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.
• 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 |
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Pages (from-to) | 113-121 |
Number of pages | 9 |
Journal | Journal of Clinical Epidemiology |
Volume | 88 |
Early online date | 8 Jun 2017 |
DOIs | |
Publication status | Published - Aug 2017 |
Keywords
- randomized controlled trials
- clinical trial methodology
- validity and reliability
- Face validity
- trial design
- Pragmatic clinical trial