Trial Forge Guidance 4: A guideline for reporting the results of randomised Studies Within A Trial (SWATs)

Catherine Arundel; Laura Clark; Adwoa  Parker; David J Beard; Elizabeth Coleman; Cindy Cooper; Declan Devane; Sandra Eldridge; Sandra Galvin; Katie Gillies; Catherine E  Hewitt; Christopher Sutton; David J. Torgerson; Shaun Treweek

doi:10.1186/s13063-024-08004-0

Trial Forge Guidance 4: A guideline for reporting the results of randomised Studies Within A Trial (SWATs)

Catherine Arundel^* (Corresponding Author), Laura Clark, Adwoa Parker, David J Beard, Elizabeth Coleman, Cindy Cooper, Declan Devane, Sandra Eldridge, Sandra Galvin, Katie Gillies, Catherine E Hewitt, Christopher Sutton, David J. Torgerson, Shaun Treweek

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background
Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.

Methods
An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.

Results
We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.

Conclusions
The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.

Original language	English
Article number	183
Number of pages	11
Journal	Trials
Volume	25
Issue number	1
Early online date	12 Mar 2024
DOIs	https://doi.org/10.1186/s13063-024-08004-0
Publication status	Published - 12 Mar 2024

Bibliographical note

Acknowledgements
We would like to thank those members of the PROMETHEUS programme who are not explicitly named as authors of this publication, but who provided valuable input to the delivery and conduct of the programme within which the guideline development sat.

PROMETHEUS programme members include co-authors CA, LK, AP, DB, CC, DD, SG, KG, CH, CS, DT, and ST and P Bower (University of Manchester), L Culliford (University of Bristol), L Doherty (University of York), and R Emsley (Kings College London). We would like to thank public contributors who provided input and comment on earlier versions of this work.

We would also like to thank the authors of the previous guidelines for reporting of embedded recruitment trials for their advice and input in the early stages of guideline development and to the independent reviewers and trialists who offered comments and piloting of the draft guideline.

Funding
Development of the SWAT reporting guideline was initiated as part of The PROMoting THE Use of SWATs (PROMETHEUS) programme, funded by the Medical Research Council (MRC) [grant number MR/R013748/1].

Keywords

Study Within A Trial
SWAT
Embedded randomised controlled trial
reporting guideline
reporting standard

Access to Document

10.1186/s13063-024-08004-0Licence: CC BY

Arundel_etal_T_Trial_Forge_Guidance_VoR
© The Author(s) 2024. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/
Final published version, 965 KBLicence: CC BY

Cite this

Arundel, C., Clark, L., Parker, A., Beard, D. J., Coleman, E., Cooper, C., Devane, D., Eldridge, S., Galvin, S., Gillies, K., Hewitt, C. E., Sutton, C., Torgerson, D. J., & Treweek, S. (2024). Trial Forge Guidance 4: A guideline for reporting the results of randomised Studies Within A Trial (SWATs). Trials, 25(1), Article 183. https://doi.org/10.1186/s13063-024-08004-0

@article{2d6845f62f664c1f9b14511842236e16,

title = "Trial Forge Guidance 4: A guideline for reporting the results of randomised Studies Within A Trial (SWATs)",

abstract = "BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.MethodsAn iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.ResultsWe developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.",

keywords = "Study Within A Trial, SWAT, Embedded randomised controlled trial, reporting guideline, reporting standard",

author = "Catherine Arundel and Laura Clark and Adwoa Parker and Beard, {David J} and Elizabeth Coleman and Cindy Cooper and Declan Devane and Sandra Eldridge and Sandra Galvin and Katie Gillies and Hewitt, {Catherine E} and Christopher Sutton and Torgerson, {David J.} and Shaun Treweek",

note = "Acknowledgements We would like to thank those members of the PROMETHEUS programme who are not explicitly named as authors of this publication, but who provided valuable input to the delivery and conduct of the programme within which the guideline development sat. PROMETHEUS programme members include co-authors CA, LK, AP, DB, CC, DD, SG, KG, CH, CS, DT, and ST and P Bower (University of Manchester), L Culliford (University of Bristol), L Doherty (University of York), and R Emsley (Kings College London). We would like to thank public contributors who provided input and comment on earlier versions of this work. We would also like to thank the authors of the previous guidelines for reporting of embedded recruitment trials for their advice and input in the early stages of guideline development and to the independent reviewers and trialists who offered comments and piloting of the draft guideline. Funding Development of the SWAT reporting guideline was initiated as part of The PROMoting THE Use of SWATs (PROMETHEUS) programme, funded by the Medical Research Council (MRC) [grant number MR/R013748/1].",

year = "2024",

month = mar,

day = "12",

doi = "10.1186/s13063-024-08004-0",

language = "English",

volume = "25",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - Trial Forge Guidance 4

T2 - A guideline for reporting the results of randomised Studies Within A Trial (SWATs)

AU - Arundel, Catherine

AU - Clark, Laura

AU - Parker, Adwoa

AU - Beard, David J

AU - Coleman, Elizabeth

AU - Cooper, Cindy

AU - Devane, Declan

AU - Eldridge, Sandra

AU - Galvin, Sandra

AU - Gillies, Katie

AU - Hewitt, Catherine E

AU - Sutton, Christopher

AU - Torgerson, David J.

AU - Treweek, Shaun

N1 - Acknowledgements We would like to thank those members of the PROMETHEUS programme who are not explicitly named as authors of this publication, but who provided valuable input to the delivery and conduct of the programme within which the guideline development sat. PROMETHEUS programme members include co-authors CA, LK, AP, DB, CC, DD, SG, KG, CH, CS, DT, and ST and P Bower (University of Manchester), L Culliford (University of Bristol), L Doherty (University of York), and R Emsley (Kings College London). We would like to thank public contributors who provided input and comment on earlier versions of this work. We would also like to thank the authors of the previous guidelines for reporting of embedded recruitment trials for their advice and input in the early stages of guideline development and to the independent reviewers and trialists who offered comments and piloting of the draft guideline. Funding Development of the SWAT reporting guideline was initiated as part of The PROMoting THE Use of SWATs (PROMETHEUS) programme, funded by the Medical Research Council (MRC) [grant number MR/R013748/1].

PY - 2024/3/12

Y1 - 2024/3/12

N2 - BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.MethodsAn iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.ResultsWe developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.

AB - BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.MethodsAn iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.ResultsWe developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.

KW - Study Within A Trial

KW - SWAT

KW - Embedded randomised controlled trial

KW - reporting guideline

KW - reporting standard

U2 - 10.1186/s13063-024-08004-0

DO - 10.1186/s13063-024-08004-0

M3 - Article

C2 - 38475795

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 183

ER -

Trial Forge Guidance 4: A guideline for reporting the results of randomised Studies Within A Trial (SWATs)

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Cite this