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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Randomized Controlled Trial
Pain One Week After an Emergency Department Visit for Acute Low Back Pain Is Associated With Poor Three-month Outcomes.
Low back pain (LBP) is responsible for more than 2.5 million visits to U.S. emergency departments (EDs) annually. Nearly 30% of patients who present to an ED with acute LBP report functional impairment or pain 3 months later. These patients are at risk of chronic LBP, a highly debilitating condition. In this study, we assessed whether three variables assessable shortly after symptom onset could independently predict poor 3-month outcomes among LBP patients who present to an ED. ⋯ More than one-third of patients reported functional impairment 3 months after an ED visit for acute, nontraumatic, nonradicular LBP. Moderate or severe LBP was less common, reported in about half as many patients (16%). Of the three hypothesized predictor variables, only persistent pain at 1 week was independently associated with poor outcomes at 3 months. Despite its important role in the outpatient setting, the STarT Back Tool was not associated with poor outcomes in this ED cohort.
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The ability of emergency physicians (EPs) to identify hydronephrosis using point-of-care ultrasound (POCUS) has been assessed in the past using computed tomography (CT) scans as the reference standard. We aimed to determine the ability of EPs to identify and grade hydronephrosis on POCUS using the consensus interpretation of POCUS by emergency radiologists as the reference standard. ⋯ Emergency physicians were found to have moderate to high sensitivity for identifying hydronephrosis on POCUS when compared with the consensus interpretation of the same studies by emergency radiologists. These POCUS findings by EPs produced more definitive results when at least moderate degree of hydronephrosis was present.
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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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Randomized Controlled Trial
Factors Associated With Patient Involvement in Emergency Care Decisions: A Secondary Analysis of the Chest Pain Choice Multicenter Randomized Trial.
Shared decision making in the emergency department (ED) can increase patient engagement for patients presenting with chest pain. However, little is known regarding which factors are associated with actual patient involvement in decision making or patients' desired involvement in emergency care decisions. We examined which factors were associated with patients' actual and desired involvement in decision making among ED chest pain patients. ⋯ Patients' reported desire for involvement in decision making was higher among those with higher health literacy. After study site and other potential confounding factors were adjusted for, only use of the decision aid was associated with observed patient involvement in decision making. As the science and practice of shared decision making in the ED moves toward implementation, high-fidelity integration of the decision aid into the flow of care will be necessary to realize desired outcomes.