TY - JOUR
T1 - Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist)
T2 - concept proposal and pilot
AU - Mol, Ben W
AU - Lai, Shimona
AU - Rahim, Ayesha
AU - Bordewijk, Esmée M
AU - Wang, Rui
AU - van Eekelen, Rik
AU - Gurrin, Lyle C
AU - Thornton, Jim G
AU - van Wely, Madelon
AU - Li, Wentao
N1 - We acknowledge the members of the consensus panel: Zarko Alfirevic, Rik van Eekelen, Vincenzo Berghella, Jack Wilkinson, Madeline Flanagan, Steve McDonald, Helen Nagels, Lyle Gurrin, Francis Githae Muriithi, Kurt Barnhart, Esmée Bordewijk, and Naomi Lee.
PY - 2023/6/20
Y1 - 2023/6/20
N2 - OBJECTIVES: To propose a checklist that can be used to assess trustworthiness of randomized 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. 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.CONCLUSIONS: The 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.
AB - OBJECTIVES: To propose a checklist that can be used to assess trustworthiness of randomized 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. 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.CONCLUSIONS: The 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.
U2 - 10.1186/s41073-023-00130-8
DO - 10.1186/s41073-023-00130-8
M3 - Article
C2 - 37337220
SN - 2058-8615
VL - 8
JO - Research integrity and peer review
JF - Research integrity and peer review
M1 - 6
ER -