A web-based data management system to improve care for depression in a multicenter clinical trial.
A web-based data management system to improve care for depression in a multicenter clinical trial.
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一个基于网络的数据管理系统，用于改善多中心临床试验中抑郁症的护理。
DOI：
10.1176/ps.53.6.671
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发表时间：
2002
影响因子：
3.8
通讯作者：
S. Oishi
中科院分区：
文献类型：
--
作者：
J. Unützer;Youlim Choi;I. Cook;S. Oishi
在2001年，超过一半的美国人可以访问互联网，许多人使用它来寻求有关抑郁症等健康问题的信息。研究人员也开始使用互联网来支持多中心研究的数据收集（2-5）。在本专栏中，我们描述了一个基于Web的数据管理系统，该系统是为了支持一项针对初级保健中晚年抑郁症的疾病管理项目（项目IMPACT）的多中心试验而开发的（6）。在早期的研究中，我们使用纸质研究记录来跟踪研究招募和干预活动。这些记录被传送到一个协调中心，由研究助理进行清理并输入数据库。这一过程耗费了大量时间和资源，而且在最初生成数据的工作人员不在的情况下，往往无法回答有关数据内容的问题。提供干预服务的临床医生认为计算机化的跟踪和提醒系统比纸质图表系统更有利于他们的临床工作。对于项目IMPACT（6），我们开发了一个基于Web的数据管理系统，18个参与诊所的研究人员可以通过互联网24小时访问该系统。该系统由加州大学洛杉矶分校（UCLA）开发，并在所有参与研究中心的研究人员的帮助下进行了测试。该系统使用运行Mac OS X的Apple Power Mac G3计算机作为服务器（Apple Computer，库比蒂诺，加利福尼亚州）来实现。并且用WebObjects（Apple）和FrontBase SQL数据库（FrontBase，Foothill Ranch，CA）编程。为了确保数据的安全性和完整性，我们使用了与电子商务应用程序中用于保护信用卡信息的技术类似的技术：用户浏览器和服务器之间的所有交换都使用安全套接字层（SSL）协议进行双向加密，以防止窃听，篡改或数据伪造。SSL协议使用128位加密算法，如RC 4，它已成为高级在线隐私保护的标准方法。作为进一步的保障措施，对服务器上所有数据的访问都受到密码保护的控制。不同的用户配置文件允许访问数据库的相关部分。例如，研究临床医生只能查看和编辑自己患者的数据。研究者可以查看其研究中心的招募和干预数据以及所有研究中心的去识别汇总数据，以进行比较。为了确保数据的安全性，我们只使用...
I n 2001 more than half of all Amer-icans had access to the Internet, and many were using it to seek information about health problems such as depression (1). Researchers have also started to use the Internet to support data collection in multicenter studies (2–5). In this column we describe a Web-based data management system developed to support a multicenter trial of a disease management program for late-life depression in primary care (Project IMPACT) (6). In earlier studies, we used paper-based study records to track study recruitment and intervention activities. These records were transmitted to a coordinating center, cleaned, and entered into a database by research assistants. This process consumed a substantial amount of time and resources , and questions about data content often could not be answered in the absence of the staff who had originally generated the data. The cli-nicians who provided intervention services thought that a computerized tracking and reminder system would better facilitate their clinical work than a paper-based charting system. For Project IMPACT (6), we developed a Web-based data management system that can be accessed over the Internet on a 24-hour basis by study staff at 18 participating clinics. The system was developed at the University of California, Los Angeles (UCLA) and was tested with the help of study staff at all participating sites. The system was implemented with use of an Apple Power Mac G3 computer running Mac OS X as a server (Apple Computer, Cupertino, Calif.) and was programmed with WebObjects (Apple) and the FrontBase SQL database (FrontBase, Foothill Ranch, Calif.). To ensure the security and integrity of our data, we used technology similar to that used to protect credit card information in e-commerce applications: all exchanges between a user's browser and the server are two-way encrypted with the secure sockets layer (SSL) protocol to prevent eavesdropping, tampering, or data forgery. SSL protocols use 128-bit cryptography algorithms , such as RC4, which have emerged as standard approaches to high-grade online privacy protection. As a further safeguard, access to all data on the server is controlled by password protection. Different user profiles allow access to relevant sections of the database. For example, study clinicians can view and edit data on their own patients only. Investigators can see recruitment and intervention data for their study site and de-identified summary data for all study sites for comparison. For additional security of the data, we use only …