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

AfterwordTheory –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?