Development of an Inflammatory Bowel Disease Research Registry Derived from Observational Electronic Health Record Data for Comprehensive Clinical Phenotyping
Development of an Inflammatory Bowel Disease Research Registry Derived from Observational Electronic Health Record Data for Comprehensive Clinical Phenotyping
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DOI：
10.1007/s10620-016-4278-z
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发表时间：
2016-11-01
影响因子：
3.1
通讯作者：
Binion, David G.
中科院分区：
文献类型：
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作者：
Anderson, Alyce J. M.;Click, Benjamin;Binion, David G.
炎症性肠病(IBD)是消化道慢性炎症性疾病的异质性集合。临床、遗传和病理的异质性使得将疗效研究转化为现实世界的实践变得越来越困难。我们的目标是根据多年的观察数据建立一个全面的自然历史登记系统，以促进IBD的有效性和临床表型研究。UPMC开发了一个纵向的、同意的登记系统，其中包括预期收集的数据。所有在UPMC三级护理中心接受护理的成年IBD患者都有资格参加。电子健康记录中的详细数据可供登记册研究使用。数据直接从电子健康记录中导出，并临时组织用于研究。到目前为止，超过2565名患者参与了IBD研究登记。所有患者都有人口统计数据、临床疾病特征和病程数据，包括医疗保健利用、实验室价值、量化疾病活动和生活质量的与健康有关的问卷，以及临时组织的6年(2009-2015年)治疗分析信息。这些数据导致了适合于与疾病结果和治疗反应参数进行相关性研究的临床表型的详细定义。我们已经建立了在真实的IBD环境中检查治疗和病程有效性所需的基础设施。IBD研究登记提供了一个独特的机会来调查关于疾病的自然病程、表型关联研究、治疗有效性和护理质量研究的临床研究问题。
Inflammatory bowel disease (IBD) is a heterogeneous collection of chronic inflammatory disorders of the digestive tract. Clinical, genetic, and pathological heterogeneity makes it increasingly difficult to translate efficacy studies into real-world practice. Our objective was to develop a comprehensive natural history registry derived from multi-year observational data to facilitate effectiveness and clinical phenotypic research in IBD.A longitudinal, consented registry with prospectively collected data was developed at UPMC. All adult IBD patients receiving care at the tertiary care center of UPMC are eligible for enrollment. Detailed data in the electronic health record are accessible for registry research purposes. Data are exported directly from the electronic health record and temporally organized for research.To date, there are over 2565 patients participating in the IBD research registry. All patients have demographic data, clinical disease characteristics, and disease course data including healthcare utilization, laboratory values, health-related questionnaires quantifying disease activity and quality of life, and analytical information on treatment, temporally organized for 6 years (2009-2015). The data have resulted in a detailed definition of clinical phenotypes suitable for association studies with parameters of disease outcomes and treatment response. We have established the infrastructure required to examine the effectiveness of treatment and disease course in the real-world setting of IBD.The IBD research registry offers a unique opportunity to investigate clinical research questions regarding the natural course of the disease, phenotype association studies, effectiveness of treatment, and quality of care research.