Development of the Modified TUMMY Index. Version 1.0 24.2.14
Research type
Research Study
Full title
Development of the Modified TUMMY Index. Patient Reported Signs and Symptom Index for Pediatric Ulcerative Colitis (PRO-PUCAI).
IRAS ID
153172
Contact name
Nicholas Croft
Contact email
Sponsor organisation
Shaare Zedak Medical Centre
Research summary
The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a weighted six-item clinical non-invasive index that has been developed and validated for Paediatric UC. Its aim is to reflect as closely as possible the inflammatory activity in the colon; its development and validation reflected this aim. The PUCAI is currently scored by the clinician after thorough interview with the child and caregiver. However, recent regulatory guidance mandates that items measuring symptoms should be scored directly from the patient without a proxy. We therefore aim to adapt the PUCAI items to become a Patient Reported Outcome (PRO) in which the items of the PUCAI will be scored directly from the children and their caregivers. By a data-driven approach, other items may be also added. It should be emphasized that the derived modified-PUCAI is not aimed to be a quality of life scale but a signs and symptoms tool in paediatric UC reflecting disease-related physical state.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1078
Date of REC Opinion
17 Jul 2014
REC opinion
Favourable Opinion