Unsolicited R24 for the CFAR-Network of Integrated Clinical Sciences, CNICS

描述（由申请人提供）： 在高活性抗逆转录病毒疗法（HAART）时代，HIV/AIDS的临床治疗是极其动态的，具有前所未有的疗法组合和无数的患者和病毒学对疗法的反应。长期结果研究是必要的，以提供临床医生的最佳策略，在他们的病人的个人情况采用最新的信息。从历史上看，临床护理决策的证据是通过随机对照临床试验、基于流行病学的前瞻性临床队列和轶事报告产生的。与这些方法协同作用的一种新方法是基于利用直接来自新开发的电子病历（EMR）系统的数据并将这些数据编译成新的研究网络的结果研究。这样的EMR系统已经存在于美国的几个艾滋病研究中心（CFAR）。 CFAR综合临床系统网络（CNICS）项目是第一个可以为当代艾滋病毒研究议程做出重大贡献的资源网络。作为一个以诊所为基础的研究网络，CNICS直接反映了艾滋病毒感染者护理中日常使用的临床决策和管理方案的结果。与通过结构化访谈或通过回顾性病历审查收集的数据不同，国家信息控制系统通过在护理点收集数据，确保了与艾滋病毒疾病管理的快速变化过程有关的更广泛的信息。该系统是一个中央储存库，储存来自7个CFAR地点的电子监测报告的经核实和质量控制的数据。为个别病人护理记录的电子病历数据可通过国家信息和通信系统提供，用于基于人口的结果研究，这有助于联网，并有助于国家信息和通信系统数据系统所载数据的标准化。CNICS还正在开发一个与来自各站点电子病历的临床数据相关联的标本库。 CNICS是HIV临床、转化和基础研究的独特资源，将提供 基础设施和数据，以解决艾滋病毒护理和研究中具有挑战性和迅速发展的问题。这项建议的主要目标是建立和支持信息中心的基础设施，处理不断演变的艾滋病毒流行病这一具有挑战性的研究议程，通过制定标准作业程序和软件工具为扩大信息中心做好准备，以促进数据质量控制和传输，在5年内将信息中心扩大8至10个地点，并作为发展类似研究网络的资源。

DESCRIPTION (provided by applicant): The clinical treatment of HIV/AIDS in the era of Highly Active Anti-Retroviral Therapy (HAART) is extremely dynamic with unprecedented combinations of therapies and a myriad of patient and virologic responses to therapy. Long-term outcomes research is necessary to provide clinicians with up-to-date information on the best strategies to employ in their patients' individual situations. Historically, evidence for clinical care decisions has been generated through the conduct of randomized controlled clinical trials, epidemiology-based prospective clinical cohorts, and anecdotal reports. A new approach that will synergize with these methods is outcomes research based on the utilization of data derived directly from newly developed electronic medical record (EMR) systems and compiling such data into novel research networks. Such EMR systems are already in existence at several Centers for AIDS Research (CFAR) sites in the United States. The CFAR Network of Integrated Clinical Systems (CNICS) project is the first such resource network that can substantially contribute to the contemporary HIV research agenda. As a clinic-based research network, CNICS directly reflects the outcomes of clinical decisions and management options used daily in the care of HIV infected individuals. Unlike data collected in structured interviews or through retrospective medical record review, CNICS assures a broader range of information associated with the rapidly changing course of HIV disease management through collection of data at the point of care. The CNICS project supports a data system that is a central repository of verified and quality-controlled data from the EMRs at seven CFAR sites. The EMR data recorded for individual patient care are made available through CNICS for population-based outcomes research, which facilitates networking and contributes to the standardization of data contained in the CNICS data system. CNICS is also developing a specimen repository linked with clinical data from the sites' EMRs. CNICS is a unique resource for HIV clinical, translational, and basic research and will provide the infrastructure and data to address the challenging and rapidly evolving issues in HIV care and research. The principle goals of this proposal are to build and support the CNICS infrastructure, to address the challenging research agenda of the evolving HIV epidemic, to prepare for the expansion of CNICS by developing standard operating procedures and software tools to facilitate data quality control and transmission, to expand CNICS by 8 to 10 sites within 5 years, and to serve as a resource for the development of similar research networks.