ENSURING RELIABILITY OF OUTCOME MEASURES IN MULTICENTER CLINICAL-TRIALS OF TREATMENTS FOR ACUTE ISCHEMIC STROKE - THE PROGRAM DEVELOPED FOR THE TRIAL OF ORG-10172 IN ACUTE STROKE TREATMENT (TOAST)
ENSURING RELIABILITY OF OUTCOME MEASURES IN MULTICENTER CLINICAL-TRIALS OF TREATMENTS FOR ACUTE ISCHEMIC STROKE - THE PROGRAM DEVELOPED FOR THE TRIAL OF ORG-10172 IN ACUTE STROKE TREATMENT (TOAST)
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DOI：
10.1161/01.str.25.9.1746
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发表时间：
1994-09-01
期刊：
影响因子：
8.3
通讯作者：
MARLER, JR
中科院分区：
文献类型：
--
作者：
ALBANESE, MA;CLARKE, WR;MARLER, JR
背景和目的确保临床试验中使用的结局指标的可靠性和有效性对试验的成功至关重要。急性中风治疗（吐司）的试验是一个多中心的临床试验，是招募急性缺血性中风的患者在医疗中心看到在美国各地。方法本文介绍了一种方法来训练医生使用三个临床措施：美国国立卫生研究院（NIH）中风量表，补充运动检查，和格拉斯哥结局量表。该计划包括教育、认证、必要时的补救、监测和可靠性评估。我们的目标是确保评估者之间的评估尽可能地相互等效。结果在开始认证过程的前95名临床医生中，有75名在第一次评估中通过。其他18名医生在补救后能够完成这一过程。NIH卒中量表和补充运动检查的组内相关性均超过0.95。格拉斯哥结局量表的kappa值分别为0.61和0.62的第一和第二评级的录像带，分别为Conclusions我们的经验表明，一个程序，包括教育和认证过程可以作为设计的一部分，一个多中心的临床试验。向每个研究中心提供教育和测试录像带，以便医生接受培训和认证，这种方法是一种有效、廉价和实用的方法，可以增强和认证参与多中心研究的大量医生的专业知识。
Background and Purpose Ensuring the reliability and validity of outcome measures used in clinical trials is essential to the success of the trial. The Trial of Org 10172 in Acute Stroke Treatment (TOAST) is a multicenter clinical trial that is recruiting patients with acute ischemic stroke seen at medical centers across the United States.Methods This paper describes an approach to train physicians to use three clinical measures: the National Institutes of Health (NIH) Stroke Scale, a supplemental motor examination, and the Glasgow Outcome Scale. The program included education, certification, remediation when needed, monitoring, and reliability assessment. The goal was to ensure that interrater assessments were as equivalent to one another as possible.Results Of the first 95 clinicians who began the certification process, 75 passed during the first evaluation. Eighteen of the other physicians were able to complete the process after remediation. The intraclass correlations of both the NIH Stroke Scale and supplemental motor examination exceeded 0.95. The kappa values for the Glasgow Outcome Scale were 0.61 and 0.62 for the first and second ratings of the videotape, respectively.Conclusions Our experience suggests that a program that includes educational and certification processes can be performed as part of the design of a multicenter clinical trial. The method of providing educational and testing videotapes to each site so that physicians can be trained and certified is an effective, inexpensive, and practical approach for enhancing and certifying the expertise of the large number of physicians involved in a multicenter study.