The PRECIS-2 tool seems not to be useful to discriminate the degree of pragmatism of medicine masked trials from that of
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CLINICAL TRIAL
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 Rafael Dal-Ré 1 Received: 4 September 2020 / Accepted: 21 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose 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. Methods A search was conducted of participant-level pRCTs on medicines published on 25 influential medical journals in July 2018–December 2019. All pre-licensing (phases 1–3) and cluster pRCTs were excluded. All trials’ available reports were searched through the published article information, Google Scholar, and trial websites. Instead of providing a score to each PRECIS-2 domain, these were classified as E (explanatory), N (neutral), or P (pragmatic). Results Of 128 pRCTs, 18 (14%) were participant-level pRCTs on medicines. The full trial protocol was available for 14 trials; 12 had published the protocol and nine had additional reports published. All trials were prospectively registered, and none was funded by industry. Ten and eight were masked and open-label trials, respectively. Masked pRCTS had 34% of pragmatic and 60% of explanatory domains; open-label pRCTS had 45% pragmatic and 45% explanatory domains. Among the 10 masked trials, only one had a majority of five pragmatic domains; among the eight open-label trials, four had a majority of six or five pragmatic domains. “Follow-up” was considered explanatory in the 18 pRCTs; “primary analysis” was pragmatic in 17 pRCTs. Conclusion 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. Keywords Pragmatic trials . Explanatory trials . PRECIS-2 . Medicines . Phase 4 trials . High influential journals
Introduction Randomized controlled trials (RCTs) can be classified as explanatory and pragmatic [1]. Explanatory RCTs are those conducted in ideal conditions and are focused on internal validity (or the degree of lack of bias), aiming to evaluate the comparative efficacy of the assessed interventions; pragmatic RCTs are those conducted resembling usual clinical practice and are Supplementary Information The online version contains supplementary material available at https://doi.org/10.1007/s00228-02003030-8. * Rafael Dal-Ré [email protected] 1
Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda Reyes Católicos 2, E-28040 Madrid, Spain
focused on external validity (or generalizability) aiming to evaluate the comparative effectiveness of the assessed interventions [1, 2]. However, most RCTs have explana
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