Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Comparative Study
Effect of a practice guideline on the process of emergency department care of falls in elder patients.
To determine the effect of a practice guideline on the process of ED care in a health maintenance organization. ⋯ The educational intervention to the practice guideline for the ED management of falls in elders led to small but significant improvements in the documentation of selected history and physical examination items and the prescribing of calcium and vitamin D, and to a greater consideration of the causes of falls.
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In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. ⋯ Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.