Olola C H O, Missinou M A, Issifou S, Anane-Sarpong E, Abubakar I, Gandi J N, Chagomerana M, Pinder M, Agbenyega T, Kremsner P G, Newton C R J C, Wypij D, Taylor T E
Kenya Medical Research Institute, Centre for Geographic Medicine Research - Coast.
Methods Inf Med. 2006;45(5):483-91.
Computers are widely used for data management in clinical trials in the developed countries, unlike in developing countries. Dependable systems are vital for data management, and medical decision making in clinical research. Monitoring and evaluation of data management is critical. In this paper we describe database structures and procedures of systems used to implement, coordinate, and sustain data management in Africa. We outline major lessons, challenges and successes achieved, and recommendations to improve medical informatics application in biomedical research in sub-Saharan Africa.
A consortium of experienced research units at five sites in Africa in studying children with disease formed a new clinical trials network, Severe Malaria in African Children. In December 2000, the network introduced an observational study involving these hospital-based sites. After prototyping, relational database management systems were implemented for data entry and verification, data submission and quality assurance monitoring.
Between 2000 and 2005, 25,858 patients were enrolled. Failure to meet data submission deadline and data entry errors correlated positively (correlation coefficient, r = 0.82), with more errors occurring when data was submitted late. Data submission lateness correlated inversely with hospital admissions (r = -0.62).
Developing and sustaining dependable DBMS, ongoing modifications to optimize data management is crucial for clinical studies. Monitoring and communication systems are vital in multi-center networks for good data management. Data timeliness is associated with data quality and hospital admissions.
与发展中国家不同，计算机在发达国家的临床试验数据管理中被广泛使用。可靠的系统对于数据管理以及临床研究中的医学决策至关重要。数据管理的监测和评估至关重要。在本文中，我们描述了用于在非洲实施、协调和维持数据管理的系统的数据库结构和程序。我们概述了主要经验教训、面临的挑战和取得的成功，以及改善撒哈拉以南非洲生物医学研究中医学信息学应用的建议。
非洲五个地点的一组经验丰富的研究单位组成了一个新的临床试验网络——非洲儿童重症疟疾，研究患有疾病的儿童。2000年12月，该网络引入了一项涉及这些医院站点的观察性研究。经过原型设计后，实施了关系数据库管理系统用于数据录入和验证、数据提交以及质量保证监测。
2000年至2005年期间，共招募了25858名患者。未按时提交数据与数据录入错误呈正相关（相关系数，r = 0.82），数据提交延迟时错误更多。数据提交延迟与住院人数呈负相关（r = -0.62）。
开发和维持可靠的数据库管理系统，持续进行修改以优化数据管理对于临床研究至关重要。监测和通信系统对于多中心网络中的良好数据管理至关重要。数据及时性与数据质量和住院人数相关。
