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Trustworthiness assessment of published clinical trials -- literature review of domains and questions
  • Zarko Alfirevic,
  • Jo Weeks
Zarko Alfirevic
University of Liverpool

Corresponding Author:zarko@liv.ac.uk

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Jo Weeks
University of Liverpool
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Abstract

BACKGROUND Historically, peer reviewing has focused on the importance of research questions/hypotheses, appropriateness of research methods, risk of bias, and quality of writing. Until recently, the issues related to trustworthiness - including but not limited to plagiarism and fraud - have been largely neglected because of lack of awareness and lack of adequate tools/training. We set out to identify all relevant papers that have tackled the issue of trustworthiness assessment to identify key domains that have been suggested as an integral part of any such assessment. METHODS We searched the literature for publications of tools, checklists or methods used or proposed for the assessment of trustworthiness of randomised trials. Data items (questions) were extracted from the included publications and transcribed on Excel including the domain of assessment as described in the original publication. Both authors then independently assessed each data item to see if the original domain(s) could be re-categorised in 5 domains (governance, plausibility, plagiarism, reporting, statistics). RESULTS From the 41 publications we extracted a total of 284 questions and framed 77 summary questions grouped in 5 domains: governance (13 questions); plausibility (16 questions); plagiarism (4 questions), reporting (28 questions and statistics (16 questions). CONCLUSION The proposed menu of domains and questions should encourage peer reviewers, editors, systematic reviewers and developers of guidelines to engage in a more formal trustworthiness assessment. Methodologists should aim to to identify the domains and questions that should be considered mandatory, those that are optional depending on the resources available, and those that could be discarded because of lack of discriminatory power.
Submitted to Cochrane Evidence Synthesis and Methods
17 May 2024Reviewer(s) Assigned
11 Jun 2024Review(s) Completed, Editorial Evaluation Pending
24 Jul 20241st Revision Received
24 Jul 2024Submission Checks Completed
24 Jul 2024Assigned to Editor
24 Jul 2024Review(s) Completed, Editorial Evaluation Pending
26 Jul 2024Editorial Decision: Revise Minor
31 Jul 20242nd Revision Received
01 Aug 2024Submission Checks Completed
01 Aug 2024Assigned to Editor
01 Aug 2024Review(s) Completed, Editorial Evaluation Pending
02 Aug 2024Editorial Decision: Accept