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
Outline
• What is qualitative research?
• Why use qualitative research?
• What can qualitative research contribute to
health care and to clinical trials?
What is qualitative research?
Defined in opposition to quantitative research
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
What is qualitative research?
Tools, techniques or methods used
“Research that derives data from observation,
interviews or verbal interactions…”
Pubmed MESH (Medical Subject Heading)
What is qualitative research?
• Type of questions addressed
• “What” “how” or “why”
Autobiographical deviation
“Would you rather study what people actually
do, or what people say they do?”
Autobiographical deviation
• Statistic in medicine
What is qualitative research?
What is qualitative research?
• Variety of paradigms or orientations
What is qualitative research?
Some common tendencies
• Minimise constraint on discovery
• Flexibility
• Context and holism
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
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
Context and holism
• Ecological validity
• Multiple perspectives
• Triangulation
Why use qualitative research in health care?
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
Why use qualitative research in health care?
Health care as an “uneasy juncture of science and art”
“Despite drawing on the ever-expanding knowledge
base and range of therapies, medical practice remains
fundamentally an interpersonal experience”
• Battista R, et al., J Clinical Epidemiology 1995
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
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
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)
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)
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)
BMJ 2000: 320: 1246–125
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)
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
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
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
“Clinical trials are crumbling under modern
economic and scientific pressures”
Patient recruitment as “a major stumbling
block”
Ledford H, Nature 2011;477:526-8
•Donovan, J et al Improving design and conduct of
randomised trials by embedding them in qualitative
research: ProtecT study
•(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%
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
Slade, P et al British Journal of General Practice 2010; 60: 440-8
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?