This study evaluated the reliability of assessing transgender status in African populations using questions about current gender identification and sex assigned at birth. Data were obtained from the HIV Prevention Trials Network 075, a study designed to assess the feasibility of recruiting and retaining 400 men who have sex with men (MSM) in a 1-year prospective cohort study in Kenya, Malawi, and South Africa and conducted from 2015 to 2017. We compared responses of 401 participants to questions about gender identity obtained at the screening and enrollment visits and, for a subset of participants, in open interviews 6-9 months after enrollment.
View Article and Find Full Text PDFPost-approval changes (PACs) to marketed products are routinely introduced to continuously enhance the product lifecycle management. However, bringing a chemistry, manufacturing and control (CMC) change through the global health authorities can be a complex and lengthy process taking up to several years, therefore negatively impacting supply continuity. In order to accelerate the review and approval of regulatory submissions and ensure continuous supply to patients, the World Health Organization (WHO) is strongly supporting the implementation of reliance among National Regulatory Authorities (NRAs).
View Article and Find Full Text PDFObjectives: Low-value esophagogastroduodenoscopies (EGDs) for uncomplicated gastro-oesophageal reflux disease (GERD) can harm patients and raise patient and payer costs. We developed an electronic health record (EHR) 'eMeasure' to detect low-value EGDs.
Design: Retrospective cohort of 518 adult patients diagnosed with GERD who underwent initial EGD between 1 January 2019 and 31 December 2019.