Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Due to the acuity and time-sensitive needs of their clinical condition, patients presenting with certain emergent pathologies may lack capacity to provide meaningful prospective informed consent to participate in clinical research. For these reasons, these populations have often been excluded from research investigations. To mitigate this, regulations allowing exception from informed consent (EFIC; 21 CFR 50.24) or waiver of informed consent (WIC; 45 CFR 46.101) were developed in 1996. The purpose of this study was to identify trends in the utilization of EFIC and WIC in emergency research. We also sought to describe the disclosure of necessary prestudy regulatory requirements and justification for the use of EFIC/WIC as reported in completed EFIC/WIC clinical trials. ⋯ Since their implementation in 1996, the EFIC/WIC regulations have allowed progress in research aimed at determining optimal care for devastating life-threatening conditions. However, consistent and rigorous report of regulatory prestudy requirements and justification of the use of EFIC/WIC is lacking in clinical trial publications or on websites such as ClinicalTrials.gov. Since research without consent is an ethically sensitive issue and not widely understood, better justification of its needs within the presentation of the research itself may educate the general medical community and also reduce concerns about whether or not the regulations are being properly applied.
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Observational Study
Development and Validation of a Measure to Assess Patients' Threat Perceptions in the Emergency Department.
Threat perceptions in the emergency department (ED; e.g., patients' subjective feelings of helplessness or lack of control) during evaluation for an acute coronary syndrome (ACS) are associated with the development of posttraumatic stress disorder (PTSD), and PTSD has been associated with medication nonadherence, cardiac event recurrence, and mortality. This study reports the development and validation of a seven-item measure of ED threat perceptions in English- and Spanish-speaking patients evaluated for ACS. ⋯ This brief tool assessing ED threat perceptions has clinical utility for providers to identify patients at risk for developing cardiac-induced PTSD and is critical to inform research on whether threat may be modified in-ED to reduce PTSD incidence.
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Observational Study
Integrating Point-of-care Testing Into a Community Emergency Department: A Mixed-methods Evaluation.
Point-of-care testing (POCT) is a commonly used technology that hastens the time to laboratory results in emergency departments (ED). We evaluated an ED-based POCT program on ED length of stay (LOS) and time to care, coupled with qualitative interviews of local ED stakeholders. ⋯ In the study ED, implementation of POCT was associated with a reduction in time to test result for both troponin and chemistry. Local staff felt that faster time to test result improved quality of care; however, concerns were raised with POCT accuracy.
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This systematic review provides an assessment of the diagnostic accuracy of various historical, physical, and clinical examination features for aortic dissection. Nine articles were included, with moderate to high heterogeneity. Limitations to general practice include risk of selection bias and partial verification bias. Risk scores were included, but their use is not recommended at this time.