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 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.