Purpose: Care of the acutely injured trauma patient is integral to the practice of emergency medicine. It is currently unknown how most emergency medicine residencies structure their residents' trauma experience and little guidance for competency assessment is provided by the Residency Review Committee. Our study aimed to determine current emergency medicine residency practices in trauma resuscitation.
View Article and Find Full Text PDFBiocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDPs) and other drug-device combination products, because finished device components and packaging in these products are often in direct contact with formulation and the patient. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) discusses, in this article, the current regulatory landscape associated with biocompatibility and how biocompatibility is typically assessed for OINDPs, including risk management considerations and navigation of regulatory requirements. The article also describes current challenges related to alignment of regulatory expectations, particularly for drug-device combination products, and proposes some questions and topics for further discussion with regulatory agencies and other stakeholders to help advance alignment.
View Article and Find Full Text PDFQualitative research methods are often used to develop health interventions, but few researchers report how their qualitative data informed intervention development. Improved completeness of reporting may facilitate the development of effective behavior change interventions. Our objective was to describe how we used qualitative data to develop our stroke education intervention consisting of a pamphlet and video.
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