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

Asbjørn 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

Asbjørn 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

Research output: Contribution to journal › Article › Research › peer-review

19 Citations (Scopus)

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
Pages (from-to)	1-65
Number of pages	65
Journal	BMJ (Clinical research ed.)
Volume	389
DOIs	https://doi.org/10.1136/bmj-2024-081660
Publication status	Published - 28 Apr 2025

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10.1136/bmj-2024-081660Licence: CC BY

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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 (Clinical research ed.), 389, 1-65. Article e081660. https://doi.org/10.1136/bmj-2024-081660

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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.",

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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 (Clinical research ed.), vol. 389, e081660, pp. 1-65. https://doi.org/10.1136/bmj-2024-081660

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AU - Hróbjartsson, Asbjørn

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

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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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DO - 10.1136/bmj-2024-081660

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C2 - 40294956

SN - 0959-535X

VL - 389

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EP - 65

JO - BMJ (Clinical research ed.)

JF - BMJ (Clinical research ed.)

M1 - e081660

ER -

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

Abstract

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CONSORT 2025 statement: updated guideline for reporting randomised trials

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

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

Abstract

Access to Document

Other files and links

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Related Research Outputs

CONSORT 2025 statement: updated guideline for reporting randomised trials

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials

Cite this