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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.

Publication ,  Journal Article
Hróbjartsson, A; Boutron, I; Hopewell, S; Moher, D; Schulz, KF; Collins, GS; Tunn, R; Aggarwal, R; Berkwits, M; Berlin, JA; Bhandari, N ...
Published in: BMJ
April 28, 2025
Published version (DOI) Link to item

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 intended to be used in conjunction with the SPIRIT 2025 statement and serves as a resource for researchers planning a trial and for others interested in trial protocols.

Duke Scholars

Frank Wesley Rockhold
Author Frank Wesley Rockhold Biostatistics & Bioinformatics, Division of Biostatistics

Published In

BMJ

DOI

10.1136/bmj-2024-081660

EISSN

1756-1833

Publication Date

April 28, 2025

Volume

389

Start / End Page

e081660

Location

England

Related Subject Headings

  • General & Internal Medicine
  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences
 

Citation

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Chicago
ICMJE
MLA
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Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., … Chan, A.-W. (2025). SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. BMJ, 389, e081660. https://doi.org/10.1136/bmj-2024-081660
Hróbjartsson, Asbjørn, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F. Schulz, Gary S. Collins, Ruth Tunn, et al. “SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.” BMJ 389 (April 28, 2025): e081660. https://doi.org/10.1136/bmj-2024-081660.
Hróbjartsson A, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, et al. SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081660.
Hróbjartsson, Asbjørn, et al. “SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.” BMJ, vol. 389, Apr. 2025, p. e081660. Pubmed, doi:10.1136/bmj-2024-081660.
Hróbjartsson A, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Chan A-W. SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081660.

Published In

BMJ

DOI

10.1136/bmj-2024-081660

EISSN

1756-1833

Publication Date

April 28, 2025

Volume

389

Start / End Page

e081660

Location

England

Related Subject Headings

  • General & Internal Medicine
  • 52 Psychology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences