Designing the GALAXY study: Partnering with the cystic fibrosis community to optimize assessment of gastrointestinal symptoms

A. Jay Freeman, Meghana Sathe, Enid Aliaj, Drucy Borowitz, Barbra Fogarty, Christopher H. Goss, Steven Freedman, Sonya L. Heltshe, Umer Khan, Dara Riva, Christina Roman, Melita Romasco, Sarah Jane Schwarzenberg, Carmen A. Ufret-Vincenty, Baha Moshiree

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)598-604
Number of pages7
JournalJournal of Cystic Fibrosis
Volume20
Issue number4
Early online dateJan 12 2021
DOIs
StatePublished - Jul 1 2021

Bibliographical note

Publisher Copyright:
© 2021 Elsevier Ltd

Keywords

  • Community Involvement
  • Gastrointestinal
  • Patient reported outcome measures (proms)

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't

Fingerprint

Dive into the research topics of 'Designing the GALAXY study: Partnering with the cystic fibrosis community to optimize assessment of gastrointestinal symptoms'. Together they form a unique fingerprint.

Cite this