Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials

Richards, D. A. et al. (2019) Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials. BMJ Open, 9(11), e032081. (doi: 10.1136/bmjopen-2019-032081) (PMID:31772096) (PMCID:PMC6886933)

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It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

Item Type:Articles
Glasgow Author(s) Enlighten ID:Wyke, Professor Sally and Craig, Professor Peter
Authors: Richards, D. A., Bazeley, P., Borglin, G., Craig, P., Emsley, R., Frost, J., Hill, J. J., Horwood, J., Hutchings, H., Jinks, C., Montgomery, A., Moore, G., Plano Clark, V., Tonkin-Crine, S., Wade, J., Warren, F., Wyke, S., Young, B., and O'Cathain, A.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Social Scientists working in Health and Wellbeing
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN (Online):2044-6055
Copyright Holders:© Author(s) (or their employer(s)) 2019
First Published:First published in BMJ Open 9(11):e032081
Publisher Policy:Reproduced under a Creative Commons license

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
727671Informing Healthy Public PolicyPeter CraigMedical Research Council (MRC)MC_UU_12017/15HW - MRC/CSO Social and Public Health Sciences Unit
727671Informing Healthy Public PolicyPeter CraigOffice of the Chief Scientific Adviser (CSO)SPHSU15HW - MRC/CSO Social and Public Health Sciences Unit