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.
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In 1996, the Food and Drug Administration released its Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances (the Final Rule). The Department of Health and Human Services (DHHS) also released an update of its regulations related to waiver of informed consent in emergency research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. ⋯ Although this was intentional on the part of the federal regulators so that individual protocols and research environments would direct the development of these patient safeguards, the lack of specific guidance has led to confusion on the appropriate implementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of implementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.
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Appropriateness of medication selection for older persons in an urban academic emergency department.
To determine the frequency of potentially inappropriate medication selection for older persons presenting to the ED, the most common problematic drugs, risk factors for suboptimal medication selection, and whether use of these medications is associated with worse outcomes. ⋯ Suboptimal medication selection was fairly common and was associated with worse patient-reported health-related quality of life.