JAMA : the journal of the American Medical Association
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Randomized Controlled Trial Multicenter Study Clinical Trial
Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.
To determine whether the addition of carotid endarterectomy to aggressive medical management can reduce the incidence of cerebral infarction in patients with asymptomatic carotid artery stenosis. ⋯ Patients with asymptomatic carotid artery stenosis of 60% or greater reduction in diameter and whose general health makes them good candidates for elective surgery will have a reduced 5-year risk of ipsilateral stroke if carotid endarterectomy performed with less than 3% perioperative morbidity and mortality is added to aggressive management of modifiable risk factors.
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized clinical trial of active compression-decompression CPR vs standard CPR in out-of-hospital cardiac arrest in two cities.
To compare the effectiveness of active compression-decompression (ACD) cardiopulmonary resuscitation (CPR) with a handheld suction device vs standard manual CPR in victims of out-of-hospital cardiopulmonary arrest. ⋯ There was no improvement in outcome with ACD CPR in out-of-hospital cardiac arrest in these two cities. Differences in study design, demographics, EMS systems, response intervals, training, and technique performance may contribute to the lack of improvement in initial resuscitation with ACD CPR compared with previous studies. Future research needs to control these variables to determine the reason for these differences in outcome.
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A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research. ⋯ We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.