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

Kirsty Loudon; Merrick Zwarenstein; Frank Sullivan; Peter Donnan; Ildikó  Gágyor; Hans  Hobbelen; Fernando  Althabe; Jerry A Krishnan; Shaun Treweek

doi:10.1016/j.jclinepi.2017.06.001

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

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Abstract

• 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 language	English
Pages (from-to)	113-121
Number of pages	9
Journal	Journal of Clinical Epidemiology
Volume	88
Early online date	8 Jun 2017
DOIs	https://doi.org/10.1016/j.jclinepi.2017.06.001
Publication status	Published - Aug 2017

Keywords

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

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© 2017. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Accepted author manuscript, 289 KBLicence: CC BY-NC-ND

Cite this

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title = "The PRECIS-2 tool has good inter-rater reliability and modest discriminant validity",

abstract = "• 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.",

keywords = "randomized controlled trials, clinical trial methodology, validity and reliability, Face validity , trial design, Pragmatic clinical trial ",

author = "Kirsty Loudon and Merrick Zwarenstein and Frank Sullivan and Peter Donnan and Ildik{\'o} G{\'a}gyor and Hans Hobbelen and Fernando Althabe and Krishnan, {Jerry A} and Shaun Treweek",

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.",

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doi = "10.1016/j.jclinepi.2017.06.001",

language = "English",

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AU - Loudon, Kirsty

AU - Zwarenstein, Merrick

AU - Sullivan, Frank

AU - Donnan, Peter

AU - Gágyor, Ildikó

AU - Hobbelen, Hans

AU - Althabe, Fernando

AU - Krishnan, Jerry A

AU - Treweek, Shaun

N1 - 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.

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AB - • 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.

KW - randomized controlled trials

KW - clinical trial methodology

KW - validity and reliability

KW - Face validity

KW - trial design

KW - Pragmatic clinical trial

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DO - 10.1016/j.jclinepi.2017.06.001

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JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -

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

Abstract

Keywords

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