Impact of sinus surgery in people with cystic fibrosis and chronic rhinosinusitis in the era of highly effective modulator therapy: Protocol for a prospective observational study

Christine M Liu; Jakob L Fischer; Jeremiah A Alt; Todd E Bodner; Naweed I Chowdhury; Anne E Getz; Peter H Hwang; Adam J Kimple; Jess C Mace; Timothy L Smith; Zachary M Soler; Christopher H Goss; Jennifer L Taylor-Cousar; Milene T Saavedra; Daniel M Beswick

doi:10.1371/journal.pone.0310986

Impact of sinus surgery in people with cystic fibrosis and chronic rhinosinusitis in the era of highly effective modulator therapy: Protocol for a prospective observational study

PLoS One. 2024 Sep 26;19(9):e0310986. doi: 10.1371/journal.pone.0310986. eCollection 2024.

Authors

Christine M Liu¹, Jakob L Fischer¹, Jeremiah A Alt², Todd E Bodner³, Naweed I Chowdhury⁴, Anne E Getz⁵, Peter H Hwang⁶, Adam J Kimple⁷, Jess C Mace⁸, Timothy L Smith⁸, Zachary M Soler⁹, Christopher H Goss¹⁰, Jennifer L Taylor-Cousar^{11

12}, Milene T Saavedra¹¹, Daniel M Beswick¹

Affiliations

¹ Department of Otolaryngology-Head and Neck Surgery, University of California, Los Angeles, Los Angeles, CA, United States of America.
² Department of Otolaryngology-Head and Neck Surgery, University of Utah, Salt Lake City, UT, United States of America.
³ Department of Psychology, Portland State University, Portland, OR, United States of America.
⁴ Department of Otolaryngology-Head and Neck Surgery, Vanderbilt Health, Nashville, TN, United States of America.
⁵ Department of Otolaryngology-Head and Neck Surgery, University of Colorado, Boulder, CO, United States of America.
⁶ Department of Otolaryngology-Head and Neck Surgery, Stanford University, Stanford, CA, United States of America.
⁷ Department of Otolaryngology-Head and Neck Surgery, University of North Carolina, Chapel Hill, NC, United States of America.
⁸ Department of Otolaryngology-Head and Neck Surgery, Oregon Health & Science University, Portland, OR, United States of America.
⁹ Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, United States of America.
¹⁰ Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, WA, United States of America.
¹¹ Department of Medicine, National Jewish Health, Denver, CO, United States of America.
¹² Department of Pediatrics, National Jewish Health, Denver, CO, United States of America.

Abstract

Introduction: Cystic fibrosis (CF) is commonly complicated by chronic rhinosinusitis (CRS). Despite highly effective management options, CRS in people with CF (PwCF+CRS) may be refractory to medical therapy, eventually requiring endoscopic sinus surgery. The impact of sinus surgery on pulmonary, quality of life (QOL), and other outcomes in PwCF+CRS in the expanding era of highly effective modulator therapy has not been fully elucidated. This study aims to determine if endoscopic sinus surgery can offer superior outcomes for PwCF+CRS when compared to continued medical treatment of CRS.

Methods and analysis: This multi-institutional, observational, prospective cohort study will enroll 150 adults with PwCF+CRS across nine US CF Centers who failed initial medical therapy for CRS and elected to pursue either endoscopic sinus surgery or continue medical treatment. To determine if sinus surgery outperforms continued medical therapy in different outcomes, we will assess changes in pulmonary, CF-specific QOL, CRS-specific QOL, sleep quality, depression, headache, cognition, olfaction, productivity loss, and health utility value after treatment. The influence of highly effective modulator therapy on these outcomes will also be evaluated. This study will provide crucial insights into the impact of endoscopic sinus surgery for PwCF+CRS and aid with development of future treatment pathways and guidelines.

Ethics and dissemination: This study has been approved by each institution's internal review board, and study enrollment began August 2019. Results will be disseminated in conferences and peer-reviewed journals.

Trial registration: This study was registered on ClinicalTrials.gov (NCT04469439).

Copyright: © 2024 Liu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Observational Study
Multicenter Study

MeSH terms

Adult
Chronic Disease
Cystic Fibrosis* / complications
Cystic Fibrosis* / surgery
Endoscopy
Female
Humans
Male
Observational Studies as Topic
Paranasal Sinuses / surgery
Prospective Studies
Quality of Life*
Rhinitis* / surgery
Rhinosinusitis
Sinusitis* / surgery
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04469439

Grants and funding

This work was supported by the Cystic Fibrosis Foundation (BESWIC20A0, BESWIC22Y5; https://www.cff.org/) awarded to DMB. This foundation provided support for the planning and execution of this work but did not have specific involvement in the study design, data collection, analysis, or interpretation, or decision to submit the article for publication. CML received grant support from the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health under Award Number R25DC020151 (https://www.nidcd.nih.gov/). The NIH did not play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. JAA, TEB, JCM, and TLS have received grant support from the Cystic Fibrosis Foundation related to this work in the past 36 months (BESWIC20A0). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.