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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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.
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Comparative Study
Effect of a practice guideline for emergency department care of falls in elder patients on subsequent falls and hospitalizations for injuries.
To determine the effect of a practice guideline for the ED management of falls in community-dwelling elders on selected health outcomes. ⋯ The attempted implementation of a practice guideline for the ED management of falls in community-dwelling elders did not result in a reduction in total falls, or in hospitalizations for falls, injuries, or fractures.
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Comparative Study
1998-1999 SAEM emergency medicine faculty salary and benefits survey.
The Society for Academic Emergency Medicine (SAEM) commissioned an emergency medicine (EM) faculty salary and benefits survey for all 1998 residency review committee (RRC)-EM-accredited programs using the SAEM fourth-generation survey instrument. Responses were collected by SAEM and blinded from the investigators. ⋯ Reported salaries for full-time EM residency faculty continue to rise. Significant regional differences in salaries have been present in all four SAEM surveys. Nonclinical hours are compensated at approximately one-half the rate paid for clinical hours. The demographic data indicate that EM residency faculty are working at the upper extremes of numbers of patient encounters per physician, patient acuity levels, and department lengths of stay.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group.
In the clinical trial of diaspirin cross-linked hemoglobin (DCLHb), optimal therapy required the immediate enrollment of patients with severe, uncompensated, traumatic hemorrhagic shock. When it was not feasible to obtain prospective consent, an exception to informed consent was used according to FDA regulation 21 CFR 50.24. ⋯ Informed consent in this study of an emergent therapy most often involved the use of the consent exception and consent to continue, the latter of which occurred in a timely manner. Nearly all of those who were approached for CTC approved full participation in the study, suggesting acceptance of the process outlined in the new regulations. Patients treated in a hemorrhagic shock clinical trial may differ from the general trauma patient population.