HOW TO USE APPLIED QUALITATIVE METHODS TO DESIGN DRUG USE INTERVENTIONS Introduction GETTING READY Chapter 1: Overview of Methods Chapter 2: Planning a Qualitative Study COLLECTING AND ANALYZING DATA Chapter 3: In-Depth Interview Chapter 4: Focus Group Discussion Method Chapter 5: Structured Observational Method Chapter 6: Structured Questionnaire Method SYNTHESIZING DATA AND DESIGNING INTERVENTIONS Chapter 7: Synthesizing Data to Prepare for Interventions Chapter 8: Using the Study Results to Design Interventions PRODUCED BY INRUD SOCIAL SCIENTISTS WORKING GROUP: Daniel Kojo Arhinful Ananda Mohan Das Johana Prawitasari Hadiyono Kris Heggenhougen Nick Higginbotham Folasade Bosede Iyun Jonathan Quick Dennis Ross-Degnan WORKING DRAFT December, 1996 INTRODUCTION Why This Manual? Improper use of medicines is a problem in every country. The 1985 WHO conference in Nairobi focused attention on efforts to improve drug use practices in developing countries. Subsequent efforts have included a search for standardized methodologies to study drug use, as well as costeffective interventions to improve it. Although some progress has been made, much remains to be done. The aim of this manual is to describe an approach for gathering data using applied qualitative methods to design interventions to improve drug use. The manual has been designed for district health officers, planners, and other personnel with little or no experience in those methods. The methods include In-Depth Interview, Focus Group Discussion, Structured Observation, and Structured Questionnaire. These methods have been modified and simplified to suit the practical needs in the field. In-Depth interview refers to one-on-one open-ended interactions between an interviewer and a respondent. Focus Group Discussion involves bringing together a defined group of respondents in order to investigate opinions and beliefs in an interactive setting. Structured Observation records actual behaviors in settings of interest using a predetermined guide. Structured Questionnaires use open- and close-ended que stions to investigate knowledge, attitudes, or practices of a relatively large sample of respondents. These methods can be used in many different ways. The focus of this manual is on how they can be used to understand the determinants of a problem in drug use and barriers to change in order to prepare effective interventions. Studying Drug Use Problems The use of medications in both developed and developing countries often shows a striking discrepancy with principles of clinically acceptable practice. In most developing countries the sources of misuse range from travelling drug peddlers and small grocery shops to prescribers in teaching hospitals. Examples of some of the commonly encountered inappropriate drug use include: ! Excessive use of injections where oral treatment is more appropriate, e.g., in malaria treatment; ! Multiple drug prescriptions, such as the use of several items for one condition as in diarrhea; ii ! The use of drugs when no drug is indicated, e.g., using antibiotics for simple ARI; ! The use of the wrong drug for a specific condition requiring drug therapy, e.g., tetracycline in acute watery childhood diarrhea requiring ORS; ! Self medication with prescription drugs such as psychotropics that are easily purchased over the counter; ! Patient non-compliance with a treatment regimen, such as failure to complete a full course of antibiotic therapy; ! The unnecessary use of drugs with adverse effects, e.g., dipyrone as a mild analgesic; ! The use of overly expensive drugs with cheaper alternatives, for example, a cephalosporin rather than a penicillin antibiotic. Consequences of Inappropriate Drug Use Some of the identifiable public health consequences of inappropriate use of drugs include: ! Increased morbidity and mortality due to avoidable treatment failures; ! Increased risk of unwanted effects such as adverse drug reactions; ! The emergence of drug resistance such as chloroquine resistance Plasmodium Falciparum and penicillin resistance gonococci; ! Waste of resources leading to increased costs and reduced availability of other vital drugs; ! Psychosocial effects such as when patients come to believe that there is "a pill for every ill" which may cause increased demand for drugs. Policy makers, planners, and others interested in promoting good health need specific, concrete information in order to develop effective programs to tackle these problems. Since appropriate drug use depends not only on providers but also on patients, studies to examine the reasons underlying problems in drug use must target both providers and patients, as well as their interactions. These studies must be broad enough to consider the complex of cultural, social, economic, and structural factors that can influence behaviour. Applied qualitative methods can be used to gather this kind of information in order to design an appropriate intervention. iii Designing Interventions to Improve Drug Use Interventions to improve drug use can reduce unnecessary drug expenditures and lead to improvement in the quality of health and medical care. Just as there are several factors giving rise to drug use problems, there are also multiple intervention strategies to tackle them. Three major approaches are educational, managerial, and regulatory. Educational approaches seek to inform or persuade prescribers, dispensers, and patients to use drugs in rational ways. Managerial approaches also guide decisions through the use of specific processes, forms, packages or monetary incentives. Regulatory approaches, on the other hand, seek to restrict decisions. Any of these approaches may be used to introduce changes to improve drug use. However, the success of an intervention will depend on the nature of a problem as well as the underlying reasons for the problem. Experience from several programs indicates that it is usually more effective to combine strategies to improve a single drug use problem. For example, when planning to improve the treatment of ARI, in-service training programs can be combined with supportive community education through the media. Or if working on diarrhea treatment, regulations which limit access to anti-diarrheal drugs can be combined with the educational approach of disseminating standard diarrhea treatment guidelines. Many studies have succeeded in documenting drug use problems, but few have examined the factors underlying these problems in a meaningful way. Yet such studies are needed to provide policy makers and managers with useful insights into the types of interventions that might succeed in correcting these problems. One of the main obstacles that has hindered such efforts has been the lack of simple techniques to carry out these studies. This manual aims to fill this gap and complement existing methods on how to study drug use. Contents of The Manual Following the Introduction, the manual includes three sections that describe a process for using applied qualitative methods to study a drug use problem and design an intervention. These sections are: Section I: Getting Ready 1. Overview of four applied qualitative methods and their strengths and weaknesses. 2. Description of the steps involved in planning an applied qualitative study. Section II: Collecting and Analyzing Data 3. Detailed description of steps involved in using In-Depth Interview. 4. Detailed description of steps involved in using Focus Group Discussion. iv 5. Detailed description of steps involved in using Structured Observation. 6. Detailed description of steps involved in using a Structured Questionnaire. Section III: Synthesizing Data and Designing Interventions 7. Description of how to synthesize data to prepare for interventions. 8. How to use study results to design appropriate interventions. How to Use the Manual This manual is meant as a GUIDE, or as one useful example of how applied qualitative methods can be used to develop an intervention. It is NOT meant as a set of strict instructions which must be strictly followed in exactly the same way in all situations and settings. Indeed, research methods will vary in relation to the problem, the changing context in which it occurs, and the type of material and human resources available. The steps described here can be modified and adapted to suit particular resources and study needs. However, steps described in the four methods chapters are important and should be seriously considered by anyone planning to use one or more of these methods. v GETTING READY Chapter 1: Overview of Methods Chapter 2: Planning a Qualitative Study CHAPTER ONE OVERVIEW OF APPLIED QUALITATIVE METHODS This chapter provides an overview of several applied qualitative methods. It begins with a brief description of these methods and a table of their advantages and disadvantages. The chapter ends with a brief description of how to use these methods to design interventions. 1.10: What is Applied Qualitative Research? Applied qualitative research combines simple, rapid assessment methods to find out about the meanings of behaviour, and to determine why things are the way they are or why people behave as they do. Some of the data collected by these methods may be quantified, but the analysis itself is a qualitative one . Applied qualitative assessment seeks to investigate a specific behavioral problem in enough detail to suggest the best strategies for intervening to improve it. This involves understanding the socio-cultural, economic, structural, and political contexts within which the behavior occurs. By understanding motiva tions and constraints, an intervention can be targeted in the most effective way. 1.11: Applied Qualitative Methods in Drug Use Studies Applied qualitative methods are useful for investigating a wide range of drug use problems. These may concern provider or patient behaviours, and the context in which the problem occurs. Some ways these methods can contribute include: ! exploring a topic about which little is known in order to provide insights for intervention; ! investigating the feasibility, acceptability and appropriateness of potential interventions; ! developing appropriate questionnaires at the early stage of a study; ! validating quantitative data through "triangulation," i.e., the use of multiple methods; ! complementing the quantitative component of a study by providing concrete examples or explaining observed practices; ! developing appropriate materials for educational interventions; 1-1 ! identifying problems in ongoing interventions and suggesting appropriate solutions; ! assessing the impact of on-going or completed interventions. Although applied qualitative methods can be used in all these ways, this manual will focus on how they might contribute to designing the strongest possible interventions. 1.12: Summary of Advantages and Disadvantages This manual describes four methods that have been particularly useful for understanding drug use problems: in-depth interviews, focus group discussions, structured observations and structured questionnaires. The following table briefly summarizes each of these methods and their advantages and disadvantages. Table 1.1: Summary of Main Features of Suggested Field Methods Method Advantages Disadvantages In-Depth Interview Open-ended face to face interactions, in which an interviewer tries to elicit a respondent=s knowledge, opinions, feelings, or behavior related to a defined set of topics with no predetermined list of responses Flexible and allows interviewer more opportunity to ask questions Permits observation of non-verbal expressions of respondents Can be difficult to find good interviewers Personal opinion of interviewer may creep into interview Personal contact with respondent enhances good probing Difficult to generalize results Quicker and cheaper than individual interviews involving the same number of people Depth of information may be limited since it is hard to probe individual ideas Greater pool of expertise is tapped than in individual interviews Group consensus may inhibit original, unorthodox, or minority views Focus Group Discussion Open-ended discussions facilitated by a trained moderator with a small homogeneous group (6-12) of respondents on a defined list of topics Better way than individual interviewing to explore sensitive subjects in some cultures Provides an excellent means of obtaining information from illiterate communities 1-2 A few people may dominate the discussion Success of a group discussion can be unpredictable Method Structured Observation Systematic recording of data about a set of events or interactions using a predetermined format Advantages Disadvantages It enables behavior to be recorded in context Presence of observer can affect the subjects' behavior and thereby bias the data It affords an opportunity to understand situational factors that influence behavior Observer's bias in recording can affect the information obtained It is very helpful in validating data obtained by other methods A structured format may limit the type of information collected It verifies what people do compared to what they say they do Structured Questionnaire Structured instrument containing open- &/or closeend questions used with a relatively large sample of respondents to examine knowledge, attitude, or reported practices. Samples are relatively large, so results may be more generalizable Respondents have little control over the interview process Data easily quantified and analyzed Little flexibility to collect data on aspects of the problem not covered in questionnaire Findings can be compared with those of similar studies Structural rigidity may sometimes influence responses Can validate data from interviews, focus groups, or observations 1.13: Choosing the Right Method(s) Although the applied qualitative methods in this manual can be used to examine all the underlying reasons of attitudes, behaviors and practice, each has its particular strengths and weaknesses. Some methods may be better suited for certain situations or problems, for example: a. In-Depth Interview is a suitable choice where: ! group interaction and peer pressure are likely to inhibit individual responses and make discussion unproductive; ! in certain cultures, when the topic is so sensitive that respondents would be unwilling to talk openly in a group; 1-3 b. c. d. ! it is necessary to know and understand how attitudes and behaviors link together on an individual basis; ! respondents are geographically dispersed or cannot be assembled. Focus Group Discussion is a suitable choice if: ! social network influences are strong and may influence the behavior of interest; ! group interaction is highly desired and favored to stimulate a useful discussion; ! the topic is not so embarrassing as to prompt respondents to withhold information ! a single subject area is being examined, and differences of behavior are less relevant; ! an acceptable number of target respondents can be reasonably assembled at a given location. Structured Observation method is a suitable choice if: ! the aim is to examine a behavior in its natural setting; ! to see if what people actually do confirms or contradicts what they say they do; ! collecting information on non-verbal aspects of behavior is highly desired; ! validating data obtained with other methods. Structured Questionnaires are most appropriate where: ! when the questions of interest are already well known, and the objective is to examine knowledge, attitudes, or practices in a defined population; ! information is needed from a relatively larger sample in order to generalize results from other methods; ! there is a need to follow up a preliminary enquiry to enrich results. Although each method has specific strengths, an approach using a number of different methods in complementary fashion may be the most comprehensive and effective way to study a problem. 1-4 CHAPTER TWO PLANNING AN APPLIED QUALITATIVE STUDY This chapter outlines the various activities involved in planning an applied qualitative drug use study. Following a brief section on the need for a resource person when applying these techniques, the chapter describes the major steps involved in implementing a study. It concludes with a summary of common implementation problems. 2.10: Is There Need For a Resource Person? The information provided in this manual is designed to enable investigators to be as self dependent as possible. However, health professionals typically do not have training or experience in using applied qualitative methods. In many cases, it will be necessary for such people who intend using this manual to seek assistance from someone familiar with these methods. How much assistance is needed will depend upon the previous experience of the investigator(s), personality skills, the size of the study, and the resources available to it. When considering using the services of a resource person, look for someone who: ! analyses situations critically; ! recognizes and avoids bias; ! is socially sensitive to others= feelings; ! possesses good powers of observation; ! has good interactional qualities. Where might you find such a resource person? These skills are traditionally associated with social scientists in such disciplines as anthropology, sociology, psychology, or communication studies. However, training alone is not as important as experience in actually using applied qualitative methods in the field. In practice, such people are often not easy to come by, especially at the district level in most countries. If they are available at all, they may be much in demand and the resources for engaging them may be limited. 2-1 Apart from social scientists, you could also look for health or medical colleagues who have had training in public health and some experience using similar techniques. Sometimes social and community wo rkers with experience in research could prove equally useful. 2-2 The assistance of an experienced resource person is likely to be necessary if you have no previous training and experience in using applied qualitative methods. It is advisable to find such a resource person before using these methods for the first time. 2.20: Steps in Planning an Applied Qualitative Study The recommended steps in implementing an applied qualitative study are: STEPS IN PLANNING AN APPLIED QUALITATIVE STUDY Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 2.21. Form a Working Group Identify a Specific Problem Formulate Specific Questions Choose a Package of Study Methods Identify Study Groups Plan for implementation STEP 1: Form a Working Group One important decision in the early stages of a study is to determine who will be involved in planning and implementation. The success of the study depends to a large extent on the calibre of those who will be involved in implementing it. a. Multidisciplinary Study Team There are no formal criteria for determining who should be involved. This will vary with the aims and purpose of the study. Nevertheless, as mentioned above, it is ideal if co- investigators have had training and experience in a relevant field. If not, assistance of an experienced resource person should be sought before using these methods for the first time. One excellent strategy is to form a multi-disciplinary team. Ideally, such a team would involve medical and para- medical personnel as well as social scientists. In addition, it may be helpful to include policy makers, planners, and others who are likely to benefit or implement the results of the study. Clearly, if a resource person will assist in implementing the methods, it would be appropriate to include him or her as a member of the multi-disciplinary team. 2-3 The role of the study team is to make major decisions regarding planning and implementation. Using their individual expertise and joint experience, the team can assist in keeping the study focussed on relevant issues, and drawing insights from the findings. b. Field Staff Usually, field staff will be recruited to collect data. Teachers, nurses, pharmacists, and other health staff often prove to be good and reliable data collectors. When selecting the members of a field team, some of the essential qualities to look for include: ! familiarity with the culture of the people being studied; ! ability to establish rapport and gain confidence and trust; ! knowledge of health care system and drug use terms; ! ability to speak the local language; ! ability to listen well. Depending upon the study situation, one or more of the following categories of field staff may be required: ! Supervisor(s): to coordinate field work, monitor the performance of interviewers or other field staff, and assure the quality and consistency of data collection. ! Moderator: to facilitate focus group discussions. ! Interviewers: to guide respondents from topic to topic and record responses in in-depth or structured interviews. ! Observers : to observe and encode as much as possible events, situations, or behaviors according to a pre-defined protocol. ! Recorders: to take notes about the topics discussed by respondents in a manner that will not affect the flow of a discussion as a non-participant observer. ! Assistants: to assist focus group moderators or interviewers to run sessions smoothly, especially when interference from crowds and children must be avoided. ! Translators : to translate for respondents or transcribe responses where field staff and respondents do not speak a common language. 2-4 ! 2.22. Administrative Personnel: to handle administrative business and finances related to the study. STEP 2: Identify a Specific Problem Every study begins with the recognition of a problem. The first task in a study is to identify and state explicitly the problem to be investigated. a. What is a study problem? A problem is a perceived difficulty or an observed discrepancy between what should be and what is. "The problem" is important to every study since it will guide the specific questions that must be raised by the investigator. Examples of problems that could be addressed in an applied qualitative study might be: ! a high proportion of patients in public health facilities receiving injectable vitamins and analgesics; ! continuing use of antidiarrheals in children among private practitioners; ! high frequency of antibiotic use for primary care patients with upper respiratory infections; ! greater use in hospital outpatient departments of nonsteroidal anti- inflammatory drugs than aspirin or paracetamol. Some key principles to keep in mind when selecting a problem to investigate in an applied qualitative study are: b. ! the problem should be important, either clinically or economically; ! the problem should be focused and specific; ! there should be some uncertainty about the causes of the problem or the way to address it most effectively. Background Information After you specify the problem, it is a good idea to review what is already known about it. This helps to guide the subsequent investigation, prevent duplication, and suggest appropriate questions that need to be answered. Useful sources of background information are reports of previous and other related studies on this topic, clinical records or administrative data, or 2-5 educated opinion consisting of published and unpublished papers and articles. Such information may be available from the ministry of health, the drug regulatory agency, international organizations, drug companies, or private organizations involved in health care. 2.23. STEP 3: Formulate Specific Questions The objective of the types of studies we describe in this manual is to provide the information needed to design an intervention. Once a problem has been identified, it is useful to narrow the focus of a study to a limited set of questions that may influence what kind of intervention is selected. It is helpful to plan and formulate questions in a structured way in order to make sure that no aspects of the problem or study topic are missed. For example, the case study from Pelotas, Brazil (Table 2.1), shows how one team developed a set of questions to guide an applied qualitative research study before undertaking an intervention to improve diarrhea treatment. Your task at this point is to develop a similar set of questions to guide your own study. The questions should seek to explore the problem you have identified in more depth. For example, they might examine aspects of the local social, cultural, or economic environment that influence the problem selected. They might seek to explore beliefs, attitudes, or misconceptions of health workers or patients related to the problem. When developing these questions, consider brainstorming with those in authority and other influential persons or groups in the potential target population to learn more about the way they think about the problem at hand. The following are some examples of the kinds of questions that may be answered about drug use behavior in most health care settings using applied qualitative methods. The questions are all designed to provide useful information for selecting the type of intervention that might be effective, or for targeting the intervention to particular individuals or behaviors. The questions have been arranged in the structured format followed in the Brazil case study. 2-6 CASE STUDY: IMPROVING DIARRHEA TREATMENT IN PELOTAS, BRAZIL A health center record review in Pelotas, Brazil, found specific problems in diarrhea treatment in children under five. Prior to launching an educational intervention for physicians to improve practices, the study team used patient exit interviews, physician and patient in-depth interviews, and observations of treatment episodes to answer the following questions: To Describe the Problem in Greater Detail ! Are treatment practices the same in health centers managed by the municipality, university, and state government? ! Is inadequate knowledge about diarrhea or its treatment a common problem among physicians and patients? ! What knowledge deficits exist about the causes and diagnosis of diarrhea? About the need for ORS? About the dangers of specific anti-diarrheas? About the efficacy of antibiotics or anti-parasitics? ! How do physicians think other physicians manage diarrhea? To Decide if an Intervention is Feasible ! How much do patient expectations influence physicians' treatment choices? ! How satisfied are patients with different kinds of treatment for diarrhea? ! How important is maintaining patient satisfaction to physicians? ! Do physicians feel that patients are capable of learning if the effort was made to explain about diarrhea and its treatments to them? ! Would physicians or other staff members have time for counseling patients about diarrhea or other health problems? To Target the Intervention ! How often do mothers ask directly for specific types of treatment? ! Are there non-verbal ways that mothers influence physician decision-making? ! How do physicians respond when asked for certain treatments? ! Do physicians feel a group identity with colleagues at the health center? ! To which respected peers do physicians turn with questions about treatment? ! How often do physicians approach colleagues with medical questions? To Define Specific Intervention Messages ! How important to physicians is the self-image of being a knowledgeable scientist or powerful healer? ! When physicians have changed their practices in the past, what has stimulated them to do so, and how do they feel about these changes? ! What do physicians think about prototype materials developed to promote correct diarrhea practices? To Decide Format and Style of the Intervention ! How do physicians get information about new health problems or drugs? ! Do they ever attend continuing education sessions, and are they useful? ! Do they read any journals and which ones? ! Do they learn about drugs from drug package inserts, advertisements, or drug company representatives, and is this information valuable? ! How do physicians respond when presented with summaries of the practices of their health center in relation to all similar facilities? ! How do physicians feel about different models for continuing education: group seminars, visits by medical experts, visits by pharmacists? 2-7 a. b. c. To Describe a Problem in Greater Detail ! Do practices vary greatly by location, health facility, or health provider? ! Do deficits in knowledge contribute to problem practices? ! What specific areas of knowledge are deficient: diagnostic procedures, drug efficacy, drug dosing, etc.? ! Do health providers think their practices are the same as or different from their peers? ! Do problem practices vary by diagnosis, type of patient, time of month, etc.? To Decide if an Intervention is Feasible ! What is the communication like between patients and health providers? ! How often do patients express a preference for a certain drug or type of therapy? ! How satisfied are patients with the care they receive? ! What specific aspects of care contribute to patient satisfaction? ! How important is satisfying patients to health providers? ! Do health workers try to educate patients about their illness or the drugs they prescribe? ! Are there severe constraints in the work environment that would prevent health providers from changing their behavior? ! Are there proper drugs available at all times? ! Are health providers interested in improving their practices? ! Are the administrative authorities supportive of the types of changes proposed? To Target the Intervention ! Are there particular health providers or facilities with especially poor practices? ! What is the relationship between an individual provider and the group in which he or she practices? 2-8 d. e. ! Are there features of the social, cultural, or behavioral context that could be used to influence the practices of individual health workers or patients? ! Are there particular people whose opinion is especially influential with health providers? ! Would it be possible to recruit these opinion leaders to assist in implementing the intervention? ! Is it possible to reduce the general problem of interest to more specific behaviors or practices that it would be easier to change? To Define Specific Intervention Messages ! Can specific myths about practice be identified that it is possible to debunk with scientific facts? ! Are there specific areas of miscommunication between patients and health providers that can be highlighted in an intervention? ! What kinds of educational materials are available to health providers or patients? ! When health providers or patients have changed in the past, what was it that caused them to change? ! How do health workers or patients respond to prototype intervention materials? To Decide Format and Style of Intervention ! What sources of information do health providers use to learn about health problems or drugs? ! What educational programs have health workers already attended? ! What model of continuing education is most highly rated: group seminars, workshops, visits by medical experts, etc.? ! How often do health workers interact with drug company representatives? ! Is information from drug companies considered to be biased? ! Do health workers have access to any unbiased sources of drug information? 2-9 2.24. ! Are there any ways for health workers to review their practices for the problem of interest: regular utilization reports, practice audits, departmental reviews, etc.? ! How do health workers respond when given summaries of their own practices? STEP 4: Choose a Package of Study Methods Once the study questions have been specified, you are ready to determine what methods will be suitable to answer these questions. When deciding which methods are most appropriate, there are a few general issues to consider. ! The nature of the problem, and the amount of information needed to choose among alternative intervention strategies; ! The resources needed to gather, process, and analyze the data; ! The time frame available to carry out and complete the study; ! The local research capacity to carry out and complete the study; ! The feasibility of implementing each method in the specific local environment, taking into account attitudes, logistics, and time frame. Assuming that resources and capacities are not a serious constraint, then the selection of methods is based on their advantages and disadvantages (see Table 1.1 and Section 1.13). Each method is best suited for answering different types of questions. The methods chosen should reflect the questions to be answered for a particular study. It is often best to explore a given question by more than one method. For example, Table 2.1 describes the set of study questions selected by the team in Pelothas, Brazil, that was investigating reasons for inappropriate diarrhea treatment in public health centers. They settled on a package consisting of (1) patient exit interviews using structured questionnaires; (2) in-depth interviews with a sub-sample of these patients scheduled at a later time; (3) in-depth interviews with a sample of physicians working in the health centers; and (4) structured observations of 5-10 diarrhea cases treated by each physician. The brief exit interviews were used to answer questions about patient knowledge and satisfaction. The long in-depth patient interviews explored attitudes and beliefs about diarrhea in greater detail, and investigated willingness to change treatment. Physician in-depth interviews provided detailed information about knowledge, attitudes, peer relationships, and sources of information. Focus groups were not used because of concerns about the logistics of assembling groups of doctors. Structured observations were used to learn about patient-doctor communication, and diagnostic and treatment practices. 2-10 2.25. STEP 5: Identify Study Groups One basic decision in any study is how to identify the study population. It is important that the sampling procedures are clearly determined at the beginning of the study since the quality of information will depend to a large extent on the choice of respondents. In drug use studies, the study units may be patients, prescribers in health facilities, providers in communities, and many others. Correct sampling involves the selection of a study group that is representative of the study population. Such a group has all the important characteristics of the population being studied. Incorrect sampling, that is, selecting a group that is not representative, can seriously bias study results. Sampling procedures can be categorized into probability and non-probability methods. Probability sampling methods are generally appropriate for quantitative studies, where there is a large population of interest, and random selection methods are used to choose the members to include in a study. Of the methods discussed in this manual, probability sampling would usually only be used for large questionnaire surveys (or perhaps a large survey of structured observations involving a number of health providers). Some of the methods for probability sampling are introduced in Annex A. Non-probability sampling is not based on a list of all the possible members of a study population, also known as a sampling frame. Instead, study members are chosen purposively, with an eye to representing the population in a certain way, or according to quotas. The key issue in drawing samples for applied qualitative research is being sure to gather information about all the important subgroups in the population. For example, in a study to look in more depth at ARI treatment practices, it may be important to look separately at: practices of para-medics vs. physicians; practices in rural vs. urban facilities; practices for children under five vs. older patients. This would mean including enough people from each of these subgroups to be able to compare and contrast them. How many people are enough? For in-depth interviews and focus groups, the objective is to get a general idea of the practices, beliefs, opinions, etc. in each important subgroup in order to be able to target the intervention appropriately. If there are consistent results, this would mean that only aout two focus groups per subgroup, or 3-4 in-depth interviews, would be needed. If the results in a subgroup are inconsistent, then additional focus groups or interviews would be conducted until the reasons for inconsistency are understood. For structured questionnaires (and sometimes for structured observations), a larger sample is required in order to generate quantitative summaries like percentages or averages. In these cases, a good general rule is to include 25-30 members in each important study subgroup, For example, a study might compare 25-30 urban health workers with an equal number of their rural colleagues. More detail about sampling is included in each of the following chapters describing the individual methods. 2-11 2.26. STEP 6: Plan for Implementation The final step before embarking upon the work is to map out the sequence of how various activities will proceed. This will require attention to the following activities: a. Choose Site(s) and Location(s) to be Used for the Study The specific geographic areas and health facilities need to be identified, keeping in mind the need to represent the larger population. Visit sites to become familiar with the people and logistics. This visit also provides an opportunity to arrange and prepare for subsequent activities including: ! Obtaining the necessary permission for the study from concerned authorities/people in the community. ! Identifying how study participants will be selected. ! Locating and arranging sites for group discussions and interviews when necessary. ! Obtaining basic descriptive information about the area/facility. ! Recruiting any support staff in the community that may be needed. In addition, the visit will afford an opportunity to decide the date and time for implementing individual methods. Consider the activities of the group or the community and their schedules before this decision is made. b. Select Coordinators for Each Study Component If the study will include multiple methods, it may be advisable to identify coordinators for each method. These coordinators will be responsible for identifying field staff, training them for their specific tasks, supervising the field work, and preparing the data for analysis. c. Plan the Schedule for Individual Study Components Some studies using multiple methods will implement all methods at the same time in the same sites. The plan for this type of study requires coordinating roles within each study team and scheduling the work of study teams within the selected study population (see Table 2.1). 2-12 COMPOSITION OF STUDY TEAMS Team No. 1: 1.1 In-depth (Administrator) Dr. Mannan In-depth (Medical Officer) Dr. Mannan FGD (Mothers) Dr. Shamsun Nahar (Moderator) Dr. Faisal (Note-taker) Intercept (Mothers) Ms. Panna Observation Dr. Mahamud 1.2 1.3 1.4 1.5 Team No. 2: 2.1 2.2 2.3 In-depth (Administrator) In-depth (Medical Officer) F G D (Mothers) (Moderator) 2.4 2.5 Intercept Observation Dr. Dr. Iftikar Dr. Iftikar Khadiza Mr. Matin, Dr. Jamal (Note-takers) (Mothers) Dr. Khadiza Dr. Rashid FIELD VISIT SCHEDULE Date Place of Visit 26.07.92 Sunday (1) Sonargaon THC 27.07.92 Monday (1) Bhaluka THC (2) Sreepur THC Team 1 Team 2 29.07.92 Tuesday (1) Dhamrai THC (2) Uthali THC Team 1 Team 2 2-13 Team 1 (2) Gajaria THC Team 2 Some studies may require one applied qualitative method to be completed before another can begin, for example, if focus groups are being used to develop specific items that will appear in a later questionnaire. Another example would be if patient-physician observations needed to take place before in-depth interviews with physicians were carried out to avoid biasing physician behavior dur ing the observations. The timing, sequencing, and coordination of components should be organized in the overall study schedule. After completing a schedule of study components, it is time to shift to the steps needed to implement each applied qualitative method. These steps are covered in detail in each of the four chapters which follow. 2-14 COLLECTING AND ANALYZING DATA Chapter 3: In-Depth Interview Chapter 4: Focus Group Discussion Method Chapter 5: Structured Observational Method Chapter 6: Structured Questionnaire Method CHAPTER THREE IN-DEPTH INTERVIEWS This chapter focuses on the use of in-depth interviews as an applied qualitative method in drug use studies. It begins with a brief overview of the technique and continues with a description of the various steps involved in carrying out an applied qualitative study using the in-depth interview method. 3.10: Overview 3.11: What is an In-Depth Interview? An in-depth interview is a qualitative research technique that allows person to person discussion. It can lead to increased insight into people's thoughts, feelings, and behavior on important issues. This type of interview is often unstructured and therefore permits the interviewer to encourage an informant (respondent) to talk at length about the topic of interest. The in-depth interview uses a flexible interview approach. It aims to ask questions to explain the reasons underlying a problem or practice in a target group. You can use the technique to gather ideas, to gather information, and to develop materials for drug use interventions. 3.12: Use of In-Depth Interview in Drug Use Studies One effective way to understand the reasons underlying problem behaviors is in-depth analysis. In drug use studies, areas in which the method can be used include: ! In pilot studies to generate ideas. ! To obtain greater depth of information on a topic of interest as a supplement to data received from other methods, e.g., structured questionnaire. ! To evaluate the impacts of interventions on attitudes or beliefs. This section will consider only how in-depth interviews are used to gather data to prepare for interventions. 3-1 3.20. Steps in Using In-depth Interview to Study Drug Use Problems The activities involved in using in-depth interview to study drug use problems can be organized into a series of steps. These are summarized below. A detailed discussion of each step follows the summary. TABLE 3.1: Summary of Key Steps in Conducting In-depth Interview Step 1: Plan how you will conduct the in-depth interviews. Step 2: Decide who your respondents will be. Step 3: Prepare interview guide for each category of informants. Step 4: Select your interviewers. Step 5: Train the interviewers. Step 6: Conduct the actual interviews. Step 7: Analyse the data. Step 8: Write a report and recommend intervention(s). 3.21. STEP 1: Plan How You Will Carry out the In-depth Interview Once the decision to use in-depth interview has been taken, very important planning decisions and preparations are needed. These include designing the study, identifying the target group, preparing for the fieldwork, and collecting and analysing the data. a. Consider the Need for a Resource Person Because the technique may be new to most health oriented professionals, one of the first planning decisions to consider is the need for a resource person, particularly if the investigator is not confident enough with the application of the method. Other things to consider before you decide to seek the assistance of a resource person are the size of the study and the resources available to it. 3-2 In a small exploratory study with limited resources, you could rely on a colleague who had used the method before. However, in a big study to ascertain the reasons for some observed problem behaviour, you may need the assistance of a social scientist who is well experienced in the actual use of the method.(See Section 2.10 for more tips on qualities to consider when in need of a resource person). b. Role of a Resource Pe rson Essentially, the role of any resource person at this stage will be to assist in planning the technical details of the study. This will include: ! how to obtain the study informants; ! development of interviewing guides; ! how to proceed with the field work; ! training of interviewers and other field staf; ! guidance in subsequent analysis of the field data. These aspects of the study are very important, and such professional support needs to be seriously considered if the principal investigator is not too confident about the method. 3.22. STEP 2: Decide Who Your Informants (Respondents) Will be Identifying respondents from whom you can obtain the information you need is a very important part of the study since the sources of information affects the quality of data obtained. You must therefore identify key informants who can provide useful information for the study. a. Determining Who to Select for the In-Depth Interviews The first thing to bear in mind is that in-depth interviews take much more time than structured questionnaires. It is therefore not usually practicable to interview a large sample. A typical study might include 3-4 interviews with respondents in each of 4 subgroups of interest, for a total of less than 20 interviews. To account for the small sample size, those selected for the in-depth interview must be people who are well informed about the issue to provide relevant information. Usually informants are selected for in-depth interviews in a purposive manner, that is, people with specific demographic/social characteristics are chosen to represent a defined subgroup. This involves identifying individuals from the target groups who are and must be knowledgeable about the study topic. Depending upon the nature of the problem and composition of the target population, respondents are selected from various identifiable subgroups. Respondents selected must be fairly representative of the various groups in the study population for this technique to be useful. 3-3 b. Selecting Informants: Some Examples Let us consider a study about the overuse of antibiotics in the treatment of ARI in children. After deciding to use in-depth interviews, a study team may have identified the following target groups: ! prescribers working in primary, secondary, and/or tertiary health care facilities; ! dispensers working in these same health care facilities; ! mothers with children under the age of five in the community; ! operators of drug outlets in the private or informal sector. The following example (Figure 3.1) describes two ways in which participants could be selected to represent these target groups. 3-4 Figure 3.1: Example 1: Examples Showing How Respondents May Be Selected To identify representative prescribers in public health facilities: ! List the names and locations of all health facilities in the district separately according to levels, i.e., all community clinics, all health posts/centers, all district hospitals. ! Select a small number of facilities in which the interviews are to be conducted, e.g., 2 community clinics, 2 health centers, 1 hospital. ! In each facility, choose one health worker in each category to be interviewed, e.g., village health worker, officer- in-charge, paramedic, dispenser, or pediatric specialist. If the information from the selected respondents is not consistent, additional facilities and respondents can be chosen in the same way until the reasons for the inconsistency are understood. Example 2: To identify representative mothers of children under the age of five recently treated for ARI: ! Contact the selected health facilities in the study district. ! Get a list of children under the age of five treated for recent episodes of ARI (ideally within two weeks preceding the study to enhance recall by mothers who will be interviewed). ! Decide on reasonable number of mothers to be interviewed, e.g. 2 mothers treated at each of five facilities. ! Contact the mothers in their homes and arrange interviews. If it is not feasible to identify mothers from clinic records, it may be necessary to draw the sample in the community. Village elders or local administration after have lists of families and family members. Families should be visited until two recent cases of ARI are identified. 3-5 c. Hints for Selecting Informants for In-Depth Interviews Some hints to consider when making your final selection of key informants are: 3.23. ! The informants should be unknown to the interviewers, if at all possible, in order not to increase the likelihood of their giving biased responses. ! They should not have previous knowledge of the specific issue of study. ! A conscious attempt should be made to select different categories of individuals in each target group, for example, by age, gender, status, education. STEP 3: Prepare an Interview Guide for Each Category of Respondents The guide consists of a list of questions or topics to be discussed by interviewers with respondents in the field. The quality of data obtained depends to a large extent on the quality of questions in the guide. A good guide uses general, non-directive questions or phrases instead of direct questions that may end up in "Yes" or "No" answers. The task of the investigator or team of investigators involves reviewing the study topics to develop questions that will yield relevant responses. Following are suggested stages in developing the interview guide: a. Framing the Questions 1. List the most important topics to be explored in the study. For example, for a study investigating the overuse of antibiotics in the treatment of ARI in children, we could list some of the specific topics for in-depth interviews with health workers: 2. ! which particular antibiotics are being used; ! symptoms associated with perceived need for antibiotics; ! reasons for prescribing antibiotics for the common cold; ! reported patient preference for drugs; ! sources of information about antibiotics. Identify relevant subtopics for each of the study topics Each major topic can be broken into specific subtopics that can be explored during the interviews. For example, in relation to reasons for prescribing antibiotics to treat common colds, we can list the following sub-themes: 3-6 ! beliefs about respiratory infections; ! efficacy of antibiotic s in treating infections. 3. Make a draft of possible questions that could be explored with respondents about these sub-topics. 4. Check each question against the overall study questions and take out those that are not needed to answer one or more of the study questions. 5. Check the questions again to ensure that they can help initiate discussion. Ensure that your questions are: b. ! clear and unambiguous; ! simple and easy to understand; ! not answerable by a simple Ayes@ or Ano@; ! reasonable and within the experience of the targeted respondents. Construction of Probes When writing the guide, build in useful "probes" to assist the interviewer. Probes are devices used to prompt a respondent to speak further when an initial question fails to elicit the desired information. Suppose in our antibiotic illustration the following question is asked of a prescriber: What would your reaction be if you were advised by the District Medical Officer to stop the use of antibiotics in the treatment of ARI in children? Answer: Well, I guess we'll have to wait and see what happens when the time comes. Here the respondent avoided answering the question. If his answer is accepted, his attitude about a policy against the use of antibiotics in treating ARI will not be known. It is helpful to anticipate this difficulty, and to construct "probe questions" in advance to cater for these situations. An example might be: How would you feel about the DMO issuing such a directive? The creation of appropriate probes brings a measure of control to a potentially haphazard form of questioning. 3-7 c. Sequence of Topics In general, the order of topics in in-depth interviews is never rigidly defined. Rather this is left at the discretion of the interviewer and is determined by the flow of the discussion. This is one of the reasons why interviewers need to be well trained in the art of interviewing. Design the guide in such a way that similar types of information will be elicited from all respondents. However, the particular phrasing of questions and their order or sequence may be re-defined to fit the characteristics of each interview. Example of Interview Guide Figure 3.2. shows a list of questions that may be asked in an in-depth interview to investigate the use of antibiotics by prescribers in treating ARI in children. The interview may not necessarily follow this order. More examples of in-depth interview guides are provided in annexes. 3-8 FIGURE 2: Example of Interview Guide Use of Antibiotics in the Treatment of common cold (ARI) in Children. Interview Guide for Prescribers Introduction: Self introduction, name and general affiliation Purpose of Interview We are aware that common cold (ARI) is one of the common health problems of children in this community. We are interested in knowing your views about this problem and how it is managed. It will be appreciated if we could spend some time together to discuss this issue. Interview Begins Clinic Experience How long have you been working as a (doctor, paramedic, etc.)? How long have you been working at this clinic? How many patients do you see in a day? How many of these patients are under the age of five? Diagnosis Could you please describe how respiratory infections present themselves in children in this community? How do you decide on severity of case? What are some of the symptoms of severe respiratory infection? Is it hard to recognize these symptoms? Treatment How do you usually treat mild respiratory infection in children? Do you always treat coughs this way or do you sometimes treat them differently? If yes: How do you decide on how to treat a cough? Do mothers sometimes ask for particular medicines? Use of Antibiotics When should someone prescribe an antibiotic for a child with common cold? Which antibiotics are the best to prescribe? and so forth 3-9 3.24. STEP 4: Select Your Interviewers The success of an in-depth interview depends in large part on the qualities of the interviewer. Much more communication skill is required tha n would be needed for administering ordinary questionnaire interviews. The role of the interviewer is to keep a discussion going by asking useful questions until he or she gets an appropriate response. This demands certain qualities in those selected for the task. The following qualifications are useful to consider: ! Formal training in social science or interviewing is an advantage though not a prerequisite. ! When social scientists are not available, people with secondary education in health- related areas such as nurses and community development workers or social workers with some experience in interviewing may also be suitable. Good interviewers are people who easily gain peoples= confidence and cooperation, speak clearly, and are good listeners. Additional qualities to consider are: ! knowledge of drug use issues; ! self confidence; ! ability to establish rapport; ! confident but not pompous; ! unassuming personality; ! politeness; ! articulate enough to prompt respondents to talk. 3-10 3.25. STEP 5: Train the Interviewers Training provides an opportunity to prepare the field team for their task. All field workers involved in a study attend a common training session so they can start with a common understanding of study objectives and procedures. Even experienced interviewers need to be trained, since each study will have its unique objectives, target groups, and study instruments. a. Duration of Training Training should be long enough to allow all aspects of the study to be tackled before the actual field work. The length of time may vary depending upon the size of the study and calibre of the field team. In general, however, this may take two to three days. An ideal location free from interference with the daily work routine of the field team must be secured for the training sessions. In order not to disrupt the sessions all materials and provisions, including snacks and lunch, should ideally be provided on site. b. Training Sessions At the beginning of the training, materials such as the study guides, protocols, and handouts should be given to the interviewers so that they can study them and raise any general queries during the training. The trainer must explain and discuss these materials with the interviewers. The discussion of each material should be allotted reasonable time to make it effective. The trainer should encourage a friendly and conducive atmosphere for free exchange of comments and questions. The training program can be organized in stages with specific objectives. Prepare an agenda before assembling the interviewers. Sessions will be needed on both theoretical and practical aspects of the study. The theoretical aspects cover topics including: ! outline of the goals and objectives of the study; ! overview of in-depth interviews; ! how to conduct in-depth interviews, i.e., starting, moderating, and ending the interview; ! how to take notes during interviews; ! outline of possible implementation problems; ! how to analyze the data and write a report. 3-11 The practical aspects of the training involve: ! role plays; ! pilot testing. Role Play: Provide an opportunity for each interviewer to role play the interview to gain experience before going to the field. Such role plays are also a great help in evaluating the effectiveness of individual interviewers. Go over the interview guide as many times as there are questions and comments raised by interviewers. Pilot Testing Before the actual fieldwork, you should plan to conduct a pilot test in a group similar to the target group in terms of study characteristics. This exercise affords an opportunity for the investigator and the study team to evaluate the appropriateness of the interview guides. It also enables interviewers to put into practice the skills they have learned before the actual interview. After the pilot test the study team should meet to discuss the experience in the field. Problems relating to the appropriateness, clarity, or ambiguity in the use of the guide, as well as others relating to respondents and the study environment, can then be fully discussed. Discuss any issues of translation of guides and/or notes at the training sessions. To avoid later problems, ensure that all translations are thoroughly reviewed before the group moves into the field. 3-12 TABLE 3.3: Tips on How to Conduct an In-depth Interview The "Dos" ! ! ! ! ! ! ! Begin interview with a friendly and familiar greeting. Listen with attention to capture every piece of information from respondents. Explore key words, phrases, idioms, terms as they occur in the discussion. Listen to impressions, topics avoided by informant, deliberate distortions and misconceptions or misunderstandings. Take prompt action to explore each of these. Where appropriate, use "probes." Ensure a natural flow of discussion by guiding informant from one topic to the next. "Play dumb"(be silent) to give the respondent plenty of room to talk. Be open to unexpected information. "The Don'ts" ! ! ! ! Influence or bias responses by introducing one's own perceptions or asking leading questions which encourage a particular response. Move too quickly from one topic to the next Interrupt the informant. Do not mislead about the subject matter in order to obtain information. 3-13 c. Outline Procedures for Subs equent Data Analysis You can use the opportunity provided by the field test to outline procedures for the subsequent data analysis. This involves the following steps: 3.26. ! Create teams (about two for this purpose) to discuss the questions to be answered. ! Review notes of the interviewer=s observations. ! Review each sub-theme in the interview guide for all groups of respondents, e.g., prescribers, mothers. ! Write out key findings from each subtopic for subsequent analysis. This may include the following: - demographic and socio-economic characteristics of this category of respondents; - major points of agreement across all interviews; - substantial points of disagreement between interviews; - any conclusions or implications for the design of an intervention. - group's suggestions on what to do to reduce overuse of antibiotics. STEP 6: Conduct the Actual Interviews After completing the pilot test, you are ready to start the actual data collection. Before moving into the field, however, you need to make preparations to ensure that the field work proceeds well without any logistical problems. a. Preparing for the Interviews Preparations should include the following: ! The target respondents must be contacted and a definite appointment made with them before the actual interview. It is usually best for interviews to be held in a neutral place away from any health facility or the respondent=s home where distractions are likely. Make sure that respondents will be available at the scheduled time. ! If the interview process will involve travel by the field team, arrangements for transport must be made early to ensure that the team arrives at the location on time on the day of the interview. 3-14 ! b. Besides identification cards and letters of introduction, interviewers should check to ensure they have all that is required in the field. This may include: interview guide, pen/pencil, notebook, tape recorder, batteries, cassettes, snacks, and water. Conducting the Interview On the day of the interview, the interviewer should arrive early to ensure that all arrangements are ready. When both interviewer and informant are seated, the interview can proceed as follows: 1. Introduction The respondent must be made to feel completely at ease and uninhibited in order to make the interaction enjoyable. In his/her introduction, the interviewer should: 2. ! introduce him/herself and affiliation; ! explain the general purpose of the interview to the informant (e.g., for prescribers: to investigate the treatment of ARI in children; for mothers: to find out how ARI is affecting children in the community. ! impress upon the respondent that his/her opinion is important. This can be repeated during the interview. People enjoy expressing their opinion about an issue once they are assured that it is important and legitimate. ! ask informant to introduce him/herself; ! establish rapport and assure the informant of the confidentiality of the interview. Interviewing The interview is directed at understanding the issues outlined in the guide. Begin with less sensitive issues, and move to specific issues when the informant is sufficiently relaxed. Remain alert to both verbal information and non-verbal behavior. If necessary, the respondent may be allowed to attend to office or home distractions during the interview. The interviewer can take advantage of such breaks to read his/her notes or check the guide to ensure adequate focus of the interview. Watch for time constraints on the part of respondent and apologize for time taken, with assurance to finish the interview on time. The interviewer should also try to adopt techniques to persuade the respondent to: ! elaborate on points, e.g., "What happens next? Can you please elaborate?"... etc. ! clarify issues: "What year did you join this clinic?" 3-15 ! 3. focus on new dimensions of the issue: "Can we talk about other drugs used apart from penicillin?@ Wrap-Up The interview should be concluded by thanking the respondent and allowing a few minutes for free discussion. Once the interview is formally completed, the interviewer should: c. ! Go over his/her field notes quickly to make any on-the-spot corrections and seek necessary clarifications before leaving. More complete notes can be made at a later time. ! If a tape recorder was used, check and label tapes before departing the interview site. A new tape should be used for each interview. Managing the Field Data The data from each interview must be managed appropriately to facilitate subsequent analysis. The following tasks are involved: 1. Field editing At the end of each interview, interviewers should review their notes and verbatim reports to make sure that they make sense in relation to the study questions. Comments or any observations made during the interview can also be added or clarified. Before leaving the field, interviewers should complete short summaries of the discussion, ensuring that any additional notes on the interview are included. 2. De-briefing At the end of each field trip or on a regular basis during a long study, the field supervisor or study coordinator should interview the interviewers to find out their experiences in the field. This de-briefing should cover any problems encountered in administering the guide as well as any new themes or findings from the field. While the field work lasts, it is possible to make changes in the guide to incorporate new ideas. Irrelevant questions should also be removed from the guide. 3. Transcribing If the interviews are taped, the tapes used should be transcribed verbatim or in summarized form depending upon the purpose of the study and the experience of the 3-16 person doing the analysis. Afterwards, the points that are important to the study topic should be underlined. This material should then be reconciled with field notes and comments of interviewers. 3.27. STEP 7: Analyze the Data Data analysis begins with the field note-taking of the interviewers. As a first step, therefore, the study coordinator must ensure that all field data including notes, comments, and recordings (if any) are recovered from the interviewers. The analysis can be done by hand or by computer depending upon your skill and the resources available to you. Most in-depth studies can easily be analyzed by hand though there are various computer programs that have been developed to assist this process. The assistance of an experienced resource person is especially important during data analysis. a. Analyzing the Data Many different strategies have been developed for analyzing the data from a series of in-depth interviews. A simple way of approaching the analysis involves the following steps: 1. Categorize interview material into various sub-topics. This is commonly described as the cut and paste process, and involves sorting out notes and transcriptions into the broad topics or sub-topics used in the guide, or adding any new themes from the interviews. For example, suppose during an interview with a prescriber the question is asked "How do you usually treat severe respiratory infection in a child?" Besides talking about drugs, the prescriber may mention problems mothers have in paying for treatment. Such information can be "cut and pasted" under a sub-topic, "Affordability of Treatment." This procedure ensures that "scattered pieces of information" on the same sub-topic are put together for a complete review. 2. Label each category using appropriate headings. For example, under reasons for prescribing antibiotics, responses may include delays in reporting for treatment due to inability to pay, multiple health problems, difficulty in monitoring patient compliance, patient expectation, and a pill for every illness. These categories of response can be assigned labels such as economic, social-cultural, and so on. For example, "patient expectation" and "a pill for every illness" can be put under socio-cultural reasons. This step is very useful for intervention design. 3. Describe and interpret the major findings 3-17 Analysis consists of considering responses in each topic as group, and drawing interpretive conclusions about commonly held beliefs, attitudes, or opinions. Implications for interventions should always be considered. You can also report findings by the proportion of various sub-groups interviewed giving their reasons under each category, the apparent strength with which certain attitudes are held, or issues on which there is substantial difference of opinion.. b. Using a Data Sheet for the Analysis Sometimes a data sheet can be used to organize the analysis. A data sheet lists the major topics and sub-topics of the interview guide in order to record responses in a logical manner. A data sheet for a health provider=s interview, for example, may contain the following categories: ! Personal Data of Informant: i.e., sex, age, education, etc; ! Common Presenting Complaints at Out-Patient Clinics; ! Drugs Used in Treating ARI; ! Factors Influencing the Decision to Use Antibiotics; ! Cost of Treatment; ! Dispensing Process; ! Other Comments, Suggestions, etc. For each of the sub-topics mentioned, responses of each informant are recorded from the cut and pasted material assembled from transcriptions, interviewers' notes, comments, and observations. The data sheets from the individual interviews can then be combined in an overall analysis as described above. 3.28. STEP 8: Write a Report and Recommend Interventions By the time the data analysis steps have been completed, the major findings of the study should be apparent. It will become clear which data should go into a final report. The responsibility for the report writing rests with the principal investigator(s), but if a resource person is involved, his or her skills are also most valuable at this stage. a. Outline of Report The first step in report writing is to develop an outline, bearing in mind the objectives of the study. Such an outline might contain the following sections: 3-18 ! title of study; ! objectives and methods, including data analysis; ! major findings in line with significant broad topics of the guide; ! discussion; ! conclusions; ! recommendations for interventions. All material from the field should be reviewed together and findings organized by topic and in conformity with the report outline. You should bear in mind that the results of a qualitative study using only a few in-depth interviews are difficult to generalize because of their restricted scope. However, some form of generalization can still be made, depend ing on the type and number of respondents. Hypotheses can also be formulated on the basis of the major findings, which can then be validated by use of other more quantitative methods such as structured questionnaires. 3-19 CHAPTER FOUR FOCUS GROUP DISCUSSION METHOD This chapter describes the Focus Group Discussion (FGD) method and indicates how it can be used to collect information in drug use studies. It begins with a brief overview of the method and the areas in which it can be used to study drug use problems. The major part of the chapter is devoted to the main steps involved in conducting focus groups. 4.10. Overview 4.11. What Is A Focus Group Discussion? A focus group discussion (FGD) is an in-depth field method that brings together a small homogeneous group (usually six to twelve persons) to discuss topics on a study agenda. The purpose of this discussion is to use the social dynamics of the group, with the help of a moderator/ facilitator, to stimulate participants to reveal underlying opinions, attitudes, and reasons for their behaviour. In short, a well- facilitated group can be helpful in finding out the "hows" and "whys" of human behavior. The technique is borrowed from social marketing where it was used to ascertain consumer satisfaction. The discussion is conducted in a relaxed atmosphere to enable participants to express themselves without any personal inhibitions. Participants usually share a common characteristic such as age, sex, or socio-economic status that defines them as a member of a target subgroup. This encourages a group to speak more freely about the subject without fear of being judged by others thought to be superior. The discussion is led by a trained moderator/facilitator (preferably experienced), assisted by an observer who takes notes and arranges any tape recording. The moderator uses a prepared guide to ask very general questions of the group. Usually more than one group session is needed to assure good coverage of responses to a set of topics. Each session usually lasts between one and two hours but ideally 60 to 90 minutes. 4.12. Use of FGDs in Drug Use Studies The method can be used in drug use studies in several ways. The following gives some ideas of ways to apply FGDs in the field. 4-1 a. Explore a topic about which little is known. For example, to begin the process of understanding cultural meanings of drugs in a community. b. Generate research questions if employed at the early stages of a multi- method study. c. Develop appropriate language to be used in a questionnaire. d. Complement other data in explaining people's actual thoughts, feelings, beliefs, and perceptions obtained from other methods. e. Develop appropriate materials and messages for educational interventions. 4.20. Key Steps in Conducting Focus Group Discussions (FGD) The steps in using FGDs to study a drug use problem are summarized below, followed by detailed discussion of each step. The extent to which these steps must be followed varies, however, depending on the training and experience of those involved in the data collection. TABLE 4.1: Key Steps in Conducting a FGD Step 1: Plan the entire FGD study Step 2: Decide what types of groups are needed Step 3: Select moderator and field team Step 4: Develop facilitator's guide and format for recording responses Step 5: Train field team and pretest instruments Step 6: Prepare for individual FGDs Step 7: Conduct FGDs Step 8: Analyze and interpret FGD results 4-2 4.21. STEP 1: Plan the Entire FGD Study Once the decision to use focus group method is made, you will need to plan how to carry out the study. Planning is critical because it is the area where major decisions regarding the study are made. a. What Activities Need to be Planned? Planning decisions will involve the study design, selection and training of field team, collection of data, analysis, and report writing as well as planning for interventions. Other essential supporting materials and logistics such as an office for meetings by the field team, equipment for data processing, and transport and incentives for the field team must also be planned. b. Is There Need for a Resource Person? One important decision is to determine whether a resource person is needed to assist in planning and implementing subsequent stages of the study. This decision will depend on a number of factors. These include the size of the project, the resources available to you and your own experience with focus groups. If you are not quite confident with the method or the study is large, relying on a resource person to assist at this stage can help to ensure that subsequent stages of your study proceed smoothly. Otherwise, the services of a colleague familiar with FGDs could be all that you need. c. Role of Resource Person in Training Field Staff One of the principal roles of the resource person is training of the FGD Moderators and assistants. If the field staff have no experience in applying the technique and have been involved in only clinical aspects of health, they will need considerable training. On the other hand, if staff have had some previous experience in similar studies, the task of the trainer is likely to be minimal. (See discussion of resource persons in chapter 2.) 4.22. STEP 2: Decide What Types of Groups Are Needed After developing an overall plan, you must decide the specific types of groups which will be used for your study. The following are some guiding principles: a. Identifying Target Groups Since broad generalizations are not usually made from the data obtained from FGDs alone, the common method for selecting participants for focus groups is by purposive (non-probability) sampling. An investigator selects those who, in his or her estimation, can provide the needed information. This depends on the target groups of concern to the study. 4-3 For example, consider a study to determine the attitude of prescribers and mothers in public health facilities towards the use of antibiotics in the treatment of Acute Respiratory Infection (ARI) in children. The two overall target groups will be prescribers in public health facilities and mothers who attend these clinics with their children. In selecting prescribers for a focus group discussion the study coordinator may decide to talk to prescribers working in hospital outpatient departments and health centers in separate sessions, if differences in their training or work setting might have an effect on their attitudes or behavior. This will be an example of quota sampling. On the other hand, in recruiting mothers for a similar discussion he/she may decide to draw participants from mothers in one or a few villages rather than from many villages in the district. This is a typical case of convenience sampling and, as its name implies, it is more convenient than a random sample of mothers drawn from all villages. Mothers may be further grouped into those living in villages near the district hospital and those living in remote villages, if ease of access is seen as an important determinant of behavior. When selecting participants, target those population segments likely to provide the most meaningful information, especially where differences might affect the way you design an intervention. Nevertheless, be sure that the group is representative of the larger population, though this does not imply that the results can be generalized. b. Composition of Groups Recruiting participants can require a great deal of effort if you need specific target groups. There are no rigid rules to follow, but one of the guiding principles in forming groups is that participants should have something to say about the topic of concern, and they should feel comfortable saying it to one another. For example, a group that includes both para- medics and health center officers-in-charge might not be very successful since the para-medics might be reluctant to speak in the presence of their "superiors." Forming two groups, one with paramedics and one with officers- in-charge, would more likely generate more free and open discussion. In order to separate participants into groups a screening process is sometimes required. This involves using a predetermined list and a very short questionnaire to select those who qualify and are interested in participating. Qualifying questions may include demographic characteristics, personality factors, or other variables related to the purpose of the study. Table 4.2 is an example of a screening questionnaire used in a study of family planning in Ghana. 4-4 Table 4.2: Example of a Screening Questionnaire 1. Do you have any children? Yes ............................. No ................................ Reject ............................... 2. Name: .......................................................................... 3. Age: ................................ 4. Number of children: ................ 5. Number of boys: ............. 6. Number of girls: ............... 7. Marital Status: ............................................................................................................................ 8. Educational level: ....................................................................................................................... 9. Occupation: ................................................................................................................................. 10. Religion: ...................................................................................................................................... 11. Number of years of residence in village/town: ......................................................................... 12. Do you practice family planning?: ............................................................................................ 13. What contraceptive do you use?: ............................................................................................... Selecting the Group and Conducting the Sessions A screening form was used in selecting participants for contraceptive user or non-user groups. A woman qualified if she had at least one child. For the user group, the women were, in addition: (a) Married, single, or divorced (b) current users of any modern contraceptive (c) resident in the village for a considerable length of time. Women for non-user groups had the same characteristics as the users except that they had either never used contraceptives or were not using them at present. c. Number of Groups Practically, the number of focus groups you conduct will depend on the purpose of the study. Thus, more sessions may be needed, for example, to explore the reasons for the use of antibiotics in the treatment of ARI, in contrast to a simpler exploratory goal of discovering the terms people use to refer to antibiotics for the purpose of designing a questionnaire. 4-5 In general, however, the more similar the study population in terms of social characteristics, the fewer groups that will be needed. If there are several distinct target subgroups in the study population, you should run separate FGDs for each, e.g., groups composed entirely of doctors run separately from those of pharmacists, or groups with men run separately from those with women. One useful strategy is to conduct as many FGDs as are necessary to provide an adequate ans wer to the study questions. A minimum of two FGDs should be planned with each target subgroup. After these two sessions with each subgroup, if results are consistent, there may not be a need for any more FGDs in this subgroup. However, if important inconsistencies emerge, additional FGDs should be conducted until the reasons for the inconsistencies are explained. One focus group discussion for any meaningful topic in a particular target group is certainly never enough. d. Group Size Practically, the size of the group should facilitate a dynamic interaction between the participants. Having a too small or too large group would make this difficult. The best size is at least six members, but not more than twelve. Groups of less than four or more than twelve are difficult to manage, and the benefits of group dynamics that make FGDs effective are usually lost. e. Contacting and Informing Participants The initial contacting of participants may occur by mail, telephone, or in person. Personal contact may be the most feasible way in most developing countries. Recruiting can be done at a clinic, the market, or by going from house to house in the community. When you enter a community or institution to recruit, it is advisable to contact the head of the community, or the person in charge of the institution, to obtain permission. These people can help you with vital information about particular cultural practices and habits of the local population or community, as well as identifying participants who meet the target criteria.. Provide prospective participants with information about the study but restrict this to a general description, including the fact that it will involve a group discussion. If any form of incentive is to be provided, such as refreshments or transport, this should be indicated along with when and how it will be provided. Invited participants should be notified a few days before the discussion. 4.23. STEP 3: Select Moderator and Field Team The selection of the personnel who will be invo lved in the study is essential since the success of FGDs depends on the calibre of staff. 4-6 a. Field Staff Requirements The usual staff requirements for focus group discussion are: 1. A Moderator/Facilitator who has a very demanding role as the discussio n leader of the group. This involves the following: ! directing the discussion and not taking over the group; ! encouraging participants to express their feelings and opinions and communicate among themselves during the discussion; ! building rapport to gain the confidence and trust of the participants and thereby probe beneath the surface of comments and responses; ! maintaining flexibility and being as neutral as possible: if the discussion wanders away from the topic, he or she subtly directs it back without offending participants; ! controlling the time allotted to each topic and to the entire discussion. In view of the high leadership and communication skills required of FGD moderators, you need to select them carefully. Generally, educational background such as sociology, mass communication, or psychology, as well as experience in moderating focus groups, are useful. These requirements are, however, not essential, nor are they enough. The key qualification is an appropriate personality, since the procedures for moderating a group can be learned during training. Key personality traits include: sensitivity, willingness to listen, tolerance for different views, ability to focus a discussion, and assertiveness in supporting as well as cutting off the expression of opinions. Experience has shown that nurses, teachers, community leaders among others have proved very skillful as moderators. 2. An Observer/Recorder is also present, mainly to observe the session and take notes. The observer/recorder is responsible for the use and care of any tape recorder or other equipment. It is good to have the note taker trained in how to be objective in recording discussions and observing non- verbal expressions. Participants must be informed of the presence and role of the observer at the beginning of the session. He or she should be seated away from the group. Even though the observer/recorder is not expected to take part in the discussion, he or she may do so in a few exceptional cases, for example: 4-7 3. ! if the moderator overlooks a useful point raised by a participant; ! to suggest a new question or topic relevant to the study; ! if the moderator has missed a an important topic in the guide. Other Staff Depending on need, other staff may sometimes be recruited to assist in running the discussion, but they do not necessarily constitute part of the group. 4.24. ! Assistants: useful for sessions where interference from crowds and children has to be controlled. ! Translators: sometimes necessary where the moderator is not fluent in a local language. STEP 4: Develop Moderator's Guide and Format for Recording Responses The main purpose of the guide is to provide direction for the group discussion. To ensure that all related issues are covered in the study, it is recommended that all parties involved in the study have an input or consult in its preparation. a. Structure and Sequence of Topics Discussion guides will differ depending upon the topic under investigation and the target populations (e.g., physicians, pharmacists, mothers of children under five). Nevertheless, the general categories of questions in a guide for focus group discussions include: b. ! General questions which are designed to open the discussion and to allow participants to reveal common perceptions and attitudes. The sequence of questions on a given topic should proceed from the general to the specific. ! Specific questions designed to reveal key information and show the feelings and attitudes of participants. ! Probe questions designed to reveal more in-depth information or to clarify earlier statements or responses. Wording of Guide Questions in FGDs are generally less structured in order to elicit flexible response. The guide must be phrased in simple language. Avoid long and complex statements and make sure that the meanings are clear. 4-8 Do not word questions to make people feel guilty or embarrassed. For example, instead of asking: "Why don't you go to the health center when your child has a serious cough?," the same question might be phrased: "What do you think might happen if you go to the health center when your child has a cough?” The questions must be framed in an "open-ended" style to enable participants to respond freely. Example (to prescribers at health centers): "How do you feel about treating cough with antibiotics?" This question allows respondents to discuss their satisfaction or dissatisfaction with antibiotics. It does not, however, place a judgment on antibiotic treatment, limit them to any specific antibiotic, nor indicate what other drugs may be used in addition to antibiotics. Questions should never imply what is acceptable and what is not. Suppose you are interested in knowing what other drugs are combined with antibiotics in the treatment of cough. This will require a question to encourage participants to speak about a range of other drugs. You would not want to ask a question like: Bad Example: ADo you think drugs besides antibiotics are needed for cough?@ This question can be answered yes or no, and it also suggests that other drugs are not needed, and participants may be reluctant to talk about what they actually do. It would be better to ask: Example: AI would like us to talk about drugs that are used for cough. Can you tell me about some of the drugs that are commonly used?” This questions allows the respondents to answer in any way they choose, but it also suggests to them that there is a range of drugs that can be used for cough. It is important to avoid questions that have a yes/no answer. Occasionally it is possible to get a quick "Yes" or "No" answer which can then be further explored, but generally it is not a good way of questioning since such answers do not encourage lively discussion. c. Number of Topics Most FGD guides consist of fewer than a dozen topics, though the moderator may frequently probe responses and add new topics as the actual interview progresses. It is recommended that the guide be written with just one hour in mind to allow time for additions to be made in the field. Table 4.3. is an example of a list of questions in an FGD Guide on the overuse of antibiotics in the treatment of cough (ARI). 4-9 Table 4.3: Example of FGD Guide on Overuse of Antibiotics in Treatment of Cough 1. Introduction [Narrative welcoming participants, describing reasons for discussion, and setting up the general ground rules for the session] Ground Rules 1. 60-90 minutes (tape recorded -- observer and note taker) 2. Speak clearly/one at a time 3. Conversation/all participate 4. No right/wrong answers 5. Assurance of anonymity and confidentiality 2. Diagnosis Can we talk about when your child gets a cough (ARI)? In your own experience, how do doctors find out what is wrong with the child at these times? Probe: Do they depend mostly on symptoms or lab tests? What are some of the tests for? What are the common reasons for cough? 3. Treatment of Cough Let us talk now about the treatment of cough at the health centers. Can you tell me the common drugs that are prescribed for cough at the health centers? 4. Patient Expectation I would like to know more about how you feel about the treatment your child receives for cough. Do you usually come to the health centers with any expectations about the treatment you will receive? Probe: Do you prefer certain kinds of treatment? What do you do if your expectations are not met? Do you try to convince doctors to give you the treatment you prefer? 5. Attitude towards Antibiotics Can you tell me something about how you feel about antibiotics as a treatment for cough? Probe: Do you know the names of specific antibiotics that you think are good? Do you prefer pills or injections? Do they use other remedies/drugs for treating cough? What are some of these? Why do you use these remedies/drugs? 4-10 4.25. STEP 5: Train Field Team and Conduct Pilot Test The field team's ability to perform well depends on their previous experience, and on how they are trained for a particular study. Training is a very important part in ensuring the success of the study. a. Training Hints Before you begin the training, you need to make sufficient preparations to ensure that all aspects are covered and everything proceeds smoothly. The following are useful hints to assist in the training. ! Choose a comfortable location for the training. ! Keep all training sessions as simple as possible. ! Use simple language: complex language may make the tasks and concepts difficult to understand. ! Allow regular practice through role plays in order for team members to gain confidence in their abilities. ! Allow sufficient time for field practice or rehearsals. b. Training Package 1. Theory Sessions Depending upon previous experience of the field team with focus groups, the training package should involve several or all of the following theory sessions: ! ! Introduction to Focus Groups ! What are focus groups? ! How helpful are focus groups in drug use studies? What information will we be collecting? ! What specific drug use problem(s) are we investigating? ! What are the objectives and rationale for the study? 4-11 ! ! ! 2. Preparing for the Individual FGDs ! Becoming familiar with the FGD guide ! Reason for role plays Conducting the FGD ! Roles of the field team members ! Activities before the session: pre-arrangements and visits; checklist for FGD ! Activities during the session: reception/refreshment; opening the meeting/introduction; conducting and recording the session/group dynamic tips; closing. ! Activities after the session: field debriefing; transcribing and expanding field notes. office debriefing; Analysis and report writing of FGD results: ! Data analysis: Individual session reports; combined analysis. ! Report writing Practice Sessions Role playing involves a mock discussion in which members of the field team assume roles as moderator, observer and participants as a way of practicing the technique. While the session is going on, other members of the field team observe and give their objective feedback after the role play. More than one trial should be held with field team members while changing roles each time. Pilot testing is essential because it provides: ! an opportunity to determine if the wording in the guide is appropriate for eliciting discussion, i.e., whether it is understood as intended; ! a way of checking the effectiveness of training of field team members; ! much needed field practice for the staff to develop confidence; ! a means to identify potential problems likely to be encountered in the actual study. 4-12 c. On-going Revision of FGD Guide Results of pilot tests will provide more information or new insights that are important for the study and interesting to participants. Each new focus group may lead to changes in the guide. In consultation with moderator(s) and other study investigators, the field coordinator should be able to modify the guide while the study is in progress. 4.2.6. STEP 6: Prepare for the Individual FGDs Between training field staff and starting the actual field work, an important link is preparing for the individual FGDs. This includes the following: a. Site Selection and Location for FGD Visit the project site(s) together with the field team and locate a place for the group meeting some days before the scheduled time. This will enable you to familiarize yourself with available logistics. The site for the discussion must be easily accessible to participants and convenient to the field team. The selected site must also be neutral (usually not a health facility) and large enough to accommodate all the participants and the field team. b. Date and Time For most focus groups in communities the ideal time is evening, while for those involving health staff late afternoon is often the best time, when the daily office routine is over. Make a time table that will guide how you will proceed with the field work after deciding the site(s), day(s), and time(s). See an example of a project time table in the annex. c. FGD Checklist Ensure that all equipment is ready before the field work. A checklist may include the following: (a) Arrange Transport Chairs, Mats, etc. Refreshments Other incentives, if any (b) Bring to the Field Tape Recorder Microphone (if needed) 3 blank 60 minute cassettes Batteries (plus extra) Moderator's guide Recording forms Test all recording materials a day before you go to the field to ensure that they are in working condition. 4-13 4.27. STEP 7: Conduct the FGD The climax of all the preparations made for the study is the actual FGD. On the day of the discussion a host, usually the moderator, and other members of the field team should be present at the venue before participants arrive. Snacks or drinks may be served to welcome the participants and put them at ease. a. Conducting the Discussion In general, the session proceeds in the following main stages: 1. ! Introduction; ! Warm-up; ! Discussion; ! Wrap-Up/Summary. Introduction The moderator's brief introduction is aimed at making respondents relaxed, initiating rapport, and establishing the "ground rules" for the discussion to follow. In it the moderator: ! speaks in a casual, friendly manner to help respondents relax; ! introduces himself/herself by giving his/her name and sometimes providing information about himself/herself; ! explains the general purpose of the group meeting to foster group feeling; ! encourages respondents to feel free to give their frank and honest opinions, explaining that there are no right or wrong answers, and it is okay to have feelings different from others; ! establishes neutrality by assuring respondents that he/she (moderator) has no connection with the subject of discussion that will affect his/her feelings; ! gives respondents the group rules: speak clearly and one at a time, avoid interrupting one another, and allow all participants a chance to speak; ! explains the purpose of any recording equipment that is being used; ! assures the group of confidentiality. 4-14 2. Warm-Up This stage includes self introductions by respondents. They are asked to give their names and other information about themselves, for example mothers may give age and numbers of children. The moderator must show interest in what participants have to say, for example, by making eye contact and attending to each introduction. The moderator must sometimes probe for clarity and understanding of information. He or she must also confine discussion only to the introductory formalities to avoid digressions. 3. Discussion This part begins the actual discussion of the study topic. At this stage efforts are directed at understanding the issues surrounding each topic. The moderator's role at this phase is very demanding. The following are some strategies the moderator can use to generate a healthy discussion: 4. ! Maintain a friendly and warm attitude to make participants feel comfortable. ! Do not behave like an expert. ! Build rapport by showing sensitivity to the needs and feelings of participants. ! Pretend to convey a lack of complete understanding sometimes with statements such as: "I didn't know that. Can you tell me more about it?" ! Pause when necessary to allow participants to think more or provide additional information. It is helpful to use incomplete statements like: "I don't know, maybe in some cases .... and wait for response. ! Use in-depth probes to clarify responses given by a participant, for example by asking: "Could you explain further?" or "I don't understand ... " or by repeating the response as a question: "...It's effective?" ! Know when to keep quiet and use it to your advantage, and do not let quietness intimidate you. ! Encourage participants to communicate among themselves. Wrap-Up Summary The last five to ten minutes of the session consists mainly of summarizing and recapping the identifying themes of the group. 4-15 This is meant to assist the moderator, the recorder, and the respondents in understanding what has occurred during the session. It also provides an opportunity for respondents to alter or clarify their positions or add any remaining thoughts they may have. The steps involved may be ordered as follows: ! Inform participants that the meeting is closing and ask for any comments; relevant ones could be explored in depth. ! Thank the participants and acknowledge that their ideas have been valuable and will be utilized. ! Serve refreshments and listen for additional comments as the group breaks up. ! Provide participants with any information they need but do not feel obliged to comment on everything that everyone says. The moderator and recorder need to meet to review and complete their notes after the session, and to evaluate the success of the discussion. b. Debriefing It is important to hold regular debriefing sessions between the investigator(s) and field team to discuss progress. In cases where the investigator accompanies the field team to the field, a short field debrief lasting about fifteen minutes, can be held immediately after the field session. It should be limited to issues that might be forgotten by the time a full debriefing session is held. A full debriefing takes place with the entire study team. The session can be used to assess whether the discussions are providing the information required to meet the study objectives. If not, necessary changes may be made in the guide and approach. It is advisable to prepare a meeting agenda to "guide" the debriefing session. c. Recording and Managing Information in FGDs 1. Note-taking The simplest way to record information in FGDs is note-taking by the observer. It is not essential for the person to have shorthand skills for this task, but practice in note-taking during pilot testing will be helpful. Other non-verbal feedback such as tone of voice, laughter, or posture should be noted, as these may suggest attitudes useful for the report. The observer must not inject personal judgments when recording notes. Comment should be put in brackets. Similarly, direct quotes from participants should be marked with quotation marks. 4-16 After the session, the observer should go back over the notes to add any further detail. (Figure 4.1 is an example of the structure of an FGD observer's notebook.) 4-17 Figure 4.1: Format of Contents of Observers' Notes The recorder's notes would usually include the following: 1. Group: (Identification of participating group) 2. Date: (of group) 3. Time: (group began and ended) 4. Name of Community/Group of Professionals: (brief description of it and any other information that may bear on the activities of the participants (e.g., distance from next town, conditions of health services)) 5. Meeting Place: (location and brief description (i.e., big, convenient) and how this could affect the discussion) 6. Participants: (including number and personal characteristics and other kinds of relevant information such as presence of children) 7. Group Dynamics: (general description, level of participation, dormant participants, interest level, boredom, anxiety, etc.) 8. Interruptions: (occuring during the session) 9. Impressions and Observations 10. Seating Diagram of the group. (It is best to have the group seated in a circle.) 11. Running Notes on discussion of various topics. 4-18 2. Cassette Recordings Since taking accurate notes on an entire discussion can be difficult, it is ideal if a tape recorder can be used. Though transcribing tapes is not easy, tapes also serve as permanent records of the FGD and can be listened to many times to clear up any doubts or confusion. They also make it easy for an investigator to assess the performance of the field team. The tape recorder must not, however, be allowed to interfere with a discussion. Asking participants to speak into the tape recorder, for instance, may disrupt the FGD dynamics as the microphone is passed. After the session, all tapes used must be transcribed and edited for analysis. 3. Video Recording Video is mainly used in developed countries. If a video camera is available, it may be used with discretion depending upon how much experience your group has had with such technology. Video recording provides a record of both what participants say and how they say it. CARTOON-PROVIDE A SKETCH CAPTIONED What happened to group dynamics at this discussion? 4.28. STEP 8: Analyze and Interpret FGD Results Focus group analysis is a process that begins when you enter the field and continues until completion of the final report. This continuous process avoids the situation of accumulating a mass of data that may be difficult to cope with at the end of a study. Since the moderator and the observer/recorder are the key actors in gathering the information the investigator should work closely with them in analyzing the data. a. How much Analysis is Required? The amount of analysis required in any focus group study will vary with the purpose of the study, its design, and the extent to which conclusions can be drawn from the data available. A simple analysis using notes/feedback material of the field team may suffice in exploratory studies where the conclusions of the study are straightforward. In general, however, analysis of focus groups involves various activities, each of which is important for producing the final report. These include: 4-19 1. Field Notes and Debriefings [Refer to the in-depth interview analysis] Field notes include written notes and comments on both verbal and non-verbal exchanges during the FGD compiled by the moderator and the observer. Debriefing notes compiled immediately after the sessions afford a quick and easy way of summarizing the data while the events of the FGD are still clearly in the minds of the field staff (see Step 7 above). Taken together, the field notes and debriefings can give a snapshot of the key findings from each session. 2. Session Summaries Within a day or two after the completion of each FGD, the moderator should complete a session summary. Working with his/her field notes and notes from the field debriefing (if completed) the moderator should prepare a 2-3 page summary of the session covering the following: 3. ! number and type of participants ! place and length of session ! moderator=s evaluation of how successful the session was in achieving meaningful interactions among all participants and staying focused ! key findings from the session for each of the major topics in the moderator=s guide, including useful non- verbal information ! unexpected findings and insights, especially regarding factors that may increase or decrease the success of the intervention. Transcripts Transcribing is very demanding. It is therefore recommended that transcript analysis be carried out as soon as the transcripts become available and not when all the focus groups are completed. The following guidelines may be followed for analysis of transcripts: ! First, read through the transcripts with the study questions in mind; note any impressions and major opinions from the discussion. ! Second, read the transcripts again, this time looking at each specific topic of interest or importance defined in the moderator=s guide. Also note any new areas of interest raised in the session. ! Third, read through each transcript again and strike out any responses that might have been forced on participants through poor moderating. Also, you may remove sections that have been poorly transcribed or that do not make sense. 4-20 4. ! Begin a coding process by marking the transcripts according to various sub-topics or areas of interest to indicate what participants are talking about. For instance, in analysing data concerning the use of antibiotics in the treatment of ARI, every time a participant mentions antibiotic use, you can mark the section to indicate this by saying ANTIBU (ANTIBIOTIC USE). At the end of each page, therefore, your transcripts will have various code words running down the side. This makes it easier for you to identify areas of interest. ! Prepare as many code words as necessary to meet your information needs, but try to keep these simple and short. Note also that not all responses will fall into the neat categories of information that you hope to obtain. If you come across a new response that introduces a new idea or topic of importance, code it. You may need a code book for the exercise. ! The final task of the analysis involves using the list of information required to check what information you have actually obtained. This will tell you whether the objectives of your study are being met or not. Alter your question guide for the next session if you are not getting close. Log Book Some studies use a log book to organize the transcribed analysis. It consists of a table that enables the investigator to record the responses according to selected topics of interest. The idea behind the log book is to retain the full range of responses in order to be able to spot relevant issues. Topics of interest are written on the left column of the page while the right side is divided into columns for the various FGD sessions. Responses are then tallied under each column as and where they occur according to sub themes. Approaching the analysis this way enables the investigator to find out how many times an issue was discussed across all the focus groups, as well as how many times a response was given. The approach is very useful when combining FGD results from different discussion groups. (i.e., prescribers, paramedics, patients, etc.). This approach is similar to the process of synthesis across methods. (See Chapter Seven.) An example of a log book for a study on the overuse of antibiotics is provided in Table 4.4. 4-21 Table 4.4: Example of Log Book on Use of Antibiotics Reasons for Preferring Antibiotics # of Mentions of Issue by Session # of participants 3 4 5 6 Pressure from families and peers Prevention against pneumonia Appropriate treatment for cold and coughs Better/more powerful drugs Complaints/requests from patients Fear of losing patients Severity of symptoms a. Writing the Report If you have used all the methods mentioned so far, the following may be available to you for your report writing: log book, codes from transcripts, session summaries, field notes, and debriefing notes. Your task in report writing involves deciding which responses are important to include in the report and which can be omitted. Findings are presented according to topics or issues of interest. Use quotations to illustrate strongly expressed thoughts, beliefs, and emotions by the participants. Remember to describe the overall consensus of the groups by sub-topics in the moderator's guide. Majority and minority feelings, as well as apparent differences in feelings by 4-22 characteristics of respondents (e.g., sex and age) should be distinguished. Your final report must therefore reflect the variety of participants' ways of thinking about the subject of study. Many focus group reports do not indicate how many participants discussed a certain issue. The common style is to say: "The majority of participants said ... " or "Few of them, however, felt....." Depending upon the purpose of the research, such presentations can be sufficient and useful. Nevertheless, it is sometimes useful to dwell a bit on frequency of occurrence of particular issues. b. Interpretation of Findings Interpretation involves explaining your findings in terms of the problem or question you want to answer. In the course of the study, you may have developed some ideas about what the respondents are saying. This is the time to question yourself about how significant the information you have gathered is to the problem under investigatio n. As much as possible involve the rest of the team, particularly the moderators and observers in this exercise since they had a direct contact with the groups. Based on the discussion of findings, the investigator may then be in a position to make useful recommendations for planning and developing an intervention. Any recommendations about how future studies should be conducted must also be noted. In general, the format of the focus group report should consist of: ! title of study ! objectives and methods, including data analysis ! major findings in line with significant broad topics of the moderator=s guide ! discussion ! conclusions ! recommendations for interventions. 4-23 CHAPTER SUMMARY Following is a summary of the main issues discussed in this chapter. FOCUS GROUP DISCUSSION (FGD) METHOD IN DRUG USE STUDIES OVERVIEW What is Focus Group Discussion? Use of FGDs in Drug Use Studies KEY STEPS IN CONDUCTING FOCUS GROUP DISCUSSIONS STEP 1: Plan the entire FGD What activities need to be planned? Is there the need for a resource person Role of resource person in training field staff STEP 2: Decide what types of groups are needed Method of sampling (selection criteria) Composition of groups Number of groups Group size Contacting and informing participants STEP 3: Select moderator and field team Field staff requirements moderator observer/recorder other staff STEP 4: Develop moderator's guide and format for recording responses Structure and sequence of topics Wording of guide Number of topics Example of an FGD guide STEP 5: Train field team and conduct pilot test Training hints Training package theory sessions practice sessions On-going revision of FGD guide 4-24 STEP 6: Prepare for the individual FGDs Site selection and location for FGD Date and time Plan for supporting materials or FGD checklist STEP 7: Conduct the FGD Conducting the Discussion Introduction Warm-up Discussion Wrap-up summary Debriefing Collecting and managing information in FGD STEP 8: Analyze and interpret FGD results How much analysis is required? debriefing notes transcripts log book Writing the report Interpretation of findings Example of format of an FGD report List of Tables List of Figures List of Tables Table 4.1 Key Steps in Conducting FGD Table 4.2 Example of a Screening Questionnaire Table 4.3 Format of Contents of Observer's Notes Table 4.4 Example of a Log Book Table 4.5 A hypothetical example of an FGD report List of Figures Figure 4.1 Example of Format of a Focus Group Moderator's Guide 4-25 CHAPTER FIVE STRUCTURED OBSERVATION Structured Observation is potentially one of the most useful field methods in drug use studies. This chapter is devoted to a brief overview of the method and a detailed description of the main steps involved in conducting an observational drug use study. 5.10: Overview 5.11: What is Structured Observation Observation is a technique that involves directly observing behaviour with the purpose of describing it. To observe means to examine an object, or an individual, or group of people, or an event with all of the senses. Recording of observations may take many forms, from simple and casual to exact and sophisticated. For example, an observer may observe an event and then complete a checklist on whether or not key behaviours occurred. Or the observer may write notes on everything that happens in his or her presence. More sophisticated recording may involve audio-visual devices. The technique can be classified into participant and non-participant observations. Participant observation takes place when an observer participates with the people and in the events he or she is observing. Non-participant observation occurs when an observer observes events without interacting with the person(s) being observed. Non-participant observation may further be classified as structured or unstructured. The aim of unstructured observation is to observe and record behaviour in a holistic way without the use of a pre-determined guide. Structured observation, on the other hand, refers to a technique in which an observer observes events using a guide that has been planned in advance. The focus of this chapter is on structured observation. Events in structured observation are recorded according to an observation guide. The observer is not involved in the activities being observed, but records them as inconspicuously as possible. However, it must be pointed out that the presence of even a "neutral" and non- interacting observer may influence the behaviors of the person(s) or events being observed. Although structured observation may seem simple, obtaining useful data requires reliable observers, an informative observational guide, and the cooperation of those being observed. This presents the issue of bias in the observation process in both the observer and the person being 5-1 observed. The observer's bias includes his or her subjective judgment regarding events being observed. For example, if the observer has a positive attitude towards the person being observed, he or she may record positive observations and ignore negative behaviours. To overcome this bias, an observer must be trained to be neutral and non-judgmental towards persons being observed. From the perspective of the person being observed, bias occurs when the person being observed alters his or her usual performance of an activity in order to impress the observer. In a diarrhoea study in one country for example, when prescribers were informed that the observation concerned diarrhea, they examined infants who had diarrhea longer than they did other patients. The examination took about 5-7 minutes for diarrhea cases, whereas the examination for other patients took only 1-2 minutes. Surrogate Patient Technique To overcome certain problems of bias, some studies employ the use of surrogate patie nts. In this technique a client suitably dressed and prepared presents at a health facility or dispensing/drug sale outlet with a complaint requiring treatment. The complaint may concern the same individual or the treatment may be for another person, suc h as a child. When combined with direct interviews, the method affords an investigator the opportunity to contrast what providers say they do with what they actually do. The reasons for the discrepancies can then be ascertained using in-depth interviews or focus groups. 5.12: Use of Structured Observation in Drug Use Studies In drug use studies structured observation can be used independently or as supplement to other methods. As an independent method, it can be used to observe situations in health facilities. This will involve part or all the sequence of events commencing when a patient comes to register until he or she leaves the health center. In general, the goal for using the observational method in drug use studies involves one or more of the following: ! To generate research hypotheses in pilot studies where very little is known about the problem. ! To collect information not available in any other way, such as communication patterns during a provider-patient encounter. ! To supplement other data as part of a multiple assessment approach where observation may aid in the interpretation of data. As a supplementary method, structured observation can also be made during focus group discussions (FGDs), in-depth interviews, or interviews using a structured questionnaire. It can also be used to supplement quantitative methods of data collection, such as prescribing surveys. 5-2 5.20: Key Steps in Conducting Structured Observations The steps listed in Table 5.1. can be followed in applying the structured observational method to study drug use problems. The list is followed by a more detailed discussion of each step. TABLE 5.1: Key Steps in Conducting Structured Observations Step 1. Decide if a resource person is needed. Step 2. Determine what is to be observed. Step 3. Choose the observers. Step 4. Develop observation guides. Step 5. Select the setting for the observations. Step 6. Train observers and pre test observations. Step 7. Conduct the observations. Step 8. Analyze and interpret the observational findings. 5.21. STEP 1: Decide If a Resource Person Is Needed Use of structured observations in a drug use study requires certain skills which those involved in the clinical aspects of health may lack. One of the first decisions to make is whether the assistance of a resource person is needed. The following are some points to consider. a. Assessing the Need for a Resource Person The assistance of a resource person is very helpful, but whether you need one or not will depend on a number of factors. These include size of the study, the resources available for it, and the experience of the investigator and others on the study team. If the study is small, you may rely on the services of someone who can consult for brief periods when you need his/her services. However, if it is a large study you may need to look for someone who can devote sufficient time to the study. The use of a resource person can be very 5-3 important to the success of the study, particularly if you have no experience with observational methods. b. Who to consider as a Resource Person The role of a resource person is to assist in planning the observation protocol and preparing for subsequent stages of the study. The first choice for a resource person would be a social scientist who has the knowledge, skills, and actual field experience in using structured observational methods. Where it is difficult to find a social scientists to assist, others whose jobs are behaviourally oriented and who have actually done some work using observations such as colleagues in public health or community development officers, can be equally useful. In any case, the resource person needs to have knowledge about the health care system and the context of drug use in the locality. 5.22. STEP 2: Determine What Is to Be Observed The beginning of preparing an observation protocol is to determine what behaviours or encounters will be observed on the field. The following describes some guidelines. a. Selection Criteria As with all applied qualitative methods, the purpose of the study will determine who and what is to be observed. Since structured observation is often used to validate data obtained from other methods, appropriate sources of information must be identified. For example, suppose the purpose of an observation encounter is to verify a claim by providers that they give antibiotics to children who present with ARI because their accompanying parents ask for them. Since you cannot observe all patients in the targeted population, you will need to develop a method to select encounters to represent this group. Most clinic-based observational studies use a convenience sample of patients who happen to be available at the time of data collection. Thus, all patients who report with cough on a particular day at a certain health center might be observed. A random sample of patients with cough in the community during a given period would be impractical to obtain. b. Sources of Information An investigator using structured observations must decide beforehand what the target of attention of the study will be. Pertinent issues to consider before designing the observation protocol include: ! Is the emphasis to be on drug prescribing habits, adequate patient care, patient behaviour, the health system context, or all of these? 5-4 ! Will the focus of attention be the health provider, the patient, or the prescribing encounter? ! Will the observation take place in hospitals, health centers, private drug outlets, or some other place? ! Will the observation cover the interaction of prescriber and patient, or the whole situation at the health facility or drug outlet? ! What are the possible opportunities in the observing environment for the observer to blend in and become less obtrusive? ! What is the most appropriate recording system for this situation? The final decisions must be based upon the aims and goals of the study and the practical aspects of collecting the data. Remember to narrow attention to data that are useful in designing an intervention, and not other interesting but possibly unnecessary information. 5.23. STEP 3: Choose the Observers In preparing for data collection, you need to select the most appropriate field staff to carry out the observations. The following are essential prerequisites to consider when recruiting field staff. a. Qualities to Consider When Selecting Observers The following observer qualities are helpful in ensuring accurate data: ! Familiarity with the cultural background of the people being observed and ability to understand their language is a key qualification. ! Familiarity with pharmaceutical and general medical terms is a benefit, and may be an absolute prerequisite for certain studies.. ! Knowledge about social research techniques is an advantage. ! A secondary or high school education may be sufficient if the medical aspects of the behaviour being observed are not complex.. ! Observers must be able to sit quietly and observe without interfering. 5-5 Ideally, structured observation would use two observers to ensure reliable information. However, it may not always be possible to have two observers for every situation. Besides, it may be more difficult for two observers to stay "unnoticed" than one person. With adequate training, a single observer should be able to produce high-quality and consistent data. b. Observer's Role in Structured Observation In structured observations, the observer watches events unfold without affecting them and records these events in appropriate categories (on an already prepared checklist). The observer is like a video recorder. He or she should record as objectively as possible all relevant events, situations, and behaviours. To minimize bias, the observer tries to be as unobtrusive as possible so that subjects feel at ease and comfortable in carrying out their daily activities. The best way is to "sit quietly as a fly on the wall in the corner" so that the subject forgets that the observer is in the same room. The observer must maintain interest in the events being observed. Otherwise he or she will carry out the observation mechanically and risk failing to notice some important events. 5.24. STEP 4: Develop Observation Guides The basis for structured observations is the observation guide. A preliminary list of issues to be observed, and the categories in which to record them, must be prepared in advance based on the objectives of the study. A list of common items that can be observed during clinical encounters at a health facility is included in Table 5.2. a. Who Prepares the Guide? Usually the investigator(s) and/or the resource person directing the study is/are the appropriate persons responsible for writing the guide. However, it is advisable and helpful to involve the observers to enable them have input and familiarize themselves with the study. Useful input might also be obtained from people who would have special insight into the interactions being observed (e.g., experienced clinicians, community leaders), or administrators who will be involved in later interventions. b. Structure and Contents of Guide Since it is difficult to predict observable behavior in advance, a draft protocol can initially be partially structured. More attention should be paid to specific aspects that appear central to the problem as the study proceeds, and a final observation guide prepared. The guide should be prepared to suit local situations; the input of the field team is particularly useful. You may also find it useful to begin with the instruments and protocols presented in the annex, and adapt them to the local environment and problem of interest. 5-6 Table 5.2 Items That Can Be Observed During Clinical Encounters in a Health Facility 1. REGISTRATION: ! impressions ! payment 2. ! ! ! SCREENING: does it occur? who does it? content 3. ! ! ! WAITING: what do parents and patients do? any health education opportunities? how long? 4. CLINICAL CONSULTATION: ! physical environment: private, others present, place for patient to sit, exam. bed, greeting ritual ! medical history: duration, associated symptoms (fever, chills, chest pain, cough, yellowish sputum in cough), appetite (eating, drinking), previous treatment ! clinical exam: temperature, pulse, breathing (rate, in-drawing of space between the ribs), touching, listening to the chest. ! use of instruments(stethoscope, BP machine, etc.) ! interaction: warm, cold, patient encouraged to speak, type of language (technical vs. nontechnical, local vs. non-local) ! explanation of illness: causes, prognosis ! advice: about prevention (environment, hand washing, food storage, clean water, latrines), ! about feeding (fluids, breast feeding), explanation about drugs ! length of time ! how encounter is terminated: prescribing on termination, reassurance, warm, abrupt ! prescriber washes hands after examination. 5. WAIT FOR DRUGS: ! how long? ! what happens during the waiting period? 6. ! ! ! DISPENSING ENCOUNTER: physical environment: private, possible to talk with dispenser how are drugs dispensed: packaging, sterile technique for injection, labeling communication: instructions about how to take, side effects/precautions, prevention and care, patient asks questions 5-7 c. Useful Events to Observe During Clinical Encounters The most frequent target of observation in drug use studies is the clinical encounter between health provider and patient. The following are key events that can be observed during the clinical encounter: 1. Aspects of Clinical Process Polypharmacy The focus of the observation is on how many drugs a provider prescribes for a patient and why. Observation can take place in a health center, or in clinical examination areas during a working day. The observer can sit quietly close by the prescriber and record the drugs being given to the patient and any discussion about reasons for multiple drug therapy. Non-pharmaceutical therapy The focus of the observation is on any instances in which a provider consults with a patient without prescribing any drugs, and why. In drug use studies, the observation usually takes place in the consulting room, although observing interactions between patients and nurses or dispensers may also be informative.. Selection of Drugs The focus of the observation is on the choice of drugs, and reasons for specific choices. Many different aspects of the decision- making process can be covered: adequacy of history taking and examination; discussion of alternatives with patients; patient requests for particular drugs; the use of generic names; stock availability; and so forth. Two prescribing choices that have received particular attention are use of antibiotics and injections. Which antibiotics are being given to patients, and for what diagnoses? What are the opportunities for laboratory investigation, and are they used appropriately? For injections, in addition to why they are given and whether they are necessary, observation can also focus on adequacy of sterile practice. Information about use, risks, side effects The focus of the observation is on the information communicated to the patient about prescribed drugs, on both whether communication takes place at all and whether it is adequate. Issues addressed can include how and when to take the drugs prescribed, possible side effects and what to do if they occur, as well as responses to patient questions or concerns. These interactions can be observed in the consultation room as well as in the dispensing room. 5-8 2. Features of provider-patient interaction In addition to the more clinical aspects of the encounters between patients and health providers, the observational method can be used to study the nature of the interaction between them. It is often non-clinical aspects of the encounter that determine the overall quality of care from the patient=s perspective. The following aspects of the encounter can be included in the observation guide. 5.25. ! exchange of greetings between provider and patient; ! verbal expressions of concern by the provider; ! conversation between provider and patient; ! nonverbal expressions such as smile, touch, tone of voice; ! eye contact between provider and patient; ! duration of the encounter; ! language used during the encounter; ! advice given by the provider; ! questions posed by the patient; ! how provider ends the interaction. STEP 5: Select the Setting for the Observations Before beginning the field work, you need to decide the sites, days, times, and other related issues for the observations. The following steps outline the preparations that need to be made. a. Site Selection and Permission Some days or weeks before the field work, the investigator should visit the location of the study to learn about the setting and people in order to make a final selection of study sites. When this visit is made, it is possible to obtain permission to carry out the observations from relevant authorities. The meeting can be used to inform local leaders about the purpose of the study, and how it is intended to benefit them, and how many observers will be involved. Before deciding on the specific site, date, and time of the study, discuss the issues with the local authorities. This could ensure their support and cooperation. Sometimes the places and times 5-9 offered by local authorities require compromise in the intended study plans. Time constraints can often be overcome by doing the observations over several days, rather than on only one working day. b. Date and Time The availability of cases for observation depends on local patterns of health service use. The investigators and the contact personnel at the observation sites must decide the days on which it is best to collect the data. Remember to schedule observations at the time of day and week when an appreciable number of cases can be obtained. For health centres, it is usually best to conduct observations in the morning between 8:00 and 1:00. Attendances are likely to be low at week-ends and holidays. For observations in households and private retail outlets, early mornings before work and late evenings after work are optimum in most communities. c. Decide on Observation Sites The number of observation sites will be influenced by the objectives of the study, the number of available and accessible sites, and the need to adequately represent the target population. Difference in attendance at various sites must also be considered. The decision about how many sites to include will therefore vary from place to place. If the study aims to assess practice in a large group of health facilities, a minimum of 10 randomly selected sites would generally be needed. d. Determine Number of Observations per Site The number of observations per site is again dependent upon the study objectives, logistics, attendance, and so forth. Usually observations can be made at the place of registration, the waiting room, the consultation room or at the dispensary. There is no rule for deciding how many observations per site, but at least 20-30 would be recommended to adequately describe practices at each site. 5.26. STEP 6: Train Observers and Pilot Test Observations Structured observation may not appear as complicated as other applied qualitative methods such as FGD and in-depth interview. However, observable behavior may be so complex and rapid that observers may fail to detect interesting and important aspects if they are not properly trained. Observers need to be well trained to enable them take note of interesting unforeseen events which may not be indicated in their guides. 5-10 a. Useful Hints for the Trainer The following are some useful hints to guide the training: b. ! Find a suitable location for the training that allows participants to be comfortable and removed from their usual work setting; ! Involve the entire field team in all aspects of the training; ! Allot sufficient time for each session, especially the practical sessions like role plays and pilot observations; ! Use simple materials for the training; ! Use appropriate language, i.e., local language, for the training sessions; ! Set sufficient time aside for discussions, and questions from the trainees; ! Evaluate the sessions in a formal way to allow improvement over time. Training Agenda Theoretical issues that must be covered in the training include the following: c. ! What is structured observation and why is the method useful? ! What are the objectives of the study? ! Why is structured observation appropriate for the study? ! How are unstructured observations conducted? ! How will structured observations be conducted in this study? ! How are field problems to be dealt with? ! How will field data be handled and summarized in the daily report? Practical Aspects of Training Role play is a very effective practical approach for training observers how to observe. In role play, the observers play scenes to depict the activities and roles at a health facility. Models could include registration clerks/nurses, a doctor, a dispenser, other paramedics, and patients. While 5-11 some of the observers act the scene, others observe the activity. They record events according to items in the guide as well as those that they observe themselves. During the role play, the trainer observes the observers, and later comments on their performance. For example: observer busily writing instead of paying close attention to an event. When beginning training, it can be most useful to start with exercises in unstructured observation. Create hypothetical events/situations and let trainees describe them. This helps to bring out the observational strengths and weaknesses of trainees for the trainer. This might be done by having two trainees observe the same events during a role play, after which they would each write one paragraph to describe the key aspects of what they observed. Discussing their descriptions with the trainer and the other observers can help them to focus on important issues. After they become comfortable with unstructured observation, trainees can be introduced to the structured observation guide and taught the meaning of each item in the protocol. They can then role play again, and use the structured form to record data. After the role play sessions, it is important to pilot test and revise the guide before beginning actual field work. The uses of the pilot test include the following: 5.27. ! to check whether the observational guide is suited to actual situations; ! allows observers to become familiar with the guide; ! spot which parts of the guide need to be revised. STEP 7: Conduct the Observations After pilot testing and revising the guide as needed, you are now ready to begin the field work. a. Preparing for Field Work Ensure that the following are available for use by observers before they move into the field. ! ! ! ! Latest version of the observation guide and data collection forms Notebook for making notes Pens/Pencils Any other recording equipment such as tape recorder that will be used It is of utmost importance that observers dress appropriately for the field. Appropriate dress will vary from group to group and from community to community, but the guiding criterion is that dress should be chosen to be unobtrusive. For example, an observer wearing a suit to collect data in a village health post would stand out and interfere with normal activities. On the other 5-12 hand, an observer wearing a lab coat in a consultancy area in a health center can often blend most easily into the background. b. Conduct the Observations On the day of the observation, observers should arrive early at the health facility to make the necessary preparations before the health facility commences work. Such preparations will include locating observation positions. Being in position as patients arrive can help observers appear more natural. When everything is set the observation can proceed as follows: 1. Getting Started It may sometimes be necessary to inform and explain your presence to those being observed. How this is done depends on the setting and people involved. It is best to have your host at a health facility (usually the officer in charge) do this introduction. At this very first stage, display friendliness and show interest. A prospective observer must gain the trust, confidence and cooperation of subjects. However, even after achieving this, the observer's presence may sometimes influence behaviour and events being observed. The observer must be aware of this possibility and try to prevent it by positioning himself/herself away from the center of activity, and by writing as inconspicuously as possible. It may also reduce bias if the first few encounters observed are not included in the sample, giving time for everyone to become used to the observer=s presence. 2. Observing Remain reasonably detached yet attentive. Observers must record observations as systematically and accurately as possible. The use of observational guides or forms should enable them to record events easily. It is also important to write notes about events that are not included in the guides or forms. These qualitative data will add flavor to the interpretation of the more structured items and could provide unexpected, but relevant information. For example, the fact that female patients are not touched by male health workers may not have been captured by the observation protocol, but could be a key finding for developing an intervention. Observers may also make sketches of observation situations and note other non-verbal communication. 5-13 3. Wrap-Up At the end of the session remember to thank the health facility staff and your host. In some situations, it may be appropriate to thank patients or their accompanying person immediately after the encounter. On the other hand, it is best to wait until the end of a day's field work before you say thank you to health facility staff. Sort out any problems you might have encountered with your host if it is within his/her means to help before the next observations begin. c. Regular Review of Data During the field work, there must be a regular review of the data by the investigator with the observers. This is very helpful for ensuring the accuracy of recordings especially at the early stages of the study. Such a review also provides an opportunity for the investigator to discuss any problems encountered by observers in the field. d. Recording Information in Structured Observations An observation protocol must strike the correct balance between brevity and comprehensiveness in recording data during the observations. Generally, relying on the observer's memory is ideal but risky because notes made after the observation can be distorted. However, making extensive notes during the observation may also distract subjects and cause the observer to miss some important events while occupied with note taking. Observation guides with which observers have been familiarized through training are an effective means of recording data. The observers can check appropriate categories in the guides and write notes in available space for comments and other observations. Normally, because events are itemized in the guide, structured observation may not always need extensive supplementary notes. Nonetheless, notes of unexpected events not included in the guide should be recorded. 5.28. STEP 8: Analyze and Interpret the Observational Findings The final stages of the observational study involve analyzing and interpreting the data from the field. This can be done manually or with the aid of a computer depending upon local capability, as well as the objectives and size of the study. a. When does Analysis Begin? The analysis of structured observational data begins the moment the data collection begins. The exercise involve a number of activities which include; 5-14 b. ! Routine debriefing sessions involving observers and investigators. This aspect of data management can improve the quality of the final results. ! Comparing notes of observers from daily field trips. This makes it possible to compare the performance of different observers, and to spot and remove irrelevant parts of their field notes. It also provides an opportunity to add new themes or topics which are found useful while the data collection lasts. How much Analysis is Required? Since structured observation is partly quantitative and partly qualitative, the analysis involves procedures for both types of data. Whether it is done manually or with the aid of a computer, the analysis involves the following: ! Categorization of data: This is the first formal stage of the analysis. The qualitative part of the data comprising descriptions of behaviours of people, events, and situations recorded as free text must first be categorized. This begins by reading through the raw data and placing similar responses in identifiable categories. Usually, the data collected with structured observation forms about planned events are already categorized. If the data are to be analyzed by computer, some software requires that numeric codes be assigned to different categories (e.g., A0" assigned to ANo,@ and A1" to AYes@ responses. The qualitative data that has been categorized previously may also need to be coded with numbers. ! c. Summarizing the data: This stage involves analyzing the coded information in order to describe the frequency of responses for each item or theme. Report percentages for each response category for pre-planned observations. You may also describe the qualitative aspects in a narrative style, although certain qualitative issues could equally be quantified and presented as percentages. The data summaries should present the key quantitative and qualitative findings from the observations that would guide the design of an intervention. Doing Analysis with a Computer Using a computer to analyze data from structured observation can be more costly and time consuming than manual analysis. If the data set is small, it is advisable to avoid comp uterization. If a computer analysis is to be used, the following steps can be followed after coding the data: ! Choose appropriate software: Various computer software programs are available; two of the most popular are Epi Info and dBase. It is suggested you see a resource person for assistance before you choose a program. 5-15 d. ! Enter the data: Before entering data, you need to develop a data entry format to allow transfer of coded data into the computer. Data entry needs to be validated, often by entering data twice and comparing the entries. Data entry errors must be thoroughly edited out before analyzing the data. . ! Run the analysis: After editing the data, you are now ready to run the desired analyses. You can analyze the contents of each response under various subthemes using frequency distributions, and compare responses in different categories of the target population using two-way or three-way tables.. Writing the Report Writing the report is the responsibility of the investigators, but involving the entire study team will ensure that all important aspects are covered. Discussion of findings by the team will often trigger unexpected insights about the reasons for problems or ways of improving them. The report should focus on recommendations for policy changes or specific interventions to solve the problem being studied. The major sections of the report of an observational study are: Introduction: Statement of problem, research objectives, rationale, scope, operational definition, outline of the chapter. Methodology: Research approach and method, instruments, study setting, sampling, personnel, field work organization and supervision, mode of data analysis. Findings: This embodies tabulating and deascribing the study results. Discussion: Underlying reasons and explanations of the main findings. Conclusion and Recommendations: Inferences, suggestions, and likely follow-up interventions. Interpreting the findings involves drawing conclusions about intervention design based on both quantitative summaries and the qualitative data analysis. Other data which can help in interpreting findings include observers= notes from the field, existing research findings, as well as educated opinion on the subject. The conclusions and recommendations should stay primarily focused on the issues that will contribute to the design of an intervention. 5-16 CHAPTER SIX STRUCTURED QUESTIONNAIRES This chapter focuses on structured questionnaires and how they can be used in drug use studies. It begins with a brief overview of the questionnaire method and indicates the types of study questions for which it is most suited. The greater part of the chapter is devoted to a discussion of the steps involved in using the method to study a particular drug use problem. 6.10: Overview 6.11: What is a Structured Questionnaire? A questionnaire is a group or sequence of questions designed to elicit information from an informant or respondent when asked by an interviewer or completed unaided by the respondent. When an interviewer is involved, the questionnaire is sometimes referred to as an interview. An unstructured questionnaire is an instrument or guide used by an interviewer who asks questions about a particular topic or issue. Although a question guide is provided for the interviewer to direct the interview, the specific questions and the sequence in which they are asked are not precisely determined in advance. A structured questionnaire, on the other hand, is one in which the questions asked are precisely decided in advance. When used as an interviewing method, the questions are asked exactly as they are written, in the same sequence, using the same style, for all interviews. Nonetheless, the structured questionnaire can sometimes be left a bit open for the interviewer to amend to suit a specific context. A semi-structured questionnaire is a mix of unstructured and structured questionnaires. Some of the questions and their sequence are determined in advance, while others evolve as the interview proceeds. The focus of this chapter is on structured questionnaires. The list of questions that make up a structured questionnaire may be open ended or close ended, depending on how the questions are framed and asked An open-ended question is one in which possible responses are not supplied in advance. Each respondent=s statements should be recorded as fully as possible and in the respondent's own words. Open-ended questions are very useful for exploring sensitive issues and investigating topics concerning beliefs, attitudes, and practices. 6-1 A close-ended question usually provides a set of responses or options from which a respondent indicates his/her choice. Where the study topic concerns factual issues, or is a familiar one with a limited range of responses, close-ended questions are particularly useful. 6.12: Use of Structured Questionnaire in Drug Use Studies The structured questionnaire method can be used to study various aspects of drug use behavior involving providers and consumers. The method is appropriate to use where the study is aimed at: ! Estimating the prevalence of existing beliefs or attitudes as a means of confirming data obtained with either unstructured interview or other qualitative methods. ! Finding out more information to complement or follow up a previous exploratory study. The purpose of this may be to check the validity of previously collected data or observations to enrich the overall results of a study. ! Comparing responses in subgroups of a large population, such as knowledge about different drugs, the type of drugs used, how much they cost, and so on. 6.20: Steps for Using Structured Questionnaires Drug use studies that employ the structured questionnaire method share some of the characteristics of other methods. Several steps are involved; these are outlined and described below. 6-2 Table 6.1: Key Steps in Using a Structured Questionnaire in Drug Use Studies Step 1: Plan how to carry out the study. Step 2: Define and identify the target group for the study. Step 3: Develop the questionnaire(s) and guides. Step 4: Select interviewers and other field team personnel. Step 5: Train field personnel and pilot test the questionnaire. Step 6: Prepare and conduct the field work. Step 7: Analyze and interpret the data. 6.21. STEP 1: Plan How to Carry out the Study a. Why is Planning Necessary? When planning a questionnaire study, you must first make a number of decisions regarding various aspects of the study and how it will proceed. These decisions will all have a major impact on the implementation and success of the study. During the planning you must decide which target group will answer your questionnaire, how to select a sample, design the questionnaire, and select and train interviewers. In addition, you need to plan study logistics and equipment. These include stationery, forms, transport and whether incentives will be offered to respondents. Field allowance for interviewers must also be decided at this stage. These issues are addressed in the rest of this chapter. b. Is there the Need for a Resource Person? Planning and implementing a questionnaire study is an interesting but demanding task. Whether or not it is necessary to find a resource person to assist in planning and implementing the study will depend upon factors such as the scope of the study, available resources, and your own experience and confidence in applying the technique. 6-3 Of all the methods described in this manual, questionnaires are the most familiar to many health professionals, and the one technique with which many people have had experience. An investigator with some experience may be able to manage a small study by merely following the steps described here, since the skills required to design and implement a structured questionnaire are not as demanding as other methods. For a large study, you may consider the assistance of a social scientist who is experienced in questionnaire design and survey research. 6.22. STEP 2: Identify the Target Group One important decision is to identify the study population (the target groups of respondents who can best provide the information you need). The following steps provide a guide to the issue of sampling. a. Determine Type of Sampling Probability sampling methods are most commonly used in structured questionnaire studies. The purpose for using the questionnaire method usually involves confirming a hypothesis or generalizing the results of a study so relatively larger samples selected by probability methods are appropriate. The common probability sampling methods include: ! simple random sampling ! systematic sampling ! stratified sampling ! cluster sampling ! multi-stage sampling These methods are described briefly in Annex A. The basic principle underlying probability sampling is that the selection of any respondent or unit in the study population is based on a known (usually equal) probability. The most appropriate method for a particular study depends on the size of the target population, what lists of members are available, and whether the population is organized in natural clusters like villages or health centers. [See also How to investigate drug use in health facilities: selected drug use indicators (WHO/DAP/93.1) for a more detailed discussion on sampling procedures.] Sometimes, because of logistical constraints, the sample for studies of the knowledge, attitudes, or satisfaction of patients attending health facilities, or of patients with specific health problems, will not be selected randomly, but in the order in whic h they present for treatment (a convenience sample). In such samples, we must assume that patients in general, or patients with specific problems, present Arandomly@ from the underlying pool in the community, and that 6-4 generalization to the larger underlying population is justified. Sometimes surveys will avoid sampling patients who attend early in the morning (more likely to be emergencies), or those who attend on market days (more likely to have no specific complaint) in order to avoid bias. b. Who should be Selected? The target population for a questionnaire survey will be chosen based on the drug use problem, the study objectives, and how the results are to be used. For example, you might be interested in inappropriate diarrhea treatment in the community. Previous research may have shown that most patients are treated without prescription in private pharmacies and drug retail outlets. A questionnaire survey of provider knowledge and beliefs may target all counter attendants in licensed pharmacies if that is an identifiable group for whom an intervention might be mounted. The most important principle is to ensure that all segments of the target population are well represented. Sometimes questionnaire surveys will include Aproxy@ cases; if so, criteria for who can be included must be clearly specified at the beginning. For example, in studying the use of antibiotics for treating ARI, an investigator is likely to talk to mothers with children who report with an episode of ARI. In cases where patients are accompanied by other relatives such as an aunt or neighbor, instead of the mother, the study should specify whether these persons can be interviewed or not. c. Number to Interview Sample size depends upon the aim of your study, and in particular how precise the sample estimates must be. Using the antibiotic example, if the purpose is simply to explore beliefs and attitudes about antibiotics in the treatment of cough in children, a small sample may be sufficient. However, if the purpose of a study is to estimate specific knowledge deficits in a population of paramedics in order to design a curriculum, a larger sample might be necessary. Generally, if the goal of the study is to test a hypothesis or generalize the findings to a large population, then an adequate representative sample -- usually a large one -- must be taken to achieve a reliable result. d. Contacting Respondents Respondents to a study may be contacted by mail, telephone, or personal contact; the latter is usually the most feasib le in developing countries. It is wise to contact the community or institution where the sample will be drawn in advance of the study. Depending on the focus of the study, contact people may include the chief or community head, health center officer- in-charge, or local government representative. Such influential people can later assist with field organization and logistics, and especially with providing an up-to-date list of the members of the target population (a sample frame). 6-5 During the initial contact, the aim of the study, when and for how long it will take place, and how it will benefit them should be explained to the agencies involved. Such information may encourage greater cooperation. 6.23. STEP 3: Develop the Questionnaire(s) and Guides The design of a questionnaire and how questions are worded can greatly influence the reliability of the data collected. Developing a structured questionnaire is a relatively familiar activity, since questionnaires are so commonly used. Despite this, creating a good questionnaire is not a simple task, but one which requires careful testing and retesting. The suggested sequence of steps to assemble a questionnaire is: a. 1. Determine the contents of the questionnaire. 2. Formulate the questions. 3. Order the questions. 4. Arrange the questionnaire. 5. Translate the questionnaire (if necessary). Determine the Contents of the Questionnaire The first task is to determine which topics the questionnaire will cover and how it will be administered. The number of topics will depend on the objectives of the study, and on the length of time it is reasonable to expect respondents to cooperate. Remember that the information collected should be relevant to the design of an intervention. The most frequent problem in questionnaire design is asking too many questions that are not directly useful or relevant. You can organize your work as follows: ! Outline the most important objectives of the study. ! List under each objective the types of information directly relevant and necessary in meeting these objectives. ! Rearrange and organize the lists into separate sub-themes or sections of the questionnaire. ! Decide how the questionnaire will be administered; i.e., whether it will be filled in by respondents themselves or by an interviewer (which is more common in developing countries). 6-6 b. Formulate the Questions After identifying the sections of the questionnaire, you must formulate individual questions to gather the specific pieces of information needed. Wording questions so that they are uniformly understood and tap into the desired category of response requires patience, practice, and, above all, pre-testing. Some general guidelines on good question formulation include: 1. Each question must be clear, simple, and specific For example, a question such as "Where do you normally seek treatment when your child falls ill?" may be perceived differently by different respondents. AIllness@ can include many different types of health problems, and varying degrees of severity. AWhere@ can be interpreted as a physical location or a type of practitioner. ANormally@ is an imprecise word that means different things to different people. ASeek treatment@ may exclude self- medication in the minds of some respondents. To overcome this problem, it is best to specify questions in clear, short and simple language. You may for instance break the question into pieces to assist respondents, for example, by asking specifically about ARI. Further limiting the duration to the last two weeks preceding the study or the last episode of illness will also enhance recall of respondent. You can further ask them to mention specifically the various actions they took since the illness was noticed. These may involve the following questions: Has your child been ill with cough within the past two weeks? (If the answer is yes): Did you visit anyone for advice or treatment? Did you give the child any medicines? (If the respondent indicates medicine(s) were given): Would you please list any medication(s) that the child has used since the illness started? 2. Each question must measure one thing at a time Questions which measure two or more different things should be avoided. For example, the question "How do you and your staff normally treat children who present with cough?" should be divided into several questions to enable the respondent to give separate answers for different types of prescribers in the facility, since they may each have a preferred way of treating cough. 3. Questions should not be biased Leading questions can lead to biased responses. A leading question is one which suggests the expected answer. For example, the question: "When a child presents with ARI, do you prescribe 6-7 an antibiotic?" is a leading one because it mentions antibiotic. An alternative would be to ask "What do you do when a child presents with ARI?" Leading questions may also arise when presumptions are made about the respondents. For example, the question: "What additional fluids did you give your child when he was last ill with cough?" is biased because of the presumption that when the child has had an attack of cough, the respondent would give the child extra fluids. A better set of questions might be: "Has your child had cough within the last two weeks?" (If yes): "Did you take any action?" (If yes): "What action did you take?" 4. Questions must be free from ambiguity Words which are vaguely defined or have double meanings should be avoided. The question: "What kind of patient was he?" may lead to different types of responses such as `"poor" or "rich," "simple" or "complex," "cooperative" or "un-cooperative," and so on. Also, "double barreled" questions, such as: "Do you think ampicillin and tetracycline are effective for treating cough?" are not good questions since a respondent could like one and not the other. In this case, a Yes or No response would not truly reflect the respondent's opinion. Divide such questions into two, each containing a single idea. c. Sequence the Questions After framing the questions, they must be organized in a sequence that is helpful for respondents. Following is a useful approach: ! Ensure a logical order of topics, and of questions within a topic. Ideas should flow smoothly from one question to another, moving from more general questions to more specific ones within each topic. ! Begin with relatively non-controversial and interesting questions, e.g., How many years have you worked at this health post?" ! Place sensitive questions concerning personal information such as age, education, occupation, and income at the end of the questionnaire since respondents may be unwilling to answer them if they are asked early, before a relationship of trust has been established. ! If the response to one question is likely to influence the response to another question, these questions should be separated. 6-8 ! d. Any instructions for skipping one or more questions should be clearly indicated and, if possible, written in a different font or typeface. Arrange the Questionnaire Finalizing the draft questionnaire involves planning the layout to make it both "consumer" and "user" friendly. This involves the following: e. ! Provide necessary headings and spaces for labeling and identifying all questionnaires, ie., identifying information for respondent, date and place of interview, as well as name of interviewer. ! Provide necessary instructions at the start of each section of the questionnaire. Give guidance and reminders at relevant sections to the interviewers. ! Provide sufficient space between questions. ! Be consistent with codes or boxes for pre-categorized answers. ! Provide enough space for writing down answers to open-ended questions. Translate the Questionnaire (if necessary) Most interviews involving patients in developing countries are conducted in local languages. To ensure consistency in the use of words and meanings, questionnaires must be thoroughly translated before the field work begins. One effective way of checking the accuracy of translations is to have a different translator do a back translation into the original language in which the questionnaire was written. The two versions can then be compared to iron out any differences. Table 6.2. is an example of a questionnaire. 6-9 Table 6.2.: Example of A Structured Questionnaire DRUG USE STUDIES IN ACUTE RESPIRATORY INFECTION (ARI) Client Intercept Questionnaire Name of District.......................................................................... Date of Interview.............................................. Name of Town............................................................................. Name of Interviewer......................................... Name of Facility.......................................................................... Name of Patient........................................................................... DIAGNOSIS 1. Can you tell me in your own words what the problem is with your child? 2. Why did you choose to come to this facility today for treatment? 3. Have you ever been to this facility before? Yes________ No________ 4. Did you try any other kind of treatment before you came here? Yes________ No________ If yes: What kind of treatment was that? DRUG USE 5. Could you please show me the drugs you were given here today? Examine drugs to be able to later fill in the questions on drug labeling on the dispensing form. Did anyone here tell you how to use these drugs? Yes________ No________ Did you understand what they explained to you? Yes________ No________ b. The drugs you were given? No________ If yes: Who was it that explained this to you? Table 6.2. 6. Yes (Continued) Could you please explain the use of each drug to me? Hold each drug in turn for the adult to see. Drug Described Use a. 6-10 b. c. d. e. SATISFACTION WITH CARE 7. Are you satisfied with the treatment obtained? Yes________ No________ The way the child was examined? Yes________ No________ The drugs you were given? Yes________ No________ 8. If you could change one thing about the care here to make it better, what would that b e? 9. If your child=s cough does not improve after taking these drugs, what do you plan to do? SOCIO-DEMOGRAPHIC CHARACTERISTICS 10. Sex of Respondent Male_______ 11. Highest level of education (Check one): Female________ Primary ______________________ Other Tertiary Secondary ______________________ Other (Specialties)____________________ University ______________________ No formal education __________________ 6-11 ____________________ 6.24. STEP 4: Select Field Personnel The calibre of field personnel who administer the questionnaire have a great influence on the quality of data. In structured questionnaire interviews, the field team personnel usually include interviewers and supervisors. a. Selecting Interviewers The interviewer is the one who "sells" the aims, objectives, and intended use of the information to the respondents. The following are qualities to consider when recruiting interviewers. 1. Educational qualifications Administering a structured questionnaire does not necessarily require high qualifications. Usually people with high school or second cycle education who can read and write well would be appropriate. In fact, using personnel with high qualifications may even prove risky since such people have a greater tendency to get bored with repetitive work. 2. Personal qualities The following are useful personal qualities in an interviewer: ! ability to develop rapport with people; ! ability to speak all la nguages, if multiple languages are being used; ! fluency in local language where this is essential; ! ability to work alone and under difficult conditions; ! honest and with a strong motivation to work; ! previous experience in conducting interviews; ! good communication skills. Someone who is shy, aggressive, or has an unpleasant appearance is not likely to be a good interviewer 6-12 b. Selecting Supervisors A supervisor is responsible for seeing that the field work is done properly. In addition to the personal qualities listed under Interviewer (above), the role of the supervisor demands the following additional qualities: ! ability to work with an motivate people; ! highly motivated and intelligent; ! considerable field experience is most preferable; In general the duties of a supervisor include: ! consulting relevant authorities when a team enters a community or an institution for the necessary permission; ! checking the progress of the interviewers in the field; ! acting as point of contact between interviewers in the field; ! maintaining schedules and coordinating work in the field; ! solving any problems or difficulties that need to be resolved in the field; ! reviewing and editing completed interview schedules on a daily basis to avoid or minimize any problems during the analysis; ! re-interviewing small samples of respondents on important aspects of the interview to provide some measure of quality control in the data obtained. You may decide to select your personnel through interview, or written test (for language competency). It is advisable to make the selection provisional, subject to good performance during training and field testing. 6.25. STEP 5: Train Field Personnel and Pilot-test Questionnaire The purpose of training is to impart the needed skills to the field team before they embark upon the field work. The training curriculum must cover both the technical aspects of questionnaire surveys, as well as practical training in how to implement them effectively. 6-13 a. Technical Background on Structured Questionnaires Provide interviewers with adequate background knowledge on structured questionnaires and the survey process. This theoretical aspect of the training must include the following: b. ! an overview of structured questionnaires; ! how questionnaires will be used in this drug use study; ! the role of field personnel, including interviewers and supervisors; ! how to sample and locate respondents in the field; ! how to gain rapport with respondents and conduct a successful interview; ! how to record, process, or edit data in the field; ! how the data will be analyzed. Relevant Background Knowledge about the Study Inform the team about the problem, purpose and objectives of the stud y so that they can understand it in context. Provide information about the study community and target population. Discuss the possible problems that could be encountered with respondents on the field. Explain any anticipated sensitivities on the part of community leaders, facility administrators, or respondents. This is especially important if it is possible that the questionnaire is seen as evaluating or judging knowledge or performance. c. Instructions for Recording Responses Much of a structured questionnaire is completed by an interviewer marking or circling the appropriate response. In order to avoid inconcsistency, it should be made clear exactly how the interviewer is to complete each item. For multiple response lists, indicate whether the interviewer is to read the list to respondents, and also whether multiple responses are possible. If the interviewer makes a mistake filling in a question, explain how the mistake is to be corrected ( e.g., by blocking out, erasing, circling with an X, etc.). Each respondent has to answer open-ended questions in his or her own way. The interviewer therefore needs to be cautious in recording open-ended responses. Such responses should be written in full. However sometimes this is impractical, and interviewers must learn to extract the key information. The respondent can be asked politely to repeat a response if it is not well understood. 6-14 Interviewers must not spend a lot of time writing since this can interrupt the flow of the session. Abbreviations are very useful, but interviewers should avoid those that are difficult to read later. Introducing a common set of abbreviations for vocabulary that will be frequently used is very helpful. d. Role Play Sessions The practical sessions of training consist of two parts. First are the role plays in which interviewers and other field staff practice among themselves in artificially created situations. Interviews should play the part of both interviewers and respondents. The trainer and other experienced interviewers can observe and comment on the performance of interviewers in order to improve both the interviewers' style and the questionnaire. e. Pilot Tests As with all applied qualitative methods, it is important to pilot test the questionnaire and the field procedures. This involves trying out the prepared questionnaire in a group and an environment similar to that expected in the actual study situation. It affords interviewers the opportunity to practice all the activities that they are expected to carry out in the field. Functionally, pilot tests serve to: 6.26. ! assist interviewers in becoming familiar with the questionnaire; ! help improve and sharpen interviewing skills; ! afford a means of checking, revising, and finalizing the questionnaire by improving the clarity and order of questions and removing ambiguous and unnecessary questions; ! enable the investigator to learn about possible problems that lie ahead, thereby providing an opportunity to make changes in the study organization before embarking on the field work. STEP 6: Prepare for the Field Work Once the training and pilot testing and over, you are almost ready to move into the field. Preliminary preparations do, however, need to be made to ensure that the field work proceeds successfully. 6-15 a. Review and Revise the Questionnaire After the pilot test, review and revise the questionnaire and the guidelines for the actual field work. This review should take into account all issues related to the successful administration of the questionnaire. These will include the following: ! interviewer's approach to respondents; ! target response rates; ! what to do about partial or irrelevant responses; ! mistakes in following instructions on the questionnaires; ! time required for completing the interview. Before printing the final questionnaire, have it thoroughly proof read to correct any hidden mistakes. b. Prepare a Work Plan As part of your preparation for the field work, you need a work plan and a time-table of how you will proceed with the field interviews. Particularly if the study is a large one with several interviewers and other staff, your work schedule will involve: c. ! composition of various teams of interviewers and supervisors; ! assignment of teams to specific locations or delineated areas; ! transportation and accommodation arrangements; ! schedule of work. Plan for Supporting Materials Before you finally move into the field, ensure that instruments and other interviewing materials and logistics for the field work are ready. Your checklist should include: ! introductory letters; ! sufficient questionnaires for the interviews; ! waterproof folders for the questionnaires in case of rain (if needed); 6-16 ! instruction list for interviewers and supervisors; ! pens/pencils and note books for interviewers and supervisors; ! bags for carrying interviews and materials. 6.27. STEP 7: Administer the Questionnaire a. The Interview Process Interviews are best conducted with respondents alone in a place that offers reasonable comfort and privacy. Providers and patients/clients may be interviewed in a health facility or drug retail outlet. Community members can also be interviewed in their homes which is where they are most likely to stock and take their medicines. The interview session can be divided in three stages: introduction and rapport building; interviewing; and closing the interview. 1. Introduction and Rapport Building The opening part of the interview is aimed at introducing the respondent to the topic and making him/her relaxed for the interview. The interviewer seeks to do the following: . 2. ! greet the respondent, keeping with local custom; ! introduce himself/herself; ! briefly explain the purpose of the interview; ! assure respondent that responses will be anonymous and confidential; ! politely ask respondent to introduce himself/herself; ! seek respondent's consent to start interview Interviewing After establishing rapport, the most important aspect of the interview is asking questions in a standardized way. Following are interviewing techniques to guide the interviewer: ! Questions should be asked without changing the wording, order, or emphasis. Rationale: All respondents should be given the same information and asked the same questions, under similar conditions. 6-17 3. ! Instructions which introduce sections of the questionnaire must be read out clearly and distinctly. Rationale: These instructions help respondents think about and prepare their answers. ! Interviewers must read out questions at a reasonable pace. Rationale: If the interview is rushed, respondents may give answers that tend to come to mind first instead of thinking about questions; if the pace is too slow, the interview can drag along and tire respondents. ! If a question is not understood, the interviewer must repeat the question in the same words, with the same emphasis and the same instructions. Rationale: Putting questions in different words can easily change the meaning and emphasis. ! Interviewers must avoid returning to questions which could previously not be answered. Rationale: Repeating questions this way can expose the intent and influence the responses. ! The interviewer must show neutrality as much as possible. Rationale: Certain reactions by an interviewer can change the attitude of a respondent. Examples are: frowning or irritated voice, smiling or laughing suspiciously, winking an eye, or raising eyebrows. Closing the Interview Before the interview is brought to an end, the interviewer must politely thank the respondent, explain that the interview is now completed, and ask if the respondent has any comments or questions. It is a good idea to ask respondents if they felt that the interview captured all of their opinions about the subject matter. Often respondents will offer useful opinions that may not have been covered in any of the questions. In the final wrap- up, the interviewer must remember to: ! repeat the value placed on the respondent=s opinions and their likely bene fits; ! reassure the respondent of confidentiality; ! express goodwill or polite farewell. 6-18 Remember: the interview does not end until the interviewer has said Athank you@ to the respondent. b. Anticipating and Managing Possible Problems There are some problems that are commonly encountered during interview surveys. Sometimes these can be anticipated and prevented. Common problems and suggested ways to deal with them include: ! A respondent refuses an interview altogether: The best way to guard against refusals is by polite introduction, explaining the intended benefits of the study, and assuring the potential respondent that the interview will be brief. When refusals occur, note any reasons for the refusal and leave the respondent. ! A respondent abandons the interview halfway: Keeping interviews on track and moving along at a good pace will decrease abandoned interviews. Well-designed questionnaires also help by maintaining the respondent=s interest. When interviews are abandoned, record any comments as to why this occurred. ! Respondent gives careless answers: Well-trained interviewers are always alert for respondents who do not seem to be responding seriously or thoughtfully. Sometimes the respondent is temporarily distracted or hurried, and the interview can be re-scheduled for completion at another time. In any case, record any doubts and suspicions, and indicate obviously suspicious answers. ! Noisy environment: Queues of patients, curious onlookers, and young children can all distract respondents. Finding a more private place for the interview is the best solution. If this is impossible, carry on as best as you can; find out from the respondent whether something can be done about the problem. ! Others present try to intrude in respondent's answers: Any unusual activity in a health facility or home tends to attract interest. Onlookers can bias responses not only by directly answering questions, but also because respondents may not be able to give honest answers in their presence. Politely ask helpful onlookers to stop; at the extreme, suspend and re-schedule the interview with the consent of the respondent. 6-19 ! 6.28. Aggressive and other unacceptable behavior change in respondents: Sometimes a particular question or simply an overly lengthy interview can trigger hostility in a respondent. In these situations, end the interview with a polite excuse; record the actual details of the closure on the questionnaire. STEP 8: Analyze and Interpret the Data After the field work, data from the questionnaires must be processed, analyzed, and presented in the form of a report. The process involves the following activities: a. Processing Questionnaire Data 1. Check and Edit Questionnaires For purposes of easy identification, all questionnaires must be numbered separately after they have been completed. Field supervisors should maintain a log of the number of completed questionnaires received from interviewers each day. This helps to prevent lost questionnaires, and also can be used to check interviewer productivity. Interviewers should routinely edit questionnaires under the supervision of the field supervisor to correct errors, omissions, or logical inconsistencies in filling them. The process is particularly useful at the early stages of data collection, as it allows errors to be fed back to the interviewers in order to avoid further mistakes. Before the data process begins, a complete re-check and editing is necessary to clean the data. 2. Categorize Responses The first stage of data processing involves categorizing the responses. This is the process of listing all responses to a question under clearly defined options. In structured questionnaire, categorization is necessary for open-ended questions. For example, an answer to the question: "Why did you choose to come here today for treatment?" , could contain possible categories such as "accessibility", "faith in treatment", "treatment is scientific", and "referred". The process begins by first examining the raw data to draw up a list of clearly defined responses for each question. Each category should be precisely described in a few words. Again, the list of categories for each question should not be too long as this can make the analysis difficult. For each question, place similar responses under one category. The process takes the analysis a step on to coding. 6-20 3. Code Data Coding involves assigning symbols to categories. Commonly, numbers are used. Coding makes data processing easier, particularly where the ana lysis involves the use of a computer. Codes are written on each questionnaire next to the responses. It is ideal to maintain consistency in coding by writing the codes on one side, i.e., either left or right margin of the questionnaire, since this facilitates speed and helps minimize errors in data entry. For each question, if the number of categories does not exceed 9, which may be the case in most situations, assign A1" to the first category, A2" to the second category, and so on. If the number of categories exceeds 9, assign "01" to the first group, "02" to the second group, "03" to the third group, and so on. When developing a coding list, it is advisable to give the same code to common responses, irrespective of the question, to minimize mistakes by coders. Example: No = ? Yes = 1 There are no common types of missing values that must be assigned codes. Sometimes a response is missing because the respondent did not know the answer; this is sometimes assigned the code A8" or A88" in numerically coded questions or ADK@ in categorical systems. A response can also be missing if the respondent refuses to answer, the interview was not finished, the item was skipped, or for other reasons; these missing values are after assigned A9" or A99" codes in numeric systems, or ANA@ if categories are used. When you have finished developing your codes, compile them into a code book and ensure that there are enough copies for all coders. During coding a supervisor must periodically review a sample of each coder's work to ensure that coding is being done correctly. 4. Analyzing Data After coding, the stages of analysis will vary depending upon whether it is manual or involves a computer. If the analysis is manual, the use of dummy tables or a master sheet is very helpful. 1. Using data master sheets When data are to be analyzed manually, you will need tools for organizing the coded data from the questionnaires and aggregating them into summary tables. The data master sheet is one tool for organizing data. This technique is particularly helpful for small samples. Basically, it is a sheet containing the various coded responses on the questionnaire that makes it easier to tally the individual responses by hand. 6-21 The advantage of using a master sheet is that direct counts can be done easily for coded responses, e.g., for socio-economic and other background characteristics. It may not be feasible to use master sheets if the questionnaire involves many open-ended responses. In such cases, hand compilation may be more useful in order to capture the whole range of responses. Table 6.3. is an example of part of a master sheet. Table 6.3. Example of a Data Master Sheet Respondent ID Sex Age Diagnosis Prescriber Drugs No. Prescribed Satisfaction Antibiotic? Inject ion? With drugs Knowledge With care About diagnosis About drugs 1 2 3 Etc. TOTAL 2. Using Tally Sheets After data have been organized on master sheets, it is easier to compute totals for individual variables. However, the other advantage is that more complex data presentations can be developed easily from the master sheets, such as two-way and three-way tables. To develop a complex data presentation, it is first necessary to lay out a dummy table that will contrast totals within categories. An example of a dummy table contrasting level of satisfaction for patients who received or did not receive an injection by diagnosis is shown in Table 6.4. Table 6.4. Example of a Dummy Table Received Injection Satisfied No Injection Not satisfied ARI Diarrhea Malaria Other Diagnoses 6-22 Satisfied Not Satisfied Once a dummy table has been laid down, each respondent=s data from the master sheet can be recorded as a tick mark in the appropriate cell of the table. After all respondents= data are entered, tallying the tick marks gives the totals for the sample as a whole. 3. Using a microcomputer for analysis If a study involves a large volume of data, it is generally easier if a computer is used for the analysis. This will, however, also depend upon the resources available. The following steps provide guidance on how computerized analysis would be conducted. 4. Choose appropriate software Various computer software programs are available for use in processing data. For most drug use studies some of the common ones include the following: ! Epi Info version 5 or 6. ! spreadsheet LOTUS 123 program ! dBase or other database management program ! Statistical Package for Social Sciences (SPSS) or other statistical package Before you decide on what program to use, however, it is advisable to consult an expert in the area. In fact such a person ought to be consulted at the planning stage of writing the questionnaire in order to pre-plan how questions should be framed, and what kind of analysis could be done. This has the adva ntage of preventing or minimizing difficulties in analysis. 5. Enter data For the data to be entered into a computer, a data entry format must first be developed. This is a screen containing the questions in the questionnaire with a space provided for entering appropriate responses. Epi Info 6 is especially well-suited for developing data entry routines directly from the wordprocessing files used to print the questionnaire. When this has been done, the data are then entered into the computer in their coded form. It is fastest to have specially trained data entry clerks do the data entry. 6. Edit data After all data have been entered into the computer, a verification must be done to correct errors and omissions made in the process. Examples of such obvious mistakes may involve wrong codes such as entering 6 as code for sex when the allowable codes for sex in most cases are 0 or 1, and so on. 6-23 To avoid or minimize such mistakes, it is sometimes possible to build checks into the program to detect and refuse such data entry mistakes. Another option is to enter data twice and have the computer check the equivalence of both entries. 7. Carry Out Analyses The great advantage of using a computer lies in its ability to do several kinds of analysis in a relatively short time. After the data have been cleaned, you can run the analysis to obtain the needed output. Results can be produced in the form of graphs, tables, charts, and a range of statistical tests. You need to decide the most appropriate and useful but also interesting way of making this presentation. c. Presenting and Interpreting Data Two basic approaches are involved in the presentation and interpretation of data from structured questionnaires. The approach is determined by the nature of the questions asked; ie., whether they are close-ended or open-ended. The analysis of close-ended questions, which are more or less quantitative, involves: ! First summarizing the information in a tabular or statistical form, and then ! Describing in words or text the information presented. The presentation can be descriptive or analytical depending upon the purpose of the study and the intended use of the results. Simple statistical procedures that are used in most studies include calculating averages, percentages, proportions and ratios. As already mentioned, presentations can be in the form of tables, graphs, pie charts and several others as best as the investigator can manage. Open-ended questions may also be reported as percentages if categorized and coded, but the content of each response or categories of any particular question may also be analyzed in more depth. As much as possible, responses that ask for knowledge, attitudes, and practices should be described as well as quantified. The last stage of the data presentation is interpretation. It involves explaining the underlying reasons for the findings, and drawing implications from them. The discussion can highlight the significance of the main findings by contrasting them with other studie s on the subject. Based on the findings and discussion, recommendations for further action can be made. This may involve the introduction of interventions such as health education, targeted at the community people, or policy changes to streamline the managerial capacity of the institution(s) involved. 6-24 d. Writing the Report Findings from a questionnaire study are presented in the form of a report. An outline of the final report should ideally be developed at the initial stage of the study and reviewed after the pilot test. The components of the final report should consist of the following: Introduction: Statement of problem, research objectives, rationale, scope, operational definition, outline of the chapter. Methodology: Research approach and method, instruments, study setting, sampling, personnel, field work organization and supervision, mode of data analysis. Findings : This embodies tabulating and describing the study results. Discussion: Underlying reasons and explanations of the main findings. Conclusion and Recommendations: Inferences, suggestions, and likely follow-up interventions. 6-25 SYNTHESIZING DATA AND DESIGNING INTERVENTIONS Chapter 7: Synthesizing Data to Prepare for Interventions Chapter 8: Using the Study Results to Design Interventions CHAPTER SEVEN SUMMARIZING DATA TO PREPARE FOR INTERVENTIONS The primary focus of this chapter is on how data from applied qualitative methods may be summarized to prepare for an intervention, especially in studies that have used multiple methods. Following a discussion on the use of multiple methods, the chapter describes a structured process for organizing and summarizing data. 7.10: Using Multiple Methods The applied qualitative methods described in this manual can be used to enrich our understanding of the factors causing a drug use problem and of the potential barriers to correcting it before we attempt to design and implement an appropriate intervention. Frequently we use several methods together in a coordinated way to achieve the best understanding and to design the strongest intervention. As described in previous chapters, each applied qualitative method is well-suited to answer different types of questions. In planning a study, we must decide which me thod is likely to contribute useful information to answering each of the study questions we have identified. Often the best results are obtained by using more than one method; the issues explored by different methods will usually overlap or complement each other. For example, to learn about the reasons for a high rate of antibiotic use in treating acute respiratory infections, we decide to combine exit interviews with patients, questionnaires and focus groups with health workers, and structured observations of clinical consultations. The questionnaires and focus groups may both be used to look at prescriber preferences for drugs to treat ARI, with the questionnaires aimed at understanding levels of knowledge and the prevalence of different opinions about drugs, while the focus groups look more at underlying reasons and beliefs. The structured observations might gather data on the adequacy of diagnosis, treatment choice, and patient-prescriber communication, while the patient exit interviews examine prior expectations, satisfaction with treatment, and understanding of prescribed drugs. One way to think about summarizing the data from multiple methods is in terms of taking photographs of objects, such as houses in a given town. Photographs can be taken from front or back; from far away to see the houses in their setting, or from close- up to get more detail; in 7-1 daytime or at night. All the photos are true and objective pictures of the houses, but none gives the whole story; each photo provides a piece of the truth. Only when the photos are considered as a composite will our perception be complete. Even then we may still need to infer details about the houses that appear in none of the photos from the features that do. Similarly, each quantitative and qualitative method is like an individual photo. Quantitative methods tend to take pictures from a distance, and use the same camera, held the same way, with the same film, and the same shutter speed; qualitative methods are more concerned with close-up and detail, and they generally give more freedom to the photographer to be inventive in his/her use of the camera. Collecting and putting together our different research photos gives us the most complete picture of the problem and its causes. Viewing the problem from a number of different angles helps to increase the appropriateness and potential impact of an intervention. Each applied qualitative method generates its own type of data, as well as its own separate findings and conclusions. The team which implements each method may or may not know about the findings from other methods; in fact, there may be an advantage to obtaining several independent viewpoints by having different people implement each method. However, the use of multiple methods results in a large volume of data, and the findings are not necessarily compatible. It can be difficult to sort through, combine, and summarize data from individual methods in order to draw conclusions about an optimal intervention. There are a number of different strategies that researchers use for combining and summarizing data from multiple studies -- there is no correct way of approaching this task. This chapter will describe one strategy for summarizing data that is based on a process of structured interaction among all the individuals who have been involved in planning or implementing the individual methods. This process is organized around the set of questions you developed when the study was first planned. If you (or the resource person assisting in this study) are familiar with another strategy for integrating data from multiple methods, you should certainly feel free to vary the process described here, or to use an alternate process. However, the key features of whatever process you choose should be taking account of all the available data and staying focused on the implications of the data for intervention. 7.20: Summarizing the data Typically, a drug use problem is first defined in quantitative terms, e.g., overuse of antibiotics to treat acute respiratory infections in certain health facilities, or low rates of compliance with treatment for tuberculosis in a given region. An applied qualitative study can help us understand in greater depth why and under what circumstances an identified problem occurs, and how we might be able to correct it. Each applied qualitative method adds additional pieces of information to our understanding. However, when multiple methods have been used, it can be difficult to integrate all this information into a comprehensive overview of what we know about a problem and its possible solutions. It helps to have an efficient process for combining and summarizing findings; the following steps describe one process for achieving this. 7-2 a. Hold a Data Summary Meeting Often health managers or investigators leading a study will not actually implement the field work. Separate individuals or teams may be commissioned to carry out each method and prepare a report analyzing the findings. Sometimes there will be very little communication during the field work phase between the study leaders and the implementors of each method. One strategy for summarizing the data and findings from a multi- method study is to hold a joint meeting of everyone involved in the study, called a data summary meeting. Such a meeting can last from one to three days, depending on the number, scope, and complexity of the studies that were carried out. The structure and content of the data summary meeting are reviewed below. b. Report Each Method Separately To be sure that everyone at the meeting is familiar with each of the studies, the first activity should be a presentation of separate reports by each study team. These reports can be presented according to the format in which they have been prepared. However, each study report should cover at a minimum: the specific study questions addressed; details of the methodology; a review of results; and a brief discussion of conclusions. Brief written summaries of the findings, tables, or graphs should be distributed to all participants. It is best to limit group discussion after each individual report to clarification about methods or results. Detailed discussion of specific findings or of their implications for intervention design should be limited until all groups have had a chance to present their separate reports. Sometimes findings will suggest important issues to be considered during the later discussion about interventions. Each of these issues should be listed in a visible place (e.g., on a white board or poster paper) as it is raised, but not discussed at length. By compiling such a list, you can be sure that all relevant issues will be covered in the integrated discussion that will follow. c. List All Data Relevant to Each Study Question You began your study by formulating a set of questions you felt needed to be answered in order to design an intervention (see Chapter 2). Each applied qualitative method was chosen to address a specific subset of these questions. Usually no single method can provide answers to all the questions asked. On the other hand, many of the questions will have been addressed by more than one method, each of which examines the question from a different viewpoint. After individual methods and results have been presented, the next step in the data summary process is to gather together all the data that are relevant to each individual study question. These lists of data items will then be used to develop a unified answer to each question. 7-3 Return to the list of questions you originally prepared. Proceeding one by one through the subtopics and the individual questions, try to assemble all of the data that seem relevant from all of the available sources. Additional topics that were raised during the individual presentations should be considered as separate questions within the topic where they fit best. As each question is asked, it should be discussed at length. Everyone in the data summary meeting is free to contribute: ! specific findings from one or more of the qualitative studies or facts, as represented by a quantitative result, a table, a graph; ! quotations or anecdotes, which seem to crystallize an insight about the question from one of the methods; ! opinions, either personal or expressed by one or more of the respondents in a qualitative study. Each contribution should be written in summary form on the white board or on poster paper as it is made, along with the source for the data (e.g., prescribing survey, focus group with physicians, patient exit interviews, etc.). Order is not important. An example showing the data relevant to the first study question in the Pelotas diarrhea study is presented in Table 7.1. d. Develop a Summary Answer to Each Study Question When there are no more contributions of data for a question, the group should try to develop a summary answer that reflects all the known information. As far as possible, the summary answers should be a series of simple descriptive statements. A summary answer for the Pelotas data presented above about differences in treatment across institutional setting is shown in Table 7.2. Of course, it may not be possible to create a simple summary answer for every question. Often the findings about a particular question will be complementary, but sometimes results will contradict each other. For example, prescribers or patients may respond in a certain way to interviewers= questions about their practices, yet an observer may see the same people acting in a way which contradicts their responses. Contradictory findings can be useful, since they may point to areas that need particular attention during an intervention. Such areas of conflicting or ambiguous results should be clearly noted. When the summary answers for all questions have been completed, you will have an organized and compact presentation of the data in your study. You should now have a good idea whether an intervention will be feasible, and be ready to make decisions about how this intervention should look. However, before designing the intervention, you should familiarize yourself with the general information on interventions presented in the next chapter. 7-4 Table 7.1 Example of Data List to Answer a Study Question Question: Are treatment practices the same in health centers managed by the municipality, the university, and the state government? Data Source state prescribing survey ORS antibiotic metronidazole Data Item % of cases receiving: municipality 51% 22% 11% university government. 24% 49% 16% 53% 16% 31% exit interviews patients at the municipal and state government clinics tend to be of lower socioeconomic status that those at the university health centers exit interviews a similar percentage of patients report being Asatisfied@ or Avery satisfied@ with the care they have received in all clinics (84% in municipality; 89% in university; 76% in state government) patient in-depth patients see the university physicians more as Aspecialists@ and Aexperts@ compared to other physicians patient in-depth patients seem to prefer the drugs they get at the university clinics (usually brand names) but they generally do not like to go there for Asimple@ problems like diarrhea because the fees are higher physician in-depth university physicians tend to see ORS as Afirst aid@ that patients can receive at a public clinic, so they often do not bother to prescribe it physician in-depth physicians in municipal and state clinics report that they have been trained in the WHO diarrhea case management protocol, but university physicians have received no such training observations the waiting area and consultation rooms tend to be more crowded, dirtier, and less comfortable in municipal clinics observations examination time is significantly longer in university clinics (4.7 mins) compared to municipal (2.3 mins) or state government (2.5 mins) observations public health nurses were observed carrying out group health education sessions for patients in some of the municipal and state clinics; no sessions were observed in the university clinics 7-5 Table 7.2 Example of Summary Statement About a Study Question Question: Are treatment practices the same in health centers managed by the municipality, the university, and the state government? Summary: Prescribing for diarrhea in municipal and state government health facilities is quite similar, except for metronidazole. ORS (given to about half of patients) appears to be underused, while antibiotics (about 20% of patients) are slightly overused. In state facilities, there is considerable overuse of metronidazole (31% of patients), but the reasons for this are not known. Examination time is very short in both settings (less than 2.5 minutes). In university clinics, there is considerably more room for improvement in prescribing, since many more patients receive antibiotics (49%), while many fewer receive ORS (24%). Doctors in these clinics have not yet been trained in the WHO case management protocol. However, there may be resistance to such a standard protocol, since doctors seem to feel they have more advanced practices. Patients are generally satisfied with treatment in all clinics. However, when they can afford the fees, patients seem to prefer university clinics. Possible reasons for this include: they are seen by the doctor for a much longer time; the staff are seen to be more Aexpert@; they receive brand name drugs, including antibiotics; the general clinic facility is more comfortable. Any intervention that would include a patient education component seems quite feasible. There is already patient education taking place in the waiting area in municipal and state facilities, delivered by public health nurses. Staff is actually more available in university clinics, but they are not yet being used for this purpose. 7-6 CHAPTER EIGHT USING STUDY RESULTS TO DESIGN INTERVENTIONS This chapter deals with selecting and designing interventions. Decisions about intervention design should be influenced by what you know about the effectiveness of different types of intervention, together with what you have learned about the specific problem you are addressing and the context in which it occurs. After a brief overview of interventions, the chapter provides guidance about using the information you collected to design interventions. 8.10: Intervention Strategies The ultimate objective of the applied qualitative studies described in this manual is to design an intervention to improve an identified drug use problem. To assist in this process, you carried out targeted studies to answer a series of questions aimed at learning more about the underlying causes of the problem, the motivations of prescribers and consumers, and possible constraints to changing their behaviors. Armed with this new information, you are now ready to design an intervention that you feel will be most likely to stimulate change. 8.11: Type of Interventions When designing interventions, there are many options to choose from and a range of factors to consider. Before launching into the design process, it is help ful to have an overview of the kinds of interventions that have been tried in other settings. Interventions can be broadly grouped into three categories: educational, administrative, and regulatory. Although it helps to organize our thinking about interventions to group them in this way, it is important to note that the most effective interventions combine elements from all three types of intervention. 1. Educational Approaches Educational approaches are based on communicating information and persuading health providers or consumers to behave in a different way. They are most helpful when knowledge deficits, mistaken beliefs, or access to biased information are contributing causes of the observed problem. Because the behavior and opinions of peers can be very persuasive in stimulating a 8-1 change in behavior, educational interventions are also very promising when it is possible to facilitate learning in peer groups of health providers or patients. Examples of commonly- used forms of education include: ! ! ! ! 2. printed materials -- clinical literature, newsletters, advertisements, etc. training programs -- basic, post- graduate, and in-service face-to-face persuasive approaches, either one-on-one or in small groups media-oriented approaches, e.g., posters, radio, tele vision Administrative Approaches Administrative (or managerial) approaches use processes and tools designed to guide decisionmaking by health providers or consumers. Administrative approaches can work either through supportive processes that make it easier to perform a preferred behavior, or through barriers against discouraged practices. These supports or barriers may include: ! ! ! ! 3. guides for prescribing and dispensing -- limited lists of drugs, standard treatment guidelines, clinical pathways, standard order forms, etc. systems for improving the selection, procurement, and distribution of drugs drug utilization review combined with feedback to providers financial incentives -- practice budgets, patient cost sharing, drug pricing, etc. Regulatory Approaches Regulatory approaches are designed to restrict decision making -- to remove choices about drug use behavior from the hands of prescribers, dispensers, or consumers and put them in the hands of policymakers or managers. There are many possible areas of regulatory activity, including: ! ! ! ! market controls -- banning drugs that are unsafe or of doubtful efficacy, refusing to register products that are not cost-effective, etc. licensing restrictions -- enforcing regulations about prescribing by non-physicia n health workers, or pharmacy dispensing of prescription-only drugs, etc. prescribing controls -- limiting certain drugs to particular types of prescribers, changing products from prescription-only to over-the-counter, etc. dispensing controls -- requiring adequate product labeling, mandated patient counseling by dispensers, limiting the number of drugs dispensed per patient, etc. 8-2 8.12: Strengths and Weaknesses of Interventions No intervention approach is equally effective at dealing with every problem or perfect for every situation. In general, each of the three broad categories of intervention has its own strengths and weaknesses, and particular interventions in each category may be more or less effective depending on the circumstances. Table 8.1 summarizes some of the overall strengths and weaknesses of the three basic intervention approaches. Table 8.1: Strengths and Weaknesses of Intervention Approaches Intervention Strengths Weaknesses Educational Approach ! works best if knowledge deficits are an underlying problem ! best results if message is clearly focused on specific issue ! more effective with single individuals or small groups ! repetition and reinforcement of messages strengthens results ! knowledge often cannot overcome system barriers ! disappointing results with broad messages and large groups ! can be labor intensive if there is a large target group ! transfer of staff or counterpromotion by drug companies can dissipate results Administrative Approaches ! works best when systems can be set up to make it easier to follow recommended behaviors ! can be used to support and sustain educational programs ! very effective if target group assesses own practices ! improved supervision can have positive spin-off effects ! open to abuse if administrative changes are not accepted by target group ! formularies, guidelines, protocols need periodic revision ! information systems may be hard to establish and maintain Regulatory Strategy ! works best if safety is an issue, and problem behaviors are easy to isolate and eliminate ! frequently easy to implement ! can give powerful and rapid results for certain problems ! best if combined with other approaches ! frequently produces unexpected negative results ! may be open to abuse ! often difficult to enforce ! impact difficult to measure 8-3 8.13. Caution About Regulatory Approaches Regulatory interventions often cut with a blunt sword. Although they are frequently easier to implement than educational or administrative interventions, they can have unintended side effects. Examples of some of the ways regulations can fail to be effective include: ! prescribers substitute drugs that are clinically worse or more costly than the products removed by the regulation ! consumers turn to Aunofficial@ health providers or to the black market to gain access to banned drugs ! problem behavior changes while a regulation is in effect and enforced, but returns to old patterns as soon as enforcement lessens ! prescribers or dispensers change their record-keeping practices to make regulatory oversight difficult One example of an unintended negative effect occurred in a country that banned all antidiarrheal drugs for children. After the products were removed from the market, there was a reduction in the use of antidiarrheals, but increases in the use of liquid antibiotic preparations and metronidazole were also noted. It appears that prescribers had substituted antibiotics and metronidazole, which they were allowed to use for infective diarrhea, for the antidiarrheals that they were being educated no t to use. Implementing a regulations without taking into account the understanding and acceptance of prescribers and consumers may cause unwanted side effects. For instance, generics prescribing policies are in place in public health facilities in many countries. When prescribers are not well informed about the advantage of generics, they may not comply with generic prescribing. They may also transfer their negative perceptions to patients, which will further jeopardize the implementation of the policy. In addition, withdrawing drugs without proper information to the general public can create confusion and uncertainty for consumers, especially if they use these drugs routinely. For regulatory actions to be effective, there is usually a need to incorporate information and education to health providers and consumers. 8.14: Combining Approaches Interventions are usually much more effective when they combine a number of different approaches to attack the same problem. Education of prescribers aimed at encouraging a new approach to treating a certain problem can be combined with posters or pamphlets aimed at patients and consumers supporting these changes. Administrative systems like formularies, standard treatment guidelines, or utilization review can be put in place to support the changes targeted in an education program. Regulations that remove some drugs from the market can be combined with education for prescribers and consumers to explain why this action was taken and 8-4 to suggest alternatives. Each of the activities in a combined intervention reinforces, sustains, and extends the overall impacts. For example, a successful intervention occurred in Mexico City where the treatment of diarrhea in social security clinics was unsatisfactory. The first component of the intervention was an educational workshop for clinic staff to develop their own treatment algorithm for this problems. After the workshop, treatment of children with diarrhea according to the algorithm improved from 24.5% to 51.2% of cases. For the next six months, the physicians who attended the workshop monitored their own practice and participated in a process of peer review, which further improved appropriate case management to 71.6%. After 18 months the improvement had been maintained. During this period, there were only minor changes in a control group of prescribers who had not participated in the workshops and peer review. 8.15: Making Intervention Choices When designing an intervention, the challenge is to choose an approach that will produce the desired changes for the least cost without any unnecessary negative consequences. Some key factors to consider in this choice include: ! Likelihood of Success: Choose an approach that is likely to succeed based on experience elsewhere or on your own analysis of the situation. ! Cultural and Political Feasibility: Choose programs that fit well within your cultural, political, and bureaucratic environment. ! Technical Feasibility: The availability of technical resources like trainers or data systems must match the requirements of the intervention. ! Cost: Interventions that require large recurrent expenditures, or where savings on drug expenditures do not clearly exceed costs, are not likely to be politically acceptable or financially feasible. ! Potential for Broader Impact: Interventions that can be extended to other members of the target group, to the rest of the country, or to other drug use problems should receive higher priority. ! Potential for Negative Impact: Interventions that might result in negative outcomes -e.g., shifts to other expensive or unsafe drugs, increases in use for other services, diversion of patients to other providers -- should be carefully evaluated before they are implemented on a widespread basis. In general, no intervention is final. There is always a need for sustained effort, further supportive measures, and additional refinements. Interventions that do not succeed immediately can be strengthened based on information you collect during evaluation. Therefore you may want to begin with the intervention that is limited, feasible, and relatively simple to implement, measure its effectiveness, and then extend it in ways that are more complex or demanding. 8-5 8.20: Using Applied Qualitative Data in Intervention Design The previous chapter described a process for systematically answering a set of questions you had posed to gain a more in-depth understanding of a problem. From discussions at a synthesis meeting, you and the other investigators should have a clearer idea about the causes of the problem and factors that will encourage or discourage change. The specific problem behaviors should be clearly defined, as should the target groups of prescribers or patients likely to gain the most from an intervention. You may have ideas about the general style of intervention that might be effective. However, because until this point you have been exploring the problem rather than designing an intervention, many details and practical issues may still be unclear. You must now focus on using the information gained during your applied qualitative study to design the details of an intervention. If time permits, you can begin this process as the last activity in a synthesis meeting, so that the individuals involved in the applied qualitative studies can contribute. However, that setting and group of people included in such a meeting may not always be appropriate for this task. In addition, some aspects of intervention design may require additional fact- finding or discussion with others who were not part of the applied qualitative studies. Depending on your own situation, decide how best to undertake the activity described below. Table 8.1 contains a list of issues that you should consider when designing an intervention. For interventions that will have an educational component, the issues involve: (1) defining target groups and target behaviors; (2) selecting the best educational approach and materials; and (3) implementing the educational program. For administrative approaches, the issues to consider include: (1) the appropriateness of various supportive administrative systems, such as formularies, clinical guidelines, audit and feedback, reminders, supervisory programs, incentives, etc.; and (2) strategies for implement ing administrative changes effectively. When considering regulatory changes, important issues include: (1) strategies for promoting positive changes following regulation and for minimizing unintended negative impacts; and (2) implementation monitoring and enforcement. Finally, for all interventions, whatever the mix of approaches, one key topic to consider during intervention design is monitoring, evaluation, and dissemination of results. One way to proceed with the intervention design process is to systematically consider each of the questions in Table 8.1. These questions address a large number of design decisions ranging from the early stages of intervention planning through implementation and evaluation. Determine if each of the issues is relevant to your situation, and if so, how you will account for the issue during intervention design. Refer throughout this process to the data lists and summary statements you prepared during the synthesis session, since these should give you concise answers to many of the major issues to be dealt with during intervention design. 8-6 Table 8.1 Issues to Consider in Designing an Intervention Type Educational Interventions Questions to Consider Target Group and Target Behaviors ! Who is the target group for the intervention? ! What behaviors are expected to change and what alternatives will be recommended? ! What specific knowledge deficits are associated with problem behaviors? ! Why should target group members adopt the new behaviors? ! How will the members of target group be contacted? ! How will the objectives of the intervention be explained? Educational Approach and Materials ! What is the best educational format: self- learning, one-on-one, small groups, seminar? ! How can peer relations or opinion leaders be used to facilitate change? ! What are the main intervention messages? ! How can communication between health workers and patients be improved? ! What print materials will be used to deliver the educational messages? ! Who will prepare printed materials? ! How and with whom will printed materials be pre-tested? Implementation ! Who is the most credible sponsor of the educational/training program? ! Who will conduct the actual educational/training activities? ! How will the educators/trainers be trained? ! Who will plan and schedule the educational/training activities? ! Where will the educational/training sessions be carried out? Administrative Interventions Designing Administrative Systems ! Would implementation of formularies, limited drug lists, or clinical guidelines help to change practice? ! What incentives can encourage health workers to use formularies or clinical guidelines? ! Do prescribing and dispensing practices very widely among health workers or facilities? ! Are health workers aware of how their own practices compare with those of their peers? 8-7 Type Questions to Consider ! What would be the best way to collect and feed back data to health providers about comparative practice? ! Are some poor practices due to forgetfulness by prescribers or failure to consider alternatives? ! How could reminder systems be used, e.g., management information systems, structured order forms, etc.? ! How can the supervisory system or self- monitoring be used to foster and sustain improvement? ! How does the system or promotion or evaluation influence practice? ! Are there physical or infrastructural limitations that will prevent change? ! What is the influence of financial incentives on practice? ! Do consumers have sufficient information about drug pricing to guide their decision making? Implementation ! What training will be needed for the prescribers and dispensers who will be using the new systems? ! What training will be needed for the staff expected to implement and monitor the planned systems? ! If formularies, drug lists, or clinical guidelines will be used, who will participate in their development and how will they be kept up to date? ! What supporting printed materials are required? ! How can positive changes in practice be reinforced over time? Regulatory Interventions Impacts of Regulatory Changes ! Are there existing regulations that contribute to problem practices? ! Which specific regulations need to change to improve practice? ! Would limiting access to certain drugs improve their use? ! What would be the impact of removing problem drugs from the market? ! How are providers and consumers likely to respond to the proposed changes in regulations? ! If access to certain drugs is restricted, which drugs (or other services) are likely to be substituted? ! What is the potential for shifts in utilization as a response to regulatory changes, e.g., more use of traditional providers, increase in sales on the black market, bypassing of the referral system, etc? Implementation 8-8 Type Questions to Consider ! Which educational programs are needed to explain regulatory changes to health providers and consumers and prevent unintended effects? ! Would active enforcement of regulations improve practice? ! Which staff are available to enforce compliance with regulations? ! How will responses to regulatory changes be monitored? All Interventions 8.30. Monitoring, Evaluation, and Dissemination ! Who will supervise the implementation of the intervention? ! What data systems need to be developed to monitor changes in practice? ! Who will collect and assess monitoring data? ! Who will be responsible for evaluating the impacts of the intervention?? ! What are the key outcome measures? ! When and how will outcome data be measured? ! What data will be collected to measure implementation cost, efficiency, and cost-effectiveness? ! When will the target groups be informed about results? ! Who will prepare the report evaluating the intervention, and when? ! How will results of the intervention be disseminated to policymakers? EVALUATING THE IMPACT OF INTERVENTIONS Evaluating whether an intervention achieves its desired impact -- i.e., improving use of drugs in a cost-effective manner -- is often neglected. In many situations, interventions are implemented without prior field testing to demonstrate their effectiveness in the existing system. This risks a waste of financial and human resources and may further increase the burden of health care services. It is wrong to assume that if an intervention takes place, its behavior change objectives have been accomplished. For example, the fact that clinical guidelines for primary care facilities are produced does not mean that prescribers will utilize the guidelines, or that prescribing practices will improve. Evaluating impacts is an important component of any intervention strategy. The following points should be considered in designing an evaluation: ! An evaluation plan should be developed along with the implementation plan. Before any intervention is disseminated widely, it is imperative to test whether it can be successfully implemented in the local health care setting. 8-9 ! Impacts of an intervention should be evaluated according to the most relevant behaviors and messages targeted. Depending on the objectives of the intervention, evaluation measures may include changes in knowledge or perceptions about a specific practice, the process of care, the types of drug prescribed, the cost of prescribing, changes in clinical outcomes, and so forth. Indicators should also be selected according to their reliability and the feasibility of collecting the required data. ! Valid evaluation of impacts requires appropriate methodology. At a minimum, this usually includes measuring outcomes before and after an intervention, and comparing changes in a group which receives the intervention with changes during the same period in a comparison group which does not. ! Long-term sustainability of the impacts of an intervention is always desirable. Changes observed immediately after an intervention has taken place often disappear after a period of time unless there is repetition and reinforcement of the intervention messages. For this reason, it is useful to measure key outcome indicators again after a longer period has elapsed (1-2 years) to be sure that positive changes are sustained. 8-10 ANNEX A: 1. SAMPLING TECHNIQUES Non Probability Sampling Methods There are two common types of non probability sampling, namely convenience or purposive sampling and quota sampling. a. Convenience Sampling Convenience sampling is that in which the study units that happen to be available at the time of data collection are selected for purposes of convenience. Most clinic based studies use this method. It is the common method for selecting participants to a focus group discussion. b. Quota Sampling Quota sampling is used when it is considered that convenience sampling would not provide a desired balance of study units. For example when assessing patient understanding of how to take drugs, a quota sample could be used to ensure that both males and females are covered in the study. Non probability sampling methods are less representative than probability sampling methods and thus inappropriate if the objective of a study is to generalize findings. They are often used in qualitative methods because of their flexibility in adapting to local situations and settings. 2. Probability Sampling Methods Probability sampling techniques are those that involve the random selection of study units by chance. For this to be possible, a sampling frame must exist. There are a number of probability sampling techniques and any of them could be used in a study depending upon the study problem and the purpose of the study. These comprise; Simple Random Sampling (SRS) a. Simple Random Sampling (SRS) This is the simplest form of probability sampling. It involves: ! making a numbered list of all units in the study; ! deciding the size of your sample; ! choosing the number you require. 1 For example, suppose we are faced with a problem of selecting 60 households in a community of 360 households to learn more about their attitudes towards the use of antibiotics in cough. We could proceed by first giving each household a number. These numbers are then written on small pieces of paper and placed in a box. Numbers are then picked from the box up to the required total, making sure that that the box is well shaken each time to ensure the principle of equal and random selection. b. Systematic Sampling The principle involved in using this method is similar to the SRS, but with an added condition that the selection of units is based on regular intervals starting from a determined point. To use the example above, we can obtain our interval by dividing 360 by 60 which gives 6. Once the sample interval has been determined, the first unit is then drawn between 1 and 6. Afterwards, every sixth case must be drawn until the total sample of 60 has been drawn. The technique is particularly useful where large numbers are involved such as the sampling of prescription records. For instance, if we need 30 prescriptions from a register in a health facility which contains 50 pages of 25 lines per page, the sampling interval must be calculated by dividing the product of 50 and 25 by 30 to obtain 41.7. Based on this figure, every 42nd prescription would be selected for the study. c. Stratified Sampling This is an alternative method to systematic sampling and preferable where the sampling frame contains distinct populations. For example, assuming our antibiotics study covers an entire district, it would be necessary to ensure that both rural and urban facilities are adequately covered. This would not be possible using the SRS or systematic sampling techniques. Alternatively, using a procedure that groups study units who are similar in certain characteristics into strata ensures that all relevant groups are appropriately covered. In drug use studies stratified sampling could be used to sort facilities into various levels of care, i.e., community clinics from health centers and both from district hospitals. When the method is used, the final stage of selecting the units is also based on the principle of equal selection by chance. d. Cluster Sampling Assuming our district is a large one with a landscape that makes travelling around facilities difficult, then cluster sampling offers a better alternative. This involves selecting clusters or groups of study participants or units rather than on individual basis. Clusters may be villages or families or a specified group of patients or 2 providers. For example, if we want to select two facilities for study in a geographically difficult area, then we could select a cluster of two facilities by randomly selecting a single facility and then selecting another one close to it. The method saves time in data collection. e. Multi-Stage Sampling This is a combination of all the methods described above and is very useful if the purpose of the structured observation method is to generalize study results from diverse populations. As the name implies, it involves sampling in two or more stages as follows: 1. 2. 3. 4. Forming clusters and selecting a random sample of these. Making a separate list of all study units within each of the selected clusters. Selecting study units separately from each cluster in the sample. Interviewing selected study units. For example, if we intend to select 12 health facilities in a district with 36 facilities, we can first group them into the various clusters or levels of health care such as community clinics, health centers, and hospitals. We can then randomly select our 12 facilities from the 3 groups. This is two-stage sampling. If we want to select 30 prescriptions from each facility, we can continue from this stage with the process described in selecting every 42nd prescription under systematic sampling. This is three-stage sampling. 3 ANNEX B: BIBLIOGRAPHY GENERAL Laing RO., "Rational Drug Use: An Unsolved Problem" Tropical Doctor,Vol ? 1990. Hudelson PM., Qualitative Research for Health Programmes. 1994, WHO/MNH/PSF/94, Geneva. Heggenhougen K, Draper A. Medical Anthropology and Primary Health Care. 1990, London School of Tropical Medicine and Hygiene, London. Varkevisser CM, Pathmanathan I, Brownlee A, (1993) Designing and Conducting Health Systems Research Projects. Health Systems Research Training Series, Vol. 2 Part 1, Ottawa Lutz, W. (1986). Planning and Organizing a Health Survey. International Epidemiological Association, Switzerland. 4 CHAPTER 3: IN-DEPTH INTERVIEW 1. PATH. Developing health and family print materials for low-literate audiences: a guide. PATH, 1988; pp. 17-18. 2. UNICEF. Baseline data for FGN/UNICEF 1991/95 country program: Manual for rapid assessment procedures. UNICEF, 1991; pp. 1-5. 3. World Health Organization. How to investigate drug use in health facilities: selected drug use indicators. Geneva: World Health Organization, 1993 (WHO/DAP/93.1). FURTHER READINGS 4. Scrimshaw SCM, Hurtado Elena, (1987). Rapid Assessment Procedures for Nutrition and Primary Health Care: Anthropological Approaches to Improving Programme Effectiveness, pp. 1112. 5. Kashyap P, Young RH. (19??). Rapid Assessment of Community Nutrition Problems: a Case Study of Parbhani, India, pp. 3-5. 6. Forcese DP, Richer S. (1973). Social Research Methods. Englewood Cliffs NJ: Prentice-Hall, Inc., pp. 168-177. 7. Lockerbie L., Lutz W., (1986) Questionnaire Design, International Epidemiological Association, Switzerland. 8. Hepburn W., Lutz W., (1986) Interviewing and Recording, International Epidemiological Association, Switzerland. 5 CHAPTER 4: FOCUS GROUP DISCUSSION Varkevisser CM, Pathmanathan I, Brownlee A, (1993) Designing and Conducting Health Systems Research Projects. Health Systems Research Training Series, Vol. 2 Part 1, Ottawa Scrimshaw SCM, Hurtado E. Rapid Assessment Procedures for Nutrition and Primary Health Care. 1987, University of California Press, Los Angeles Dawson S, Manderson L, Tallo VL., The Focus Group Manual. 1992, World Health Organization, Geneva. Bernard HR. Methods in Cultural Anthropology. 1988, Sage Publications, California. Stewart DL, Shamdasani PN. Focus Groups, Theory and Practice. 1990, Sage Publications, California. Folch-Lyon E, Trost JF. "Conducting Focus Group Sessions." Studies in Family Planning Dec. 1981; 12(12):443-448. Heggenhougen K, Draper A. Medical Anthropology and Primary Health Care. 1990, London School of Tropical Medicine and Hygiene, London. Peelers RF. Methodology of Health Behavior Research. 1989, Esoc. Publication Nr. 19; Program for Appropriate Technology in Health (PATH). Focus Group Discussion Use in the Preparation of Materials. [DATE??] Washington DC. 6 CHAPTER FIVE: STRUCTURED OBSERVATION OTHER READINGS Grady KE, Wallston S., Reasearch in Health Care Settings. Newbury Park: Sage, 1991. Oladepo O, Oyejide CO, Oke EA., "Training Field Workers to observe Hygiene-related behaviour." World Forum 12, 1991. Nietzel MT, Bernstien DA, Introduction to Clinical Psychology. Englewood Cliffs, NJ: Prentice Hall, 1987. Varkevisser CM, Pathmanathan I., Brownlee A., Designing and Conducting Health Systems Reasearch Projects, Vol. 2, Part 1. Ottawa: IDRC, 1993. 7 CHAPTER SIX: 1. STRUCTURED QUESTIONNAIRE World Health Organization (1993). How to Investigate Drug Use in Health Facilities: Selected Drug Use Indicators. Geneva: (WHO/DAP/93.1). Additional Readings Abrahamson, J.H. (1979). Survey Methods in Community Medicine. Churchill Livingstone, Edinburgh, 114-115. Selltiz, C, Wrightsman, L.S., Cook, S.W. (1976). Research Methods in Social Relations. Holt, Rinehart and Winston; New York, 542-557. Denzin, N.K. (1970). The Research Act in Sociology. Aldine Publishing Company, Chicago. Varkevisser, C.M., Pathmanathan, I., Brownlee, A. (1993). Designing and Conducting Health Systems Research Projects, Vol. 2, Part 1. International Development Research Centre, Ottawa. Hepbun, W., Lutz, W. (1986). Interviewing and Recording. International Epidemiological Association, Switzerland. Lockerbie, l. Lutz, W. (1986). Questionnaire Design. International Epidemiological Association, Switzerland. Lutz, W. (1986). Planning and Organizing a Health Survey. International Epidemiological Association, Switzerland. 8 ANNEX C: EXAMPLES OF MODERATOR=S GUIDES FOR IN-DEPTH INTERVIEWS Example 1: Bangladesh Diarrhoea Study - In-Depth Interview Guide for Administrators Example 2: Bangladesh Diarrhoea Study - In-Depth Interview for Prescribers Example 3: Nigeria Malaria Study - In-depth Interview for Prescribers Example 4: Nigeria Malaria Study - In-depth Interview for School Teachers Example 1: Bangladesh Diarrhea Study - In-depth Interview Guide for Administrators Introductory Remarks I am _______________ from _____________________ General purpose of the study Aims of the interview How long it will last Any questions? Warm Up How long have you been the administrator of this thana health complex? Could you please give a brief description of your daily activities? Probe : Time spent in patient care; Private practice after hours Extent of Diarrhoeal Problem and Felt Concern about it How serious a problem is diarrhoeal disease in your thana (at this time)? Probe: Severity of the child's condition Describe a typical case What proportion needs hospitalization Criteria for hospitalization How frequently cases arrive very late Extent and sources of worry Mothers Perception of Diarrhoea and Education About Diarrhoea At what stage of the disease do mothers bring their children here for treatment? How much distress do these mothers feel when they bring in the child? Probe: Why they do wait so long? What do they try at home first? At home, what can mothers do that would improve the way that diarrhoea is managed? Probe: Continue breast feeding; Home made ORS Early start to management What activities are currently carried out by this thana health complex to promote/improve diarrhoea management at home by mothers? Probe: How do mothers feel about ORS as a main treatment? Do they like it/Why/Why not? ANNEX C - 1 Attitudes towards Prescribing for Diarrhoea What are the main factors that influence the decisions that prescribers make in relation to diarrhoeal diseases? Probe: Patient's condition? Previous drugs already started taking? Whether expect mother to return for follow up? Mothers demand for specific drugs? Do you feel that certain patients with diarrhoea need antibiotics for treatment? Probe: Which ones? Advantages and disadvantages of antibiotics? Many M.Os also have a private practice after they finish work at the thana. In what ways does the M.O.s prescribing practices for private patients influence how they prescribe at the thana? Probe: What influence do "Medical Reps" have in the M.O.s prescribing practices? Administrator's Role in Management of Diarrhoeal Cases For diarrhoea cases, what are the major problems you face in providing effective services at this Thana ? Probe: How can these major problems be solved? What do you think are the most effective ways for influencing the way medical officers prescribe for diarrhoeal cases? Probe: Do you have discussions with them? What issues do you discuss with them? What role do you see for pharmacists? How can pharmacists give feedback to prescribers? Comments Are there any other major influences on prescribing for diarrhoea that we have not talked about? What are those? CLOSE: Thank administrator for his/her comments. ANNEX C - 2 Example 2: Bangladesh Diarrhea Study - In-depth Interview for Prescribers Introduction I am _________________________ from ________________________. General purpose of the study Aims of the interview How long it will last Any questions? Knowledge About Diseases In The Community What are the most commo n diseases/illnesses reported by patients in this health facility? Probe: How about diarrhoeal diseases? (If not mentioned) How common is it in relation to other common diseases? Nature Of Diarrhoeal Cases Can you describe to me the characteristics of patients who usually suffer from diarrhoeal diseases? Probe: Age, socio-economic status Housing and water supply What is the usual condition of children with diarrhoea when they come to see you? Probe: Some types of diarrhoea more severe than others? Some types of children worse than others? Do you have any concerns about this? Knowledge About Mothers= Perception of Diarrhoea What do mothers think about diarrhoea when their children get it. Probes: What are their anxieties? What feeding practices do they adopt/observe (i.e., breast feeding, home-made fluids) Do they use medications before seeking treatment? Capacity for Diarrhoea Case Management Do you think this facility is adequately equipped for diarrhoeal case management? Probes: Is there a standard treatment guideline? Investigation facilities Sources of obtaining new information on case management Have you had any special training in diarrhoea management? Probe: When was the training? What were the contents of the training? Any comment on usefulness and adequacy of training? ANNEX C - 3 Diarrhoea Management Strategies How do you treat a "typical" diarrhoeal case? Probe: Do you feel confident treating diarrhoea with only ORS? Why or why not? What are some of the drugs you normally use and why do you use them? Probe: How about antibiotics? Anything to stop the diarrhoea? What kinds of things influence you to use other drugs besides ORS in managing diarrhoea? Probe: Any specific clinical signs? Length of recovery Concern for patients expectations? Does patient load play any part in this? Staff Functions and Relationships How do the different members of the staff contribute to patient (curative) care? Probes: Head of facility Other prescribers Pharmacists Can you think of ways that other staff might contribute more to care for diarrhoea? Probe: What are some of the shortfalls? Who has time available to spend with patients? Promoting ORS What suggestions do you have for promoting the use of ORS in treating watery diarrhoea? Probe: Among prescribers By mothers By drug sellers In the community. Comments Is there anything else important you can think of about treating diarrhoea that we have not talked about? CLOSE: Thank health worker for his/her comments. ANNEX C - 4 Example 3: Nigeria Malaria Study - In-depth Interview for Prescribers INTRODUCTORY REMARKS I am _______________ from _____________________ You are? _________________________________________________________ We=ve been told that malaria is one of the common health problems in this area. We are interested to know more about your view about malaria and how you manage it. We are also interested in any problems or concerns you might have. We would appreciate it if you could spend about 20-30 minutes with us discussing malaria treatment. Is this okay with you? Do you have any questions? WARM UP What is your position here? How long have you been working here? Do you have a heavy work load? How many patients would you say you see in a week? On average, about how many patients a week do you end up treating for malaria? DIAGNOSIS How do malaria cases usually present here? What kinds of symptoms do patients usually have? Probe: Any other way they present? How do you decide that patients presenting this way have malaria? Probe: Questions asked in history Physical examination - temperature blood smear How do you decide if the malaria is mild or severe? How do you decide about whether a patient needs to be hospitalized? Probe: Any specific clinical signs? What percentage of cases need hospitalization? Do you get cases arriving very late? TREATMENT AND COST How do you usually treat mild malaria? Probe: What would a typical prescription look like How many drugs/injections do you prescribe? What are they? ANNEX C - 5 Why do you recommend this treatment/combination of treatments? Probe: Any concerns about drug resistance? Preference for injections? Patient preference How do you usually treat severe malaria? Probe: What would a typical prescription look like How many drugs/injections do you prescribe? What are they? How much does it cost to treat a typical case of malaria? Probe: What about a serious case? Are patients able to afford this cost? Are patients able to get the drugs they need here most of the time or do they have to go elsewhere? Probe: Which drugs are not available? Why are those drugs not available? Where do patients go to get these drugs? PATIENT EXPECTATIONS Do you think that patients expect a specific treatment of malaria from you? Probe: What kind of treatment? Any injections expected? Why do they feel this way? COMMENTS Is there anything else that we have not covered that you can tell me about malaria and how you treat it? CLOSE: Thank you. ANNEX C - 6 Example 4: Nigeria Malaria Study - In-depth Interview for School Teachers INTRODUCTORY REMARKS I am _______________ from _____________________ You are? _________________________________________________________ We=ve been told that malaria is one of the common health problems in this area. We are interested to know more about the views of community members about malaria, and your experience with it as a teacher. We are also interested in any problems or concerns you might have. We would appreciate it if you could spend about 15-20 minutes with us discussing malaria. Is this okay with you? I would like to go over some of the general rules for our conversation. There are no correct answers Want your opinions Confidentiality Minimal interruptions No observers Do you have any questions? WARM UP What is your position here at the school? How long have you been working here? Probes: How long living in this area? Where is your home area? Do you think that malaria is an important problem in this school and in this area? COMMUNITY PERCEPTION OF MALARIA Can you describe to me some of the things that people in this community believe about malaria? Probes: What do they think causes the disease? What is your view on this? How do people in this community know when someone has malaria? What is your opinion about this? Do you think most people have a good idea of when they have malaria? Do people here do anything to try to prevent malaria? Probes: Do they take any herbs of drugs to prevent getting the disease? Use bednets? Use insecticides? Any environmental sanitation? ANNEX C - 7 Avoid going out at certain hours? MALARIA TREATMENT I am interested in what someone usually does when they think they have malaria. What do people do first? Probe: What are the reasons for these actions? Does everyone do that? What do they do next if that does not work? How do people treat malaria in this community? Probes: What type of treatment do people prefer for malaria when they go to the health centres? Name/colour/taste of tablets preferred. Do they have any preference between injections and tablets? Why? What are some of the home remedies people use in treating malaria? Probes: Which are the most popular? Which are the most effective? When do people use home remedies rather than drugs? When people go to a government clinic or hospital to treat malaria, what do they expect? Probes: Are their expectations usually fulfilled? If not, what would they do? How about you? Are people given enough information on how to take medicine when they go to the clinic? Probes: What are some of the things they are not told? Who do you think should be telling them these things? How could this be improved? COMMENTS Are there any suggestions or comments about malaria that we haven't yet talked about which you want to discuss? CLOSE: Thank you. ANNEX C - 8 ANNEX C1: Example of Interview Guide for Mothers at OPD Assessing Use of Antibiotics in Treatment of Respiratory Infections Introduction: As in the interview guide for the prescribers. General Background: Mother and community. Interview Start: Could you please tell me what treatments are available in the community for treatment of colds in young children. What about your educational background, age, number of children alive, marital status etc. ... Just to tell me a little bit about your status. Community Perception of Causes of Respiratory Infection: As a care giver to young children and a member of this commuknity, what do people here believe causes respiratory infections in young children? What about your own belief? How do you know a child has respiratory infection? What specific signs are there for each type of respiratory infection? Treatment Of Respiratory Infections In Children: What treatments are available in this community for treatment of colds in young children? Probe: The types of treatment mothers prefer most? What traditional remedies are available in community? Ask about popular home remedies used by people. At what stage in the course of the ailment do mothers or care givers take their children to the clinic/hospital or contact modern orthodox health facility? Probe into: * * * * * * Types of treatment given by clinic/doctor. Kinds of drugs/tables or injections given - provide names or descriptions. Medications given for treatment of mild, severe colds in children. Perception of mothers on effectiveness of the drugs? Mothers' expectations from different courses of treatment - what about antibiotics (use local concepts and terminologies). Medications mothers prefer for (a) mild (b) severe colds. Cost of Treatment (Medications) of Colds in Children: * * * * How much do you have to pay for a typical treatment of episode of respiratory infection of your young child? What about payment for (a) antibiotics (b) other drugs. What about costs of treatment of severe colds for your child? What differences occur in prices or payment in a government and private clinic? Are mothers able to afford the costs? What difficulties are experienced by mothers over payment for medications? 9 Dispensing Process: From your experience, do mothers get prescribed drugs at the clinic pharmacy often or most of the time? * * * What sources do mothers rely on most for drug supply when they visit government clinics? What other sources? Do mothers get specific instructions on how their children should use prescreibed drugs? What instructions? Suggestions: Is there any point you still want to elaborate upon on how children are treated for episodes of colds? What suggestions do you have for improvement of health care for children in the community, at clinic? Any other comments? Close: Expression of appreciation. Note: The draft interview guides can be discussed with colleagues or preferably proof-read by them before a training session with interviewers to ensure its test of suitability. 10 ANNEX C2: The following are draft outlines of protocols for observation of the prescribing and dispensing processes. Most will come from direct observation. Some will need to be filled in at the end of the visit or end of the day from the patient record. CLINICAL PROCESS OBSERVATION FORM IDENTIFYING INFORMATION Sequence #: Health Facility: ___________________________________ Date: Patient Age: Provider Type: <5 5-12 Doctor over 12 CMO DIAGNOSTIC COMMUNICATION Sex: Nurse Prescriber Asks Length of current problem episode? Presence of: fever? headache? malaise? muscle weakness? loss of appetite? chills? vomiting? bitter taste? Patient mentions malaria? Previous treatment for this episode? Any previous drugs taken this episode? Last time treated for malaria? Name of drug used to treat last time? Patient finished last course of treatment? Comments 11 Patient Volunteers Not Discussed EXAMINATION Yes Does Not Apply No Temperature measured? Patient touched for fever? Pulse felt? Conjunctivitis/Sclera of eye examined? Tongue examined? Listens to chest? Palpates abdomen? Comments TREATMENT Yes No Does Not Apply Yes No Does Not Apply Injection given (If injection) Sterile technique followed Advised lab test? Advised exam at different facility? Advised return visit if not better? Comments COMMUNICATION Patient asks for: injection? chloroquine? halofantrine? Provider explains how to use drugs? Provider offers advice on malaria prevention? Provider offers nutrition advice? Comments 12 PROVIDER-PATIENT INTERACTION Yes Patient greets prescriber? Prescriber greets patient? Friendly conversation? Provider gives reassurance to patient? Patient encouraged to describe problem freely? Doctor listens to responses? Provider ends encounter abruptly? Patient appears to want more information? WRAPUP Observer: ___________________________ Length of consultation (mins): Notes: 13 No Does Not Apply DISPENSING OBSERVATION FORM IDENTIFYING INFORMATION Sequence #: Health Facility: Patient Age: Date: <5 5-12 over 12 Sex: COMMUNICATION Dispenser Initiated Patient Initiated Not Discussed No Does Not Apply Description of drugs dispensed? Instructions on how to take drugs? Cautions, side effects mentioned? Information about prevention/care? DISPENSING ACTIONS Yes (If injection) Sterile technique followed Drugs labeled with (Check one or more): Patient name Drug name How to take No label Type of package in which drugs dispensed (Check one or more): Plastic/glass bottle Folded Paper Plastic bag None WRAPUP Observer: _____________________________ Length of dispensing process (seconds): Notes: 14 Envelope ANNEX C.3: EXAMPLE OF QUESTIONNAIRE Study Title: AN ASSESSMENT OF THE OUTPATIENT CARE PROCESS IN SELECTED HEALTH CENTERS Specific Objectives: 1. To estimate the proportion of outpatients adequately during consultation. 2. To assess the dispensing process at the health centers. 3. To identify the main reasons for patients' satisfaction/dissatisfaction with the treatment received. PATIENT INTERCEPT INTERVIEW (Introduction) 1. What is the main complaint/ailment for which you have come here to seek treatment? 2. Is this your first visit for this ailment? (1) Yes (Skip to Q.4) 3. How long ago was your last visit? .....days 4. (2) No .....months before Did you consult any practitioner for this episode of illness before coming here? (1) Yes (2) No (Skip to Q.6) 5. Whom did you consult? (Probe to specify type of practitioner) 6. Has the doctor of this facility told you the name of the disease? 15 (1) Yes (2) No (Skip to Q.8) 7. What is the disease/diagnosis? (Skip to Q.9) 8. Did you ask the doctor the name of your disease? (1) Yes (2) No 9. Did the doctor physically examine you? (1) Yes (2) No 10. Do you feel that physical examination was necessary to diagnose your disease? (1) Yes (2) No 11. Did you have the chance to fully describe your illness to the doctor? (1) Yes (2) No 12. Did the doctor advise any laboratory test? (1) Yes (2) No 13. How many drugs did you receive from this facility? .......... (Check the patient's prescription) 14. Did the doctor here give you a prescription for a drug that you must buy outside of this facility? (1) Yes: How many? ........ (Number) (2) No (Skip to Q.15) 15. Did the pharmacist explain to you how to take the drug? (1) Yes (2) No 16 16. Would you please tell me how to take the drugs? (Look at the prescription and compare patient's answer) 1st Drug (1) Correctly stated (2) Not correct 2nd Drug (1) Correctly stated (2) Not correct 3rd Drug (1) Correctly stated (2) Not correct 17. Would you please rate your satisfaction or dissatisfaction with the treatment you have received? (1) Highly satisfied (Skip to Q.19) (2) Satisfied (Skip to Q.19) (3) Okay (Skip to Q.19) (4) Dissatisfied (5) Highly dissatisfied 18. What are the main reasons for your dissatisfaction? (Record maximum three reasons) (1) (2) (3) 19. Will you visit this health facility again in case of sickness? (1) Yes (2) No 20. Do you have any specific complaint about any aspect of the health facility? (1) Yes (2) No (Skip to Q.22) 21. What is your complaint? 22. Do you have suggestions on how to improve patient care? 17 (1) Yes (2) No (Skip to Q.24) 18 23. What are these suggestions? (Record maximum three suggestions) (1) (2) (3) 24. Do you have any other comments on the facility? (1) Yes (No) (Stop interview; thank patient) 25. What are your comments? (1) (2) (3) Stop interview and thank patient. Name of Interviewer: Signature: Date: 19 ANNEX D: EXAMPLES OF MODERATOR=S GUIDES FOR FOCUS GROUP DISCUSSIONS Example 1: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Prescribers Example 2: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Pharmacists Example 3: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Mothers Example 4: Nigeria Malaria Study - Moderator's Focus Group Guide for Nurses Example 5: Nigeria Malaria Study - Moderator's Focus Group Guide for Community Members Example 6: WHO/CDD Drug Sellers Study - Moderator's Focus Group Guide for Drug Sellers Example 1: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Prescribers 1. Introduction [Narrative welcoming participants, describing the reasons for the discussion, and setting up the general ground rules for the session]. 2. Diarrhoeal Disease as a Problem First, I would like to know a bit about the type of diarrhoea cases you commonly see. How would you describe them? 3. 3.1 Diagnosis and Treatment of Diarrhoea by Prescribers Can we talk about how you also deal with diarrhoea cases starting with diagnosis. What do you depend on for diagnosis of diarrhoea? Probe: Do you depend mostly on clinical features. What investigations do you think are necessary in these cases? How often are these done? 3.2 Use of ORS by prescribers How do you feel about ORS as a way of treating diarrhoea? Probe: Do you always prescribe ORS? Why or why not? For what kinds of cases does ORS work best? Are there cases when ORS is not enough or not necessary? Are there times when there is no supply of ORS? If so, what do you do then? 4. Use of other Drugs in Diarrhoea Treatment I would like to talk about other drugs for treating diarrhoea. Can you tell me a bit more about the other drugs that you sometimes use? Probe: What are the names of some of these drugs? Why do you use those particular drugs? How do you decide when to use them? When you are treating children, what are the advantages and disadvantages of using: * antibiotics? * metronidazole? * antidiarrhoeals? * injections? (IV fluid) Are there any other useful drugs we have not talked about? What guideline do you follow for prescribing in diarrhoeal cases? 5. Knowledge of Health Workers about Mothers' Perceptions of Diarrhoea I would like to know something about the mothers who come to your clinic to get treatment for diarrhoea for their children. How do mothers present diarrhoea cases to you? Probe: At what point in the episode do they usually come for treatment? What questions do you usually ask them? Do they usually treat these kinds of cases at home before they come to your clinic? Could you give me some examples of how? What do you think about these home treatment? ANNEX D - 1 6. Influence of Patient Expectations I would like to know more about mothers and how they feel about treating diarrhoea in their children. When they come to see you, do mothers usually come with any expectations about the kind of treatment they will receive? Probe: Do they have any prejudices about certain kinds of treatment? How strongly do they usually feel about that? Do they ever ask for injections? What would they do if you ignored their expectations? Do you ever try to convince them differently? What usually happens then? 7. Patients Knowledge and Attitudes Toward ORS Can you tell me something about what mothers know about ORS? Probe: How (where/whom) do they usually get to know about ORS? Do they ever use ORS on their own when their children get diarrhoea? 8. Promotion of the Use of ORS What is the reaction of mothers when they are given only ORS when they come for treatment? Probe: Are they satisfied? Why or why not? Could you convince mothers who are not satisfied to accept only ORS as treatment? How would you do this? 9. Role of prescribers in Education of Mothers Do you think that mothers know enough in general about how to prevent diarrhoea, and how to manage it when their children become sick? Probe: What else do mothers need to know? (Hint: from doctors experience) How should this be done? What role could you play in this? What things would need to change for this to happen? 10. Role of Pharmacist Has the pharmacist in your health complex any role/say in the choice of drugs for patients? Probe: Do you have discussions with the pharmacis t about drugs used for treatment? Do you get regular feedback from the pharmacist, about these drugs? 11. Prescriber Education About Therapeutics I would like to hear about how you get/learn new information about treatment of health problems and drugs. Can you tell me something about this? Probe: What would you do if you had a health problem you had not treated before? Do you ever have difficulties hearing about new drugs or new information on treatment of diseases? Do you have suggestions on how to obtain such information easily? Have you ever discussed the treatment of diarrhoea with medical representatives (Drug Reps)? 12. Closing Finally are there any other major things influencing prescribing for diarrhoea that we have not yet talked about? What are these? [Narrative to terminate the discussion, elicit questions and ask participants their impressions about the conversation, and thank them for their co-operation]. ANNEX D - 2 Example 2: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Pharmacists 1. Introduction (Narrative welcoming of participants, describing specific reasons for the discussion, and setting up the general ground rules for the session) 2. The Role of Pharmacist in the Health Facilities First, I would like to know about your position and role in the health facility where you work. I am interested in what you think and feel about this role. Probe: Are you also involved in ordering or procurement of drugs to the dispensary? Do you also maintain an inventory of drugs? If the prescribed drug is not available, what do you do? How do prescribers see your role? How do patients see your role? What is your feeling about the patient load? Do you have any suggestions for improving drug procurement and storage? 3. Diarrhoeal Disease as a Problem Can we talk about diarrhoeal diseases and their treatment in your health complexes? What are the types of main outpatient diarrhoea cases that are presented. Listen to responses, then Probe: Does it regularly affect all age groups? How do you feel about it? 4. Use of ORS What do you think/feel about ORS as a way of treating diarrhoea? Probe: How often is ORS prescribed? For what kinds of cases does ORS work best? Are there instances when ORS alone is not enough for treatment? Do you think the taste of ORS has any influence in its use for children? How? Do you have any suggestions about this? 5. 5.1 Use of Other Drugs in Diarrhoea Treatment I would like you to talk about other drugs that are usually prescribed by doctors for treating diarrhoea. Probe: What are the names of some of these drugs? Can you tell me the reasons why these drugs are prescribed? Do you often dispense those drugs with ORS? What about these (if not mentioned) * antibiotics? * metronidazole? * antidiarrhoeals ? * injections? 5.2 Are there any other useful drugs for diarrhoea we have not talked about? 6. 6.1 Drug Prescribing And Dispensing What is your opinion about prescribing by trade names. Probe: When the suggested trade name is not available, what do you do? 6.1.1 Do you think the dosage schedule is properly given in the prescription? Why or why not? ANNEX D - 3 Probe: Is there anything you could do about this? If you know that the dosage schedule is not correct, what do you do? Do the patients ask you for directions about drugs prescribed for them? Do you see any other problems related to prescription? 6.1.2 Can we talk about dispensing in your facility. I would like to know specifically about how you actually dispense different dosage forms. Probe: How do you dispense two or more types of tablets to patients? Are you confident that patients will identify and take them (various drugs) properly? Are there any suggestions to improve the situation? 6.2 Can you tell me what you know about the way doctors in your facility treat diarrhoea? Does the practice of private doctors/drug outlets influence the way doctors in your facility prescribe? If yes, how? 7. Knowledge of Pharmacists About Mother's perceptions of Diarrhoea I would like to know about the perception of mothers (who come to the health complexes to get treatment) about diarrhoea (in their children). How do mothers determine when their children have diarrhoea? Probe: At what point in the diarrhoeal episode do they usually come for treatment? Do they normally try some solution before they come for treatment? Could you give me some examples of these home treatments? What do you think about these (home treatments)? 8. Patients Knowledge and attitude Toward ORS Could you tell me about how mothers get to know/hear about ORS? Probe: What do they think about it? Do they ever use ORS on their own when their children get diarrhoea? Why or why not? Are mothers able to make "home made solution" on their own? 9. Promotion of the Use of ORS Are mothers usually satisfied when their children get only ORS when they come for treatment for diarrhoea? Probe: Why or why not? Could you convince mothers who are not satisfied to accept ORS as the only treatment to do so? How would/could this be done 10. Role of Pharmacist in Educating Mothers Do you think that mothers know enough in general about how to manage diarrhoea, when their children suffer from it? Probe: Is there anything else that mothers need to know? How should this be done? What role could you play in this? What things need to be changed for this to happen? 11. Pharmacist Education About Therapeutics Finally, I would like to hear about how you get new information about new drugs. What are some of the ways that you learn about these things? Probe: Do you have difficulties in learning about new drugs? Are there any suggestions you could make to remedy this situation? Do you think you need further training? What type of training do you need? ANNEX D - 4 How would you benefit from such training? 12. Closing Before we close the discussion, is there anything that you would like to add or to give new comments to what have been discussed before? (Narrative to terminate the discussion, elicit questions and ask participants their impressions about the conversation, and thank them for their co-operation). ANNEX D - 5 Example 3: Bangladesh Diarrhoea Study - Moderator's Focus Group Guide for Mothers Introduction [Narrative welcoming participants, describing the reasons for the discussion and setting up the general ground subjects for the session] 1. Perception and Knowledge About Diarrhoea First, I would like to get some idea from you about diarrhoea. How are you able to tell when your child has diarrhoea? What are some of the main symptoms you look for to determine that it is diarrhoea? Probe: Listen to response and probe: Please tell me beside loose stool what else would you look for in a diarrhoeal child? What may be the cause of diarrhoea? Is there a way to prevent your children getting diarrhoea? Do you think that when you get diarrhoea, the baby may get it from you? What preventive measures do you take? 2. Severity or Threat of Diarrhoea Please tell me if your child is not treated what are the problems the child is likely to undergo. Probe: Are you worried that the child may be seriously ill? Why do some child die from diarrhoea? Can you tell me about that? 3. Management of Diarrhoea by Mothers I would like to know about what you do when your child gets diarrhoea. What do you do when you suspect this? Probe: What else do you do? Do you go to a practitioner? What type of practitioner do you go? What happens when your child does not respond to this kind of treatment? How many days after the onset of diarrhoea do you send/bring your child to the hospital? 4. Knowledge about ORS I would like to hear what you know about ORS. Can you tell me please. Probe: Can you describe what ORS does and how it works? How and where did you learn about ORS? Can you prepare it yourself, How? How do you give it and for how long? Have you used any other kind of fluids to treat diarrhoea before knowing about ORS? What are those fluids? Did you like ORS or these fluids when you used them? Why or why not? 5. Sources for obtaining ORS Can you tell me some possible sources for obtaining ORS? Probe: Do you ever have problems in getting ORS when you want it? What kind of problem is it? Is the problem due to its cost? ANNEX D - 6 6. Attitude Towards ORS Are you satisfied when you are given only ORS to treat diarrhoea when you go to the health centre? Why or why not? Probe: Do you feel that ORS is a good treatment for diarrhoea? Why or why not? Do you prefer home made or packed ORS? Why or why not? When ORS does not cure the diarrhoeal baby, what is your feeling about ORS then? 7. Educational about Diarrhoea Management I would like to know about how confident you feel about managing diarrhoea yourself. Probe: Do you like to know any thing more about the home management of diarrhoea? Where would you be able to find out about such information you want to know? Is there any one whose opinions about these things you specially trust? 8. Feeding and Breast feeding Practice Can you tell me something about what you think children should eat and drink while they are having diarrhoea? Probe: Is this different from what you normally give your child? Do you increase or decrease certain kinds of food? Should you continue to breast feed your child during diarrhoea episode? Why do you prefer the kind of diet when your child has diarrhoea? 9. Use of Other Drugs to treat Diarrhoea I would like to hear about some of the other medication besides ORS that your child receives for diarrhoea at the health centre. Can you describe any other drugs children sometimes receive there to treat diarrhoea? Probe: Do you like it better when your child get one of these other drugs. Do you think your child needs these drugs? What do these drugs do? Do you insist on the other drugs or the doctor prescribed it himself? If these drugs are not provided at the thana do you ever go somewhere else to get them? Where do you go? Did you get to know of these drugs from any worker at the health centre? 10. Attitude Towards System I would like to hear about your views on the health services delivered to you? What were your expectations when you arrived at the health centre? Were the expectations fulfilled? Why or why not? What time did you come to the health centre If late, why did you come late? 11. Closing: [Narrative to terminate discussion, elicit questions and ask participants their impression about the conversation, and thank them for their co-operation]. ANNEX D - 7 Example 4: Nigeria Malaria Study - Moderator's Focus Group Guide for Nurses 1. Introduction I am __________ from _____________, and my colleague who is assisting in this session is ____________. We have been asked by the Federal Ministry of Health to learn more about the problem of malaria in this area in order to establish programs to improve the treatment of this important health problem. We would like to welcome you, and thank you for agreeing to participate in this discussion. We know that as nurses working in health centres and hospitals, you are on the front-line in dealing with the problem of malaria. Your insights and opinions will teach us a great deal about the perceptions of community members about malaria, and how personnel within the public health system are dealing with malaria treatment. [Set up the general ground rules for the session.] i) 90 minutes (tape recorded; observer and note taker) ii) Speak clearly/one at a time iii) Conversations/all participate iv) Want everyone's opinions v) No right/wrong answers vi) Courage of convictions 2. Common Health Problems in Community First, I would like to know more generally about the diseases seen at the health centres in this area. What are the most common ones? [If malaria is not mentioned, specifically bring it up]. Probe: What proportion of all cases present with malaria? How does malaria rank in perceived importance to other problems? On what are they basing their opinion about importance? Does the community perceive malaria to be an important problem? 3. Malaria Cases I would like to hear a bit more about malaria cases. Probe: a) Age b) Severity c) Seasonal variation d) Economic status 4. Knowledge of Nurses about Patients' Perception of Malaria I would like to know about what patients who come to the health centre for treatment think about malaria as a disease? Probe: At what stage after attack do they usually come for treatment? What questions are they usually asked? Do they usually use some medications before they come for treatment? What are some of these? What do you think about that (self medication and drugs used by patients themselves)? ANNEX D - 8 5. Malaria Diagnosis Can we talk about the diagnosis of malaria? In your own experience, how do health workers arrive at the diagnosis of malaria? Probe: Do they depend mostly on clinical features or laboratory investigations? What investigations do the prescribers request? How often are these done? 6. Treatment of Malaria Let us talk now about the actual treatment of malaria at the health centres. Can you tell me the common drugs that are prescribed for malaria at the health centres? 7. Patient Expectation I would like to know more about how patients feel about the treatment they receive for malaria. Do they usually expect to receive certain kinds of treatment when they come? Probe: Do they have prejudices about certain kinds of treatment? What do they do if their expectations are not met? How do they feel about the treatment they get? How do you convince them to accept the treatment they are given? 8. Attitude towards Chloroquine Can you tell me something about how patients feel about chloroquine as a treatment of malaria? Probe: What is the attitude of patients towards chloroquine? Do they use other drugs for treating malaria? What are some of these other drugs? Why do you think they use these other drugs? 9. Polypharmacy What is your opinion on the use of multiple drugs in the treatment of an episode of malaria? Probe: For what type of patients is this common? In your opinion, are these justified? Why, or why not? 10. Use of Injections Let us discuss the use of injection in the treatment of malaria. Probe: What factor(s) determine when a patient with malaria should get an injection? How is this decision influenced by patient demand/expectation? What will happen if expectation (if it exists) is not met or is ignored? 11. Role of Nurses in Prescribing at Health Centres What part do you play in patient care/prescribing at the health facilities? Probe: Are you satisfied with this role? Why, or why not? What else can you do? 12. Role of Nurses in Education on Malaria Prevention How much do you think the community knows about malaria prevention? Probe: What else do they need to know? How should this be done? What role can you play in this? 13. Closing Are there any important issues about treatment of malaria that we have not talked about? What are these? ANNEX D - 9 Example 5: Nigeria Malaria Study - Moderator's Focus Group Guide for Community Members 1. Introduction I am __________ from _____________, and my colleague who is assisting in this session is ____________. We have been asked by the Federal Ministry of Health to learn more about the problem of malaria in this area in order to establish programs to improve the treatment of this important health problem. We would like to welcome you, and thank you for agreeing to participate in this discussion. Your opinions will teach us a great deal about the perceptions of community members about malaria, and how well we are doing in the public health system in coping with this problem. [Set up the general ground rules for the session.] i) 90 minutes (tape recorded; observer and note taker) ii) Speak clearly/one at a time iii) Conversations/all participate iv) Want everyone's opinions v) No right/wrong answers vi) Courage of convictions 2. Common diseases Could you tell me please, what are the common illnesses in this community? Probe: Which is the most common illness? Which is the most important? (If malaria is not mentioned:) What about malaria? How important is it? What do you think is the cause of malaria? Probe: What makes some people get malaria while others do not? Are certain people less likely by nature, or is it something that they do? Are there things people can do to prevent malaria? Is malaria more common at certain times of year? 3. Malaria Recognition and Care Seeking How would you know when has malaria? Probe: What are the most common symptoms? (Probe until no more are mentioned.) Are there different kinds of malaria? Are some cases more severe? How can you tell what kind of malaria someone has? Do the symptoms differ in adults and children? What do people usually do when they think they have malaria? Probe: Does everyone do that, or do some people behave differently? Was it different in the past? What determines how someone will deal with their malaria? Do people do different things for adults and children? ANNEX D - 10 How would malaria be treated at a government clinic and how much would it cost? Probe: By a private doctor At the traditional healer At the patent medicine store What happens if a person goes for treatment and the malaria does not get better? Probe: Is this common? Do people always do things in the same order? Are some drugs better or more powerful than others? 4. Malaria Treatment at Health Centres Please explain to me what normally happens when you go to a government health centre with malaria. Start from the time that you arrive at the clinic until when you leave. Probe: history, examination, temperature, blood test, treatment, advice, etc. Is it the same at all health centres Is it the same for adults and children? When you go for malaria treatment at a health centre, what kind of drugs do you usually get? Probe: How many different drugs are given? What do these drugs do? Are they all equally important? What is the best drug? How do you know that? When you are given the drugs, what advice are you normally given? Probe: Who gives you this advice? Is it helpful? Are there other things that you wish they would explain? 4. Use of Injections What do you think about treating malaria with injections? Probe: Are injections or tablets are better for treating malaria? Do you expect to receive and injection for malaria? Are some doctors more likely to give injections than others? 6 Conclusion Are there any important issues about treatment of malaria that we have not talked about? What are these? ANNEX D - 11 Example 6: WHO/CDD Drug Sellers Study - Moderator's Focus Group Guide for Drug Sellers INTRODUCTION AND STATEMENT OF PURPOSE ! Hello, my name is Health. ! I would like to talk to you about diarrhoeal disease, the customers who visit your shop to be treated for it, and the drugs they usually buy. ! Please feel free to discuss the questions I ask openly and honestly. There are no correct answers to them, and anything you think or feel will be valuable. We hope to be able to learn a lot from each of you. ! I will try to make sure that we have time to talk about all we are supposed to, and that you all have a chance to give your opinions. ! I would like to introduce , who also works with the CDD Programme. She will be taking notes during our discussion, so that we can remember to put everything you discuss into our report. ! You will see that she is also going to tape our conversation. This will be another way for us to remember what is said when we are writing our report. The tape will not be used for any other purpose. . I work with the Diarrhoea Disease Control Programme of the Ministry of WARM-UP ! I would like to give you a chance to get to know one another. Could you please tell us your name and describe a little about the pharmacy/drug shop in which you work? Go around circle and wait for each person to introduce himself or herself. ! This is the last time you will be asked to speak one by one. After this, please feel free to jump into the conversation any time you would like to say something. TOPICS Diarrhoeal Disease and Treatment ! First, I would like to get some impressions from you about diarrhoea? Could you tell me when you think of diarrhoea, what is the first thing that comes to your mind? Listen for responses, then probe: Can you tell me more about that? Could you give me an example? How do you feel about that? ! What do you do for a customer who comes into your shop and asks your help for a case of diarrhoea in her two-year old child? What else do you ask? Do you tell her anything else? Do you always do the same thing? Why or why not? ANNEX D - 12 ! Why do you use drugs to treat diarrhoea in children? How do you decide when to use drugs? Which drugs do you prefer? ! What are the advantages and disadvantages of using ORS? Lomotil syrup? Tetracycline? Streptomagma? Why is that? Is it always this way? ! What would you do to convince your colleagues to sell more ORS to treat diarrhoea? Who would be most receptive? Are there reasons why they might not be convinced? Behaviour of Customers ! How do customers usually decide on which drugs to purchase for a case of diarrhoea? Do you help them decide in any way? Do they buy different drugs for adults and children? Which drugs are the most popular? ! What do customers say about ORS? Do they know what it is for? Where have they heard about it? Do they know how to use it? Are they satisfied with it? ! How would your customers react if you suggest that they purchase ORS for every case of diarrhoea in a child? Do they expect such advice? Would they follow your advice? Would they still buy other drugs? What would convince them? Role of Information ! How do you learn about new drugs or new ways to treat health problems? Any other ways? How about doctors? How about other people in the pharmacy profession? Which way is most important? Why? ! What kind of information would you like to have? Anything else? Where could you get this information? Would you have time to read about new ideas? ! Who would you trust to give you reliable information? Anyone else? Why? How about the Ministry of Health? The Faculty of Pharmacy? ANNEX D - 13 Why? Economic Incentives ! Do customers ever have a hard time paying for the drugs they need? How do you know who will have trouble paying? What do you do? ! Do customers equate the price of a drug with how well it works? Is there a price below which customers feel that a drug is not worthwhile? Are there any exceptions to this? ! Do customers who can't afford all their drugs ever ask your advice about which drugs to buy? How often? What do you do? Anything else? ! Are some drugs more profitable to you than others? Which ones? Does this ever change? Why or why not? ! Would there be reasons why you might actively promote a product that is less profitable? For what reasons? Can you think of a case where this happens now? What is the smallest profit you could accept for such products? ! Is ORS a profitable drug for your store? Why is this the case? Does the cost of ORS affect sales? Does it compete with any other drugs? Which ones? CLOSURE OF GROUP ! I'm sorry but we seem to have run out of time. May I ask if anyone has any final issues they feel they would like to bring up? [Allow brief discussion.] ! I would like to thank each of you for your time and valuable contribution. You have helped us to learn a lot, and we are most grateful. ANNEX D - 14 ANNEX E: EXAMPLES OF STRUCTURED OBSERVATION PROTOCOLS Example 1: Bangladesh Diarrhoea Study - Clinical Encounter Observation Form Example 2: Bangladesh Diarrhoea Study - Dispensing Process Observation Form Example 3: Nigeria Malaria Study - Clinical Process Observation Form Example 4: WHO/CDD Drug Sellers Study - Pharmacy Encounter Observation Form Example 1: Bangladesh Diarrhea Study - Clinical Encounter Observation Form IDENTIFYING INFORMATION Health Facility: _________________________ Visit ID: ______________ Dept:_____________ Date:__________ Time of Visit:__________ Patient Age (yrs,mos): ___________ Sex:___________ Accompanied by: ______________ PRESCRIBER-PATIENT INTERACTION Length of Clinical Consultation (minutes): ______________ Provider Type: _______________ DIAGNOSTIC COMMUNICATION Prescriber Asked Patient Volunteered Not Discussed Length of diarrhoea episode Association of onset with foods eaten Diarrhoea frequency/volume Appearance of Stool Child still eating/drinking/breastfeeding Previous treatment for this episode __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ EXAMINATION/TREATMENT Examined Not Does Examined Temperature (measured or felt) __________ Pulse __________ Skin turgor __________ Fontanelle (if child under 6 months) __________ Diaper examined (if soiled) __________ Stool culture ordered __________ Sterile technique followed for injection __________ COMMUNICATION/ADVICE Specific drugs/injection desired Information on drugs prescribed Eating/feeding/breastfeeding advice Information about diarrhoea prevention Prescriber Initiated __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ __________ Initiated ANNEX E - 1 Not Apply __________ __________ __________ __________ __________ __________ __________ Patient Not Discussed __________ __________ __________ __________ __________ __________ __________ __________ DESCRIPTION OF CLINICAL ENCOUNTER 1. Patient greets prescriber Yes __________ No __________ 2. Prescriber reciprocates greeting Yes __________ No __________ 3. Friendly conversation Yes __________ No __________ 4. Reassurance to the child Yes __________ No __________ 5. Reassurance to the adult Yes __________ No __________ 6. Friendly eye contact with adult Yes __________ No __________ 7. Encouraged to describe problem freely Yes __________ No __________ 8. Doctor ask questions about history, origins of problem? Yes __________ No __________ 9. Doctor listens to responses Yes __________ No __________ 10. Doctor explains exam, treatment Yes __________ No __________ 11. Doctor uses technical language only Yes __________ No __________ 12. Clinical encounter ends abruptly Yes __________ No __________ 13. Adult appears to want more advice or information Yes __________ No __________ Adult appears to expect additional treatment that was not given Yes __________ No __________ Adult appears to understand child's disease and treatment after doctor's explanation Yes __________ No __________ 14. 15. OBSERVER NOTES AND COMMENTS: ANNEX E - 2 Example 2: Bangladesh Diarrhea Study - Dispensing Process Observation Form IDENTIFYING INFORMATION Health Facility: _________________________ Visit ID: ______________ Dept:_____________ Date:__________ Time of Visit:__________ Patient Age (yrs,mos): ___________ Sex:___________ Accompanied by: ______________ DISPENSER-PATIENT INTERACTION Length of dispensing process (seconds): _____________ Dispenser: ___________________________ Type: ______________________________________________________________________ COMMUNICATION Prescriber Initiated __________ __________ __________ __________ Description of the drugs dispensed Instructions on how to take drugs Cautions, side effects mentioned Information about prevention/care Initiated Patient Not Discussed __________ __________ __________ __________ __________ __________ __________ __________ DISPENSING ACTIONS Sterile technique followed for injection Yes No Does Not Apply __________ __________ __________ How to take:________ No label: ________ Drugs labeled with (Check one or more): Patient name:________ Drug name: ________ Type of package in which drugs dispensed (Check one or more): Plastic/glass bottle: ________ Folded paper: ________ Plastic bag: ________ None: ________ ANNEX E - 3 Envelope: ________ DESCRIPTION OF THE DISPENSING ENCOUNTER 1. Conversation initiated by dispenser 2. Conversation initiated by patient/caretaker Yes __________ No __________ 3. Explanation given by dispenser Yes __________ No __________ 4. Questions raised by patient/caretaker Yes __________ No __________ 5. Dispenser answered patient questions Yes __________ No __________ 6. Dispenser explained about drugs Yes __________ No __________ 7. Dispenser used technical language only Yes __________ No __________ 8. Dispenser used local language Yes __________ No __________ 9. Patient/client asked for more drugs 10. Dispenser marked unavailable drugs on prescription Yes __________ No __________ Dispenser told patient/client to buy unavailable drugs at outside store Yes __________ No __________ 11. Yes Yes __________ __________ OBSERVER NOTES AND COMMENTS: ANNEX E - 4 No No __________ __________ Example 3: Nigeria Malaria Study - Clinical Process Observation Form IDENTIFYING INFORMATION Health Facility: _________________________ Visit ID: ______________ Dept:_____________ Date:__________ Time of Visit:__________ Patient Age (yrs,mos): ___________ Sex:___________ Accompanied by: ______________ PRESCRIBER - PATIENT INTERACTION Length of Clinical Consultation (minutes)_____________ Provider Type:___________________ DIAGNOSTIC COMMUNICATION Prescriber Asked Patient Volunteered Not Discussed Length of current episode? Patient mentions malaria? Previous treatment for this episode? Last time treated for malaria? Name of drug used to treat last time? Finished last course of treatment? ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ Risk factors (near river, near bush, mosquitoes, etc.)? ________ ________ ________ Communication about presence of: fever? ________ headache? ________ malaise? ________ muscle weakness? ________ loss of appetite? ________ chills? ________ vomiting? ________ metal taste in mouth? ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ If patient is a child: Child-vomiting? Child still eating/drinking? ________ ________ ________ ________ ________ ________ EXAMINATION/TREATMENT Examined Not Does Examined Temperature measured? Patient touched for fever? Pulse felt? Sclera of eyes examined? Tongue examined? ________ ________ ________ ________ ________ ________ ________ ANNEX E - 5 Not Apply ________ ________ ________ ________ ________ ________ ________ ________ Listens to chest? Palpates abdomen? ________ ________ ANNEX E - 6 ________ ________ ________ ________ TREATMENT Yes No Injection given? Sterile technique followed for injection? Advised lab test? Advised exam at different facility? Advised return visit if not better? ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ COMMUNICATION/ADVICE Prescriber Initiated Patient asked for: injection? chloroquine? halfantrine? other specific drug? ________ Patient Not Discussed Initiated ________ ________ ________ ________ ________ Provider explained drugs prescribed? Provider advised about mosquitoes? Provider advised about prevention? Provider advised about nutrition? Does Not Apply ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ QUALITY OF PROVIDER-PATIENT INTERACTION Patient greeted prescriber? Prescriber greeted patient? Friendly conversation? Provider reassured patient? Patient encouraged to describe problem freely? Doctor listened to responses? Encounter ended abruptly? Patient appears to want more information? Yes No ________ ________ ________ ________ ________ ________ ________ ________ Does Not Apply ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ ________ OBSERVER NOTES AND COMMENTS: ANNEX E - 7 Example 4: WHO/CDD Drug Sellers Study - Pharmacy Encounter Observation Form Age of person with diarrhoea: (1=< 1 year / 2=1-4 years / 3=5 and over): ______ Identity of person visiting shop (1=mother / 2=father / 3=sibling / 4=other): ______ Presence of absence of prescription: (1=came with prescription / 2=no prescription) ______ Sales attendant type (1=Pharmacist / 2=Assistant Pharmacist / 3=Other): ______ 1. Which of the following issues were discussed during the visit? Sales Attendant Mentioned First Presence of fever / blood in stool ______ Presence of vomiting / stomach pains ______ Dehydration / loss of fluid ______ Food, fluids, or drugs taken by patient ______ Description of what specific drugs do ______ Use of traditional remedies ______ ______ Use of ORS/ORT ______ ______ Proper dosage / frequency of drugs ______ Cautions / side effects of drugs ______ 2. 3. Customer Mentioned First ______ ______ ______ ______ ______ ______ ______ ______ ______ Not Discussed ______ ______ ______ ______ ______ ______ ______ Which of the following did the shop attendant recommend? Visit a doctor if the diarrhoea persists, child vomits, or runs a fever Continue to give fluids and foods, or increase fluid to prevent dehydration ______ ______ If advice was given: What was the customer's reaction to the advice? (1=Accepted without question / 2=Accepted but asked questions / 3=Accepted after persuasion) / 4=Did not accept) ______ Which products were recommended? Write 'NONE' if none were recommended. # of Units # of Units Name Recommended Purchased Price Paid a.___________________________________ ________ ________ __________ b.___________________________________ ________ ________ __________ c.___________________________________ ________ ________ __________ d.___________________________________ ________ ________ __________ e.___________________________________ ________ ________ __________ 4. Who seems most responsible for the treatment given: a medical practitioner, the sales attendant, or the customer? Explain why, and describe any factors you feel influenced the behaviour of the sales attendant or customer. ______________________________________________________________________________________ ______________________________________________________________________________________ ANNEX E - 8 ______________________________________________________________________________________ ANNEX E - 9 ANNEX F: EXAMPLES OF STRUCTURED QUESTIONNAIRES Example 1: Bangladesh Diarrhoea Study - Patient Intercept Interview Example 2: Nigeria Malaria Study - Patient Intercept Interview Example 3: Nepal Drug Retailers Study - Retailers= Questionnaire Example 1: Bangladesh Diarrhea Study - Patient Intercept Interview IDENTIFYING INFORMATION Health Facility: _________________________ Patient Age (yrs,mos): ___________ Date:__________ Sex:___________ Time of Visit:__________ Dept:_____________ Visit ID: ________ Accompanied by: ______________ Total Time: _________________ COMPLAINT AND PREVIOUS TREATMENT 1. What is the main complaint/ailment for which you have come here to seek treatment? 2. Have you visited this health facility before today to treat this specific illness? Yes ________ No ________ (skip to Q3) How long ago was your first visit? _________________________________________ 3. Did you consult anyone else to treat this illness before coming here? Yes ________ No ________ (skip to Q4) Whom did you consult? (specify type of practitioner) _______________________________________ INFORMATION ABOUT DIAGNOSIS AND TREATMENT 4. Has a health worker at this facility told you the name of your illness? Yes ________ No ________ (skip to Q5) What illness did they say you have? ___________________________________________ (skip to Q6) 5. Did you ask the doctor the name of your illness? Yes ________ No ________ 6. Did the doctor physically examine you? Yes ________ No ________ 7. Do you feel you had the chance to fully tell about your illness to the doctor? Yes ________ No ________ Did the doctor advise any laboratory tests? Yes ________ No ________ 8. INFORMATION ABOUT DRUGS 9. How many drugs did you receive today from this facility? __________ 10. Did the doctor here prescribe any drugs that you must buy outside of this facility? Yes ________ No ________ (skip to Q.11) Yes ________ No ________ How many drugs? ___________ 11. Did the pharmacist explain how to take your drugs? 12. Would you please tell me how you will take these drugs? (Hold up each drug the patient received one at a time, and allow patient to describe its use. Patient is allowed to read any information written on the drug package or the prescription.) Drug 1:_______________________________ Drug 2:_______________________________ Drug 3:_______________________________ Drug 4:_______________________________ Correctly stated ______ Correctly stated ______ Correctly stated ______ Correctly stated ______ Not correct ______ Not correct ______ Not correct ______ Not correct ______ PATIENT SATISFACTION 13. How satisfied are you with the treatment you received today? Would you say you were (Read options): Very satisfied ______ Satisfied ______ Dissatisfied ______ Very dissatisfied ______ 14. What are the main reasons you feel this way? 15. Would you visit this facility again in case of another illness? Yes ________ No ________ Do you have any complaints about anything at this facility? Yes ________ No ________ (skip to Q17) 16. What is the complaint? _________________________________________________ 17. Can you suggest any ways to improve patient care at this facility? 18. Do you have any other comments about this facility? . End interview by thanking the patient. Example 2: Nigeria Malaria Study - Patient Intercept Interview 1. What is the main problem for which you have come here to seek treatment? ______________________________________________________________________________ ______________________________________________________________________________ 2. Is this your first visit to this facility for this ailment? ( ) Yes ( ) No 3. What did you do when you first experienced these symptoms? ______________________________________________________________________________ ______________________________________________________________________________ 4. Did you receive treatment from any practitioner for this illness before coming here? ( ) Yes ( ) No (skip to Q5) (If yes) From whom did you receive care? ______________________________________________________________________________ 5. Were you told the name of your problem today by the doctor? ( ) Yes ( ) No (skip to Q6) (If yes) What illness did the doctor tell you that you have? ______________________________________________________________________________ 6. Were you physically examined by the doctor? ( ) Yes ( ) No 7. Did you have a chance to fully explain about your illness to the doctor? ( ) Yes ( ) No 8. Did the doctor take blood from you for a test? ( ) Yes ( ) No 9. Which medicines did the doctor recommend for you? Which did you receive today from this facility? Name of Medicine Received from facility ____________________________________________ _________ ____________________________________________ _________ ____________________________________________ _________ ____________________________________________ _________ 10. ____________________________________________ _________ Were you given a prescription for purchase of drugs outside this facility? ( ) Yes. How many drugs?________ ( ) No 15. Were you given any injection? Yes ( ) No ( ) 16. Would you please tell me how you will take the drugs your received? Drug 1: correctly stated ( ) not correct ( ) Drug 2: correctly stated ( ) not correct ( ) Drug 3: correctly stated ( ) not correct ( ) Drug 4: correctly stated ( ) not correct ( ) 17. Overall, would you say you are very satisfied, satisfied, dis satisfied, or very dissatisfied with your experience in this facility today? Very Satisfied ( ) Satisfied ( ) Dissatisfied ( ) Very Dissatisfied ( ) 18. Could you please tell me why you feel this way? ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ 19. Would you visit this health facility again in case of another illness? ( ) Yes ( ) No 20. What are your suggestions for ways we can improve care at this facility? ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ Example 3: Nepal Drug Retailers Study - Retailers= Questionnaire IDENTIFYING INFORMATION Interviewer _____________________________________ Date _____________________ Retailer sample number __________________________________________________________ District ________________________________ Town/Village ______________________ Development Committee ___________________________________________________________ Ward Number ___________________ Shop Name ________________________________ Owner Name ____________________________________________________________________ INTRODUCTION (Greet) I am _______________. from Chemists and Druggists Association. We are conducting a study to find out about the condition of retailers in different parts of the country. Would you mind spending a little time (about one hour) with us, discussing your work? Yes ________ No (why) ___________________________________________________________________________ Is this a good time for us to discuss, or could you suggest a time? Now _________ Appointment time: ______________________________________________________________ Kept appointment: ______________________________________________________________ Missed appointment: ______________________________________________________________ 1. SHOP CHARACTERISTICS I would like to ask a little about this shop and your stocks. 1. What year was this shop was established? _______________ 2. How long have you been working here? ___________ years 3. How many other people work here? ___________________________________________________ ___________ months 4. How do you find out about new drugs introduced into the market? (Do not prompt. Check all that are mentioned) ________ From wholesalers ________ From customers' prescriptions ________ Talking to health providers ________ Drug company representatives ________ Drug company advertisements ________ Other retailers ________ OTHER: __________________________________________________________ II. CUSTOMER PROFILE Now I would like to ask some questions about this area and what kind of customers you are getting. 5. Is there a health post or hospital nearby? 1. Yes ________ 2. No ________ 6. About how many customers visited the shop yesterday? _______________________ 7. Was that a usual number, more than usual, or less than usual? 1. usual ---> Go to part d. 2. less than usual 3. more than usual What would you say is the usual number? __________________________ 8. Of the people who visited your shop yesterday, what number came with prescriptions? _________________ 9. What are the 3 most common problems that people come to get medicine for? (a) ________________________________________________________________________ (b) ________________________________________________________________________ (c) ________________________________________________________________________ 10. I would like to read you a list of illnesses and ask you if in general you have many customers, some, or only a few coming for each of these illnesses. worms pneumonia cough and cold fever weakness of pregnancy diarrhoea diarrhoea with blood skin disease 11. MANY 1 1 1 1 1 1 1 1 SOME 2 2 2 2 2 2 2 2 FEW 3 3 3 3 3 3 3 3 DON'T KNOW 9 9 9 9 9 9 9 9 Do you find that most people who come ask you for a specific medicine by name, or do you usually recommend what they should buy? [Check one] 1. Customer usually asks for medicine by name 2. Usually recommend 3. Both are equally common 12. III. What do you do to attract customers? (PROMPT: Anything else? Prompt until no more responses.) (a) ____________________________________________________________________ (b) ____________________________________________________________________ (c) ____________________________________________________________________ DIARRHOEA Now I would like to talk a little about diarrhoea. LAST CASE --------------- First I would like to ask you about your last case of a child with diarrhoea. 13. Was the child brought to you, or did someone come (without the child) to ask for a drug? 1. 2. Child was brought Someone came without the child 14. Do you know how old was the child? _______ years 15. Do you know, was it a boy or a girl? 1. 2. 3. 16. 17. ________ Don't know Boy Girl Don't know What were the symptoms described to you? ______ Frequency stools _____ ______ Watery stools _____ ______ Mucous in stool _____ ______ Vomiting _____ ______ Fever _____ ______ Dehydration _____ [TICK all that are mentioned by the retailer. Do not prompt.] Loose stools Blood in stool Stomach pain Nausea Weakness Sunken fontanelle ______ ______ ______ Sunken eyes No urine Mouth is dry Not taking liquid drinks Skin dry ______ OTHER: _______________________________________________________ _____ _____ What did you recommend for that child? [FOR DRUGS ASK: What was the name? What was the quantity you recommended? What is the unit cost? ] ______ Referred to:_________________________________________________________ ______ Drugs recommended -- list below Brand name Number of units Unit cost __________________________________________ _____________ ____________ __________________________________________ __________________________________________ _____________ ____________ _____________ ____________ 18. Which product is the best in the list you recommended, and why? ____________________________________________________________________________ ____________________________________________________________________________ 19. Was there any reason to believe that the child was dehydrated? 1. Yes 2. No--------------------Go to Question III-I. 3. Don't know Which of the medicines that you recommended, if any, could be useful to correct dehydration? Name of Medicine: ________________________________________________________________ 20. Did you offer any other advice to the customer? 1. Yes 2. No--------------------Go to Question IV-A. (If yes:) What advice did you give? [PROMPT UNTIL NO MORE RESPONSES WITH: Any other advice? DO NOT read list.] __________ Continue feeding as usual _____________ Increase feeding __________ Decrease feeding _____________ Stop feeding __________ Continue breast feeding _____________ Stop breast feeding __________ Other fluids recommended: _____________________________________________ __________ Other treatment recommended: ___________________________________________ IV. GENERAL DIARRHOEA QUESTIONS Now I would like to ask you some general questions about children with diarrhoea. 21. About how many customers a week do you have coming for diarrhoea at this time of year? _______ 22. About how many of these are for adults with diarrhoea, and how many are for children? ________ Adults 23. ________ Children _________ Don't know What time of year -- that is, what months -- do you have the most customers for diarrhoea? ____________________________________________________________________________ 24. In your opinion, what are the characteristics of mild diarrhoea in a child? (Do not prompt) __________ Frequency stools ___________ Loose stools __________ Watery stools ___________ Blood in stool __________ Mucous in stool ___________ Stomach pain __________ Vomiting ___________ Nausea __________ Fever ___________ Weakness __________ Dehydration OTHER: __________________________________________________________________ 25. In your opinion, what are the characteristics of severe diarrhoea in a child? (Do not prompt) __________ Frequency stools ___________ Loose stools __________ Watery stools ___________ Blood in stool __________ Mucous in stool ___________ Stomach pain __________ Vomiting ___________ Nausea __________ Fever ___________ Weakness __________ Dehydration OTHER: __________________________________________________________________ 26. How do you know if a child is dehydrated? (Do not prompt) ______ Sunken eyes ______ Sunken fontanelle ______ No urine ______ Not taking liquid drinks ______ Mouth is dry ______ Skin dry ______ Weakness ______ OTHER: __________________________________________________________ 27. (i) (ii) In order of frequency, what products do you commonly recommend for a child with diarrhoea? Can you tell me why you recommend each product? This is, what do each of these products do? (i) PRODUCT 28. (ii) REASON FOR RECOMMENDING When a child is dehydrated do you recommend any other medicines in addition to those you listed? 1. Yes 2. No--------------------Go to Question IV-I. (If yes:) Which medicines? ____________________________________________________________________________ ____________________________________________________________________________ 29. Do customers ever demand particular brands? 1. Yes 2. No--------------------Go to Question IV-J. (If yes:) In order of frequency, what do they most often demand? 30. (a) ____________________________________________________________________ (b) ____________________________________________________________________ (c) ____________________________________________________________________ (d) ____________________________________________________________________ (e) ____________________________________________________________________ Do you ever refer customers with a child who has diarrhoea? 1. Yes 2. No -------------------- Skip to Section V. (If yes:) To whom do you refer customers? ____________________________________________________________________ (If yes:) ___ ___ ___ ___ ___ ___ ___ ___ ___ For what reasons would you refer a child with diarrhoea? [TICK all that are mentioned. Do not prompt.] Non-availability of drug at shop ___ Frequency stools Watery stools ___ Loose stools Mucous in stool ___ Blood in stool Stomach pain ___ Vomiting Nausea ___ Fever Weakness ___ Dehydration Sunken fontanelle ___ Sunken eyes Not taking liquid drinks ___ No urine Mouth is dry ___ Skin dry ___ OTHER: _______________________________________________________ 22. ORS 31. Do you have ORS in stock? Yes ________ No ________ 32. Which brands of ORS do you have in stock? What is the price? Product Price (a) _____________________________________ ____________ (b) _____________________________________ ____________ (c) _____________________________________ ____________ (d) _____________________________________ ____________ (e) _____________________________________ ____________ 33. Taking into account the price you can get from wholesalers, which brand gives you the best profit? ___________________________________________________________________________ 34. In your opinion, how does ORS help a child with diarrhoea? [Tick all responses mentioned; do not prompt.] ___ Stops diarrhoea ___ Prevents dehydration ___ Treats dehydration ___ Gives energy ___ 35. OTHER: ___________________________________________________________ Each week, about how many customers buy ORS? How many of these are children and how many are adults. Total Sales ____________ Adults ____________ 36. VI. Children ____________ Don't know age ____________ What do customers think about ORS? What do they tell you? [Tick all responses mentioned; do not prompt.] ___ ___ ___ ___ ___ Is effective Only for children Replaces water Is inexpensive Stops diarrhoea ___ ___ ___ ___ Is not effective Only for adults Provides energy Is expensive ___ OTHER ____________________________________________________________ ARI Now I would like to talk a little about respiratory problems. LAST CASE --------------- First I would like to ask you about your last case of a child with respiratory problems. 37. Please remember the last child with cough and cold/pneumonia you recommended. Was the child brought to you, or did someone come (without the child) ask for the drug? 1. Child was brought 2. Someone came without the child 38. Do you know how old was the child? _______ years _________ Don't know 39. Do you know, was it a boy or a girl? 1. Boy 2. Girl 3. Don't know 40. What were the symptoms described to you? [TICK all that are mentioned by the retailer. Do not prompt.] 41. 42. ___ ___ ___ ___ ___ fever sore throat cough indrawn chest fast breathing ___ ___ ___ ___ ___ runny nose ear pain noisy breathing headache pain in chest or ribs ___ OTHER: ___________________________________________________________________ What products did you recommend for that child? [What was the name? What was the quantity you recommended? What is the unit cost?] Brand name Number of units Unit cost (a)_______________________________________ ___________ ____________ (b)_______________________________________ ___________ ____________ (c)_______________________________________ ___________ ____________ (d)_______________________________________ ___________ ____________ Which product is the best of the ones you recommended, and why? ____________________________________________________________________________ ____________________________________________________________________________ 43. What other advice, if any, did you offer to the customer? [PROMPT UNTIL NO MORE RESPONSES WITH: Any other advice? DO NOT read list.] ___ No other advice ___ Feeding advice: ________________________________________________________ ___ Breast feeding advice: ___________________________________________________ ___ Home remedies suggested: _______________________________________________ VII. GENERAL QUESTIONS ABOUT ARI 44. About how many customers a week do you see for respiratory problems at this time of year? ______ ____ 45. How many of these are for adults with respiratory problems , and how many are for children? ________ Adults 46. ________ Children _________ Don't know What time of year -- that is, what months -- do you have the most customers for respiratory problems ? ____________________________________________________________________________ 47. What are the common respiratory problems in children? ____________________________________________________________________________ ____________________________________________________________________________ 48. When customers come about a child with cough or cold, what do they usually tell you? (TICK all symptoms mentioned. Do NOT prompt.) ___ fever ___ runny nose ___ sore throat ___ ear pain ___ cough ___ noisy breathing ___ indrawn chest ___ headache ___ fast breathing ___ pain in chest or ribs ___ extreme sleepiness ___ weakness ___ 49. 50. OTHER: __________________________________________________________________ How do you know when a child has pneumonia? What symptoms will the child have? ___ fever ___ runny nose ___ sore throat ___ ear pain ___ cough ___ noisy breathing ___ indrawn chest ___ headache ___ fast breathing ___ pain in chest or ribs ___ extreme sleepiness ___ weakness ___ OTHER: __________________________________________________________________ (i) In order of frequency, what products do you commonly recommend for a child with cough and cold? Can you tell me why you recommend each product? This is, what do each of these products do? (ii) (i) PRODUCT (ii) REASON FOR RECOMMENDING 51. Do customers ever demand particular products? 1. Yes 2. No -------------------- Go to Question VII-I. (If yes:) In order of frequency, which products do they most often demand for cough and cold in a child? 52. (a) ____________________________________________________________________ (b) ____________________________________________________________________ (c) ____________________________________________________________________ (d) (e) ____________________________________________________________________ ____________________________________________________________________ (f) ____________________________________________________________________ Do you have co-trimoxazole in stock? 1. Yes 2. No -------------------- Go to Question VII-K. (If yes:) Which brands of co-trimoxazole do you have? What is the price? Product Price (a) _____________________________________ ____________ (b) _____________________________________ ____________ (c) _____________________________________ ____________ (d) _____________________________________ ____________ (e) _____________________________________ ____________ 53. Taking into account your price from wholesalers, which of these brands gives you the best profit? ____________________________________________________________________________ 54. Do you have amoxicillin in stock? 1. Yes 2. No -------------------- Go to Question VII-M. (If yes:) Which brands of amoxicillin do you have? What is the price? Product Price (a) _____________________________________ ____________ (b) _____________________________________ ____________ (c) _____________________________________ ____________ (d) _____________________________________ ____________ (e) _____________________________________ ____________ 55. Taking into account your price from wholesalers, which of these brands gives you the best profit? ____________________________________________________________________________ 56. Do you ever refer customers with a child who has a respiratory illness? 1. Yes 2. No -------------------- Skip to Section VIII. (If yes:) To whom do you refer customers? ____________________________________________________________________ (If yes:) retailer. ___ ___ ___ ___ ___ ___ ___ VIII. For what reasons would you refer a child with respiratory illness? [TICK all that are mentioned by the Do not prompt.] fever ___ runny nose sore throat ___ ear pain cough ___ noisy breathing indrawn chest ___ headache fast breathing ___ pain in chest or ribs extreme sleepiness ___ weakness OTHER: __________________________________________________________________ PREGNANCY Now I would like to talk to you about problems in pregnant women. LAST CASE -- First I want to ask some questions about your last case of a pregnant women who was pale and weak. 57. Did the women come herself or did someone else come for her? If someone else, who? ___ Herself ___ Husband ___ Female relative ___ Male relative ___ Friend ___ Other: __________________________________ 58. While asking the medicines, what were the symptoms described to you? [TICK all that are mentioned.] 59. ___ ___ ___ ___ ___ ___ Weakness Nausea Loss of appetite Bleeding Leaking of fluid Fever ___ ___ ___ ___ ___ ___ Tiredness Back pain Dizziness Vomiting Problems with last pregnancy Severe lower abdominal pain ___ OTHER: __________________________________________________________________ Can you tell me what you recommended for that woman? Non-Drug Recommendations: ________________________________________________________ __________________________________________________________________________ FOR EACH DRUG RECOMMENDED ASK: What was the name? What was the quantity you recommended? What is the unit cost? Brand name Number of units Unit cost IX. (a)_______________________________________ ___________ ____________ (b)_______________________________________ ___________ ____________ (c)_______________________________________ ___________ ____________ (d)_______________________________________ ___________ ____________ (e)_______________________________________ ___________ ____________ GENERAL PROBLEMS OF PREGNANCY Now I would like to ask some general questions about pregnancy. 60. 61. When a customer comes for problems during pregnancy, what kind of problems do they usually tell you about? ___ ___ ___ ___ ___ ___ Weakness Nausea Loss of appetite Bleeding Leaking of fluid Fever ___ OTHER: ___________________________________________________________________ (i) In order of frequency, which products do you commonly recommend for a pregnancy case who is pale and weak? (ii) Can you tell me why you recommend each product? This is, what do each of these products do? PRODUCT 62. ___ ___ ___ ___ ___ ___ Tiredness Back pain Dizziness Vomiting Problems with last pregnancy Severe lower abdominal pain REASON FOR RECOMMENDING Do you ever refer a pregnant customer who is pale and weak? 1. 2. Yes No -------------------- Go to Question IX-D. (If yes:) To whom do you refer customers? ____________________________________________________________________ (If yes:) For what reasons would you refer such customers? [TICK all that are mentioned by the retailer. Do not prompt.] ___ Non-availability of drug ___ Weakness ___ Tiredness ___ Nausea ___ Back pain ___ Loss of appetite ___ Dizziness ___ Bleeding ___ Persistent vomiting ___ Leaking of fluid ___ Problems with last pregnancy ___ Fever ___ Severe lower abdominal pain ___ 63. 64. OTHER: ___________________________________________________________________ In order of frequency, what products do customers usually request for paleness and weakness in pregnancy? (a) ____________________________________________________________________ (c) ____________________________________________________________________ (c) ____________________________________________________________________ (d) ____________________________________________________________________ Which of these products do y ou think is the best, and why? ____________________________________________________________________________ ____________________________________________________________________________ 65. Do you have FerSolate brand of iron (ferrous sulphate) in stock? 1. Yes 2. No 66. Which other brands of iron do you have in stock? What is the price? Brand Price (a) _____________________________________ ____________ (b) _____________________________________ ____________ (c) _____________________________________ ____________ (d) _____________________________________ ____________ (e) _____________________________________ ____________ 67. Taking into account the price you can get from wholesalers, which of these brands gives you the best profit? ____________________________________________________________________________ 24. SOURCES OF INFORMATION 68. Have you ever been taught how common problems should be managed? 1. Yes 2. No----------------Go to Question X-B. (If yes:) From where have you found out about these therapies? ____________________________________________________________________ 69. How do you generally find out about the use of drugs? ____________________________________________________________________________ ____________________________________________________________________________ 70. Do you have books that discuss how common health problems should be managed? 1. Yes 2. No ----------- Go to Question X-D. (If yes, ask the following questions about these sources and record the answers in the table below) (i) What are the names of the books? (ii) How often have you used each of these books in the last 2 weeks? (iii) What do you find most useful about each of the books? (iv) Could I see the book? (i) Name of Book 71. (ii) Times Used in 2 weeks (iii) What is most useful? (iv) Book in shop (Y or N) (If not mentioned in the previous question, ask:) Do you have the Drug Retailer's Handbook? 1. Yes 2. No ----------- Go to Question X-E. (If yes, ask:) (ii) How many times in the last two weeks have you used it? ______________ times (iii) How useful is it? _________________________________________________________ (iv) How could it be made more useful for you in your work? ___________________________________________________________________________ ___________________________________________________________________________ (v) Why don't you use the manual more often? ___________________________________________________________________________ ___________________________________________________________________________ 72. Does a doctor come here to examine patients? 1. yes, respondent is a doctor 2. yes , another doctor comes here 3. no---------------- Go to Question X-F. (If yes:) 1. 2. 4. 5. How often? Every day A few times a week Once a week Less than once a week 73. In general, how many doctors are there in the area? _________________________________________ 74. Do you ever discuss with doctors about the types of medicines to be brought? 1. Yes 2. No 75. Do you ever discuss with them the use of drugs for a particular problem? 1. Yes 2. No XI. TRAINING 76. May I know if you ever took the Drug Sellers Orientation Course? 1. Yes 2. No-----------------Go to Question XI-B 3. Don't Know -----Go to Question XI-B (If yes:) About how many years ago was that? __________ Can you remember the year? __________ (If yes:) What would have made the course more useful for you in your work? ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ 77. Have you cleared the orientation examination? 1. 2. 3. 4. Yes, pass No, fail-------------------------------------Go to Question XI-C. Never heard from Kathmandu ---------Go to Question XI-C. Don't remember --------------------------Go to Question XI-C. (If passed ask:) When did you pass the examination? 1. Same year took course 2. Following year 3. Don't Remember 78. Are you the owner of this shop 1. Yes 2. No 79. Who else besides you dispenses in this shop? ____________________________________________________________________________ ____________________________________________________________________________ 80. Which of them have qualified through the orientation course? ____________________________________________________________________________ ____________________________________________________________________________ XII. OBSERVATION Sex of respondent Size of shop male female _________ room(s) Room 1: ________________________ room length: _____________ by breadth: ___________________ Room 2: ________________________ room length:_____________ by breadth: _____________________ Room 3: ________________________ room length:_____________ by breadth: _____________________ Facing of the shop? _____________________________________________________________ Examination place? yes no Fridge? yes no Electricity? yes no Fan? yes no Heater Type Electrical Kerosene Charcoal Carpet? yes no Curtain? yes no
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