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. 2018 Feb 23;19(1):139.
doi: 10.1186/s13063-018-2535-5.

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Shaun Treweek  1 , Simon Bevan  2 , Peter Bower  3 , Marion Campbell  4 , Jacquie Christie  5 , Mike Clarke  6 , Clive Collett  7 , Seonaidh Cotton  4 , Declan Devane  8 , Adel El Feky  4 , Ella Flemyng  9 , Sandra Galvin  8 , Heidi Gardner  4 , Katie Gillies  4 , Jan Jansen  10 , Roberta Littleford  11 , Adwoa Parker  12 , Craig Ramsay  4 , Lynne Restrup  13 , Frank Sullivan  14 , David Torgerson  12 , Liz Tremain  2 , Matthew Westmore  2 , Paula R Williamson  15
Affiliations

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Shaun Treweek et al. Trials. .

Abstract

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

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Conflict of interest statement

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable

Competing interests

MC, SC, DD, AF, ST, HG, KG and MW are members of the Trial Forge Steering Group. MC is responsible for the SWAT repository. EF is employed by BioMed Central and ST is a Senior Editor for Trials. All other authors report no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Meta-analysis of three evaluations of the effect on trial recruitment of a bespoke, tailored and user-tested method of developing a Participant Information Leaflet
See this image and copyright information in PMC

References

    1. Treweek S, Altman DG, Bower P, Campbell M, Chalmers I, Cotton S, et al. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. Trials. 2015;16:261. doi: 10.1186/s13063-015-0776-0. - DOI - PMC - PubMed
    1. Anon Education section—Studies Within A Trial (SWAT) J Evid Based Med. 2012;5:44–45. doi: 10.1111/j.1756-5391.2012.01169.x. - DOI - PubMed
    1. Clarke M, Savage G, Maguire L, McAneney H. The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research. Trials. 2015;16(Suppl 2):209. doi: 10.1186/1745-6215-16-S2-P209. - DOI - PubMed
    1. Walters SJ, Bonacho dos Anjos Henriques-Cadby I, Bortolami O, Flight L, Hind D, Jacques RM, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7:e015276. doi: 10.1136/bmjopen-2016-015276. - DOI - PMC - PubMed
    1. Sully BGO, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166. doi: 10.1186/1745-6215-14-166. - DOI - PMC - PubMed

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