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Comment
. 2018 May 21;16(1):76.
doi: 10.1186/s12916-018-1071-1.

Informing real-world practice with real-world evidence: the value of PRECIS-2

Gila Neta  1 , Karin E Johnson  2
Affiliations
Comment

Informing real-world practice with real-world evidence: the value of PRECIS-2

Gila Neta et al. BMC Med. .

Abstract

Real-world evidence is needed to inform real-world practice. Pragmatic controlled trials are intended to provide such evidence by assessing the effectiveness of medicines and other interventions in real-world settings, as opposed to explanatory trials that assess efficacy in highly controlled settings. Dal-Ré and colleagues (BMC Med 16:49, 2018) recently performed a literature review of studies published between 2014 and 2017 to assess the degree to which studies that self-identified as pragmatic were truly so. The authors found that over one-third of randomized controlled trials of drugs and biologics that were self-labeled as pragmatic used placebo controls (as opposed to usual care), tested medicines before licensing, or were conducted in a single site. Further, they proposed that, in order to improve the reliability of the 'pragmatic' label, investigators should assess their trials using the PRECIS-2 tool upon submission to funders, ethics boards, or journals. We appreciate the value of PRECIS-2 as an indicator to assess the pragmatic versus explanatory features in a trial, and we herein highlight the potential challenges and opportunities that may arise with its systematic and widespread use.

Keywords: Effectiveness; Explanatory trials; PRECIS-2; Pragmatic trials; Real-world evidence; Usual clinical practice.

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Conflict of interest statement

Authors’ information

GN is an epidemiologist and program officer in Implementation Science at the National Cancer Institute’s Division of Cancer Control and Population Sciences. KEJ is a senior research associate at IMPAQ International in the Pharmaceutical Health Services Research practice area. Their previous research focused on the application of PRECIS-2 to rate PCT domains.

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Comment on

References

    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group. Pragmatic Trials in Healthcare (PRACTIHC) group Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390. - DOI - PMC - PubMed
    1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637–648. doi: 10.1016/0021-9681(67)90041-0. - DOI - PubMed
    1. Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005;365(9453):256–265. doi: 10.1016/S0140-6736(05)70156-2. - DOI - PubMed
    1. Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10:37. doi: 10.1186/1745-6215-10-37. - DOI - PMC - PubMed
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. doi: 10.1136/bmj.h2147. - DOI - PubMed

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