Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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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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Editorial Comment Review
Changing clinical practice in geriatric emergency medicine.
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Differences in interpretation of the residency review committee (RRC) directive concerning resident scholarly activity have resulted in inconsistencies in the practical fulfillment of this responsibility among the various training programs in emergency medicine. During a workshop organized by the SAEM Research Directors' Interest Group (RDIG), a consensus statement was developed regarding the scope, definition, and purpose of the scholarly project requirement. ⋯ While each residency program must implement the RRC residency requirements in a manner that best suits the needs and culture of its individual environment, a concurrence of definition and approach to satisfying the scholarly project requirement would provide better consistency in resident training. Guidelines developed by consensus during the SAEM RDIG workshop may serve as a general recipe that can be used to fulfill the goals of the scholarly project and the spirit of the RRC directive.
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This article seeks to provide readers with a framework to enable them to assess the quality of the published description or evaluation of a triage system. Similarities between the triage process and the process of diagnosis and the nature of clinical decision rules are noted. Criteria that triage evaluations should meet are recommended, based on methodology suggested from evidence-based medicine, the development of clinical decision rules, and evaluation of diagnostic tests.
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Review Case Reports
Clinical decision making: an emergency medicine perspective.
Clinical decision making (CDM) describes a form of qualitative inquiry that examines the thought processes involved in making medical decisions. A significant body of literature exists on the orderly "hypothetico-deductive" model of clinical decision making. ⋯ The concept of diagnostic uncertainty and the utility of the diagnosis of unknown etiology in the disposition phase of the emergency patient visit are discussed. Finally, a unique EM perspective on clinical decision-making errors is presented.