1. Development of CCFA Partners Kids & Teens: an Internet-Based Cohort of Pediatric IBD Michael D. KappelmanWenli Chen Christopher F. MartinBeth Jaeger Erin StoeberLucy Goble Tania KamphausRobert S. Sandler Millie D. Long

2. DISCLOSURES Nothing to disclose

3. Background Prospective cohorts of pediatric IBD are needed to: Study disease natural history Identify prognostic factors and/or environmental risk factors of relapse Evaluate of the safety and effectiveness of treatments Most pediatric IBD cohorts in the U.S. rely on center-based recruitment and data collection Involve patients followed at large and/or academically oriented practices Very time and resource intensive Focus on physician-reported data and biosample collection CCFA Partners is an Internet-based cohort of adults with IBD Large and diverse study population: >12,000 patients from all 50 states, treated in academic and private practice settings Web-based recruitment and data collection efficient and cost-effective Focus on patient reported exposures, health behaviors, and outcomes

4. Objective To develop an internet based cohort of pediatric IBD patients in collaboration with the Crohn’s and Colitis Foundation of America

5. Methods Recruited children (< 18 years of age) with self-reported IBD through email invitations to CCFA constituents, promotion on the CCFA website, social media, and chapter events After informed consent/assent, parents and their children completed a baseline web-based survey containing questions regarding: Demographics Disease characteristics (hospitalization, surgery, anthropometrics, location, extent) Disease activity (Patient Global Assessment, Short CDAI, PUCAI, and Manitoba Index) Treatments Adherence Quality of life (Impact 35) and other Patient Reported Outcomes

6. Methods 2 Surveys developmentally appropriate, with increasing levels of self-report based upon age Validated survey instruments used when available At 3 month intervals, an update on study progress and educational materials developed by CCFA emailed to participants Follow up surveys planned Q6 months Enrollment and linkage to adult CCFA Partners planned upon 18 th birthday

7. www.ccfapartners.org

11. Preliminary Findings (First 4 months) Enrollment: 570 Participants from 47 U.S. states and 6 countries 316 male (55%), 254 female (45%) 422 CD (74%), 134 UC (24%), 14 IC (2%) Median age: 13 years Median age at diagnosis: 9 years

12. Treatment Patterns CD n=422UC n=148 Current Medications N (%) 5-ASA (oral)117 (27)57 (38) Prednisone41 (9)23 (15) Immunomodulator186 (43)52 (34) Biologic220 (51)28 (18) Medications ever- used 5-ASA (oral)251 (58)116 (76) Prednisone354 (82)129 (85) Immunomodulator294 (68)84 (55) Biologic249 (57)57 (38) Surgery71 (16)26 (17)

13. Patient Reported Outcomes *Higher IMPACT scores indicate better HRQOL

14. Patient Reported Outcomes

15. Conclusion CCFA Partners Kids & Teens is a novel internet-based cohort of pediatric IBD Partnership between CCFA, patient community, and research community Channel for all children with IBD to participate in research, regardless of treating physician/practice Preliminary findings suggest that internet based recruitment and data collection are feasible Growth in enrollment and long term cohort retention will be critical to the success of this project

16. Implications and future directions Focus on PROs will become increasingly important in observational research Complement to clinical endpoints, which are rapidly moving towards mucosal healing rather than measures of patient well being Dual enrollment and linkage with clinical cohorts (i.e. Risk, Protect) will allow analyses that combine clinician-reported data, patient-reported data, and biospecimens Long term outcomes of pediatric IBD Opportunity for follow up after patients transition from pediatric care Platform for ancillary studies Secondary analyses, supplemental surveys, simple clinical trials, biospecimen collection

17. Please Get involved Submit ancillary studies Promote study to your patients