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.Peer reviewedPostprin

Althabe, Fernando

Donnan, Peter

Gágyor, Ildikó

Hobbelen, Hans

Krishnan, Jerry A.

Loudon, Kirsty

Sullivan, Frank

Treweek, Shaun

Zwarenstein, Merrick

Sullivan, Frank M.

Donnan, Peter T.

Hobbelen, Hans J.S.M.

GRO.publications (Univ. Göttingen)

Journal of Clinical Epidemiology

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

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

Discovery Research Portal

The PRECIS-2 tool has good interrater reliability and reasonable 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

Crossref

OBJECTIVE: 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 inter-rater reliability.STUDY DESIGN AND SETTING: Over 80 international trialists, methodologists, clinicians and policymakers created PRECIS - 2 helping to ensure face and content validity. The inter-rater reliability of PREC IS - 2 was measured using 19 experienced trialists who used PRECIS - 2 to score a diverse sample of 15 RCT 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: Inter-rater reliability was generally good, with seven out of nine domains having an ICC 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 paper and website provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers and funders.</p

Krishnan, Jerry A

Hanze UAS repository

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.Peer reviewe

Aberdeen University Research

English

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

Objective&nbsp; 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 inter-rater reliability.&nbsp;  Study design and Setting&nbsp; Over 80 international trialists, methodologists, clinicians and policymakers created PRECIS - 2 helping to ensure face and content validity. The inter-rater reliability of PREC IS - 2 was measured using 19 experienced trialists who used PRECIS - 2 to score a diverse sample of 15 RCT 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.&nbsp;  Results&nbsp; Inter-rater reliability was generally good, with seven out of nine domains having an ICC over 0.65.Flexibility (Adherence) and Recruitmenthad 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.&nbsp;  Conclusion&nbsp; We have assessed the validity and reliability of PRECIS - 2. An elaboration paper and website provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers and funders

Sullivan, Frank M

Donnan, Peter T

Gagyor, Ildiko

Stirling Online Research Repository (RIOXX)

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 predictorsof 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

Hobbelen, Hans J. S. M.

University of St. Andrews - Pure

GRO.publications

Stirling Online Research Repository

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

Abstract

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GRO.publications (Univ. Göttingen)

Discovery Research Portal

Crossref

Hanze UAS repository

Aberdeen University Research

Stirling Online Research Repository (RIOXX)

University of St. Andrews - Pure

GRO.publications

Hanze UAS repository

Stirling Online Research Repository