ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER

眼内炎玻璃体切除术研究(EVS)是一项前瞻性、随机、 旨在确定平坦部的作用的多中心临床试验 玻璃体切割术在细菌性玻璃体损伤早期治疗中的应用 眼内炎。这是一个用作协调中心的应用程序 对于这项研究，主要负责研究组织、数据 管理和统计分析。随附的学习椅 申请书提出了研究方案，并作为附录包括 手工操作和数据采集表。 来自加州大学流行病学数据中心的研究人员 匹兹堡建议继续与研究主席和其他人合作 临床研究人员将对研究方案、手册进行最终修订 业务和数据收集表格。协调中心将设在 负责制定随机方案、中期监测和 向安全和数据监测委员会报告。数据将是 在IBM数据中心系统上接收、处理和管理 微型计算机和大型计算机VAX。这项试验将比较治疗 眼内炎的治疗策略和“治疗意向”将是 主要的分析方法。将开发和测试分析方法 在数据采集阶段和最终分析和报告期间 在最后一个阶段中生成。

The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.