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

By S. Lewin, C. Glenton, Andrew D. Oxman. British medical journal, 2009

708 citations recorded by the source corpus.

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 Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors.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

Subfields: Education, General Health Professions, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/a3ca1f88af52e80658249a2a131ac6e624cd5e16

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In Education

In General Health Professions

In Statistics and Probability

Citations in the corpus

Three techniques for integrating data in mixed methods studies (2010, background): “Recent empirical studies of mixed methods research in health show, however, a lack of integration between components,”
PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews (2014, background): “However, these terms may become more relevant in the future as more trials and interventions incorporate qualitative research [12].”
Achieving integration in mixed methods designs-principles and practices. (2013, methodology): “Although there are many potential gains from data integration, the extent to which mixed methods studies implement integration remains limited (Bryman 2006; Lewin, Glenton, and Oxman 2009).”
Interventions to reduce social isolation and loneliness among older people: an integrative review (2018, background): “This concern is reflected in recent guidance which calls for greater integration of qualitative research methods in interventional designs, in order to better understand implementation, receipt, and setting of interventions and interpretation of outcomes (Oakley et al. 2006, Lewin et al. 2009).”
Patients’ Accounts of Increased “Connectedness” and “Acceptance” After Psilocybin for Treatment-Resistant Depression (2017, neutral): “Qualitative studies are an important adjunct to quantitative data (Hill, Chui, & Baumann, 2013; Lewin, Glenton, & Oxman, 2009; Midgley, Ansaldo, & Target, 2014).”