SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
University of Southern Denmark · Odense University Hospital · +45 more institutions
Abstract
High quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information. The document is…
Citation impact
- FWCI
- 219.90
- Percentile
- 100%
- References
- 476
Authors
39- AHAsbjørn HróbjartssonCorresponding
University of Southern Denmark, Odense University 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
- Elaboration
- Guideline
- Computer science
- Alternative medicine
- Medicine
- Pathology
- Philosophy