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TrialsTrialsTrials1745-6215BioMed Central 1745-6215-14-S1-O5210.1186/1745-6215-14-S1-O52Oral PresentationWhat can qualitative research do for randomised controlled trials? A systematic mapping review O'Cathain Alicia 1Thomas Kate 1Drabble Sarah 1Rudolph Anne 1Hewison Jenny 21 University of Sheffield, Sheffield, UK2 University of Leeds, Leeds, UK2013 29 11 2013 14 Suppl 1 2nd Clinical Trials Methodology Conference: Methodology MattersPublication of this supplement was funded by the 2nd Clinical TrialsMethodology Conference.O52 O52 Copyright © 2013 O'Cathain et al; licensee BioMed Central Ltd.2013O'Cathain et al; licensee BioMed Central Ltd.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.18-19 November 2013 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK
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Objective
To develop an empirically-based framework of the aspects of randomised controlled trials addressed by qualitative research.

Design
Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals.

Data sources
Medline, Premedline, Embase, The Cochrane Library, Health Technology Assessment, PsychINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA.

Eligibility criteria
Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research; reported in English.

Results
296 articles met the inclusion criteria. They had a wide international authorship. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pre-trial stage (28%, 82/296).

Conclusions
A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pre-trial stage and being explicit within their articles about the learning for trials and evidence-based practice.


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