The National Institutes of Health, Food and Drug Administration, and journal editors require examination of sex as a biological variable in the design, analysis and reporting of studies, including clinical trials. As 52% of adults living with HIV worldwide are women, sex-specific analyses can provide insight into HIV prevention, pathogenesis, treatment, cure and HIV-associated conditions. CROI 2018 guidelines recommended reporting of sex-specific analyses. Members of the Women’s Health Inter-Network Scientific Committee (WHISC) of the ACTG and IMPAACT networks reviewed adherence to these guidelines in oral presentations during CROI 2018.
Two independent reviewers from WHISC reviewed each original oral presentation’s webcast to determine whether the abstract was relevant to both sexes and if it included human participants, animals, or specimens from humans or animals. If those criteria were met, reviewers assessed whether sex demographics were provided and whether sex-delineated outcomes or sex-stratified analyses were presented. lf not, the reviewer determined whether an explanation was provided for excluding this information. Descriptive statistics summarized results.
Of 83 original oral presentations, 16 (19%) were deemed relevant to one sex only and were excluded from the analysis. Of the remaining 67 relevant to both sexes, 35 (52%) presented the distribution of the study sample by sex; 7 (10%) presented sex distributions but mislabeled them as ‘gender’; and 25 (37%) did not. Basic science and animal studies were less likely to report sex distribution (1/13, 8%) compared to human observational studies and clinical trials (41/54, 76%). Only 16 (24%) of all oral presentations relevant to both sexes included sex-stratified analyses or sex-delineated outcomes. The remaining 51 (76%) did not, with only a subset (8, 12%) providing an explanation for why sex stratification was not presented. Of the 28 presentations from clinical trials, 25 (89%) included sex distribution, but only 6 (21%) presented results by sex.
Despite CROI 2018 providing guidelines for presentations consistent with US federal mandates on reporting by sex, more than a third of oral presentations failed to report sex demographics and only a quarter included sex-stratified analyses. Further education of researchers on guidelines requiring reporting of sex as a biological variable is essential to maximize knowledge about sex differences and similarities in HIV and its associated conditions.