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

Research output: Contribution to journalArticle

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

Original languageEnglish
Article numbere032081
JournalBMJ open
Issue number11
Early online date26 Nov 2019
Publication statusE-pub ahead of print - 26 Nov 2019

Bibliographical note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

King's Authors


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.

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