Responsiveness and convergent validity of the chronic rhinosinusitis patient‐reported outcome (CRS‐PRO) measure in CRS patients undergoing endoscopic sinus surgery

Abstract

Background:The chronic rhinosinusitis patient-reported outcome (CRS-PRO) measure is a 12-item measure with previously demonstrated validity in chronic rhinosinusitis (CRS) patients receiving medical therapy. This study establishes the factor structure, responsiveness, and convergent validity of the CRS-PRO following endoscopic sinus surgery (ESS). Methods: Northwestern CRS Subject Registry patients had pre-ESS, 3-month (n = 111; CRS without nasal polyps [CRSsNP] = 60, CRS with nasal polyps [CRSwNP] = 51), and 6-month (n = 86; CRSsNP = 47, CRSwNP = 39) post-ESS assessments where patients completed the CRS-PRO, 22-item Sino-Nasal Outcome Test (SNOT-22), and four Patient-Reported Outcomes Measurement (PROM) Information System (PROMIS) short forms (general health measures). Patients had pre-ESS objective testing (endoscopic and radiographic assessment).Factor analysis was conducted using principal axis factoring with varimax rotation on the baseline CRS-PRO. The clinically important difference (CID) was estimated using both distribution-based and anchor-based methods. Results: Factor analysis found the CRS-PRO comprised the "rhinopsychologic," "facial discomfort," and "cough" factors, which were responsive to ESS and correlated with the other PROMs. The changes observed in the CRS-PRO at 3 months had strong correlation with the corresponding changes in SNOT-22 (r = 0.792, p < 0.0001) and moderate correlations with changes in PROMIS fatigue and sleep domains. These changes had a very large effect size (Cohen's d 1.44) comparable to the longer SNOT-22 (Cohen's d 1.41) with slightly larger effect sizes observed in CRSwNP compared to CRSsNP patients.Similar convergent validity and responsiveness were observed in the 6-month data. The CRS-PRO CID was estimated to be between 5.0 and 7.5 (midpoint 6.0) using distribution-based and anchor-based methods.

CRS‐PRO and SNOT‐22 correlations with type 2 inflammatory mediators in chronic rhinosinusitis

“…These were acquired before ESS and at 6‐ to 12‐month post‐ESS follow‐up. Scores for each individual question were recorded and total score as well as each subdomain score were recorded for each individual survey 23,24 . For all these measures, an increase in disease severity is indicated by a higher score (SNOT‐22: range, 0‐110; CRS‐PRO: range, 0‐48).…”

“…These include the rhinologic, extranasal, ear/facial, psychologic, and sleep disturbance subdomains 24 . Similarly, a recent factor analysis of the CRS‐PRO revealed 3 distinct subdomains: rhinopsychologic, facial discomfort, and cough 23 . These symptom domains are aggregations of individual questions whose responses track with each other and may reflect sources of variance on a PROM.…”

“…We found that the shorter CRS-PRO has equal responsiveness and a better correlation with radiographic changes after medical management or endoscopic sinus surgery when compared with the longer SNOT-22. [21][22][23] PROMs are developed to represent the patient experience with a specific condition and, frequently, the individual questions fall into groups of different symptoms that reflect a similar concept. The SNOT-22 has been broken down into 5 distinct symptom domains via factor analysis.…”

Use of intraoperative frontal sinus mometasone‐eluting stents decreased interleukin 5 and interleukin 13 in patients with chronic rhinosinusitis with nasal polyps

“…It differs from the SNOT‐22 primarily in that it was developed with extensive input from patients who had CRS defined using current definitions of CRS including its two major phenotypes. At 12 items, it is also more concise than the SNOT‐22 21–23 . Pre‐ESS CRS‐PRO was completed for 36 (69%) patients and pre‐ESS SNOT‐22 was completed for 42 (81%) patients.…”

Year in review: 2021 IFAR article summary

“…Senior et al 46 demonstrated that an exhalation delivery system with fluticasone improved symptoms for patients with CRS irrespective of whether patients used conventional delivery nasal steroid sprays previously. Lin et al 47 showed that the Chronic Rhinosinusitis Patient-Reported Outcome survey is a valid and responsive instrument for assessing QoL changes in patients undergoing sinus surgery. Little et al 48 prospectively validated the Sinus Control Test (SCT) in a multicenter cohort of 218 patients after ESS.…”