Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Lehana Thabane; Arnav Agarwal; Valeria Raparelli; Dipayan Chaudhuri; Karen E A Burns; Emilie Belley-Cote; Frédérick D'Aragon; Louise Pilote; Vincent Issac Lau; Kimia Honarmand; David Granton; Jan O Friedrich; Vatsal Trivedi; Varuna Prakash; Daniel Wiseman; Myanca Rodrigues; Julie Reid; Benedetta Perna; Riccardo Spaggiari; Valeria Fortunato; Gianluca Risdonne; Michelle Kho; Sandra VanderKaay; Carolina Gomez-Builes; Celina Lin; Maha Al Mandhari

doi:10.1136/bmjopen-2023-081118

BMJ Open (May 2024)

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Lehana Thabane,
Arnav Agarwal,
Valeria Raparelli,
Dipayan Chaudhuri,
Karen E A Burns,
Emilie Belley-Cote,
Frédérick D'Aragon,
Louise Pilote,
Vincent Issac Lau,
Kimia Honarmand,
David Granton,
Jan O Friedrich,
Vatsal Trivedi,
Varuna Prakash,
Daniel Wiseman,
Myanca Rodrigues,
Julie Reid,
Benedetta Perna,
Riccardo Spaggiari,
Valeria Fortunato,
Gianluca Risdonne,
Michelle Kho,
Sandra VanderKaay,
Carolina Gomez-Builes,
Celina Lin,
Maha Al Mandhari

Affiliations

Lehana Thabane: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Arnav Agarwal: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Valeria Raparelli: 3 Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Dipayan Chaudhuri: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Karen E A Burns: 20 Department of Medicine, University of Toronto, Toronto, Ontario, Canada
Emilie Belley-Cote: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Frédérick D'Aragon: 12 Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada
Louise Pilote: 18 Department of Medicine, McGill University, Montreal, Quebec, Canada
Vincent Issac Lau: 15 Department of Critical Care Medicine, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
Kimia Honarmand: 5 Division of Critical Care, Mackenzie Health, Vaughan, Ontario, Canada
David Granton: 1 Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada
Jan O Friedrich: 1 Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada
Vatsal Trivedi: 1 Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada
Varuna Prakash: 1 Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada
Daniel Wiseman: 14 Departments of Medicine and Critical Care Medicine, McGill University, Montreal, Quebec, Canada
Myanca Rodrigues: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Julie Reid: 2 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Benedetta Perna: 3 Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Riccardo Spaggiari: 3 Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Valeria Fortunato: 3 Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Gianluca Risdonne: 3 Department of Translational Medicine, University of Ferrara, Ferrara, Italy
Michelle Kho: 8 School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
Sandra VanderKaay: 8 School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
Carolina Gomez-Builes: 11 Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada
Celina Lin: 16 Department of Medicine, Division of Physical Medicine & Rehabilitation, McMaster University, Hamilton, Ontario, Canada
Maha Al Mandhari: 11 Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada

DOI: https://doi.org/10.1136/bmjopen-2023-081118
Journal volume & issue: Vol. 14, no. 5

Abstract

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Objective To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.Design Systematic review.Data sources We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.Study selection Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.Data abstraction and synthesis 4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.Results We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).Conclusions Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.PROSPERO registration number CRD42022282565.

Published in BMJ Open

ISSN: 2044-6055 (Online)
Publisher: BMJ Publishing Group
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://bmjopen.bmj.com

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