Evidence map›Paper›PMID 37337220›Full record

ArticleResearch integrity and peer review2023

Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist): concept proposal and pilot.

Ben W Mol, Shimona Lai, Ayesha Rahim, Esmée M Bordewijk, Rui Wang, Rik van Eekelen, Lyle C Gurrin, Jim G Thornton, Madelon van Wely, Wentao Li

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Research integrity and peer review, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 21 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

62 citing papers in PubMed, 21 syntheses or guidelines pooled it.

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  12. Interventions to Address Disparities in Perinatal Outcomes by Ethnicity: A Systematic Review.BJOG : an international journal of obstetrics and gynaecology · 2025
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  13. Intraperitoneal chemotherapy for gastric cancer.The Cochrane database of systematic reviews · 2025
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  14. Synchronised approach for intrauterine insemination in subfertile couples.The Cochrane database of systematic reviews · 2025
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2 more citing papers are in PubMed but not listed here.

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

10 authors.

Ben W MolDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Shimona LaiDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Ayesha RahimDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Esmée M BordewijkCentre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Rui WangDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Rik van EekelenCentre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Lyle C GurrinCentre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Parkville, Australia. lgurrin@unimelb.edu.au.
Jim G ThorntonFaculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.
Madelon van WelyCentre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Wentao LiDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs).

designA 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. The initial checklist was set-up by a core group who had been involved in the assessment of problematic RCTs for several years. We piloted this in a consensus 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 results were then discussed in consensus meetings. OUTCOME: The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes 19 items organised into seven domains that are applicable to every RCT: 1) Governance, 2) Author Group, 3) Plausibility of Intervention Usage, 4) Timeframe, 5) Drop-out Rates, 6) Baseline Characteristics, and 7) Outcomes. Each item can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have a majority of items rated at a major concern level, then editors, reviewers or evidence synthesizers should consider a more thorough investigation, including assessment of original individual participant data.

conclusionsThe TRACT checklist is the first checklist developed specifically 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.

Indexed as

ChecklistRandomised controlled trialsResearch integrityTrustworthiness

Identifiers

PMID37337220
PMCPMC10280869

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.