SPIRIT 2025 Statement
University of Toronto · Women's College Hospital · +47 more institutions
Abstract
Importance: The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. Observations: We completed a scoping…
Citation impact
- FWCI
- 62.56
- Percentile
- 100%
- References
- 51
Authors
39- ACAn-Wen ChanCorresponding
University of Toronto, Women's College Hospital
- IBIsabelle Boutron
Inserm, Université Paris Cité, Sorbonne Université, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université Sorbonne Paris Nord, Sorbonne Paris Cité, Assistance Publique – Hôpitaux de Paris, Hôtel-Dieu de Paris, Centre de Recherche Épidémiologie et Statistique
- SHSally Hopewell
University of Oxford
- DMDavid Moher
Ottawa Hospital, Ottawa Hospital Research Institute
- KFKenneth F. Schulz
University of North Carolina at Chapel Hill
Topics & keywords
- Checklist
- Medicine
- Protocol (science)
- Consolidated Standards of Reporting Trials
- Delphi method
- Randomized controlled trial
- Psychological intervention
- Delphi