Deriving Crohn Disease Efficacy Endpoints from Diary and Endoscopic Data
Abstract: Clinical efficacy analyses in Crohn disease combine patient-reported symptoms, endoscopic assessments, laboratory values, concomitant medication use, and other clinical measures. Turning these sources into reproducible endpoints requires explicit rules for assessment windows, source selection, scoring, missing data, and treatment failure. This paper presents an anonymized programming framework for deriving the Crohn Disease Activity Index (CDAI), the two-item patient-reported outcome (PRO2), and the Simple Endoscopic Score for Crohn Disease (SES-CD), then assembling those measures into an analysis-ready efficacy dataset. The framework uses a visit-centered diary window, preserves segment-level endoscopic scores, and applies endpoint-specific missing-data rules with derivation flags. It also describes a traceability structure from collected data to component analysis datasets and composite endpoints. Illustrative values and thresholds are examples of protocol-defined conventions, not universal recommendations. No patient-level results are presented. The main implementation lesson is to keep observed components, derived scores, and response classifications distinct, with every transformation traceable to the protocol, statistical analysis plan, and source records.
Keywords: Crohn disease, clinical endpoints, PRO2, CDAI, SES-CD, ADaM, missing data
How to Cite?: Jyoti (Jo) Agarwal, Satyakam Singh, "Deriving Crohn Disease Efficacy Endpoints from Diary and Endoscopic Data", Volume 10 Issue 1, January 2021, International Journal of Science and Research (IJSR), Pages: 1749-1752, https://www.ijsr.net/getabstract.php?paperid=SR210129112542, DOI: https://dx.doi.org/10.21275/SR210129112542