How to Investigate Adherence to Antiretroviral Treatment An Indicator-Based Approach WHO/EMP/MIE/2011.1
WHO/EMP/MIE/2011.1 How to Investigate Adherence to Antiretroviral Treatment An Indicator-Based Approach WHO/EMP/MIE/2011.1 How to Investigate Adherence to Antiretroviral Treatment An Indicator-Based Approach How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 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How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach. ii 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) Management Sciences for Health (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 Management Sciences for Health (MSH) 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, Management Sciences for Health (MSH) 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 iii How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 Management Sciences for Health (MSH) 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 Management Sciences for Health (MSH) Saul Kidde National AIDS Control Program Hudson Balidawa UK Management Sciences for Health (MSH) John Chalker, Larysa Szalapaj (IT consultant) USA Management Sciences for Health (MSH) Julie Frye, Keith Johnson, Lewis Parish, Amber Thomson Harvard Medical School Drug Policy Research Group Dennis Ross-Degnan, Catherine Vialle-Valentin, Anita Wagner Zambia Management Sciences for Health (MSH) Oliver Hazemba National AIDS Control Program Abel Mwalele, Harold Witola University of Zambia, Department of Community Medicine Seter Siziya iv Acronyms AIDS ART ARV HIV IAA IHCAR INRUD MPS MSH NACP Sida Susp WHO acquired immune deficiency syndrome antiretroviral therapy antiretroviral human immunodeficiency virus Initiative on Adherence to Antiretrovirals Division of International Health of the Karolinska Institute International Network for the Rational Use of Drugs WHO Medicine Policy and Standards Management Sciences for Health National AIDS Control Programme Swedish International Development Cooperation Agency Suspension World Health Organization v 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 vi 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 vii How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 viii 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. 1 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 2 Introduction 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’. 3 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 4 1 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; nonadherence, 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. 5 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 6 Chapter 1 Overview of manual 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 (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 Percentage of patients attending clinic within three days of appointment N/A = Data not collected 72 (58–99) 78 (15–100) 92 (38–100) 77 (46–96) 87 (72–99) 80 (20–100) 96 (67–100) N/A Indicator Attendance, dispensing, and gap 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.‛ 7 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Table 2. Number of records with pill counts and self reports Ethiopia Uganda Rwanda Kenya Total 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 Number of records examined Conclusion from feasibility tests The INRUD-IAA field tests examined four categories of indicators for adherence to ARV medicines and treatment defaulting: 1. 2. 3. 4. Self-reported adherence from exit interviews. Days supplied by medicine. Patient attendance. 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, selfreports in clinic records appear more promising. However, the consistency of the datagathering methods needs to be assessed. The four field tests provide strong evidence that adherence targets can be met in resourcepoor 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. 8 2 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?‛ 9 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 selfreported 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. 10 Chapter 2 Core indicators of adherence 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. 11 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. Source of data Pharmacy records. 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). 12 Chapter 2 Core indicators of adherence 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 13 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. Source of data Pharmacy records. 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. 14 3 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. 15 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 16 Chapter 3 Indicators for possible determinants of adherence 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. 17 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 18 Chapter 3 Indicators for possible determinants of adherence 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 Comments Number of patients seen for AIDS consultative services in last week (both on ART and not on ART)/number of support staff. 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. 19 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 20 Chapter 3 Indicators for possible determinants of adherence 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. 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 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. 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 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. 21 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. Source of data Facility interview. 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?‛ 22 Chapter 3 Indicators for possible determinants of adherence 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. 23 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 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 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. 24 4 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. 25 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 26 Chapter 4 Survey design 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 27 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 28 Chapter 4 Survey design 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. 29 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 30 5 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: Data Collection Overview Customization Accessing the data entry forms Printing data entry sheets for data collection Filling in the Forms Facility Questionnaire Retrospective Dispensing Data Exit Interviews Some comments about workflow Second Data Entry Consolidation 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. 31 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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, faithbased, 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. 32 Chapter 5 Data collection tools and how to modify, print and fill them in 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. 33 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 34 Chapter 5 Data collection tools and how to modify, print and fill them in 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. 35 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach You will be taken to the Country Customization sheet. It looks like this: Facility Types Teaching Hospital Referral hospital Zonal Hospital District Hospital Other Hospital Health Center or Clinic Regions TH RH ZH DH OH HC Northern Southern Eastern Western Central Facility Management Government Private Mission Other NGO Other Gov Priv FBO NGO Other Supply Sources Government Global Fund PEPFAR NGO Other Gov GF PEP NGO Other Location Name Urban Rural ADULTS ARV First Line 1 2 3 4 5 6 7 8 9 10 Abbreviation Lamivudine 150mg tab 3TC Stavudine 40 mg tab D4T Stavudine 30 mg tab D4T Nevirapine 200 mg tab NVP Efavirenz 200 mg tab EFV Efavirenz 600 mg tab EFV ZDV 300 mg tab +3TC 450 mg tab ZDV,3TC 7 1 2 3 4 5 6 7 8 9 10 CHILDREN ARV First Line Abbreviation Efavirenz 50 mg or 100mg tab Efavirenz 30mg/ml syrup Nevirapine 10mg/ml syrup Lamivudine 10mg/ml syrup Zidovudine 100 mg tab Zidovudine 10 mg/ml syrup Stavudine 15mg tab Stavudine 20 mg tab Stavudine 1mg/ml syrup EFV EFV NVP 3TC ZDV ZDV D4T D4T D4T 9 Drugs for Opportunistic Infections 1 2 3 4 5 6 7 8 9 10 Cotrimoxazole 480 mg or 960 mg tab Cotrimoxazole 240mg/5ml susp Fluconazole 150 mg or 200 mg tab Miconazole Gel Erythromycin 250 mg or 500 mg tab Nystatin 10,000 IU/ml oral drops Acyclovir 200 mg tab Acyclovir 5% Cream Folic Acid 5mg tab 9 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: 36 Chapter 5 Data collection tools and how to modify, print and fill them in 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: 37 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 38 Chapter 5 Data collection tools and how to modify, print and fill them in Select the option to Enable this content and press OK. 39 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Control form The INRUD Control form will be shown. Save & close options Form name Reminder: how to access customization Tick boxes indicating completion of data entry First Entry access & control Main control section for entry of collected data Form printing section Second Entry access & control 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. 40 Chapter 5 Data collection tools and how to modify, print and fill them in 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 41 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 backto-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. 42 Chapter 5 Data collection tools and how to modify, print and fill them in 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 3 Stavudine 30 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 43 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 7 Stavudine 15 mg tab D4T 8 Stavudine 20 mg tab D4T 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 44 Chapter 5 Data collection tools and how to modify, print and fill them in 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 = 45 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 46 Chapter 5 Data collection tools and how to modify, print and fill them in 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. 47 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 48 Chapter 5 Data collection tools and how to modify, print and fill them in 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 Seq. No. B Patient identifier C Age in years at index visit 1 49 D Gender M/F E Date initiation ARVs How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 Index visit dispensing Index visit Date any ARV drugs dispensed (dd/mm/yy) # days of ART dispensed on that day J K Visit 2 dispensing Date any ARV drugs dispensed (dd/mm/yy) # days of ART dispensed on that day N O Visit 3 dispensing 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.) 50 Chapter 5 Data collection tools and how to modify, print and fill them in 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 If yes BZ If missed CA 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). 51 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 52 Chapter 5 Data collection tools and how to modify, print and fill them in 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 o Are you the one who usually gives this child his/her medicine? 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. 53 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 Pt # Age in Yrs C D E F 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. 54 Chapter 5 Data collection tools and how to modify, print and fill them in 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. 55 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 56 Chapter 5 Data collection tools and how to modify, print and fill them in 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 Name of first ARV in patient regimen P # times per day Q Patient knows # times per day Y/N R # 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. 57 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Columns W–Z 7. If there are three ARVs, also write in columns W–Z. AF Reason for missing doses (Code 1-15) AG 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. 58 Chapter 5 Data collection tools and how to modify, print and fill them in 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 Example 1: Example 2: Example 3: Step 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 1 First Entry Facility Questionnaire 2 Second Entry Facility Questionnaire 3 First Entry Retrospective Dispensing Data 4 Second Entry Retrospective Dispensing Data 5 First Entry Exit Interviews 6 Second Entry Exit Interviews 1 First Entry Facility Questionnaire 2 First Entry Exit Interviews – commencement of 3 First Entry Retrospective Dispensing Data – commencement of 4 Second Entry Facility Questionnaire 5 First Entry Retrospective Dispensing Data – completion of 6 Second Entry Retrospective Dispensing Data 7 First Entry Exit Interviews – completion of 8 Second Entry Exit Interviews 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. 59 6 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 60 Chapter 6 Planning and field methods 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. 61 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 62 Chapter 6 Planning and field methods 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? 63 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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) 64 Chapter 6 Planning and field methods 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 communicates with the team leaders and data collectors and goes them to ensure that the agreed procedures are being followed. The the study coordinator if the team has any unresolved issues or if which should be communicated to the other teams. Following is a copy of a checklist for coordinator activity as a guide. 65 coordinator regularly out into the field with team leader can phone there is a new finding How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Table 11. Coordinator checklist Coordinator checklist Task Organize the survey process Permissions and approval Select and prepare sample sites Recruit team leaders Recruit data collectors Organize transport Organize computers Give airtime Create medicines list Pilot test Finalize forms Completed If needed, seek approval for the survey from National AIDS Control Programme 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 4 suitable team leaders and agree on terms and conditions Recruit 12-16 suitable data collectors and agree terms and conditions Book vehicles large enough to transport each team for the duration of the survey If possible, locate at least one laptop computer for each team Make sure that each team leader has enough airtime to communicate with the survey coordinator With the team leaders decide on the needed list of adult and child ARVs and the other key medicines lists Test the data collecting methods in a facility 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 Copies Prepare official letter of introduction for team leaders 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) 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 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) Task Training slides 66 Completed Chapter 6 Planning and field methods 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) 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 Assemble material for survey Finalize arrangements Supervise survey After the survey Analyse data Report writing Present results 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 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 the actual survey, ensuring each day that all team leaders are doing well and sorting out any questions 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 Provide copy of survey forms to data analyser to complete summary forms 1–4 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 Coordinate presentation/feedback of results 67 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 68 7 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. 69 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 60 minutes Brief description of complementary indicators that will help with interpretation 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 60 minutes Number of sites to be visited by each team 3. How data are collected Show data collection forms Brief overview of the four different data collection forms Data collection form package 20 minutes This manual 90 minutes This manual 60 minutes This manual 60 minutes This manual 180 minutes for team leaders Data collection 60 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 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 8. Revise all forms 70 Chapter 7 Training of data collectors and team leaders Topic Materials Revisit all areas of discussion and interpretation 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 Time form package This manual Data collection forms Data entry forms (1/2 day) Schedule (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) 71 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 72 8 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. 73 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 74 Chapter 8 Data entry and data processing 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: 75 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 76 Chapter 8 Data entry and data processing 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: 77 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 78 Chapter 8 Data entry and data processing 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: 79 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 80 Chapter 8 Data entry and data processing 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. 81 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 82 Chapter 8 Data entry and data processing 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. 83 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 84 Chapter 8 Data entry and data processing 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. 85 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 86 Chapter 8 Data entry and data processing 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. 87 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 88 9 CHAPTER 9 --- Interpretation of data and followon 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: 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 1. 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 89 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 90 Chapter 9 Interpretation of data and follow-on questions 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 91 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 92 10 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. 93 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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: 94 Chapter10 Report outline 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. 95 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 96 Chapter10 Report outline 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. 97 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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’. 98 Chapter10 Report outline Note the ‘paste link’button 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: 99 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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/enus/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 100 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. How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 102 A.2 APPENDIX 2 --- Data collection forms 2A. Retrospective dispensing form How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 104 Appendix 2 Data collection forms 2B. Patient identifier forms Patient Identifier form: Retrospective Pt # Visit date Pt Identifier Pt # 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 40 105 Visit date Pt Identifier How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 2C. Patient exit interviews EXIT INTERVIEWS Side 1 Date Facility # A Pt # 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 B Age in Yrs C D E F Facility Name H I Time Normal Cost home to Gender, activity Y Months home to clinic (in M / F Occupation /N on trt. clinic mins) 106 J K L M N Time in All Non All ARVs All other clinic All ARVS ARVS well Meds well today (in dispensed dispensed labelled labelled mins) Y/ N Y/N Y/N Y/N Appendix 2 Data collection forms EXIT INTERVIEWS side 2 A O Name of first ARV in patient regimen Pt # P # times per day Q R Facility # ________________ S T U V pt knows pt knows # Doses # times # times missed # Doses per day missed in Name of second ARV # times per day in last 3 Y/N last 3 days in patient regimen per day Y/N days W Name of third ARV in patient regimen X Y Z AF AG # pt knows # Doses times # times missed Reason for If "Other" then per per day in last 3 Missing doses specify reason for day Y/N days (Code 1-15) missing doses: AH Codes for column AG 1 2 1 = Toxicity-Sde effect 3 2= Shared with others 4 3=Forgot 5 4= Felt Better 5= Too ill 6 7 ` 6=Stigma 8 7=Drug out of stock 9 8=Patient ran out of pills or lost them 10 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 (specify column AG) 19 20 21 22 23 24 25 26 27 28 29 30 107 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 2D. Facility interview questionnaire 108 Appendix 2 Data collection forms 109 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 110 Appendix 2 Data collection forms 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 111 A.3 APPENDIX 3 --- Training slides 112 Appendix 3 Training slides 113 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 114 Appendix 3 Training slides 115 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 116 Appendix 3 Training slides 117 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 118 Appendix 3 Training slides 119 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 120 Appendix 3 Training slides 121 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 122 Appendix 3 Training slides 123 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 124 Appendix 3 Training slides 125 A.4 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 126 Appendix 4 Report template 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 Click here to enter text. Key Words Adherence, antiretroviral, indicators, HIV/AIDS, 127 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 ......................................................................................................................................... 137 128 Appendix 4 Report template 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 129 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. Click here to enter text. Click here to enter text. Click here to enter text. Click here to enter text. 130 Appendix 4 Report template 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 Click here to enter text. Data entry Click here to enter text. 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 well131 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 [Select the table above with a right click, select update link.] 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 [Select the table above with a right click, select update link.] 132 Appendix 4 Report template 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 [Select the table above with a right click, select update link.] Exit Interviews The intention was to do 30 exit interviews per facility, with the main indicator being a selfreport 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. 133 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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 Click here to enter text. Click here to enter text. Table 5. Numbers of facilities visited, exit interviews conducted and records reviewed Total Number Facility Median Number of facilities surveyed 0 Number of exit interviews 0 Number of records reviewed 0 Maximum Minimum [Select the table above with a right click, select update link.] 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. 134 Appendix 4 Report template Table 6. Adherence indicators Facility Median Maximum Minimum Self Report (from Exit interviews) % Self report full adherence over last 3 days ? ? ? % Days Covered by Medicine Dispensed 0 0 0 Gap in Meds of >30 Days (if still on tx) 0 0 0 % still in treatment 0 0 0 % Attended next appointment on or before day of appointment ? ? ? % Attended within 3 days of next appointment 0 0 0 % Did NOT attend within 30 days of next appointment 0 0 0 % of all Appointments attended after medicine ran out 0 0 0 DISPENSING (from record review) ATTENDANCE (from record review) [Select the table above with a right click, select update link.] Possible determinants of Adherence by source of Information Facility Forms Click here to enter text. Table 7. Selected results of facility questionnaire Indicator Median 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) [Select the table above with a right click, select update link.] 135 Maximum Minimum How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Exit Interview Forms Click here to enter text. Click here to enter text. Table 8. Selected results of the exit interviews Indicator Median Maximum Minimum 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 (%) [Select the table above with a right click, select update link.] Retrospective Record Review Results Click here to enter text. Click here to enter text. Table 9. Selected results from the retrospective record review Indicator Median Maximum Minimum Average Age % Female Mean Months on treatment [Select the table above with a right click, select update link.] CONCLUSION Click here to enter text. [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.] Click here to enter text. Click here to enter text. Click here to enter text. 136 ANNEX 1: Facility interview results in detail Table 1:1. Facility data-1 Facility 1 % ARVs Now % ARVs Now % OI Key in Stock in Stock Medicines (Adult List) (Child List) Now in Stock Average % Days ARVs in Stock (Adult List) Average % Days ARVs in Stock (Child List) Average % Days OI Key Medicines in Stock 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Ave or % Maximum Median Minimum 137 Weekly Number of Patients Number of Hours per Week Pts/ Hour/ Clinician # days supply of Pts/ ARVs given Week/ to new Support staff patients # days supply of ARVs given to ongoing patients How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Table 1:2. Facility data-2 Facility 1 Access to Lab Private space for CD4 or for Adherence Viral Load Counselling Child Care Food for Patients Link Patients Have with Other Connection National ART Persons with the Local Treatment Living with HIV Community Guidelines 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 138 Donor ART Treatment Guidelines ART Storage Guidelines Appendix 4 Report template ANNEX 2: Exit interview results in detail Table 2:1. Exit Interviews data Facility 1 # Interviews Average Age % Can Do Average Average % Normal Months on Female Activity Treatment Average Time in Clinic Average Travel Time 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Ave or % Maximum Median Minimum 139 Average cost to travel % Do Not Know Dosage % non % ARV ARV Meds % Non% self Meds Well Well % ARVs ARVs report full Labelled Labelled dispensed dispensed adherence How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach ANNEX 3: Retrospective record review results in detail Table 3.1. Retrospective data Facility 1 # Pts Mean Age % Female % Days % with Gap in % last % all Covered by Medicines Dispensing appointments % Attend next Medicines if >30 Days if Covered Any attended AFTER appt after visit %, Attended Still in Still in of Last 30 medicines 3 months within 3 days Treatment Treatment Days consumed ago of next appt %, Did not attend within 30 days of next appt 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 140 A.5 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 141 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 142 A.6 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. 7. 8. 9. The percentage of facilities with a copy of the national ART treatment guidelines The percentage of facilities with a copy of a donor's ART treatment guidelines The percentage of facilities with a copy of guidelines on ART storage 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 143 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 144 Appendix 6 Complementary indicators of determinants of adherence 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 145 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach Rationale To provide optimal care in line with national policies it is advantageous to have guidelines that can be followed. Source of data Facility interview. 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. 12. The average number of days' supply of ARVs usually given to new patients. The average number of days' supply of ARVs usually given to experienced patients. 146 Appendix 6 Complementary indicators of determinants of adherence 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. 14. 15. The percentage of facilities that provide food for patients. The percentage of facilities that have a formal system for linking patients with other persons living with HIV as support partners. 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. Source of data Facility interview. 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. 147 How to Investigate Adherence to Antiretroviral Treatment: An Indicator-Based Approach 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. 148
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