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CONSORT 2025 statement: updated guideline for reporting randomised trials

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Sally Hopewell, An–Wen Chan, Gary S Collins, Asbȷorn Hrobȷartsson, David Moher, Kenneth F Schulz, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A Berlin, Nita Bhandari, Nancy J Butcher, Marion K Campbell, Runcie C W Chidebe, Diana Elbourne, Andrew 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 Torgerson, Sunita Vohra, Ian R White, Isabelle Boutron , 2025-04-14 22:00:00

Contents
AbstractIntroductionSummary pointsDecision to update the SPIRIT and CONSORT statementsDevelopment of CONSORT 2025Main changes to CONSORT 2025Summary of main changes in CONSORT 2025Addition of new checklist itemsCompletely revised checklist itemsDeletion of checklist itemIntegration of checklist items from key CONSORT extensionsStructure and organisation of checklist itemsScope of CONSORT 2025Implication and limitationsEthics statementsEthical approvalAcknowledgmentsFootnotes
  1. Sally Hopewell, professor1,
  2. An-Wen Chan, professor2,
  3. Gary S Collins, professor3,
  4. Asbjørn Hróbjartsson, professor4 5,
  5. David Moher, professor6,
  6. Kenneth F Schulz, professor7,
  7. Ruth Tunn, research fellow1,
  8. Rakesh Aggarwal, professor8,
  9. Michael Berkwits, director9,
  10. Jesse A Berlin, professor10 11,
  11. Nita Bhandari, senior scientist12,
  12. Nancy J Butcher, professor13 14,
  13. Marion K Campbell, professor15,
  14. Runcie C W Chidebe, researcher16 17,
  15. Diana Elbourne, professor18,
  16. Andrew Farmer, professor19,
  17. Dean A Fergusson, professor20,
  18. Robert M Golub, professor21,
  19. Steven N Goodman, professor22,
  20. Tammy C Hoffmann, professor23,
  21. John P A Ioannidis, professor24,
  22. Brennan C Kahan, principal research fellow25,
  23. Rachel L Knowles, principal research fellow26,
  24. Sarah E Lamb, professor27,
  25. Steff Lewis, professor28,
  26. Elizabeth Loder, professor29 30,
  27. Martin Offringa, professor13,
  28. Philippe Ravaud, professor31,
  29. Dawn P Richards, director of patient and public engagement32,
  30. Frank W Rockhold, professor33,
  31. David L Schriger, professor34,
  32. Nandi L Siegfried, professor35,
  33. Sophie Staniszewska, professor36,
  34. Rod S Taylor, professor37,
  35. Lehana Thabane, professor38 39,
  36. David Torgerson, professor40,
  37. Sunita Vohra, professor41,
  38. Ian R White, professor25,
  39. Isabelle Boutron, professor42 43

  1. 1Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK

  2. 2Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, ON, Canada

  3. 3UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK

  4. 4Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark

  5. 5Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark

  6. 6Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada

  7. 7Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

  8. 8Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

  9. 9Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, GA, USA

  10. 10Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, NJ, USA

  11. 11JAMA Network Open, Chicago, IL, USA

  12. 12Centre for Health Research and Development, Society for Applied Studies, New Delhi, India

  13. 13Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, ON, Canada

  14. 14Department of Psychiatry, University of Toronto, Toronto, ON, Canada

  15. 15Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK

  16. 16Project PINK BLUE – Health & Psychological Trust Centre, Utako, Abuja, Nigeria

  17. 17Department of Sociology and Gerontology, Miami University, OH, USA

  18. 18Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK

  19. 19Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

  20. 20Ottawa Hospital Research Institute, Ottawa, ON, Canada

  21. 21Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

  22. 22Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA, USA

  23. 23Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, QLD, Australia

  24. 24Departments 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

  25. 25MRC Clinical Trials Unit at University College London, London, UK

  26. 26University College London, UCL Great Ormond Street Institute of Child Health, London, UK

  27. 27NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK

  28. 28Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, UK

  29. 29The BMJ, BMA House, London, UK

  30. 30Harvard Medical School, Boston, MA, USA

  31. 31Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Paris, France

  32. 32Clinical Trials Ontario, MaRS Centre, Toronto, ON, Canada

  33. 33Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

  34. 34Department of Emergency Medicine, University of California, Los Angeles, CA, USA

  35. 35South African Medical Research Council, Cape Town, South Africa

  36. 36Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, UK

  37. 37MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK

  38. 38Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada

  39. 39St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada

  40. 40York Trials Unit, Department of Health Sciences, University of York, York, UK

  41. 41Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada

  42. 42Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France

  43. 43Centre d’Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France
  1. Correspondence to: S Hopewell sally.hopewell{at}csm.ox.ac.uk

Abstract

Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users.

Methods We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts.

Results We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item.

Conclusion Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

Introduction

“Readers should not have to infer what was probably done; they should be told explicitly.” Douglas G Altman 1

Randomised trials, when appropriately designed, conducted, analysed, and reported, are generally considered the highest quality evidence in evaluating healthcare interventions. Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are thoroughly and accurately reported. To interpret a trial accurately, readers need complete and transparent information on its methods and findings. However, extensive evidence displays that the completeness of reporting of randomised trials is inadequate23 and that incomplete reporting may be associated with biased estimates of intervention effects.4 Similarly, having a clear and transparent trial protocol is important because it prespecifies the methods used in the trial, such as the primary outcome, thereby reducing the likelihood of undeclared post hoc changes.5

Efforts to improve the reporting of randomised trials gathered impetus in the early 1990s and resulted in the Standardised Reporting of Trials (SORT) and Asilomar initiatives in 1994. Those initiatives then led to publication of the CONSORT (Consolidated Standards of Reporting Trials) statement in 1996,6 revised in 20017 with an accompanying explanation and elaboration document.8 CONSORT was then updated in 2010,9 along with an updated explanation and elaboration article.10 Similar problems related to the lack of complete and transparent reporting of trial protocols led to the development of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement, published in 2013,11 and its accompanying explanation and elaboration document12 explaining the principles underlying the statement.

CONSORT is endorsed by numerous journals worldwide and by prominent editorial organisations, including the World Association of Medical Editors (WAME), International Committee of Medical Journal Editors (ICMJE) and Council of Science Editors (CSE). The introduction of CONSORT within journals has been shown to be associated with improved quality of reports of randomised trials. Some evidence shows that journal endorsement of CONSORT is associated with better reporting and that reporting is improving over time.2131415 A Cochrane review of 50 evaluations of 16 604 trials assessed the association between journals’ endorsement of CONSORT and the reporting of trials they published; 25 of 27 CONSORT checklist items were more completely reported when a trial was published in a CONSORT endorsing as opposed to non-endorsing journal.214 However, a causal effect cannot be proven. At a minimum, CONSORT has sensitised many end users (eg, authors, journal editors, and peer reviewers) to how important careful and thorough reporting can be for randomised trials.

SPIRIT and CONSORT are evidence based guidelines that comprise a checklist of essential items that should be included in protocols and primary reports of completed randomised trials, respectively, and a diagram that documents the flow of participants through a trial. These statements provide guidance to authors on the minimum information that should be included in the reporting of trials to ensure that trial protocols and trial reports are clear and transparent. They are published alongside explanation and elaboration documents, which provide the meaning and rationale for each checklist item, examples of good reporting, and relevant empirical evidence where possible.

In January 2020, the SPIRIT and CONSORT executive groups met in Oxford, UK. As the SPIRIT and CONSORT statements are conceptually linked, with overlapping content and similar dissemination and implementation strategies, the two groups decided it was more effective to work together and formed one group.

Summary points

  • To interpret a randomised trial accurately, readers need complete and transparent information on its methods and findings

  • The CONSORT 2025 statement provides updated guidance for reporting the results of randomised trials, that reflects methodological advancements and feedback from end users

  • The CONSORT 2025 statement consists of a 30-item checklist of essential items, a diagram for documenting the flow of participants through the trial, and an expanded checklist that details the critical elements of each checklist item

  • Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent

Decision to update the SPIRIT and CONSORT statements

SPIRIT and CONSORT are living guidelines and it is vital that the statements are periodically updated to reflect new evidence, methodological advancements, and feedback from users; otherwise, their value and usefulness will diminish over time.16 Updating the SPIRIT 2013 and CONSORT 2010 statements together was also an opportunity to further align both checklists and to provide users with consistent guidance in the reporting of trial design, conduct, analysis, and results from trial protocol to final publication. Harmonising the reporting process should improve usability and adherence, and lead to more-complete reporting.17 Here, we introduce the updated CONSORT 2025 statement; the updated SPIRIT 2025 statement is published separately.18

Development of CONSORT 2025

The methods used to update the CONSORT statement followed the EQUATOR Network guidance for developers of health research guidelines19 and have been described in detail elsewhere.2021 In brief, we first conducted a scoping review of the literature to identify published comments suggesting modifications and additions or reflecting on strengths and challenges of CONSORT 2010, the findings of which have been published separately.22 We also developed a project specific database (SCEBdb) for empirical and theoretical evidence related to CONSORT and risk of bias in randomised trials.23 The evidence identified in the scoping review was combined with evidence from, and recommendations provided by the lead authors of, certain key existing CONSORT extensions whose checklist items apply to all trials (Harms,24 Outcomes25), or a considerable number of trials26 (Non-pharmacological Treatment27), other related reporting guidelines (the template for intervention description and replication (TIDieR)28), and recommendations from other sources (eg, personal communications).

Using the existing CONSORT 2010 checklist as the starting point, a list of potential modifications or additions to the checklists was then created using the gathered evidence from the scoping review and recommendations. This list of potential changes was presented to end users for feedback in a large international online Delphi survey, involving 317 participants who responded to round 1, 303 to round 2 and 290 to round 3. Delphi participants were identified through existing SPIRIT and CONSORT collaborations, and professional research networks and societies. Participants were also recruited via an expression of interest form on the SPIRIT-CONSORT update project website. A broad range of end user roles were represented, the most frequent being statisticians/methodologists/epidemiologists (n=198), systematic reviewers/guideline developers (n=73), trial investigators (n=73), clinicians (n=58), journal editors (n=47), and patient representatives (n=17) (numbers not mutually exclusive). During the three-round Delphi survey, participants were asked to rate on a 5-point Likert scale the extent to which they agreed with the inclusion of each item in the updated CONSORT checklist. Free text boxes were provided for comments on each item and to suggest additional new checklist items.

The Delphi survey results were then presented and discussed at a two-day online expert consensus meeting via Zoom, on 1 and 2 March 2023, attended by 30 invited international participants representing the different stakeholder groups included in the Delphi survey. During the meeting, each new and modified CONSORT checklist item was discussed and agreement sought. An anonymous poll via Zoom was used to help establish the level of support for items where the discussion indicated differing opinions; these polls were advisory and no formal consensus threshold was specified.

After the expert consensus meeting, the executive group held a two-day, in-person writing meeting in Oxford on 25 and 26 April 2023, where the format and wording of each new or modified CONSORT checklist item was reviewed and agreed on. The draft checklist was then circulated to consensus meeting participants to confirm whether they represented the group consensus or needed clarification. CONSORT items were further revised by the executive group in response to this feedback. The finalised items address the minimum content for inclusion in a trial report, although that should not deter prospective authors from including additional information that they deem important or that facilitates replication. Members of the executive group and the 30 invited consensus meeting participants are authors of the manuscript and their names are listed at the end of the manuscript.

Main changes to CONSORT 2025

We have made a number of substantive changes to the CONSORT 2025 checklist (see box 1). We have added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions (Harms,24 Outcomes,25 Non-pharmacological Treatment27) and other related reporting guidelines (TIDieR 28). We also restructured the CONSORT checklist, with a new section on open science, which includes items that are conceptually linked, such as trial registration (item 2), where the trial protocol and statistical analysis plan can be accessed (item 3), sharing of de-identified participant level data (item 4), and funding and conflicts of interest (item 5). We have also harmonised the wording between CONSORT and SPIRIT checklist items and clarified and simplified the wording of some items. For a detailed comparison of the changes made in the CONSORT 2025 checklist from CONSORT 2010, see appendix 1. We have also updated the CONSORT explanation and elaboration document,29 which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting.

Box 1

Summary of main changes in CONSORT 2025

Addition of new checklist items

  • Item 4: added item on data sharing, including where and how individual de-identified participant data, statistical code, and any other materials can be accessed.

  • Item 5b: added item on financial and other conflicts of interest of manuscript authors.

  • Item 8: added item on how patients and/or the public were involved in the design, conduct, and/or reporting of the trial.

  • Item 12b: added item on eligibility criteria for sites and for individuals delivering the interventions, where applicable

  • Item 15: added item on how harms and other unintended effects were assessed.

  • Item 21: added items to define who is included in each analysis (eg, all randomised participants) and in which group (item 21b), and how missing data were handled in the analysis (item 21c).

  • Item 24: added item on intervention delivery, including how the intervention and comparator were actually administered (item 24a) and details of concomitant care received during the trial (item 24b).

Completely revised checklist items

  • Item 3: revised item to include where the statistical analysis plan can be accessed in addition to the trial protocol.

  • Item 10: revised item to include reporting of important changes to the trial after it commenced, including any outcomes or analyses that were not prespecified.

  • Item 26: revised item to specify for each primary and secondary outcome—the number of participants included in the analysis and the number of participants with available data at each time point for each treatment group.

Deletion of checklist item

Integration of checklist items from key CONSORT extensions

  • Addition of items related to reporting of how harms24 were assessed and analysed (items 7, 15, 21a, 23a, 27), how outcomes25 were measured and analysed (items 14, 26), and how the intervention2728 and comparator were actually administered and by whom (item 24).

Structure and organisation of checklist items

  • Restructuring of checklist, with a new section on open science, which includes items that are conceptually linked such as trial registration (item 2), where the trial protocol and statistical analysis plan can be accessed (item 3), sharing of de-identified participant level data (item 4), and funding and conflicts of interest (item 5).

  • Aligned wording of some CONSORT checklist items with that of SPIRIT checklist items and vice versa.

  • Clarified and simplified wording of some items.

RETURN TO TEXT

To help facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. This is similar to the model proposed by the COBWEB (CONSORT-based web tool)30 and COBPeer (CONSORT based peer review tool)31 studies and used in the 2020 PRISMA guidance for reporting systematic reviews.32 The expanded checklist comprises an abridged version of elements presented in the CONSORT 2025 explanation and elaboration document,29 with examples and references removed (see appendix 2).

Scope of CONSORT 2025

The CONSORT 2025 statement comprises a 30-item checklist and provides a minimum set of items to be included in a report of a randomised trial (table 1) and a diagram for documenting the flow of participants through a trial (fig 1). We strongly recommend the CONSORT 2025 statement be used alongside the CONSORT 2025 explanation and elaboration document.29 The CONSORT 2025 statement supersedes the CONSORT 2010 statement, which should no longer be used. Journal editors and publishers should update their instructions to authors to refer to CONSORT 2025. CONSORT 2025 provides guidance for reporting all randomised trials but focuses on the most common type, the two-group parallel design.

Table 1

CONSORT 2025 checklist of information to include when reporting a randomised trial

Fig 1
Fig 1

CONSORT 2025 flow diagram. Flow diagram of the progress through the phases of a randomised trial of two groups (ie, enrolment, intervention allocation, follow-up, and data analysis). CONSORT=Consolidated Standards of Reporting Trials

Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions. Examples of extensions for trial designs include recommendations for adaptive designs,33 cluster trials,34 crossover trials,35 early phase trials,36 factorial trials,37 non-inferiority and equivalence trials,38 pragmatic trials,39 multi-arm trials,40 n-of-1 trials,41 pilot and feasibility trials,42 and within-person trials.43 Other extensions include non-pharmacological treatments,27 outcomes,25 patient reported outcomes,44 surrogate outcomes,45 social and psychological interventions,46 harms,24 abstracts,47 and health equity.48 We will engage with the leaders of these extensions to implement a process for aligning them with the updated CONSORT 2025 statement. In the meantime, we recommend that readers use the existing version of the relevant CONSORT extension(s).

Implication and limitations

The objective of the CONSORT 2025 statement is to provide a minimum set of recommendations to authors about the content they should include in order to report their trials in a clear, complete, and transparent manner.910 Readers, peer reviewers, clinicians, guideline writers, patients and the public, and editors can also use CONSORT 2025 to help them appraise the reporting of randomised trials. We also strongly recommend the submission of a completed CONSORT 2025 checklist as part of the manuscript submission process, detailing where in the manuscript checklist items are reported, and uploaded as part of the supplementary materials.49 An explicit description of what was done and what was found, without ambiguity or omission, best serves the interests of all readers.9

It is important to note that CONSORT 2025 and SPIRIT 2025 do not include recommendations for designing, conducting, or analysing trials, but nevertheless the recommendations contained here can help researchers in the design, conduct, and analysis of their trial by highlighting key issues to consider. Updating the SPIRIT and CONSORT statements together was also an opportunity to align reporting in both checklists and to provide users with consistent guidance in the reporting of trial design, conduct, and analysis, from the trial protocol to final publication.17 Thus, clear and transparent reports of trial protocols should in turn facilitate properly designed and well conducted trials. In addition, transparent reporting of trial results can reveal deficiencies in research if they exist and allow better estimates of their prevalence and severity. Importantly, however, CONSORT 2025 is not meant to be used as a quality assessment instrument. Rather, the content of CONSORT 2025 focuses on reporting items related to the internal and external validity of randomised trials.

With CONSORT 2025, we do not suggest a rigid structure for the reporting of randomised trials. Instead, the format of articles should abide by the journal’s individual style and its “Instructions to Authors.” Authors should address checklist items somewhere in the article, with sufficient detail and clarity.9 We also promote the use of additional online supplementary material to allow for more detailed reporting of the trial methods and results than may be permissible within the typical length of some print journal articles. Full data and code sharing offers another, higher level of transparency and we recommend providing detailed information on whether this is happening or planned to happen (eg, after some time) in a randomised trial.

CONSORT urges clarity and transparency of reporting which reflects the actual trial design, conduct, and analysis. High quality reporting is an important step when considering issues related to reproducibility.50 We encourage trial authors to detail what was done and to acknowledge if something was not done or was modified, ensuring alignment of information with that reported in the trial protocol, statistical analysis plan, and trial registry. A joint SPIRIT-CONSORT website (https://www.consort-spirit.org/) has been established to provide more information about the CONSORT and SPIRIT statements, including additional resources and training materials aimed at researchers, research trainees, journal editors, and peer reviewers. The website also includes resources aimed at patients and the public that explain the importance of clear and transparent reporting of randomised trials and their importance in the delivery of evidence based healthcare.

CONSORT 2025 represents a living guideline that will continue to be periodically updated to reflect new evidence and emerging perspectives. Such an approach is important to ensure the guidance remains relevant to end users, including authors, patients and the public, journal editors, and peer reviewers.

Ethics statements

Ethical approval

Ethical approval was granted by the Central University Research Ethics Committee, University of Oxford (R76421/RE001). All Delphi participants provided informed consent to participate.

Acknowledgments

SPIRIT-CONSORT executive group: Sally Hopewell, University of Oxford, UK; An-Wen Chan, University of Toronto, Canada; Asbjørn Hróbjartsson, University of Southern Denmark, Odense, Denmark; David Moher, University of Ottawa, Canada; Kenneth Schulz, University of North Carolina at Chapel Hill, USA; Isabelle Boutron, Université Paris Cité, France. Gary Collins and Ruth Tunn, both of University of Oxford, UK, were also involved in leading the SPIRIT and CONSORT 2025 update.

SPIRIT-CONSORT 2025 consensus meeting participants: Rakesh Aggarwal, Jawaharlal Institute of Postgraduate Medical Education and Research, India; Michael Berkwits, Office of the Centers for Disease Control and Prevention, USA (formally JAMA and the JAMA Network at time of consensus meeting); Jesse A Berlin, Rutgers University/JAMA Network Open USA; Nita Bhandari, Society for Applied Studies, India; Nancy J Butcher, The Hospital for Sick Children, Canada; Marion K Campbell, University of Aberdeen, UK; Runcie CW Chidebe, Project PINK BLUE, Nigeria/Miami University, Ohio, USA; Diana Elbourne, London School of Hygiene and Tropical Medicine, UK; Andrew J Farmer, University of Oxford, UK; Dean A Fergusson, Ottawa Hospital Research Institute, Canada; Robert M Golub, Northwestern University, USA; Steven N Goodman, Stanford University, USA; Tammy C Hoffmann, Bond University, Australia; John PA Ioannidis, Stanford University, USA; Brennan C Kahan, University College London, UK; Rachel L Knowles, University College London, UK; Sarah E Lamb, University of Exeter, UK; Steff Lewis, University of Edinburgh, UK; Elizabeth Loder, The BMJ, UK; Martin Offringa, Hospital for Sick Children Research Institute, Canada; Dawn P Richards, Clinical Trials Ontario, Canada; Frank W Rockhold, Duke University, USA; David L Schriger, University of California, USA; Nandi L Siegfried, South African Medical Research Council, South Africa; Sophie Staniszewska, University of Warwick, UK; Rod S Taylor, University of Glasgow, UK; Lehana Thabane, McMaster University/St Joseph’s Healthcare, Canada; David Torgerson, University of York, UK; Sunita Vohra, University of Alberta, Canada; and Ian R White, University College London, UK.

We dedicate CONSORT 2025 to the late Doug Altman who was instrumental in the development of the SPIRIT and CONSORT statements and whose files and correspondence contributed to this update following his death. We gratefully acknowledge the contributions of all those who participated in the SPIRIT-CONSORT 2025 update Delphi survey. We also acknowledge Camilla Hansen Nejstgaard for conducting the scoping review of the literature to identify suggested changes to CONSORT 2010 and for comparing CONSORT 2025 with RoB2, Lasse Østengaard for developing the SCEB (SPIRIT-CONSORT Evidence Bibliographic) database of empirical evidence to support the development of CONSORT, Jen de Bayer and Patricia Logullo for their involvement during the consensus meeting, and Lina El Ghosn for initial drafting of the expanded CONSORT checklist. The CONSORT 2025 statement is being simultaneously published in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine.

Footnotes

  • Contributors: SH, IB, A-WC, AH, KFS, and DM were responsible for the concept; SH, IB, A-WC, GSC, AH, KFS, and DM were responsible for the funding. SH, IB, A-WC, GSC, AH, KFS, RT, and DM drafted specific sections of the manuscript. All authors then critically revised the manuscript for important intellectual content and approved the final version. SH is the guarantor of this work. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: The 2025 update of SPIRIT and CONSORT was funded by the MRC-NIHR: Better Methods, Better Research (MR/W020483/1). The funder reviewed the design of the study but had no role in the collection, analysis, or interpretation of the data; in the writing of the report; or in the decision to submit the article for publication. The views expressed are those of the author(s) and not necessarily those of the NIHR, the MRC, or the Department of Health and Social Care.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/conflicts-of-interest/ and declare: 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, a statistical editor for The BMJ and NIHR Senior Investigator, 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. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. DLS is JAMA associate editor and receives editing stipends from JAMA and Annals of Emergency Medicine.

  • Patient and public involvement: The CONSORT 2025 checklist items and the explanations here were developed using input from an international Delphi survey and consensus meeting. The Delphi survey was advertised via established patient and public involvement (PPI) networks, and 17 respondents self-identified as a “patient or public representative” and completed the Delphi survey. In addition, three of the participants in the expert consensus meeting were patient or public representatives who were leaders in advancing PPI.

  • Dissemination to participants and related patient and public communities: CONSORT 2025 will be disseminated via a new website, consort-spirit.org, which will include materials designed for patients and the public.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

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