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. 2025 Apr 28;22(4):e1004589.
doi: 10.1371/journal.pmed.1004589. eCollection 2025 Apr.

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

An-Wen Chan  1 , Isabelle Boutron  2   3 , Sally Hopewell  4 , David Moher  5 , Kenneth F Schulz  6 , Gary S Collins  7 , Ruth Tunn  4 , Rakesh Aggarwal  8 , Michael Berkwits  9 , Jesse A Berlin  10   11 , Nita Bhandari  12 , Nancy J Butcher  13   14 , Marion K Campbell  15 , Runcie C W Chidebe  16   17 , Diana R Elbourne  18 , Andrew J Farmer  19 , Dean A Fergusson  20 , Robert M Golub  21 , Steven N Goodman  22 , Tammy C Hoffmann  23 , John P A Ioannidis  24 , Brennan C Kahan  25 , Rachel L Knowles  26 , Sarah E Lamb  27 , Steff Lewis  28 , Elizabeth Loder  29   30 , Martin Offringa  13 , Philippe Ravaud  31 , Dawn P Richards  32 , Frank W Rockhold  33 , David L Schriger  34 , Nandi L Siegfried  35 , Sophie Staniszewska  36 , Rod S Taylor  37 , Lehana Thabane  38   39 , David J Torgerson  40 , Sunita Vohra  41 , Ian R White  25 , Asbjørn Hróbjartsson  42   43
Affiliations

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

An-Wen Chan et al. PLoS Med. .

Abstract

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 relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document.

Conclusions and relevance: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: support from MRC-NIHR for the submitted work; SH, IB, A-WC, AH, KFS, and DM are members of the SPIRIT-CONSORT executive group. SH, IB, A-WC, AH, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre and a statistical editor for The BMJ, DM is the director of the Canadian EQUATOR Centre, and member of The BMJ’s regional advisory board for North America, IB is deputy director and PR is director of the French EQUATOR Centre, TCH is director of the Australasian EQUATOR Centre, JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE which receives funding from Roche-Product. AF is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement; and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. DLS is JAMA Associate Editor and receives editing stipends from JAMA and Annals of Emergency Medicine. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09.

Figures

Fig 1
Fig 1. SPIRIT 2025 diagram of the schedule of enrolment, interventions, and assessments.
Recommended content can be displayed using various schematic formats. *List target time points and acceptable time windows in this row (e.g., 30 ± 3 days). †Arrow indicates continuous delivery of intervention (e.g., drug). ‡Example illustrates delivery of comparator at discrete time points (e.g., psychotherapy).
See this image and copyright information in PMC

Comment in

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