Publication Abstract Display
Type: Published Abstract
Title: Low rate of sex-specific analyses in CROI presentations suggests room to improve.
Authors: Gandhi M, Smeaton L, Vernon C, Connick E
Year:
Publication: CROI
Volume: Issue: Pages:
Abstract: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 associated conditions. CROI 2018 abstract guidelines recommended reporting of sex-specific analyses when possible. 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 from CROI 2018. Each original oral presentation’s webcast was reviewed by at least two independent reviewers from WHISC regarding whether the abstract was relevant to both sexes and if it included human participants, vertebrate animals, or specimens from humans or animals. If so, reviewers determined whether sex demographics were provided and whether sex-delineated outcomes or sex-stratified analyses were presented. lf not, the presentation was evaluated to determine whether an explanation was provided for excluding this information. Descriptive statistics were used to summarize results. Of 83 oral presentations, 16 (19%) were deemed relevant to one sex only and were excluded from further consideration; 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 (1/13, 8%) compared to human observational studies and trials (41/54, 76%). Only 16 (24%) of 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) providing an explanation for why sex stratification was not performed. Of the 28 presentations from clinical trials, 25 (89%) included sex distribution, but only 6 (21%) presented results by sex. Despite guidelines for CROI 2018 consistent with US federal mandates on sex reporting, more than a third of oral presentations failed to report sex demographics and only a quarter included sex-stratified analyses. Further education of researchers regarding guidelines for consideration of sex as a biological variable is essential to maximize knowledge about sex differences and similarities in HIV and its associated conditions.

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