SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

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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UNC Libraries
Published
2025-05-02
DOI
https://doi.org/10.17615/y7ag-b051
Primary Topic
Meta-analysis and systematic reviews
Type
article
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0.00

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article

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

R. Tunn, Rakesh Aggarwal, Lehana Thabane, Robert Golub et al.
UNC Libraries
Meta-analysis and systematic reviews
article

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

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

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.

UNC Libraries
University of North Carolina at Chapel Hill (US)
University of Miami, Northwestern University, University of Ottawa, Ottawa Hospital Research Institute, London School of Hygiene and Tropical Medicine, McMaster University, Bond University, University of Alberta, National Institute for Health and Care Research, University of Exeter, University of Warwick, University College London, University of Oxford, University of Glasgow, University of Aberdeen, South African Medical Research Council, University of Toronto, Hospital for Sick Children, Syddansk Universitet, Jawaharlal Institute Of Postgraduate Medical Education and Research, Centers for Disease Control and Prevention, University of North Carolina at Chapel Hill, Medical Research Council
Openalex Percentile: Top 66%
Meta-analysis and systematic reviews
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