Picking the good apples: statistics versus good judgment in choosing stent operators for a multicenter clinical trial.

Academic Article

Abstract

  • BACKGROUND AND PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
  • Published In

  • Stroke  Journal
  • Keywords

  • clinical trial, quality control, stroke, Cerebral Revascularization, Choice Behavior, Clinical Competence, Endarterectomy, Carotid, Humans, Judgment, Physicians, Prospective Studies, Stents
  • Digital Object Identifier (doi)

    Author List

  • Howard G; Voeks JH; Meschia JF; Howard VJ; Brott TG
  • Start Page

  • 3325
  • End Page

  • 3329
  • Volume

  • 45
  • Issue

  • 11