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

Research Integrity and Peer Review

Research

Lyle C. Gurrin¹  Esmée M. Bordewijk²  Rik van Eekelen³  Madelon van Wely⁴  Shimona Lai⁵  Ayesha Rahim⁵  Wentao Li⁵  Rui Wang⁵  Ben W. Mol⁶  Jim G. Thornton⁷ 

[1] Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Parkville, Australia;Centre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands;Centre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands;Department of Epidemiology & Data Science, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands;Centre for Reproductive Medicine, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands;Department of Epidemiology & Data Science, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands;Netherlands Satellite of the Cochrane Gynaecology and Fertility Group, Amsterdam UMC, Amsterdam, the Netherlands;Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia;Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia;Aberdeen Centre for Women’s Health Research, University of Aberdeen, Aberdeen, UK;Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK;

关键词: Research integrity;    Trustworthiness;    Randomised controlled trials;    Checklist;   

DOI  :  10.1186/s41073-023-00130-8

 received in 2022-09-30, accepted in 2023-03-29,  发布年份 2023

来源: Springer

【 摘 要 】

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.OutcomeThe 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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