Evidence map›Paper›PMID 31910861›Full record

ArticleTrials2020

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

Shaun Treweek, Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky and 17 more

Abstract read
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 6 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

25 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Guideline
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  5. Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021
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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

27 authors.

Shaun TreweekHealth Services Research Unit, University of Aberdeen, Aberdeen, UK. streweek@mac.com.ORCID http://orcid.org/0000-0002-7239-7241
Simon BevanNational Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
Peter BowerMRC North West Hub for Trials Methodology Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.
Matthias BrielDepartment of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
Marion CampbellHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jacquie ChristieGSK Medicines Research Centre, Stevenage, UK.
Clive CollettHealth Research Authority, London, UK.
Seonaidh CottonHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Declan DevaneHRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.
Adel El FekyHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Sandra GalvinHRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.
Heidi GardnerHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Katie GilliesHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Kerenza HoodCentre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.
Jan JansenDivision of Acute Care Surgery, University of Alabama at Birmingham, Birmingham, USA.
Roberta LittlefordUniversity of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
Adwoa ParkerYork Trials Unit, University of York, York, UK.
Craig RamsayHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Lynne RestrupPublic and patient representative, Aberdeen, UK.
Frank SullivanSchool of Medicine, St Andrews University, St Andrews, UK.
David TorgersonYork Trials Unit, University of York, York, UK.
Liz TremainNational Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
Erik von ElmCochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
Matthew WestmoreNational Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.
Hywel WilliamsCentre of Evidence-Based Dermatology, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Paula R WilliamsonMRC North West Hub for Trials Methodology Research, Department of Biostatistics University of Liverpool, Liverpool, UK.
Mike ClarkeNorthern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.

Funding

Chief Scientist Office HSRU1Medical Research Council G0901530Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2MRC Network of Hubs for Trials Methodology Research Grant Reference: MR/L004933/1- B2
6 · The paper itself

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.

Indexed as

Clinical Decision-MakingEvidence-Based MedicineHumansPractice Guidelines as TopicRandomized Controlled Trials as TopicResearch Design

Identifiers

PMID31910861
PMCPMC6945587

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.