Discordance of chronic rhinosinusitis disease control between EPOS guidelines and patient perspectives identifies utility of patient-rated control assessment.

BACKGROUND: The objective of this study was to determine concordance of patient-reported chronic rhinosinusitis (CRS) disease control with CRS disease control assessed according to European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) criteria. METHODS: In 421 participants, CRS disease control was determined using EPOS criteria which include the burden of 5 symptoms measured on a binary scale, use of rescue medications in the prior 6 months and presence of diseased mucosa on nasal endoscopy. Symptom severity was also assessed using a visual analogue scale (VAS). Participants rated their CRS disease control as "controlled","partly controlled" or "uncontrolled". RESULTS: Patient-reported and EPOS-based CRS disease control ratings agreed for 49.6% of participants. Amongst cases of disagreement, EPOS guidelines assessed worse CRS disease control relative to 92.9% of patients. Facial pain/pressure and impaired sense of smell distinctly associated with patient agreement with EPOS guidelines on having "uncontrolled" CRS. Higher VAS symptom scores were associated with worse patient-reported CRS disease control (i.e., agreeing with EPOS guidelines). Removal of the nasal endoscopy criterion improved agreement between patients' and EPOS control assessments, and replacement of this criterion with patient-reported control further aligned EPOS guidelines with patient perspectives. CONCLUSIONS: EPOS guidelines regularly assess worse CRS control than assessed by patients. The lack of more gradated symptom severity criteria and inclusion of nasal endoscopy may contribute to discordance of EPOS guidelines with patient-reported CRS control. Replacement of nasal endoscopy findings with a measure of patient-reported CRS disease control better aligns EPOS CRS disease control guidelines with patients' perspectives.

Individual symptom visual analogue scale severity scores for determining EPOS guideline-based chronic rhinosinusitis disease control.

BACKGROUND: The goal of this study was to determine how to translate visual analogue scale (VAS) symptom scores to the binary, descriptive symptom scales used in the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) criteria for chronic rhinosinusitis (CRS) disease control. METHODS: 309 CRS patients were recruited. All patients rated their burden of 5 symptoms (nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell loss, sleep disturbance or fatigue) using the binary EPOS descriptive symptom scales and a VAS (on a scale of 0 to 10). In addition, participants completed a 22-item Sinonasal Outcome Test (SNOT-22) and rated their overall CRS disease control as "controlled", "partly controlled" or "uncontrolled" Results: Symptom burdens measured by VAS, binary descriptive EPOS scale and SNOT-22 were associated with worsening CRS disease control reported by participants. Each symptom had a distinct VAS score cut-off that strongly predicted the uncontrolled option on the corresponding binary descriptive EPOS symptom scale. However, the predictive ability of VAS for rhinorrhea/ postnasal drip was disparately worse than the other 4 symptoms. When considering all symptom data simultaneously, a VAS score higher than 3.5 strongly predicted the uncontrolled option on the corresponding binary descriptive EPOS symptom scale for all 5 symptoms. CONCLUSIONS: A VAS symptom score of higher than 3.5 translates to the uncontrolled option in the binary, descriptive symptom scale of the EPOS control criteria. The rhinorrhea/postnasal drip descriptive symptom scale translates disparately worse to VAS scores and may be considered for revision in future criteria.

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.