CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Daniela R Junqueira¹, Liliane Zorzela¹, Susan Golder², Yoon Loke³, Joel J Gagnier⁴, Steven A Julious⁵, Tianjing Li^{6

7}, Evan Mayo-Wilson⁸, Ba Pham⁹, Rachel Phillips¹⁰, Pasqualina Santaguida¹¹, Roberta W Scherer¹², Peter C Gøtzsche¹³, David Moher^{14

15}, John P A Ioannidis¹⁶, Sunita Vohra¹⁷; CONSORT Harms Group

Collaborators, Affiliations

Collaborators

CONSORT Harms Group:
Stephen Evans, Ann Fonfa, Thomas A Lang, Elizabeth Loder, Laura Weeks

Affiliations

¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
² Department of Health Sciences, University of York, York, UK.
³ Norwich Medical School, University of East Anglia, Norwich, UK.
⁴ Department of Epidemiology and Biostatistics, Department of Surgery, Western University, London, ON, Canada.
⁵ Design, Trials and Statistics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
⁶ Department of Ophthalmology, School of Medicine, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁷ Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁸ Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
⁹ Knowledge Translation Programme, Unity Health Toronto, Toronto, ON, Canada.
¹⁰ Faculty of Medicine, School of Public Health, Imperial College London, London, UK.
¹¹ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada.
¹² Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹³ Institute for Scientific Freedom, Hørsholm, Denmark.
¹⁴ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁵ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹⁶ Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, Stanford University, Stanford, CA, USA.
¹⁷ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada svohra@ualberta.ca.

PMID: 37094878
DOI: 10.1136/bmj-2022-073725

Free article

Randomized Controlled Trial

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Daniela R Junqueira et al. BMJ. 2023.

Free article

. 2023 Apr 24:381:e073725.

doi: 10.1136/bmj-2022-073725.

Authors

Collaborators

CONSORT Harms Group:
Stephen Evans, Ann Fonfa, Thomas A Lang, Elizabeth Loder, Laura Weeks

Affiliations

¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
² Department of Health Sciences, University of York, York, UK.
³ Norwich Medical School, University of East Anglia, Norwich, UK.
⁴ Department of Epidemiology and Biostatistics, Department of Surgery, Western University, London, ON, Canada.
⁵ Design, Trials and Statistics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
⁶ Department of Ophthalmology, School of Medicine, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁷ Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁸ Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
⁹ Knowledge Translation Programme, Unity Health Toronto, Toronto, ON, Canada.
¹⁰ Faculty of Medicine, School of Public Health, Imperial College London, London, UK.
¹¹ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada.
¹² Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹³ Institute for Scientific Freedom, Hørsholm, Denmark.
¹⁴ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁵ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹⁶ Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, Stanford University, Stanford, CA, USA.
¹⁷ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada svohra@ualberta.ca.

PMID: 37094878
DOI: 10.1136/bmj-2022-073725

No abstract available

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support from NACTRC for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Collaborators

Affiliations

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Authors

Collaborators

Affiliations

Conflict of interest statement

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources