TUMMY-CD
Research type
Research Study
Full title
Development and evaluation of the TUMMY-CD Index
IRAS ID
201711
Contact name
N. Croft
Contact email
Sponsor organisation
IWK Health Centre
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The current study aims to develop a pediatric PRO which is valid and reliable to assess symptoms and disease activity for pediatric Crohn’s Disease. This is a multi-centre, international study involving 3 Phases.
Phase 1 will produce a list of signs and symptoms relevant to children and teens with Crohn's disease. Concept elicitation interviews will be conducted with pediatric Crohn's disease patients and their caregivers, and items will be tabulated to generate a list of the top 10 signs and symptoms that are observed by patients when experiencing a flare. Recall period will also be determined in this phase. Finally, cutoffs for age-appropriate versions will be determined from this phase, including one version for caregiver proxy.
Phase 2 will further explore the top named signs and symptoms, verify appropriate language and determine preferences in rating scales. Cognitive debriefing interviews will be performed, and interim analyses will be conducted in order to reduce response options and determine age appropriate scales.
Phase 3 will validate the tool against other clinical measures of Crohn's disease activity. Pediatric Crohn’s disease patients and their caregivers will complete the TUMMY-CD Index as well as the IMPACT-III, a disease-specific health related quality of life (HRQOL) scale. A gastroenterologist will complete the PCDAI scale, including blood lab values (if ordered as part of clinical care). Fecal calprotectin levels will be measured for each participant. All measures will be compared to the results of the TUMMY-CD Index to suggest its ability to determine when a patient is experiencing a flare. A sub-set of participants will complete this phase at a second time-point, to ensure test-retest reliability and responsiveness. Those that have a colonoscopy ordered as part of clinical care will complete the TUMMY-CD index on the same day, and results will be compared for further validation.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0012
Date of REC Opinion
13 Jan 2017
REC opinion
Favourable Opinion