How do we engage with the lesbian, gay, bisexual, and transgender community in blood donation and research? Reflections from the Assessing Donor Variability and New Concepts in Eligibility study.

Background: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study was a multicenter cross-organizational collaboration to collect data to inform possible changes in blood donor selection criteria for men who have sex with men. Multiple recruitment approaches were used, and these may be applicable to current efforts in LGBTQ+ community engagement to recruit new blood donors.

Methods: Fieldwork for ADVANCE was a partnership between blood collection organizations (BCOs) and LGBTQ+ community organizations.

Patterns of platelet use evaluated in EHR networks of the Biologics Effectiveness and Safety Initiative, 2012-2018.

Background: U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products.

A Generalized approach to the operationalization of Software Quality Models.

Comprehensive measures of quality are a research imperative, yet the development of software quality models is a wicked problem. Definitive solutions do not exist and quality is subjective at its most abstract. Definitional measures of quality are contingent on a domain, and even within a domain, the choice of representative characteristics to decompose quality is subjective.

Real-world data to improve organ and tissue donation policies: lessons learned from the tissue and organ donor epidemiology study.

Background: The transplantation of human organs, and some human tissues, is often the only life-saving therapy available for serious and life-threatening congenital, inherited or acquired diseases. However, it is associated with a risk of transmission of communicable diseases from donor to recipient. It is imperative to understand the characteristics of the donor population (including both potential and actual donors) to inform policies that protect recipient safety.