Evidence map›Paper›PMID 40295741›Full record

ReviewNature medicine2025

SPIRIT 2025 statement: updated guideline for protocols of randomized trials.

An-Wen Chan, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F Schulz, Gary S Collins, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A Berlin and 29 more

2 registry-linked trialsAbstract readReview
PubMed Publisher
In one paragraph

Review in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 90 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07621042 nanot yet recruitingnot on this mapstarted 2027, after this paper: background citation

Effect of Brief Breathwork and Mindfulness Interventions on Anxiety, Psychological Flexibility and Physiological Variables in Spanish-Speaking University Students: a Four-Arm Randomized Controlled Trial

TypeinterventionalSponsorValencian International University (VIU)Ran2027 to 2027Enrolled240ConditionsAnxiety, Psychological Flexibility, StressArmsBox Breathing, Cyclic Sighing, Mindfulness AH Exhalation, Mindful Cyclic Sighing
NCT07755839 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors

TypeinterventionalSponsorAveiro UniversityRan2026 to 2028Enrolled60ConditionsCancer-related Cognitive Impairment, Cancer-related Cognitive Dysfunction, Cancer-related Cognitive Difficulties, Depression and Anxiety SymptomsArmsCanCOG® - Cogntive Rehabilitation in Cancer
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 1 synthesis or guideline pooled it.

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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

An-Wen ChanDepartment of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada. anwen.chan@utoronto.ca.
Isabelle BoutronUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.ORCID http://orcid.org/0000-0002-5263-6241
Sally HopewellOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6881-6984
David MoherCentre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0003-2434-4206
Kenneth F SchulzDepartment of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Gary S CollinsUK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2772-2316
Ruth TunnOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-1187-1808
Rakesh AggarwalJawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.ORCID http://orcid.org/0000-0001-9689-494X
Michael BerkwitsOffice of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jesse A BerlinDepartment of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA.
Nita BhandariCentre for Health Research and Development, Society for Applied Studies, New Delhi, India.ORCID http://orcid.org/0000-0003-0349-087X
Nancy J ButcherChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Marion K CampbellAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.ORCID http://orcid.org/0000-0001-5386-4097
Runcie C W ChidebeProject PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.ORCID http://orcid.org/0000-0002-6025-776X
Diana R ElbourneDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Andrew J FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6170-4402
Dean A FergussonOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Robert M GolubDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Steven N GoodmanDepartment of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA.
Tammy C HoffmannInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia.ORCID http://orcid.org/0000-0001-5210-8548
John P A IoannidisDepartments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.ORCID http://orcid.org/0000-0003-3118-6859
Brennan C KahanMRC Clinical Trials Unit at University College London, London, UK.
Rachel L KnowlesUniversity College London, UCL Great Ormond Street Institute of Child Health, London, UK.ORCID http://orcid.org/0000-0002-5490-7682
Sarah E LambNIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
Steff LewisEdinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh, UK.
Elizabeth LoderThe BMJ, BMA House, London, UK.
Martin OffringaChild Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-4402-5299
Philippe RavaudUniversité Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France.ORCID http://orcid.org/0000-0001-8264-9206
Dawn P RichardsClinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada.
Frank W RockholdDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.ORCID http://orcid.org/0000-0003-3732-4765
David L SchrigerDepartment of Emergency Medicine, University of California, Los Angeles, CA, USA.
Nandi L SiegfriedSouth African Medical Research Council, Cape Town, South Africa.ORCID http://orcid.org/0000-0002-4081-1698
Sophie StaniszewskaWarwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK.
Rod S TaylorMRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-3043-6011
Lehana ThabaneDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
David J TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Sunita VohraFaculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Ian R WhiteMRC Clinical Trials Unit at University College London, London, UK.
Asbjørn HróbjartssonCentre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The protocol of a randomized 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. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized 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 enrollment, 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.

Indexed as

Guidelines as TopicRandomized Controlled Trials as TopicResearch DesignChecklistConsensusDelphi TechniqueHumans

Identifiers

PMID40295741

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.