A total of 232 patients with CRS were enrolled during the study period. All patients elected and underwent endoscopic sinus surgery for CRS and completed all necessary study documentation at baseline. Baseline SF-6D utility values were available for 230 / 232 patients (99.1%), with 2 having incomplete or illegible evaluations. Follow-up utility values (≥6 months) after ESS were available for 168/232 (72.4%) of enrollees at an average of 17.5(6.3) months following surgery. Patients lost to follow-up were analyzed with respect to age, gender, and comorbidities, with no significant differences appreciated compared to those who did complete the study protocol. Patients included in follow-up analysis did have lower baseline utility scores compared to those lost to follow-up (0.62 vs 0.66; P =0.011).
Demographics, medical comorbidities, and social history for the study cohort are detailed in . The average age was 47.8(14.1) with just over half male gender. Nasal polyposis was present in 44.4% and 59.1% had undergone a prior sinus surgical procedure. Preoperative disease severity measures are shown in . Baseline scores on CT, endoscopy, olfaction, and QOL are similar to those published in other surgical cohorts with CRS.
Baseline demographics, comorbid conditions, and clinical characteristics (n=232)
Baseline measure of CRS disease severity (n=232)
The mean utility value for the baseline health state of all patients with CRS was 0.65 (95% CI: 0.63–0.66), with a range 0.37–0.96. On bivariate analysis, baseline utility values were found to be different between men and women (0.66 vs. 0.63; P =0.037; ) and those with depression compared to those without depression (0.61 vs. 0.66; P=0.012). A trend for worse scores was seen in younger patients compared to older subjects, although this did not reach significance (P=0.104). Those patients with polyps did report slightly better baseline utility values than those without polyps (P=0.029). Differences in baseline utility were examined among subgroups defined by medical comorbidities after adjusting for age, gender, and depression in multivariate modeling. Utility values did not differ significantly based on prior surgery or the presence of allergies, asthma, ASA intolerance, or septal deviation.
Mean baseline SF-6D utility values across demographic, comorbid, and clinical characteristics (n=230)
Correlation between utility and baseline disease severity was assessed. The strongest correlation was seen between utility value and disease-specific QOL as measured by the RSDI total score (r= −.660; P<0.001; ). Robust correlations were not seen between utility values and baseline CT, endoscopy, or olfactory scores.
Correlation between utility value and CRS disease severity measures. SF-6D = Short Form 6D; RSDI=Rhinosinusitis Disability Index; CT=computed tomography; SIT=Smell Identification Test.
After endoscopic sinus surgery, a significant improvement in utility values was seen in the overall study cohort (P<0.001). Utility values improved by 0.087 (95% CI: 0.06–0.12; P<0.001) in patients with no history of sinus surgery and 0.062 (95% CI: 0.04–0.09; P<0.001) in those undergoing a revision procedure (). Significant improvement was found across all subgroups with the exception of patients with self-reported depression, for which the results did not quite reach significance (P=0.100). The degree of reported improvement was similar between all patient subgroups, with the exception that patients who presented without nasal polyposis reported significantly more mean improvement in utility following ESS than those with polyps ().
Mean changes in SF-6D utility values across demographic, comorbid, and clinical characteristics (n=168)
Change in utility after surgery was also compared in subgroups defined by demographics and medical comorbidities using multivariate regression modeling. None of the measured covariates significantly influenced improvement in utility after surgery, including age, gender, asthma, aspirin intolerance, and depression. Similar to baseline findings, change in utility after surgery correlated strongly to change in RSDI total score (r = −0.604; P<0.001) but not changes in other disease severity metrics.
The baseline health state utility value of CRS patients was found to be well below the weighted average norm of the US population (0.81) and similar to that seen in many other chronic diseases (). Similarly, the overall change in utility after sinus surgery appears comparable to those seen after medical or surgical treatments utilized in other chronic conditions (). The change in utility value after ESS exceeded the minimal clinically important difference for both primary and revision surgical procedures.
ESRD=end stage renal disease; HD=hemodialysis; mod=moderate; meds=medications; CAD=coronary artery disease; PCI=percutaneous coronary intervention; CHF=congestive heart failure; COPD=chronic obstructive pulmonary disease; US=United States.
PD=Parkinson’s disease; CPAP=continuous positive airway pressure; TNF=tumor necrosis factor alpha.