Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration.

User-centered design of central venous access device documentation.

Objective: Safe care of central venous access devices (CVAD) requires clinicians be able to identify key CVAD properties from insertion until safe removal. Our objective was to design and evaluate interfaces to improve CVAD documentation quality and information retrieval.

Materials And Methods: We applied user-centered design (UCD) to CVAD property documentation interfaces.

Lessons Learned from OpenNotes Learning Mode and Subsequent Implementation across a Pediatric Health System.

Background: The 21st Century Cures Act has accelerated adoption of OpenNotes, providing new opportunities for patient and family engagement in their care. However, these regulations present new challenges, particularly for pediatric health systems aiming to improve information sharing while minimizing risks associated with adolescent confidentiality and safety.

Objective: Describe lessons learned preparing for OpenNotes across a pediatric health system during a 4-month trial period (referred to as "Learning Mode") in which clinical notes were not shared by default but decision support was present describing the upcoming change and physicians could request feedback on complex cases from a multidisciplinary team.

Prevalence of Posttraumatic Stress Disorder Symptoms Among Young Athletes After Anterior Cruciate Ligament Rupture.

Background: The risk of depression and the fear of reinjury were documented in recent investigations of patients after anterior cruciate ligament (ACL) ruptures. The extent of psychological trauma accompanying these injuries among young athletes, however, has never been assessed.

Hypothesis: Posttraumatic stress disorder (PTSD) symptoms after ACL injury are present among young athletes with high athletic identities.