European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Aug 2020
Articles provided insufficient information to conduct an appropriate retrospective assessment of the pragmatic/explanatory features of medicine trials with the PRECIS-2 tool.
To assess whether, in the retrospective assessment of the pragmatic/explanatory features of pragmatic randomized controlled trials (pRCTs), the nine PRECIS-2 domain scores using the information provided in articles were modified after using the information reported in other publicly available sources. ⋯ Articles describing the trial main results are usually insufficient for the appropriate retrospective assessment of the pragmatic/explanatory features of a pRCT by authors not involved in the conduct of the trial. To address this issue, editors should require the submission of the original full protocol and final full protocol with the history of amendments to be published as supplementary material to the article.