Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Clinical trial investigators often assemble internal study monitoring committees (SMCs) to measure individual or group adherence with trial performance benchmarks. We examined the processes and results of study monitoring in an international trial of out-of-hospital cardiac arrest. ⋯ Study monitoring procedures may play an important role in ensuring the performance quality in acute care clinical trials.
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The Global Emergency Medicine Literature Review (GEMLR) conducts a systematic annual search of peer-reviewed and gray literature relevant to global emergency medicine (EM) to identify, review, and disseminate the most rigorously conducted and widely relevant research in global EM. ⋯ In 2018, the total number of articles relevant to global EM that were identified by our search continued to increase. Studies and reviews focusing on pediatric infections, several new and traditionally underrepresented topics, and landscape reviews that may help guide clinical care in new settings represented the majority of top-scoring articles. A shortage of articles related to the development of EM as a specialty was identified.
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Multicenter Study Clinical Trial Observational Study
Risk Factors for Sedation-Related Events During Acute Agitation Management in The Emergency Department.
The objective was to describe the incidence, nature, and risk factors for adverse events (AEs) among patients who received parenteral sedation for acute agitation in an emergency department (ED) setting. ⋯ Sedation-related AEs are common, especially respiratory events. Elderly patients, sedation with multiple sedatives within 60 minutes, and alcohol intoxication increased the risk.
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Public Deliberation as a Novel Method for an Exception from Informed Consent Community Consultation.
Community consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community's values and opinions about informed consent procedures for a pediatric trauma trial. ⋯ Structured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.