Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Randomized Controlled Trial Multicenter Study
The Association of Health Status and Providing Consent to Continued Participation in an Out-of-hospital Cardiac Arrest Trial Performed Under Exception From Informed Consent.
Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. ⋯ Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.
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Randomized Controlled Trial
Accounting for Repeat Enrollments During an Emergency Clinical Trial: The Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART).
The objectives were to describe the frequency of repeat enrollment within a specific exception from informed consent trial testing benzodiazepine treatment of prehospital status epilepticus and to estimate the effect of repeat enrollments on the analysis of the primary outcome. ⋯ In clinical trials of emergency conditions with interval complete resolution, accounting for repeat enrollments is feasible. The RAMPART experience demonstrated that in this setting the within-subject correlation is low and can be accounted for at relatively low statistical cost.
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Randomized Controlled Trial
Improving Patient Knowledge and Safe Use of Opioids: A Randomized Controlled Trial.
The use of opioid analgesics in the United States has significantly increased in recent years. However, there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice. The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics. ⋯ This simple strategy improved several, but not all, aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone. Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications.
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The American Board of Emergency Medicine (ABEM) Maintenance of Certification (MOC) program requires every ABEM-certified physician to attest to participating in a quality improvement (QI) activity every 5 years. Understanding the type and frequency of these QI activities could inform the emergency medicine community about the variety of QI activities in which emergency physicians (EPs) are involved. These QI activities could provide ideas for the development of additional quality measures. ⋯ This report demonstrates that diverse QI activities occur in emergency departments (EDs) across the United States. The majority of reported projects are nested in a few categories, following recognized areas of emphasis in emergency care, particularly in areas using time-sensitive metrics.
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The objective was to assess relative incidence of clinical adverse effects between patients receiving, and not receiving, iodinated contrast prior to thrombolysis. ⋯ No consistent harms were observed in association with intravenous iodinated contrast prior to rt-PA administration. It is reasonable to continue CTA prior to thrombolysis as clinically indicated.