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TUMMY-UC ObRO (2-8)

for children 2 to <8 years
About

TUMMY-UC ObRO (for children 2 to younger than 8)

Aim: To capture signs and symptoms of children with ulcerative colitis (UC)

These questions should be completed by the caregiver. 

We ask how your child has been doing because of the colitis since yesterday at this time (last 24 hours). 

It is important that the time the TUMMY-UC is completed each day is kept consistent; ideally at the end of the day, when your child goes to sleep.    

Please answer the questions based on behaviors that you have observed in your child and things that he/she may have said to you that indicate how he/she has been feeling.

 

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Questionnaire
calculator
I. Which of the following best describes your child’s behaviors relating to stomach pain since yesterday at this time (last 24 hours)?
The list of behaviors may assist in scoring the question but not all behaviors are required. My child behaves in a way that shows me that he/she has:
II. How many times did you poop since yesterday at this time (last 24 hours)?
Count the number of all visits to the bathroom when he/she pooped, including accidents in the underwear or pants. If he/she pooped a few times during one visit to the bathroom count them as one time.
III. When thinking about your child’s poop, please choose the best answer that describes the most blood you have seen since yesterday at this time (last 24 hours)?
IV. How often did you see blood in your child's poop since yesterday at this time (last 24 hours)?
V. What have most of your child's poops looked like since yesterday at this time (last 24 hours)?
VI. Which of the following best describes your child’s behaviors relating to weakness, since yesterday at this time (last 24 hours)?
We are asking about weakness related to colitis and not being tired from not sleeping enough. The list of behaviors may assist in scoring the question but not all behaviors are required. My child behaves in a way that shows me that he/she is:
VII. Did your child wake up to go poop last night?
VIII. Which of the following best describes your child’s behaviors relating to urgency since yesterday at this time (last 24 hours)?
The list of behaviors may assist in scoring the question but not all behaviors are required. My child behaves in a way that shows me that he/she:
Total Score: 0

The TUMMY-UC is a patient-reported outcome (PRO) measure for pediatric UC, with an adolescent version (self-reported by children and adolescents aged 8 and above) and an observer-reported version (obRO) for caregivers of children aged <8 years.  A total of 208 children and their caregivers underwent qualitative concept elicitation interviews followed by cognitive debriefing interviews to finalize the eight items of the index (abdominal pain, stool frequency, stool consistency, nocturnal stooling, amount of blood, frequency of bleeding, fatigue, and urgency) and their weights. A separate study determined the conceptual equivalence of the PRO and obsRO versions, for integrating their scores when used in cohorts including children both under and over the age of 8 years.

The TUMMY-UC has high reliability in repeated assessments over subsequent days and after 10 days and excellent construct validation when measured against endoscopic scores, the IMPACT-III questionnaire, the Pediatric Ulcerative Colitis Activity Index (PUCAI), global assessment of disease activity, fecal calprotectin and other biochemical biomarkers (REF). Responsiveness to change was high (area under the curve=0.93 [95% CI 0.86-0.99]). The score has excellent discrimination of disease activity, with a score of <9 defining remission (area under the ROC curve 0.95 [95%CI 0.93–0.99]). The TUMMY-UC was developed in accordance with European Medicines Agency guidance and has received a letter of support from the Qualification Team encouraging its use in clinical trials to further explore its psychometric properties in large datasets (https://www.ema.europa.eu/en/documents/other/letter-support-tummy-uc-patient-observer-reported-outcome-paediatric-ulcerative-colitis-uc_en.pdf).

 Cutoff values of TUMMY-UC to determine disease state: 
TUMMY-UC < 9 (remission)
TUMMY-UC 9-40 (mild disease)
TUMMY-UC 41-60 (moderate disease)
TUMMY-UC >60 (severe disease). 

A change score of at least 10 points is the minimally important difference and defines meaningful response.

The TUMMY-UC is valid using scores from either one or two consecutive days.