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

Kirsty Loudon* (Corresponding Author), Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Ildikó Gágyor, Hans Hobbelen, Fernando Althabe, Jerry A Krishnan, Shaun Treweek

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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• The original PRECIS tool did not have its validity and reliability formally measured.
• The inter-rater reliability of PRECIS-2 was measured using 19 raters (trialists from seven countries) to score a varied sample of 15 RCT protocols.
• Inter-rater reliability was generally good, with seven of nine domains having an Intraclass Correlation Coefficient over 0.65.
• 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.
• The validity and reliability of PRECIS-2 has been assessed.
Original languageEnglish
Pages (from-to)113-121
Number of pages9
JournalJournal of Clinical Epidemiology
Early online date8 Jun 2017
Publication statusPublished - Aug 2017

Bibliographical note

This work was supported by the Chief Scientist Office (CSO) of Scotland grant CZH/4/773, the UK Medical Research Council and the University of Dundee work through the provision of a stipend for KL and from the Health Services Research Unit at the University of Aberdeen, which is core funded by the CSO of the Scottish Government Health Directories. We are grateful to all the participants who assisted in this study: F Althabe, A-W Chan, D Altman, D Bratton, E Brass, M Campbell, G Forbes, B Gaglio, R Glasgow, H Hobbelen, S Hopewell, J Krishnan, D Riddle, J Segal, D Steinfort, P Tugwell, SN Van der Veer, VA. Welch, C Witt.


  • randomized controlled trials
  • clinical trial methodology
  • validity and reliability
  • Face validity
  • trial design
  • Pragmatic clinical trial


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