Evidence map›Paper›PMID 38475795›Full record

ArticleTrials2024

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

C E Arundel, L K Clark, A Parker, D Beard, E Coleman, C Cooper, D Devane, S Eldridge, S Galvin, K Gillies and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

C E ArundelYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK. catherine.arundel@york.ac.uk.
L K ClarkYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
A ParkerYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
D BeardNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, UK.
E ColemanYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
C CooperClinical Trials Research Unit, University of Sheffield, Sheffield, UK.
D DevaneHRB-Trials Methodology Research Network, University of Galway, Galway, Ireland.
S EldridgeWolfson Institute of Population Health, Queen Mary University of London, London, UK.
S GalvinHRB-Trials Methodology Research Network, University of Galway, Galway, Ireland.
K GilliesHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
C E HewittYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
C SuttonSchool of Health Sciences, The University of Manchester, Manchester, UK.
D J TorgersonYork Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
S TreweekHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
PROMETHEUS GROUP

Funding

Medical Research Council MR/R013748/1
6 · The paper itself

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.

trial registrationEQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.

Indexed as

Guidelines as TopicRandomized Controlled Trials as TopicHumansEmbedded randomised controlled trialReporting guidelineReporting standardStudy within A TrialSWAT

Identifiers

PMID38475795
PMCPMC10935912

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.