52nd NATIONAL CONFERENCE OF IPHA

1. CRM-IPHA-UNFPA-SPZ-Delhi-080308 1 52nd NATIONAL CONFERENCE OF IPHA PLENARY SESSION CHRONIC REPRODUCTIVE MORBIDITY Dr. Sanjay P. Zodpey, MD, PhD Director, Public Health Education, Public Health Foundation of India (PHFI), New Delhi

2. CRM-IPHA-UNFPA-SPZ-Delhi-080308 2 52nd NATIONAL CONFERENCE OF IPHA PLENARY SESSION Methodological Issues Involved in the Detection of Chronic Reproductive Morbidities including Strategic Interventions for Prevention, Early Detection, and Management Sanjay P. Zodpey, MD, PhD

3. CRM-IPHA-UNFPA-SPZ-Delhi-080308 3 SCOPE OF PRESENTATION Emphasis on CRM specific issues Emphasis � not on individual diseases Basis � Review of studies Scarcity of information - CRM

4. CRM-IPHA-UNFPA-SPZ-Delhi-080308 4 Study Design Setting Duration of Study Sample Size / Power Analysis / Sampling Selection of Subjects Study Variables Data Collection Techniques Study Instruments

5. CRM-IPHA-UNFPA-SPZ-Delhi-080308 5 Measurement Devices & Technical Procedures Randomization / Matching Interventions Follow up Procedures Bias Informed Consent Ethical and IRB Clearance Statistical Methods

6. CRM-IPHA-UNFPA-SPZ-Delhi-080308 6 CHRONIC REPRODUCTIVE MORBIDITY (CRM) - ISSUES The primary need in any research is adequate, accurate and reliable information to base assumptions The methodological issues are complicated by: Varying time-spans of diseases A prevalent culture of silence and Poor diagnostic methods

7. CRM-IPHA-UNFPA-SPZ-Delhi-080308 7 Methodological issues in research: Early detection (diagnostic and screening) Detection (prevalence and incidence studies) Risk factor identification (analytic studies) Community perceptions (qualitative tools) Designing strategic interventions for prevention�(clinical and community trials, operational research) and Case management (clinical trials)

8. CRM-IPHA-UNFPA-SPZ-Delhi-080308 8 MEASURING REPRODUCTIVE HEALTH Current focus � mortality Even Global Burden of Disease Study is mortality-centric and fails to capture the spectrum of reproductive morbidity and associated disability

9. CRM-IPHA-UNFPA-SPZ-Delhi-080308 9 MEASURING REPRODUCTIVE HEALTH Measurement Trap: Narrow conceptualization of women�s reproductive health Poor existing data sources Focus solely on measures of disease, particularly mortality Lack of community based data

10. CRM-IPHA-UNFPA-SPZ-Delhi-080308 10 KEY ISSUES IN METHODOLOGY - CRM Recruitment strategies Self reported reproductive morbidities (SRRM) Biologic measurements

11. CRM-IPHA-UNFPA-SPZ-Delhi-080308 11 RECRUITMENT STRATEGIES Many studies are underpowered because of inadequate enrollment Care seeking for reproductive health among women is inadequate and inequitable in India because of A lack of access to resources Limited decision making power Restricted autonomy and Reduced freedom of movement

12. 12 RECRUITMENT STRATEGIES Little research has been done to compare different recruitments models Participants were recruited from an outpatient clinic and community Community supported enrolment process (community preparation, reproductive health education and screening of potential participants) yielded higher recruitment and retention

13. CRM-IPHA-UNFPA-SPZ-Delhi-080308 13 RECRUITMENT STRATEGIES Clinic and hospital based research on reproductive tract: Advantages Protecting privacy and confidentiality Obtaining appropriate examination and interviewing space is easier Collection and transportation of laboratory specimens presents fewer difficulties

14. CRM-IPHA-UNFPA-SPZ-Delhi-080308 14 RECRUITMENT STRATEGIES Clinic and hospital based research on reproductive tract: Limitations Women avoid treatment because of lack of knowledge Shame and embarrassment Stigma and inhibitions

15. CRM-IPHA-UNFPA-SPZ-Delhi-080308 15 SELF REPORTED REPRODUCTIVE MORBIDITIES (SRRM) Community based prevalence of reproductive morbidity using household interview surveys Advantages over other approaches that rely on hospital statistics / medical examinations

16. CRM-IPHA-UNFPA-SPZ-Delhi-080308 16 SRRM - ADVANTAGES A greater depth of population is covered (given higher response rates and lower cost) Interpretation of findings is simplified Generalization to the source population is achieved Potential to estimate the prevalence of conditions that may only be self-reported

17. Identify conditions that escape the attention of health services Investigate individual, social and environmental determinants Assess the consequences or impact of illness CRM-IPHA-UNFPA-SPZ-Delhi-080308 17

18. CRM-IPHA-UNFPA-SPZ-Delhi-080308 18 SRRM - LIMITATIONS For mild conditions: Urban Estimates > Rural Estimates For severe conditions: Urban Estimates = Rural Estimates With higher educational and income level: Increase in reporting of morbidities

19. CRM-IPHA-UNFPA-SPZ-Delhi-080308 19 SRRM � QUALITATIVE METHODS Addition of qualitative investigations help to improve the conceptual and methodological limitations of household interview survey as well as the interpretation of results Such investigations document how women describe in their own words their experience with illness, signs and symptoms, and probable cause or consequences of illness

20. SRRM � QUALITATIVE METHODS Self-report of a morbidity that requires clinical or diagnostic tests to confirm diagnosis may provide an estimate of people�s knowledge of disease rather than estimate its true prevalence

21. CRM-IPHA-UNFPA-SPZ-Delhi-080308 21 SRRM � QUALITATIVE METHODS The commonly utilized ethnographic and anthropological methods are: Informal, open-ended interviews In-depth interviews Illness narratives Sorting and ranking of key concepts FGDs

22. CRM-IPHA-UNFPA-SPZ-Delhi-080308 22 CHALLENGES IN SRRM Many conditions are asymptomatic Are stigmatized and thus likely to be misreported Prevalent culture of silence with reluctance to reveal private problems to strangers Women�s inferior status within the family Conditions are frequently prevalent and their symptoms are considered the norm and thus are not reported as morbidity

23. CRM-IPHA-UNFPA-SPZ-Delhi-080308 23 Prevalence estimates based on SRRM are generally more specific than sensitive Different approaches to asking questions influence estimates of validity Different interviewers and interview conditions influence the reliability of prevalence estimates

24. CRM-IPHA-UNFPA-SPZ-Delhi-080308 24 SRRM � LIMITATIONS OF EXISTING LITERATURE Some studies use a combination of self-reported & observed morbidity but fail to compare findings in terms of sn & sp Other studies are not specifically designed to compare self-reported and observed morbidity Suffer from low participation or case identification rates Collect observed morbidity data limited to symptomatic women or to women who self-report

25. CRM-IPHA-UNFPA-SPZ-Delhi-080308 25 SRRM � ESTIMATES DEPENDANT ON PREVALENCE When a specific morbidity�s prevalence is low (e.g. = 5%), a survey tool with a specificity and sensitivity of > 50% will always overestimate the prevalence of disease, unless the specificity approaches 100% The sn and sp of a set of questions depend upon the prevalence of reported symptoms in the population under study

26. CRM-IPHA-UNFPA-SPZ-Delhi-080308 26 Sensitivity is biased upwards and specificity downwards if the study population has a higher proportion of symptomatic women than the general population The opposite is true if the study population has a lower proportion of symptomatic women

27. CRM-IPHA-UNFPA-SPZ-Delhi-080308 27 EARLY FINDINGS FROM INDUSTRIALIZED COUNTRIES Methodological Issues: SRRM is only slightly to moderately associated with observed morbidity for a range of conditions The high degree of false negative self-reports prevents valid estimation of the prevalence Psychological and behavioral factors, along with health and medical knowledge, influence SRRM

28. CRM-IPHA-UNFPA-SPZ-Delhi-080308 28 RECENT FINDINGS FROM INDUSTRIALIZED COUNTRIES Methodological Issues: Document wider range of agreement between self-reported and observed morbidity in aggregate For larger studies evaluating a range of chronic illnesses, under-reporting was more problematic than over-reporting

29. CRM-IPHA-UNFPA-SPZ-Delhi-080308 29 RECENT FINDINGS FROM DEVELOPING COUNTRIES Methodological Issues: Questions the validity, reliability and comparability of the estimates obtained Studies that rely on self reported morbidity to estimate prevalence do not include validation components Prevalence estimates appear to be sensitive to minor differences in methodology

30. CRM-IPHA-UNFPA-SPZ-Delhi-080308 30 Methodological Issues: Non-standardized interviewing techniques The use of open-ended or closed questions The degree of probing The inclusion of proxy respondents Variations in the length of recall periods Limited concordance between an episode of illness and the recall period

31. CRM-IPHA-UNFPA-SPZ-Delhi-080308 31 Methodological Issues: Failure to encourage local populations to participate in the design of questionnaires and sampling approaches The neglect of traditional providers and alternative care sources SRRM and observed morbidity measure different phenomena

32. CRM-IPHA-UNFPA-SPZ-Delhi-080308 32 MEASURING REPRODUCTIVE HEALTH � USE OF ALGORITHMS Methodological Issues: Interview-based diagnosis of morbidity through use of algorithms that combine different categories of self-reported morbidity have significant advantages Brief algorithms may be as sensitive and specific as longer interview schedules A range of algorithms for the diagnosis of interest may be used in different situations

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35. CRM-IPHA-UNFPA-SPZ-Delhi-080308 35 WHY DO WE NEED BIOLOGIC MEASUREMENT? Traditionally, epidemiologists have used interview information, which is subject to recall bias Many conditions, such as asymptomatic STIs may not be recognized by respondents

36. CRM-IPHA-UNFPA-SPZ-Delhi-080308 36 BIOLOGIC MEASUREMENTS - LIMTATIONS Biologic measurement requires clinical examinations or specialized investigations, which are invasive and often costly Transporting viable organisms for microbiologic culture is difficult Generalization of such findings is limited by the self selection of clinic populations

37. CRM-IPHA-UNFPA-SPZ-Delhi-080308 37 METHODOLOGICAL CHALLENGES Ensuring a close interaction with the community Provision of appropriate medical treatment Complementing quantitative and qualitative methods Handling under-reporting of morbidities

38. METHODOLOGICAL CHALLENGES Devising methods to improve reporting validity Sample loss and self selection in reproductive diseases Establishing standard definitions for diseases

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