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. 2022 Dec;49(12):1320-1333.
doi: 10.1111/jcpe.13707. Epub 2022 Sep 4.

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

Courtney Michelson  1 , Khadijeh Al-Abedalla  2 , Julie Wagner  1 , Helen Swede  1 , Eric Bernstein  1 , Effie Ioannidou  1
Affiliations

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

Courtney Michelson et al. J Clin Periodontol. 2022 Dec.

Abstract

Aim: 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).

Materials and methods: 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.

Results: 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.

Conclusions: 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.

Keywords: clinical trial; gender; periodontal therapy; periodontitis; sex.

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