Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
HIV Med. 2011 May;12(5):269-78. doi: 10.1111/j.1468-1293.2010.00879.x. Epub 2010 Oct 18.
New forms of HIV/AIDS therapy require new surveillance instruments to meet shifting public health demands. The Clinical Surveillance of HIV Disease (ClinSurv HIV) project was established in 1999 as a collaboration between major HIV treatment centres in Germany and the Robert Koch Institute (RKI). The project contributes to national HIV surveillance and focuses on the changing epidemiology of HIV/AIDS after the introduction of new therapies in 1995.
ClinSurv HIV is designed as an open multicentre observational cohort study of HIV-infected patients. Anonymized data on diagnoses, treatment and laboratory parameters are collected in a standardized format. Data are currently sampled biannually via 11 centres specializing in HIV diagnosis and care within the legal framework of the German Protection against Infection Act [Infektionsschutzgesetz (IfSG)].
A total of 14874 patients were enrolled in the study by 30 June 2009. Of these, 10221 patients (68.7%) were enrolled after 1 January 1999 and 6006 patients (40.4%) were known to have been diagnosed as positive for HIV before 1999. Evaluation indicators, such as the number of newly enrolled patients per half-year period, loss to follow-up, completeness of data per case, availability of data per possible clinical contact, and internal quality control parameters, show a very stable evolution in the cohort, which although open, can be observed. Comparison with the national HIV surveillance data suggests a high degree of representativeness according to major demographic variables.
Bearing in mind the obvious strengths and weaknesses discussed, the German ClinSurv HIV cohort provides a broad range of research opportunities in the field of HIV/AIDS both within Germany and in international collaborative research.
新形式的艾滋病毒/艾滋病治疗需要新的监测手段来满足不断变化的公共卫生需求。临床艾滋病毒疾病监测（ClinSurv HIV）项目于 1999 年成立，是德国主要艾滋病毒治疗中心与罗伯特科赫研究所（RKI）之间的合作项目。该项目为国家艾滋病毒监测做出了贡献，并侧重于 1995 年新疗法引入后艾滋病毒/艾滋病的流行病学变化。
ClinSurv HIV 是一项针对艾滋病毒感染者的开放性多中心观察队列研究。以标准化格式收集有关诊断，治疗和实验室参数的匿名数据。目前，根据德国感染保护法[感染保护法（IfSG）]的法律框架，通过 11 个专门从事艾滋病毒诊断和护理的中心，每两年对数据进行一次抽样。
截至 2009 年 6 月 30 日，共有 14874 名患者入组该研究。其中，10221 名患者（68.7％）在 1999 年 1 月 1 日之后入组，6006 名患者（40.4％）在 1999 年之前被诊断为艾滋病毒阳性。评估指标，如每半年新入组患者的数量，随访丢失，每个病例的数据完整性，每个可能的临床接触的数据可用性以及内部质量控制参数，显示队列非常稳定，尽管是开放的，但可以进行观察。与国家艾滋病毒监测数据的比较表明，根据主要人口统计学变量，该队列具有高度的代表性。
考虑到讨论的明显优势和劣势，德国 ClinSurv HIV 队列在德国和国际合作研究领域为艾滋病毒/艾滋病提供了广泛的研究机会。
