Development and Validation of the TUMMY-UC: A Patient-Reported Outcome for Pediatric Ulcerative Colitis.

Autor:	Marcovitch L; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel., Focht G; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel., Carmon N; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel., Tersigni C; Department of Gastroenterology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada., Ledder O; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel., Lev-Tzion R; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel., Church PC; Department of Gastroenterology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada., Hyams JS; Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center, Hartford, Connecticut., Baldassano RN; Division of Gastroenterology, Hepatology and Nutrition, The Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania., Bousvaros A; Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, Massachusetts., Mack DR; Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario (CHEO) and Research Institute and University of Ottawa, Ottawa, Ontario, Canada., Hussey S; National Children's Research Centre, University College Dublin (UCD), Dublin, Ireland., Otley A; Division of Pediatrics, Izaak Walton Killam (IWK) Health Centre, Halifax, Nova Scotia, Canada., Croft NM; Blizard Institute, Faculty of Medicine, Queen Mary University of London, London, United Kingdom., Kappelman MD; Multidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Griffiths AM; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada., Turner D; Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: turnerd@szmc.org.il.
Jazyk:	angličtina
Zdroj:	Gastroenterology [Gastroenterology] 2023 Apr; Vol. 164 (4), pp. 610-618.e4. Date of Electronic Publication: 2022 Dec 17.
DOI:	10.1053/j.gastro.2022.12.006
Abstrakt:	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. (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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