Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 29:16:323-332.
doi: 10.2147/JAA.S372598. eCollection 2023.

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial

Jorge F Maspero  1 , Asif H Khan  2 , Carl Philpott  3 , Peter W Hellings  4 , Claire Hopkins  5 , Martin Wagenmann  6 , Shahid Siddiqui  7 , Jérôme Msihid  8 , Scott Nash  7 , Chien-Chia Chuang  9 , Siddhesh Kamat  7 , Paul J Rowe  10 , Yamo Deniz  7 , Juby A Jacob-Nara  10
Affiliations

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial

Jorge F Maspero et al. J Asthma Allergy. .

Abstract

Purpose: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases.

Methods: In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50 for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4-83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma.

Results: In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity.

Conclusion: In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

Keywords: chronic rhinosinusitis with nasal polyps; health-related quality of life; symptom burden.

PubMed Disclaimer

Conflict of interest statement

JFM reports research grants, speaker fees, and advisory board membership from AstraZeneca, Novartis, and Sanofi, speaker fees and advisory board membership from Boehringer Ingelheim, research grants and advisory board membership from GlaxoSmithKline, speaker fees from Menarini and Uriach, and advisory board membership from Merck Sharpe & Dohme. AHK, JM, C-CC, PJR, and JAJ-N are employees and may hold stock and/or stock options in Sanofi. CP reports advisory board membership and/or consultancy fees from GlaxoSmithKline, Guidepoint, M3 Global Research, Olympus, Sanofi, and Stryker, receiving grants from the Bernice Bibby Research Trust, NIHR, Rosetrees Trust, Royal College of Surgeons, and Sir Jules Thorn Trust, and is a trustee of Fifth Sense. PWH reports advisory board membership of Regeneron Pharmaceuticals Inc. and Sanofi. CH reports advisory board membership from GlaxoSmithKline, OptiNose, Sanofi, and Smith & Nephew. MW is a member of national and international scientific advisory board (consulting), has received fees for lectures, grants for research projects from ALK-Abelló A/S, Allakos, AstraZeneca, GlaxoSmithKline, HAL, Meda Pharmaceuticals, Novartis, Otonomy, Inc., Roche, Sanofi-Aventis, Stallergenes Greer, Strekin AG, and Teva Pharmaceuticals. SS is a former employee and may hold stock and/or stock options in Regeneron Pharmaceuticals Inc. SN, SK, and YD are employees and may hold stock and/or stock options in Regeneron Pharmaceuticals Inc. The authors report no other conflicts of interest in this work.

Figures

None
Graphical abstract
Figure 1
Figure 1
SF-36 and EQ-VAS scores for patients with CRSwNP from SINUS-24 vs patients with other chronic diseases [references: SF-36; EQ-VAS31].
See this image and copyright information in PMC

References

    1. Hopkins C. Chronic rhinosinusitis with nasal polyps. N Engl J Med. 2019;381(1):55–63. doi:10.1056/NEJMcp1800215 - DOI - PubMed
    1. Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of disease in chronic rhinosinusitis with nasal polyps. J Asthma Allergy. 2021;14:127–134. doi:10.2147/JAA.S290424 - DOI - PMC - PubMed
    1. Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract. 2016;4(4):565–572. doi:10.1016/j.jaip.2016.04.012 - DOI - PMC - PubMed
    1. Abdalla S, Alreefy H, Hopkins C. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012;37(4):276–282. doi:10.1111/j.1749-4486.2012.02527.x - DOI - PubMed
    1. Seys SF, De Bont S, Fokkens WJ, et al. Real-life assessment of chronic rhinosinusitis patients using mobile technology: the mySinusitisCoach project by EUFOREA. Allergy. 2020;75(11):2867–2878. doi:10.1111/all.14408 - DOI - PMC - PubMed