European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Apr 2021
The PRECIS-2 tool seems not to be useful to discriminate the degree of pragmatism of medicine masked trials from that of open-label trials.
To assess, with all available trial information, whether the assessment of the PRECIS-2 nine domains could provide a clear distinction between medicine masked pragmatic randomized controlled trials (pRCTs) and open-label pRCTs. ⋯ The PRECIS-2 tool seems not to be sensitive enough to clearly discriminate between medicine masked pRCTs and open-label pRCTs. When conducting systematic reviews, it is suggested that the PRECIS-2 tool should not be used to support placing masked trials in the pragmatic side of the explanatory/pragmatic continuum.