TY - JOUR
T1 - Development and Validation of the TUMMY-UC
T2 - A Patient-Reported Outcome for Pediatric Ulcerative Colitis
AU - Marcovitch, Liron
AU - Focht, Gili
AU - Carmon, Natalie
AU - Tersigni, Claudia
AU - Ledder, Oren
AU - Lev-Tzion, Raffi
AU - Church, Peter C.
AU - Hyams, Jeffrey S.
AU - Baldassano, Robert N.
AU - Bousvaros, Athos
AU - Mack, David R.
AU - Hussey, Séamus
AU - Otley, Anthony
AU - Croft, Nicholas M.
AU - Kappelman, Michael D.
AU - Griffiths, Anne M.
AU - Turner, Dan
N1 - Publisher Copyright:
© 2023 AGA Institute
PY - 2023/4
Y1 - 2023/4
N2 - Background & Aims: The TUMMY-UC is a patient-reported outcome measure for pediatric ulcerative colitis (UC) with an observer-reported outcome version for children aged <8 years. It includes eight items selected by concept elicitation interviews. We aimed to finalize the TUMMY-UC by cognitive interviews (stage 2) and to evaluate the index for its psychometric properties (stage 3). Methods: The TUMMY-UC items were first finalized during 129 cognitive debriefing interviews. Then, in a prospective, multicenter validation study, 84 children who underwent colonoscopy or provided stool for calprotectin completed the TUMMY-UC and various measures of disease activity. Assessments were repeated after 7 and 21 days for evaluating reliability and responsiveness. Results: During stage 2, the items were formatted with identical structure to ensure conceptual equivalence and weighted based on ranking of importance. In stage 3, the TUMMY-UC total score had excellent reliability in repeated assessments (intraclass correlation coefficient, 0.90; 95% confidence interval, 0.84–0.94). It also had moderate to strong correlations with all constructs of disease activity: r = 0.70 with UC endoscopic index of severity, r = 0.63 with the IMPACT-III questionnaire, r = 0.43 with calprotectin, r = 0.80 with the Pediatric Ulcerative Colitis Activity Index, r = 0.75 with global assessment of disease activity, and r = 0.46 with C-reactive protein (all P < .015). The index had excellent discrimination of disease activity, with a score of <9 defining remission (area under the receiver operating characteristic curve, 0.95; 95% confidence interval, 0.93–0.99). The ΔTUMMY-UC showed high responsiveness and differentiated well between children who experienced changed from those with no change. Conclusions: The TUMMY-UC, constructed from patient-reported outcome and observer-reported outcome versions, is a reliable, valid and responsive index that can be now used in practice and clinical trials.
AB - Background & Aims: The TUMMY-UC is a patient-reported outcome measure for pediatric ulcerative colitis (UC) with an observer-reported outcome version for children aged <8 years. It includes eight items selected by concept elicitation interviews. We aimed to finalize the TUMMY-UC by cognitive interviews (stage 2) and to evaluate the index for its psychometric properties (stage 3). Methods: The TUMMY-UC items were first finalized during 129 cognitive debriefing interviews. Then, in a prospective, multicenter validation study, 84 children who underwent colonoscopy or provided stool for calprotectin completed the TUMMY-UC and various measures of disease activity. Assessments were repeated after 7 and 21 days for evaluating reliability and responsiveness. Results: During stage 2, the items were formatted with identical structure to ensure conceptual equivalence and weighted based on ranking of importance. In stage 3, the TUMMY-UC total score had excellent reliability in repeated assessments (intraclass correlation coefficient, 0.90; 95% confidence interval, 0.84–0.94). It also had moderate to strong correlations with all constructs of disease activity: r = 0.70 with UC endoscopic index of severity, r = 0.63 with the IMPACT-III questionnaire, r = 0.43 with calprotectin, r = 0.80 with the Pediatric Ulcerative Colitis Activity Index, r = 0.75 with global assessment of disease activity, and r = 0.46 with C-reactive protein (all P < .015). The index had excellent discrimination of disease activity, with a score of <9 defining remission (area under the receiver operating characteristic curve, 0.95; 95% confidence interval, 0.93–0.99). The ΔTUMMY-UC showed high responsiveness and differentiated well between children who experienced changed from those with no change. Conclusions: The TUMMY-UC, constructed from patient-reported outcome and observer-reported outcome versions, is a reliable, valid and responsive index that can be now used in practice and clinical trials.
KW - ObsRO
KW - PRO
KW - PUCAI Scale
KW - Patient-Reported Outcome
KW - Ulcerative Colitis
UR - http://www.scopus.com/inward/record.url?scp=85148913405&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2022.12.006
DO - 10.1053/j.gastro.2022.12.006
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 36539016
AN - SCOPUS:85148913405
SN - 0016-5085
VL - 164
SP - 610-618.e4
JO - Gastroenterology
JF - Gastroenterology
IS - 4
ER -