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

Richards, David A; Bazeley, Patricia; Borglin, Gunilla; Craig, Peter; Emsley, Richard; Frost, Julia; Hill, Jacqueline; Horwood, Jeremy; Anne Hutchings, Hayley; Jinks, Clare; Montgomery, Alan; Moore, Graham; Plano Clark, Vicki L; Tonkin-Crine, Sarah; Wade, Julia; Warren, Fiona C; Wyke, Sally; Young, Bridget; O'Cathain, Alicia

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Authors

David A Richards

Patricia Bazeley

Gunilla Borglin

Peter Craig

Richard Emsley

Julia Frost

Jacqueline Hill

Jeremy Horwood

Hayley Anne Hutchings

Alan Montgomery

Graham Moore

Vicki L Plano Clark

Sarah Tonkin-Crine

Julia Wade

Fiona C Warren

Sally Wyke

Bridget Young

Alicia O'Cathain



Abstract

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.

Journal Article Type Article
Acceptance Date Nov 6, 2019
Online Publication Date Nov 26, 2019
Publication Date Nov 26, 2019
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 11
Pages 1-5
DOI https://doi.org/10.1136/bmjopen-2019-032081
Publisher URL http://doi.org/10.1136/bmjopen-2019-032081
PMID 31772096

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