Overall symptom severity as a patient-reported outcome measure for chronic rhinosinusitis: what it reflects and how to measure it.

BACKGROUND: The objective of this study was to identify how - and to what extent - overall symptom severity (OSS) score reflects individual chronic rhinosinusitis (CRS) symptoms and whether it can be measured using alternatives to the standard visual analog scale (VAS). METHODS: CRS patients from four sites across three continents rated their OSS scores, severities of nasal obstruction, nasal drainage, decreased sense of smell, facial pain/pressure and sleep disturbance using a standard VAS, VAS with labeled tick marks at every 1 centimeter, and by writing down their OSS on a scale of 0 - 100 (which was divided by 10), all of which lead to severity scores ranging from 0 - 10 in 0.1 intervals. Quality of life was measured using the SNOT-22 and EQ-5D VAS. RESULTS: In 311 CRS patients, OSS score was significantly correlated with SNOT-22 and EQ-5D VAS. OSS score was most greatly associated with the mean of all individual symptom severity scores. From individual CRS symptoms, OSS was most greatly associated with nasal obstruction followed by nasal drainage and facial pain/pressure severities. These results held true for participants with and without nasal polyps. Measurement of OSS and individual symptom severity scores using a standard VAS, tick-marked VAS, and write-in option had near-perfect consistency. CONCLUSIONS: We demonstrate for the first time that OSS largely reflects the mean of individual CRS symptom severities, although OSS is=== most weighted by nasal obstruction severity. OSS and individual symptom severity scores can be measured using a standard VAS, tick-marked VAS or write-in prompt with near-perfect consistency.

Patient-reported chronic rhinosinusitis disease control is a valid measure of disease burden.

BACKGROUND: Disease control is an important treatment goal for chronic uncurable conditions such as chronic rhinosinusitis (CRS). The objective of this study was to determine whether patient-reported CRS disease control is a valid reflection of disease burden. METHODS: Prospective longitudinal study of 300 CRS patients (35% CRS with nasal polyps, 65% CRS without nasal polyps). At enrollment and at a subsequent follow-up timepoint, all participants were asked to rate their CRS disease control as 'not at all', 'a little', 'somewhat', 'very', 'completely' as well as to complete a 22-item Sinonasal Outcome Test (SNOT-22) and the 5-dimension EuroQol general health questionnaire from which the visual analogue scale (EQ-5D VAS) was used. RESULTS: At enrollment and follow-up timepoints, patient-reported CRS disease control was significantly correlated with SNOT-22 and EQ-5D VAS scores. The change in patient-reported CRS disease control was significantly correlated with change in SNOT-22 and change in EQ-5D VAS scores. There was significant cross-sectional and longitudinal correlation between patient-reported control and all SNOT-22 subdomain scores. A SNOT-22 score of ≤25 points or lower, or an EQ-5D VAS score of ≥77 was predictive of having well - (i.e. 'very' or 'completely') controlled CRS. CONCLUSIONS: Patient-reported CRS disease control is a valid measure of CRS disease burden and general QOL. A patient-reported assessment of CRS disease control could be considered as a component of a more comprehensive measure of CRS disease control.

Multi-institutional minimal clinically important difference of the 22-item Sinonasal Outcome Test in medically managed chronic rhinosinusitis.

BACKGROUND: With a rapid proliferation of clinical trials to study novel medical treatments for CRS, the objective of this study was to study the minimal clinically important difference (MCID) of the 22-item Sinonasal Outcome Test (SNOT-22) in medically-managed CRS patients. METHODS: A total of 183 medically-treated CRS patients were recruited. All patients completed a SNOT-22 at enrollment and subsequent follow up visit. Distribution and anchor-based methods were used for MCID calculation. These data were combined with data from a previously published study on SNOT-22 MCID in 247 medically managed CRS patients to determine a final recommended MCID value using the combined cohort of 430 patients. RESULTS: In our cohort, distribution- and anchor-based methods -"using both sinus-specific and general health anchors-"provided greatest support for a 12-point SNOT-22 MCID, which had approximately 55% sensitivity but 81% specificity for detecting patients explicitly reporting improvement in their sinus symptoms and general health. In the combined cohort of 430 patients, we also found greatest support for a 12-point SNOT-22 MCID, which had approximately 57% sensitivity and 81% specificity for detecting patients explicitly reporting improvement in their sinus symptoms and general health. We also find evidence that the MCID value may be higher in CRS patients without nasal polyps compared to those with nasal polyps. CONCLUSIONS: Our results - which include data from patients from two different institutions and regions - confirm a SNOT-22 MCID of 12 in medically managed CRS patients. The SNOT-22 MCID was specific but not sensitive for identifying CRS patients experiencing improvement in symptoms or general health.