PI: Dr. David Mack
Study contact: [email protected]
Study contact full name: Ruth Singleton
Research Area: Inflammatory Bowel Disease
Who to contact regarding participation: [email protected]
The reason we are asking you and your child to be in this study is so you can help us figure out the best way to assess symptoms and disease activity according to the patient. This new questionnaire will be called TUMMY-CD Index, and will have questions based on how patients, or their caregivers view their symptoms, not clinicians. Medical language can be difficult to understand, especially for children, so it is very important that the wording used in the TUMMY-CD Index is clear and age-appropriate.
Recent regulatory guidance mandates that items measuring the signs and symptoms of Crohn’s Disease in clinical trials should be scored directly from the patient without a proxy. We therefore aim to develop a Patient Reported Outcome (PRO) for pediatric CD in which items will be generated based on the reported level of importance according to patients. The index is intended to be to be used in pediatric CD clinical trials to evaluate signs and symptoms over time. The scoring of the TUMMY-CD index will yield a new PRO score. An additional observer reported outcome (ObsRO) measure will be created for those children who cannot self-report.