SPIRIT 2025 statement: updated guideline for protocols of randomised trials

作者：An‐Wen Chan, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F. Schulz, Professor Gary S. Collins, R. Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A. Berlin, Nita Bhandari, Nancy J. Butcher, Marion Campbell, Runcie C.W. Chidebe, Diana R. Elbourne, Andrew A. Farmer, Dean A. Fergusson, Robert M. Golub, Steven N. Goodman, Tammy Hoffmann, John P. A. Ioannidis, Brennan C Kahan, Rachel Louise Knowles, Sarah E Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi Louise Siegfried, Sophie H. Staniszewska, R. S. Taylor, Lehana Thabane, David John Torgerson, Sunita Vohra, Ian R. White, Asbjørn Hróbjartsson · 发表于：BMJ · 年份：2025 · DOI：10.1136/bmj-2024-081477 · 被引用次数：403 · 研究领域：Meta-analysis and systematic reviews、Ethics in Clinical Research、Health Policy Implementation Science

IMPORTANCE: The protocol of a randomised 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. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other rel...