The PRECIS-2 tool has good interrater reliability and modest discriminant validity

Kirsty Loudon, Merrick Zwarenstein, Frank M. Sullivan, Peter T. Donnan, Ildikó Gágyor, Hans J. S. M. Hobbelen, Fernando Althabe, Jerry A. Krishnan, Shaun Treweek

Research output: Contribution to journalArticlepeer-review

32 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)113-121
JournalJournal of Clinical Epidemiology
Volume88
Early online date8 Jun 2017
DOIs
Publication statusPublished - Aug 2017

Keywords

  • Randomized controlled trials
  • Clinical trial methodology
  • Validity and reliability
  • Face validity
  • Pragmatic clinical trial
  • Trial design

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