Real-world replication of randomized controlled trial results for carotid endarterectomy
Real-world replication of randomized controlled trial results for carotid endarterectomy
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DOI：
10.1001/archneur.64.10.1496
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发表时间：
2007-10-01
影响因子：
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通讯作者：
Ghali, William A.
中科院分区：
文献类型：
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作者：
Feasby, Thomas E.;Kennedy, James;Ghali, William A.
背景：颈动脉内膜剥脱术(CE)的有效性已在随机临床试验(RCT)中得到证实，但该结果是否能在常规临床实践中复制仍存在疑问，特别是在无症状患者中，这些试验显示的绝对风险降低很小。特别是，随着时间的推移，CE的长期益处需要较低的短期不良事件发生率。目的：确定CE术后短期不良事件的发生率是否符合主要RCT建立的标准和主要临床实践指南推荐的标准。设计、设置和患者：我们使用来自全面病历回顾的临床详细数据来衡量CE的短期不良结果，重点是住院死亡和中风，并将结果与RCT的结果进行比较。结果：对于有症状的患者，住院期间缺血性卒中或病死率为3.9%；对于无症状的患者，这一比例为2.6%。将我们的住院结果外推到CE后30天的随机对照试验结果显示，有症状患者的中风或死亡率为4.9%，无症状患者的中风或死亡率为4.1%。这些结果与有症状患者的主要随机对照试验结果相当或更好，但对无症状患者略差。约45%的医院不良事件发生率高于权威临床实践指南的推荐值。结论：这项基于人群的大规模研究表明，针对CE的随机对照试验结果在现实世界中是可以实现的。然而，一些医院的不良事件超过了建议的最高比率，这一发现突显了持续监测结果和相关质量改进努力的必要性，以确保所有相关提供者和机构实现预期结果。
Background: The efficacy of carotid endarterectomy (CE) has been shown in randomized clinical trials (RCTs), but doubts remain about whether the results can be replicated in routine clinical practice, especially in asymptomatic patients for whom the absolute risk reduction shown in the trials is small. In particular, a low rate of short-term adverse events is required for the long-term benefits of CE to accrue over time.Objective: To determine whether the incidence of short-term adverse events after CE met the standards established by the major RCTs and those recommended by major clinical practice guidelines.Design, Setting, and Patients: We used clinically detailed data derived from a comprehensive medical record review to measure the short-term adverse outcomes of CE, focusing on in-hospital death and stroke, in 3283 cases in western Canada in 2000 and 2001, and compared the results with those from the RCTs.Results: For symptomatic patients, the in-hospital ischemic stroke or death rate was 3.9%; for asymptomatic patients, the rate was 2.6%. Extrapolating our in-hospital results to the 30-day post-CE results of the RCTs gave stroke or death rates of 4.9% for cases involving symptomatic patients and 4.1% for cases involving asymptomatic patients. These results are comparable to or better than those of the major RCTs for symptomatic patients but slightly worse for asymptomatic patients. About 45% of hospitals had adverse event rates higher than those recommended by authoritative clinical practice guidelines.Conclusions: This large population-based study shows that the RCT results for CE can be achieved in the real world. However, the finding that some hospitals exceeded the maximum suggested rates of adverse events highlights the need for continuous outcome monitoring and associated quality improvement efforts to ensure that all providers and institutions involved achieve desired outcomes.