SPIRIT 2025 statement: updated guideline for protocols of randomised trials

<h2>Summary</h2> 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. We aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. 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. 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. 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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Publication Details

Journal
The Lancet
Published
2025-04-28
DOI
https://doi.org/10.1016/s0140-6736(25)00770-6
Citations
43
Primary Topic
Meta-analysis and systematic reviews
Type
article
Field-Weighted Citation Impact
60.14
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article

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

R. Tunn, Rakesh Aggarwal, Martin Offringa, Lehana Thabane et al.
43 citations
The Lancet
Meta-analysis and systematic reviews
60.14
article

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

R. Tunn, Rakesh Aggarwal, Martin Offringa, 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, An‐Wen Chan, Elizabeth Loder, Runcie C.W. Chidebe, Kenneth F. Schulz, Diana Elbourne, Ian R. White, Steven N. Goodman, Professor Gary S. Collins, Andrew A. Farmer, Isabelle Boutron, Dean Fergusson, Steff Lewis, David Moher, Sarah E Lamb, John P. A. Ioannidis, Sunita Vohra, Nancy J. Butcher, David L. Schriger, Nandi Siegfried, Marion Campbell, Frank W. Rockhold, Tammy Hoffmann, Rachel L Knowles, David Torgerson, Asbjørn Hróbjartsson
article en
43 citations

Abstract

<h2>Summary</h2> 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. We aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. 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. 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. 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.

The LancetVol. 405(10491)
Rutgers, The State University of New Jersey (US), South African Medical Research Council (ZA), Northwestern University (US), University of North Carolina at Chapel Hill (US), Bond University (AU), Centers for Disease Control and Prevention (US), Harvard University (US), University of Alberta (CA), Inserm (FR), University of California, Los Angeles (US), University of Southern Denmark (DK), University of Toronto (CA), University of Aberdeen (GB), Université Paris Cité (FR), University of Exeter (GB), Great Ormond Street Hospital (GB), Ottawa Hospital (CA), Hospital for Sick Children (CA), Odense University Hospital (DK), Women's College Hospital (CA), University of Warwick (GB), Sorbonne Université (FR), University of Oxford (GB), Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR), Clinical Research Institute (US), London School of Hygiene & Tropical Medicine (GB), Université Sorbonne Paris Nord (FR), MRC Clinical Trials Unit at UCL (GB), Sorbonne Paris Cité (FR), Society for Applied Studies (IN), Assistance Publique – Hôpitaux de Paris (FR), Chief Scientist Office (GB), Centers for Disease Control and Prevention (UG), Robarts Clinical Trials (CA), MRC/CSO Social and Public Health Sciences Unit (GB), Open Invention Network (United States) (US), Duke Medical Center (US), NIHR Exeter Clinical Research Facility (GB), Hôtel-Dieu de Paris (FR), Stanford Medicine (US), Cochrane (DK), Centers for Disease Control and Prevention (KE), National Primary Health Care Development Agency (NG), Impact (CA), Ottawa Hospital Research Institute (CA), University College London (GB), University of York (GB), St. Joseph’s Healthcare Hamilton (CA), Jawaharlal Institute of Post Graduate Medical Education and Research (IN), British Medical Association (GB), Miami University (US), Medical Research Council (GB), Stanford University (US), McMaster University (CA), University of Edinburgh (GB)
Openalex Percentile: Top 0%
Meta-analysis and systematic reviews
60.14
DOIOpen Access PDFOpenAlex
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