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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, Hutchings, Hayley Anne, Jinks, Clare, Montgomery, Alan, Moore, Graham ORCID:, Plano Clark, Vicki L, Tonkin-Crine, Sarah, Wade, Julia, Warren, Fiona C, Wyke, Sally, Young, Bridget and O'Cathain, Alicia 2019. Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials. BMJ Open 9 (11) , e032081. 10.1136/bmjopen-2019-032081

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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: Article
Date Type: Publication
Status: Published
Schools: Social Sciences (Includes Criminology and Education)
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Funders: Medical Research Council
Date of First Compliant Deposit: 28 November 2019
Date of Acceptance: 26 November 2019
Last Modified: 08 Jul 2023 06:09

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