CF Tummy Tracker: A Cystic Fibrosis-Specific Patient-Reported Outcome Measure for Daily Gastrointestinal Symptom Burden.

ABSTRACT:

Objective

To develop a cystic fibrosis (CF)-specific patient-reported outcome measure (PROM) to measure the daily burden of gastrointestinal symptoms for people with cystic fibrosis (pwCF) aged 12 years and older and address the lack of validated outcome measures for gastrointestinal symptoms in CF.

Patients and methods

CF Tummy Tracker was developed through a 5-stage approach in accordance with regulatory guidance. This included development and refinement of a conceptual framework; item generation; refinement; reduction; selection; and initial PROM testing. A mixed-methods approach, consisting of expert panel discussions, a focus group, interviews, and an online survey, was used. In initial testing, participants completed the PROM daily for 14 days via a smartphone applicat

SUBMITTER: Calthorpe RJ 

PROVIDER: S-EPMC12191005 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature