Effects of a one year reusable contraceptive vaginal ring on vaginal Microflora and the risk of vaginal infection: An open-label prospective evaluation

Background A contraceptive vaginal ring (CVR) containing Nestorone® (NES) and ethinyl estradiol (EE) that is reusable for 1-year (13 cycles) is under development. This study assessed effects of this investigational CVR on the incidence of vaginal infections and change in vaginal microflora. Methods There were 120 women enrolled into a NES/EE CVR Phase III trial and a microbiology substudy for up to 1-year of cyclic product use. Gynecological examinations were conducted at baseline, the first week of cycle 6 and last week of cycle 13 (or during early discontinuation visits). Vaginal swabs were obtained for wet mount microscopy, Gram stain and culture. The CVR was removed from the vagina at the last study visit and cultured. Semi-quantitative cultures for Lactobacillus, Gardnerella vaginalis, Enterococcus faecalis, Staphylococcus aureus, Escherichia coli, anaerobic gram negative rods (GNRs), Candida albicans and other yeasts were performed on vaginal and CVR samples. Vaginal infections were documented throughout the study. Results Over 1-year of use, 3.3% of subjects were clinically diagnosed with bacterial vaginosis, 15.0% with vulvovaginal candidiasis, and 0.8% with trichomoniasis. The detection rate of these three infections did not change significantly from baseline to either Cycle 6 or 13. Nugent scores remained stable. H2O2-positive Lactobacillus dominated vaginal flora with a non-significant prevalence increase from 76.7%at baseline to 82.7% at cycle 6 and 90.2% at cycle 13, and a median concentration of 107 colony forming units (cfu) per gram. Although anaerobic GNRs prevalence increased significantly, the median concentration decreased slightly (104 to 103cfu per gram). There were no significant changes in frequency or concentrations of other pathogens. High levels of agreement between vaginal and ring surface microbiota were observed. Conclusion Sustained use of the NES/EE CVR did not increase the risk of vaginal infection and was not disruptive to the vaginal ecosystem

Towards causal benchmarking of bias in face analysis algorithms

Measuring algorithmic bias is crucial both to assess algorithmic fairness, and to guide the improvement of algorithms. Current methods to measure algorithmic bias in computer vision, which are based on observational datasets, are inadequate for this task because they conflate algorithmic bias with dataset bias. To address this problem we develop an experimental method for measuring algorithmic bias of face analysis algorithms, which manipulates directly the attributes of interest, e.g., gender and skin tone, in order to reveal causal links between attribute variation and performance change. Our proposed method is based on generating synthetic ``transects'' of matched sample images that are designed to differ along specific attributes while leaving other attributes constant. A crucial aspect of our approach is relying on the perception of human observers, both to guide manipulations, and to measure algorithmic bias. Besides allowing the measurement of algorithmic bias, synthetic transects have other advantages with respect to observational datasets: they sample attributes more evenly allowing for more straightforward bias analysis on minority and intersectional groups, they enable prediction of bias in new scenarios, they greatly reduce ethical and legal challenges, and they are economical and fast to obtain, helping make bias testing affordable and widely available. We validate our method by comparing it to a study that employs the traditional observational method for analyzing bias in gender classification algorithms. The two methods reach different conclusions. While the observational method reports gender and skin color biases, the experimental method reveals biases due to gender, hair length, age, and facial hair

Gender differences in local and systemic reactions to inactivated influenza vaccine, established by a meta-analysis of fourteen independent studies

In order to determine whether there is a difference between genders in reported adverse reactions to inactivated influenza vaccine, a computerized database of serological studies was investigated. A standardized questionnaire was used to evaluate vaccine reactogenicity. A total of 1,800 vaccinees in 14 studies were analyzed separately for two age groups ( or = 60 years of age). Females reported significantly more local reactions than males. The pooled odds ratio for the outcome measure "any local reaction" was 0.32 (95% confidence interval, 0.26-0.40, significant) and 0.54 (95% Cl, 0.41-0.70, significant) for young and elderly adults, respectively. Similar results were obtained for the outcome measure "any systemic reaction." Previous exposure to influenza or influenza vaccine had no influence on reactogenicity. There were no gender differences in sero-responses. In conclusion, gender should be regarded as a predictor of reported reactions to influenza vaccine in both young and elderly adults and should be addressed in future study designs