OBJECTIVES-1. To measure the proportion of patients with chronic rhinosinusitis (CRS) who experience clinically significant improvement after endoscopic sinus surgery (ESS) in a prospective, multi-institutional fashion. 2. To identify preoperative characteristics which predict clinically significant improvement in quality of life (QOL) after ESS. STUDY DESIGN-Prospective, multi-institutional cohort study SETTING-Academic tertiary care centers SUBJECTS & METHODS-302patients with CRS from three centers were enrolled between July 2004 and December 2008 and followed for an average of 17.4 months postoperatively. Preoperative patient characteristics, computed tomography (CT) scan, endoscopy score and pre-and postoperative quality of life (QOL) were collected. Univariate and multivariate analyses were performed.

Objective Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a disease process that is driven, in part, by intrinsic mucosal inflammation. Surgery plus continued medical therapy is commonly elected by medically recalcitrant, symptomatic patients. The objective was to evaluate the prevalence of nasal polyp recurrence up to 18-months after endoscopic sinus surgery (ESS) with congruent continuing medical management. Study Design Prospective, multi-center cohort of adult patients undergoing ESS for medically recalcitrant CRSwNP performed between August, 2004 and February, 2015. Methods All patients received baseline nasal endoscopy quantified using Lund-Kennedy grading. All patients included for final analysis provided at least 6-month postoperative endoscopy examinations. Multivariate analysis was used to identify risk factors for polyp recurrence. Results 363 CRSwNP patients having undergone ESS involving polypectomy were enrolled. A total of 244 (67%) participants had graded postoperative endoscopies with average of follow-up of 14.3[±7.0] months. Surgery plus postoperative medical management significantly improved endoscopy total scores at 6-months (p<0.001). The recurrence of nasal polyposis 6-months after ESS was 35% (68/197), compared to 38% (48/125) after 12-months, and 40% (52/129) after 18-months. Multivariate analysis identified both prior ESS (OR=2.6, 95% CI: 1.5–4.6; p=0.001) and worse preoperative polyposis severity (OR=1.4, 95% CI: 1.1–1.8; p=0.016) as risk factors for recurrent polyposis. Conclusions Polyp recurrence is common after ESS with control of polyps up to 18-months found in approximately 60–70% of patients. Investigation into both surgical and medical management strategies is warranted to improve upon the observed prevalence of recurrence.

Background Prior study demonstrated that baseline Sinonasal Outcomes Test-22 (SNOT-22) aggregate scores accurately predict selection of surgical intervention in patients with chronic rhinosinusitis (CRS). Factor analysis of the SNOT-22 survey has identified 5 distinct domains that are differentially impacted by endoscopic sinus surgery (ESS). This study sought to quantify SNOT-22 domains in patient cohorts electing both surgical or medical management and post-interventional change in these domains. Methods Patients CRS were prospectively enrolled into a multi-institutional, observational cohort study. Subjects elected continued medical management or ESS. SNOT-22 domain scores at baseline were compared between treatment cohorts. Post-intervention domain score changes were evaluated in subjects with at least 6-month follow-up. Results 363 subjects were enrolled with 72(19.8%) electing continued medical management while 291(80.2%) elected ESS. Baseline SNOT-22 domain scores were comparable between treatment cohorts in sinus-specific domains (Rhinologic, Extra-nasal rhinologic, and Ear/facial symptoms, p>0.050); however, the surgical cohort reported significantly higher psychological (16.0(8.4)vs.12.0(7.1); p<0.001) and sleep dysfunction (13.7(6.8)vs.10.5(6.2); p<0.001) than the medical cohort. Effect sizes for ESS varied across domains with Rhinologic and Extra-nasal rhinologic symptoms experiencing the greatest gains (1.067 and 0.997, respectively) while Psychological and Sleep dysfunction experiencing the smallest improvements (0.805 and 0.818, respectively). Patients experienced greater mean improvements after ESS in all domains compared to the medical management (p<0.001). Conclusions Subjects electing ESS report higher sleep and psychological dysfunction compared to medical management but have comparable sinus-specific symptoms. Subjects undergoing ESS experience greater gains than medical management across all domains; however these gains are smallest in the psychological and sleep domains.

Objective-Assess whether the presence of mucosal eosinophilia correlates with surgical outcomes in patients with chronic rhinosinusitis. Study Design-Prospective cohort Setting-Tertiary medical centerSubjects and Methods-Adult patients with chronic rhinosinusitis were prospectively enrolled and demographic data and medical comorbidities recorded. Preoperative quality-of-life (QOL) was measured by the Chronic Sinusitis Survey (CSS), Rhinosinusitis Disability Index (RSDI), and Short Form-36 General Health Survey (SF-36). Sinus mucosal specimens were collected at the time of surgery and the degree of eosinophilia quantified. Postoperative QOL was measured and differences in QOL improvement were compared between those with and without eosinophilia.Results-A total of 102 patients had both histopathologic and QOL outcome data available for review. Follow-up averaged 16.5 months. Patients with eosinophilia showed significantly less improvement in the RSDI total (17.9 vs 25.0; p=0.044), RSDI functional (5.7 vs 8.8; p=0.018), CSS medication (3.6 vs 17.3; p=0.013), SF-36 general health (0.6 vs 9.6; p=0.008), SF-36 physical role (16.1 vs 34.7; p=0.036), and SF-36 vitality (11.9 vs 21.2; p=0.034) scales than those without eosinophilia. The greatest improvement in QOL was seen in patients without eosinophilia or polyps and the least improvement seen in those with eosinophilia but without polyps. Conclusion-The presence of mucosal eosinophilia at the time of surgery consistently predicted less improvement in both disease-specific and general QOL compared to those without eosinophilia. The impact of eosinophilia on outcomes was greatest for patients without nasal polyposis, a group which demonstrated the least improvement in QOL measures.

Objective Describe detailed histopathologic findings from a cohort of patients with chronic rhinosinusitis and evaluate whether histologic measures correlate with baseline clinical factors. Study Design Cross-sectional study with planned data collection Setting Tertiary medical center Subjects and Methods Adult patients with chronic rhinosinusitis were prospectively enrolled and demographic data and medical comorbidities recorded. Disease severity was measured by computed tomography (CT), endoscopy, Smell Identification Test (SIT), the Chronic Sinusitis Survey, Rhinosinusitis Disability Index, and SF-36 General Health Survey. Mucosal specimens were assessed for the presence of mucosal inflammation, including cellular (eosinophils, neutrophils, lymphocytes, mast cells, plasma cells, macrophages), epithelial (squamous metaplasia, basement membrane thickening, goblet cells), and stromal markers (subepithelial edema, fibrosis). Histopathologic findings were correlated to baseline clinical factors. Results A total of 147 subjects were enrolled with histologic samples available for review. Presence of inflammatory markers was diverse with lymphocytes present in 100% of subjects, eosinophils in 49.7%, and neutrophils found in 0.7%. Total eosinophil counts correlated with the presence of nasal polyposis (r =-0.367;p<0.001), asthma (r=0.264;p=0.001), and aspirin intolerance (r=0.279; p=0.001). Mucosal eosinophilia correlated with worse disease severity on CT (r=0.414;p<0.001), endoscopy (r=0.376; p<0.001), and SIT (r=-0.253;p=0.002) with the highest correlations seen in subgroups without nasal polyps. Histopathologic findings did not significantly correlate with any quality-of-life measure. Conclusion Mucosal eosinophilia correlates with objective disease severity as defined by CT, endoscopy, and SIT scores. Although other histologic markers of inflammation are present, none show similar correlations. The presence of mucosal eosinophils does not correlate with quality-of-life scores.

OBJECTIVES/HYPOTHESIS The primary study goal was to measure health state utility values in patients with chronic rhinosinusitis (CRS) before and after undergoing endoscopic sinus surgery (ESS). A secondary goal was to assess the meaning of these values by comparing them with other chronic disease processes and currently available medical or surgical treatments. STUDY DESIGN Prospective, observational cohort study METHODS Adults with CRS were enrolled after electing ESS and observed over a 5-year period. Baseline demographic and medical comorbidities were recorded for each patient, as well as computed tomography (CT), endoscopy, olfaction, and disease-specific quality of life scores. Utility values were derived using the Short-Form 6D (SF-6D) at baseline and again after surgery. RESULTS The mean SF-6D utility value for the baseline health state of all patients with CRS (n=232) was 0.65 (95% CI: 0.63–0.66). Baseline utility values correlated with disease-specific QOL as measured by the Rhinosinusitis Disability Index (RSDI) (r=−0.660; P<0.001), but not baseline CT, endoscopy, or olfactory scores. Follow-up utility values (≥6 months) after ESS 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. CONCLUSIONS Patients with CRS who failed medical therapy and elected to undergo ESS report health state utility values which are significantly lower than the United States population norm. Utility values showed improvement after ESS which was statistically and clinically significant. These results provide the initial data necessary for formal cost-effectiveness analyses incorporating ESS.

Importance Patient-reported measures are designed to detect a true change in outcome, but they are also subject to change from biases inherent to self-reporting: changing internal standards, changing priorities, and changing interpretations of a given instrument. These biases are collectively known as `response shifts' and can obscure true change after medical interventions. Objective To determine the presence of response shifts in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery. Design, Setting, and Participants Multisite, prospective, observational cohort study conducted at academic tertiary care centers between February 2011 and May 2013. Study participants comprised a population-based sample of 514 adults (age ≥18 years) with CRS, who elected surgical intervention for continuing medically refractory symptoms. Intervention Endoscopic sinus surgery. Main Outcome and Measures Preoperative and postoperative data from the 22-item Sinonasal Outcome Test (SNOT-22) survey instrument was characterized using exploratory factor analysis. Subsequent longitudinal structural equation models were estimated to test structure, potential response shifts, and true change in the SNOT-22. Results A total of 339 participants (66.0%) provided survey evaluations at baseline and 6-month follow-up. Factor analysis of the SNOT-22 revealed 5 correlated, yet distinguishable, underlying factors. Endoscopic sinus surgery had a differential impact across these factors, with the largest effect size in rhinologic symptoms (mean[SD] SNOT-22 score before and after surgery, 13.18[5.11] and 7.37[5.48], respectively; d= −1.13 [P < .001] and extranasal rhinologic symptoms (8.31[3.46] and 4.83[3.68], respectively; d= −1.00 [p<0.05]) (d is an effect size measure defined as the difference in means divided by the presurgery SD). Endoscopic sinus surgery had a smaller, yet significant, effect size on the remaining 3 factors: ear/facial symptoms (7.32[4.6] and 3.90[4.1], respectively; d= −0.74; P<0.001), psychological dysfunction (11.90[7.21] and 6.50[6.69], respectively; d= −0.75; P<0.05), and sleep dysfunction (10.12[5.59] and 5.88[5.37], respectively; d= −0.76; P<0.001). Participants were found to undergo recalibration, reprioritization, and reconceptualization of symptoms after intervention; however, the magnitude of these response shifts was small and not clinically significant. Conclusions and Relevance The SNOT-22 measures 5 distinct factors, not a single construct. Reporting of individual subscale scores may improve sensitivity of this instrument in future studies. Participants undergoing endoscopic sinus surgery experience only clinically insignificant response shifts, validating assessment of change through use of presurgery and postsurgery SNOT-22 responses.

Objective Disease-specific reductions in patient productivity can lead to substantial economic losses to society. The purpose of this study was to: 1) define the annual productivity cost for a patient with refractory chronic rhinosinusitis (CRS) and 2) evaluate the relationship between degree of productivity cost and CRS-specific characteristics. Study Design Prospective, multi-institutional, observational cohort study. Methods The human capital approach was used to define productivity costs. Annual absenteeism, presenteeism, and lost leisure time was quantified to define annual lost productive time (LPT). LPT was monetized using the annual daily wage rates obtained from the 2012 US National Census and the 2013 US Department of Labor statistics. Results A total of 55 patients with refractory CRS were enrolled. The mean work days lost related to absenteeism and presenteeism was 24.6 and 38.8 days per year, respectively. A total of 21.2 household days were lost per year related to daily sinus care requirements. The overall annual productivity cost was $10,077.07 per patient with refractory CRS. Productivity costs increased with worsening disease-specific QoL (r=0.440; p=0.001). Conclusion Results from this study have demonstrated that the annual productivity cost associated with refractory CRS is $10,077.07 per patient. This substantial cost to society provides a strong incentive to optimize current treatment protocols and continue evaluating novel clinical interventions to reduce this cost.