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Research, Methods, Statistics

Guidelines for Reporting Outcomes in Trial ReportsThe CONSORT-Outcomes 2022 Extension

To identify the key insights or developments described in this article
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JAMA
Published Online: December 13, 2022
Special Communication
Nancy J. Butcher, PhD1,2;
Andrea Monsour, MPH1;
Emma J. Mew, MPH, MPhil1,3;
An-Wen Chan, MD, DPhil4;
David Moher, PhD5,6;
Evan Mayo-Wilson, DPhil7;
Caroline B. Terwee, PhD8,9;
Alyssandra Chee-A-Tow, MPH1;
Ami Baba, MRes1;
Frank Gavin, MA10;
Jeremy M. Grimshaw, MBCHB, PhD11,12;
Lauren E. Kelly, PhD13,14;
Leena Saeed, BSc, BEd1;
Lehana Thabane, PhD15;
Lisa Askie, PhD16;
Maureen Smith, MEd17;
Mufiza Farid-Kapadia, MD, PhD1;
Paula R. Williamson, PhD18;
Peter Szatmari, MD19,20;
Peter Tugwell, MD6,12,21,22;
Robert M. Golub, MD23;
Suneeta Monga, MD2,20;
Sunita Vohra, MD24;
Susan Marlin, MSc25,26;
Wendy J. Ungar, MSc, PhD1,27;
Martin Offringa, MD, PhD1,27,28
Author Affiliations
  • 1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
  • 2Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
  • 3Department of Chronic Disease Epidemiology, School of Public Health, Yale University, New Haven, Connecticut
  • 4Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, Ontario, Canada
  • 5Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  • 6School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
  • 7Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
  • 8Amsterdam University Medical Centers, Vrije Universiteit, Department of Epidemiology and Data Science, Amsterdam, the Netherlands
  • 9Department of Methodology, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
  • 10public panel member, Toronto, Ontario, Canada
  • 11Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  • 12Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  • 13Department of Pharmacology and Therapeutics, University of Manitoba, Winnipeg, Canada
  • 14Children’s Hospital Research Institute of Manitoba, Winnipeg, Canada
  • 15Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  • 16NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
  • 17patient panel member, Ottawa, Ontario, Canada
  • 18MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, England
  • 19Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  • 20Department of Psychiatry, The Hospital for Sick Children, Toronto, Ontario, Canada
  • 21Bruyère Research Institute, Ottawa, Ontario, Canada
  • 22Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  • 23Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
  • 24Departments of Pediatrics and Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada
  • 25Clinical Trials Ontario, Toronto, Canada
  • 26Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada
  • 27Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada
  • 28Division of Neonatology, The Hospital for Sick Children, Toronto, Ontario, Canada
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  • Special Communication
    Guidelines for Reporting Outcomes in Trial Protocols
    Nancy J. Butcher, PhD; Andrea Monsour, MPH; Emma J. Mew, MPH, MPhil; An-Wen Chan, MD, DPhil; David Moher, PhD; Evan Mayo-Wilson, DPhil; Caroline B. Terwee, PhD; Alyssandra Chee-A-Tow, MPH; Ami Baba, MRes; Frank Gavin, MA; Jeremy M. Grimshaw, MBCHB, PhD; Lauren E. Kelly, PhD; Leena Saeed, BSc, BEd; Lehana Thabane, PhD; Lisa Askie, PhD; Maureen Smith, MEd; Mufiza Farid-Kapadia, MD, PhD; Paula R. Williamson, PhD; Peter Szatmari, MD; Peter Tugwell, MD; Robert M. Golub, MD; Suneeta Monga, MD; Sunita Vohra, MD; Susan Marlin, MSc; Wendy J. Ungar, PhD; Martin Offringa, MD, PhD
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Key Points

Question  What outcome-specific information should be included in a published clinical trial report?

Findings  Using an evidence-based and international consensus–based approach that applied methods from the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, 17 outcome-specific reporting items were identified.

Meaning  Inclusion of these items in clinical trial reports may enhance trial utility, replicability, and transparency and may help limit selective nonreporting of trial results.

Abstract

Importance  Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis.

Objective  To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.

Evidence Review  Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports.

Findings  The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18).

Conclusions and Relevance  This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

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Guidelines Research, Methods, Statistics
Article Information

Corresponding Author: Nancy J. Butcher, PhD, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, 686 Bay St, Toronto, ON M5G 0A4, Canada (nancy.butcher@sickkids.ca).

Accepted for Publication: October 25, 2022.

Author Contributions: Dr Butcher had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Butcher.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Monsour.

Obtained funding: Offringa.

Administrative, technical, or material support: Monsour, Mew, Baba.

Supervision: Butcher, Offringa.

Conflict of Interest Disclosures: Dr Butcher reported receiving grant funding from CHILD-BRIGHT and the Cundill Centre for Child and Youth Depression at the Centre for Addiction and Mental Health (CAMH) and receiving personal fees from Nobias Therapeutics. Ms Mew reported receiving salary support through a Canadian Institutes of Health Research doctoral foreign study award. Dr Kelly reported receiving funding from the Canadian Cancer Society, Research Manitoba, the Children’s Hospital Research Institute of Manitoba, Mitacs, and the SickKids Foundation. Dr Askie reported being a co-convenor of the Cochrane Prospective Meta-Analysis Methods Group. Dr Farid-Kapadia reported currently being an employee of Hoffmann La-Roche and holding shares in the company. Dr Williamson reported chairing the COMET initiative management group. Dr Szatmari reported receiving funding from the CAMH. Dr Tugwell reported co-chairing the OMERACT executive committee; receiving personal fees from the Reformulary Group, UCB Pharma GmbH, Parexel International, PRA Health Sciences, Amgen, AstraZeneca, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech, Roche, Genzyme, Sanofi, Horizon Therapeutics, Merck, Novartis, Pfizer, PPD Inc, QuintilesIMS (now IQVIA), Regeneron Pharmaceuticals, Savient Pharmaceuticals, Takeda Pharmaceutical Co Ltd, Vertex Pharmaceuticals, Forest Pharmaceuticals, and Bioiberica; serving on data and safety monitoring boards for UCB Pharma GmbH, Parexel International, and PRA Health Sciences; and receiving unrestricted educational grants from the American College of Rheumatology and the European League of Rheumatology. Dr Monga reported receiving funding from the Cundill Centre for Child and Youth Depression at CAMH; receiving royalties from Springer for Assessing and Treating Anxiety Disorders in Young Children; and receiving personal fees from the TD Bank Financial Group for serving as a chair in child and adolescent psychiatry. Dr Ungar reported being supported by the Canada research chair in economic evaluation and technology assessment in child health. No other disclosures were reported.

Funding/Support: This work, project 148953, received financial support from the Canadian Institutes of Health Research (supported the work of Drs Butcher, Kelly, Szatmari, Monga, and Offringa and Mss Saeed and Marlin).

Role of the Funder/Sponsor: The Canadian Institutes of Health Research had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimers: Dr Golub is Executive Deputy Editor of JAMA, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance. This article reflects the views of the authors, the Delphi panelists, and the consensus meeting panelists and may not represent the views of the broader stakeholder groups, the authors’ institutions, or other affiliations.

Additional Contributions: We gratefully acknowledge the additional contributions made by the project core team, the executive team, the operations team, the Delphi panelists, and the international consensus meeting panelists (eAppendix 3 in the Supplement). We thank Andrea Chiaramida, BA, for administrative project support and Lisa Stallwood, MSc, for administrative manuscript support (both with The Hospital for Sick Children). We thank Petros Pechlivanoglou, PhD, and Robin Hayeems, PhD, for piloting and providing feedback on the format of the Delphi survey (both with The Hospital for Sick Children). We thank Roger F. Soll, MD (Cochrane Neonatal and the Division of Neonatal-Perinatal Medicine, Larner College of Medicine, University of Vermont), and James Webbe, MB BChir, PhD, and Chris Gale, MBBS, PhD (both with Neonatal Medicine, School of Public Health, Imperial College London), for pilot testing the CONSORT-Outcomes 2022 extension checklist. None of these individuals received compensation for their role in the study.

Additional Information: The project materials and data are publicly available on the Open Science Framework at https://osf.io/arwy8/.

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