Howard George, Voeks Jenifer H, Meschia James F, Howard Virginia J, Brott Thomas G
From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), University of Alabama at Birmingham, School of Public Health; Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Department of Neurology, Mayo Clinic Jacksonville, FL (J.F.M., T.G.B.).
Stroke. 2014 Nov;45(11):3325-9. doi: 10.1161/STROKEAHA.114.006807. Epub 2014 Sep 11.
The Carotid Revascularization Endarterectomy Versus Stenting Trial was completed with a low stroke and death rate. A lead-in series of patients receiving carotid artery stenting was used to select the physician-operators for the study, where performance was evaluated by complication rates and by peer review of cases. Herein, we assess the potential contribution of statistical evaluation of complication rates.
The ability to discriminate between stent operators who can successfully meet the published guideline of <3% combined rate of stroke and death is calculated under the binomial distribution, based on a small consecutive case series (n=24 patients).
A criterion of ≤2 stroke or death events among the 24 patients (<8% event rate) was required of operators. Setting such a high criterion, however, ensures an inability to exclude operators who cannot meet the criteria. In fact, if a good operator is defined as having a 2% event rate and a poor operator as a 6% event rate, even a series of 240 patients would (on average) still exclude 5.4% of the good operators and include 4.6% of the poor operators.
The low periprocedural event rates in the trial suggest success in separating skillful operators from less skillful. However, it seems unlikely that statistical assessment of event rates in the lead-in contributed to successful selection, but rather successful selection was more likely because of peer review of subjective and other factors including patient volume and technical approaches.
http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
颈动脉血运重建术内膜切除术与支架置入术试验以低卒中及死亡率完成。一系列先行接受颈动脉支架置入术的患者被用于挑选参与研究的医生操作者，通过并发症发生率及病例同行评审来评估其表现。在此，我们评估并发症发生率统计评估的潜在作用。
基于一个小的连续病例系列（n = 24例患者），在二项分布下计算区分能够成功达到已发表的卒中与死亡率合并率<3%指南的支架操作者的能力。
要求操作者在24例患者中发生≤2次卒中或死亡事件（事件发生率<8%）。然而，设定如此高的标准会确保无法排除不符合标准的操作者。事实上，如果将优秀操作者定义为事件发生率为2%，差的操作者定义为事件发生率为6%，即使是一系列240例患者（平均而言）仍会排除5.4%的优秀操作者，并纳入4.6%的差的操作者。
试验中围手术期事件发生率低表明在区分熟练操作者与不太熟练操作者方面取得了成功。然而，先行期事件发生率的统计评估似乎并未有助于成功选拔，更有可能的是，成功选拔是由于对主观因素及包括患者数量和技术方法在内的其他因素的同行评审。
