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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The PRECIS-2 tool has good interrater reliability and modest discriminant validity
Journal of Clinical Epidemiology, Volume 88, Year 2017
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Description
Objectives PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 is a tool that could improve design insight for trialists. Our aim was to validate the PRECIS-2 tool, unlike its predecessor, testing the discriminant validity and interrater reliability. Study Design and Setting Over 80 international trialists, methodologists, clinicians, and policymakers created PRECIS-2 helping to ensure face validity and content validity. The interrater reliability of PRECIS-2 was measured using 19 experienced trialists who used PRECIS-2 to score a diverse sample of 15 randomized controlled trial protocols. Discriminant validity was tested with two raters to independently determine if the trial protocols were more pragmatic or more explanatory, with scores from the 19 raters for the 15 trials as predictors of pragmatism. Results Interrater reliability was generally good, with seven of nine domains having an intraclass correlation coefficient over 0.65. Flexibility (adherence) and recruitment had wide confidence intervals, but raters found these difficult to rate and wanted more information. Each of the nine PRECIS-2 domains could be used to differentiate between trials taking more pragmatic or more explanatory approaches with better than chance discrimination for all domains. Conclusion We have assessed the validity and reliability of PRECIS-2. An elaboration study and web site provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers, and funders. © 2017 Elsevier Inc.
Authors & Co-Authors
Zwarenstein, Merrick F.
Canada, London
Western University
Sullivan, Frank M.
United Kingdom, St Andrews
School of Medicine
Canada, Toronto
North York General Hospital
Donnan, Peter T.
United Kingdom, Dundee
University of Dundee
Gágyor, Ildikó
Germany, Gottingen
Universitätsmedizin Göttingen
Althabe, Fernando A.
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Krishnan, Jerry A.
United States, Chicago
University of Illinois at Chicago
Treweek, Shaun P.
United Kingdom, Aberdeen
University of Aberdeen
Statistics
Citations: 46
Authors: 7
Affiliations: 10
Identifiers
Doi:
10.1016/j.jclinepi.2017.06.001
ISSN:
08954356
Study Approach
Quantitative