Effect of Continued Medical Therapy on Productivity Costs for Refractory Chronic Rhinosinusitis

Importance  It is estimated that lost productivity related to chronic rhinosinusitis (CRS) costs society in excess of $13 billion per year in the United States. Given this tremendous cost to society, it is important to evaluate the effect of current interventions on improving this productivity loss.

Objective  To define the change in productivity costs in patients with refractory CRS who select continued medical therapy.

Design, Setting, and Participants  Observational cohort study. Thirty-eight patients with a guideline-based diagnosis of CRS whose initial appropriate medical therapy failed were enrolled from 4 tertiary-level rhinology clinics. The study was conducted from December 6, 2010, to April 23, 2013, and data analysis was performed from December 6, 2010, to June 1, 2015.

Interventions  Continued medical therapy for CRS.

Main Outcomes and Measures  The human capital approach was applied to quantify productivity costs. Absenteeism, presenteeism, and lost leisure time were quantified to define annual lost productive time, which was measured at enrollment (baseline) and at a minimum of 6 months after treatment. Lost productive time was monetized using the annual daily wage rates obtained from the 2012 US National Census and the 2013 US Department of Labor statistics.

Results  Thirty-eight patients with refractory CRS who selected continued medical therapy had a mean (SD) baseline annual productivity cost of $3464 ($4900) per patient. After continued medical therapy for a mean of 12.8 (4.8) months, productivity costs were $2730 ($3720) (before vs after continued medical therapy productivity cost, P = .74). Mean annual absenteeism was reduced from 5 (12) days to 2 (8) days (P = .02). Mean annual presenteeism (17 [27] days reduced to 15 [23] days; P = .93) and mean annual household days lost (7 [7] days reduced to 6 [6] days; P = .51) were maintained at baseline levels. There were no significant differences in productivity outcomes based on endoscopy, the 22-item Sinonasal Outcome Test score, age, or polyp status (all P ≥ .11).

Conclusions and Relevance  Patients with refractory CRS often make treatment decisions based on the degree of quality-of-life and productivity impairment. Outcomes from this study suggest that productivity in patients with refractory CRS who have minor reductions in baseline productivity can remain stable with continued medical therapy. Physicians can use this information to inform appropriate patients with CRS of their expected outcomes from continued medical therapy.

Chronic rhinosinusitis (CRS) significantly reduces daily productivity,^1-4 and the degree of lost work is associated with the severity of quality-of-life (QOL) impairment.¹ It is estimated that lost productivity related to CRS costs society in excess of $13 billion per year in the United States.⁵ Given this tremendous cost to society, it is important to evaluate the effect of current interventions on improving this productivity loss. An earlier study⁶ evaluated the effect of endoscopic sinus surgery (ESS) on reducing productivity costs related to CRS. The outcomes demonstrated that ESS was associated with reducing a mean annual baseline productivity cost from $9190 to $3373 per patient.

Although ESS is an effective intervention for select patients with CRS,⁷ some patients make a preference-sensitive decision to continue with medical therapy as opposed to undergoing surgery. A study by Soler et al⁸ demonstrated that the degree of baseline QOL impairment was a major driver in the decision to choose between medical therapy and surgery. Patients with less impairment (ie, better QOL) have a higher probability of selecting continued medical therapy over surgery. Given that continued medical therapy is a viable treatment option for refractory CRS, it is important to define the effect on productivity level to inform patients of expected outcomes.

The purpose of this study was to evaluate a cohort of patients who made a decision to continue medical therapy for management of refractory CRS to define the baseline productivity cost and determine how productivity costs change after treatment. The primary outcome was the incremental change in productivity costs during continued medical therapy for refractory CRS. Because patients who select medical therapy often have a better baseline QOL,⁸ we hypothesized that baseline productivity costs would be lower and would remain stable after continued medical therapy for refractory CRS.

The methods used for this study have been reported^1,6 and are summarized in this section. All patient-level data were collected prospectively in a multi-institutional, international (United States and Canada) observational study.⁹ Patients with CRS (based on American Academy of Otolaryngology–Head and Neck Surgery guidelines¹⁰) whose initial medical therapy failed (as defined by a minimum treatment course of 3 months of a topical nasal corticosteroid, a minimum 7 days of a systemic corticosteroid, and 2 weeks of a broad-spectrum antibiotic) and who chose to proceed with continued medical therapy were included in this study. Patients who were part of the original medical cohort¹ but chose to cross over to receive ESS were excluded. Patients with ciliary dysfunction, cystic fibrosis, or granulomatous diseases were excluded. Questionnaires were administered at the time of enrollment and at planned study visits every 6 months for 18 months. Data obtained from the last follow-up evaluation were used to calculate mean outcomes after continued medical therapy. The present study was approved by the research ethics boards of all participating centers (Oregon Health and Science University, Medical University of South Carolina, and University of Calgary). Patients provided written informed consent at the time of enrollment. There was no financial compensation for participation. The study was conducted from December 6, 2010, to April 23, 2013, and data analysis was performed from December 6, 2010, to June 1, 2015.

Lost productive time (LPT) was defined as the per-person workdays lost due to refractory CRS. We assumed the following mean paid work time per patient: 8 hours per day for 5 days per week with 4 weeks of vacation each year. This calculation provided a total of 48 paid workweeks and a total of 240 paid workdays per year.

Based on current recall recommendations, absenteeism was quantified by asking participants both the number of full workdays missed and the number of work hours missed due to CRS in the past 3 months.^11-13 As defined above, a cumulative loss of 8 hours of work was equal to 1 full workday missed.

Presenteeism was measured based on the Quantity and Quality Questionnaire.^14,15 Patients were asked to report, on average, the degree (percentage) of their reduced daily work performance owing to CRS in the past 3 months. Healthy baseline performance was assumed to be 100% productivity. It was assumed that the mean productivity level within the past 3 months reflected the patients’ productivity within the preceding 6-month period. The annual number of workdays missed because of CRS-related presenteeism was calculated using the following formula: P = (E – A) × p, where P is the number of missed workdays owing to presenteeism, E is the expected number of annual workdays (ie, 240), A is the number of workdays missed owing to absenteeism, and p is the percentage of reduced performance at work.¹³ Annual LPT was calculated by summing the workdays lost from both presenteeism and absenteeism because of CRS.

Household productivity loss was calculated by asking patients how much time each day was consumed at home to care for their sinuses. It was assumed the potential household productivity and leisure time available for weekdays is 7 hours per day (5 pm to 12 am) and on weekend days is 15 hours per day (9 am to 12 am) for 52 weekends per year. Therefore, 7 household hours lost per weekday or 15 household hours lost per weekend would equal 1 household workday lost. Household productivity is reported separately from paid workdays missed since it has a different monetary valuation.

The human capital approach was used to monetize productivity losses. To accurately reflect the productivity cost to society, we used the median annual US societal wage rate of $30 853 based on the 2012 US National Census.¹⁶ Assuming 48 workweeks per year at 40 hours per week and 8 hours per day, this total produces a mean daily income of $128.55 per patient.¹⁶ This value was used to monetize the paid work LPT.

Household productivity was valued by assuming it was equal to the hourly wage of a housekeeper. Using the 2013 US Department of Labor statistics,¹⁷ we calculated a mean hourly wage rate for a housekeeper as $10.49, which, at 8 hours per day, produced a daily household monetized LPT of $90.91.

Productivity costs for each patient were calculated at baseline (ie, time of enrollment) and after the longest interval from baseline to the follow-up appointment (6, 12, or 18 months). Patient-level data enabled us to statistically evaluate the association between productivity costs and several CRS-specific characteristics, including patient demographics, disease subtypes, comorbidities, degree of QOL reduction using the 22-item Sinonasal Outcome Test (SNOT-22),¹⁸ and endoscopy scores using the Lund-Kennedy scoring system.¹⁹

Improvements in productivity costs after continued medical therapy between comorbid characteristics, as well as study participants with and without follow-up, were assessed using the Mann-Whitney test for nonparametric distributions. Wilcoxon signed rank tests were used to evaluate significant improvement over time both before and after all medical therapy measures where appropriate. Fisher exact testing was also used to evaluate the difference in frequency measures between participants with and those without follow-up evaluation. All comparisons were reported with a type I error probability determined at the P = .05 level of significance.

A total of 38 study participants with a minimum of 6 months of follow-up were included for final analysis. Mean (SD) follow-up time after medical therapy was 12.8 (4.8) months. The mean age of the participants was 56.9 (13.8) years (range, 26-81 years), with a higher prevalence of women (21 [55%]). Comorbid characteristics included nasal polyposis (14 [37%]) and asthma (14 [37%]). The mean baseline SNOT-22 score was 45.9 (18.1) (range, 6-88), and the mean baseline endoscopy score was 5.5 (3.7) (range, 0-12).

The baseline work productivity level in patients selecting continued medical therapy was 92%. After a mean of 12.8 (4.8) months of medical therapy, there was minor improvement in the mean daily work productivity level to 93%. There was a statistically significant reduction in paid work absenteeism (from 5 [12] days to 2 [8] days; P = .02). There were no significant changes in presenteeism and household work. Overall, paid work productivity losses (absenteeism + presenteeism) were reduced from a mean of 22 days to 17 days per year, producing a net gain of 5 days of paid work per year.

Patients who continued medical therapy reported a mean of 15 minutes per day caring for their sinus disease at enrollment. Sinus care time at home decreased to a mean of 14 minutes per day after 12 months of medical therapy. The 1-minute reduction in daily time required to perform maintenance therapy for CRS resulted in a savings of 1 household day per year (P = .51) (Table 1). Overall, there was a nonsignificant reduction in the mean (SD) annual productivity cost after continued medical therapy (from $3464 [$4900] to $2730 [$3720]; P = .74).

The degree of change in productivity costs during continued medical therapy for various CRS subgroups were evaluated and are outlined in Table 2. Overall, there were no significant differences in productivity costs between subgroups (all P ≥ .11).

This prospective study evaluated the productivity outcomes in a select group of patients with refractory CRS who made a decision to continue medical therapy rather than undergoing ESS. Patients who continued medical therapy had mild reductions in their baseline productivity (92%). Although the results need to be validated with a larger sample, outcomes from this study suggest that continued medical therapy can maintain baseline productivity level in this select cohort of patients with CRS. These outcomes may be used to improve patient-centered care for CRS by informing the appropriate patients of their expected outcomes from continued medical therapy.

Patients who have persistent symptoms of CRS despite appropriate initial medical management, such as saline irrigation, topical or oral corticosteroids, and oral antibiotics,²⁰ are often faced with a preference-based decision to either continue with medical therapies or undergo ESS. Although evidence suggests that the degree of baseline QOL impairment can predict treatment choice,⁸ physicians must also adequately inform patients about their expected outcomes to optimize the chances that the treatment decision reflects patient preferences rather than physician preferences. For example, 2 recent studies^21,22 have quantified the expected QOL outcomes after ESS by stratifying patients based on their preoperative SNOT-22 score. Physicians can use this information to inform patients of their individualized expected outcomes based on their baseline QOL impairment rather than provide patients with an aggregate expected outcome. Information from these and other studies^23,24 can be used to educate patients about the expected outcomes from various treatment options and improve patient-centered care.

Although the results from this study failed to demonstrate that continued medical therapy provides a significant decrease in baseline productivity cost, there are several important findings. First, patients with refractory CRS who continued medical therapy had relatively mild reductions in their daily productivity and lower annual baseline productivity costs compared with patients who chose to undergo ESS (Table 3).⁶ This difference supports the notion that patients cluster in various phenotypic groups and make treatment decisions partially based on their degree of productivity impairment.^8,25 Second, the annual productivity cost after 12 months of continued medical therapy was $2730 per patient, which was similar to the annual productivity cost after ESS ($3373).⁶ This finding demonstrates that there may be a floor effect for improving productivity costs. Our current medical management strategies do not cure CRS but rather control it; thus, long-term maintenance therapy and productivity costs are involved. Use of these long-term interventions emphasizes the need to continue research on novel treatments for patients with CRS with the hope that a cure will be developed. Third, a study by Bhattacharyya,⁴ which used an administrative database to identify a population-based cohort of patients with CRS, reported mean annual absenteeism related to CRS as 5.8 workdays, which was significantly lower than the mean absenteeism reported⁶ from a select cohort of patients with refractory CRS who elected to undergo ESS (22 days). However, the absenteeism rate of 5.8 days per year reported in the Bhattacharyya study was similar to the rate of 5 days in our cohort of patients with CRS who selected continued medical therapy. This similarity suggests that, on a population-based scale, patients with CRS may have a less severe inflammatory phenotype with milder reductions in productivity and can remain stable with medical therapy compared with a select group of patients who have a more severe phenotype with larger productivity impairment and undergo ESS. Finally, the productivity outcomes from continued medical therapy identified in the present study are applicable only to patients who have mildly reduced baseline productivity (mean baseline productivity in this study was 92%). Specifically, the outcomes of continued medical therapy cannot be applied to patients who report larger baseline impairments in QOL and productivity. For example, a study by Smith and Rudmik²⁶ demonstrated that patients who had large reductions in baseline QOL and daily productivity developed further reductions in productivity with continued medical therapy. Therefore, applying the outcomes from the present study to the correct CRS patient cohort is important for accurate patient counseling.

The major limitation of this study is the small sample size with risk of a type II error (ie, accepting the null hypothesis when there was an effect present). Although a larger sample may demonstrate a statistically significant difference in productivity costs before and after continued medical therapy, the results from this study can be used to help inform patients about their expected outcomes from continued medical therapy. For example, patients with refractory CRS who have only mild productivity impairment may be informed that the best available evidence indicates that continued medical therapy would maintain their productivity level.

Patients with refractory CRS often make treatment decisions based on their degree of QOL and productivity impairment. Outcomes from the present study suggest that patients with refractory CRS who select continued medical therapy tend to have mild reductions in baseline productivity and that the productivity outcomes can be maintained with continued medical therapy. Physicians can use this information to discuss the expected outcomes from continued medical therapy with patients.

Corresponding Author: Luke Rudmik, MD, MSc, Division of Otolaryngology–Head and Neck Surgery, Department of Surgery, University of Calgary, Richmond Road Diagnostic and Treatment Centre, 1820 Richmond Rd SW, Calgary, AB T2T 5C7, Canada (lukerudmik@gmail.com).

Submitted for Publication: July 1, 2015; final revision received and accepted September 3, 2015.

Published Online: October 29, 2015. doi:10.1001/jamaoto.2015.2321.

Author Contributions: Dr Smith had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Rudmik, DeConde.

Acquisition, analysis, or interpretation of data: Rudmik, Smith, Mace, Schlosser, DeConde.

Drafting of the manuscript: Rudmik, Mace, DeConde.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Mace.

Obtained funding: Smith.

Administrative, technical, or material support: Smith, Mace.

Study supervision: Rudmik, Soler, Smith, Schlosser, DeConde.

Conflict of Interest Disclosures: Dr Soler reported being a consultant for Brainlab and Olympus Corp, Dr Smith reported being a consultant for Intersect ENT Inc, Dr Schlosser reported being a consultant for Olympus Corp and Arrinex, and Dr DeConde reported being a consultant for Intersect ENT Inc. No other disclosures were reported.

Funding/Support: This study was supported by grants R01 DC005805 (Drs Soler and Smith and Mr Mace) and R03 DC013651-01 (Dr Soler) from the National Institutes of Health.

Role of the Funder/Sponsor: The National Institutes of Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.