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

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

doi:10.1136/bmjopen-2023-081118

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

BMJ Open. 2024 May 7;14(5):e081118. doi: 10.1136/bmjopen-2023-081118.

Authors

David Granton¹, Myanca Rodrigues², Valeria Raparelli^{3

4}, Kimia Honarmand^{2

5}, Arnav Agarwal^{2

6}, Jan O Friedrich^{1

7}, Benedetta Perna³, Riccardo Spaggiari³, Valeria Fortunato³, Gianluca Risdonne³, Michelle Kho^{8

9}, Sandra VanderKaay⁸, Dipayan Chaudhuri^{2

10}, Carolina Gomez-Builes¹¹, Frédérick D'Aragon^{12

13}, Daniel Wiseman¹⁴, Vincent Issac Lau¹⁵, Celina Lin¹⁶, Julie Reid², Vatsal Trivedi^{1

11}, Varuna Prakash¹, Emilie Belley-Cote^{2

17}, Maha Al Mandhari¹¹, Lehana Thabane², Louise Pilote^{18

19}, Karen E A Burns^{20

2

7

21}

Affiliations

¹ Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
² Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
³ Department of Translational Medicine, University of Ferrara, Ferrara, Italy.
⁴ University Center for Studies on Gender Medicine, University of Ferrara, Ferrara, Italy.
⁵ Division of Critical Care, Mackenzie Health, Vaughan, Ontario, Canada.
⁶ Division of General Internal Medicine, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ Critical Care and Medicine Departments, Unity Health Toronto, Toronto, Ontario, Canada.
⁸ School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
⁹ Physiotherapy Department, Research Institute of St. Joe's Hamilton, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
¹⁰ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹¹ Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.
¹² Department of Anesthesiology, Universite de Sherbrooke, Sherbrooke, Quebec, Canada.
¹³ Centre de Recherche du Centre Hospitalier, Universite de Sherbrooke, Sherbrooke, Quebec, Canada.
¹⁴ Departments of Medicine and Critical Care Medicine, McGill University, Montreal, Quebec, Canada.
¹⁵ Department of Critical Care Medicine, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada.
¹⁶ Department of Medicine, Division of Physical Medicine & Rehabilitation, McMaster University, Hamilton, Ontario, Canada.
¹⁷ Department of Medicine, Divisions of Cardiology and Critical Care, McMaster University, Hamilton, Ontario, Canada.
¹⁸ Department of Medicine, McGill University, Montreal, Quebec, Canada.
¹⁹ Department of Medicine, Research Institute of the McGill University Health Centre, Montreal, Ontario, Canada.
²⁰ Department of Medicine and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada Karen.Burns@unityhealth.to.
²¹ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.

PMID: 38719297
DOI: 10.1136/bmjopen-2023-081118

Abstract

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.

Keywords: Health Equity; INTENSIVE & CRITICAL CARE.

Publication types

Systematic Review
Research Support, Non-U.S. Gov't

MeSH terms

Cardiology
Clinical Trials as Topic
Critical Care* / statistics & numerical data
Female
Gender Equity
Humans
Journal Impact Factor
Male
Periodicals as Topic / statistics & numerical data
Sex Factors