Chronic Constipation and IBS-C Treatment and Outcomes Real World Research Platform (CONTOR): A Large, Longitudinal Observational Study

Abstract

Introduction: CONTOR is a longitudinal, observational platform combining administrative claims and patient survey data to examine associations between symptoms, treatments, and outcomes among chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) patients. Our objective is to describe baseline characteristics of CIC and IBS-C patients participating in CONTOR. Methods: Fully-insured patients ≥18 years old were identified from a large, geographically-diverse US health plan based on claims from 12/2012-6/2015. Criteria included: ≥1 medical claim for constipation (564.0x), IBS (564.1x), or abdominal pain (789.0x), plus ≥1 pharmacy claim for a stool softener/laxative; or ≥1 claim for linaclotide or lubiprostone. At baseline, participants completed surveys including measures of general and disease-specific health-related quality of life (HRQOL) and symptom-specific work productivity and activity impairment, and assessments of symptom severity, treatment use and satisfaction, and 7-day daily diaries of treatments and symptoms. Data were collected over 12 months through quarterly surveys, monthly medication updates, and a 7-day daily diary at month 12; data presented are from the baseline survey and baseline diary. Results: Of 18,590 patients invited to participate, 2052 eligible respondents completed the baseline survey; 1747 completed the baseline diary. The majority were female; mean age was 47 years (Table). Respondent and non-respondent demographics did not differ meaningfully. Approximately 38% and 44% reported physician diagnoses of CIC and IBS-C, respectively. Nearly all reported experiencing bowel/abdominal symptoms for ≥2 years, with nearly half experiencing symptoms for >10 years. Almost three-quarters have been treated for bowel/abdominal symptoms for ≥2 years; probiotics, polyethylene glycol, and linaclotide were the most commonly reported treatments used in the last 7 days. Overall, respondents reported multiple bothersome abdominal and bowel symptoms as well as diminished HRQOL and work productivity due to their CIC/IBS-C. Conclusion: CONTOR, the first comprehensive, real-world longitudinal platform among CIC and IBS-C patients, illustrates the chronic symptom burden associated with these conditions. CONTOR participants reported lengthy and complex treatment histories with patients experiencing burdensome and disruptive symptoms for many years, highlighting the clinical challenges these conditions present to physicians.Table 1: CONTOR baseline characteristics (N=2,052)*Table 2: CONTOR baseline characteristics (N=2,052)*