Development of an Inflammatory Bowel Disease Research Registry Derived from Observational Electronic Health Record Data for Comprehensive Clinical Phenotyping

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

The Onset of Clinical Manifestations in Inflammatory Bowel Disease Patients

“…One study from North America demonstrated that UC is more common in the Hispanic population (26) . Several studies in the world have shown that even though UC is still the most prevalent IBD in some places, CD has been the most incident IBD (27,28) . In places with a higher incidence of IBD, the number of CD patients already surpasses that of UC patients (27,29) .…”

“…Several studies in the world have shown that even though UC is still the most prevalent IBD in some places, CD has been the most incident IBD (27,28) . In places with a higher incidence of IBD, the number of CD patients already surpasses that of UC patients (27,29) . In our study, we noticed a small difference in the numbers of CD and UC patients.…”

Epithelioid Granulomas Associate With Increased Severity and Progression of Crohn’s Disease, Based on 6-Year Follow-Up

“…The Inflammatory Bowel Disease Center at the University of Pittsburgh Medical Center maintains a prospective natural history registry that tracks more than 3000 consented patients and has been described in detail. 13 Specific data are collected at the time of office encounters regarding disease activity (Harvey Bradshaw Index [HBI]) and behavior, quality of life (Short Inflammatory Bowel Disease Questionnaire), medication use, and health care use. Unless otherwise noted, medication use was defined as having at least one prescription for the drug in question during the study period.…”

Lasting Impact of Clostridium difficile Infection in Inflammatory Bowel Disease

“…13 Briefly, IBD patients are consented and enrolled in a prospective, longitudinal, natural history registry, which organizes real world patient care data from 2009 to the present time. All data from the registry is derived from the electronic medical record and systematically processed and transformed for research.…”

“…13 All IBD related healthcare utilization including clinic visits, telephone encounters, hospitalizations, emergency room (ER) visits, and IBD related surgeries were derived from the IBD registry and temporally organized by calendar year. Healthcare utilization was also quantified by financial charges, which includes charge data for all healthcare services including, but not limited to, gastrointestinal care.…”