Chronic rhinosinusitis (CRS) is an inflammatory disease of the nasal airways and paranasal sinuses with a high disease burden [1,2]. Patient-reported outcome (PRO) instruments are measures of disease severity and symptom burden in chronic diseases [3]. The FDA noted that the Sinonasal Outcome Test (SNOT-22) was the best currently available PRO instrument [4]. However, the SNOT-22 has several shortcomings, the most pertinent being that the SNOT-22 was not developed using input from patients with current definitions of CRS. PRO measures developed and validated on patients with the currently defined phenotypes of CRS are needed to support clinical trials in CRS. This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS to better measure the experience of patients with CRS.
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. 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, SNOT-22, and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later.
Figure: 12-item CRS-PRO instrument with a 5-point Likert scale scoring system. were scored 0-4, with 4 representing the most severe. CRS, Chronic rhinosinusitis; PRO, patient-reported outcome.
CRS-PRO – Please answer each of the following questions about how your chronic rhinosinusitis affects you.
After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. A total of 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 of 0.89 and Pearson’s correlation of 0.82 (P<0.01). The 12-item CRS-PRO correlated highly with SNOT-22 (r=0.83, P<0.00005) demonstrating its concurrent validity.
The CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions. This study demonstrates the preliminary validity and reliability of the CRS-PRO instrument. Applying CRS-PRO prospectively in larger patient cohorts, will provide improved CRS patient care and acceptability for future use in FDA clinical trials.
References
- Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. EPOS 2012: European Position Paper on Rhinosinusitis and Nasal Polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012;50:1-12.
- Orlandi RR, Kingdom TT, Hwang PH, Smith TL, Alt JA, Baroody FM, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol 2016;6(Suppl 1):S22-209.
- U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices an
- 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.e1-1540.e2.