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Protocol for a CONSORT extension for reporting Pragmatic and Explanatory trials designed using the PRECIS tool. (CONSORT-PRECIS)
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DOI：10.1016/j.jclinepi.2026.112379.png)
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Abstract
En 中文
• Transparent reporting of completed randomized clinical trials, including clarity about their intention and the alignment of design choices with that intention, is essential for maximizing their value to the scientific, healthcare, and patient and public communities. • However, the latest guideline for the reporting of trials with pragmatic intentions is CONSORT extension for pragmatic trials was published in 2008, requiring a mid-career update to incorporate new evidence when reporting these trials. • In this study, we rename CONSORT extension for pragmatic trials to CONSORT extension for reporting Pragmatic and Explanatory trials designed using the PRECIS tool (CONSORT-PRECIS) to accommodate the expanded understanding of pragmatism and explanatoriness and to help authors enhance their attention when reporting these trials.
Keywords:
CONSORT
explanatory trials
pragmatic trials
PRECIS
randomized controlled trials
reporting guideline
CONSORT
Consolidated Standards of Reporting Trials
CONSORT-PRECIS
RCTs with declared pragmatic or explanatory intention designed using the PRECIS tool
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
PRESS
Peer Review of Electronic Search Strategies
PRISMA-ScR
Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews
PRECIS RCTs
pragmatic and explanatory randomized trials designed using the PRECIS tool
RCTs
Randomized Controlled Trials
REB
Research Ethics Board
SPIRIT
Standard Protocol Items: Recommendations for Intervention Trials
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