Lack of attention to sex and gender in periodontitis-related randomized clinical trials: A meta-research study.

Abstract

This meta-research study aimed to investigate the level of compliance with the Sex and Gender Equity in Research (SAGER) Guidelines for the inclusion, analysis, and reporting of sex/gender, in periodontitis-related randomized controlled trials (RCTs). Following the inclusion of RCTs related to the treatment of periodontitis published between 2018 and 2019, we applied the SAGER checklist to assess the adherence to sex/gender reporting guidelines. We used non-parametric descriptive statistics and correlation models to test the association of the dependent outcome with other variables. One hundred and one articles were included in the analysis. The female enrolment ranged between 30% and 94%. Twenty-six studies enrolled less than 50% of female participants. The overall SAGER score (OSS) of item fulfilment ranged between 0 and 7 items with an average of 1.9 items signifying poor guideline adherence to the SAGER guidelines. These findings were not associated with the corresponding author gender (p= .623), publication year (p= .947), and funding source (p= .133). However, a significant but negative correlation with journal impact factor (r= -0.253, p= .026) was observed. Sex and gender were frequently disregarded in clinical trial reporting. This oversight might limit the understanding of sex/gender differences in periodontitis-related clinical trials.