CCFA Partners Kids & Teens Cohort
Crohn’s disease (CD) and ulcerative colitis (UC) affect nearly 1.2 million Americans with estimated direct costs of $6 billion annually. Typical symptoms (e.g., abdominal pain, bloody diarrhea) result in substantial morbidity, including hospitalization and surgery, missed work and school, and diminished HRQOL. Approximately 20% of IBD cases begin in childhood and 10% of cases are in children or adolescents under the age of 17. Despite this, much of the evidence used to formulate treatment recommendations stems from placebo-controlled trials in adults.
In July 2013, Crohn’s and Colitis Foundation Partners (an ongoing partnership of over 10,000 patients with IBD) launched CCFA Partners Kids & Teens, a parallel study of childhood IBD. Nearly 25% of individuals with IBD are diagnosed during childhood or adolescence. The needs of these young patients are different, as they are undergoing rapid physical and mental growth and development while coping with this illness, so we formed a dedicated research partnership for this special group. By joining, kids and their parents will complete online surveys twice a year, and receive feedback directed at the specific quality of life issues affecting kids and teens with IBD. Both CCFA Partners and CCFA Partners Kids & Teens are sponsored by The Crohn’s & Colitis Foundation.
Real world, population-based clinical effectiveness and comparative effectiveness research in children are required to better understand the risks and benefits of IBD therapies for pediatric populations. As with clinical studies in children with other chronic illnesses, generally accepted endpoints do not adequately reflect patients’ well-being. In contrast, PROs evaluate what is most important to patients and caregivers about IBD and its treatment--symptoms, signs, functional status, and perceptions. Studies of PROMIS instruments developed to assess health domains in children indicate that they discriminate well among known groups of disease activity and severity. However, much remains to be learned about the performance of PROMIS measures in children with IBD. The current PEPR project with the CCFA Kids and Teens cohort aims to enhance the clinical meaningfulness and usefulness of these PROMIS measures.
