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PreprintCited by 150Meta-analysis and systematic reviewsPharmaceutical industry and healthcareAcademic integrity and plagiarism

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

A checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist)

Open access
Mol, Ben W, Lai, Shimona, Rahim, Ayesha, Bordewijk, Esmée M, Wang, Rui, Eekelen, Rik van, Gurrin, Lyle C, Thornton, Jim G, Wely, Madelon van, Li, Wentao·2023·Research Integrity and Peer Review
DOI 10.21203/rs.3.rs-2119486/v1PMC PMC10280869

Preprint — published as 10.1186/s41073-023-00130-8 · Paper page

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Abstract

Objectives: To develop a checklist to screen, for trustworthiness, papers reporting the results of randomised controlled trials (RCTs). Design: A screening tool was developed using the four-stage approach proposed by Moher et al. This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting as part of a Delphi method. The initial checklist was set-up by a core group who had been involved in the assessment of dubious RCTs for several years. We piloted this in a Delphi panel of several stakeholders, including health professionals, reviewers, journal editors, policymakers, researchers and evidence-synthesis specialists. Each member was asked to score three articles with the checklist and the the results were then discussed in two Delphi sessions. Results: The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes seven domains that are applicable to every RCT: governance, author group, plausibility of intervention usage, timeframe, drop-out rates, baseline characteristics and outcomes. Each domain contains two or three signalling questions that can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have significant concerns, then editors or reviewers should consider a more thorough investigation, including assessment of original individual participant data. Conclusions: The TRACT checklist is the first checklist developed in a formal process to detect trustworthiness issues in RCTs. It might help editors, publishers and researchers to screen for such issues in submitted or published RCTs in a transparent and replicable manner.

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Authors
Mol, B. W., Lai, S., Rahim, A., Bordewijk, E. M., Wang, R., Eekelen, R. V., Gurrin, L. C., Thornton, J. G., Wely, M. V., & Li, W.
Affiliations
  • University of Aberdeen (GB)
  • Monash University (AU)
  • Amsterdam UMC Location University of Amsterdam (NL)
  • Amsterdam UMC, location AMC
  • The University of Melbourne (AU)
  • University of Nottingham (GB)
Corresponding author
Gurrin, Lyle C
ORCID
Venue
Research Integrity and Peer Review
Publisher
Research Square Platform LLC
Published
2023-01-11
Volume
8
Issue
1
Pages
6-6
ISSN
2058-8615 (ISSN-L)
DOI
10.21203/rs.3.rs-2119486/v1
PMC
PMC10280869
OpenAlex
W4381250920
Cited by
149
References
24
Citations by year
2026: 46 · 2025: 47 · 2024: 42 · 2023: 14
FWCI
27.64
Type
journal article
Language
en
Open access
Licence
Locations
  • Research Integrity and Peer Review (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion, other-oa)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
  • Social Sciences › Education › Academic integrity and plagiarism
Keywords
trustworthiness assessment, randomized controlled trials, screening tool, research integrity, questionable research practices, peer review, individual patient data, dropout rates

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