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Mixed methods in medical research
Robert PoolCentre for International Health, Hospital Clinic, University of Barcelona
London School of Hygiene & Tropical Medicine
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THE BACKGROUND
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Social science & medicine
• Increasing demand for qualitative social science in medical research programmes due to:
– Realisation that illness is social as well as biological (adherence, acceptability, treatment seeking); the need to understand beliefs in order to change behaviour, fashionable
– Better interdisciplinary communication
• Consultation, collaboration, integration
• Cooperation depends on suppressing/ignoring underlying differences
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Why mix methods?
1. To triangulate (get closer to the truth)
2. To develop (sequential use)
3. To complement (examine different aspects)
4. To broaden (discover wider context, new perspectives)
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THE PROJECT
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Microbicides Development Programme
Objective: To determine the efficacy and safety of two concentrations of “PRO 2000/5 Gel” compared to placebo in preventing vaginally acquired HIV infection
Primary outcome: acquisition of HIV infection
Sample: 10,000 women
Process: Feasibility Pilot Phase III
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Study sites
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Quantitative trial data
• Women followed up for 12 months
• Regular clinic visits (every 4 weeks) for:– condom & gel distribution– applicator returns– clinical exams– lab tests (STDs, HIV & pregnancy)– clinical & behavioural interviews (CRF)
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Issues
Interpreting the trial result depends on the accuracy of sexual behaviour and adherence data
But self-reporting is unreliable
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Key questions
• How do you know that participants understand the categories and questions in the way you intend?
• How do you ask sexual behaviour questions across different cultures & vernaculars in a standardised way that enables meaningful comparison?
• How do you know that your sexual behaviour data are accurate?
• How do you know whether women have used the product (properly)?
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The social science
• Qualitative social science integrated to address these issues
• Random subsample (100 women at each site)• In-depth interviews with women & partners• Coital diaries• Focus group discussions• Ethnography
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Explore & clarify standard categories & questions
• Almost all the central concepts in sexual behaviour research are ambiguous: – marriage, regular partner, casual partner– sex acts, condom use, etc.
• Get emic meanings
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THE TRIANGULATION PROCESS
Women
Case Record Form
Coital Diary4 weeks before CRF
Comparison Form
1. Interview2. Comparison &
probing inconsistencies
IDI T&T Nvivo
Summaries
Summaries
Nvivo
T&TIDI
1. Interview2. Compariso
n with women
Male partners
Women, community
Summaries
T&T NvivoFGDs
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In-depth interview guide
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Consistency of CRF data
• In 53% (254/482) some inconsistency
• Mainly under-reporting of sex acts and over-reporting of gel and condom use on CRF
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sex acts gel condom
IDI
CRF
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Two main sets of reasons for the inaccuracies in the CRF:– The participant forgetting or not understanding. – The interviewer not asking, not listening, or not
understanding
• Confirmed by recording of CRF interviews
• Training, memory aid, short recall periods, clarification of terminology
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Getting closer to the truth
• You can get more accurate data on sexual behaviour (get closer to the truth) if you:
• Clarify key concepts & categories
• Need to identify and solve inconsistencies during the study
• Ensure continuous feedback between different teams, methods and data sets
• Engage in dialogue with participants
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THE ISSUES
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1. How do you deal with inaccuracies once you’ve found them?
• Unresolved inconsistencies (uncertainty)?
• Resolved inconsistencies: – change the database?– extrapolate?
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2. What do you do with key categories that remain ambiguous?
Sex acts/rounds/days
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3. How do you take into account the influence of the research process on the data?
• On behaviour (condom use, practices)
• On symptom perception (itching)
• On how people categorise their experience (definition of sex acts)
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4. How do you deal with “ethics”?
The misplaced application of clinical trial ethics to social science research:
• Flexibility of questions and “instruments” (open interviews, CD)
• Flexibility of procedures (recording CRF interview, follow up women)
• Observation
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Conclusion
• Mixed models rather than mixed methods
• Combine emic and etic approaches
• Follow up and solve inconsistencies during the study
• Reform “ethics” procedures
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How do we decide which data are most accurate?Case Record Form
2 sex acts in the last week
Coital Diary Ticked “sex” 7 times
In-depth Interview
Reported that she’d had sex 7 times
IDI probing When asked about the inconsistency with the CRF she explained that in the CRF interview she had been asked about sex acts and not rounds.
Partner IDI Her partner reported having had sex 7 times in the same period
CONCLUSION 7 sex acts; CRF underreporting
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Opposing theoretical paradigms
Positivism Constructivism
Reality Single, objective Multiple, constructed
Knowledge Neutral & objective Influenced by knower
Values No role Influence facts
Generalisation
Time & context free Time & context bound
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Different methods
QUANT QUAL
Data type Numerical Narrative
Sample size Large Small
Instruments Closed Open
Aim Explain Explore, understand
Process Fixed Interative
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Also:
• Continuation of the trial depends on informed consent
• Success of product depends on acceptability