CureGN

摘要 治疗肾小球疾病研究网络(CureGN)是一个国际多中心的国家肾脏病研究所 糖尿病与消化和肾脏疾病(NIDDK)资助的微小糖尿病患者的观察性研究 疾病改变、局灶性节段性肾小球硬化、膜性肾病或免疫球蛋白A(IgA) 肾病，目的是提高患者对这些情况和结果的了解。自.以来 2014年，CureGN已在60多个临床站点招募了2600多名患者。广泛的临床数据包括 每年收集三次，以确定注册时的病程、治疗和关键结果 前3年学习，此后每年学习两次。为了收集这些数据，协调员浏览临床记录 要查找信息，请将其输入研究的基于网络的数据输入系统(ArborLink)，并响应查询 在季度的基础上，通常需要重新打开临床记录。考虑到几乎普遍采用 电子健康记录(EHR)和医疗保健信息技术的最新进展，机会 利用电子病历提取进行数据收集为CureGN过渡到更多 现代合唱研究。尽管有潜力，但将多个机构的电子健康记录数据统一到 研究数据集面临着巨大的挑战。新的移动医疗技术使患者能够分享他们的 直接与研究人员共享数据，将来自多个医疗系统的电子病历数据无缝集成到单个数据中 消息来源。此外，其他研究数据收集活动，如调查和验证的患者报告结果 可以通过同一应用程序直接评估管理。这项技术已应用于 像NIH这样的大型研究资助了我们所有人，并拥有在CureGN远程数据收集的巨大潜力。 这项初步研究将(1)论证电子健康记录数据共享的可行性和科学效用 MyDataHelps移动应用程序和(2)在两个数据中确定应用程序功能的优先目标 收集和参与者参与未来的CureGN研究。试点研究将于下午4点实施。 CureGN网站，每个参与的临床中心(PCC)各一家。标准的数据质量检查将是 实施并与手动数据收集和输入ArborLink进行比较，以评估 通过该方法收集的EHR数据的可靠性。最后，试点研究小组将与 利益相关者，包括现场调查员、研究协调员和研究参与者，以评估这种类型 未来可以在整个网络中利用移动技术的优势。试点研究的时间和 准备一份全面的财团铺设计划对CureGN的成功继续至关重要。

ABSTRACT Cure Glomerulonephropathy Research Network (CureGN) is an international multi-center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded observational study of patients with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or Immunoglobulin A (IgA) nephropathy, with the goals to improve understanding of these conditions and outcomes for patients. Since 2014, CureGN has enrolled over 2600 patients at more than 60 clinical sites. A wide range of clinical data are collected to characterize disease course, treatment, and key outcomes at enrollment, three times yearly for the first 3 study years, and twice yearly thereafter. To collect these data, coordinators navigate the clinical record to locate information, enter it into the study's web-based data entry system (ArborLink), and respond to queries on a quarterly basis, oftentimes requiring re-opening of the clinical record. Given the near-universal adoption of electronic health records (EHR) and recent advances in health care information technology, opportunities to leverage EHR extraction for data collection present an important opportunity for CureGN to transition to a more modern chort study. Despite its potential, harmonization of EHR data across multiple institutions into curated research data sets has significant challenges. New mobile health technologies allow patients to share their data directly with researchers, seamlessly integrating EHR data from multiple health systems into a single data source. In addition, other study data collection activities such as survey and validated patient reported outcome administration can be assessed directly through the same application. This technology has been applied in large studies such as the NIH-funded All of Us and holds great potential for remote data collection in CureGN. This pilot study will (1) demonstrate the feasibility and scientific utility of EHR data sharing using the MyDataHelps mobile application and (2) identify priority targets for application functionality in both data collection and participant engagement in future CureGN studies. The pilot study will be implemented at four CureGN sites, one from each Participating Clinical Center (PCC). Standard data quality checks will be implemented and comparisons to manual data collection and entry into ArborLink will be made to assess reliability of EHR data collection through this method. Finally, the pilot study team will engage with stakeholders including site investigators, study coordinators, and research participants to assess how this type of mobile technology can be leveraged across the network in the future. The timing of the pilot study and preparation of a full consortium roll-out plan are critical to the successful continuation of CureGN.