Designing the GALAXY study: Partnering with the cystic fibrosis community to optimize assessment of gastrointestinal symptoms
Autor: | Melita Romasco, Baha Moshiree, Sarah Jane Schwarzenberg, Dara Riva, Steven D. Freedman, Meghana Sathe, Drucy Borowitz, A. Jay Freeman, C. Roman, Christopher H. Goss, Sonya L. Heltshe, Barbra Fogarty, Umer Khan, Carmen A. Ufret-Vincenty, E. Aliaj |
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Rok vydání: | 2021 |
Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Dieticians Patient-Reported Outcomes Measurement Information System medicine.medical_specialty Cystic Fibrosis Gastrointestinal Diseases Psychological intervention Disease Article 03 medical and health sciences 0302 clinical medicine Bristol stool scale Quality of life (healthcare) Patient experience medicine Humans Longitudinal Studies Patient Reported Outcome Measures Prospective Studies business.industry 030104 developmental biology 030228 respiratory system Family medicine Pediatrics Perinatology and Child Health Patient-reported outcome Symptom Assessment business |
Zdroj: | J Cyst Fibros |
ISSN: | 1569-1993 |
Popis: | Background Gastrointestinal (GI) involvement among persons with cystic fibrosis (CF) is highly prevalent, representing a significant source of morbidity. Persons with CF have identified GI concerns as a top research priority, yet universal clinical outcome measures capturing many of the GI symptoms experienced in CF are lacking. The GALAXY study was envisioned to address this unmet need. Methods The GALAXY study team partnered with Community Voice, a community of patients with CF and their caregivers, to identify the patient reported outcome measures that most accurately reflected their experience with GI symptoms in CF. We also surveyed CF care teams to identify the comfort level of various team members (providers, nurses and dieticians) in managing a variety of GI conditions. Results Members of Community Voice identified the combination of PAC-SYM, PAGI-SYM, PAC-QOL and the Bristol Stool scale with three additional symptom-specific questions as patient-reported outcome measures that comprehensively captured the CF experience with GI disease. CF care team providers reported a high level of comfort in treating GI conditions including constipation (92%), GERD (93%), and gassiness (77%), however comfort level was limited to only first-line interventions. Conclusion By partnering with persons with CF as well as their caregivers and medical providers, the GALAXY study is designed to uniquely capture the prevalence and severity of GI involvement among persons with CF in a manner that reflects the CF patient experience. The results of GALAXY will inform the development of future interventional trials and serve as a reproducible and objective study endpoint. |
Databáze: | OpenAIRE |
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