Reese P A, Bundy B N, Colombano S P, Blessing J A
J Med Syst. 1983 Jun;7(3):235-42. doi: 10.1007/BF00993285.
The Gynecologic Oncology Group (GOG) is a multiinstitutional, multidisciplinary cooperative group. Its clinical trials encompass the planning, initiation, execution, analysis, and presentation of results of management and treatment of patients with gynecologic cancer. The GOG Statistical Office, located at Roswell Park Memorial Institute, is responsible for data management and analysis of all patients entered into GOG protocols. Present annual accrual is approximately 1,600 patients; 37 protocols are active, while follow-up continues on 9 studies that are closed to patient entry. RPMIS is a formatted video-based system of programs for file creation, data entry, editing, updating, retrieval, and report generation. It has been utilized in more than 500 intrainstitutional research studies at Roswell Park. In the past, data management for the GOG had been based on computer entry via punched cards, and on hand-filled reports. The switch to RPMIS used required major reorganization of the data-handling process and was first attempted on a limited basis. As the advantages of RPMIS became evident, the whole data management operation was gradually converted to the new system. In this paper, batch processing and RPMIS utilization are compared and contrasted in terms of time saved, human engineering, quality control, and satisfaction of information requests.
妇科肿瘤研究组(GOG)是一个多机构、多学科的合作组织。其临床试验涵盖妇科癌症患者管理与治疗结果的规划、启动、实施、分析及结果呈现。位于罗斯威尔帕克纪念研究所的GOG统计办公室负责对所有进入GOG方案的患者进行数据管理和分析。目前每年入组患者约1600例;有37项方案正在实施,同时对9项已停止入组患者的研究继续进行随访。RPMIS是一个基于格式化视频的程序系统,用于文件创建、数据录入、编辑、更新、检索和报告生成。它已在罗斯威尔帕克超过500项机构内研究中得到应用。过去,GOG的数据管理基于穿孔卡片的计算机录入和手工填写报告。向RPMIS的转换需要对数据处理流程进行重大重组,最初是在有限范围内尝试。随着RPMIS的优势变得明显,整个数据管理操作逐渐转换为新系统。本文从节省时间、人体工程学、质量控制和信息请求满意度等方面对批处理和RPMIS的使用进行了比较和对比。