Gender-gap in randomized clinical trials reporting mortality in the perioperative setting and critical care: 20 years behind the scenes

Carolina S Romero; Nicolò Maimeri; Alessandra Bonaccorso; Martina Baiardo-Redaelli; Gaetano Lombardi; Otito Frances Iwuchukwu; Alessandro Ortalda; Benedikt Schmid; Magdalena Fleming; Giovanni Landoni

doi:10.1016/j.conctc.2023.101117

Gender-gap in randomized clinical trials reporting mortality in the perioperative setting and critical care: 20 years behind the scenes

Contemp Clin Trials Commun. 2023 Apr 2:33:101117. doi: 10.1016/j.conctc.2023.101117. eCollection 2023 Jun.

Affiliations

¹ Department of Anesthesia, Critical Care and Pain Unit, University General Hospital, Spain.
² Department of Methods in Research, European University of Valencia, Valencia, Spain.
³ Anesthesia and Intensive Care Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.
⁴ American College of Clinical Pharmacology, Fairleigh Dickinson University School of Pharmacy & Health Sciences, New Jersey, United States.
⁵ Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wurzburg, Wurzburg, Germany.
⁶ Department of Anaesthesiology and Intensive Care, Czerniakowski Hospital, Warsaw, Poland.
⁷ Vita-Salute San Raffaele University, Center for Intensive Care and Anesthesiology (CARE) San Raffaele Hospital Head of SIAARTI Clinical Research Committee, Milan, Italy.

Abstract

Background: Women researchers might experience obstacles in academic environments and might be underrepresented in the authorship of articles published in peer-reviewed journals.

Material and methods: This is a cross-sectional analysis of female-led RCTs describing all interventions reducing mortality in critically ill and perioperative patients from 1981 to December 31, 2020. We searched PubMed/MEDLINE and EMBASE with the keywords RCTs and mortality. The gender of the first author was extracted and descriptive analysis was performed including the year of publication, impact factor, country of the first author, and methodological aspects.

Results: We analyzed 340 RCTs, of which 42 (12%) were led by female researchers. The presence of women increased from 8% (14/172) until 2010 up to 17% (28/168) in 2010 and beyond. The United States, the United Kingdom, and Brazil were the main countries of origin of female researchers. Women authors conducted mainly single-center and single-nation studies as compared to male authors. The median impact factor of the target journal was 6 (3-27) in women vs. 7 (3-28) in men, with a p-value of 0.67; Critical Care Medicine, JAMA, and The New England Journal of Medicine were the most frequent target journals for both women and men.

Conclusion: In the last 40 years, only one out of eight RCTs had a woman as the first author but the presence of women increased up to 17% by 2010 and beyond. The impact factor of publication target journals was high and not different between genders.

Keywords: Critically ill patient; Diversity; Equity; Gender gap; Inclusion; RCT.

Publication types

Review