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TUMMY-UC PRO (8-18)

PRO for children 8-18 years
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TUMMY-UC PRO (for children 8-18 years)

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

These questions ask about how you have been feeling because of your colitis since yesterday at this time (last 24 hours). 

It is best that you complete the TUMMY-UC before you go to bed at night and report the time since you went to bed last night until now. However, it may be completed at any time during the day on condition that the time during the day remains the same.   

Please answer honestly. There are no right or wrong answers.

 

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Questionnaire
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I. What is the worst your tummy has hurt since yesterday at this time (last 24 hours)?
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 you pooped, including accidents in your underwear or pants. If you poop a few times during one visit to the bathroom, count them as one time
III. When thinking about your 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 poop since yesterday at this time (last 24 hours)?
V. What did most of your poops look like since yesterday at this time (last 24 hours)?
VI. Did your colitis make you feel weak since yesterday at this time (last 24 hours)?
We are asking about weakness related to colitis and not being tired from not sleeping enough
VII. Did you wake up to go poop last night?
VIII. How badly have you needed to poop when you got the feeling to poop since yesterday at this time (last 24 hours)?
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.