Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield, CT
Yiran Zhang, PhD1, William K. Mountford, BSc, MSc, PhD2, Jennifer Su Thompson, BSc, MD2, Ling Zhang, MSc, MSPH2, Maureen Carlyle, MPH1, John White, MSc1, Valery Walker, BSc1, Florian Rieder, MD3 1Health Economics & Outcomes Research, Optum, Eden Prairie, MN; 2Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT; 3Digestive Diseases and Surgery Institute; Lerner Research Institute, Program for Global Translational Inflammatory Bowel Diseases; Cleveland Clinic Foundation, Cleveland, OH
Introduction: Fibrostenosis is a frequent complication of Crohn’s disease (CD).1,2 Current management of CD-related fibrostenosis (fsCD) typically involves surgical intervention.1,2 Medical therapies are not available.2 Moreover, real-world data (RWD) in fsCD are limited, and specific algorithms to identify fsCD are lacking.2 Here, we describe the development and validation of an algorithm for identifying patients with fsCD, using a large US administrative claims database.
Methods: A claims-based classification algorithm was developed to identify cases of fsCD which were then validated through medical chart review. For algorithm development, a logistic model was used to analyze claims-based evidence of fsCD-related events that could best identify which patients had fsCD (presumptive cases; Table). Eligible patients were ≥7 years old with a diagnosis of CD, but not endometriosis or intestinal malignancy, and full commercial health insurance or Medicare Advantage (Part D) coverage, between 07-01-16 and 06-30-19. Bootstrapping was used for internal validation of the model results. During chart abstraction, specific clinical characteristics based on clinician-endorsed rules were collected as evidence of fsCD. Final outcomes included negative and positive predictive values (NPV/PPV), sensitivity, and specificity in classifying patients as having or not having fsCD.
Results: The algorithm consisted of two components, whereby having one of the following identified fsCD: a diagnosis of CD-related intestinal obstruction (≥2 non-diagnostic medical claims on different dates) or a regression-based probability, using the equation in the Table (footnote 4). Of the 18,609 patients included in algorithm development, 300 fsCD presumptive cases and 300 presumptive controls were selected as the validation cohort and compared against medical charts; 216 cases and 277 controls were correctly identified by the algorithm. When applied to the full sample (N=18,609), the algorithm yielded a weighted PPV, NPV, sensitivity, and specificity of 72%, 92%, 70%, and 93%, respectively (Table).
Discussion: Development of a claims-based algorithm for identifying fsCD appeared to demonstrate a high degree of accuracy when validated against medical chart review. Further refinement of classification algorithms is needed to improve the characterization of the prevalence and burden of fsCD using data sources from other countries.
References 1. Rieder F, et al. Gut 2024;73:854-866; 2. Dehghan M, et al. BMJ Open Gastroenterol 2021;8:e000781.
Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
Yiran Zhang, PhD1, William K. Mountford, BSc, MSc, PhD2, Jennifer Su Thompson, BSc, MD2, Ling Zhang, MSc, MSPH2, Maureen Carlyle, MPH1, John White, MSc1, Valery Walker, BSc1, Florian Rieder, MD3. P2599 - Development and Validation of a Claims-Based Algorithm to Identify Fibrostenotic Crohn’s Disease, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.