Surgical results: a justification of the surgeon selection process for the ACAS trial. The ACAS Investigators.
Surgical results: a justification of the surgeon selection process for the ACAS trial. The ACAS Investigators.
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手术结果：ACAS 试验的外科医生选择过程的合理性。
DOI：
10.1016/s0741-5214(96)70277-x
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发表时间：
1996
影响因子：
4.3
通讯作者：
Howard,VJ
中科院分区：
文献类型：
--
作者：
Moore,WS;Young,B;Baker,WH;Robertson,JT;Toole,JF;Vescera,CL;Howard,VJ
目的选择外科医生参与前瞻性随机试验，比较手术方法与药物治疗的疗效，这是至关重要的，因为它将直接影响研究的结果和手术的未来使用。我们报告的成功的方法用于选择外科医生谁参加了无症状颈动脉粥样硬化研究（ACAS）通过检查手术的发病率和死亡率和outcome of the study.MethodsA手术管理委员会建立了审计外科医生谁愿意参加这项研究的标准。这些参数包括每年至少12例颈动脉内膜切除术（CEA）的最低性能和每位外科医生最近50次连续CEA的审计，其中无症状患者的综合神经系统发病率和死亡率<3.0%，所有适应症（包括有症状患者）的综合神经系统发病率和死亡率<5.0%。来自48个医疗中心的164名外科医生申请参加ACAS。117例获得批准，他们5641例手术的综合经验得出无症状和有症状患者的合并神经系统发病率和死亡率为2.3%。CEA对无症状患者的发病率和死亡率为1.7%。这些外科医生，加上1991年2月以后招募的外科医生，成为ACAS试验的研究者，负责825例随机分配到手术组的患者的手术护理，其中724例患者实际接受了CEA。在30天围手术期内，1例患者（0.14%）死亡，10例患者（1.38%）发生卒中，卒中或死亡的合并发生率为1.52%。5年中风事件发生率在手术组（包括围手术期发病率和死亡率）为5.1%，相比之下，11%的患者接受药物治疗，产生的相对风险降低53%，有利于手术（p =0.004）。这实质上影响了有利于CEA的研究结果。（J VASC SURG 1996;23：323-8.）
PurposeThe selection of surgeons to participate in a prospective randomized trial comparing the efficacy of a surgical method with medical management is critically important because it will have a direct impact on the outcome of the study and the future use of the operation. We report the success of the method used for selecting surgeons who participated in the Asymptomatic Carotid Atherosclerosis Study (ACAS) by examining the surgical morbidity and mortality rates and the outcome of the study.MethodsA Surgical Management Committee established criteria for auditing surgeons who wished to participate in the study. The parameters included a minimum performance of at least 12 carotid endarterectomies (CEA) per year and an audit of each surgeon's last 50 consecutive CEAs with required documentation of a combined neurologic morbidity and mortality rate of <3.0% for asymptomatic patients and <5.0% for all indications including symptomatic patients.ResultsAs of February 1991, 164 surgeons from 48 medical centers applied for ACAS participation. One hundred seventeen were approved, and their aggregate experience of 5641 operations yielded a combined neurologic morbidity and mortality rate of 2.3% for asymptomatic and symptomatic patients combined. The morbidity and mortality rate for CEA on asymptomatic patients was 1.7%. These surgeons, plus those recruited after February 1991, became investigators in the ACAS trial and were responsible for the surgical care of 825 patients who were randomized to the surgical arm. Seven hundred twenty-four patients actually underwent CEA. One patient (0.14%) died and ten patients (1.38%) had strokes within the 30-day perioperative interval, for a combined stroke or death incidence of 1.52%. The 5-year stroke event rate in the surgical group (including perioperative morbidity and mortality rates) was 5.1%, compared with 11% of patients treated medically, yielding a relative risk reduction of 53% in favor of surgery ( p =0.004).ConclusionsA method for selecting surgeons for participation in the ACAS trial was successful in providing low perioperative morbidity and mortality rates. This materially influenced the outcome of the study in favor of CEA. (J VASC SURG 1996;23:323-8.)