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Lack of attention to sex and gender in <scp>periodontitis‐related</scp> randomized clinical trials: A meta‐research study

Courtney Michelson, Khadijeh Al‐Abedalla, Julie Wagner, Helen Swede, Eric R. Bernstein, Effie Ioannidou

2022Journal Of Clinical Periodontology17 citationsDOIOpen Access PDF

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.

Topics & Concepts

MedicinePeriodontitisRandomized controlled trialChecklistMeta-analysisClinical trialInclusion (mineral)GuidelineDemographyPsychologyInternal medicinePathologySocial psychologyCognitive psychologySociologySex and Gender in HealthcareOral microbiology and periodontitis researchEthics in Clinical Research
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