Trustworthiness assessment of published clinical trials: Literature review of domains and questions

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 randomized trials. Data items (questions) were extracted from the included publications and transcribed on Excel including the assessment domain. Both authors then independently recategorised each data item in five domains (governance, plausibility, plagiarism, reporting, and statistics).

Results: From the 41 publications we extracted a total of 284 questions and framed 77 summary questions grouped in five domains: governance (13 questions), plausibility (17 questions), plagiarism (4 questions), reporting (29 questions), and statistics (14 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 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.

Figure 1

PRISMA flowchart showing the selection process.