Methodology and Initial Results From a Real-World Observational Cohort of Patients With Inflammatory Bowel Disease: TARGET-IBD

Benjamin Click; Edward L Barnes; Benjamin L Cohen; Bruce E Sands; John S Hanson; Miguel Regueiro; David T Rubin; Marla C Dubinsky; Derek R Gazis; Laura Dalfonso; Janet S Hildebrand; Julie M Crawford; Millie D Long

doi:10.1093/crocol/otab023

Methodology and Initial Results From a Real-World Observational Cohort of Patients With Inflammatory Bowel Disease: TARGET-IBD

Crohns Colitis 360. 2021 May 13;3(3):otab023. doi: 10.1093/crocol/otab023. eCollection 2021 Jul.

Authors

Affiliations

¹ Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA.
² Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
³ Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁴ Atrium Health Gastroenterology and Hepatology, Charlotte, NC, USA.
⁵ Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.
⁶ Division of Pediatric Gastroenterology, The Susan & Leonard Feinstein IBD Clinical Center at Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Target RWE, Inc., Durham, NC, USA.

Abstract

Background: Data on care patterns for inflammatory bowel disease (IBD) from large-scale, diverse clinical cohorts in real-world practice are sparse. We developed a real-world cohort of patients receiving care at academic and community sites, for comparative study of therapies and natural history of IBD.

Methods: We describe novel methodology of central abstraction of clinical data into a real-world IBD registry with patient reported outcomes (PROs). Baseline demographics, clinical characteristics, healthcare utilization, and disease metrics were assessed. Bivariate statistics were used to compare demographic and clinical data by Crohn disease (CD) or ulcerative colitis (UC) and site of care (academic, community).

Results: In 1 year, 1343 IBD patients (60.1% CD, 38.9% UC) were recruited from 27 academic (49.5%) and community (50.5%) sites, exceeding expectations (110% enrolled). Most participants also consented to provide PROs (59.5%) or biosamples (85.7%). Overall, 48.7% of the cohort provided a baseline PRO, and 62.6% provided a biosample. Compared to UC, CD subjects had higher prior (34.1% CD vs 7.7% UC; P < 0.001) and current (72.1% vs 47.9%; P < 0.001) biologic utilization. CD participants from academic sites had more complicated disease than those from community sites (62.5% vs 46.8% stricturing/penetrating; 33.5% vs 27% perianal; 36.8% vs 14.5% prior biologic, respectively). Nearly all (90.4%) participants had endoscopic data of whom 37.7% were in remission. One-year retention was 98.4%.

Conclusions: Centralized data abstraction and electronic PRO capture provided efficient recruitment into a large real-world observational cohort. This novel platform provides a resource for clinical outcomes and comparative effectiveness research in IBD.

Keywords: Crohn disease; academic; community; comparative effectiveness; real-world; registry; ulcerative colitis.