

Book vehicles large enough to transport each team for the duration of the survey

Organize computers

If possible, locate at least one laptop computer for each team

Give airtime Make sure that each team leader has enough airtime to communicate with the survey coordinator

Create medicines list

With the team leaders decide on the needed list of adult and child ARVs and the other key medicines lists

Pilot test Test the data collecting methods in a facility

Finalize

forms

Finalize the data collection forms. Have enough for the trainings mentioned below—this means at least one of each form per participant with some extra ones.

Prepare for training team leaders

Training room

Organize room with an LCD projector and the training slides

Official letters

Prepare official letter of introduction for team leaders

Copies Print and photo copy all materials for training session and field test and assemble equipment

o One copy per data collection team of the official letter of introduction

o Two copies per person of a complete set of survey forms o One copy of this manual per data collector o Additional materials such as pens and calculators o A computer per team leader with preloaded data entry

forms o One clipboard per person for taking notes

Prepare for training data collectors

Training

room

Organize room with an LCD projector and the training slides (This will need to be larger than the room for team leader training)

Task Completed

Copies Print and photo copy all materials for training session and field

test o One copy per data collection team of the official letter of

introduction o Two copies per person of a complete set of survey forms o One copy of this manual per data collector o Additional materials such as pens and calculators o A computer per team leader with preloaded data entry forms o One clipboard per person for taking notes

Prepare information on transport, distance and security for each data collector

Training

slides

Obtain sample pharmacy records and sample stock cards to copy onto a transparency or photocopy for distribution to data collection teams (these will be used during the discussion)

Chapter 6


67

Train team leaders and data collectors

Train team leaders

Assemble training slides Train the four team leaders over two days Include a site visit to field-test methods

Help team leaders train the data collectors over the next four days (including site visits)

Assemble material for survey

Print final forms for survey

Print and photo copy all materials for actual survey—make sure each team will have enough forms to finish their survey

This means that for each facility there should be

o One copy per data collection team of the official letter of introduction to the local health authorities and facilities to be surveyed

o Exit interview forms: six (one per team member) o Patient selection forms: six o Retrospective forms: nine (each of 25 patients) o Facility forms: two o (This includes a complete set of forms for the facility chief in

case they need it)

Make sure each team has at least one laptop computer with two

copies of the data entry forms loaded as well as copies of the printed forms file

Finalize arrangements

Make sure: o Hotels are booked o Team leader should have the money for fuel and for

emergencies o Data collectors and team leaders should have their per diems o Team leaders should have a mobile phone with air time and

the telephone numbers of each facility and facility pharmacist

Supervise survey

Supervise the actual survey, ensuring each day that all team leaders are doing well and sorting out any questions

After the survey

After the survey, check again that all data have been collected, random sampling was used, and that the forms were completed correctly—also check any computations

Collect written reports from data collectors on the data collection process and in particular anything that will be important in interpreting the results

Analyse data Provide copy of survey forms to data analyser to complete summary forms 1–4

Report writing

Provide copy of summary forms, graphs, data analysis and notes from data collectors to report writer

Oversee writing of report

Review report prior to finalization

Edit content and layout of report

Present results

Coordinate presentation/feedback of results



68

7

69

CHAPTER 7 --- Training of data collectors and

team leaders

If the information gained from this survey is to have any meaning, then it is essential that all

data collectors have the same interpretation of the questions and the same way of asking

questions in the interview. To ensure this, an intense training period is needed.

During the training, each of the data collection tools needs going through column by

column, question by question, during which time all the different ways of possibly

interpreting the questions need to be discussed and a consensus reached. Some of the

misunderstandings have been described in the instructions on how to fill in the form in

chapter 4, such as writing times in minutes and not hours and minutes in the exit interview.

If one person writes 1.5 (hours) and another writes 90 (minutes) for time to get to clinic, then

the comparison is meaningless. Everyone must write in the same unit format. Similarly, if

one person writes the number of tablets and another writes the number of days, again the

comparison becomes meaningless. With the exit interviews; if one person asks a question in

one way and another in another way, then the answers cannot be compared. Training and

practice on the exit interview is essential.

Remember:

You can only get meaningful data if all data collectors have the same understanding.

The skill of the facilitator for the training is to be able to imagine everything that can

be misunderstood and discuss.

Assumed mutual understanding is a misunderstanding in the making.

If something can go wrong, it will go wrong.

The facility interview will be filled in by the team leader only. This means that there needs to

be time, at least half a day, for training the team leaders on the facility form.

Training team leaders before data collectors

It may be a good idea to hold a two-day training for team leaders and then have the team

leaders act as facilitators for the three-day training of the data collectors. The syllabi will be

similar, but more emphasis is needed on the facility questionnaire with the team leaders as

they will be responsible for carrying that out. The two sample syllabi are described in table

12 below. Typically, the training of team leaders may take one and a half to two days and for

data collectors will take two and a half to three days.



70

The vital thing to remember throughout is that all situations that will be encountered need

to be understood the same way by all team leaders and all data collectors.

Some PowerPoint slides are included on the CD-ROM which may be helpful, but the

training is possible without them if everyone has copies of the forms under discussion and

the manual.

Sample training syllabus

Table 12. Model training course for team leaders and data collectors

Topic Materials Time

1. Overview of adherence to ART medicines

Importance of adherence and problems of measurement

Possible methods of measurement with strengths and weaknesses

Indicators of adherence that the survey plans to collect

Brief description of complementary indicators that will help with interpretation

60 minutes

2. Overview of the project

What the survey is for and what is the NACP’s interest in the indicators

Role of the data collectors

Work to be carried out; start and finish dates

Days to work and compensation

Organization of teams

Number of sites to be visited by each team

60 minutes

3. How data are collected

Show data collection forms

Brief overview of the four different data collection forms

Data

collection form

package

20 minutes

4. Exit interview form

Overview

How to introduce yourself to the patient

Practice in appropriate languages (role play)

Go through form column by column

Role play with critique

In groups of three, practice being interviewer, interviewee, and observer to critique the interview

This manual 90 minutes

5. Retrospective sampling

Overview of principles of random sampling

Standardize methods of sampling and extracting pharmacy and clinical records

Discussion on what to do in circumstances of different sorts of record keeping


6. Dispensing retrospective form

Overview

Go through form column by column discussing alternative interpretations


7. Facility questionnaire (Note: Only the team leaders will fill this in, so they need careful training)

Overview

Go through form column by column discussing alternative interpretations

This manual

180 minutes for team leaders

8. Revise all forms Data

collection 60 minutes

Chapter 7

Training of data collectors and team leaders

71

Topic Materials Time

Revisit all areas of discussion and interpretation form package

9. Field practice

Visit and collect complete set of data for 1-2 facilities; complete facility summary table and report and double enter the data

This manual

Data collection

forms

Data entry forms

(1/2 day)

10. Final discussion

Review experiences of field test and address concerns and questions

Assign data collectors to working teams

Finalize data collection plan and organization of work (schedules. transport, communication, mobile phone numbers and call-in schedules)

Schedule (1/2 day)



72

8

73

CHAPTER 8 --- Data entry and data processing

The data entry has already been mentioned during the data collection process in Chapter 5.

The data entry sheets look identical to the written sheets, so it is just a process of transferring

the written material to the data entry worksheets. As far as possible, this should be done

during data collection, but it must be done carefully and be well checked.

Data entry general points

a) Ensuring accuracy

The quality of the information generated by the adherence survey depends on the accuracy

of data entry. Team leaders and survey coordinator have overall responsibility for the

quality of the data, and should supervise data entry personnel on a regular basis.

b) Double entry

All data need to be entered twice by two different people. This is because entering detailed

data such as long columns of yes and no can lead to a substantial numbers of errors. The

quickest and most efficient way to find these data entry errors is to have a second person

enter all data a second time and then identify where the items entered disagree.

c) Saving and backing up your work

It is recommended that you save the data entry sheets periodically as you work to prevent

data loss in the event of power failure.

Data entry procedures

To enter the data a new instance of the questionnaire should be opened. For instructions on

how to do this see section ‘Accessing Data Entry Forms’, Chapter 5.



74

The middle portion of the control form looks like this:

The Enter or maintain data columns are as follows:

Buttons for the selection of forms

Completed fields/Completed records list

Expected records list

Completion tickboxes

Buttons for the selection of forms

Use your cursor or mouse to click on the button with the form label you wish to work with.

Completed fields/Completed records list

When you have entered data on each form the system will record how many fields or

records you have entered.

Expected records list

The system records the number of retrospective dispensing data records and the number of

exit interview that are expected from this facility.

As has already been mentioned elsewhere in this document the retrospective sample of

patients is 100 and the requested number of exit interview is 30. It is recognized that in some

circumstances these quantities of records are not available. In this case the data entry person

is required to enter an estimated number of records that will be entered into each of these

two sheets. The system can then use these numbers in deciding whether the user has entered

sufficient data to enable the task of completing the form.

Completion tickboxes

The system will automatically tick the boxes on the right to indicate that the form has been

completed.

Chapter 8 Data entry and data processing

75

The forms are as follows:

First Entry Facility Questionnaire

First Entry Retrospective Dispensing Data

First Entry Exit Interviews

Second Entry Facility Questionnaire

Second Entry Retrospective Dispensing Data

Second Entry Exit Interviews

This form was designed so that it would be easy for the user to work through the list of

forms to complete and to be able to see at a glance where you are in entering data for a

facility.

See section ‘Some comments about workflow’ in Chapter 5, for examples as to how you can

work with this form. Each second entry form corresponds to a first entry form. You will not

be permitted to access a second entry form until its corresponding first entry is completed.

It is recommended that you:

Enter the First Entry Facility Questionnaire first. This is because the facility ID is used to

generate the document name of the file.

Save the file by choosing the folder you want to save it to and selecting the option to

save.

Work down the list of worksheets, one form at a time, enter the data completely for that

sheet, returning to the Control Form (by clicking the ‚Go back to List‛ button) to view

progress and select the next task.

The system will name the document for the First Entry as ‚Master_FCxxxx.xls‛ where ‘xxxx’

is the Facility Identifier code you entered for the facility on the facility sheet. For the second

entry the system will generate the name as ‘Second_FCxxxx.xls’. When finished, each

document will contain three forms.

When you switch between first and second entry forms, the system should automatically

save the document for you before proceeding to the next form.

Data validation

The content and type of data entered into each form are validated as the data are entered,

where appropriate. In some cases the responses are restricted to the values in pull-down

lists. In other cases, such as the entry of numbers or dates, the system will assist you in

entering the data correctly.

For the Retro and Retro – Second Entry sheets there are error counters at the top of the

page, which look like this:



76

This is because there are hidden columns doing calculations on the retrospective sheet. If

there is an error of data entry these calculations may not work, in which case an error shows

at the end of the row. For example if a date or an entry for the number of days of medication

given is missing then at the end of the row (column CF) there will appear in red:

. It is not possible to press the ‘first entry completed’ button on the tool bar

until these have corrected. Therefore if there is an error in the row, check the row carefully.

If all else fails, cell by cell ‘clear contents’ (rather than ‘delete’) to make sure apparently

empty cells are really empty.

Ensure that the current number of errors on page is 0 before completing the sheet.

For your information the system will record the number of valid records entered into the

Retrospective Dispensing Data and Exit Interview sheets, for example:

This is for your information and guidance.

Second entry differences

As data are entered into the Second Entry sheets, the system compares the data to those

entered in the First Entry.

If some of the data are different, the print will turn red and a red triangle will appear in the

top right hand corner of the cell as follows, for example:

If you place the cursor over the cell a flag will appear as follows:


77

In this example, the first data entry person had entered M for Male and the second had

entered F. The flag pops up to tell you that the value differs from the first data entry. Check

which is correct and ensure that the correct data is entered on the Second Entry sheets.

In the Second Entry sheets unresolved differences between that sheet and its corresponding

First Entry sheet are reported as errors. When there are no more errors on these sheets, the

cells at the top of the sheets that said:

are automatically changed to:

Navigation

On the Retro and Retro – Second Entry sheets there is a button to give you immediate

access to the form printing sheets:

On the Exit and Exit – Second Entry sheets there is a button to give you immediate access to

the form printing sheets:

From any of the data entry sheets if you wish to return to the Control form use the button to

‘Go back to List’:

From any of the data entry sheets if you wish to confirm that data entry for that sheet is

completed used the button to ‘Complete’:

Completion

To ‘Complete’ the data entry for any of the forms means that you have no further data to

enter on that form and that you do not need to return to it. When you select the ‘Complete’

button, the system issues a message asking you whether you are sure that you wish to

complete, for example:



78

The text of the message varies for each type of sheet.

Respond by selecting either the ‘Yes’ or ‘No’ buttons.

If you select ‘No’ you will remain on the current sheet. If you select ‘Yes’ the system will

verify whether it is able to complete the form and then return you to the Control form.

Conditions for completion

For facility questionnaires:

The system will check that a reasonable proportion of the possible data entry fields are

completed before you will be able to complete these forms. In addition for the Second Entry,

the data should match the first and there should be no errors.

For retro dispensing data:

If you select the ‘Complete’ button the system will validate that you have entered the

expected number of interview records. You will see the following message:

Select ‘No’ to correct the number of records.

Your cursor will be placed in the cell at the top of the sheet:


79

The system needs some information about what will constitute a reasonable number of

retrospective dispensing data records for this facility. Enter a number into the field:

Then select the ‘Complete’ button again. This time you will see the completion warning:

When you select the ‘Yes’ button, you will be returned to the Control Form:

You can see that in the example above the facility entry and the retrospective dispensing

data check boxes are completed. Note that you can no longer access those sheets.

For Exit Interviews:



80

If you select the ‘Complete’ button the system will validate that you have entered the

expected number of interview records. You will see the following message:

Select ‘No’ to correct the number of Exit Interviews to expect.

Your cursor will be placed in the field at the top of the sheet:

The system needs some information about what will constitute a reasonable number of exit

interview records for this facility. Enter a number into the field:

Then select the ‘Complete’ button again. This time you will see the completion warning:


81

When you select the ‘Yes’ button, you will be returned to the Control Form:

You can see that in the example above the facility entry, retrospective dispensing data and

exit interview check boxes for the First Entry are completed. Note that you can no longer

access those sheets.

Note also that when the expected number of records or interviews are entered the system

permits a small margin for error. In the example above we said that we expected to enter 30

Exit Interviews but only completed 29. If the differences between the actual and expected are

significant the check boxes will not be ticked. In this case you should either enter more data

or adjust the expected number of records.

During the Second Entry

When entering the second set of data you should complete all the records and fields that you

can and when you have finished use the ‘Complete’ button to return to the Control List.

Facility Questionnaire

In the case of Second Entry Facility Questionnaire, have completed entering the data when

you select ‘Complete’ you will see the following message, just as in the First Entry:

If you have completed the data entry select ‘Yes’, otherwise select ‘No’ and complete it.



82

Retrospective dispensing data

When you are in Second Entry Retrospective Dispensing Data, you will see, at the top of the

page the following information. This is the number of records that were entered during the

First Entry. This is for your information. You are not required to enter any further

information about the total number of records.

Also at the top of the page, further to the right is information about the number of records

you have entered so far:

This information is updated as you enter records.

When you select the ‘Complete’ you will see the following message, just as in the First Entry:

Select ‘Yes’ when there are no more records to enter and no errors to correct.

Exit interviews

At the top of the page you will see the following information:

This is the number of patient interview records that was entered into the First Entry. This is

for your information; there is no requirement to enter any data. Also at the top of the page,

further to the right you will see:

This shows the number of exit interviews that you have recorded in the Second Entry so far.

This information is updated as you enter records.


83

When you have completed entering the data and select ‘Complete’ you will see the following

message, just as in the First Entry:

Select ‘Yes’ when there are no more records to enter and no errors to correct.

Alternative ways of working

It is recommended that all of the data entered for one facility is done from one computer.

The basis of this recommendation is that the system may easily cross-check data on different

sheets and assist you in controlling the process when you use the Control form. It is

recognized that circumstances may arise which require that the data entry is continued on a

different machine. If this happens we suggest that both of the First and Second Entry

workbooks relating to a facility are transferred to the other machine and that the data entry

is completed according to the guidelines in this chapter. There are a number of ways in

which this might be done, one example is by saving the workbooks onto a memory stick and

restoring them on another machine.

Data consolidation for all facilities

Once all the data for all the facilities have been entered twice and the corrections made, and

all three forms in all Master files for all facilities have on every page:

The data can be imported into the summary file.

All the data for all sheets needs to be entered twice before importing to

the consolidated data file.



84

Consolidation Step 1: Open Consolidation file

The consolidation routines are in the document ‚Consolidate.xlt‛. This is a document

template. To access it, either select it by double clicking with your cursor or right click, and

select the option New:

When the file is open the security warning should be visible.

This is the Macro Warning and it appears each time you enter the application. Its purpose is

to ensure that you enable those macros and other components necessary, but without

violating the security of your PC. Macros perform the functions required to consolidate the

different sets of facility questionnaire data. The sheet contains instructions which you can

follow.


85

From the security warning, select Options (circled in red, in the image above). You will see

the Security Alert window:

Select the option to Enable the content, and then press OK.



86

The main facility summary sheet will be presented. Take this opportunity to save your

document, choosing a name for it: it will automatically suggest ‚Consolidated1.xls‛ but you

can save it under any name.

In this consolidated workbook there are several worksheets, which are shown as follows and

are in this order.

The first is a Facility sheet gathering all the data for all facilities. There is then a retrospective

sheet for all patients (Retro. all pts) and an exit sheet for all patients (Exit all pts.). These are

followed by two more retrospective sheets, one for new patients who had been on ART for 3

or fewer months, and one for experienced patients who had been on ART for more than 3

months (Retro. new, Retro. experienced). There are then two more exit interview consolidation

forms also for new and experienced patients. (Exit new, Exit experienced). The final sheet is a

Summary sheet.

When all the data for the facility, exit, and retrospective forms has been entered twice and all

the corrections have been made, go to the Facility consolidation form, where you will find

an Import button.

Press the import button and the following window appears.

You have two choices— Import the data from individual files or from all files in a folder.

Consolidation Option 1: Import one facility file at a time

For the first option:

a) Choose Browse in the top right.

b) Find the master file of the single facility data you want to import.

c) Press the button Import the file.


87

All the data for that facility will be imported into the consolidated file. If you haven’t

confirmed the first data entry and corrected all the errors with the second data entry a

warning notice comes up.

In this case press ‚OK‛. No information will be imported. Go back to the file and make sure

all sheets are ready for importation.

If all sheets are ready, then the data will be imported for that facility onto all the worksheets.

This should be done for each facility in turn. This is more systematic than the next

alternative.

Consolidation Option 2: Import all facility files at once

The second option is to wait until you have entered all the data for all facilities twice and all

the corrections have been made:

a) Make sure all the completed double entered and ready master files are in one folder

on their own.

b) Make sure all separate second entry files are in a different folder.

c) In the consolidation file go to the Facility worksheet, where you will find an Import

button.

Press the import button and the following window appears.



88

d) Browse the ‚importing all files in a folder‛ option by pressing the Browse button next

to this line.

e) Locate and select the folder.

f) Press the Import all xls files in folder button.

All data will be imported.

Data processing

The spreadsheets have a number of hidden columns and rows, so that data processing is

done automatically. The median value of all the indicators are produced on consolidation

sheets for each facility and the median, maximum, minimum, 25th, and 75th percentile

values for all the facilities together.

Data summarization and report creation

The consolidation workbook contains a sheet ‘Summary’ that, as its name suggests, collates

and organizes information from the other worksheets in the consolidation workbook. Data

here are grouped and formatted in tables in preparation for inclusion in a report. A report

document is available with a predefined structure and placeholders for these tables, as

linked data and for reminders and suggestions of things useful to include in the report to

assist the authors in the timely production of a presentable report - see Appendix 4. It is

advised that the consolidation tasks are completed prior to working on the report.

In addition Chapter 10 provides guidance on the report production part of the process.

9

89

CHAPTER 9 --- Interpretation of data and follow-

on questions

The pattern of survey results may give clues as to the reason for poor adherence at that

facility and therefore help to guide appropriate interventions to improve the situation. It is

important to present the results to key stakeholders and discuss the reasons for the results.

Remember that the results are only indicators and in themselves only suggestive; the

reasons need investigating. For all the retrospective data, the results depend on record

keeping, and the problem may be nothing to do with patient behaviour but due to poor

record keeping. One must not rush to judgement. Whenever feedback is given, start with positive

findings. When being critical, be constructive.

The key adherence indicators that related to clinical outcomes were the five core indicators

chosen and reported on here:

1. Percentage of patients with full self-reported adherence in last three days (from exit

interview)

2. Average percentage of days covered by medicine dispensed over six months

3. Percentage of patients with ≥ 30 days gap in medicines dispensed

4. Percentage of patients attending clinic appointment as scheduled

5. Percentage of patients attending clinic within three days of appointment

Alternate indicators 6 and 7:

6. Percentage of all visits in the last six months made before the days of medicine supplied at the

previous visit have been consumed

7. Percentage of all visits in the last six months made within 3 days of when the medicine

supplied at the previous visit have been consumed

These may present with different patterns of results which may suggest different causation

that should be investigated. Examples of results’ patterns—

If indicator 2 is high and indicator 3 is low (most days covered by medicine

dispensed and very few gaps of 30 days or more)

These results show that patients are receiving their medicine correctly and people are

therefore attending the clinic when they should be. This is encouraging, but all these results

really show is that the patients are receiving their medicines - but it does not mean that they

are taking them correctly. A facility in the Uganda feasibility study showed the average



90

percentage of days covered by medicine dispensed over 6 months was 96.9%, while the

percentage of patients with a gap of 30 days or more in medicines dispensed was 1.0%.

The evidence for this comes through the self-report indicator 1 (percentage of patients with

full self-reported adherence in last three days from exit interview). If this self-reported

adherence indicator is also high, we can deduce that the facility is working well. If this

indicator is lower, it suggests that patients need more counselling and support on the

importance of correct medicines consumption. In the Ugandan facility, the percentage of

patients with full self-reported adherence in the previous three days was 96.7%, showing

that these patients were well counselled.

If indicator 2 is low and 3 is high (only a few days covered by medicine dispensed

and many gaps of 30 days or more)

It shows that patients are not receiving enough of their medicine.

If indicators 4 and 5 are low (many missing their appointment and not attending

within three days)

The most likely reason is that patients are missing a high percentage of their appointments

(indicator 4 and alternate 6 would be low) and the fact that many have gaps of more than 30

days would suggest that people are missing appointments for a long time (indicator 5 would

also be low). If this is the case, there is a need to ask why patients are missing their

appointments. It may be for several reasons:

The counselling sessions may not emphasize the importance of patients keeping their

appointments.

Appointments may not be given at the times the patients are able to come.

The clinic may not be open when the patients are able to come.

If patients miss their appointment, the clinic may not be open for another week.

The date of the appointment may not have been made clear to the patients.

There may be access problems, such as rainy season, impassable roads, excessive

cost.

There may have been stockouts of ARVs.

Indicators 4 and 5 are high.

If indicators 4 and 5 are not low then it suggests that the patients have come on time but

they have not received their medicine. The likely problem is the medicine supply at the

Chapter 9 Interpretation of data and follow-on questions

91

facility. This can be checked on during the facility interview and followed up in the

pharmacy.

If indicators 2 and 3 are low, (few days covered by medicine dispensed but few

gaps of 30 days or more)

It shows that many patients are not receiving enough days of medicine, but there are only a

few that are missing them for a long period of time. In other words there will be several

short gaps rather than one large gap. This may be reflected in the following:

Indicator 4 is low and indicator 5 is high

If many patients are missing their given appointment but attending within three days (4 is

low and 5 is high), it indicates that many patients are missing their appointments, but

attending within three days. One explanation would be that patients have a few extra days

of pills and only attend when they have run out of their pills. However, this would result in

indicator 2 being high (a high percentage of days covered by medicines dispensed). If

indicator 2 is low (few days covered by medicine dispensed), then it means that patients are

coming after their pills have run out but are coming within 3 days.

These reasons need to be investigated. They could be because:

The counselling sessions may not emphasize the importance of patients keeping their

appointments.

Appointments may not be given at the times the patients are able to come.

The date of the appointment may not be being made clear to the patients.

Indicators 4 and 5 are low

With both 4 and 5 low, many patients are missing their appointments, not attending within 3

days, but attending in less than 30 days after their appointment. Again, the reasons need

investigating. It could easily be that the clinic is only open once a week, so if the

appointment is missed the patient cannot attend again for seven days.

Dissemination of results to key stakeholders

After the survey has been finished, it is advisable to hold a meeting of key stakeholders at

each facility where there seems to be a problem. At this meeting present the results and

discuss the possible causes to suggest recommendations for interventions to improve the

situation.

Wherever possible, provide feedback at all the facilities including those performing well. By

congratulating and reinforcing positive results, you may maintain or improve their



92

performance. In addition, you may learn the reasons for their good performance, which can

be shared with less well-performing facilities.

The advantages of this approach will be that there is a strong possibility of finding reasons

for the results and, in addition, that it will create motivation to design and adopt needed

interventions.

10

93

CHAPTER 10 --- Guidance notes on survey report

template

When the survey is completed a report needs to be written to share with the stakeholders

interested in the survey. Two templates called ‚Adherence Survey Report Template (docx

version).docx‛ (for Word 2007) or ‚Adherence Survey Report Template (doc version).doc‛

(for Word 2003) are included on the CD-ROM. The content can be seen in Appendix 4.

The production of the survey report has been standardized to make the process of

producing it more efficient and to provide support, in the form of reminders and

suggestions, to assist the authors in the timely production of a presentable report. If you

follow the instructions most of the tables will be filled in automatically and in the text there

is guidance as to what to say.

These notes provide guidance on how to proceed to take advantage of certain features and

facilitate swift, accurate and complete report production.

Process description

The creation of the report is preceded

by and dependent upon a number of

activities. These include:

– Entry of the questionnaire data

– Consolidation of questionnaires

– Review and revision of data

– Report production

It is recommended that the user

proceeds through each of these steps

in turn, in particular through the

review of the consolidated data prior

to commencement of the report work,

as this will ensure that the data are

correct and in place ready for presentation and is likely to make it easier for the author to

consider the interpretation of the study results.



94

A full description of the processes is included in the document ‘Adherence Indicator Manual

– May 2010’. The main purpose of this document is to focus on the report functions.

Review summaries - Consolidate summary data

The consolidation process precedes the preparation of data. It is recommended that you

complete all of the consolidation work before moving to the report.

During the consolidation process data are transferred into the consolidation document from

the individual questionnaires. Data are placed in a number of different worksheets in the

workbook:

In addition statistical calculations and summaries are made at the time. These form the basis

of the data presented in the report.

The consolidation report contains a spreadsheet ‘Summary’ that collates all of the

information in the format in which it is required for the report. Modification of these tables

will affect the way that they are presented in the report. However, it is suggested that this is

the best place to undertake such tasks.

To review the summary data open the ‘Summary’ worksheet: the tables are arranged across

the worksheet, for example:

Chapter10 Report outline

95

The black border surrounds the data that will be included in the report. The text description

in the worksheet is for reference only.

The worksheet contains many such tables:

The data here are derived from multiple sources. They may be reviewed and modified here,

as required.

Report document

There are four major components to the report template. These are: report structure,

standard text, placeholder text or hints, and tables. In addition the user may revise the

document styles of the report to suit his or her needs.

Report Structure

The report is structured in such a way as to make it clear and easy to read, however, other

structures may also be appropriate or there may be occasions on which it is necessary to veer

away from the suggested structure.

Standard text

Standard or boilerplate text is automatically incorporated into the template and may be

modified, except that it is a helpful and repetitive component of the report and as such it is

not essential that it be modified.

Placeholder text

Large sections of the report make use of placeholder text. his comes in two forms: one is the

Microsoft Office placeholder text and the other consists of both rich and plain text controls.

Placeholder text gives hints, within square brackets, as to what the report author might

consider including in that section. When the cursor is placed within those brackets, the

entire contents will be highlighted. Typing causes the placeholder text to be removed and

the new information to be inserted in its place. Once the placeholder text has been deleted it

will not reappear. It can be reinstated by using the undo function, reversing any actions

taken following the deletion of the placeholder text.



96

An example of placeholder text is:

[Suggest whether any interventions are need to improve certain facilities' performance.]

Rich and plain text controls work in a similar way, but have been created using the functions

of Microsoft Office 2007: Developer: Design Mode: Controls: Rich Text and Text. As with

placeholder text, the entered text overwrites the control text. When the user places their

cursor over the text the suggestion or reminder appears in a tab. When the text is

overwritten the ‘click here...’ text disappears.

An example of a plain text control is:

Click here to enter text.

For ease of recognition both of these sorts of text have been included in blue. When the final

report is submitted it would be consistent for the colour of these text paragraphs to be

changed to that of the rest of the report.

Updating tables and links

When you open the report object you will see the following window. It appears because

each of the tables have been included as linked objects within the report and the software is

now asking whether to update those links with any data which may have changed.

Select the ‘Yes’ option.

It may be that the prepared data are not stored in the location that was linked within the

report document. If you know that your summarized data are in a different location take the

following steps:

From the Microsoft Office Button, select the option to ‘Prepare’. In the list of options you will

see ‘Edit Links to Files’, select this option.


97

When you select this option you will be given a list of all of the linked objects within the

document. Each of these represents one of the tables in the report. You may update the links

from here, open source documents and change the sources from here. If you have struggled

to take any of these options you may chose to break the links using the option in this menu

and then, copy and paste-link the Microsoft Excel object in the report document – replacing

the suggested table with the one you have prepared and require.



98

Replacing tables

To replace the tables entirely from a Microsoft Excel sheet, select the ‘Paste’ pull down from

the Home Clipboard options. You will see the follow menu:

Select ‘Paste Special’. This will show the following window from where you can select the

sort of paste options you require. To retain the links with the original sheet use the left-hand

button ‘Paste link’ and select the object type of ‘Microsoft Office Excel 2003 Worksheet’.

Note in the Result text at the bottom a description is given of the resulting action. Check this

is what you require before selecting ‘OK’.


99

Once you have these links in place the table in the report document will be updated

automatically if the source data are changed.

Opening the report document

When the report document is opened the user is presented with a message box:

If the ‘No’ option is selected, the links to external data are retained, but are not updated

automatically. If you wish to update the data from the linked source, right click on the table

required for update, you will see the following menu:

Note the ‘paste

link’button



100

Use the ‘Update Link’ option to refresh the data.

Note: from the same menu you can open the Worksheet object. This can be very useful for

later maintenance and reviewing calculations.

Resources

For troubleshooting advice:

1. Understanding linked data in MS Office 2007: http://office.microsoft.com/en-

us/word-help/link-or-embed-an-excel-worksheet-HA010120810.aspx

2. If you receive a warning that the file format differs from the file format specified in

the file extension (working with templates and non-template documents:

http://support.microsoft.com/kb/948615

http://office.microsoft.com/en-us/word-help/link-or-embed-an-excel-worksheet-HA010120810.aspx

http://office.microsoft.com/en-us/word-help/link-or-embed-an-excel-worksheet-HA010120810.aspx

http://support.microsoft.com/kb/948615

A.1

APPENDIX 1 --- Frequently asked questions

1. Why is it necessary to measure adherence?

Because of the ever present threats of treatment failure and resistance.

2. What use will it be to have a standardized method of measurement?

Standardization is needed so that rates can be compared over time and between facilities. A

manager may know:

How a facility is doing at that moment

How it is doing over time

How it compares to other facilities

To assess the effectiveness of interventions to improve adherence levels.

All of these indicators will, in turn, give a yardstick for managers to concentrate energies

and resources on poorer performing facilities for maximal system strengthening.

3. Why is more than one indicator needed?

The problem with measuring adherence to ARVs is that it is a behaviour that takes place in

the privacy of the patient’s home. Therefore, all measures are indirect and subject to

different biases and inaccuracies. However all of these correlate with clinical outcome.

4. How do we sample facilities?

See Chapter 4, opening paragraph.

5. How do we sample patient records?

Use Figure 1 in Chapter 4.

6. Which dates do we use for dispensing and patient attendance?

Use Table 6 in Chapter 4.

7. Who should we have permission from to do the survey?

The National AIDS Control Programme and/or a local ethical review board.

8. Who should I communicate with in the facilities?

It is important to ask permission from the head of the facility and let the head of the facility

and the head of the HIV/AIDS clinic know your intention. It is often useful to communicate

with the pharmacist to ensure that you are planning your visit on a day when patients are

expected.



102

9. Who should be the survey coordinator?

They need the ability to oversee all stages of the survey including design, recruitment of

team leaders and data collectors, training, data collection, data processing, data analysis,

report writing, and dissemination.

10. Do we need other team leaders?

It depends on how many facilities you intend to survey. If it is 20, as recommended, then

that is a lot of work for one team. Therefore it is probably a good idea to have more than one

team and each will need a team leader.

11. Who should we choose as a team leader?

They need to have the capacity to assess the record-keeping system and efficiently decide

how to sample for the retrospective records. They also need to know how to communicate

with the facility managers and manage the work of the team so that all people are busy at all

times.

12. Who should we choose as data collectors?

Data collectors should be familiar with pharmaceutical terms to be able to reliably extract

information from records, and to record it accurately during observations. The most

effective data collectors are persons with clinical experience such as physicians, nurses,

pharmacists, paramedical staff, or senior medical or pharmacy students.

Data collection can be tedious, and requires an aptitude for concentration and attention to

detail. The best data collectors combine the discipline to collect data in a standardized way

with the flexibility to adapt procedures to the requirements of unusual situations. People

who have these traits but lack technical knowledge can be trained to perform effectively and

will improve with experience; people without them will never perform effectively,

regardless of their technical qualifications.

13. Can we adapt the data collection forms?

Yes you can change the medicines lists, the types of hospitals, the regions or areas, the types

of management and the types of drug suppliers: see Customization in Chapter5.

14. How do we print the forms and how many do we need?

See Printing Data Entry Forms in Chapter 5.

A.2

APPENDIX 2 --- Data collection forms

2A. Retrospective dispensing form



104

Appendix 2 Data collection forms

105

2B. Patient identifier forms

Patient Identifier form: Retrospective

Pt # Visit date Pt Identifier Pt # Visit date Pt Identifier

1 21

2 22

3 23

4 24

5 25

6 26

7 27

8 28

9 29

10 30

11 31

12 32

13 33

14 34

15 35

16 36

17 37

18 38

19 39

20 40



106

2C. Patient exit interviews

EXIT INTERVIEWS Side 1

Date

A B C D E F H I J K L M N

Pt #

Age in

Yrs

Gender,

M / F Occupation

Normal

activity Y

/ N

Months

on trt.

Cost

home to

clinic

Time

home to

clinic (in

mins)

Time in

clinic

today (in

mins)

All ARVS

dispensed

Y/ N

All Non

ARVS

dispensed

Y / N

All ARVs

well

labelled

Y/N

All other

Meds well

labelled

Y / N

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

Facility Name

Facility #


107

EXIT INTERVIEWS side 2 Facility # ________________

A O P Q R S T U V W X Y Z AF AG AH

Pt #

Name of first ARV in

patient regimen

# times

per day

pt knows

# times

per day

Y/N

# Doses

missed in

last 3 days

Name of second ARV

in patient regimen

# times

per day

pt knows

# times

per day

Y/N

# Doses

missed

in last 3

days

Name of third ARV in

patient regimen

#

times

per

day

pt knows

# times

per day

Y/N

# Doses

missed

in last 3

days

Reason for

Missing doses

(Code 1-15)

If "Other" then

specify reason for

missing doses:

Codes for column

AG

1

2 1 = Toxicity-Sde effect

3 2= Shared with others

4 3=Forgot

5 4= Felt Better

6 5= Too ill

7 ` 6=Stigma

8 7=Drug out of stock

9 8=Patient ran out of

10 pills or lost them

11 9= Travel problems

12 10= Inability to pay

13 11=Alcohol

14 12=Depression

15 13=Took Holy Waters

16 14= Fasting

17 15=Change regimen

18 16 = Other

19 (specify column AG)

20

21

22

23

24

25

26

27

28

29

30



108

2D. Facility interview questionnaire


109



110


111

2E. Questionnaire template form list

The Questionnaire template (Questionnaire.xlt) is issued with the following customizable forms: Maintainable via Customization of template 1. Country Customization

Maintainable via Customization of template by ‘unhide’ worksheet option. 2. Facility 3. Retro 4. Facility – Second Entry 5. Retro – Second Entry 6. Facility – Printing 7. Dispens Retro – printing 8. PT Identifier for printing May need to be customized for local languages 9. Exit 10. Exit – Second Entry 11. Exit Int – Printing No data to maintain 12. Blank 13. Macro warning sheet

2F. Consolidation template form list

The Consolidation template (Consolidated.xlt) is issued with the following forms: Accessible from Consolidation template 1. Macro warning 2. Facility 3. Retro. all pts 4. Retro. new 5. Retro. experienced 6. Exit all pts 7. Exit new 8. Exit experienced

A.3

112

APPENDIX 3 --- Training slides

Appendix 3 Training slides

113



114


115



116


117



118


119



120


121



122


123



124


125

A.4

126

APPENDIX 4 --- Report template

Survey of Facility Performance for their Patient Population’s Adherence to Antiretroviral Medicines

For Region(s): Placeholder for regions

Survey Dates:

Survey Coordinator: Click here to enter text. Report Date: 23 June 2010

Appendix 4 Report template

127

Acknowledgements

With thanks and recognition of the team leaders:

Click here to enter text. And to the teams of data collectors:

Placeholder for data collectors


Key Words

Adherence, antiretroviral, indicators, HIV/AIDS,



128

CONTENTS

ACRONYMS ..................................................................................................................................... 129

BACKGROUND ............................................................................................................................... 130

Facility Sampling ..................................................................................................................... 131

Logistics .................................................................................................................................... 131

Data Collection Instruments .................................................................................................. 131

Facility Interviews ................................................................................................................... 131

Exit Interviews ......................................................................................................................... 133

Retrospective Record Review ................................................................................................ 133

RESULTS ........................................................................................................................................... 134

Adherence Indicators .............................................................................................................. 134

Possible determinants of Adherence by source of Information ........................................ 135

Facility Forms ........................................................................................................................... 135

Exit Interview Forms............................................................................................................... 136

Retrospective Record Review Results .................................................................................. 136

CONCLUSION ................................................................................................................................. 136

ANNEXES ......................................................................................................................................... 137


129

ACRONYMS

ADR Adverse drug reaction

ART Antiretroviral therapy

ARV Antiretroviral

DH District hospital

FBO Faith-based organization

GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria

HC Health centre

INRUD International Network for the Rational Use of Drugs

OI Opportunistic infection



130

BACKGROUND

The methods we have followed in performing this survey follow those developed by the

International Network for the Rational Use of Drugs Initiative on Adherence to

Antiretrovirals (INRUD-IAA). The methods are designed to be able to use a standardized set

of indicators for looking at the adherence performance of the patient population of a facility

and to compare them to other facilities.

The information for the main indicators are derived from self-report from interviews and on

adherence, based on missed days from pharmacy records; and on appointment-keeping,

based on information from attendance registers.

Other system indicators have also been collected for availability and stock-outs, from

pharmacy records; time and expenses to travel to the clinic, time in clinic, dispensing rate,

patient knowledge rate and drug labelling rate from exit interviews.

The survey used three forms based on record review, patient exit interviews and interviews

with the facility director and the pharmacist. Data from the forms was double entered in an

analysis program developed by INRUD-IAA.






131

METHODS

Facility Sampling

A list of all facilities that treated patients with antiretroviral medicines in the country was

obtained through Click here to enter text. The facilities selected are shown in Table 1.

Table 1. Facilities selected

Facility Name Region Type of facility Facility management

[Select the table above with a right click, select update link.]

Logistics

Permissions

Click here to enter text. Teams


Data entry


Data Collection Instruments

Data collection instruments included:

A Facility Interview form

A Patient Exit Interview form

A Retrospective Data Form

Facility Interviews

The Facility Interview forms included questions on the days and hours the clinic is open and

whether it is open at convenient times, such as evenings or weekends. The workload per

clinician and per support staff was also calculated. The availability of private space for

counselling and laboratory services for CD4 and viral load were noted. A list of key Adult

ARVs, ARVs for children and non-ARV medicines that should be present in a well-



132

functioning clinic had been developed according to national treatment guidelines and the

most common opportunistic infections (Tables 2, 3 and 4). Whether these medicines were in

stock at the time of the visit and the number of days over the last 90 they had been in stock

was noted. Additional questions are asked on whether there were guidelines on ART use

and storage present, the criteria for starting patients on ART, ordering CD4 tests and viral

loads and the cost of these procedures; and the usual number of days of therapy given.

Table 2. Key adult ARVs that should be in stock in all facilities

1 Lamivudine 150 mg tab

2 Stavudine 40 mg

3 Stavudine 30 mg

4 Nevirapine 200 mg

5 Efavirenz 200 mg

6 Efavirenz 600 mg

7 ZDV + 3TC 450 mg

8

9

10


Table 3. Key children’s ARVs that should be in stock in all facilities

1 Efavivenz 50 mg or 100 mg

2 Efavirenz syrup

3 Nevirapine syrup 10 mg/ml

4 Lamivudine syrup 10 mg/ml

5 Zidovudine 100 mg tab

6 Zidovudine syrup 10 mg/ml

7 Stavudine 15 mg

8 Stavudine 20 mg

9 Stavudine syrup

10



133

Table 4. Non-ARV key medicines that should be in stock in all facilities

1 Cotrimoxazole tab 480 or 960 mg

2 Cotrimoxazole susp 240 mg/5 ml

3 Fluconazole tab 150 or 200 mg

4 Miconazole gel

5 Erythromycin tab 250 or 500 mg

6 Nystatin oral drops 10,000 IU/ml

7 Aciclovir 200 mg

8 Aciclovir cream

9 Folic acid 5 mg

10


Exit Interviews

The intention was to do 30 exit interviews per facility, with the main indicator being a self-

report on adherence in recent days. At the same time, team members collected information

on other factors affecting adherence, such as the time spent getting to clinic, time spent in

clinic, whether medicines are accurately labelled, and whether the patient knows how to

take the medicine correctly. All questions were practiced in the various languages from the

different regions. The definition of ‚properly labelled‛ included each medicine being in

separate container or envelope with the medicine name, dose per time, and number of times

per day written on it.

To manage the exit interviews with the patients on ARV, when the patient went to collect

their medication the pharmacist or dispenser asked them to attend an interview, provided

they had not started on that exact day.

Retrospective Record Review

The aim was to sample 100 records from patients attending for ART during the month seven

months before the month of data collection. The main purposes of the retrospective record

review were to:

Monitor dispensing

Follow dispensing over six months (183 days), starting from the month seven months

before the month of data collection. See if there are any gaps in treatment of more than

30 days and to see if the patient is still in treatment at the end of the period.



134

Monitor attendance

Look at an appointment three months before data collection and see if the patient attends

the next appointment, and, if not, whether they attend in the next 3 or 30 days.

Record adherence

Record Adherence through self-report, pill count, or both if recorded.

Other aspects of the patient and clinical care were noted, including: age, gender, months on

treatment, WHO stage, CD4 count at initiation of treatment and CD4 count in the last six

months. From this data were calculated:

o the CD4 testing rate (percentage of patients with documented CD4 test results in

last six months);

o the percentage of patients achieving CD4 count >300 cells per µl on most recent

laboratory test;

o the percentage of patients with a documented viral load test in last six months;

o the percentage of patients achieving viral load counts <400 copies per ml on the

most recent laboratory test in the last three months

RESULTS



Table 5. Numbers of facilities visited, exit interviews conducted and records reviewed

Median Maximum Minimum

Number of facilities surveyed 0

Number of exit interviews 0

Number of records reviewed 0

Facility Total Number


Adherence Indicators

The main adherence indicators are as shown in Table 6. This shows that Click here to enter

text. Full facility level results of the surveys can be seen in the Appendices.


135

Table 6. Adherence indicators

Median Maximum Minimum

% Self report full adherence over last 3 days ? ? ?

DISPENSING (from record review)

% Days Covered by Medicine Dispensed 0 0 0

Gap in Meds of >30 Days (if still on tx) 0 0 0

0 0 0

? ? ?

0 0 0

0 0 0

0 0 0

Self Report (from Exit interviews)

% Did NOT attend within 30 days of next appointment

% of all Appointments attended after medicine ran out

% still in treatment

ATTENDANCE (from record review)

% Attended next appointment on or before day of appointment

% Attended within 3 days of next appointment

Facility


Possible determinants of Adherence by source of Information

Facility Forms


Table 7. Selected results of facility questionnaire

Indicator Median Maximum Minimum

Patient load/week

Number hours/week

Patients/hour/clinician

Patients/week/support staff

Access to lab services (%)

Private adherence rooms (%)

% ARVS in stock (adult %)

% days (in previous 90) ARVS (adult %) in stock

ARVS in stock (children %)

% days (in previous 90) ARVS (children %) in stock

% OI key medicines in stock

% days (in previous 90) key medicines in stock

Convenient operating time (open weekends or evenings)




136

Exit Interview Forms



Table 8. Selected results of the exit interviews


Able to do normal activity (%)

Avg. travel time to clinic (minutes)

Avg. time in clinic (minutes)

Know ARV dosage (%)

ARV Medicine properly labelled (%)

Non ARV Medicine properly labelled (%)

All ARVs dispensed (%)

All non-ARVs dispensed (%)


Retrospective Record Review Results



Table 9. Selected results from the retrospective record review


Average Age

% Female

Mean Months on treatment


CONCLUSION


[Include Self report, Attendance &Dispensing coverage.]

[Comment on the median facility as well as the variety between facilities ]

[Suggest whether any interventions are need to improve certain facilities' performance.]




137

ANNEX 1: Facility interview results in detail

Table 1:1. Facility data-1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Ave or %

Maximum

Median

Minimum

% ARVs Now

in Stock

(Child List)

% OI Key

Medicines

Now in Stock

Average %

Days ARVs

in Stock

(Adult List)

Average %

Days OI Key

Medicines in

Stock

Weekly

Number of

Patients

Number of

Hours per

Week

Pts/ Hour/

Clinician

Pts/

Week/

Support staff

# days

supply of

ARVs given

to new

patients

# days

supply of

ARVs given

to ongoing

patientsFacility

% ARVs Now

in Stock

(Adult List)

Average %

Days ARVs

in Stock

(Child List)



138

Table 1:2. Facility data-2

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Facility

Access to Lab

for CD4 or

Viral Load

Private space

for Adherence

Counselling Child Care

Food for

Patients

Link Patients

with Other

Persons

Living with HIV

Have

Connection

with the Local

Community

National ART

Treatment

Guidelines

Donor ART

Treatment

Guidelines

ART Storage

Guidelines


139

ANNEX 2: Exit interview results in detail

Table 2:1. Exit Interviews data

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Ave or %

Maximum

Median

Minimum

% non

ARV Meds

Well

Labelled

% ARVs

dispensed

% Non-

ARVs

dispensed

% self

report full

adherence

Average

Time in

Clinic

Average

Travel

Time

Average

cost to

travel

% Do Not

Know

DosageFacility

Average

Age

Average %

Female

#

Interviews

% ARV

Meds Well

Labelled

% Can Do

Normal

Activity

Average

Months on

Treatment



140

ANNEX 3: Retrospective record review results in detail

Table 3.1. Retrospective data

1 0.00%

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Ave or %

Maximum

Median

Minimum

%, Did not

attend within

30 days of

next appt

% with Gap in

Medicines

>30 Days if

Still in

Treatment

% last

Dispensing

Covered Any

of Last 30

Days

% all

appointments

attended AFTER

medicines

consumed

% Attend next

appt after visit

3 months

ago

%, Attended

within 3 days

of next apptFacility # Pts Mean Age % Female

% Days

Covered by

Medicines if

Still in

Treatment

A.5

141

APPENDIX 5 --- Complementary indicators of

adherence

Pill count-based adherence measures

Pill counts are used by some ART programmes to compare a patient’s actual and expected

consumption since the pharmacy last dispensed the medicine. If records include pill counts,

the data can be used to calculate the pill count adherence measures. Because pill count

recording is relatively rare, these indicators are only collected where possible.

Pill Count 1. Full adherence (pill count)—Percentage of patients with perfect recent

adherence to ARV treatment

Pill Count 2. Average adherence (pill count)—Average percentage of recent ARV doses

taken

Rationale Some programmes use pill counts to monitor adherence. Pill counts at two consecutive visits can be used to estimate adherence between those two visits.

Source of data Pill counts from clinical or pharmacy records.

Data collection Based on record review of the same systematic sample of 100 patients used

for the core adherence indicators.

Data are needed on both the total number of pills taken home during the previous visit (including pills remaining in the bottle at that time plus newly dispensed pills that were added) and the number of pills remaining in the bottle brought to this visit.

Computation Consumption rate for each patient = (number of days of pills taken home in

previous visit - number of days of pills remaining in bottle this visit)/(number of days that have elapsed since previous visit) × 100.

Note: If any consumption rate is >100 percent, then change it to 100 percent.

Full adherence—(Number of patients for whom consumption rate equals 100 percent /number of patients with pill count data).

Average adherence—(Sum of consumption rates across all patients/number of

patients with pill count data).

Comments and pitfalls

Some patients dispose of medicines if they know that pill counts will be conducted at the clinic. Pill counts require considerable effort. If clinics already count pills, this method can provide alternate adherence measures. If a patient is taking > 1 ARV, these indicators should be calculated separately for each

medication.

Self report-based adherence measures from clinical or pharmacy

records

When collected from patient exit interviews, this is a core indicator where the question and

mode of asking has been standardized. Using clinical records to measure this indicator is

possible only if the question has been asked consistently and recorded routinely. For this

reason the self report written in clinical notes is a complementary adherence indicator. In



142

practice, the recall period they may have asked about could vary from their adherence

yesterday to since the last clinic visit.

The indicator chosen here using self-reporting is the same as used from exit interviews.

Self Report 1. Percentage of patients with full adherence to ART (i.e., no doses missed

in the recall period, which is three days in the INRUD-IAA methodology)

Rationale Perfect (or > 95%) adherence is the primary treatment goal.

Source of data Patient self-report—―In the last 3 days (or at least a standardized number of days) have you missed any of the ARV doses you were supposed to take?‖ (Response: Y/N)

Data collection Pharmacy or clinical records based on the same sample of 100 patient records sampled for the core indicators.

Computation (# of patients responding N/# of patients asked) × 100.

Comments Question can be asked for last 1, 2, 3, 4, or 7 days. For any of these periods, this indicator is the equivalent of the 95% adherence rate (missing 1 dose in 7 days is 7.7% of doses on a twice daily regimen). Calculation can be the same if

the question is asked for 30 days or for the period since last clinic visit, but interpretation would differ.

Pitfalls The only hope of getting an honest answer is if the interviewer or clinician is friendly and non-officious. Interviewers or clinicians need to be trained to ask the question in a uniform way.

A.6

143

APPENDIX 6 --- Complementary indicators of

determinants of adherence

There are many other pieces of information that can be collected that may affect a patient’s

ability or willingness to adhere to treatment. Many of these can be collected from the facility

interview but many others would need to come from clinical records. This therefore would

include an extra level of effort of pulling out the relevant clinical records and reading them.

So, these are complementary indicators as this level of effort is not needed to obtain the core

adherence indicators. They may however be relevant for explaining the adherence results

and designing suitable interventions.

1. Complementary facility indicators

Laboratory Tests

1. CD4 testing rate—Percentage of patients with documented CD4 test at treatment

initiation

2. CD4 testing rate—Percentage of patients with documented CD4 test results in last six

months

3. Viral load testing rate—Percentage of patients with documented viral load test in last

six months

Clinical Outcomes

4. Achievement of CD4 target—Percentage of patients achieving CD4 count > 350 cells

per µl on most recent laboratory test in the last six months

5. Achievement of viral load target—Percentage of patients achieving viral load counts

< 400 copies per ml on most recent laboratory test in last six months

Guidelines

6. The percentage of facilities with a copy of the national ART treatment guidelines

7. The percentage of facilities with a copy of a donor's ART treatment guidelines

8. The percentage of facilities with a copy of guidelines on ART storage

9. The percentage of facilities that follow a clinical guideline for starting patients on

ART

2. Quality of treatment

10. Adherence to standard treatment guidelines (STGs)—Percentage of patients whose

current treatment is consistent with national STGs



144

Days' Supply of Medicine Dispensed

11. The average number of days' supply of ARVs usually given to new patients

12. The average number of days' supply of ARVs usually given to experienced patients

Facility Services and Contact with the Community

13. The percentage of facilities that provide food for patients

14. The percentage of facilities that have a formal system for linking patients with other

persons living with HIV as support partners

15. The percentage of facilities that have connection with the local community, such as

churches or other organizations

3. Complementary demographic indicators

1. Tuberculosis status—Percentage of patients with TB comorbidity

2. WHO disease stage at initiation of ARVs—Percentage of patients diagnosed as stage

I, II, III and IV at initiation

1. Complementary Facility Indicators

Laboratory tests

CD4 and viral load testing rate:

1. Percentage of patients with documented CD4 test results at initiation of treatment.

2. Percentage of patients with documented CD4 test results in last six months.

3. Percentage of patients with documented viral load test in last six months.

Rationale Increase in CD4 count over time is an indirect measure of success in controlling HIV. Routine testing for CD4 can assist in adherence monitoring.

Source of data Clinical records.

Data collection Based on same sample of 100 patients find the clinical records and search for

CD4 count at initiation and most recent CD4 count and viral load.

Computation Initiating CD4 testing rate—(number of patients with documented CD4 count at initiation of ART/number of patients searched) × 100.

CD4 testing rate—(number of patients with documented CD4 count in last 6 months/number of patients searched) × 100.

Viral load testing rate—(number of patients with documented viral load in last 6 months/number of patients searched) × 100.

Comments This will give a much more accurate assessment than the simple questioning during the facility interview. However, it does involve finding the clinical records for the 100 patients. Not all facilities do routine CD4 counts or viral loads for all patients.

Appendix 6 Complementary indicators of determinants of adherence

145

Clinical Outcomes

4. Achievement of CD4 target—Percentage of patients achieving CD4 count > 350 cells

per µl on most recent laboratory test in the last 6 months.

5. Achievement of viral load target—Percentage of patients achieving viral load counts

<400 copies per ml on most recent laboratory test in last 6 months.

Rationale Increase in CD4 and reduction in viral load are the primary outcomes intended for ARV therapy. If resources permit, routine monitoring of CD4 and viral load are the best ways to measure the clinical impact of ARV therapy and, indirectly, adherence.

Source of data Clinical records.

Data collection Based on same sample of 100 patients find the clinical records and search for

most recent CD4 count and viral load. Record whether they are more or less than 350 cells per µl for the CD4 and < 400 copies per ml for viral load.

Computation CD4 target—(number of patients with documented CD4 count on most recent laboratory test in the last six months > 350 cells per µl/number of patients

with a laboratory test result) × 100.

Viral load target—(number of patients with documented viral load test on most recent laboratory test in the last 6 months < 400 copies per ml/number of patients with a laboratory test result) × 100.

Comments This is only partly relevant because CD4 counts are affected by other factors,

such as length of time on treatment and by other infections. Therefore there may be other reasons for levels than adherence.

Guidelines

6. The percentage of facilities with a copy of the national ART guidelines

7. The percentage of facilities with a copy of a donor ART guidelines

8. The percentage of facilities with a copy of guidelines on ART storage

9. The percentage of facilities that follow a clinical guideline for starting patients on

ART



146

Rationale To provide optimal care in line with national policies it is advantageous to have guidelines that can be followed.


Data collection While doing the facility interview ask to see copies of the different guidelines.

If you can’t hold them in your hand they are not there.

Computation National ART treatment guidelines—The presence of a national ART treatment guidelines.

Donor ART treatment guidelines—The presence of a donor ART treatment

guidelines.

ART storage guidelines—The presence of an ART storage guidelines.

Clinical guidelines for starting patients on ART—Whether the facility manager says that the facility follows the clinical guidelines for starting patients on ART.

Comments The presence of written guidelines does not mean they are being followed.

2. Quality of treatment

10. Adherence to STGs—Percentage of patients whose current treatment is consistent

with national STGs

Rationale Patients treated according to established guidelines for ARVs are more likely to

be adherent to care.

Source of data Clinical records for the sample of 100 patients in indicators 4–10.

Data collection Patient clinical records are examined to determine if current treatment is

consistent with national STG for selection and dosing of ARVs.

Computation (Number of patients whose last treatment was consistent with STGs/number of patients records examined) × 100.

Comments Need to prepare a list of recommended STG regimens in the system of care. This may be difficult for data collectors to record reliably. In practice, it may be better to record each patient’s regimen for later evaluation.

Number of days' supply of medicine dispensed

11. The average number of days' supply of ARVs usually given to new patients.

12. The average number of days' supply of ARVs usually given to experienced

patients.

Appendix 6 Complementary indicators of determinants of adherence

147

Rationale The number of days of ARVs dispensed dictates how often the patient has to return to the clinic. The more frequent, the more time is sacrificed to

treatment, but also the more contact the patient has with the clinic. Both of these factors may affect adherence.

Source of data Facility Interview and Retrospective data form.

Data collection While doing the facility interview ask whether the clinic has a normal protocol for the numbers of days of ARVs dispensed to new and to experienced patients. Also observe the most frequent numbers when filling in the retrospective data form.

Computation New Patients—The stated average number of days of ARVs dispensed to new patients.

Experienced Patients—The stated average number of days of ARVs dispensed to experienced patients.

Comments This information can be checked while filling in the retrospective dispensing data form. If there is a disagreement in the results, what is found on the

dispensing data form will be more accurate.

Facility services and contact with the community

13. The percentage of facilities that provide food for patients.

14. The percentage of facilities that have a formal system for linking patients with

other persons living with HIV as support partners.

15. The percentage of facilities that have connection with the local community, such as

churches or other organizations.

Rationale When poor patients start ART, their appetite improves and they start to put on weight. The increased appetite represents increased cost. This can be facilitated by the programme providing food to the patients during their first months of treatment. With chronic diseases by far the majority of the patient’s

time is spent in the community rather than in the facility. Therefore community support and community linkages are key to helping the patient adhere.


Data collection While doing the facility interview ask whether the clinic has a policy for giving food to patients; whether they have a formal system for linking patients with other persons living with HIV as support partners; and whether they have connection with the local community, such as churches or other organizations.

Computation Food—Does the facility provide food to patients?

Linking patients with other persons living with HIV as support partners—Does the facility have a formal linking system?

Linkage with the community—Does the facility have active links?

Comments This information can be checked for completeness by asking patients in the exit interviews.

3. Complementary demographic indicators

1. Tuberculosis status—Percentage of patients with TB comorbidity.

2. WHO disease stage at initiation of ARVs: Percentage of patients diagnosed as stage I,

II, III and IV at initiation.



148

Rationale TB status and disease stage effect outcomes and may effect adherence.

Source of data Clinical and pharmacy notes.

Data collection TB status and disease stage at initiation can be noted while checking the 100 sampled patient records for the adherence and defaulting indicators. However

the clinical records will need to be selected as well.

Computation TB status—(Sum all patients with TB diagnoses at initiation divided by sum all patients) × 100.

WHO disease stage—(Sum all patients with WHO stage I, II, III and IV at

initiation divided by sum all patients) × 100.

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