Abstract
Background:
Productivity loss and activity limitations due to chronic rhinosinusitis (CRS) are known to contribute to the significant economic and personal burden of disease. The purpose of this study was to evaluate productivity and activity impairment before and after endoscopic sinus surgery (ESS) for medically refractory CRS.
Methods:
Prospective, multi-institutional, observational cohort study. Patients diagnosed with medically refractory CRS completed the Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire before surgery and approximately 6-months post-procedure. Factors associated with minimal clinical important differences (MCID) for productivity and activity impairment were identified.
Results:
A total of 279 study participants were screened for inclusion, of which 176 (63.1%) with postoperative follow-up were included in the final cohort. Preoperative productivity and activity impairment were described in 63.2% and 69.8% of patients, respectively. Among those patients, postoperative improvement equaling at least one MCID was reported in both productivity (76.1%) and activity (76.4%) impairment. Multivariate regression identified sphenoidotomy (odds ratio [OR]=4.18, 95% CI:1.03–17.02) as the only factor associated with increased likelihood of productivity improvement, whereas septoplasty during ESS (OR=8.45, 95% CI:2.33–30.68) and migraine (OR=0.35; 95% CI:0.12–0.96) were associated with differential odds of activity improvement.
Conclusions:
CRS is associated with a substantial burden on productivity and activity that significantly improves after treatment with ESS. These data may facilitate improved patient counseling and shared-decision making regarding surgical management for CRS.
MeSH Key Words: Sinusitis, efficiency, treatment outcome, quality of life, surgery
INTRODUCTION
Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of the nasal mucosa and paranasal sinuses associated with a significant economic burden.1,2 Recent studies have evaluated CRS-associated costs, as analyses of disease-specific costs are important for clinicians to pursue optimal, individualized treatment strategies, and for policy makers to make informed decisions regarding healthcare resource allocation.1–5 Direct costs for patients with CRS are well described and predominantly stem from outpatient ambulatory and emergency room visits, prescription medication, surgery, and associated comorbidities.1,3 The total annual direct cost attributed to CRS in the U.S. is estimated to be $8.6 billion.1,4 However, comprehensive cost evaluation requires an understanding of additional personal and societal disease-costs such as productivity-loss and physical disability, which are assessed as indirect costs.3
Indirect costs are a significant burden among patients with CRS, with an annual productivity cost of approximately $10,000 per patient.5 Productivity loss can be attributed to decreased work performance (presenteeism) and missing time from work (absenteeism).5 These costs may lead to personal financial challenges due to lost employment or wages, which may contribute to limitations in optimal disease management.5,6 Psychosocial quality of life (QOL) domains may further impact productivity and activity.7
Use of validated survey instruments to evaluate work and activity impairment due to CRS may facilitate improved economic estimations, patient counseling regarding treatment strategies, and a more comprehensive evaluation of postoperative outcomes.7 The primary objective of this study was to evaluate work productivity and activity impairment before and after surgical treatment for medically refractory CRS. We hypothesize that patients with medically refractory CRS have high disease-related work productivity and activity impairment that improves after surgical treatment.
METHODS and MATERIALS
Sample Population
Enrollment originated from an observational, prospective research investigation of human subjects funded by the National Institute on Deafness and Other Communication Disorders (Bethesda, MD.; 3R01-DC005805). Participants were enrolled via invitation from heterogeneous patient populations presenting to academic, rhinology centers in the U.S.: Oregon Health & Science University (Portland, OR.), Medical University of South Carolina (Charleston, SC.), University of Utah (Salt Lake City, UT.), University of Colorado (Aurora, CO.), and University of Virginia (Charlottesville, VA.). The Institutional Review Board at each site provided ethical review and oversight. Participants were excluded from final cohort selection if they provided incomplete or inaccurate responses to patient-reported outcome measures during the study.
Adult patients (≥18 years) received a confirmed diagnosis of symptomatic and medically recalcitrant CRS, with nasal polyposis (CRSwNP) or without nasal polyposis (CRSsNP), from a fellowship-trained rhinologist following current practice guidelines from the American Academy of Otolaryngology-Head and Neck Surgery.8,9 Symptoms at presentation included nasal congestion, mucopurulent drainage, facial pain or pressure, and olfactory impairment. Participants provided voluntary, written, informed consent during initial enrollment. Prior to enrollment, participants elected to pursue endoscopic sinus surgery (ESS) for treatment following counseling from each enrolling clinician per standard of care.
Endoscopic Sinus Surgery
Primary or revision ESS was performed under general anesthesia. Surgery included unilateral/bilateral maxillary antrostomy, partial/total ethmoidectomy, sphenoidotomy, and frontal sinusotomy (Draf II-III). Inferior turbinate reduction, which may have included turbinate outfracture, and/or septoplasty were performed if indicated. Postoperatively, patients were prescribed nasal saline irrigations, topical corticosteroid sprays/rinses, oral corticosteroid tapers, or broad-spectrum antibiotics, as indicated, to optimize early postoperative healing.
Clinical Covariates and Disease Measures
Electronic health records (EPIC, Verona, WI.) were reviewed and participants provided demographic and social history including age, sex, race, ethnicity, household income, educational attainment, and history of smoking or alcohol use. Comorbid diagnoses included asthma, migraine, diabetes mellitus (type 1 or 2), depression, anxiety, obstructive sleep apnea, aspirin-exacerbated respiratory disease (AERD), allergy determined by positive skin prick or allergen specific IgE, allergic rhinitis, primary ciliary dyskinesia or cystic fibrosis (CF), autoimmune disease, and oral corticosteroid dependency. Prior sinus surgery and types of surgical procedures performed were recorded.
Disease severity was measured using assessments collected during the standard of care and used for clinical investigation. Paranasal sinuses were evaluated preoperatively and endoscopic exams were staged by the enrolling physician using the Lund-Kennedy scoring system (range: 0–20).10 High resolution computed tomography (CT) imaging was utilized and staged by enrolling physicians in accordance with the Lund-Mackay scoring system (range: 0–24).11 Participants also completed the 22-item SinoNasal Outcome Test (SNOT-22, summarized global score range 0–110) to measure symptom severity prior to ESS.12 Higher scores on these severity measures indicate worse disease severity.
Work Productivity and Activity Impairment (WPAI)
During enrollment meetings participants were asked to complete a brief, self-administered survey designed to quantify the perceived impact of CRS on productivity and activity. The Work Productivity and Activity Impairment: Specific Health Problem (WPAI-SHP) survey evaluates 6 questions that assess the impact of sinusitis on the ability to work and perform regular activities over the 7-days prior to completion.13 Results for 3 questions regarding absenteeism and time working are provided as number of hours over prior 7-day period. Results for 2 questions evaluating productivity loss and activity impairment are evaluated on a scale of 0 (i.e. no effect on work or daily activities) to 10 (i.e. complete prevention of work or performing daily activities).
Absenteeism attributable to CRS was calculated by dividing the number of hours of work missed from sinusitis over the total number of hours of work missed and total hours worked, multiplied by 100 to provide a percentage.7 Presenteeism was calculated by dividing the integer response to the impact of sinusitis on productivity while working, which utilizes a scale of 0 to 10, by the maximum response of 10 and then multiplied by 100 to provide a percentage.7 Work productivity impairment due to CRS was calculated as the sum of absenteeism due to CRS with the product of presenteeism and percentage of time at work. Activity impairment was calculated by dividing the integer response to the impact of sinusitis on regular daily activities, other than work at a job, by 10 and multiplied by 100 to provide a percentage.
Participants were asked to complete the WPAI-SHP preoperatively and ~6-months postoperatively. Enrolling clinician/surgeons were blinded to responses. Respondents were partially dichotomized during statistical analyses depending on whether or not they provided an indication of current employment (e.g. ‘Working for pay’) at time of enrollment. For participants not employed at time of enrollment and follow-up, only percentages of activity impairment were determined.
Biostatistical Analyses
Data security was ensured through assignment of unique study identification numbers for participants and removal of all patient identifiers prior to transfer into a central, closed-environment, relational database (Access; Microsoft Corporation; Redmond, WA). All descriptive analyses and statistical comparisons were completed using SPSS software (version 28.0; IBM Corporation, Armonk, NY.). WPAI-SHP outcome scores were evaluated using Q-Q plots and Shapiro-Wilk tests of normality, which directed statistical applications. Means with standard deviations (SD) or standard errors (SE) and medians with interquartile ranges (IQR; Q1–Q3) are reported, as applicable to underlying findings of data dispersion. Median values were compared using nonparametric statistics including unadjusted, bivariate Mann-Whitney U or Wilcoxon matched-pair signed-rank testing.
The minimal clinical important difference (MCID) was defined as ½ SD of the preoperative mean work productivity impairment and activity impairment scores.14 The method of MCID calculation utilized in this study is widely accepted, appears to be reflective of human psychology, and has been utilized in outcomes-based CRS research.14,15 Binary logistic regression was employed using forward selection (p<0.10) and backwards elimination (p<0.05) stepwise procedures to screen independent clinical characteristics, demographic cofactors, and surgical procedures associated with significantly different factors for improvement in work productivity and activity impairment equal to at least one MCID. Odds ratios (OR) and 95% confidence intervals (CIs) are provided with type-I error rates (p-values) for the final model, while adequacy of model fit was evaluated with Hosmer-Lemeshow goodness-of-fit tests (X2HL).16
RESULTS
Final Study Population
A total of 279 study participants met study inclusion criteria and provided informed consent prior to ESS between November 2016 and November 2020. Exclusion criteria was applied to participants who provided incomplete preoperative WPAI-SHP survey responses (n=12). Postoperative follow-up WPAI-SHP surveys were completed by a total of 176 (65.9%) participants an average of 7.1 ± 2.2 months after enrollment. Differential follow-up sample sizes were delineated for WPAI-SHP productivity and activity impairment measures and stratified by indications of current employment status (Figure 1). Participant characteristics, comorbidity, and preoperative study measures are described in Table 1 for the final cohort. Interventional surgical procedures are further described in Table 2.
Figure 1:
Flowchart of study inclusion and respondent follow-up. CRS, chronic rhinosinusitis; WPAI-SHP, the Work Productivity and Activity Impairment, Specific Health Problem survey.
Table 1:
Characteristics of the final study cohort at enrollment prior to ESS (n=176)
| Characteristics / comorbidity: | Mean [±SD] | N (%) |
|---|---|---|
| Age at enrollment (years) | 50.1 [±15.7] | ---- |
| Males* | ---- | 86 (48.9%) |
| Females | ---- | 90 (51.1%) |
| White/Caucasian | ---- | 156 (88.6%) |
| African American | ---- | 14 (8.0%) |
| Asian | ---- | 3 (1.7%) |
| American Indian/Alaska native | ---- | 2 (1.1%) |
| Hispanic/Latino ethnicity | ---- | 8 (4.5%) |
| Education level completed: | ||
| High school | ---- | 54 (30.7%) |
| Post-secondary | ---- | 76 (43.2%) |
| Graduate school | ---- | 46 (26.1%) |
| Household income category: | ||
| $0-$25,000 | ---- | 24 (13.6%) |
| $26,000 - $50,000 | ---- | 38 (21.6%) |
| $51,000 - $75,000 | ---- | 25 (14.2%) |
| $76,000 - $100,000 | ---- | 23 (13.1%) |
| $100,000+ | ---- | 47 (26.7%) |
| Unknown / unwilling to provide | ---- | 19 (10.8%) |
| Nasal polyposis (CRSwNP) | ---- | 98 (55.7%) |
| Previous sinus surgery / ESS: None | ---- | 86 (48.9%) |
| Previous sinus surgery / ESS: ≥1 | ---- | 90 (51.1%) |
| Fungal ball | ---- | 2 (1.1%) |
| Odontogenic sinusitis | ---- | 1 (0.6%) |
| Asthma | ---- | 88 (50.0%) |
| Migraine | ---- | 34 (19.3%) |
| Diabetes mellitus | ---- | 17 (9.7%) |
| Depression | ---- | 57 (32.4%) |
| Anxiety | ---- | 49 (27.8%) |
| Obstructive sleep apnea | ---- | 35 (19.9%) |
| Tobacco use (current) | ---- | 6 (3.4%) |
| Tobacco use (former) | ---- | 42 (23.9%) |
| Tobacco use (none) | ---- | 128 (72.7) |
| Alcohol use (current) | ---- | 85 (48.3%) |
| AERD | ---- | 29 (16.5%) |
| Allergic rhinitis | ---- | 89 (50.6%) |
| Allergy | ---- | 98 (55.7%) |
| Primary ciliary dyskinesia / CF | ---- | 3 (1.7%) |
| Autoimmune disease | ---- | 26 (14.8%) |
| Oral corticosteroid dependency | ---- | 17 (9.7%) |
| Lund-Kennedy endoscopy score | 7.2 [±3.7] | ---- |
| Lund-Mackay CT score | 13.7 [±5.5] | ---- |
| WPAI-SHP measures: | Median [Q1, Q3] | Mean [±SD] | N (%) |
|---|---|---|---|
| Absenteeism** | 0.0% [0.0%, 8.6%] | 9.7% [±21.7%] | ---- |
| Presenteeism** | 30.0% [10.0%, 60.0%] | 32.4% [±28.3%] | ---- |
| Time at work** | 97.7% [77.9%, 100.0%] | 84.6% [±24.1%] | ---- |
| Work productivity impairment ** | 30.0% [8.1%, 60.0%] | 34.6% [±30.5%] | ---- |
| Activity impairment | 30.0% [10.0%, 67.5%] | 36.4% [±29.0%] | ---- |
self-reported gender; ESS, endoscopic sinus surgery; SD, standard deviation; N, sample size; Q1, first quartile; Q3, third quartile; ASA, acetylsalicylic acid; AERD, aspirin-exacerbated respiratory disease; CF, cystic fibrosis; CT, computed tomography; WPAI-SHP, the Work Productivity and Activity Impairment, Specific Health Problem survey;
measures available only for study participants currently employed at the time of enrollment (n=116).
Table 2:
Frequency of interventional endoscopic sinus surgery procedures (n=176)
| Surgical procedures: | Unilateral Left Side N (%) | Unilateral Right Side N (%) | Bilateral N (%) |
|---|---|---|---|
| Maxillary antrostomy | 8 (4.5%) | 9 (5.1%) | 153 (86.9%) |
| Partial ethmoidectomy | 5 (2.8%) | 0 (0.0%) | 13 (7.4%) |
| Total ethmoidectomy | 4 (2.3%) | 8 (44.5%) | 145 (82.4%) |
| Sphenoidotomy | 3 (1.7%) | 8 (4.5%) | 142 (80.7%) |
| Middle turbinate resection | 6 (3.4%) | 12 (6.8%) | 68 (38.6%) |
| Inferior turbinate reduction | 2 (1.1%) | 2 (1.1%) | 29 (16.5%) |
| Frontal sinusotomy (Draf 2a) | 3 (1.7%) | 11 (6.3%) | 89 (50.6%) |
| Frontal sinusotomy (Draf 2b) | 5 (2.8%) | 1 (0.6%) | 22 (12.5%) |
| Frontal sinusotomy (Draf 3) | --- | --- | 25 (14.2%) |
| Septoplasty | 59 (33.5%) | ||
| Image guidance | 160 (90.9%) | ||
N, sample size.
Comparison of Preoperative Activity Impairment Measures
Preoperative WPAI-SHP measures are described in Table 1. Activity impairment (%) was compared between study participants with and without current employment at the time of enrollment. Subjects with refractory CRS seeking surgical intervention reported significant productivity impairment (34.6% ± 30.5%) and activity impairment (36.4% ± 29.0%). The percentage of activity impairment was not significantly different between subgroups currently employed (n=116; 35.2% [SD±28.9%]; (Median=30.0%; IQR: 10.0% to 60.0%)) and not currently employed (n=60; 38.7% [SD±29.4%]; (Median=30.0%; IQR: 10.0% to 70.0%); mean Δ=1.6%; 95% CI: −6.2% to 9.3%).
Postoperative Differences in WPAI-SHP Measures
Postoperative differences in unadjusted productivity and activity impairment were compared within-subjects (Table 3). Highly significant postoperative improvement in all WPAI-SHP measures was reported, with the largest average effect estimates reported in overall productivity and activity impairment.
Table 3:
Within-subjects comparisons of CRS-related WPAI-SHP scores in patients with postoperative follow-up.
| WPAI-SHP scores: | N | Preoperative Mean [±SD] | Postoperative Mean [±SD] | Difference (Δ) Mean [±SE] | 95% CI |
|---|---|---|---|---|---|
| Absenteeism | 106 | 9.4% [±21.9%] | 2.6% [±11.4%] | 6.8% [±2.0%] | 2.9% - 10.7% |
| Presenteeism | 106 | 32.3% [±28.2%] | 14.4% [±22.8%] | 17.8% [±2.7%] | 12.5% - 23.2% |
| Time at work | 106 | 84.8% [±24.4%] | 90.2% [±20.1%] | 5.3% [±2.5%] | 0.3% - 10.2% |
| Work productivity impairment | 106 | 34.4% [±30.4%] | 14.4% [±23.2%] | 20.0% [±2.9%] | 14.1% - 25.8% |
| Activity impairment | 176 | 36.4% [±29.0%] | 15.9% [±23.2%] | 20.5% [±2.1%] | 16.3% - 24.6% |
| WPAI-SHP scores: | N | Preoperative Median [IQR:Q1, Q3] | Postoperative Median [IQR:Q1, Q3] | Difference (Δ) Median [IQR:Q1, Q3] | p-value |
| Absenteeism | 106 | 0.0% [0.0%, 8.0%] | 0.0% [0.0%, 0.0%] | 0.0% [0.0%, 5.4%] | <0.001 |
| Presenteeism | 106 | 30.0% [10.0%, 60.0%] | 0.0% [0.0%, 20.0%] | 10.0% [10.0%, 30.0%] | <0.001 |
| Time at work | 106 | 97.7% [79.3%, 100.0%] | 100.0% [84.6%, 100.0%] | 0.0% [0.0%, 10.5%] | 0.017 |
| Work productivity impairment | 106 | 30.0% [8.3%, 60.0%] | 0.0% [0.0%, 20.0%] | 10.4% [0.0%, 34.3%] | <0.001 |
| Activity impairment | 176 | 30.0% [10.0%, 67.5%] | 0.0% [0.0%, 20.0%] | 20.0% [0.0%, 40.0%] | <0.001 |
WPAI-SHP, the Work Productivity and Activity Impairment, Specific Health Problem survey; CRS, chronic rhinosinusitis; SD, standard deviation; SE, standard error of mean; CI, confidence interval; IQR, interquartile range; Q1, first quartile; Q3, third quartile.
Median value differences were used for further comparative analysis of postoperative WPAI-SHP responses due to a lack of normally distributed scores. For those subjects with postoperative follow-up (n=176; Figure 1), median postoperative activity impairment significantly improved (p<0.001). Similar postoperative within-subject improvement in activity impairment was also observed in study participants without current employment for the study duration (n=55) with significant median postoperative activity gains of 20.0% [IQR: 0.0% to 50.0%] (p<0.001). For participants remaining employed with postoperative follow-up (n=106; Figure 1), postoperative median productivity impairment also significantly improved (p<0.001).
Differences in Activity Impairment across Independent CRS Characteristics
Overall improvement in median normal activity impairment was further evaluated within independent subgroups among all study participants with postoperative follow-up, regardless of employment status (Table 4). Significant improvement was identified across the majority of all independent CRS-related phenotypes, with a strong consistency of effect associated with postoperative improvement in normal activity impairment following ESS. Additionally, absence of each significant comorbidity was also associated with significant improvements in those same measures (p<0.001). The remaining independent subgroups not associated with statistically significant improvements were likely influenced by inadequate sample size and power (n<10).
Table 4:
Postoperative changes in median normal activity impairment (%) among all study participants with postoperative follow-up (n=176) across independent characteristics
| Preoperative characteristics / comorbidity: | N | Preoperative Median [IQR] | Postoperative Median [IQR] | Absolute Δ Median [IQR] | p-value |
|---|---|---|---|---|---|
| Age: 18–40 | 55 | 50.0% [50.0%] | 10.0% [30.0%] | 30.0% [50.0%] | <0.001 |
| Age: 41–65 | 90 | 20.0% [53.0%] | 0.0% [20.0%] | 10.0% [30.0%] | <0.001 |
| Age: ≥65 | 31 | 30.0% [70.0%] | 0.0% [20.0%] | 10.0% [40.0%] | <0.001 |
| Males | 86 | 20.0% [40.0%] | 0.0% [20.0%] | 10.0% [30.0%] | <0.001 |
| Females | 90 | 40.0% [50.0%] | 10.0% [30.0%] | 20.0% [50.0%] | <0.001 |
| White/Caucasian | 156 | 30.0% [50.0%] | 0.0% [20.0%] | 20.0% [40.0%] | <0.001 |
| African American | 14 | 25.0% [73.0%] | 0.0% [35.0%] | 5.0% [50.0%] | 0.037 |
| Asian | 3 | 50.0% [----] | 10.0% [----] | 20.0% [----] | 0.285 |
| American Indian/Alaska native | 2 | 40.0% [----] | 10.0% [----] | 30.0% [----] | 0.317 |
| Hispanic/Latino ethnicity | 8 | 15.0% [68.0%] | 0.0% [20.0%] | 15.0% [57.0%] | 0.176 |
| Education level completed: | |||||
| High school | 54 | 30.0% [70.0%] | 10.0% [33.0%] | 5.0% [40.0%] | <0.001 |
| Post-secondary | 76 | 40.0% [60.0%] | 0.0% [20.0%] | 20.0% [50.0%] | <0.001 |
| Graduate school | 46 | 20.0% [40.0%] | 0.0% [20.0%] | 20.0% [30.0%] | <0.001 |
| Household income category: | |||||
| $0-$25,000 | 24 | 60.0% [45.0%] | 30.0% [60.0%] | 10.0% [48.0%] | 0.005 |
| $26,000 - $50,000 | 38 | 50.0% [53.0%] | 0.0% [30.0%] | 20.0% [50.0%] | <0.001 |
| $51,000 - $75,000 | 25 | 40.0% [60.0%] | 10.0% [30.0%] | 20.0% [45.0%] | 0.008 |
| $76,000 - $100,000 | 23 | 10.0% [50.0%] | 0.0% [10.0%] | 10.0% [40.0%] | 0.005 |
| $100,000+ | 47 | 30.0% [30.0%] | 10.0% [20.0%] | 20.0% [30.0%] | <0.001 |
| Unknown / unwilling to provide | 19 | 20.0% [60.0%] | 0.0% [20.0%] | 20.0% [50.0%] | 0.005 |
| CRSsNP | 78 | 40.0% [50.0%] | 0.0% [23.0%] | 20.0% [50.0%] | <0.001 |
| CRSwNP | 98 | 20.0% [60.0%] | 0.0% [23.0%] | 10.0% [40.0%] | <0.001 |
| Previous sinus surgery: None | 86 | 30.0% [50.0%] | 0.0% [20.0%] | 20.0% [50.0%] | <0.001 |
| Previous sinus surgery: ≥1 | 90 | 30.0% [60.0%] | 10.0% [30.0%] | 10.0% [40.0%] | <0.001 |
| Fungal ball | 2 | 0.0% [0.0%] | 5.0% [----] | 5.0% [----] | 0.317 |
| Odontogenic sinusitis | 1 | 50.0% [0.0%] | 0.0% [0.0%] | 50.0% [0.0%] | 0.317 |
| Asthma | 88 | 30.0% [60.0%] | 10.0% [20.0%] | 10.0% [38.0%] | <0.001 |
| Migraine | 34 | 40.0% [50.0%] | 20.0% [43.0%] | 15.0% [32.0%] | <0.001 |
| Diabetes mellitus | 17 | 50.0% [75.0%] | 0.0% [25.0%] | 20.0% [50.0%] | 0.007 |
| Depression | 57 | 50.0% [50.0%] | 10.0% [35.0%] | 20.0% [35.0%] | <0.001 |
| Anxiety | 49 | 50.0% [40.0%] | 20.0% [30.0%] | 20.0% [35.0%] | <0.001 |
| Obstructive sleep apnea | 35 | 40.0% [70.0%] | 0.0% [30.0%] | 20.0% [50.0%] | <0.001 |
| Tobacco use (current) | 6 | 0.0% [25.0%] | 0.0% [0.0%] | 0.0% [25.0%] | 0.180 |
| Tobacco use (former) | 42 | 40.0% [63.0%] | 5.0% [30.0%] | 20.0% [43.0%] | <0.001 |
| Tobacco use (none) | 128 | 30.0% [50.0%] | 0.0% [28.0%] | 20.0% [40.0%] | <0.001 |
| Alcohol use (current) | 85 | 30.0% [50.0%] | 0.0% [20.0%] | 20.0% [30.0%] | <0.001 |
| AERD | 29 | 20.0% [60.0%] | 0.0% [25.0%] | 10.0% [45.0%] | 0.008 |
| Allergic rhinitis | 89 | 30.0% [60.0%] | 10.0% [20.0%] | 20.0% [40.0%] | <0.001 |
| Allergy | 98 | 30.0% [60.0%] | 10.0% [30.0%] | 15.0% [32.0%] | <0.001 |
| Primary ciliary dyskinesia / CF | 3 | 60.0% [----] | 30.0% [----] | 0.0% [----] | 0.655 |
| Autoimmune disease | 26 | 30.0% [63.0%] | 10.0% [33.0%] | 10.0% [33.0%] | 0.022 |
| Oral corticosteroid dependency | 17 | 50.0% [55.0%] | 10.0% [30.0%] | 20.0% [50.0%] | 0.003 |
| Lund-Kennedy endoscopy score: ≥ 7* | 88 | 30.0% [60.0%] | 10.0% [30.0%] | 10.0% [40.0%] | <0.001 |
| Lund-Kennedy endoscopy score: < 7 | 85 | 30.0% [55.0%] | 0.0% [20.0%] | 20.0% [40.0%] | <0.001 |
| Lund-Mackay CT score: ≥ 14* | 99 | 30.0% [50.0%] | 0.0% [30.0%] | 10.0% [30.0%] | <0.001 |
| Lund-Mackay CT score: < 14 | 77 | 30.0% [50.0%] | 0.0% [20.0%] | 20.0% [45.0%] | <0.001 |
| SNOT-22 total score: ≥48* | 92 | 55.0% [50.0%] | 10.0% [40.0%] | 20.0% [50.0%] | <0.001 |
| SNOT-22 total score: <48 | 84 | 20.0% [30.0%] | 0.0% [18.0%] | 10.0% [30.0%] | <0.001 |
P-values associated with Wilcoxon signed-rank testing. IQR, interquartile range as a difference between the first quartile (Q1) and third quartile (Q3); CRS, chronic rhinosinusitis; CRSsNP, CRS without nasal polyposis; CRSwNP, CRS with nasal polyposis; ASA, acetylsalicylic acid; AERD, aspirin exacerbated respiratory disease; CF, cystic fibrosis; CT, computed tomography.
median score threshold values.
Differences in Work Productivity Impairment across Independent CRS Characteristics
Improvement in median work productivity impairment was also assessed within independent subgroups among those study participants who indicated current employment both before and after ESS (Table 5). Significant improvement was identified across the majority of all independent CRS-related phenotypes, with a strong consistency of effect associated with postoperative improvement in work productivity after ESS. Additionally, absence of each significant comorbidity was also associated with significant improvements (p<0.001). The few independent subgroups not associated with significant work productivity improvement may be influenced by reduced sample sizes (n<10) and inadequate statistical power. However, independent cofactors of high-school education, lowest household income, former smoking status, and autoimmune disease appeared not to be associated with statistically significant postoperative improvements in work productivity impairment.
Table 5:
Postoperative changes in median work productivity impairment (%) among currently employed study participants with CRS (n=106) across independent characteristics
| Preoperative characteristics / comorbidity: | N | Preoperative Median [IQR] | Postoperative Median [IQR] | Absolute Δ Median [IQR] | p-value |
|---|---|---|---|---|---|
| Age: 18–40 | 38 | 40.8% [45.0%] | 9.4% [23.0%] | 15.7% [43.0%] | <0.001 |
| Age: 41–65 | 60 | 26.2% [54.0%] | 0.0% [19.0%] | 10.0% [30.0%] | <0.001 |
| Age: ≥65 | 8 | 10.0% [29.0%] | 0.0% [8.0%] | 10.0% [37.0%] | 0.395 |
| Males | 54 | 14.8% [37.0%] | 0.0% [10.0%] | 10.0% [30.0%] | <0.001 |
| Females | 52 | 40.8% [52.0%] | 10.0% [30.0%] | 19.6% [42.0%] | <0.001 |
| White/Caucasian | 94 | 29.4% [52.0%] | 0.0% [20.0%] | 10.0% [30.0%] | <0.001 |
| African American | 9 | 48.0% [72.0%] | 0.0% [23.0%] | 25.7% [49.0%] | 0.028 |
| Asian | 1 | 33.5% [0.0%] | 15.5% [0.0%] | 18.0% [0.0%] | 0.317 |
| American Indian/Alaska native | 2 | 35.2% [----] | 9.4% [----] | 25.8% [----] | 0.180 |
| Hispanic/Latino ethnicity | 4 | 33.3% [83.0%] | 0.0% [15.0%] | 33.3% [68.0%] | 0.180 |
| Education level completed: | |||||
| High school | 23 | 27.4% [63.0%] | 11.1% [30.0%] | 0.0% [26.0%] | 0.112 |
| Post-secondary | 53 | 37.4% [52.0%] | 0.0% [20.0%] | 18.0% [43.0%] | <0.001 |
| Graduate school | 30 | 19.8% [38.0%] | 0.0% [10.0%] | 10.0% [30.0%] | <0.001 |
| Household income category: | |||||
| $0-$25,000 | 12 | 57.4% [57.0%] | 22.5% [64.0%] | 21.1% [51.0%] | 0.074 |
| $26,000 - $50,000 | 20 | 38.7% [56.0%] | 4.5% [28.0%] | 14.5% [32.0%] | 0.003 |
| $51,000 - $75,000 | 15 | 39.0% [31.0%] | 15.5% [49.0%] | 20.0% [30.0%] | 0.016 |
| $76,000 - $100,000 | 17 | 10.0% [56.0%] | 0.0% [0.0%] | 10.0% [53.0%] | 0.008 |
| $100,000+ | 34 | 15.0% [38.0%] | 0.0% [20.0%] | 9.4% [30.0%] | 0.009 |
| Unknown / unwilling to provide | 8 | 30.8% [55.0%] | 0.0% [8.0%] | 30.8% [53.0%] | 0.018 |
| CRSsNP | 40 | 39.5% [52.0%] | 4.9% [20.0%] | 18.5% [44.0%] | <0.001 |
| CRSwNP | 66 | 25.4% [43.0%] | 0.0% [18.0%] | 10.0% [28.0%] | <0.001 |
| Previous sinus surgery: None | 50 | 28.1% [37.0%] | 0.0% [18.0%] | 10.0% [43.0%] | <0.001 |
| Previous sinus surgery: ≥1 | 56 | 30.0% [54.0%] | 1.7% [29.0%] | 12.9% [30.0%] | <0.001 |
| Fungal ball | 1 | 0.0% [0.0%] | 0.0% [0.0%] | 0.0% [0.0%] | >0.999 |
| Odontogenic sinusitis | 1 | 20.0% [0.0%] | 0.0% [0.0%] | 20.0% [20.0%] | 0.317 |
| Asthma | 55 | 30.0% [57.0%] | 0.0% [20.0%] | 10.0% [30.0%] | <0.001 |
| Migraine | 21 | 44.0% [58.0%] | 10.0% [53.0%] | 23.3% [51.0%] | 0.007 |
| Diabetes mellitus | 7 | 10.0% [72.0%] | 0.0% [15.0%] | 10.0% [56.0%] | 0.068 |
| Depression | 36 | 39.5% [48.0%] | 8.5% [28.0%] | 19.1% [44.0%] | <0.001 |
| Anxiety | 30 | 30.0% [59.0%] | 5.7% [20.0%] | 18.5% [50.0%] | 0.002 |
| Obstructive sleep apnea | 13 | 33.5% [68.0%] | 0.0% [28.0%] | 18.0% [43.0%] | 0.018 |
| Tobacco use (current) | 3 | 0.0% [----] | 0.0% [0.0%] | 0.0% [----] | 0.317 |
| Tobacco use (former) | 18 | 26.2% [73.0%] | 5.0% [53.0%] | 9.4% [26.0%] | 0.118 |
| Tobacco use (none) | 85 | 30.0% [50.0%] | 0.0% [19.0%] | 16.5% [42.0%] | <0.001 |
| Alcohol use (current) | 55 | 26.2% [34.0%] | 0.0% [20.0%] | 15.0% [30.0%] | <0.001 |
| AERD | 21 | 20.0% [52.0%] | 0.0% [10.0%] | 8.9% [50.0%] | 0.003 |
| Allergic rhinitis | 56 | 30.0% [53.0%] | 0.0% [20.0%] | 13.6% [36.0%] | <0.001 |
| Allergy | 63 | 30.0% [52.0%] | 8.0% [26.0%] | 10.0% [30.0%] | <0.001 |
| Primary ciliary dyskinesia / CF | 1 | 62.5% [0.0%] | 20.0% [0.0%] | 42.5% [0.0%] | 0.317 |
| Autoimmune disease | 12 | 42.4% [68.0%] | 15.0% [57.0%] | 5.0% [58.0%] | 0.093 |
| Oral corticosteroid dependency | 11 | 44.8% [54.0%] | 8.0% [30.0%] | 26.2% [79.0%] | 0.011 |
| Lund-Kennedy endoscopy score: ≥ 7* | 56 | 30.0% [53.0%] | 0.0% [20.0%] | 13.6% [30.0%] | <0.001 |
| Lund-Kennedy endoscopy score: < 7 | 48 | 28.7% [60.0%] | 0.0% [20.0%] | 10.0% [43.0%] | <0.001 |
| Lund-Mackay CT score: ≥ 14* | 66 | 23.7% [52.0%] | 0.0% [20.0%] | 10.0% [30.0%] | <0.001 |
| Lund-Mackay CT score: < 14 | 40 | 38.7% [48.0%] | 0.0% [20.0%] | 20.2% [43.0%] | <0.001 |
| SNOT-22 total score: ≥48* | 54 | 47.0% [51.0%] | 10.0% [33.0%] | 19.1% [51.0%] | <0.001 |
| SNOT-22 total score: <48 | 52 | 10.0% [29.0%] | 0.0% [10.0%] | 10.0% [26.0%] | <0.001 |
P-values associated with Wilcoxon signed-rank testing. IQR, interquartile range as a difference between the first quartile (Q1) and third quartile (Q3); CRS, chronic rhinosinusitis; CRSsNP, CRS without nasal polyposis; CRSwNP, CRS with nasal polyposis; ASA, acetylsalicylic acid; AERD, aspirin exacerbated respiratory disease; CF, cystic fibrosis; CT, computed tomography.
median score threshold values.
Minimal Clinically Important Differences
Among all patients with postoperative follow-up (n=176), a total of 94 (53.4%) respondents reported improvement in normal activity impairment equal to at least one MCID (≥14.5%; Table 3). Excluding subjects with preoperative activity impairment less than 14.5% (n=53; 30.2%), a total of 94 of 123 (76.4%) reported postoperative improvement also equaling at least one MCID. Among study participants indicating current work employment for the follow-up duration (n=106), a total of 51 (48.1%) respondents reported improvement in work productivity impairment equaling at least one MCID (≥15.2%). Excluding those subjects with preoperative work productivity less than 15.2% (n=39; 36.8%), a total of 51 of 67 (76.1%) reported postoperative improvement equaling at least one MCID.
Multivariate analysis concentrated on predicting treatment response in only those study participants with preoperative work productivity and activity impairment (n=123 and n=67, respectively). Seven independent covariates were screened and identified (p<0.10) as potential significant risk factors associated with differences in the odds of improvement equaling at least one MCID in activity impairment. After multivariate adjustment, final binary logistic regression modeling retained 2 significant, independent cofactors associated with differential odds of improvement: septoplasty during ESS (OR=8.45; 95% CI: 2.33–30.68; p=0.001), and comorbid migraine (OR=0.35; 95% CI: 0.12–0.96; p=0.04) with adequate modeling goodness-of-fit (X2HL=0.22; p=0.90) and without evidence of multicollinearity. Binary logistic regression screening procedures did not identify any patient demographic, comorbid condition, or surgical procedure associated with significant differences in improvement equaling at least one MCID in work productivity impairment (all p≥0.133) with the exception of unilateral/bilateral sphenoidotomy during ESS (OR=4.18; 95% CI: 1.03–17.02; p=0.046).
DISCUSSION
CRS is associated with a significant economic burden, in part driven by productivity losses and diminished QOL.17 Patients with refractory CRS often make treatment decisions based upon QOL and productivity impairment, so understanding these aspects of the patient experience is key to inform individualized treatment strategies and improve healthcare resource allocation.18 This study identified substantial productivity and activity impairment in the refractory CRS population, and ESS was associated with significant improvements in productivity (10.4%) and activity (20.0%) impairment across the majority of demographic and clinical variables. This study also identified MCID values for improvements in productivity impairment (≥15.2%) and activity impairment (≥14.5%).
U.S. productivity loss associated with CRS is estimated to exceed $13 billion annually.19 Prospective evaluation of indirect costs is critical, as these costs are generally several times greater than direct medical costs and associated with patient QOL.17,20 In 2014, Rudmik et al. identified patients with refractory CRS had annual productivity costs of approximately $10,000, and in 2018 Chowdhury et al. similarly identified productivity costs of approximately $12,000 per patient.5,17 In 2017, Rudmik et al. found patients with refractory CRS undergoing ESS had reduced productivity costs by nearly $6,000, and in 2018 Beswick et al. found monetized productivity losses reduced by approximately $5,000 following ESS.21,22 Stankiewicz et al. evaluated WPAI-SHP productivity loss among patients with CRS and disease of the maxillary or maxillary and anterior ethmoid sinuses undergoing balloon dilation, noting a mean preoperative productivity loss of 38.3% that improved to 11.6% on 6-month follow-up.7 Our findings among patients with a broader spectrum of CRS-phenotypes are similar, noting a mean preoperative productivity loss of 34.4% and presenteeism rate of 32.4%. This study also identified a median postoperative improvement in productivity loss improving from 30.0% preoperatively to 0.0% on 6-month follow-up.
This study is the first to define MCID scoring thresholds for improvement in productivity impairment among refractory CRS and found 76.1% of patients reported clinically significant improvements in postoperative productivity impairment. Beswick et al. evaluated socioeconomic factors impacting productivity loss among patients with refractory CRS undergoing ESS, finding lower income and Medicare insurance were not associated with productivity improvements.23 In the current study, nearly all demographic and clinical factors were associated with postoperative productivity improvement. Some variables without significant improvement were thought to be due to low subgroup sample sizes (n<10). However, lowest household income and high school education were not associated with significant productivity changes. Patients in these subgroups may be working part-time, which has been associated with lower income than full-time employment and reduced completion of higher educational degrees, and fewer hours working may be associated with reduced disease-associated productivity loss.24,25 Part-time work has also been associated with worse health outcomes, which may impact postoperative improvement.25 Comorbid autoimmune disease and former smoking status were also not associated with a significant postoperative improvement in productivity. However, all of these subgroups reported a median improvement in postoperative productivity, suggesting a consistency of treatment effect. These data suggest that ESS is associated with consistent improvements in productivity impairment, but further evaluation into the influence of socioeconomic factors on postoperative productivity improvement is warranted. Additionally, performance of sphenoidotomy was the only variable associated with an increased likelihood of productivity improvement. The implication of this finding is unclear, as no measures of disease severity or other surgical factors had comparable results. This finding may be suggestive of complete rather than targeted surgery for CRS, and DeConde et al. found patients with CRS undergoing complete ESS had greater improvements in postoperative SNOT-22 scores.26 Further evaluation of surgical extent on QOL is warranted.
While there has been a concerted effort to evaluate CRS-associated productivity loss, there has been minimal evaluation into CRS-associated physical limitations. Stankiewicz et al. also evaluated activity impairment among their cohort, noting mean preoperative activity impairment of 40% that improved to 12.6% after 6-month follow-up.7 These findings are again similar to our cohort, with a mean preoperative activity impairment of 36.4%. Our study also identified a median postoperative improvement in activity impairment improving from 30.0% preoperatively to 0.0% on 6-month follow-up, and 76.4% of patients reported clinically significant improvements.
The etiology for this substantial CRS-associated physical disability is likely multifactorial. Patients with CRS commonly report significant sleep dysfunction, which has correlated with CRS-specific QOL.27,28 Fatigue is also highly prevalent among patients with CRS.27,29 Both fatigue and sleep dysfunction have shown significant improvements after ESS, which may be associated with the activity improvements identified.29,30 Additionally, cognitive dysfunction and bodily pain may be improved after ESS.31,32 Depression is also common among these patients, and has been associated with functional limitations.33,34 Depression severity has shown to improve following ESS, suggesting that improvement in mental health conditions may be a factor in improving activity limitations after surgery among these patients.35
Additionally, nearly all variables were associated with improved postoperative activity impairment, suggesting most patients can expect activity improvement after ESS, independent of demographic or comorbidity status. Septoplasty was the only variable identified on regression associated with increased odds of activity improvement. Septoplasty is frequently performed during ESS, as septal deviation may impair surgical visualization and contribute to persistent nasal obstruction.36 Relief of nasal obstruction among patients with septal deviation may be associated with improved QOL and activity impairment.37 These patients may also have improved application of topical medical therapies after ESS. While there is conflicting evidence regarding the impact of septoplasty on CRS outcomes, these findings suggest that concurrent septoplasty may be associated with greater improvements in postoperative activity.36,38,39 Septoplasty was performed at the discretion of the surgeon, so septal surgery may not be beneficial in all patients. Migraine was the only variable associated with a reduced odds of activity improvement, however, migraine was still associated with a significant postoperative median improvement in activity impairment. DeConde et al. previously identified that patients with CRS and migraine experience improvements in QOL comparable to those without migraine, and together these findings may further assist in counseling patients with CRS and comorbid migraine.40
It is important to place these findings in perspective of the broader population and other disease states utilizing the WPAI survey. While normative data is lacking, control populations of U.S. adults identified mean productivity impairment of 6.9–7.1% and mean activity impairment of 14.0–17.3%.41,42 Mean preoperative productivity impairment in our medically-refractory CRS cohort was 34.4%, lower than findings for Crohn’s disease (CD; 51.9%) but higher than ulcerative colitis (UC; 24.7%), chronic obstructive pulmonary disease (COPD; 24.9%), heart failure (HF; 29.1%), rheumatoid arthritis (RA; 29.1%), and asthma (15.8–16.8%).43–48 Mean activity impairment in our cohort was 36.4%, lower than CD (56.6%), UC (43.4%), HF (43.2%), and COPD (39.9%), but higher than RA (33.3%) and asthma (28.1%−28.4%).43–48 Evaluation among our CRS cohort identified mean 6-month productivity improvement of 20.0%, lower than post-treatment productivity improvement in RA (32.6%) and CD (21.4%), but higher than UC (12.6%) and asthma (2.8%).43–45,49 Our cohort also identified mean 6-month activity improvement of 20.5%, lower than post-treatment activity improvement in RA (38.8%) and CD (25.9%), but higher than UC (19.5%) and asthma (4.5%).43–45,49 Comparative data is still nominal and many studies report outcomes from medical management, so future studies may benefit from utilizing the WPAI for a more standardized comparison of outcomes among patients with CRS after ESS.
Strengths of this study include a multi-institutional, prospectively enrolled cohort with a confirmed CRS diagnosis and utilization of a disease-specific validated survey. However, there are potential limitations. Work and activity impairment utilized results from a 7-day period prior to survey completion, providing a short evaluation period, but may have limited the potential for recall bias and over- or under-reporting WPAI-SHP measures. Differences between medical and surgical management as well as initial and revision surgery were not characterized. Prospective information on biologic use was also not obtained. Economic evaluation of medical management compared to ESS, including biologic use, is warranted. Only participants with follow-up data were included, which may confer selection bias, and the prevalence of incomplete follow-up may limit generalizability. Income was not adjusted for geographic location. Patients were enrolled from academic rhinology practices, and disease complexity as well as severity of medical comorbidities may limit external generalizability.
CONCLUSION
Patients with refractory CRS report a substantial disease burden on work productivity and activity, both of which are significantly improved after ESS. Approximately 76% of patients are able to obtain clinically significant postoperative improvements in productivity and activity impairment based upon MCID calculations performed. These data may improve patient counseling and shared-decision making regarding surgical management for CRS.
Funding Disclosures:
T.L.S., Z.M.S., R.J.S., J.A.A., V.R.R., and J.C.M. were supported for this investigation by a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD), one of the National Institutes of Health (NIH), Bethesda, Maryland, USA (3R01-DC005805; Co-PI: T.L.S./Z.M.S.). Public clinical trial registration (www.clinicaltrials.gov) ID# NCT02720653. This funding organization did not contribute to the design or conduct of this study; preparation, review, approval or decision to submit this manuscript for publication. There are no relevant financial disclosures for V.C.P., J.H.K., M.G., K.Y.D., or J.L.M.
Footnotes
Conflicts of Interest: None
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