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

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 settin...

Full description

Saved in:
Bibliographic Details
Published in:BMC medicine 2018-05, Vol.16 (1), p.76-76, Article 76
Main Authors: Neta, Gila, Johnson, Karin E
Format: Article
Language:English
Subjects:
Analysis
Clinical decision making
Clinical medicine
Clinical trials
Decision making
Effectiveness
Explanatory trials
Intervention
Literature reviews
Management
Methods
Patient satisfaction
Pragmatic trials
PRECIS-2
Ratings & rankings
Real-world evidence
Reliability analysis
Usual clinical practice
Validity
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1741-7015
1741-7015
DOI:10.1186/s12916-018-1071-1