RESUMO
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 ages 8-12âyears, 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 (intra-class correlation coefficientâ=â0.92 [95% confidence interval 0.74-0.98]). The obsRO scores were always within the same disease-activity category as the corresponding PRO score (ie, 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 (râ=â0.94 and râ=â0.90, respectively, Pâ<â0.001) and the pediatric UC activity index (râ=â0.95 and râ=â0.96; Pâ<â0.001). These data support conceptual equivalence between the PRO and obsRO TUMMY-UC versions, and provide support for their incorporation into one score.