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. 2020 Jan 7;21(1):33.
doi: 10.1186/s13063-019-3980-5.

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed

Shaun Treweek  1 , Simon Bevan  2 , Peter Bower  3 , Matthias Briel  4 , Marion Campbell  5 , Jacquie Christie  6 , Clive Collett  7 , Seonaidh Cotton  5 , Declan Devane  8 , Adel El Feky  5 , Sandra Galvin  8 , Heidi Gardner  5 , Katie Gillies  5 , Kerenza Hood  9 , Jan Jansen  10 , Roberta Littleford  11 , Adwoa Parker  12 , Craig Ramsay  5 , Lynne Restrup  13 , Frank Sullivan  14 , David Torgerson  12 , Liz Tremain  2 , Erik von Elm  15 , Matthew Westmore  2 , Hywel Williams  16 , Paula R Williamson  17 , Mike Clarke  18
Affiliations

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed

Shaun Treweek et al. Trials. .

Abstract

The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.

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Conflict of interest statement

ST is an Editor-in-Chief of Trials. MB is a Senior Editor of Trials. HG, FS and ST are authors on the Cochrane Review used for Example 1. KG is now lead author of the update to the Cochrane Review used for Example 2.

Figures

Fig. 1
Fig. 1
Summary of the cumulative evidence for the effect of telephone reminders on trial recruitment. The dotted lines represent decision thresholds of 0%, 5%, 10% and 15% that trialists can consider when deciding whether to use the intervention in their own trial
Fig. 2
Fig. 2
Summary of the cumulative evidence for the effect of monetary incentives on trial retention. The dotted lines represent decision thresholds of 0%, 5%, 10% and 15% that trialists can consider when deciding whether to use the intervention in their own trial
See this image and copyright information in PMC

References

    1. Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;(2):MR000013. 10.1002/14651858.MR000013.pub6. - PMC - PubMed
    1. Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, et al. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;(12):MR000032. 10.1002/14651858.MR000032.pub2. - PMC - PubMed
    1. Marcano Belisario JS, Huckvale K, Saje A, Porcnik A, Morrison CP, Car J. Comparison of self administered survey questionnaire responses collected using mobile apps versus other methods (Protocol). Cochrane Database Syst Rev. 2014;(4):MR000042. - PMC - PubMed
    1. Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, et al. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018;24(1):240–253. doi: 10.1111/jep.12805. - DOI - PubMed
    1. Raftery J, Young A, Stanton L, Milne R, Cook A, Turner D, et al. Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. Health Technol Assess. 2015;19:1–138. doi: 10.3310/hta19110. - DOI - PMC - PubMed

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