Agreement on Symptoms Between Children With Ulcerative Colitis and Their Caregivers: Towards Developing the TUMMY-UC.

ABSTRACT As part of the development of the TUMMY-UC, a patient-reported outcome (PRO) measure for pediatric ulcerative colitis (UC), we aimed to explore agreement on UC symptoms between children and their caregivers. We conducted 44 interviews with children aged 8-12 years, who completed the PRO version of the TUMMY-UC, and their caregivers, who completed the observer-reported outcome (obsRO) version. There was excellent agreement between the total TUMMY-UC PRO and obsRO scores (ICC = 0.92 (95%CI 0.74-0.98)). The obsRO scores were always within the same disease-activity category as the corresponding PRO score (i.e. remission, mild and moderate-severe disease). There was a strong correlation of the TUMMY-UC PRO and obsRO scores with physician global assessment of disease activity (r = 0.94 and r = 0.90, respectively, p < 0.001) and the pediatric UC activity index (PUCAI) (r = 0.95 and r = 0.96; p < 0.001). These data support conceptual equivalence between the PRO and obsRO TUMMY-UC versions, and provide support for their incorporation into one score.