The TUMMY-UC score is a valid patient- and observer-reported outcome instrument for pediatric ulcerative colitis (UC), according to study results published in Gastroenterology.
Previously, researchers from Shaare Zedek Medical Center in Israel developed the TUMMY-UC instrument for pediatric patients with UC and included 8 items selected during elicitation interviews. In this study, the instrument was finalized by conducting 129 cognitive debriefing interviews with children (n=107) aged 2 to 18 years and/or their caregivers. The instrument was then validated using a prospective, multicenter study conducted in Canada, the United States, England, and Israel, in which children (n=84) aged 2 to 18 years with UC underwent colonoscopy or provided a stool sample.
The children included in the elicitation interviews and validation study had a mean age of 11±4 and 12.1±4.3 years, 39% and 48% were boys, and 78% and 74% were White, respectively. Among this group, 69% and 73% had pancolitis, 49% and 73% had a previous severe flare, 31% and 25% had moderate to severe disease, 90% and 76% had received steroids, and 53% and 55% had received treatment with biologics, respectively.
Of the 8 TUMMY-UC items, the children rated frequency of rectal bleeding, amount of rectal bleeding, stool frequency, and abdominal pain items as the most important, whereas caregivers rated amount of rectal bleeding, frequency of rectal bleeding, stool frequency, and stool consistency as the most important items. Based on these responses, the 3 items ranked as most important by both patients and caregivers were weighted 50% higher than other items.
High interclass correlation coefficient (ICC) scores were observed between repeated TUMMY-UC assessments at days 1 and 2 (ICC, 0.88; P <.001), 11 and 12 (ICC, 0.95; P <.001), and 25 and 26 (ICC, 0.90; P <.001). Stratified by age, patient-reported and caregiver-reported TUMMY-UC outcomes had high total score agreement (ICC, 0.93).
During validation, the TUMMY-UC total score was correlated with caregiver-completed Pediatric Ulcerative Colitis Activity Index (PUCAI) disease activity score (r, 0.87; P <.001), calprotectin levels (r, 0.80; P <.001), IMPACT quality of life questionnaire (r, 0.68; P <.001), IMPACT bowel score (r, 0.43; P =.015), Ulcerative Colitis Endoscopic Index of Severity (UCEIS) total colonic score (r, 0.66; P <.001), UCEIS rectosigmoid score (r, 0.63; P <.001), C-reactive protein levels (r, 0.46; P <.001), and albumin levels (r, -0.38; P =.003).
A reduction of at least 10 points in the TUMMY-UC score differentiated between patients with active disease or in remission based on PUCAI score (area under the receiver operating characteristic curve [AUROC], 0.88; sensitivity, 77%; specificity, 87%; P <.001) and Likert global assessment score (AUROC, 0.94; sensitivity, 100%, specificity; 82%; P <.001).
The results of this study may have been limited as few patients in the validation cohort had severe disease.
The study authors conclude, “TUMMY-UC, constructed from patient and caregiver components, is a reliable, valid, and responsive index which can now be used in clinical practice and as an outcome measure in clinical trials.”
Disclosure: An author declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Marcovitch L, Focht G, Carmon N, et al. Development and validation of the TUMMY-UC, a Patient Reported Outcome for Pediatric Ulcerative Colitis. Gastroenterology. 2022;S0016-5085(22)01390-7. doi:10.1053/j.gastro.2022.12.006