Regulatory challenges for the resuscitation outcomes consortium.
Regulatory challenges for the resuscitation outcomes consortium.
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DOI：
10.1161/circulationaha.107.764084
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发表时间：
2008-10-07
期刊：
影响因子：
37.8
通讯作者：
Resuscitation Outcomes Consortium Investigators
中科院分区：
文献类型：
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作者：
Tisherman SA;Powell JL;Schmidt TA;Aufderheide TP;Kudenchuk PJ;Spence J;Climer D;Kelly D;Marcantonio A;Brown T;Sopko G;Kerber R;Sugarman J;Hoyt D;Resuscitation Outcomes Consortium Investigators
复苏研究具有挑战性，但至关重要，因为对许多危及生命的疾病几乎没有有效的治疗方法。在美国，心血管疾病一直是导致死亡和发病的主要原因。尽管估计各不相同，但美国心脏协会估计，美国每年有15万例院外心脏骤停，尽管医学上取得了进展，但存活率几乎没有改善(5%)。2造成严重失血性休克或创伤性脑损伤的创伤性损伤是1至44岁儿童死亡的主要原因，也是导致发病的主要原因。3为了使治疗在这些危及生命的情况下有效，必须立即给予治疗，通常是在事件发生的地点。4因此，研究人员和监管机构发现，知情同意的典型标准不能适用于紧急情况。2004年，国家心肺血液研究所组织了复苏结果联盟(ROC)，对创伤和心脏骤停的新疗法进行同时的院前研究。该财团由美国和加拿大的11个地区中心和一个数据协调中心组成。
Resuscitation research is challenging but vital because few effective therapies exist for a number of life-threatening conditions. Cardiovascular disease has been a leading cause of death and morbidity in the United States. Although estimates vary, the American Heart Association estimates 150 000 out-of-hospital cardiac arrests each year in the United States, 1 with little improvement in survival (5%) despite medical advances. 2 Traumatic injury, resulting in severe hemorrhagic shock or traumatic brain injury, is the leading cause of death in persons 1 to 44 years of age and is a leading cause of morbidity. 3 For treatments to be effective in these life-threatening situations, they must be administered immediately, usually at the site of the event. 4 Consequently, researchers and regulatory agencies find that typical standards for informed consent cannot be applied in the emergency setting.In 2004, the National Heart, Lung and Blood Institute organized the Resuscitation Outcomes Consortium (ROC) to conduct simultaneous prehospital studies of novel therapies for trauma and cardiac arrest. The consortium consists of 11 regional centers in the United States and Canada and a data coordinating center.