Department of Global Biostatistics and Data Science, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, United States of America.
Departments of Pediatrics and Internal Medicine, Sections of Pediatric & Adult Infectious Diseases, School of Medicine, Tulane University, New Orleans, Louisiana, United States of America.
PLoS One. 2019 Mar 28;14(3):e0214284. doi: 10.1371/journal.pone.0214284. eCollection 2019.
Situated in southeastern Sierra Leone, Kenema Government Hospital (KGH) maintains one of the world's only Lassa fever isolation wards and was a strategic Ebola virus disease (EVD) treatment facility during the 2014 EVD outbreak. Since 2006, the Viral Hemorrhagic Fever Consortium (VHFC) has carried out research activities at KGH, capturing clinical and laboratory data for suspected cases of Lassa fever. Here we describe the approach, progress, and challenges in designing and maintaining a data capture and management system (DCMS) at KGH to assist infectious disease researchers in building and sustaining DCMS in low-resource environments. Results on screening patterns and case-fatality rates are provided to illustrate the context and scope of the DCMS covered in this study. A medical records system and DCMS was designed and implemented between 2010 and 2016 linking historical and prospective Lassa fever data sources across KGH Lassa fever units and its peripheral health units. Data were captured using a case report form (CRF) system, enzyme-linked immunosorbent assay (ELISA) plate readers, polymerase chain reaction (PCR) machines, blood chemistry analyzers, and data auditing procedures. Between 2008 and 2016, blood samples for 4,229 suspected Lassa fever cases were screened at KGH, ranging from 219 samples in 2008 to a peak of 760 samples in 2011. Lassa fever case-fatality rates before and following the Ebola outbreak were 65.5% (148/226) and 89.5% (17/19), respectively, suggesting that fewer, but more seriously ill subjects with Lassa fever presented to KGH following the 2014 EVD outbreak (p = .040). DCMS challenges included weak specificity of the Lassa fever suspected case definition, limited capture of patient survival outcome data, internet costs, lapses in internet connectivity, low bandwidth, equipment and software maintenance, lack of computer teaching laboratories, and workload fluctuations due to variable screening activity. DCMS are the backbone of international research efforts and additional literature is needed on the topic for establishing benchmarks and driving goal-based approaches for its advancement in developing countries.
位于塞拉利昂东南部的凯内马政府医院（KGH）拥有世界上仅有的拉沙热隔离病房之一，并且在 2014 年埃博拉疫情爆发期间是埃博拉病毒病（EVD）的战略治疗设施。自 2006 年以来，病毒出血热联盟（VHFC）一直在 KGH 开展研究活动，为疑似拉沙热病例采集临床和实验室数据。在这里，我们描述了在 KGH 设计和维护数据采集和管理系统（DCMS）的方法、进展和挑战，以帮助传染病研究人员在资源匮乏的环境中建立和维持 DCMS。提供筛查模式和病死率的结果，以说明本研究中涵盖的 DCMS 的背景和范围。在 2010 年至 2016 年期间，设计并实施了一个医疗记录系统和 DCMS，将 KGH 拉沙热病房及其周边卫生单位的历史和前瞻性拉沙热数据源链接起来。使用病例报告表（CRF）系统、酶联免疫吸附测定（ELISA）板阅读器、聚合酶链反应（PCR）机器、血液化学分析仪和数据审核程序来捕获数据。2008 年至 2016 年期间，KGH 共筛查了 4229 例疑似拉沙热病例的血液样本，样本量从 2008 年的 219 例到 2011 年的峰值 760 例不等。埃博拉疫情爆发前后，拉沙热病死率分别为 65.5%（148/226）和 89.5%（17/19），这表明，埃博拉疫情爆发后，前往 KGH 的拉沙热患者人数减少，但病情更严重（p=0.040）。DCMS 面临的挑战包括拉沙热疑似病例定义的特异性较弱、患者生存结局数据的采集有限、网络成本、网络连接中断、低带宽、设备和软件维护、缺乏计算机教学实验室以及由于筛查活动的变化导致的工作量波动。DCMS 是国际研究工作的骨干，需要更多关于该主题的文献，以建立基准，并为发展中国家推进 DCMS 提供基于目标的方法。
