Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions

Methodological study

Bibliographic Data

ID23357076
AuthorsSimon Lewin (0000-0001-7521-9515, University of London, corresponding author), Claire Glenton (0000-0002-7558-7737, South African Medical Research Council), Andrew D Oxman (0000-0002-5608-5061, Nasjonalt Kunnskapssenter for Helsetjenesten)
Year2009
Volume339
Issuesep10 1
Pagesb3496-b3496
Publication date2009-09-10
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueBMJ (JOURNAL)
Journal identifiersISSN: 0007-1447 • E-ISSN: 0267-0623
PublisherBMJ (PUBLISHER • GB)
DOI10.1136/bmj.b3496
PMID19744976
OpenAlexW1990973473
LanguageEN
Citations received75
References cited9

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 METHODS: Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors.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

Blinding · Clinical trial · Health care · MEDLINE · Psychological intervention · Qualitative property · Qualitative research · Randomized controlled trial · Systematic review · Computer Science · Health Policy Implementation Science · Internal Medicine · Medicine · Meta-analysis and systematic reviews · Nursing · Qualitative Research Methods and Applications · Surgery