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

Lewin, S; Glenton, C; Oxman, AD; (2009) Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ, 339. b3496. ISSN 1468-5833 DOI:

Text - Published Version
License: Creative Commons Attribution Non-commercial

Download (128kB) | Preview


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 METHODS: Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors.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.

Item Type: Article
Faculty and Department: Faculty of Public Health and Policy > Dept of Social and Environmental Health Research
PubMed ID: 19744976
Web of Science ID: 269754800002


Download activity - last 12 months
Downloads since deposit
Accesses by country - last 12 months
Accesses by referrer - last 12 months
Impact and interest
Additional statistics for this record are available via IRStats2

Actions (login required)

Edit Item Edit Item