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Protocol for a SPIRIT extension for reporting Pragmatic and Explanatory trial protocols designed using the PRECIS tool. (SPIRIT-PRECIS)
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DOI：10.1016/j.jclinepi.2026.112380.png)
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Abstract
En 中文
• Transparent reporting of both pragmatic and explanatory trial protocols with regard to their intention, and the degree to which their design choices match their primary intention, is important. • However, no clear reporting guideline for protocols of randomized clinical trials with clearly stated intention (either pragmatic or explanatory) exist. • We will develop a SPIRIT extension for reporting Pragmatic and Explanatory trial protocols designed using the PRECIS tool (SPIRIT-PRECIS), to help authors improve the completeness of reporting for pragmatic or explanatory trial protocols which can promote transparency and confidence in trial results.
Keywords:
explanatory trials
pragmatic trials
PRECIS
randomized controlled trials
reporting guideline
SPIRIT
CONSORT
Consolidated Standards of Reporting Trials
EQUATOR
Enhancing the QUAlity and Transparency Of health Research
JBI
Joanna Briggs Institute
OSF
Open Science Framework
PRECIS-2
PRagmatic Explanatory Continuum Indicator Summary 2
PRECIS RCTs
pragmatic and explanatory randomized trials designed using the PRECIS tool
PRESS
Peer Review of Electronic Search Strategies
PRISMA-ScR
Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews
RCTs
Randomized Controlled Trials
REB
Research Ethics Board
SPIRIT
Standard Protocol Items: Recommendations for Intervention Trials
SPIRIT-PRECIS
Pragmatic and Explanatory Trial protocols designed using the PRECIS tool
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