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.
Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review / Granton, David; Rodrigues, Myanca; Raparelli, Valeria; Honarmand, Kimia; Agarwal, Arnav; Friedrich, Jan O; Perna, Benedetta; Spaggiari, Riccardo; Fortunato, Valeria; Risdonne, Gianluca; Kho, Michelle; Vanderkaay, Sandra; Chaudhuri, Dipayan; Gomez-Builes, Carolina; D'Aragon, Frédérick; Wiseman, Daniel; Lau, Vincent Issac; Lin, Celina; Reid, Julie; Trivedi, Vatsal; Prakash, Varuna; Belley-Cote, Emilie; Al Mandhari, Maha; Thabane, Lehana; Pilote, Louise; Burns, Karen E A. - In: BMJ OPEN. - ISSN 2044-6055. - 14:5(2024). [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
Raparelli, Valeria;Fortunato, Valeria;
2024
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
