Original Research—Sinonasal Disorders
Early versus Delayed Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis: Impact on Health Care Utilization
Otolaryngology– Head and Neck Surgery 2015, Vol. 152(3) 546–552 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814565606 http://otojournal.org
Michael S. Benninger, MD1, Raj Sindwani, MD1, Chantal E. Holy, PhD2, and Claire Hopkins, MD, FRCS(ORL-HNS)3
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Abstract Objective. To evaluate the impact of early versus delayed endoscopic sinus surgery (ESS) in terms of postoperative health care utilization, using a patient cohort with chronic rhinosinusitis (CRS). Study Design. Retrospective administrative database analysis. Setting. US-based primary and secondary sites of care. Subjects and Methods. CRS patients with ESS in 2010—with no other ESS before 2010 and with complete medical history from 2004 to 2012—were identified within the MarketScan database. Patients were characterized by time interval of first sinusitis or nasal polyposis diagnosis to ESS and grouped as following: group 1, \ 1 year (n = 818); group 2, 1 to \2 years (n = 247); group 3, 2 to \3 years (n = 274); group 4, 3 to \4 years (n = 364); group 5, 4 to \5 years (n = 595); and group 6, 5 years (n = 535). Outpatient visits/procedures and prescriptions associated with sinusitis and/or nasal polyps were analyzed for 1 year preoperatively and 2 years postoperatively. Subanalyses were conducted on separate cohorts with or without asthma or polyps, within each group. Results. Patients in group 1 had significantly fewer visits and prescriptions than patients in group 6 (postoperative visits: group 1, 4.45 [95% CI, 4.06-4.84]; group 6, 6.70 [95% CI, 6.107.30; prescriptions: group 1, 4.54 [95% CI, 4.12-4.96]; group 6, 7.61 [95% CI, 6.92-8.31]). Gradual increases in utilization were observed from groups 1 to 6. Subanalysis of patients with and without asthma or polyps showed similar findings. Conclusion. Early intervention after diagnoses of CRS, with or without asthma or polyps, is associated with lower health care utilization than intervention after many years of medical management. Keywords endoscopic sinus surgery, chronic rhinosinusitis, administrative database, observational research, long-term follow-up study, time to surgery
Received August 28, 2014; revised November 20, 2014; accepted December 4, 2014.
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ndoscopic sinus surgery (ESS) is recommended for patients suffering from chronic rhinosinusitis (CRS) refractory to medical management, and recent controlled prospective trials have shown it to be more effective than continuous medical management in terms of patientreported outcomes and CRS-related drug utilization.1 In addition, over longer periods, medical management alone has been shown to become ineffective.2 Recent guidelines have thus recommended that patients with 12 weeks of failed medical management be considered for surgery,3 although no data exist indicating the actual time frame for most patients from diagnosis to surgery. A recent analysis of the UK National Comparative Audit of Surgery for Nasal Polyposis indicated that nearly 40% of all patients presenting for surgery had suffered from symptoms related to CRS for more than 5 years.4 In the United States, time to surgery has not been characterized, although recent analyses suggest that the surgical decision may be strongly associated with patients’ own assessments of morbidity.5 CRS has been shown to be associated with a number of inflammatory processes, including goblet cell hyperplasia, subepithelial edema, and fibrosis. These inflammatory responses have also been shown to be associated with changes in sinonasal tissue architecture.6 No data have been published, however, to determine the extent of such tissue changes with unresolved disease over long periods. A recent UK-based investigation has evaluated postoperative patient-reported outcomes of those treated
1
Head and Neck Institute, Cleveland Clinic, Cleveland, Ohio, USA Acclarent Inc, Menlo Park, California, USA 3 ENT Department, Guy’s Hospital, London, UK 2
This article was presented at the 2014 AAO-HNSF Annual Meeting & OTO EXPO; September 21-24, 2014; Orlando, Florida. Corresponding Author: Michael S. Benninger, MD, Chairman, Head and Neck Institute, Professor of Surgery, Lerner College of Medicine, The Cleveland Clinic, 9500 Euclid Avenue, A-71, Cleveland, OH 44195, USA. Email: [email protected]
Benninge et al surgically within 12 months of disease versus those treated after 5 years. This study suggested that patients treated after 5 years, while still benefiting from the surgery, experienced overall worse outcomes than did patients treated early. The benefits of surgery in those patients were also of shorter duration than in patients treated early, suggesting that advanced, longer-term disease may be more difficult to treat.4 The reported ineffectiveness of medical management over the long term, the known inflammatory processes and remodeling affecting sinonasal tissues during the disease, and the early evidence of poorer postoperative prognosis in long- versus short-term patients all suggest that time to surgery may play a critical role in postoperative sinonasal outcomes. In this study, we tested the hypothesis that patients treated earlier in the disease state may have lower sinusrelated postoperative health care utilization—suggestive of a potentially better health outcome—than patients treated later in the disease continuum. To test this hypothesis, large patient cohorts with complete medical history over multiple years were required. This analysis was completed with a US-based administrative claims database, evaluating patients with ESS and with complete medical and prescription history available over a 9-year period.
Methods The study is a retrospective analysis of a large administrative database designed to collect and pay for medical and drug claims (also known as claims-based analysis), with no identification of individual patients; therefore, it was exempt from the need to obtain institutional review board approval.
Cohort Identification The study was conducted with the MarketScan Commercial Claims and Encounter database. All patients with sinus surgery code (CPT-4 31254-31288 [Common Procedure Terminology, 4th ed]) in 2010 were identified. To be included in the final cohort count, patients were required to be continuously enrollment in the database—for both medical and drug claims—from January 01, 2004, to December 31, 2012. Patients with any sinus surgery before the index 2010 surgery, as well as patients without a diagnosis of CRS (ICD-9, 473.X) before surgery, were eliminated from the study.
Timing of First Diagnosis All patients’ outpatient records were analyzed for their first sinusitis or polyposis diagnosis from 2004 onward (ICD-9, 473.X or 471.X or 461.X). The time interval between the first sinusitis or polyposis diagnosis and the date of surgery was calculated for all patients. Patients were then grouped according to the duration of that time interval. The following groups were formed, with all intervals representing time from first diagnosis to surgery: group 1, \1 year; group 2, 1
547 and \2 years; group 3, 2 and \3 years; group 4, 3 and \4 years; group 5, 4 and \5 years; group 6, 5 years.
Comorbid Conditions All patients’ outpatient records were queried for primary or secondary diagnoses of respiratory and related comorbidities. The timing at which these comorbidities were first recorded was also analyzed relative to that of first sinus disease diagnosis and that of sinus surgery. Comorbid conditions were considered diagnosed at time of surgery if the diagnosis was rendered within 30 days of surgery, this time window allowing for recording of perioperative observations. The following codes were used to identify specific conditions: asthma (ICD-9, 493.XX and V17.5), nasal polyposis (ICD-9, 471.X), allergy (ICD-9, 477.8 and 477.9), aspirin intolerance (ICD-9, 995.0, 995.2, 995.20, 995.27, 995.29, 995.3, V14.6, V14.8), diabetes (ICD-9, 250.XX), and depression (ICD-9, 311 and 300.4).
Frequency of Visits and Procedures Related to Sinus Disease To evaluate the frequency of medical visits and procedures associated with sinus disease, all patients’ outpatient records were further analyzed for diagnoses (primary or secondary) of polyps or sinusitis (as indicated above) or visits with procedures specific to treatment of sinus conditions (CPT-4, 30000 to 31999). All distinct visits were identified for all patients and characterized according to time of the visits in relation to time of surgery and grouped according to immediate pre- or postoperative year. Procedures performed the year before surgery, including the day of surgery, were included in baseline data; thus, year 1 started at postoperative day 1 and included all days up to postoperative day 365; year 2 included days 366 to 730. Data beyond year 2 was censored, as it did not include 100% data for the entire cohort. Consolidated analyses of all postoperative procedures were also conducted to show a total count of procedures per patient per group, over the entire 2-year postoperative study period.
Drug Utilization All prescriptions belonging to a therapeutic class relevant to sinus disease and filled within 14 days of a CRS-associated visit or procedure as identified above were analyzed for all patients. The drug therapeutic classes included in this study were as follows: antibiotics, antifungals, antihistamines, anti-inflammatory drugs, antitussives, antivirals, bronchodilators, corticosteroids, decongestants, expectorants, immunosuppressants, leukotriene modifiers, nasal steroids, and pain medications. The timing at which the prescriptions were filled was analyzed in relation to the timing of the index surgical procedure and grouped according to the time categories indicated above. Consolidated analyses of all prescriptions and prescriptions per drug category were also conducted to show a total prescription count and a total prescription count per drug
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Otolaryngology–Head and Neck Surgery 152(3)
Figure 1. Flow diagram describing patients selected for inclusion in the study. CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
type, per patient per group, over the entire 2-year study period. The analysis of prescription frequency per drug type was conducted to evaluate the impact of each drug type on total frequency.
Subanalysis To evaluate the impact of asthma or polyps on visits and prescription utilization, the analyses described above were repeated separately for cohorts without asthma (‘‘no asthma cohorts’’) and cohorts with asthma (‘‘asthma only cohorts’’) and, in a separate subanalysis, in cohorts without polyps (‘‘no polyps cohort’’) and cohorts with polyps (‘‘with polyps cohort’’).
Statistical Analyses Descriptive statistics and analyses (means, standard errors of the mean, and confidence intervals) were calculated with SAS Enterprise Guide 4.3 (SAS Institute, Cary, NC). Continuous data are presented as means with 95% confidence intervals or standard errors of the mean (a = 0.05). With frequency of visits and prescriptions being nonnormally distributed, Kruskal-Wallis tests were conducted to evaluate statistical differences among multiple groups. For tests showing significance based on Kruskal-Wallis P values, a subsequent Wilcoxon rank-sum 2-sample test was conducted between the 2 ‘‘extreme’’ groups: group 1 (\1 year) and group 6 (5 years).
Results Patient Cohorts and Demographics In 2010, the MarketScan database covered a total of 48.7 million lives, of which 35.5 million had at least 12 months of continuous enrollment. A CONSORT-like flow diagram describing patient identification for the study is shown in Figure 1. Group size and demographic information are included in Table 1. Average age ranged from 44.1 to 46.0 years, with no significant differences across groups. Group 1 had a larger proportion of men versus all other groups. At the time of first diagnosis, patients in group 6 had lower rates of all recorded comorbidities than patients in group 1. However, by the time of surgery, there were significantly more respiratory comorbidities in group 6 than group 1. The average number of sinusitis- and polyposis-related visits and prescriptions for all patients in each group is shown in Table 2. Overall, the average number of prescriptions was closely correlated to the number of visits. Postoperatively, patients in group 1 filled approximately 1.02 prescriptions per visit and patients in group 6, approximately 1.13. Both the number of visits and the number of prescriptions increased gradually from group 1 to group 6, with patients in group 1 filling an average of 4.54 prescriptions for 4.45 visits and patients in group 6 filling an average 7.61 prescriptions for 6.70 visits (analysis of both
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Table 1. Demographics and Prevalence of Related Comorbidities at Time of First Sinusitis Diagnosis and at Time of ESS.
No. Mean (SE) age at index surgery, y Male, % Patients with diagnosed comorbidities at time of ESS, % (No.) Asthma Polyps Asthma and polyps Samter triad Depression Patients with diagnosed comorbidities at time of first CRS, % (No.) Asthma Polyps Asthma and polyps Samter triad Depression
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
\1 y
1 and \2 y
2 and \3 y
3 and \4 y
4 and \5 y
5 y
818 46.15 (0.47) 61.61
247 43.90 (0.87) 46.15
274 44.26 (0.82) 45.26
364 45.16 (0.69) 46.15
595 45.58 (0.56) 41.68
535 45.75 (0.59) 35.51
20.3 (166) 30.44 (249) 6.72 (55) 1.34 (11) 9.78 (80)
25.1 (62) 33.2 (82) 9.31 (23) 1.62 (4) 10.53 (26)
32.85 (90) 27.01 (74) 12.04 (33) 3.28 (9) 17.51 (48)
34.07 (124) 32.14 (117) 12.09 (44) 1.1 (4) 17.86 (65)
35.8 (213) 37.48 (223) 12.94 (77) 2.69 (16) 16.3 (97)
45.42 (243) 39.07 (209) 18.88 (101) 3.74 (20) 20.94 (112)
18.34 (150) 0.12 (1) 0 (0) 0 (0) 9.29 (76)
15.79 (39) 0 (0) 0 (0) 0 (0) 9.72 (24)
18.98 (52) 0 (0) 0 (0) 0 (0) 9.12 (25)
16.76 (61) 0 (0) 0 (0) 0 (0) 9.62 (35)
10.25 (61) 0.17 (1) 0 (0) 0 (0) 5.21 (31)
5.23 (28) 0 (0) 0 (0) 0 (0) 1.5 (8)
Abbreviation: CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
Table 2. Average Frequency of Chronic Rhinosinusitis–Related Visits and Prescriptions over the 2-Year Postoperative Time Frame, by Groups. Average No. (95% CI) Group 1: \ 1 y 2: . 1 and \ 2 3: . 2 and \ 3 4: . 3 and \ 4 5: . 4 and \ 5 6: . 5 y
y y y y
Visits
Prescriptions
4.45 (4.06-4.84) 4.95 (4.37-5.54) 5.53 (4.78-6.29) 5.49 (4.95-6.04) 6.51 (5.84-7.17) 6.70 (6.10-7.31)
4.54 (4.12-4.96) 5.31 (4.67-5.94) 6.31 (5.50-7.12) 6.14 (5.55-6.74) 7.35 (6.60-8.10) 7.61 (6.92-8.31)
variables for all groups: Kruskal Wallis, P \ .0001; analysis of both variables for groups 1 and 6: Wilcoxon 2-sample test: P \ .0001). A breakdown of visits and prescriptions per pre- and postoperative year is shown in Figures 2 and 3, respectively. In both cases, the number of visits or prescriptions within the first postoperative year was approximately 3-fold greater than in postoperative year 2. At both time points, however, the frequency of visits and prescriptions in group 1 was significantly lower than those in group 6. A further analysis was conducted to determine whether all drug types were affected by this finding. Table 3 shows key categories of drugs and whether their utilization was significantly different between patients in groups 1 versus group 6. The Wilcoxon 2-sample test shows the P value for
each drug type. As shown in this table, most drugs associated with treatment of CRS were prescribed significantly more frequently for patients in group 6 versus group 1. Figure 4 shows the frequency of prescriptions by drug type, for those drugs with greatest impact on total frequency, for each group. The increase in frequency of prescription for those drug categories appear nearly linear from groups 1 to 6. As indicated above, by time of surgery, there were significantly more patients with asthma in group 6 versus group 1. To determine the potential confounding effect of asthma and to further understand the impact of asthma on utilization, a subanalysis was conducted in which patients with asthma were eliminated from groups 1 and 6 (‘‘no asthma’’ subcohort) or in which only patients with asthma were included in subgroups of groups 1 and 6 (‘‘only asthma’’ subcohort). Figure 5 shows the number of visits and prescriptions for groups 1 and 6 in each subcohort. Overall, patients with asthma had a significantly greater number of visits and prescriptions for sinusitis than did patients without asthma, regardless of group. Importantly, however, the trend of increased health care utilization from groups 1 to 6 was observed in the ‘‘no asthma’’ and ‘‘only asthma’’ subgroups. In both cases, patients in group 1 had significantly fewer visits or prescriptions than patients in group 6. A similar subanalysis was conducted dividing each group into cohorts with or without reported diagnoses of polyps (Figure 6). Whereas utilization was not significantly different between cohorts with and without polyps, in both cases, patients in group 6 had significantly greater health care utilization than did patients in group 1.
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Figure 2. Average number of chronic rhinosinusitis–related visits per year per group (with standard errors). At both time points, group 1 had a significantly lower number of visits than group 6.
Figure 3. Average number of CRS-related prescriptions per year per group (with standard errors). At both time points, group 1 had a significantly lower number of prescriptions than group 6. CRS, chronic rhinosinusitis.
Discussion In this study, the impact of time from first sinusitis and/or sinonasal polyposis diagnosis to ESS surgery for CRS was evaluated in terms of patients’ postoperative health care utilization. Patients were subdivided into groups based on the number of years from their first sinus/polyp diagnosis to time of surgery, and their postoperative health care use over a 2-year period was evaluated. Interestingly, health care use increased in a near-linear fashion as time from first diagnosis to surgery lengthened, demonstrating that patients with the longest delay from first diagnosis to surgery experienced greatest postoperative sinus- and/or polyposis-related health care utilization, whereas patients treated early were much
Otolaryngology–Head and Neck Surgery 152(3) more likely to have limited postoperative health care utilization for their condition. In our study, groups were not matched for prevalence of respiratory comorbidities, because we hypothesized that increased time to surgery would indeed lead to increased rates of comorbid conditions, and matching cohorts may thus eliminate the real-world impact of waiting. By the time of surgery, there was a significantly greater proportion of patients with asthma in group 6 versus group 1. This observation was also reported in the UK audit analysis, where a significantly greater proportion of patients with asthma were identified in the cohort that had waited 5 years for surgery. Our initial findings suggest an overall worsening of the patients’ respiratory conditions as the preoperative period lengthens. This raises the question whether reducing the burden of sinus disease through sinus surgery early in the course of the disease may result in disease modification in relationship to the development of the clinical manifestations of asthma. There is growing evidence that such disease modification can occur, for example, with the early treatment of allergic rhinitis through immunotherapy. In this particular case, the risk of developing asthma was reduced.7 Further research is required to understand the rate of progression of respiratory comorbidities in patients with continued sinus disease and the impact of ESS on those comorbidities. To account for a possible confounding effect of asthma— the main cost driver for patients with rhinosinusitis8—populations with and without asthma were evaluated separately. In both cases, the findings that increased time to surgery was associated with increased postoperative utilization were maintained. Thus, whereas ESS was shown to effectively provide relief to patients with asthma,9,10 their utilization still remained greater than that of patients treated earlier in the disease continuum. A similar analysis based on polyps versus no polyps showed that, again, patients with more than 5 years of CRS history had greater utilization than that of patients with only 1 year, but the difference in utilization between patients with and without polyps was not significant. This finding could have been a result of the fact that mild or moderate polyposis is not consistently reported in claims databases, so the ‘‘no polyps’’ cohort may have included patients with polyps. Depression has often been discussed in studies related to sinusitis. Whereas direct cause-and-effects between depression and sinus disease have not been demonstrated,11,12 many studies have reported greater rates of depression in patients with sinusitis versus patients without. It is therefore not surprising that rates of depression were relatively high in our study versus the reported 7.3% expected in the general US population.13 However, the increased prevalence of depression with time to treatment has not been demonstrated, suggesting a possible association between long-term unresolved sinus disease and increased rates of diagnosed depression.
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Table 3. Average Number of Prescriptions by Drug Type in Groups 1 and 6.a Average No. of Prescriptions (95% CI) Drug Categories Antibiotics Antifungals Antihistamines Antitussives Antivirals Bronchodilators Corticosteroids Leukotriene modifiers Pain management Nasal steroids
Group 1
Group 6
P Value
1.65 (1.49-1.82) 0.07 (0.04-0.09) 0.22 (0.18-0.26) 0.05 (0.03-0.07) 0.02 (0.01-0.03) 0.11 (0.07-0.15) 0.5 (0.44-0.58) 0.12 (0.09-0.016) 0.54 (1.02-1.26) 1.14 (0.46-0.63)
2.94 (2.68-3.19) 0.21 (0.15-0.28) 0.38 (0.29-0.46) 0.25 (0.18-0.31) 0.06 (0.03-0.08) 0.19 (0.12-0.25) 0.84 (0.71-0.97) 0.3 (0.21-0.37) 0.9 (1.28-1.67) 1.5 (0.73-1.03 )
\.0001 \.0001 .0009 \.0001 .0035 .001 \.0001 .0001 \.0001 .0001
a
The drug types listed had significantly greater utilization in group 6 versus group 1.
Figure 4. Average number of prescriptions over the entire postoperative period (with standard error). For all types, the number of prescriptions for group 1 was significantly lower than for group 6.
Figure 5. Average number of visits and prescriptions over the entire 2-year postoperative period, for patients with and without asthma. Differences between groups 1 and 6 were significant. CRS, chronic rhinosinusitis.
The potential implications of our study’s overall results may be significant. From a patient’s standpoint, delayed surgery may be associated with greater postoperative health care needs, potentially reflective of poorer ultimate prognosis. From a societal standpoint, the cost of sinus disease has recently been shown to be extremely high, as patients not only require continuous care but also have poorer productivity than do patients without the disease.14,15 There are a number of important limitations in this study. With this study being based on administrative claims, it is of course possible that some miscoding of diseases and conditions may have occurred and that some patients may have had symptoms for longer or shorter duration than that shown here. More important, however, the requirement for inclusion in the study was a complete preoperative medical history for 7 years. It is possible that some patients had no symptoms for some of these years and a reoccurrence of symptoms before surgery. These
patients may have been characterized as being treated early on in the disease state when in fact they may have had a disease before 2004, followed by a relatively long period free of symptoms. Similarly, patients who had sinus surgery before 2004 would have been included in this study, as medical history before that point could not be checked for all patients. In addition, the severity of patients’ sinus conditions, typically captured via clinical instruments such as patient-reported outcomes, is not available in the database. Thus, health care utilization and comorbid conditions were discussed herein as a proxy of patient severity. Whether patients differed significantly in the severity of their actual sinus disease is unknown; however, as shown in other studies, more severe patients tend to select surgical intervention faster, whereas less severe patients tolerate persistent symptoms longer16—accordingly, this bias would favor increased utilization in the early cohort and thus reduce the differences shown.
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Otolaryngology–Head and Neck Surgery 152(3) Sponsorships: None. Funding source: The license to the MarketScan Database was paid for by Johnson & Johnson.
References
Figure 6. Average number of visits and prescriptions over the entire 2-year postoperative period, for patients with and without polyps. Differences between groups 1 and 6 were significant. CRS, chronic rhinosinusitis.
Finally, delays owing to other comorbid conditions, such as cardiovascular optimization, anticoagulation, diabetic control, and obesity control, as well as other unknown confounders, may have affected outcomes. To add strength to this study, however, similar results were seen with a completely different clinical database in a different country.17
Conclusion In our study, CRS patients receiving sinus surgery within 12 months of sinus and/or polyposis diagnoses had significantly less sinusitis-related postoperative health care utilization than did patients treated after more than 5 years of disease. Surgical intervention in the earlier stages of chronic sinus disease was associated with fewer postoperative health care visits and prescriptions. Interestingly, our results also showed that increased unresolved time to surgery was associated with greater rates of asthma. The underlying reason for this association is unknown and warrants further research. Author Contributions Michael S. Benninger, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published; Raj Sindwani, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published; Chantal E. Holy, contribution to study design, data analysis, manuscript drafting, final approval of version to be published; Claire Hopkins, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published.
Disclosures Competing interests: Chantal. E. Holy is an employee of Acclarent (a Johnson & Johnson Company); Claire Hopkins, Johnson & Johnson, reimbursement for speaker at meeting; consulting agreement for OASIS Registry.
1. Smith TL, Kern R, Palmer JN, et al. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013;3:4-9. 2. Smith KA, Rudmik L. Impact of continued medical therapy in patients with refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014;4:34-38. 3. Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl. 2012;23:3. 4. Hopkins C, Lund V. For patients with chronic rhinosinusitis: does time to endoscopic sinus surgery impact outcomes? Prospective findings from the National Comparative Audit of Surgery for Nasal Polyposis and Chronic Rhinosinusitis. Rhinology. In press. 5. Soler ZM, Rudmik L, Hwang PH, Mace JC, Schlosser RJ, Smith TL. Patient-centered decision making in the treatment of chronic rhinosinusitis. Laryngoscope. 2013;123:2341-2346. 6. Pawankar R, Nonaka M. Inflammatory mechanisms and remodeling in chronic rhinosinusitis and nasal polyps. Curr Allergy Asthma Rep. 2007;7:202-208. 7. Lin SY, Suarez-Cuervo C, Segal J. Efficacy of sublingual immunotherapy-reply. JAMA. 2013;310:644-645. 8. Benninger MS, Holy CE. The impact of endoscopic sinus surgery on health care use in patients with respiratory comorbidities. Otolaryngol Head Neck Surg. 2014;151:508-515. 9. Spector S. The linkage between rhinitis, sinusitis and ashtma. Clin Applied Immunol Rev. 2001;1:229-234. 10. Nair S, Bhadauria RS, Sharma S. Effect of endoscopic sinus surgery on asthmatic patients with chronic rhinosinusitis. Indian J Otolaryngol Head Neck Surg. 2010;62:285-288. 11. Mace J, Michael YL, Carlson NE, Litvack JR, Smith TL. Effects of depression on quality of life improvement after endoscopic sinus surgery. Laryngoscope. 2008;118:528-534. 12. Litvack JR, Mace J, Smith TL. Role of depression in outcomes of endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2011;144:446-451. 13. Chandra RK, Epstein VA, Fishman AJ. Prevalence of depression and antidepressant use in an otolaryngology patient population. Otolaryngol Head Neck Surg. 2009;141:136-138. 14. Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014;124:2007-2012. 15. Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013;34:328-334. 16. DeConde AS, Mace JC, Bodner T, et al. SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis [published online October 16, 2014]. Int Forum Allergy Rhinol. 17. Hopkins C, Andrews P, Holy CE. Does time to endoscopic sinus surgery impact outcomes in chronic rhinosinusitis? Retrospective analysis using the UK Clinical Practice Research Database. Rhinology. In press.
Early versus Delayed Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis: Impact on Health Care Utilization
Otolaryngology– Head and Neck Surgery 2015, Vol. 152(3) 546–552 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814565606 http://otojournal.org
Michael S. Benninger, MD1, Raj Sindwani, MD1, Chantal E. Holy, PhD2, and Claire Hopkins, MD, FRCS(ORL-HNS)3
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Abstract Objective. To evaluate the impact of early versus delayed endoscopic sinus surgery (ESS) in terms of postoperative health care utilization, using a patient cohort with chronic rhinosinusitis (CRS). Study Design. Retrospective administrative database analysis. Setting. US-based primary and secondary sites of care. Subjects and Methods. CRS patients with ESS in 2010—with no other ESS before 2010 and with complete medical history from 2004 to 2012—were identified within the MarketScan database. Patients were characterized by time interval of first sinusitis or nasal polyposis diagnosis to ESS and grouped as following: group 1, \ 1 year (n = 818); group 2, 1 to \2 years (n = 247); group 3, 2 to \3 years (n = 274); group 4, 3 to \4 years (n = 364); group 5, 4 to \5 years (n = 595); and group 6, 5 years (n = 535). Outpatient visits/procedures and prescriptions associated with sinusitis and/or nasal polyps were analyzed for 1 year preoperatively and 2 years postoperatively. Subanalyses were conducted on separate cohorts with or without asthma or polyps, within each group. Results. Patients in group 1 had significantly fewer visits and prescriptions than patients in group 6 (postoperative visits: group 1, 4.45 [95% CI, 4.06-4.84]; group 6, 6.70 [95% CI, 6.107.30; prescriptions: group 1, 4.54 [95% CI, 4.12-4.96]; group 6, 7.61 [95% CI, 6.92-8.31]). Gradual increases in utilization were observed from groups 1 to 6. Subanalysis of patients with and without asthma or polyps showed similar findings. Conclusion. Early intervention after diagnoses of CRS, with or without asthma or polyps, is associated with lower health care utilization than intervention after many years of medical management. Keywords endoscopic sinus surgery, chronic rhinosinusitis, administrative database, observational research, long-term follow-up study, time to surgery
Received August 28, 2014; revised November 20, 2014; accepted December 4, 2014.
E
ndoscopic sinus surgery (ESS) is recommended for patients suffering from chronic rhinosinusitis (CRS) refractory to medical management, and recent controlled prospective trials have shown it to be more effective than continuous medical management in terms of patientreported outcomes and CRS-related drug utilization.1 In addition, over longer periods, medical management alone has been shown to become ineffective.2 Recent guidelines have thus recommended that patients with 12 weeks of failed medical management be considered for surgery,3 although no data exist indicating the actual time frame for most patients from diagnosis to surgery. A recent analysis of the UK National Comparative Audit of Surgery for Nasal Polyposis indicated that nearly 40% of all patients presenting for surgery had suffered from symptoms related to CRS for more than 5 years.4 In the United States, time to surgery has not been characterized, although recent analyses suggest that the surgical decision may be strongly associated with patients’ own assessments of morbidity.5 CRS has been shown to be associated with a number of inflammatory processes, including goblet cell hyperplasia, subepithelial edema, and fibrosis. These inflammatory responses have also been shown to be associated with changes in sinonasal tissue architecture.6 No data have been published, however, to determine the extent of such tissue changes with unresolved disease over long periods. A recent UK-based investigation has evaluated postoperative patient-reported outcomes of those treated
1
Head and Neck Institute, Cleveland Clinic, Cleveland, Ohio, USA Acclarent Inc, Menlo Park, California, USA 3 ENT Department, Guy’s Hospital, London, UK 2
This article was presented at the 2014 AAO-HNSF Annual Meeting & OTO EXPO; September 21-24, 2014; Orlando, Florida. Corresponding Author: Michael S. Benninger, MD, Chairman, Head and Neck Institute, Professor of Surgery, Lerner College of Medicine, The Cleveland Clinic, 9500 Euclid Avenue, A-71, Cleveland, OH 44195, USA. Email: [email protected]
Benninge et al surgically within 12 months of disease versus those treated after 5 years. This study suggested that patients treated after 5 years, while still benefiting from the surgery, experienced overall worse outcomes than did patients treated early. The benefits of surgery in those patients were also of shorter duration than in patients treated early, suggesting that advanced, longer-term disease may be more difficult to treat.4 The reported ineffectiveness of medical management over the long term, the known inflammatory processes and remodeling affecting sinonasal tissues during the disease, and the early evidence of poorer postoperative prognosis in long- versus short-term patients all suggest that time to surgery may play a critical role in postoperative sinonasal outcomes. In this study, we tested the hypothesis that patients treated earlier in the disease state may have lower sinusrelated postoperative health care utilization—suggestive of a potentially better health outcome—than patients treated later in the disease continuum. To test this hypothesis, large patient cohorts with complete medical history over multiple years were required. This analysis was completed with a US-based administrative claims database, evaluating patients with ESS and with complete medical and prescription history available over a 9-year period.
Methods The study is a retrospective analysis of a large administrative database designed to collect and pay for medical and drug claims (also known as claims-based analysis), with no identification of individual patients; therefore, it was exempt from the need to obtain institutional review board approval.
Cohort Identification The study was conducted with the MarketScan Commercial Claims and Encounter database. All patients with sinus surgery code (CPT-4 31254-31288 [Common Procedure Terminology, 4th ed]) in 2010 were identified. To be included in the final cohort count, patients were required to be continuously enrollment in the database—for both medical and drug claims—from January 01, 2004, to December 31, 2012. Patients with any sinus surgery before the index 2010 surgery, as well as patients without a diagnosis of CRS (ICD-9, 473.X) before surgery, were eliminated from the study.
Timing of First Diagnosis All patients’ outpatient records were analyzed for their first sinusitis or polyposis diagnosis from 2004 onward (ICD-9, 473.X or 471.X or 461.X). The time interval between the first sinusitis or polyposis diagnosis and the date of surgery was calculated for all patients. Patients were then grouped according to the duration of that time interval. The following groups were formed, with all intervals representing time from first diagnosis to surgery: group 1, \1 year; group 2, 1
547 and \2 years; group 3, 2 and \3 years; group 4, 3 and \4 years; group 5, 4 and \5 years; group 6, 5 years.
Comorbid Conditions All patients’ outpatient records were queried for primary or secondary diagnoses of respiratory and related comorbidities. The timing at which these comorbidities were first recorded was also analyzed relative to that of first sinus disease diagnosis and that of sinus surgery. Comorbid conditions were considered diagnosed at time of surgery if the diagnosis was rendered within 30 days of surgery, this time window allowing for recording of perioperative observations. The following codes were used to identify specific conditions: asthma (ICD-9, 493.XX and V17.5), nasal polyposis (ICD-9, 471.X), allergy (ICD-9, 477.8 and 477.9), aspirin intolerance (ICD-9, 995.0, 995.2, 995.20, 995.27, 995.29, 995.3, V14.6, V14.8), diabetes (ICD-9, 250.XX), and depression (ICD-9, 311 and 300.4).
Frequency of Visits and Procedures Related to Sinus Disease To evaluate the frequency of medical visits and procedures associated with sinus disease, all patients’ outpatient records were further analyzed for diagnoses (primary or secondary) of polyps or sinusitis (as indicated above) or visits with procedures specific to treatment of sinus conditions (CPT-4, 30000 to 31999). All distinct visits were identified for all patients and characterized according to time of the visits in relation to time of surgery and grouped according to immediate pre- or postoperative year. Procedures performed the year before surgery, including the day of surgery, were included in baseline data; thus, year 1 started at postoperative day 1 and included all days up to postoperative day 365; year 2 included days 366 to 730. Data beyond year 2 was censored, as it did not include 100% data for the entire cohort. Consolidated analyses of all postoperative procedures were also conducted to show a total count of procedures per patient per group, over the entire 2-year postoperative study period.
Drug Utilization All prescriptions belonging to a therapeutic class relevant to sinus disease and filled within 14 days of a CRS-associated visit or procedure as identified above were analyzed for all patients. The drug therapeutic classes included in this study were as follows: antibiotics, antifungals, antihistamines, anti-inflammatory drugs, antitussives, antivirals, bronchodilators, corticosteroids, decongestants, expectorants, immunosuppressants, leukotriene modifiers, nasal steroids, and pain medications. The timing at which the prescriptions were filled was analyzed in relation to the timing of the index surgical procedure and grouped according to the time categories indicated above. Consolidated analyses of all prescriptions and prescriptions per drug category were also conducted to show a total prescription count and a total prescription count per drug
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Figure 1. Flow diagram describing patients selected for inclusion in the study. CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
type, per patient per group, over the entire 2-year study period. The analysis of prescription frequency per drug type was conducted to evaluate the impact of each drug type on total frequency.
Subanalysis To evaluate the impact of asthma or polyps on visits and prescription utilization, the analyses described above were repeated separately for cohorts without asthma (‘‘no asthma cohorts’’) and cohorts with asthma (‘‘asthma only cohorts’’) and, in a separate subanalysis, in cohorts without polyps (‘‘no polyps cohort’’) and cohorts with polyps (‘‘with polyps cohort’’).
Statistical Analyses Descriptive statistics and analyses (means, standard errors of the mean, and confidence intervals) were calculated with SAS Enterprise Guide 4.3 (SAS Institute, Cary, NC). Continuous data are presented as means with 95% confidence intervals or standard errors of the mean (a = 0.05). With frequency of visits and prescriptions being nonnormally distributed, Kruskal-Wallis tests were conducted to evaluate statistical differences among multiple groups. For tests showing significance based on Kruskal-Wallis P values, a subsequent Wilcoxon rank-sum 2-sample test was conducted between the 2 ‘‘extreme’’ groups: group 1 (\1 year) and group 6 (5 years).
Results Patient Cohorts and Demographics In 2010, the MarketScan database covered a total of 48.7 million lives, of which 35.5 million had at least 12 months of continuous enrollment. A CONSORT-like flow diagram describing patient identification for the study is shown in Figure 1. Group size and demographic information are included in Table 1. Average age ranged from 44.1 to 46.0 years, with no significant differences across groups. Group 1 had a larger proportion of men versus all other groups. At the time of first diagnosis, patients in group 6 had lower rates of all recorded comorbidities than patients in group 1. However, by the time of surgery, there were significantly more respiratory comorbidities in group 6 than group 1. The average number of sinusitis- and polyposis-related visits and prescriptions for all patients in each group is shown in Table 2. Overall, the average number of prescriptions was closely correlated to the number of visits. Postoperatively, patients in group 1 filled approximately 1.02 prescriptions per visit and patients in group 6, approximately 1.13. Both the number of visits and the number of prescriptions increased gradually from group 1 to group 6, with patients in group 1 filling an average of 4.54 prescriptions for 4.45 visits and patients in group 6 filling an average 7.61 prescriptions for 6.70 visits (analysis of both
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Table 1. Demographics and Prevalence of Related Comorbidities at Time of First Sinusitis Diagnosis and at Time of ESS.
No. Mean (SE) age at index surgery, y Male, % Patients with diagnosed comorbidities at time of ESS, % (No.) Asthma Polyps Asthma and polyps Samter triad Depression Patients with diagnosed comorbidities at time of first CRS, % (No.) Asthma Polyps Asthma and polyps Samter triad Depression
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
\1 y
1 and \2 y
2 and \3 y
3 and \4 y
4 and \5 y
5 y
818 46.15 (0.47) 61.61
247 43.90 (0.87) 46.15
274 44.26 (0.82) 45.26
364 45.16 (0.69) 46.15
595 45.58 (0.56) 41.68
535 45.75 (0.59) 35.51
20.3 (166) 30.44 (249) 6.72 (55) 1.34 (11) 9.78 (80)
25.1 (62) 33.2 (82) 9.31 (23) 1.62 (4) 10.53 (26)
32.85 (90) 27.01 (74) 12.04 (33) 3.28 (9) 17.51 (48)
34.07 (124) 32.14 (117) 12.09 (44) 1.1 (4) 17.86 (65)
35.8 (213) 37.48 (223) 12.94 (77) 2.69 (16) 16.3 (97)
45.42 (243) 39.07 (209) 18.88 (101) 3.74 (20) 20.94 (112)
18.34 (150) 0.12 (1) 0 (0) 0 (0) 9.29 (76)
15.79 (39) 0 (0) 0 (0) 0 (0) 9.72 (24)
18.98 (52) 0 (0) 0 (0) 0 (0) 9.12 (25)
16.76 (61) 0 (0) 0 (0) 0 (0) 9.62 (35)
10.25 (61) 0.17 (1) 0 (0) 0 (0) 5.21 (31)
5.23 (28) 0 (0) 0 (0) 0 (0) 1.5 (8)
Abbreviation: CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
Table 2. Average Frequency of Chronic Rhinosinusitis–Related Visits and Prescriptions over the 2-Year Postoperative Time Frame, by Groups. Average No. (95% CI) Group 1: \ 1 y 2: . 1 and \ 2 3: . 2 and \ 3 4: . 3 and \ 4 5: . 4 and \ 5 6: . 5 y
y y y y
Visits
Prescriptions
4.45 (4.06-4.84) 4.95 (4.37-5.54) 5.53 (4.78-6.29) 5.49 (4.95-6.04) 6.51 (5.84-7.17) 6.70 (6.10-7.31)
4.54 (4.12-4.96) 5.31 (4.67-5.94) 6.31 (5.50-7.12) 6.14 (5.55-6.74) 7.35 (6.60-8.10) 7.61 (6.92-8.31)
variables for all groups: Kruskal Wallis, P \ .0001; analysis of both variables for groups 1 and 6: Wilcoxon 2-sample test: P \ .0001). A breakdown of visits and prescriptions per pre- and postoperative year is shown in Figures 2 and 3, respectively. In both cases, the number of visits or prescriptions within the first postoperative year was approximately 3-fold greater than in postoperative year 2. At both time points, however, the frequency of visits and prescriptions in group 1 was significantly lower than those in group 6. A further analysis was conducted to determine whether all drug types were affected by this finding. Table 3 shows key categories of drugs and whether their utilization was significantly different between patients in groups 1 versus group 6. The Wilcoxon 2-sample test shows the P value for
each drug type. As shown in this table, most drugs associated with treatment of CRS were prescribed significantly more frequently for patients in group 6 versus group 1. Figure 4 shows the frequency of prescriptions by drug type, for those drugs with greatest impact on total frequency, for each group. The increase in frequency of prescription for those drug categories appear nearly linear from groups 1 to 6. As indicated above, by time of surgery, there were significantly more patients with asthma in group 6 versus group 1. To determine the potential confounding effect of asthma and to further understand the impact of asthma on utilization, a subanalysis was conducted in which patients with asthma were eliminated from groups 1 and 6 (‘‘no asthma’’ subcohort) or in which only patients with asthma were included in subgroups of groups 1 and 6 (‘‘only asthma’’ subcohort). Figure 5 shows the number of visits and prescriptions for groups 1 and 6 in each subcohort. Overall, patients with asthma had a significantly greater number of visits and prescriptions for sinusitis than did patients without asthma, regardless of group. Importantly, however, the trend of increased health care utilization from groups 1 to 6 was observed in the ‘‘no asthma’’ and ‘‘only asthma’’ subgroups. In both cases, patients in group 1 had significantly fewer visits or prescriptions than patients in group 6. A similar subanalysis was conducted dividing each group into cohorts with or without reported diagnoses of polyps (Figure 6). Whereas utilization was not significantly different between cohorts with and without polyps, in both cases, patients in group 6 had significantly greater health care utilization than did patients in group 1.
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Figure 2. Average number of chronic rhinosinusitis–related visits per year per group (with standard errors). At both time points, group 1 had a significantly lower number of visits than group 6.
Figure 3. Average number of CRS-related prescriptions per year per group (with standard errors). At both time points, group 1 had a significantly lower number of prescriptions than group 6. CRS, chronic rhinosinusitis.
Discussion In this study, the impact of time from first sinusitis and/or sinonasal polyposis diagnosis to ESS surgery for CRS was evaluated in terms of patients’ postoperative health care utilization. Patients were subdivided into groups based on the number of years from their first sinus/polyp diagnosis to time of surgery, and their postoperative health care use over a 2-year period was evaluated. Interestingly, health care use increased in a near-linear fashion as time from first diagnosis to surgery lengthened, demonstrating that patients with the longest delay from first diagnosis to surgery experienced greatest postoperative sinus- and/or polyposis-related health care utilization, whereas patients treated early were much
Otolaryngology–Head and Neck Surgery 152(3) more likely to have limited postoperative health care utilization for their condition. In our study, groups were not matched for prevalence of respiratory comorbidities, because we hypothesized that increased time to surgery would indeed lead to increased rates of comorbid conditions, and matching cohorts may thus eliminate the real-world impact of waiting. By the time of surgery, there was a significantly greater proportion of patients with asthma in group 6 versus group 1. This observation was also reported in the UK audit analysis, where a significantly greater proportion of patients with asthma were identified in the cohort that had waited 5 years for surgery. Our initial findings suggest an overall worsening of the patients’ respiratory conditions as the preoperative period lengthens. This raises the question whether reducing the burden of sinus disease through sinus surgery early in the course of the disease may result in disease modification in relationship to the development of the clinical manifestations of asthma. There is growing evidence that such disease modification can occur, for example, with the early treatment of allergic rhinitis through immunotherapy. In this particular case, the risk of developing asthma was reduced.7 Further research is required to understand the rate of progression of respiratory comorbidities in patients with continued sinus disease and the impact of ESS on those comorbidities. To account for a possible confounding effect of asthma— the main cost driver for patients with rhinosinusitis8—populations with and without asthma were evaluated separately. In both cases, the findings that increased time to surgery was associated with increased postoperative utilization were maintained. Thus, whereas ESS was shown to effectively provide relief to patients with asthma,9,10 their utilization still remained greater than that of patients treated earlier in the disease continuum. A similar analysis based on polyps versus no polyps showed that, again, patients with more than 5 years of CRS history had greater utilization than that of patients with only 1 year, but the difference in utilization between patients with and without polyps was not significant. This finding could have been a result of the fact that mild or moderate polyposis is not consistently reported in claims databases, so the ‘‘no polyps’’ cohort may have included patients with polyps. Depression has often been discussed in studies related to sinusitis. Whereas direct cause-and-effects between depression and sinus disease have not been demonstrated,11,12 many studies have reported greater rates of depression in patients with sinusitis versus patients without. It is therefore not surprising that rates of depression were relatively high in our study versus the reported 7.3% expected in the general US population.13 However, the increased prevalence of depression with time to treatment has not been demonstrated, suggesting a possible association between long-term unresolved sinus disease and increased rates of diagnosed depression.
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Table 3. Average Number of Prescriptions by Drug Type in Groups 1 and 6.a Average No. of Prescriptions (95% CI) Drug Categories Antibiotics Antifungals Antihistamines Antitussives Antivirals Bronchodilators Corticosteroids Leukotriene modifiers Pain management Nasal steroids
Group 1
Group 6
P Value
1.65 (1.49-1.82) 0.07 (0.04-0.09) 0.22 (0.18-0.26) 0.05 (0.03-0.07) 0.02 (0.01-0.03) 0.11 (0.07-0.15) 0.5 (0.44-0.58) 0.12 (0.09-0.016) 0.54 (1.02-1.26) 1.14 (0.46-0.63)
2.94 (2.68-3.19) 0.21 (0.15-0.28) 0.38 (0.29-0.46) 0.25 (0.18-0.31) 0.06 (0.03-0.08) 0.19 (0.12-0.25) 0.84 (0.71-0.97) 0.3 (0.21-0.37) 0.9 (1.28-1.67) 1.5 (0.73-1.03 )
\.0001 \.0001 .0009 \.0001 .0035 .001 \.0001 .0001 \.0001 .0001
a
The drug types listed had significantly greater utilization in group 6 versus group 1.
Figure 4. Average number of prescriptions over the entire postoperative period (with standard error). For all types, the number of prescriptions for group 1 was significantly lower than for group 6.
Figure 5. Average number of visits and prescriptions over the entire 2-year postoperative period, for patients with and without asthma. Differences between groups 1 and 6 were significant. CRS, chronic rhinosinusitis.
The potential implications of our study’s overall results may be significant. From a patient’s standpoint, delayed surgery may be associated with greater postoperative health care needs, potentially reflective of poorer ultimate prognosis. From a societal standpoint, the cost of sinus disease has recently been shown to be extremely high, as patients not only require continuous care but also have poorer productivity than do patients without the disease.14,15 There are a number of important limitations in this study. With this study being based on administrative claims, it is of course possible that some miscoding of diseases and conditions may have occurred and that some patients may have had symptoms for longer or shorter duration than that shown here. More important, however, the requirement for inclusion in the study was a complete preoperative medical history for 7 years. It is possible that some patients had no symptoms for some of these years and a reoccurrence of symptoms before surgery. These
patients may have been characterized as being treated early on in the disease state when in fact they may have had a disease before 2004, followed by a relatively long period free of symptoms. Similarly, patients who had sinus surgery before 2004 would have been included in this study, as medical history before that point could not be checked for all patients. In addition, the severity of patients’ sinus conditions, typically captured via clinical instruments such as patient-reported outcomes, is not available in the database. Thus, health care utilization and comorbid conditions were discussed herein as a proxy of patient severity. Whether patients differed significantly in the severity of their actual sinus disease is unknown; however, as shown in other studies, more severe patients tend to select surgical intervention faster, whereas less severe patients tolerate persistent symptoms longer16—accordingly, this bias would favor increased utilization in the early cohort and thus reduce the differences shown.
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Otolaryngology–Head and Neck Surgery 152(3) Sponsorships: None. Funding source: The license to the MarketScan Database was paid for by Johnson & Johnson.
References
Figure 6. Average number of visits and prescriptions over the entire 2-year postoperative period, for patients with and without polyps. Differences between groups 1 and 6 were significant. CRS, chronic rhinosinusitis.
Finally, delays owing to other comorbid conditions, such as cardiovascular optimization, anticoagulation, diabetic control, and obesity control, as well as other unknown confounders, may have affected outcomes. To add strength to this study, however, similar results were seen with a completely different clinical database in a different country.17
Conclusion In our study, CRS patients receiving sinus surgery within 12 months of sinus and/or polyposis diagnoses had significantly less sinusitis-related postoperative health care utilization than did patients treated after more than 5 years of disease. Surgical intervention in the earlier stages of chronic sinus disease was associated with fewer postoperative health care visits and prescriptions. Interestingly, our results also showed that increased unresolved time to surgery was associated with greater rates of asthma. The underlying reason for this association is unknown and warrants further research. Author Contributions Michael S. Benninger, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published; Raj Sindwani, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published; Chantal E. Holy, contribution to study design, data analysis, manuscript drafting, final approval of version to be published; Claire Hopkins, concept and study design, critical review of findings and clinical interpretation of data, critical review of manuscript, final approval of version to be published.
Disclosures Competing interests: Chantal. E. Holy is an employee of Acclarent (a Johnson & Johnson Company); Claire Hopkins, Johnson & Johnson, reimbursement for speaker at meeting; consulting agreement for OASIS Registry.
1. Smith TL, Kern R, Palmer JN, et al. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013;3:4-9. 2. Smith KA, Rudmik L. Impact of continued medical therapy in patients with refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014;4:34-38. 3. Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl. 2012;23:3. 4. Hopkins C, Lund V. For patients with chronic rhinosinusitis: does time to endoscopic sinus surgery impact outcomes? Prospective findings from the National Comparative Audit of Surgery for Nasal Polyposis and Chronic Rhinosinusitis. Rhinology. In press. 5. Soler ZM, Rudmik L, Hwang PH, Mace JC, Schlosser RJ, Smith TL. Patient-centered decision making in the treatment of chronic rhinosinusitis. Laryngoscope. 2013;123:2341-2346. 6. Pawankar R, Nonaka M. Inflammatory mechanisms and remodeling in chronic rhinosinusitis and nasal polyps. Curr Allergy Asthma Rep. 2007;7:202-208. 7. Lin SY, Suarez-Cuervo C, Segal J. Efficacy of sublingual immunotherapy-reply. JAMA. 2013;310:644-645. 8. Benninger MS, Holy CE. The impact of endoscopic sinus surgery on health care use in patients with respiratory comorbidities. Otolaryngol Head Neck Surg. 2014;151:508-515. 9. Spector S. The linkage between rhinitis, sinusitis and ashtma. Clin Applied Immunol Rev. 2001;1:229-234. 10. Nair S, Bhadauria RS, Sharma S. Effect of endoscopic sinus surgery on asthmatic patients with chronic rhinosinusitis. Indian J Otolaryngol Head Neck Surg. 2010;62:285-288. 11. Mace J, Michael YL, Carlson NE, Litvack JR, Smith TL. Effects of depression on quality of life improvement after endoscopic sinus surgery. Laryngoscope. 2008;118:528-534. 12. Litvack JR, Mace J, Smith TL. Role of depression in outcomes of endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2011;144:446-451. 13. Chandra RK, Epstein VA, Fishman AJ. Prevalence of depression and antidepressant use in an otolaryngology patient population. Otolaryngol Head Neck Surg. 2009;141:136-138. 14. Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014;124:2007-2012. 15. Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013;34:328-334. 16. DeConde AS, Mace JC, Bodner T, et al. SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis [published online October 16, 2014]. Int Forum Allergy Rhinol. 17. Hopkins C, Andrews P, Holy CE. Does time to endoscopic sinus surgery impact outcomes in chronic rhinosinusitis? Retrospective analysis using the UK Clinical Practice Research Database. Rhinology. In press.
