The role of the emergency department in acute heart failure clinical trials--enriching patient identification and enrollment.
The role of the emergency department in acute heart failure clinical trials--enriching patient identification and enrollment.
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急诊科在急性心力衰竭临床试验中的作用——丰富患者识别和入组。
DOI：
10.1016/j.ahj.2013.03.009
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发表时间：
2013
影响因子：
4.8
通讯作者：
Gheorghiade,Mihai
中科院分区：
文献类型：
--
作者：
Collins,SeanP;Levy,PhillipD;Pang,PeterS;Gheorghiade,Mihai
每年有100万急性心力衰竭（AHF）住院患者中有近80万人最初由急诊医生治疗。体征和症状通常在最初表现时最严重，但通过及时的诊断和治疗管理，可以实现快速改善。直接结果是，急诊医生为AHF的初始管理定下了基调。他们决定早期治疗决策，并决定患者是否入院或出院，如果入院，应该采取何种适当的初始护理水平（即观察，遥测，重症监护病房状态）。尽管这一关键作用，急诊科（艾德）阶段的管理往往被忽视的AHF的研究和临床试验。因此，目前对AHF患者病程早期的了解还很差，表型特征也很有限。因此，符合特定治疗干预条件的AHF患者的比例并不清楚。此外，由于AHF临床试验的传统方法依赖于基于心脏病学的研究团队在艾德表现后24小时内识别患者，因此经常错过接受非心脏病学服务的患者，并且那些被捕获的患者往往在初始治疗改善急性症状后很久才被招募。这导致心力衰竭临床试验的入组率较低，约为每个研究中心每月0.41例患者。我们描述的景观初始艾德管理，解释这可能混淆临床试验的结果，并提供一个多维的模板，成功的艾德/心脏病学合作，旨在提高患者的招募和AHF临床试验在美国的进行。
Nearly 800,000 of the 1 million patients hospitalized with acute heart failure (AHF) every year are initially treated by emergency physicians. Signs and symptoms are typically most severe at initial presentation, but with timely diagnostic and therapeutic management, rapid improvement can be achieved. As a direct result, emergency physicians set the tone for initial AHF management. They dictate early treatment decisions and determine whether patients are admitted or discharged and, if admitted, what the appropriate initial level of care should be (ie, observation, telemetry, intensive care unit status). Despite this key role, the emergency department (ED) phase of management is often overlooked in AHF research and clinical trials. Consequently, present understanding of AHF patients early in their course is poor, and phenotypic characterization has been limited. As a result, the proportion of AHF patients eligible for a given therapeutic intervention is not well known. Moreover, because the traditional approach to AHF clinical trials has relied on cardiology-based research teams to identify patients up to 24 hours after ED presentation, patients admitted to noncardiology services are often missed, and those who are captured tend to be enrolled long after initial therapy has improved acute symptoms. This has resulted in low-enrollment heart failure clinical trials, which has been approximated at 0.41 patients per site per month. We describe the landscape of initial ED management, explain how this may confound clinical trial results, and provide a multidimensional template for successful ED/cardiology collaboration aimed at improving patient enrollment and the conduct of AHF clinical trials in the United States.