Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps

Asif H Khan, Matthew Reaney, Isabelle Guillemin, Lauren Nelson, Shanshan Qin, Siddhesh Kamat, Leda Mannent, Nikhil Amin, Diane Whalley, Claire Hopkins, Asif H Khan, Matthew Reaney, Isabelle Guillemin, Lauren Nelson, Shanshan Qin, Siddhesh Kamat, Leda Mannent, Nikhil Amin, Diane Whalley, Claire Hopkins

Abstract

Objectives/hypothesis: The 22-item Sinonasal Outcome Test (SNOT-22) is a validated chronic rhinosinusitis health-related quality-of-life outcome (HRQoL) measure; however, SNOT-22 domains have not been validated specifically for chronic rhinosinusitis with nasal polyps (CRSwNP).

Study design: Validation of SNOT-22 domain structure, using data from 3 randomized, placebo-controlled, double-blinded, multicenter clinical trials of dupilumab in adults with moderate-to-severe CRSwNP.

Methods: Preliminary dimensional structure was derived by exploratory factor analyses of SNOT-22 data from a phase 2 trial (NCT01920893) of dupilumab for the treatment of CRSwNP. Data from 2 phase 3 clinical trials (NCT02912468 and NCT02898454) were then used for confirmatory factor analysis, and evaluated for reliability, construct validity, and responsiveness. In all three trials, the SNOT-22 was administered electronically on a tablet and trial participants were required to answer all items.

Results: Factor analysis supported five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. Correlations between domains were moderate to high, ranging from 0.53 (Nasal-Emotion) to 0.88 (Function-Sleep). Construct validity was mostly supported; relationships with other measures were almost always in the intended direction and magnitude. Internal consistency reliability also confirmed questionnaire structure with strong Cronbach's alpha values (all >0.80). Moderate-to-high correlations were observed between change in SNOT-22 domain scores and other study patient-reported outcome measures, along with large effect-size estimates (≥0.7), demonstrating responsiveness of the Nasal, Sleep, and Function domains. Emotion and Ear/Facial domains had small-to-moderate effect sizes.

Conclusions: Psychometric analyses support the validity, reliability, and responsiveness of five domains of SNOT-22 (Nasal, Ear/Facial, Sleep, Function, and Emotion) for assessing symptoms and impact on HRQoL in patients with CRSwNP. Laryngoscope, 132:933-941, 2022.

Keywords: Chronic rhinosinusitis; SNOT-22; health-related quality of life; nasal polyps; psychometrics.

© 2021 RTI Health Solutions, Sanofi and Regeneron Pharmaceuticals, Inc. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

Figures

Fig 1
Fig 1
Five‐factor SNOT‐22 confirmatory factor analysis based on pooled phase 3 data at (A) baseline; (B) week 24. (A) *P < .01. Goodness‐of‐fit statistics for the five‐factor confirmatory factor analysis with no cross‐loading are as follows: CFI, 0.962; TLI, 0.956; RMSEA, 0.094 (95% CI 0.089–0.098). Minor modification to allow item 16 to load on both the Sleep and Function domains reduced RMSEA to 0.076 (0.071–0.081), with the strongest loading of this item (0.487) still on the Sleep domain. Items: 1. need to blow nose; 2. nasal blockage; 3. sneezing; 4. runny nose; 5. cough; 6. post‐nasal discharge; 7. thick nasal discharge; 8. ear fullness; 9. dizziness; 10. ear pain; 11. facial pain/pressure; 12. decreased sense of smell/taste; 13. difficulty falling asleep; 14. wake up at night; 15. lack of a good night's sleep; 16. wake up tired; 17. fatigue; 18. reduced productivity; 19. reduced concentration; 20. frustrated/restless/irritable; 21. sad; 22. embarrassed. (B) Goodness‐of‐fit statistics for the five‐factor confirmatory factor analysis with no cross‐loading are as follows: CFI, 0.975; TLI, 0.971; and RMSEA, 0.084 (95% CI, 0.079–0.089). Items: 1. need to blow nose; 2. nasal blockage; 3. sneezing; 4. runny nose; 5. cough; 6. post‐nasal discharge; 7. thick nasal discharge; 8. ear fullness; 9. dizziness; 10. ear pain; 11. facial pain/pressure; 12. decreased sense of smell/taste; 13. difficulty falling asleep; 14. wake up at night; 15. lack of a good night's sleep; 16. wake up tired; 17. fatigue; 18. reduced productivity; 19. reduced concentration; 20. frustrated/restless/irritable; 21. sad; 22. embarrassed. CFI = comparative fit index; CI = confidence interval; RMSEA = root mean square error of approximation; SNOT‐22 = 22‐item Sinonasal Outcome Test; TLI = Tucker‐Lewis index.

References

    1. Dennis SK, Lam K, Luong A. A review of classification schemes for chronic rhinosinusitis with nasal polyposis endotypes. Laryngoscope Investig Otolaryngol 2016;1:130–134.
    1. Groger M, Bernt A, Wolf M, et al. Eosinophils and mast cells: a comparison of nasal mucosa histology and cytology to markers in nasal discharge in patients with chronic sino‐nasal diseases. Eur Arch Otorhinolaryngol 2013;270:2667–2676.
    1. Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract 2016;4:565–572.
    1. Naclerio RM, Baroody FM, Pinto JM. Nasal polyps and biomarkers. J Allergy Clin Immunol Pract 2017;5:1589–1590.
    1. Khan A, Vandeplas G, Huynh TMT, et al. The Global Allergy and Asthma European Network (GALEN) rhinosinusitis cohort: a large European cross‐sectional study of chronic rhinosinusitis patients with and without nasal polyps. Rhinology 2019;57:32–42.
    1. Huvenne W, van Bruaene N, Zhang N, et al. Chronic rhinosinusitis with and without nasal polyps: what is the difference? Curr Allergy Asthma Rep 2009;9:213–220.
    1. Dietz de Loos DA, Hopkins C, Fokkens WJ. Symptoms in chronic rhinosinusitis with and without nasal polyps. Laryngoscope 2013;123:57–63.
    1. Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012;50:1–12.
    1. Rosenfeld RM, Andes D, Bhattacharyya N, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg 2007;137:S1–S31.
    1. Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22‐item Sinonasal Outcome Test. Clin Otolaryngol 2009;34:447–454.
    1. Levy JM, Mace JC, Rudmik L, Soler ZM, Smith TL. Low 22‐item sinonasal outcome test scores in chronic rhinosinusitis: why do patients seek treatment? Laryngoscope 2017;127:22–28.
    1. Rudmik L, Hopkins C, Peters A, Smith TL, Schlosser RJ, Soler ZM. Patient‐reported outcome measures for adult chronic rhinosinusitis: a systematic review and quality assessment. J Allergy Clin Immunol 2015;136:1532–1540.e1532.
    1. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 2010;19:539–549.
    1. Rudmik L, Soler ZM, Mace JC, DeConde AS, Schlosser RJ, Smith TL. Using preoperative SNOT‐22 score to inform patient decision for endoscopic sinus surgery. Laryngoscope 2015;125:1517–1522.
    1. Kennedy JL, Hubbard MA, Huyett P, Patrie JT, Borish L, Payne SC. Sino‐nasal outcome test (SNOT‐22): a predictor of postsurgical improvement in patients with chronic sinusitis. Ann Allergy Asthma Immunol 2013;111:246–251.e242.
    1. DeConde AS, Bodner TE, Mace JC, Smith TL. Response shift in quality of life after endoscopic sinus surgery for chronic rhinosinusitis. JAMA Otolaryngol Head Neck Surg 2014;140:712–719.
    1. DeConde AS, Mace JC, Bodner T, et al. SNOT‐22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis. Int Forum Allergy Rhinol 2014;4:972–979.
    1. Dejaco D, Riedl D, Huber A, et al. The SNOT‐22 factorial structure in European patients with chronic rhinosinusitis: new clinical insights. Eur Arch Otorhinolaryngol 2019;276:1355–1365.
    1. Sedaghat AR, Gray ST, Caradonna SD, Caradonna DS. Clustering of chronic rhinosinusitis symptomatology reveals novel associations with objective clinical and demographic characteristics. Am J Rhinol Allergy 2015;29:100–105.
    1. Feng AL, Wesely NC, Hoehle LP, et al. A validated model for the 22‐item Sino‐Nasal Outcome Test subdomain structure in chronic rhinosinusitis. Int Forum Allergy Rhinol 2017;7:1140–1148.
    1. Talat R, Speth MM, Gengler I, et al. Chronic rhinosinusitis patients with and without polyps experience different symptom perception and quality of life burdens. Am J Rhinol Allergy 2020;34:742–750.
    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;37:276–282.
    1. U.S. Food and Drug Administration . Guidance for Industry Patient‐Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. . Accessed September 14, 2020.
    1. Jonstam K, Swanson BN, Mannent LP, et al. Dupilumab reduces local type 2 pro‐inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy 2019;74:743–752.
    1. Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS‐24 and LIBERTY NP SINUS‐52): results from two multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group phase 3 trials. Lancet 2019;394:1638–1650.
    1. Bentler PM. EQS Structural Equations Program Manual. Los Angeles, CA: BMDP Statistical Software; 1989.
    1. Tucker LR, Lewis C. A reliability coefficient for maximum likelihood factor analysis. Psychometrika 1973;38:11.
    1. Browne MW, Cudeck R. Alternative ways of assessing model fit. In: Bollen KA, Long JS, eds. Testing Structural Equation Models. Newbury Park, CA: Sage; 1993.
    1. Hu L, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Struct Equ Model 1999;6:56.
    1. Schumacker RE, Lomax RG. A Beginner's Guide to Structural Equation Modeling. Mahwah NJ: Lawrence Erlbaum Associates, Inc.; 1996.
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951;16:297–334.
    1. McGraw KO, Wong SP. Forming inferences about some intraclass correlation coefficients. Psychol Methods 1996;1:30–46.
    1. Nunnally JC, Bernstein IH. Psychometric Theory. New York, NY: McGraw‐Hill; 1994.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York, NY: Routledge; 1988.
    1. Lötvall J, Akdis CA, Bacharier LB, et al. Asthma endotypes: a new approach to classification of disease entities within the asthma syndrome. J Allergy Clin Immunol 2011;127:355–360.
    1. Wang C, Zhang L. Use of biologics in chronic sinusitis with nasal polyps. Curr Opin Allergy Clin Immunol 2019;19:365–372.
    1. Cho SH, Hamilos DL, Han DH, Laidlaw TM. Phenotypes of chronic rhinosinusitis. J Allergy Clin Immunol Pract 2020;8:1505–1511.
    1. Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology 2020;58:1–464.
    1. Bachert C, Han JK, Wagenmann M, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management. J Allergy Clin Immunol 2021;147:29–36.
    1. Naclerio R, Baroody F, Bachert C, et al. Clinical research needs for the management of chronic rhinosinusitis with nasal polyps in the new era of biologics: a National Institute of Allergy and Infectious Diseases workshop. J Allergy Clin Immunol Pract 2020;8:1532–1549.e1531.

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