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

被引：94

作者：

Junqueira, Daniela R. ^{[1
]}

Zorzela, Liliane ^{[1
]}

Golder, Susan ^{[2
]}

Loke, Yoon ^{[3
]}

Gagnier, Joel J. ^{[4
]}

Julious, Steven A. ^{[5
]}

Li, Tianjing ^{[6
,7
]}

Mayo-Wilson, Evan ^{[8
]}

Pham, Ba ^{[9
]}

Phillips, Rachel ^{[10
]}

Santaguida, Pasqualina ^{[11
]}

Scherer, Roberta W. ^{[12
]}

Gotzsche, Peter C. ^{[13
]}

Moher, David ^{[14
,15
]}

Ioannidis, John P. A. ^{[16
,17
,18
,19
]}

Vohra, Sunita ^{[1
]}

机构：

[1] Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada

[2] Univ York, Dept Hlth Sci, York, N Yorkshire, England

[3] Univ East Anglia, Norwich Med Sch, Norwich, Norfolk, England

[4] Western Univ, Dept Epidemiol & Biostat, Dept Surg, London, ON, Canada

[5] Univ Sheffield, Sch Hlth & Related Res ScHARR, Design Trials & Stat, Sheffield, S Yorkshire, England

[6] Univ Colorado, Sch Med, Colorado Sch Publ Hlth, Dept Ophthalmol, Anschutz Med Campus, Aurora, CO USA

[7] Univ Colorado, Colorado Sch Publ Hlth, Dept Epidemiol, Anschutz Med Campus, Aurora, CO USA

[8] UNC Gillings Sch Global Publ Hlth, Dept Epidemiol, Chapel Hill, NC USA

[9] Unity Hlth Toronto, Knowledge Translat Programme, Toronto, ON, Canada

[10] Imperial Coll London, Fac Med, Sch Publ Hlth, London, England

[11] McMaster Univ, Dept Hlth Res Methods Evidence & Impact HEI, Hamilton, ON, Canada

[12] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

[13] Inst Sci Freedom, Horsholm, Denmark

[14] Ottawa Hosp Res Inst, Ctr Journalol, Clin Epidemiol Programme, Ottawa, ON, Canada

[15] Univ Ottawa, Sch Epidemiol & Publ Hlth, Ottawa, ON, Canada

[16] Stanford Univ, Dept Med, Stanford, CA USA

[17] Stanford Univ, Dept Epidemiol & Populat Hlth, Stanford, CA USA

[18] Stanford Univ, Dept Biomed Data Sci, Stanford, CA USA

[19] Stanford Univ, Dept Stat, Stanford, CA USA

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2023年 / 381卷

关键词：

RUN-IN PERIODS; CLINICAL-TRIALS; ADVERSE EVENTS; SAFETY; EFFICACY; OUTCOMES; PLACEBO; ABSTRACTS; EVALUATE; PHASE-3;

D O I：

10.1136/bmj-2022-073725

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Randomised controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (ie, all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist, and elaborate on each item relevant to complete reporting of harms in randomised controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomised controlled trials should use the integrated checklist presented in this paper.

引用

页数：15

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