CureGN

治愈GN

• 批准号: 10877511
• 负责人: BRENDA W GILLESPIE
• 金额: $ 13.13万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10877511
• 关键词: Adoption; Clinical; Clinical Data; Collection; Communities; Data; Data Collection; Data Element; Data Set; Data Sources; Disease; Electronic Health Record; Electronics; Enrollment; Feedback; Focal and Segmental Glomerulosclerosis; Funding; Future; Goals; Health Technology; Health system; Healthcare; IGA Glomerulonephritis; Information Technology; Institution; International; Kidney Diseases; Manuals; Membranous Glomerulonephritis; Methods; Modernization; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Online Systems; Outcome; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pilot Projects; Preparation; Research; Research Personnel; Resources; Site; Surveys; System; Technology; United States National Institutes of Health; clinical center; clinical research site; data quality; data sharing; data standards; improved; mHealth; mobile application; mobile computing; patient engagement

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.

抽象的 治愈肾小球肾病研究网络 (CureGN) 是一个国际多中心国家研究所 糖尿病、消化系统和肾脏疾病 (NIDDK) 资助的针对患有轻微糖尿病的患者进行的观察性研究 病变、局灶节段性肾小球硬化、膜性肾病或免疫球蛋白 A (IgA) 肾病，目的是提高对患者这些病症和结果的了解。自从 2014年，CureGN已在60多个临床中心入组了2600多名患者。广泛的临床数据 收集数据以描述入组时的病程、治疗和主要结果，每年三次 前 3 个学习年，此后每年两次。为了收集这些数据，协调员浏览临床记录 查找信息，将其输入研究的基于网络的数据输入系统（ArborLink），并回答查询 每季度一次，通常需要重新打开临床记录。鉴于几乎普遍采用 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 EHR 提取进行数据收集为 CureGN 过渡到更多的机会提供了重要机会 现代弦乐研究。尽管有潜力，但将多个机构的 EHR 数据统一为精心策划的 研究数据集面临重大挑战。新的移动医疗技术使患者能够分享他们的信息 直接与研究人员共享数据，将来自多个卫生系统的 EHR 数据无缝集成到单个数据中 来源。此外，其他研究数据收集活动，例如调查和验证患者报告的结果 可以通过同一应用程序直接评估管理。该技术已应用于 大型研究，例如 NIH 资助的 All of Us，并且在 CureGN 中具有远程数据收集的巨大潜力。 该试点研究将 (1) 展示使用 EHR 数据共享的可行性和科学实用性 MyDataHelps 移动应用程序和 (2) 确定两个数据中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。试点研究将于四点进行 CureGN 站点，每个参与临床中心 (PCC) 都有一个。标准数据质量检查将 将与手动数据收集和输入 ArborLink 进行比较，以评估 通过这种方法收集 EHR 数据的可靠性。最后，试点研究小组将与 包括现场调查员、研究协调员和研究参与者在内的利益相关者来评估这种类型如何 未来可以在整个网络中利用移动技术。试点研究的时间安排和 制定完整的联盟推出计划对于 CureGN 的成功延续至关重要。

项目成果

Optimal Conservative Therapy Use among Adult Cure Glomerulonephropathy Participants with IgA Nephropathy.

• DOI: 10.34067/kid.0000000000000306
• 发表时间: 2023-12-01
• 期刊: Kidney360
• 作者: Rajasekaran A;Larkina M;Julian BA;Canetta PA;Roehm BA;Khalid M;Mariani LH;Rizk DV
• 通讯作者: Rizk DV

Validation of Diagnosis Codes to Identify Infection-Related Acute Care Events in Patients With Glomerular Disease.

• DOI: 10.1016/j.ekir.2021.08.019
• 发表时间: 2021-12
• 期刊: Kidney international reports
• 影响因子: 6
• 作者: Glenn DA;Zee J;Hegde A;Henderson C;O'Shaughnessy MM;Bomback A;Gibson K;Greenbaum LA;Mansfield S;Hu Y;Mariani L;Falk R;Hogan S;Denburg M;Mottl A;CureGN Consortium
• 通讯作者: CureGN Consortium

Clinical Characteristics and Treatment Patterns of Children and Adults With IgA Nephropathy or IgA Vasculitis: Findings From the CureGN Study.

• DOI: 10.1016/j.ekir.2018.07.021
• 发表时间: 2018-11
• 期刊: Kidney international reports
• 影响因子: 6
• 作者: Selewski DT;Ambruzs JM;Appel GB;Bomback AS;Matar RB;Cai Y;Cattran DC;Chishti AS;D'Agati VD;D'Alessandri-Silva CJ;Gbadegesin RA;Hogan JJ;Iragorri S;Jennette JC;Julian BA;Khalid M;Lafayette RA;Liapis H;Lugani F;Mansfield SA;Mason S;Nachman PH;Nast CC;Nester CM;Noone DG;Novak J;O'Shaughnessy MM;Reich HN;Rheault MN;Rizk DV;Saha MK;Sanghani NS;Sperati CJ;Sreedharan R;Srivastava T;Swiatecka-Urban A;Twombley K;Vasylyeva TL;Weaver DJ;Yin H;Zee J;Falk RJ;Gharavi AG;Gillespie BW;Gipson DS;Greenbaum LA;Holzman LB;Kretzler M;Robinson BM;Smoyer WE;Flessner M;Guay-Woodford LM;Kiryluk K;CureGN Consortium
• 通讯作者: CureGN Consortium

Clinicopathologic Significance of Predominant Lambda Light Chain Deposition in IgA Nephropathy.

• DOI: 10.1016/j.ekir.2022.08.003
• 发表时间: 2022-11
• 期刊: KIDNEY INTERNATIONAL REPORTS
• 影响因子: 6
• 作者: Ravipati, Prasanth;Freese, Rebecca L.;Royal, Virginie;Bu, Lihong;Canetta, Pietro;Gipson, Debbie;Kallash, Mahmood;Kiryluk, Krzysztof;Nast, Cynthia;Reich, Heather N.;Rheault, Michelle N.;Saha, Manish;Nachman, Patrick H.
• 通讯作者: Nachman, Patrick H.

Cure Glomerulonephropathy Pathology Classification and Core Scoring Criteria, Reproducibility, and Clinicopathologic Correlations.

• DOI: 10.1159/000534755
• 发表时间: 2023-01
• 期刊: Glomerular diseases