Published 10 September 2009, doi:10.1136/bmj.b3496
Cite this as: BMJ 2009;339:b3496

Research

Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

¹ Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London WC1E 7HT, ² Health Systems Research Unit, Medical Research Council of South Africa, ³ Norwegian Knowledge Centre for the Health Services, Oslo, Norway

Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions.

Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care.

Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group.

Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done.

Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable.

Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

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Rapid Responses:

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This is relevant beyond trials of interventions in the organisation of care

Alicia O'Cathain
bmj.com, 18 Sep 2009 [Full text]

Why are qualitative approaches not used appropriately in clinical trials?

Alexandra Greene, et al.
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