Development of the Full Qualification Package for the Pediatric PROMIS Fatigue Instrument for Children with Crohn's Disease
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PROJECT SUMMARY The PROMIS Pediatric Crohn's Disease Short Form - Fatigue will be used as a clinical measure of fatigue in children with Crohn's disease in clinical trials to examine the benefit of drugs used to treat Crohn's disease. The measure is proposed to be used as a primary or co-primary endpoint in studies that use pharmacological interventions to improve the fatigue associated with CD and as a secondary endpoint in drug trials that reduce the overall symptom burden of CD, as fatigue is a common clinical marker of symptom burden in this population. The proposed target population is children and adolescents diagnosed with Crohn's Disease (CD). The PROMIS Pediatric Crohn's Disease Short Form – Fatigue will be used to assess the change in fatigue (compared to a control) induced by a medical treatment. The instrument may be used with children 8 years to 17 years old of any gender, race, or ethnicity and any baseline symptom severity, provided the participant is able to understand and self-report in English. The primary activities proposed for this project are: 1. Use FDA feedback to revise and resubmit the Qualification Plan for the PROMIS Pediatric Crohn's Disease Short Form - Fatigue. 2. Evaluate the responsiveness of the proposed COA using data collected during a recently completed PEPR Consortium study as part of the COMBINE randomized controlled trial (NCT02772965). 3. Draft a user manual that includes easy-to-use scoring instructions and score interpretation guidance. 4. Draft and submit the Full Qualification Package for the PROMIS Pediatric Crohn's Disease Short Form - Fatigue.
