Development and Preliminary Validation of a New Patient-Reported Outcome Measure for Chronic Rhinosinusitis (CRS-PRO)

Overview

Journal J Allergy Clin Immunol Pract

Specialty Allergy & Immunology

Date 2020 May 8

PMID 32376490

Citations 11

Authors

Saied Ghadersohi

Caroline P E Price

Sally E Jensen

Jennifer L Beaumont

Robert C Kern

David B Conley

Kevin C Welch

Anju T Peters

Leslie C Grammer 3rd

Whitney W Stevens

Alexis M Calice

Elizabeth Stanton

Marisa K VanderMeeden

Robert P Schleimer

Bruce K Tan

Affiliations

Soon will be listed here.

Abstract

Background: Patient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS.

Objective: This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS.

Methods: Instrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later.

Results: After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach α, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P < .0001). The 12-item CRS-PRO correlated highly with the longer SNOT-22 (r = 0.83, P < .0001) demonstrating its concurrent validity. We also demonstrated validity and reliability in a separate analysis for patients with CRSsNP and CRSwNP.

Conclusion: The CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions.

Citing Articles

Validation of the Arabic Chronic Rhinosinusitis Patient-Reported Outcome (CRS-PRO): Translation and Cultural Adaptation.

Biadsee A, Abu Amsha N, Sowerby L, Boldes T, Kassem F Healthcare (Basel). 2025; 13(3).

PMID: 39942395 PMC: 11817419. DOI: 10.3390/healthcare13030206.

Patient-centered outcomes for clinical trials in chronic rhinosinusitis with or without nasal polyps and allergic fungal rhinosinusitis.

Klooster B, Chatterton K, Ibrahim N, Bernstein M, Shields A, Allen V J Patient Rep Outcomes. 2025; 9(1):11.

PMID: 39847130 PMC: 11757837. DOI: 10.1186/s41687-024-00833-6.

Cross‑Cultural Validation of the Chronic Rhinosinusitis Patient-Reported Outcomes (CRS-PRO) Questionnaire in Portuguese.

Sousa-Machado A, Cascao M, Sousa P, Rocha T, Castanheira A, Sowerby L Cureus. 2025; 16(11):e74875.

PMID: 39741612 PMC: 11685330. DOI: 10.7759/cureus.74875.

Assessing the Use of Patient-Reported Outcome Measures in the Routine Clinical Care of Chronic Rhinosinusitis Patients: A Canadian Perspective.

Kim H, Lee D, Shin D, Horton G, Gignac M, Lee J J Otolaryngol Head Neck Surg. 2024; 53:19160216241288806.

PMID: 39415404 PMC: 11487533. DOI: 10.1177/19160216241288806.

Collaboration between otolaryngologists and oral surgeons in maxillary sinus elevation planning.

Craig J, Saibene A, Felisati E, Felisati G Clin Implant Dent Relat Res. 2024; 26(6):1181-1189.

PMID: 39187918 PMC: 11660528. DOI: 10.1111/cid.13385.

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