Bridget Young, Department of Psychological Sciences, University of Liverpool, UK

1. Qualitative methods in research on health care and clinical trials: theoretical, methodological and ethical aspects Bridget Young, Department of Psychological Sciences, University of Liverpool, UK

2. Outline • What is qualitative research? • Why use qualitative research? • What can qualitative research contribute to health care and to clinical trials?

3. What is qualitative research?

4. Defined in opposition to quantitative research

5. What is qualitative research? Defined in opposition from quantitative research “Quantitative research typically examines relationships among variables… Qualitative research helps scientists understand the meaning of processes… ” US National Institutes of Health 2011

6. What is qualitative research? Tools, techniques or methods used “Research that derives data from observation, interviews or verbal interactions…” Pubmed MESH (Medical Subject Heading)

7. What is qualitative research? • Type of questions addressed • “What” “how” or “why”

8. Autobiographical deviation “Would you rather study what people actually do, or what people say they do?”

9. Autobiographical deviation • Statistic in medicine

10. What is qualitative research?

11. What is qualitative research? • Variety of paradigms or orientations

12. What is qualitative research? Some common tendencies • Minimise constraint on discovery • Flexibility • Context and holism

13. Minimise constraint • Allows you to ‘expect the unexpected’ • But cannot be a ‘blank slate’ • Use of sensitizing concepts (but these can be desensitizing if overused) • Consideration of ‘deviant’ or outlier cases

14. Flexibility • Methods and questions can change as research is ongoing • Raises ethical issues - conventions of biomedical ethics can be: • unduly constraining for qualitative research • underplay the risks of qualitative research • bring complexities for informed consent

15. Context and holism • Ecological validity • Multiple perspectives • Triangulation

16. Why use qualitative research in health care?

17. Why use qualitative research in health care? Between 1997-2006 • 5/3299 articles in JAMA used qualitative methods • 10/4678 articles in The Lancet • 0/2199 articles in NEJM • 121/25,193 articles in BMJ Mori H, Nakayama T, PLoS ONE 2013:8(3) e57371

18. Why use qualitative research in health care? Health care as an “uneasy juncture of science and art” “Despitedrawingon the ever-expandingknowledgebase and range of therapies, medicalpracticeremainsfundamentally an interpersonalexperience” • Battista R, et al., J Clinical Epidemiology 1995

20. Why use qualitative research? • Probing and exploration of detail • Exploration of unanticipated phenomena • In the exploratory phases of a project • Illuminate the findings of quantitative research

21. What does qualitative research contribute to health care? • Development of conceptual definitions • Development of typologies and classifications • Exploration of associations between attitudes, behaviours and experiences • Explanation of phenomena (contributing to new ideas, theories or organisational change) Green & Thorogood 2004 cited in Britten N, Patient Education and Counseling 2011;82:384-8

22. What does qualitative research contribute to health care? • Development of conceptual definitions • Development of typologies and classifications • Exploration of associations between attitudes, behaviours and experiences • Explanation of phenomena (contributing to new ideas, theories or organisational change)

24. What does qualitative research contribute? • Development of conceptual definitions • Development of typologies and classifications • Exploration of associations between attitudes, behaviours and experiences • Explanation of phenomena (contributing to new ideas, theories and organisational change)

28. What does qualitative research contribute? • Development of conceptual definitions • Development of typologies and classifications • Exploration of associations between attitudes, behaviours and experiences • Explanation of phenomena (contribution to new ideas, theories or organisational change)

29. BMJ 2000: 320: 1246–125

30. What does qualitative research contribute? • Development of conceptual definitions • Development of typologies and classifications • Exploration of associations between attitudes, behaviours and experiences • Explanation of phenomena (contributing to new ideas, theories or organisational change)

31. For each ailment that doctors cure with medications (as I am told they do occasionally succeed in doing), they produce ten others in healthy individuals by inoculating them with that pathogenic agent a thousand times more virulent than all the microbes—the idea that they are ill. • Proust, 1920

34. What can qualitative research contribute to clinical trials? • Enhance recruitment • Develop/refine the intervention • Explore issues influencing the effect of the intervention • Select and develop measurement instruments • Enhance retention

35. What can qualitative research contribute to clinical trials? • Enhance recruitment • Develop/refine the intervention • Explore issues influencing the effect of the intervention • Select and develop measurement instruments • Enhance retention

36. “Clinical trials are crumbling under modern economic and scientific pressures” Patient recruitment as “a major stumbling block” Ledford H, Nature 2011;477:526-8

37. Donovan, J et al Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecTstudy • (2002) BMJ, 325 (7367), 766-769. • Switched from using “watchful waiting” to “active monitoring” for non-radical treatment arm • Found recruiters gave more detail about radical treatment arms – advised to explain each arm of trial in same level of detail • Following these and other changes suggested by the qualitative study, recruitment to the trial increased from 30% to 65%

38. What can qualitative research contribute to clinical trials? • Enhance recruitment • Develop/refine the intervention • Explore issues influencing the effect of the intervention • Select and develop measurement instruments • Enhance retention

39. Slade, P et al British Journal of General Practice 2010; 60: 440-8

40. Afterword Theory • qualitative research informed by but also challenges theory • theory as a tool for thinking, not a template to apply Methodology • qualitative and quantitative methodologies as complementary Ethics • challenge of fitting the biomedical model • change from the inside?