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

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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.

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Most cited references 57

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Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

Larissa Shamseer, David Moher, Mike Clarke … (2015)

Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols. © BMJ Publishing Group Ltd 2014.

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Metaprop: a Stata command to perform meta-analysis of binomial data

Victoria N Nyaga, Marc Arbyn, Marc Aerts (2014)

Background Meta-analyses have become an essential tool in synthesizing evidence on clinical and epidemiological questions derived from a multitude of similar studies assessing the particular issue. Appropriate and accessible statistical software is needed to produce the summary statistic of interest. Methods Metaprop is a statistical program implemented to perform meta-analyses of proportions in Stata. It builds further on the existing Stata procedure metan which is typically used to pool effects (risk ratios, odds ratios, differences of risks or means) but which is also used to pool proportions. Metaprop implements procedures which are specific to binomial data and allows computation of exact binomial and score test-based confidence intervals. It provides appropriate methods for dealing with proportions close to or at the margins where the normal approximation procedures often break down, by use of the binomial distribution to model the within-study variability or by allowing Freeman-Tukey double arcsine transformation to stabilize the variances. Metaprop was applied on two published meta-analyses: 1) prevalence of HPV-infection in women with a Pap smear showing ASC-US; 2) cure rate after treatment for cervical precancer using cold coagulation. Results The first meta-analysis showed a pooled HPV-prevalence of 43% (95% CI: 38%-48%). In the second meta-analysis, the pooled percentage of cured women was 94% (95% CI: 86%-97%). Conclusion By using metaprop, no studies with 0% or 100% proportions were excluded from the meta-analysis. Furthermore, study specific and pooled confidence intervals always were within admissible values, contrary to the original publication, where metan was used.

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Sex and gender: modifiers of health, disease, and medicine

Franck Mauvais-Jarvis, Noel C Bairey Merz, Peter Barnes … (2020)

Summary Clinicians can encounter sex and gender disparities in diagnostic and therapeutic responses. These disparities are noted in epidemiology, pathophysiology, clinical manifestations, disease progression, and response to treatment. This Review discusses the fundamental influences of sex and gender as modifiers of the major causes of death and morbidity. We articulate how the genetic, epigenetic, and hormonal influences of biological sex influence physiology and disease, and how the social constructs of gender affect the behaviour of the community, clinicians, and patients in the health-care system and interact with pathobiology. We aim to guide clinicians and researchers to consider sex and gender in their approach to diagnosis, prevention, and treatment of diseases as a necessary and fundamental step towards precision medicine, which will benefit men's and women's health.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2024

Publication date (Electronic): 7 May 2024

Volume: 14

Issue: 5

Electronic Location Identifier: e081118

Affiliations

[1 ] departmentDepartment of Medicine and Interdepartmental Division of Critical Care , Ringgold_7938University of Toronto , Toronto, Ontario, Canada

[2 ] departmentDepartment of Health Research Methods, Evidence and Impact , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[3 ] departmentDepartment of Translational Medicine , Ringgold_9299University of Ferrara , Ferrara, Italy

[4 ] departmentUniversity Center for Studies on Gender Medicine , Ringgold_9299University of Ferrara , Ferrara, Italy

[5 ] departmentDivision of Critical Care , Ringgold_414721Mackenzie Health , Vaughan, Ontario, Canada

[6 ] departmentDivision of General Internal Medicine, Department of Medicine , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[7 ] departmentCritical Care and Medicine Departments , Ringgold_508783Unity Health Toronto , Toronto, Ontario, Canada

[8 ] departmentSchool of Rehabilitation Science , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[9 ] departmentPhysiotherapy Department, Research Institute of St. Joe’s Hamilton , Ringgold_25479St Joseph’s Healthcare Hamilton , Hamilton, Ontario, Canada

[10 ] departmentDepartment of Medicine , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[11 ] departmentDepartment of Anesthesiology and Pain Medicine , Ringgold_7938University of Toronto , Toronto, Ontario, Canada

[12 ] departmentDepartment of Anesthesiology , Ringgold_7321Universite de Sherbrooke , Sherbrooke, Quebec, Canada

[13 ] departmentCentre de Recherche du Centre Hospitalier , Ringgold_7321Universite de Sherbrooke , Sherbrooke, Quebec, Canada

[14 ] departmentDepartments of Medicine and Critical Care Medicine , Ringgold_5620McGill University , Montreal, Quebec, Canada

[15 ] departmentDepartment of Critical Care Medicine , Ringgold_12357University of Alberta Faculty of Medicine & Dentistry , Edmonton, Alberta, Canada

[16 ] departmentDepartment of Medicine, Division of Physical Medicine & Rehabilitation , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[17 ] departmentDepartment of Medicine, Divisions of Cardiology and Critical Care , Ringgold_3710McMaster University , Hamilton, Ontario, Canada

[18 ] departmentDepartment of Medicine , Ringgold_5620McGill University , Montreal, Quebec, Canada

[19 ] departmentDepartment of Medicine , Ringgold_507266Research Institute of the McGill University Health Centre , Montreal, Ontario, Canada

[20 ] departmentDepartment of Medicine , Ringgold_7938University of Toronto , Toronto, Ontario, Canada

Author notes

[Correspondence to ] Dr Karen E A Burns; Karen.Burns@ 123456unityhealth.to

Author information

David Granton http://orcid.org/0009-0005-8711-1110

Myanca Rodrigues http://orcid.org/0000-0001-7953-773X

Arnav Agarwal http://orcid.org/0000-0002-0931-7851

Michelle Kho http://orcid.org/0000-0003-3170-031X

Vincent Issac Lau http://orcid.org/0000-0002-9939-7348

Emilie Belley-Cote http://orcid.org/0000-0002-5071-076X

Lehana Thabane http://orcid.org/0000-0003-0355-9734

Louise Pilote http://orcid.org/0000-0002-6159-0628

Article

Publisher ID: bmjopen-2023-081118

DOI: 10.1136/bmjopen-2023-081118

PMC ID: 11103199

PubMed ID: 38719297

SO-VID: accff8f1-27db-4d1e-ad9c-890616b6bc0b

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 18 October 2023

Date accepted : 23 February 2024

Funding

Funded by: American Thoracic Society Recognition Award for Scientific Achievement;

Award ID: N/A

Funded by: Research Institute of St. Joseph’s Studentship Award (2023-2024);

Award ID: N/A

Funded by: Physician Services Incorporated Mid-Career Research Award;

Award ID: N/A

Funded by: Ontario Graduate Scholarship (OGS; 2021-2023);

Award ID: N/A

Funded by: National New Investigator Award from the Heart and Stroke Foundation of Canada;

Award ID: N/A

Funded by: FundRef http://dx.doi.org/10.13039/501100000024, Canadian Institutes of Health Research;

Award ID: N/A

Funded by: AFP Clinician Educator Early Career Award;

Award ID: N/A

Funded by: Canadian Institutes of Health Research Health Systems Impact Post-Doctoral Fellowship award;

Award ID: N/A

Funded by: Fond de recherche du Quebec-Sante;

Award ID: N/A

Funded by: Critical Care Trials Group trainee travel award (2019/2020);

Award ID: N/A

Funded by: Canada Research Chair in Critical Care Rehabilitation and Knowledge Translation;

Award ID: N/A

Funded by: Ministry of Health and Long-Term Care-Clinician Investigator Program;

Award ID: N/A

Funded by: CIHR Health Systems Impact Fellowship;

Award ID: N/A

Funded by: Department of Anesthesia and Pain Medicine at the University of Toronto;

Award ID: N/A

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ScienceOpen disciplines: Medicine

Keywords: intensive & critical care,health equity

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ScienceOpen disciplines: Medicine

Keywords: intensive & critical care, health equity

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

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Abstract

Objective

Design

Data sources

Study selection

Data abstraction and synthesis

Results

Conclusions

PROSPERO registration number

Related collections

Karger: Nephrology

Most cited references 57

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

Metaprop: a Stata command to perform meta-analysis of binomial data

Sex and gender: modifiers of health, disease, and medicine

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