Standardized Methods for Enhanced Quality and Comparability of Tuberculous Meningitis Studies.
Standardized Methods for Enhanced Quality and Comparability of Tuberculous Meningitis Studies.
复制标题
DOI：
10.1093/cid/ciw757
复制
发表时间：
2017-02-15
期刊：
影响因子：
--
通讯作者：
Tuberculous Meningitis International Research Consortium
中科院分区：
文献类型：
--
作者：
Marais BJ;Heemskerk AD;Marais SS;van Crevel R;Rohlwink U;Caws M;Meintjes G;Misra UK;Mai NTH;Ruslami R;Seddon JA;Solomons R;van Toorn R;Figaji A;McIlleron H;Aarnoutse R;Schoeman JF;Wilkinson RJ;Thwaites GE;Tuberculous Meningitis International Research Consortium
这一观点定义了结核性脑膜炎核心数据集，包括人口统计和临床信息、关键患者管理和监测数据以及患者结果的标准化报告。标准化方法的广泛采用将为改善患者预后提供强有力的证据基础。结核性脑膜炎（TBM）仍然是结核病流行地区死亡和残疾的主要原因，特别是在幼儿和免疫功能低下的成年人中。旨在改善结果的研究受到标准化程度低下的阻碍，这限制了研究的比较和结果的可推广性。在牛津大学越南临床研究中心组织的国际结核性脑膜炎研究会议上，我们提出了开展TBM临床研究的标准化方法。我们提出了一个核心数据集，包括在研究入组时收集的人口统计和临床信息，与患者管理和监测相关的重要方面，以及患者结果的标准化报告。为开展观察性和干预性TBM研究提出的标准应提高未来研究成果的质量，促进多中心研究和汇总数据的荟萃分析，并为建立全球TBM数据库奠定基础。
This viewpoint defines a tuberculous meningitis core dataset, including demographic and clinical information, key patient management and monitoring data, and standardized reporting of patient outcomes. Wide adoption of standardized methods will provide a robust evidence base to improve patient outcomes. Tuberculous meningitis (TBM) remains a major cause of death and disability in tuberculosis-endemic areas, especially in young children and immunocompromised adults. Research aimed at improving outcomes is hampered by poor standardization, which limits study comparison and the generalizability of results. We propose standardized methods for the conduct of TBM clinical research that were drafted at an international tuberculous meningitis research meeting organized by the Oxford University Clinical Research Unit in Vietnam. We propose a core dataset including demographic and clinical information to be collected at study enrollment, important aspects related to patient management and monitoring, and standardized reporting of patient outcomes. The criteria proposed for the conduct of observational and intervention TBM studies should improve the quality of future research outputs, can facilitate multicenter studies and meta-analyses of pooled data, and could provide the foundation for a global TBM data repository.