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

Asbjorn Hróbjartsson; Isabelle Boutron; Sally Hopewell; David Moher; Kenneth F. Schulz; Gary S. Collins; Ruth Tunn; Rakesh Aggarwal; Michael Berkwits; Jesse A. Berlin; Nita Bhandari; Nancy J. Butcher; Marion K. Campbell; Runcie C. W. Chidebe; Diana R. Elbourne; Andrew J. Farmer; Dean A. Fergusson; Robert M. Golub; Steven N. Goodman; Tammy C. Hoffmann; John P. A. Ioannidis; Brennan C. Kahan; Rachel L. Knowles; Sarah E. Lamb; Steff Lewis; Elizabeth Loder; Martin Offringa; Philippe Ravaud; Dawn P. Richards; Frank W. Rockhold; David L. Schriger; Nandi L. Siegfried; Sophie Staniszewska; Rod S. Taylor; Lehana Thabane; David J. Torgerson; Sunita Vohra; Ian R. White; An-Wen Chan

doi:10.1136/bmj-2024-081660

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

Asbjorn Hróbjartsson^*
, Isabelle Boutron
, Sally Hopewell
, David Moher
, Kenneth F. Schulz
, Gary S. Collins
, Ruth Tunn
, Rakesh Aggarwal
, Michael Berkwits
, Jesse A. Berlin
, Nita Bhandari
, Nancy J. Butcher
, Marion K. Campbell
, Runcie C. W. Chidebe
, Diana R. Elbourne
, Andrew J. Farmer
, Dean A. Fergusson
, Robert M. Golub
, Steven N. Goodman
, Tammy C. Hoffmann

John P. A. Ioannidis, Brennan C. Kahan, Rachel L. Knowles, Sarah E. Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P. Richards, Frank W. Rockhold, David L. Schriger, Nandi L. Siegfried, Sophie Staniszewska, Rod S. Taylor, Lehana Thabane, David J. Torgerson, Sunita Vohra, Ian R. White, An-Wen Chan

^*Corresponding author for this work

Neonatology

University of Southern Denmark
Centre de Recherche Epidémiologiques et Bio Statistiques de Sorbonne Paris Cité (CRESS)
Hôpital Hotel-Dieu AP-HP
University of Oxford
University of Ottawa
University of North Carolina at Chapel Hill
Jawaharlal Institute of Postgraduate Medical Education and Research
American Medical Association
Rutgers School of Public Health
Society for Applied Studies Kolkata
University of Toronto
University of Aberdeen
Project PINK BLUE - Health & Psychological Trust Centre
Miami University
London School of Hygiene and Tropical Medicine
Northwestern University
Stanford University
Bond University
University College London
University of Exeter
University of Edinburgh
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Harvard University
MaRS Centre
Duke University
University of California at Los Angeles
South African Medical Research Council
University of Warwick
University of Glasgow
McMaster University
St. Joseph's Healthcare Hamilton
University of York
University of Alberta

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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 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.

Original language	English
Article number	e081660
Journal	BMJ
Volume	389
Early online date	2025
DOIs	https://doi.org/10.1136/bmj-2024-081660
Publication status	Published - 2025

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Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D. R., Farmer, A. J., Fergusson, D. A., Golub, R. M., Goodman, S. N., ... Chan, A.-W. (2025). SPIRIT 2025 explanation and elaboration: Updated guideline for protocols of randomised trials. BMJ, 389, Article e081660. https://doi.org/10.1136/bmj-2024-081660

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title = "SPIRIT 2025 explanation and elaboration: Updated guideline for protocols of randomised trials",

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 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.",

author = "Asbjorn Hr{\'o}bjartsson and Isabelle Boutron and Sally Hopewell and David Moher and Schulz, \{Kenneth F.\} and Collins, \{Gary S.\} and Ruth Tunn and Rakesh Aggarwal and Michael Berkwits and Berlin, \{Jesse A.\} and Nita Bhandari and Butcher, \{Nancy J.\} and Campbell, \{Marion K.\} and Chidebe, \{Runcie C. W.\} and Elbourne, \{Diana R.\} and Farmer, \{Andrew J.\} and Fergusson, \{Dean A.\} and Golub, \{Robert M.\} and Goodman, \{Steven N.\} and Hoffmann, \{Tammy C.\} and Ioannidis, \{John P. A.\} and Kahan, \{Brennan C.\} and Knowles, \{Rachel L.\} and Lamb, \{Sarah E.\} and Steff Lewis and Elizabeth Loder and Martin Offringa and Philippe Ravaud and Richards, \{Dawn P.\} and Rockhold, \{Frank W.\} and Schriger, \{David L.\} and Siegfried, \{Nandi L.\} and Sophie Staniszewska and Taylor, \{Rod S.\} and Lehana Thabane and Torgerson, \{David J.\} and Sunita Vohra and White, \{Ian R.\} and An-Wen Chan",

year = "2025",

doi = "10.1136/bmj-2024-081660",

language = "English",

volume = "389",

journal = "BMJ",

issn = "0959-8146",

publisher = "British Medical Association",

}

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 2025, 'SPIRIT 2025 explanation and elaboration: Updated guideline for protocols of randomised trials', BMJ, vol. 389, e081660. https://doi.org/10.1136/bmj-2024-081660

TY - JOUR

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T2 - Updated guideline for protocols of randomised trials

AU - Hróbjartsson, Asbjorn

AU - Boutron, Isabelle

AU - Hopewell, Sally

AU - Moher, David

AU - Schulz, Kenneth F.

AU - Collins, Gary S.

AU - Tunn, Ruth

AU - Aggarwal, Rakesh

AU - Berkwits, Michael

AU - Berlin, Jesse A.

AU - Bhandari, Nita

AU - Butcher, Nancy J.

AU - Campbell, Marion K.

AU - Chidebe, Runcie C. W.

AU - Elbourne, Diana R.

AU - Farmer, Andrew J.

AU - Fergusson, Dean A.

AU - Golub, Robert M.

AU - Goodman, Steven N.

AU - Hoffmann, Tammy C.

AU - Ioannidis, John P. A.

AU - Kahan, Brennan C.

AU - Knowles, Rachel L.

AU - Lamb, Sarah E.

AU - Lewis, Steff

AU - Loder, Elizabeth

AU - Offringa, Martin

AU - Ravaud, Philippe

AU - Richards, Dawn P.

AU - Rockhold, Frank W.

AU - Schriger, David L.

AU - Siegfried, Nandi L.

AU - Staniszewska, Sophie

AU - Taylor, Rod S.

AU - Thabane, Lehana

AU - Torgerson, David J.

AU - Vohra, Sunita

AU - White, Ian R.

AU - Chan, An-Wen

PY - 2025

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AB - 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.

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U2 - 10.1136/bmj-2024-081660

DO - 10.1136/bmj-2024-081660

M3 - Article

C2 - 40294956

SN - 0959-8146

VL - 389

JO - BMJ

JF - BMJ

M1 - e081660

ER -

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

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