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Maximising the Impact of Qualitative Research in Feasibility Studies for Randomised Controlled Trials: Guidance for Researchers

Overview
Publisher Biomed Central
Date 2016 Dec 15
PMID 27965810
Citations 200
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Abstract

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

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References
1.
Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T . Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be.... BMJ. 2002; 325(7367):766-70. PMC: 1124277. DOI: 10.1136/bmj.325.7367.766. View

2.
Behets F, Van Damme K, Norris Turner A, Rabenja N, Ravelomanana N, Raharinivo M . Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections. Sex Transm Dis. 2008; 35(3):238-42. DOI: 10.1097/OLQ.0b013e31815abaa2. View

3.
Hawe P, Shiell A, Riley T . Complex interventions: how "out of control" can a randomised controlled trial be?. BMJ. 2004; 328(7455):1561-3. PMC: 437159. DOI: 10.1136/bmj.328.7455.1561. View

4.
Harris L, Tufano J, Le T, Rees C, Lewis G, Evert A . Designing mobile support for glycemic control in patients with diabetes. J Biomed Inform. 2010; 43(5 Suppl):S37-S40. DOI: 10.1016/j.jbi.2010.05.004. View

5.
Drabble S, OCathain A, Thomas K, Rudolph A, Hewison J . Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis. BMC Med Res Methodol. 2014; 14:24. PMC: 3937073. DOI: 10.1186/1471-2288-14-24. View