Otolaryngology http://oto.sagepub.com/ -- Head and Neck Surgery
Endoscopic Sinus Surgery Provides Effective Relief as Observed by Health Care Use Pre- and Postoperatively Michael S. Benninger and Chantal E. Holy Otolaryngology -- Head and Neck Surgery published online 10 February 2014 DOI: 10.1177/0194599814522419 The online version of this article can be found at: http://oto.sagepub.com/content/early/2014/02/10/0194599814522419
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Original Research
Endoscopic Sinus Surgery Provides Effective Relief as Observed by Health Care Use Pre- and Postoperatively
Otolaryngology– Head and Neck Surgery 1–8 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814522419 http://otojournal.org
Michael S. Benninger, MD1, and Chantal E. Holy, PhD2
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Abstract Objective. To analyze the impact of endoscopic sinus surgery (ESS) on overall health care utilization for the treatment of chronic rhinosinusitis (CRS).
Keywords endoscopic sinus surgery, chronic rhinosinusitis, administrative database, observational research, long-term follow-up study Received November 5, 2013; revised December 30, 2013; accepted January 14, 2014.
Study Design. Retrospective administrative database analysis. Setting. All US-based primary and secondary sites of care. Subjects and Methods. A cohort of patients with ESS (Current Procedural Terminology codes 31254-31288) in 2008 and at least 5 years of continuous medical and drug plan enrollment were included (n = 9105). Inpatient and outpatient medical history (including prescriptions) was analyzed from weeks –104 to 1104 postoperatively. Results. Health care utilization was constant up to –6 months preoperatively, at a per-patient per-week (PPPW) average of $11.75 (prescriptions, $2.44 [95% confidence interval (CI), $2.32-$2.56]; inpatient care, $ 0.82 [95% CI, $ 0.43-$1.20]; outpatient care, $8.49 [95% CI, $7.90-$9.08]). At –26 weeks preoperatively, a continuous increase from baseline levels was observed up to week –3, reaching an average PPPW of $95.37 (prescriptions, $13.74 [95% CI, $12.51-$14.96]; inpatient care, $2.73 [95% CI, $1.76-$3.70]; and outpatient care, $78.90 [95% CI, 73.65-$84.14]). From week –3 to surgery, outpatient events and prescriptions increased significantly, suggesting a decision to operate and costs associated with preoperative management. Postoperatively, costs declined rapidly, reaching baseline levels by 13 weeks postoperatively. Adverse events were reported in 388 patients (2.94% cases of hemorrhage, 0.14% cases of cerebrospinal fluid leak, 0.58% cases of orbital complications), and 572 (6.28%) patients had revision surgery. Conclusion. Patients with CRS incur ongoing, baseline levels of health care utilization. Preoperatively, CRS-related health care needs are more than 8-fold greater than those at baseline. Following ESS, health care needs declined rapidly and reached baseline levels within 13 weeks postoperatively.
C
hronic rhinosinusitis (CRS) is a common condition and is defined as ‘‘a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks’ duration.’’1 Chronic rhinosinusitis has been shown to significantly affect patient quality of life2 and productivity3 and is one of the top 10 most costly health conditions to US employers.4 As a result, the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF) and the European Rhinologic Society have facilitated publication of guidelines to help accurately diagnose and treat CRS,5,6 and a number of new evidence-based recommendations for treatments are being proposed.7-9 These recommendations and guidelines highlight the complexity of the disease, in terms of diagnosis and treatment. To better understand the health care utilization history of these patients, use of procedures and drugs, and effectiveness of sinus surgery on those with CRS, we designed a study looking at all outpatient, inpatient, and prescription-related health care utilization related to sinus disease before, during, and after endoscopic sinus surgery (ESS) in a cohort with at least 5 years of continuous
1 2
The Cleveland Clinic, Cleveland, Ohio, USA Acclarent, Menlo Park, California, USA
This article was presented at the 2013 AAO-HNSF Annual Meeting & OTO EXPO; September 29–October 3, 2013; Vancouver, British Columbia, Canada. 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]
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medical history (at least 2 years before and 2 years after surgery). Seminal research has already been conducted to estimate cost and health care utilization of patients with CRS, as well as cost before and after ESS.10,11 Bhattacharyya et al11 identified a cohort of patient younger than 65 years with a 12-month disease-free period, followed by diagnoses of CRS and sinus surgery, between 2003 and 2008. Overall health care payments in 6-month increments were analyzed and reported. Authors concluded that, compared with the year immediately prior to surgery, cost of health care (to payers) declined in the 2 years following surgery. To expand on these findings, we evaluated all conditions and outcomes—as defined by diagnoses, prescriptions, and procedures for each patients—and direct payments (for a societal perspective of direct costs) for all CRS-associated health care service in an all-comer patient cohort. Our study was conducted using the MarketScan Commercial claims database. This database is made of an employer-sponsored insured population and, in recent years, has included on a yearly basis .40 million lives. This database is particularly well suited for this analysis as it is designed to track patients longitudinally across all sites of care over multiple years.12-14
Methods The study is a retrospective analysis of a large administrative database designed to collect and pay for medical and drug claims (aka claims-based analysis), with no identification of individual patients, and therefore was exempt from the need to obtain institutional review board approval.
Cohort In 2008, the total population in the MarketScan database was 34.5 million patients, with a total of 33,296 ESS surgeries (defined by Common Procedural Terminology [CPT] fourth edition code 31254, 31255, 31256, 31267, 31276, 31287, or 31288) on 31,599 unique patients. (Surgery is defined as the medical event that includes all sinonasal procedures performed within a 24-hour period.) Of those cases, 9105 patients with continuous enrollment from January 1, 2006, to December 31, 2010, and a diagnosis of CRS within 12 months prior to surgery (based on International Classification of Diseases, Ninth Revision [ICD-9] code 473, 473.0, 473.1, 473.2, 473.3, 473.8, or 473.9) were identified.
Outpatient Care All outpatient episodes with a primary or secondary diagnosis of acute or chronic sinusitis or polyposis (ICD-9: 461.XX, 471.XX, and 473.XX) or with CPT codes associated with sinus procedures (30110, 30115, 30130, 30140, 30200, 30210, 30801, 30802, and 31000-31299 inclusive) were identified. (Outpatient events included both evaluation/ management visits as well as procedures. See Supplemental Table S1 [available at otojournal.org] for details of all inclusion and exclusion of procedures and diagnoses for outpatient episodes.) Procedures were further categorized based on main service rendered (see Supplemental Table S2, available online, for definition of all procedural categories).
Index Procedure The index surgery was queried to include all sinonasal procedures within 24 hours of CPT codes 31254 to 31288. Modifier –50 (or concurrent use of right/left modifiers) was used to identify bilateral cases.
Inpatient Care Prior to 2007, diagnosis-related group (DRG) version 24 was used, whereas DRG version 25 was used thereafter. All inpatient episodes related to either diagnoses of sinusitis (as listed for Outpatient Care above) or DRGs of sinus or asthma procedures (with or without complications and comorbidities) were identified. (See Supplemental Table S3, available online only, for all inclusion and exclusion of inpatient episodes.)
Prescriptions All prescriptions belonging to a therapeutic class relevant to CRS treatment were identified. Of those, only prescriptions filled within 14 days of an outpatient or inpatient episode as identified above were included in the analysis to limit all health care use directly to CRS disease. Prescriptions were further grouped into categories (see Supplemental Table S4, available online only, for all categories).
Time Analyses The timing of all procedures, visits, and prescriptions, relative to that of the index surgery, was analyzed as follows. Specifically, time was measured in weeks, starting at week –104 (2 years prior to surgery) and up to week 1104. The day of the surgery was identified as time 0, the week ending the day before the index surgery was defined as week –1, and the week starting on the day after the procedure was identified as week 11.
Demographics and Comorbidities
Postoperative Adverse Events
Patients were analyzed for demographic and clinical characteristics defined by ICD-9 diagnoses within 2 years prior to surgery, including asthma (ICD-9 codes 493.XX and V17.5), nasal polyposis (ICD-9 codes 471.X), allergy (ICD9 codes 477.8 and 477.9), aspirin intolerance (ICD-9 codes 995.0, 995.2, 995.20, 995.27, 995.29, 995.3, V14.6, and V14.8), diabetes (ICD-9 codes 250.XX), and depression (ICD-9 codes 311 and 300.4).
Adverse events (AEs) related to the surgical procedure were identified from inpatient and outpatient visits based on CPT and ICD-9 codes, as shown in Supplemental Table S5 (available online), from days 0 to 100 postoperatively. For orbital complications, cases where diagnoses of orbital or vision impairments were observed prior to surgery as well as postoperatively were not assumed to be associated to the surgery.
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Table 1. Demographics.a Variable
All Patients
Male Patients
Female Patients
P Valueb
Total cohort Male sex Age, mean (SD), y Asthma Nasal polyposis Allergy Aspirin intolerance Depression Diabetes History of prior surgery (within 2 years)
9105 4300 43.70 2123 2686 4856 661 903 895 548
43.45 (14.4) 836 (19.4) 1501 (34.9) 2152 (50.0) 233 (5.4) 279 (6.5) 437 (10.2) 243 (5.6)
43.92 (13.3) 1287 (26.8) 1185 (24.7) 2704 (56.3) 428 (8.9) 624 (13.0) 458 (9.5) 305 (6.3)
\0.001 \0.001 \0.001 \0.001 \0.001 0.844 0.082
(100) (47.2) (18.8) (23.3) (29.5) (53.3) (7.3) (9.9) (9.8) (6.0)
a
Values are presented as number (%) unless otherwise indicated. P values refer to differences in prevalence between male and female patients.
b
Table 2. Sinuses Treated during Endoscopic Sinus Surgery.a Sinuses Treated During the Surgery Maxillary Ethmoid Frontal Sphenoid
No. (%) of Surgeries 8395 (92) 7477 (82) 3062 (34) 2600 (29)
a
Ethmoid procedures included Current Procedural Terminology (CPT) codes 31254 and 31255, maxillary procedures included CPT codes 31256 and 31267, frontal procedures were defined by CPT code 31276, and sphenoid procedures included CPT codes 31287 and 31288.
Revision Surgery New endoscopic sinus surgery cases undertaken postoperatively (starting days 30-730) were identified. (It was assumed that procedures within 30 days of index would constitute ‘‘touch-ups’’ and should not be categorized as actual revisions.)
Payment All payments shown in this study refer to gross payments to the service providers and include payments from payers and patients (copay, deductible).
Statistical Analyses All data were analyzed using SAS Enterprise Guide 4.3 (SAS Institute, Cary, North Carolina). All findings (frequency and payments of services) are expressed as averages with 95% confidence intervals (CIs), with a = 0.05, for all time points. Relative risk ratios were calculated where applicable and presented with 95% CIs.
Results Cohort In total, 9105 patients were included in this study (8329 adults and 776 pediatric subjects). Key demographic and comorbidities are shown in Table 1.
Index Surgery Most cases included maxillary (92%) and ethmoid (82%) surgeries. Only 18.4% of all surgeries treated only 1 type of sinus, and in 15.6% cases, all 4 types of sinuses were treated (Table 2 and Table 3). The payments for the index procedure followed a log-logistic distribution with a mean of $7743. Such a positively right-skewed distribution is typical for health care costs, as a minority of patients incur significantly greater cost than average.
Inpatient Care In total, 283 patients had an inpatient admission due to CRS or related respiratory conditions as described above, and an additional 39 patients had an admission on or after the surgery with a diagnosis or procedure associated with a complication of the ESS. Of the 283 patients, 55 had more than 1 visit, for a total of 412 visits. For AEs, patients only presented once, for a total of 39 visits. Payments for inpatient visits followed an exponential distribution with an arithmetic mean cost of $7286.54 (exponential mean, $7261.88). Key diagnoses and timing of inpatient visits are shown in Figure 1A, B.
Outpatient Care Exclusive of Adverse Events and Index Procedure Figure 2 provides a graphic representation of weekly payments and utilizations per patient.
Year –2 before surgery. From weeks –104 to –52, the average number of outpatient events per patient per week (PPPW) remained flat at an average of 0.046 procedures (95% CI, 0.045-0.048) at an average payment of $8.49 (95% CI, $7.90-$9.08) PPPW. This level of health care use was maintained up to approximately week –26 (6 months prior to surgery). From 6 months to 3 weeks preoperatively. At week –26 (6 months preoperativeky), the number of events and payments was at $8.84 (95% CI, $6.64-$11.05) and 0.064 procedures (95% CI, 0.0573-0.0756) PPPW. A gradual increase in
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Table 3. Combination of Sinuses Accessed during Endoscopic Sinus Surgery and the Frequency of the Different Combinations.a Procedures Performed During the Surgery Ethmoid and maxillary All 4 sinuses Maxillary only Ethmoid and maxillary and frontal Ethmoid and sphenoid and maxillary Ethmoid only Maxillary and frontal Frontal and ethmoid Sphenoid only Frontal only Frontal and sphenoid and ethmoid Sphenoid and ethmoid Sphenoid and maxillary Maxillary and frontal and sphenoid Frontal and sphenoid
No. (%) of All Surgeries (n = 9105) 3500 1424 1218 1199 832 284 113 110 91 81 67 61 57 52 16
No. (%) of Procedures Performed Bilaterally
(38.4) (15.6) (13.4) (13.2) (9.1) (3.1) (1.2) (1.2) (1.0) (0.9) (0.7) (0.7) (0.6) (0.6) (0.2)
1445 (41.3) 554 (38.9) 322 (26.4) 389 (32.4) 270 (32.5) 73 (25.7) 37 (32.7) 26 (23.6) 13 (14.3) 22 (27.2) 11 (16.4) 14 (23.0) 12 (21.1) 14 (26.9) 4 (25.0)
a
Ethmoid procedures included Current Procedural Terminology (CPT) codes 31254 and 31255, maxillary procedures included CPT codes 31256 and 31267, frontal procedures were defined by CPT code 31276, and sphenoid procedures included CPT codes 31287 and 31288.
Figure 2. Total outpatient cost (US$) and number of visits or procedures, by week, excluding cost of surgery (time 0). ESS, endoscopic sinus surgery.
PPPW reached $78.90 (95% CI, $73.65-$84.14) and 0.46 (95% CI, 0.43-0.49), respectively.
Figure 1. (A) Inpatient visits before, at the time of, and after ESS surgery (2-year period). Inpatient visits due to management of adverse events are shown in red. (B) diagnoses for inpatient visits. CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
From 3 weeks preoperatively to index surgery. A significant subsequent surge in services was observed from week –3 to week –1, at an average increase of $80.90 PPPW, reaching 0.78 procedures (95% CI, 0.75-0.81) and $240.71 (95% CI, $263.23-$218.20) PPPW the week prior to surgery. (Index procedure payments are described in the prior section.)
health care use was then observed, both in number of procedures and payment per patient. The rate of increased cost was fairly constant at an average $3.12 PPPW. At week –3 (1 month prior to surgery), the total cost and utilization
Postoperative period. From day 1 to 5 weeks postoperatively, health care use declined rapidly, at an average rate of decline of –$48.54 PPPW. A slower rate of decline was then observed (average rate of decline, $4.52) from weeks 6 to 13. By 13 weeks postoperatively, health care utilization
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Table 4. Key Procedures and Visits by Main Categories and Time Point. No. of Outpatient Events per Patient per 6-Month Period Procedure Allergen immunotherapy Chest radiology Computed tomography radiology Diagnostic endoscopy, including debridement General evaluation and management Microbiology and laboratory services
6 Months Prior to Surgery
First 6 Months After Surgery
7 to 12 Months After Surgery
0.06 0.06 0.83 0.55 2.31 1.03
0.05 0.01 0.06 1.85 1.01 0.58
0.03 0.01 0.06 0.32 0.65 0.33
Figure 3. Frequency of prescriptions per patient and time points. (A) All drugs and (B) each drug category separately.
reached a plateau and remained stable to the end of the study period (1103 weeks), ranging from $5.78 to $21.29 PPPW. Outpatient services by category were also analyzed before and after surgery. General evaluation and management, as well as laboratory services and allergen immunotherapy, declined postoperatively, whereas endoscopy with or without debridement increased. Imaging (mostly computed tomography [CT]) was significant preoperatively as 83% patients had a CT before surgery, whereas only 6% had postoperative CTs. Table 4 lists the key procedures by patient and by 6-month increments before and after surgery.
Drug Utilization Prescription counts and costs are shown graphically from weeks –52 to 152 in Figure 3A.
Year –2 to 6 months prior to surgery. From weeks –104 to –52, the average number of prescription remained relatively flat between 0.02 and 0.03 prescriptions PPPW and an average payment of $2.44 (95% CI, $2.32-$2.56) PPPW. From 6 months to 3 weeks preoperatively. At week –26, the number of prescriptions per patient was 0.05 (95% CI,
0.045-0.055) and the payment was $3.56 (95% CI, $2.80$4.32). A steady increase in prescription utilization was then observed at an average rate of increase from weeks 226 to –5 of $ 0.46 PPPW. At the 5-week preoperative time point, the weekly per-patient prescription utilization was $12 (95% CI, $11.14-$13.99) and 0.17 prescriptions (95% CI, 0.16-0.19). From weeks –5 to –3, the utilization remained flat.
From 3 weeks preoperatively to index surgery. As observed previously with outpatient procedures, from weeks –3 to index surgery, the rate of increase in prescription use increased significantly, at a rate of $2.78 PPPW, reaching $17.36 (95% CI, $16.10-$18.62) and 0.40 prescriptions (95% CI, 0.39-0.41) per patient the week prior to surgery. Postoperative period. Postoperatively, the decline in utilization was fairly linear for the first 13 weeks, declining at a rate of $1.49 PPPW and reaching $3.35 (95% CI, $2.76$3.95) and 0.049 prescriptions (95% CI, 0.044-0.054) per patient at week 13 postoperatively. From week 13 onwards, prescription utilization remained flat, ranging from $2.04 to $4.86 PPPW.
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Table 5. Proportion of All vs Revision Patients with Comorbidities.a Relative Risk Patients with Ratio of Revision in 2-Year Revision Follow-up Surgery (95% CI) Period, % Comorbidity All Patients, % Asthma Polyps Allergy Aspirin Depression Diabetes Prior surgery
23.3 29.5 53.3 7.3 9.9 9.8 6.0
31.8 39.2 60.1 9.1 11.0 12.4 16.4
1.53 (1.29-1.81) 1.54 (1.31-1.81) 1.32 (1.12-1.55) 1.28 (0.97-1.68) 1.12 (0.87-1.44) 1.30 (1.02-1.65) 3.07 (2.50-3.76)
Abbreviation: CI, confidence interval. a Relative risk ratios for revision surgery were calculated for all comorbidities.
Prescription utilization by prescription type. Antibiotics were the first category to show increased utilization around week –28. Increase in steroid use was mostly noticeable starting week –12. All drug categories showed a similar pattern of linear increase up to week –3 and then further, rapid escalation leading to surgery. Decline in drug utilization was particularly rapid for antibiotics and pain medication and slower for steroids (Figure 3B).
Adverse Events Adverse events were experienced by a total of 348 patients, with 39 requiring inpatient treatments (see Inpatient Care section above). Hemorrhage was found in 290 patients (22 with inpatient visits), 21 patients had a cerebrospinal fluid (CSF) leak (8 with inpatient visits), and 59 patients had orbital complications (6 with inpatient visits). Average outpatient payment of complications ranged from $1622.28 for treatments of hemorrhage to $4486 for treatment of CSF leak, whereas average inpatient costs ranged from $3908 (orbital complication) to $21,844 (CSF leak).
Revisions A total of 671 revisions were identified in 572 distinct patients, with 72 patients experiencing multiple revisions. The relative risk ratio for revision surgery was greatest for patients who had a history of prior sinus surgery (relative risk ratio, 3.07; 95% CI, 2.50-3.76), as shown in Table 5.
Discussion This study was designed to understand health care utilization before and after sinus surgery as well as patient presentation and outcomes following surgery, in an all-comer population with CRS. The linear increase of health care needs from 6 months to 3 weeks prior to surgery suggests that the disease may be progressive and more difficult to treat, with increasing utilization related to continuous attempts by treating physicians to manage the CRS exacerbation using medical management.
Around week –3, a decision to proceed with surgery may have led to significant escalation in health care use, reflective of patient preparation for surgery and including treatments such as preparatory imaging and provision of perioperative medications. There is a debate about the overall role of sinus surgery as to whether it plays much of a role in long-term utilization of health care resources or has a long-term impact on quality of life in comparison to medical management.15-17 Similar to other studies,15 our data suggest that the overall health care resource utilization earlier than 6 to 9 months prior to surgery and after a few months following surgery is similar. If utilization were measured at only these time frames, then there could be a logical argument that sinus surgery has no impact on health care resources. In contrast, if utilization were measured within a short time before surgery and compared with after, there would be a strong argument that sinus surgery has a substantive impact on health care utilization.18 Our data would in essence support both of these premises. There is a clear escalation of overall resource utilization beginning approximately 6 months before surgery, strongly suggesting worsening disease, to the point that surgery is needed to get the patient, and the resources used, back to their chronic baseline. (In our study, cost and frequency of care were not analyzed separately based on care provider [eg, primary vs otolaryngologist]; as such, a subanalysis could not be completed accurately with the current methodology.) The demographics of our cohort are representative of those from other CRS publications, where average age was shown to be in the 40- to 50-year age range.19,20 Rates of aspirin intolerance were within the range of previously published studies. The diagnostic codes used for aspirin intolerance—while appropriate to identify patients allergic to aspirin—were not specific to aspirin. However, as queries were conducted in the context of CRS, and based on the alignment of our rate of aspirin intolerance to that published by others, it is conceivable that most patients identified by our diagnostic codes indeed had aspirin intolerance. Rates of asthma, polyposis, and depression were slightly lower than those previously published.19,21 These differences may be due to (1) our analysis reports rates of diagnosed conditions, which may be different from that of conditions self-reported by the patient or checked for by a physician as part of a clinical trial, and (2) rates of some conditions (eg, polyposis) may be underreported. As for prior surgery, only 6% patients in our cohort had a surgery in the 2 years prior to the index surgery. This finding is within the range of expected repeat surgeries based on studies evaluating rates of reoperation following ESS.20,22 Recent guidelines have provided some insightful recommendations for medical management of patients with CRS, recommending maximal medical therapy for approximately 12 weeks prior to surgery.23 In our study, the ramp-up of both drugs and visits was observed starting at about 6 months before surgery, as would be expected based on current practices.
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Surprisingly, only approximately 90% of patients in our cohort had preoperative CT scans. Similarly low rates of imaging have been previously reported by Hopkins et al20 from the UK Sinus Surgery Audit. The rate of revision surgery was similar to that reported by others.24 In our study, we also identified patients at risk for repeat surgery. It is interesting that beyond the welldefined risk factors such as asthma or polyps, having prior surgery within 2 years of the index procedure constituted the greatest risk of having a new surgery. Key limitations of this study include possible underreporting of diagnoses or procedures. All data were collected from the database, and while the MarketScan database undergoes significant validation, some procedures or diagnoses may not be consistently reported and therefore would not be captured in the analysis.
Conclusions This study was designed to understand payments and effectiveness of ESS in an all-comer patient population, based on health care utilization. Overall, patients with CRS experience constant health care needs, mostly outpatient. Drug use, while at a low quarterly rate, is also maintained continuously in this challenging patient population. The surgical event was observed after a clear escalation of both inpatient and outpatient health care resource utilization, suggesting that worsening and more difficult to medically manage disease leads to a decision to proceed with surgery. Postoperatively, payments and utilization resumed within approximately 13 weeks to levels observed 26 weeks prior to surgery. Author Contributions Michael S. Benninger, overall study conception and design, thorough review of analytical results, co-drafting of manuscript and clinical interpretations, final approval of the submitted version; Chantal E. Holy, contribution to study design, data acquisition and analytics, co-drafting of manuscript, final approval of the submitted version.
Disclosures Competing interests: Chantal E. Holy is an employee of Acclarent. Sponsorships: None. Funding source: Acclarent/J&J paid for the license to access the MarketScan database.
Supplemental Material Additional supporting information may be found at http://oto.sagepub .com/content/by/supplemental-data
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22. Matthews BL, Smith LE, Jones R, Miller C, Brookschmidt JK. Endoscopic sinus surgery: outcome in 155 cases. Otolaryngol Head Neck Surg. 1991;104:244-246. 23. Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl. 2012;50(23):1-12. 24. Levine HL. Functional endoscopic sinus surgery: evaluation, surgery, and follow-up of 250 patients. Laryngoscope. 1990; 100:79-84.
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Endoscopic Sinus Surgery Provides Effective Relief as Observed by Health Care Use Pre- and Postoperatively Michael S. Benninger and Chantal E. Holy Otolaryngology -- Head and Neck Surgery published online 10 February 2014 DOI: 10.1177/0194599814522419 The online version of this article can be found at: http://oto.sagepub.com/content/early/2014/02/10/0194599814522419
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Original Research
Endoscopic Sinus Surgery Provides Effective Relief as Observed by Health Care Use Pre- and Postoperatively
Otolaryngology– Head and Neck Surgery 1–8 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814522419 http://otojournal.org
Michael S. Benninger, MD1, and Chantal E. Holy, PhD2
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Abstract Objective. To analyze the impact of endoscopic sinus surgery (ESS) on overall health care utilization for the treatment of chronic rhinosinusitis (CRS).
Keywords endoscopic sinus surgery, chronic rhinosinusitis, administrative database, observational research, long-term follow-up study Received November 5, 2013; revised December 30, 2013; accepted January 14, 2014.
Study Design. Retrospective administrative database analysis. Setting. All US-based primary and secondary sites of care. Subjects and Methods. A cohort of patients with ESS (Current Procedural Terminology codes 31254-31288) in 2008 and at least 5 years of continuous medical and drug plan enrollment were included (n = 9105). Inpatient and outpatient medical history (including prescriptions) was analyzed from weeks –104 to 1104 postoperatively. Results. Health care utilization was constant up to –6 months preoperatively, at a per-patient per-week (PPPW) average of $11.75 (prescriptions, $2.44 [95% confidence interval (CI), $2.32-$2.56]; inpatient care, $ 0.82 [95% CI, $ 0.43-$1.20]; outpatient care, $8.49 [95% CI, $7.90-$9.08]). At –26 weeks preoperatively, a continuous increase from baseline levels was observed up to week –3, reaching an average PPPW of $95.37 (prescriptions, $13.74 [95% CI, $12.51-$14.96]; inpatient care, $2.73 [95% CI, $1.76-$3.70]; and outpatient care, $78.90 [95% CI, 73.65-$84.14]). From week –3 to surgery, outpatient events and prescriptions increased significantly, suggesting a decision to operate and costs associated with preoperative management. Postoperatively, costs declined rapidly, reaching baseline levels by 13 weeks postoperatively. Adverse events were reported in 388 patients (2.94% cases of hemorrhage, 0.14% cases of cerebrospinal fluid leak, 0.58% cases of orbital complications), and 572 (6.28%) patients had revision surgery. Conclusion. Patients with CRS incur ongoing, baseline levels of health care utilization. Preoperatively, CRS-related health care needs are more than 8-fold greater than those at baseline. Following ESS, health care needs declined rapidly and reached baseline levels within 13 weeks postoperatively.
C
hronic rhinosinusitis (CRS) is a common condition and is defined as ‘‘a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks’ duration.’’1 Chronic rhinosinusitis has been shown to significantly affect patient quality of life2 and productivity3 and is one of the top 10 most costly health conditions to US employers.4 As a result, the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF) and the European Rhinologic Society have facilitated publication of guidelines to help accurately diagnose and treat CRS,5,6 and a number of new evidence-based recommendations for treatments are being proposed.7-9 These recommendations and guidelines highlight the complexity of the disease, in terms of diagnosis and treatment. To better understand the health care utilization history of these patients, use of procedures and drugs, and effectiveness of sinus surgery on those with CRS, we designed a study looking at all outpatient, inpatient, and prescription-related health care utilization related to sinus disease before, during, and after endoscopic sinus surgery (ESS) in a cohort with at least 5 years of continuous
1 2
The Cleveland Clinic, Cleveland, Ohio, USA Acclarent, Menlo Park, California, USA
This article was presented at the 2013 AAO-HNSF Annual Meeting & OTO EXPO; September 29–October 3, 2013; Vancouver, British Columbia, Canada. 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]
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medical history (at least 2 years before and 2 years after surgery). Seminal research has already been conducted to estimate cost and health care utilization of patients with CRS, as well as cost before and after ESS.10,11 Bhattacharyya et al11 identified a cohort of patient younger than 65 years with a 12-month disease-free period, followed by diagnoses of CRS and sinus surgery, between 2003 and 2008. Overall health care payments in 6-month increments were analyzed and reported. Authors concluded that, compared with the year immediately prior to surgery, cost of health care (to payers) declined in the 2 years following surgery. To expand on these findings, we evaluated all conditions and outcomes—as defined by diagnoses, prescriptions, and procedures for each patients—and direct payments (for a societal perspective of direct costs) for all CRS-associated health care service in an all-comer patient cohort. Our study was conducted using the MarketScan Commercial claims database. This database is made of an employer-sponsored insured population and, in recent years, has included on a yearly basis .40 million lives. This database is particularly well suited for this analysis as it is designed to track patients longitudinally across all sites of care over multiple years.12-14
Methods The study is a retrospective analysis of a large administrative database designed to collect and pay for medical and drug claims (aka claims-based analysis), with no identification of individual patients, and therefore was exempt from the need to obtain institutional review board approval.
Cohort In 2008, the total population in the MarketScan database was 34.5 million patients, with a total of 33,296 ESS surgeries (defined by Common Procedural Terminology [CPT] fourth edition code 31254, 31255, 31256, 31267, 31276, 31287, or 31288) on 31,599 unique patients. (Surgery is defined as the medical event that includes all sinonasal procedures performed within a 24-hour period.) Of those cases, 9105 patients with continuous enrollment from January 1, 2006, to December 31, 2010, and a diagnosis of CRS within 12 months prior to surgery (based on International Classification of Diseases, Ninth Revision [ICD-9] code 473, 473.0, 473.1, 473.2, 473.3, 473.8, or 473.9) were identified.
Outpatient Care All outpatient episodes with a primary or secondary diagnosis of acute or chronic sinusitis or polyposis (ICD-9: 461.XX, 471.XX, and 473.XX) or with CPT codes associated with sinus procedures (30110, 30115, 30130, 30140, 30200, 30210, 30801, 30802, and 31000-31299 inclusive) were identified. (Outpatient events included both evaluation/ management visits as well as procedures. See Supplemental Table S1 [available at otojournal.org] for details of all inclusion and exclusion of procedures and diagnoses for outpatient episodes.) Procedures were further categorized based on main service rendered (see Supplemental Table S2, available online, for definition of all procedural categories).
Index Procedure The index surgery was queried to include all sinonasal procedures within 24 hours of CPT codes 31254 to 31288. Modifier –50 (or concurrent use of right/left modifiers) was used to identify bilateral cases.
Inpatient Care Prior to 2007, diagnosis-related group (DRG) version 24 was used, whereas DRG version 25 was used thereafter. All inpatient episodes related to either diagnoses of sinusitis (as listed for Outpatient Care above) or DRGs of sinus or asthma procedures (with or without complications and comorbidities) were identified. (See Supplemental Table S3, available online only, for all inclusion and exclusion of inpatient episodes.)
Prescriptions All prescriptions belonging to a therapeutic class relevant to CRS treatment were identified. Of those, only prescriptions filled within 14 days of an outpatient or inpatient episode as identified above were included in the analysis to limit all health care use directly to CRS disease. Prescriptions were further grouped into categories (see Supplemental Table S4, available online only, for all categories).
Time Analyses The timing of all procedures, visits, and prescriptions, relative to that of the index surgery, was analyzed as follows. Specifically, time was measured in weeks, starting at week –104 (2 years prior to surgery) and up to week 1104. The day of the surgery was identified as time 0, the week ending the day before the index surgery was defined as week –1, and the week starting on the day after the procedure was identified as week 11.
Demographics and Comorbidities
Postoperative Adverse Events
Patients were analyzed for demographic and clinical characteristics defined by ICD-9 diagnoses within 2 years prior to surgery, including asthma (ICD-9 codes 493.XX and V17.5), nasal polyposis (ICD-9 codes 471.X), allergy (ICD9 codes 477.8 and 477.9), aspirin intolerance (ICD-9 codes 995.0, 995.2, 995.20, 995.27, 995.29, 995.3, V14.6, and V14.8), diabetes (ICD-9 codes 250.XX), and depression (ICD-9 codes 311 and 300.4).
Adverse events (AEs) related to the surgical procedure were identified from inpatient and outpatient visits based on CPT and ICD-9 codes, as shown in Supplemental Table S5 (available online), from days 0 to 100 postoperatively. For orbital complications, cases where diagnoses of orbital or vision impairments were observed prior to surgery as well as postoperatively were not assumed to be associated to the surgery.
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Table 1. Demographics.a Variable
All Patients
Male Patients
Female Patients
P Valueb
Total cohort Male sex Age, mean (SD), y Asthma Nasal polyposis Allergy Aspirin intolerance Depression Diabetes History of prior surgery (within 2 years)
9105 4300 43.70 2123 2686 4856 661 903 895 548
43.45 (14.4) 836 (19.4) 1501 (34.9) 2152 (50.0) 233 (5.4) 279 (6.5) 437 (10.2) 243 (5.6)
43.92 (13.3) 1287 (26.8) 1185 (24.7) 2704 (56.3) 428 (8.9) 624 (13.0) 458 (9.5) 305 (6.3)
\0.001 \0.001 \0.001 \0.001 \0.001 0.844 0.082
(100) (47.2) (18.8) (23.3) (29.5) (53.3) (7.3) (9.9) (9.8) (6.0)
a
Values are presented as number (%) unless otherwise indicated. P values refer to differences in prevalence between male and female patients.
b
Table 2. Sinuses Treated during Endoscopic Sinus Surgery.a Sinuses Treated During the Surgery Maxillary Ethmoid Frontal Sphenoid
No. (%) of Surgeries 8395 (92) 7477 (82) 3062 (34) 2600 (29)
a
Ethmoid procedures included Current Procedural Terminology (CPT) codes 31254 and 31255, maxillary procedures included CPT codes 31256 and 31267, frontal procedures were defined by CPT code 31276, and sphenoid procedures included CPT codes 31287 and 31288.
Revision Surgery New endoscopic sinus surgery cases undertaken postoperatively (starting days 30-730) were identified. (It was assumed that procedures within 30 days of index would constitute ‘‘touch-ups’’ and should not be categorized as actual revisions.)
Payment All payments shown in this study refer to gross payments to the service providers and include payments from payers and patients (copay, deductible).
Statistical Analyses All data were analyzed using SAS Enterprise Guide 4.3 (SAS Institute, Cary, North Carolina). All findings (frequency and payments of services) are expressed as averages with 95% confidence intervals (CIs), with a = 0.05, for all time points. Relative risk ratios were calculated where applicable and presented with 95% CIs.
Results Cohort In total, 9105 patients were included in this study (8329 adults and 776 pediatric subjects). Key demographic and comorbidities are shown in Table 1.
Index Surgery Most cases included maxillary (92%) and ethmoid (82%) surgeries. Only 18.4% of all surgeries treated only 1 type of sinus, and in 15.6% cases, all 4 types of sinuses were treated (Table 2 and Table 3). The payments for the index procedure followed a log-logistic distribution with a mean of $7743. Such a positively right-skewed distribution is typical for health care costs, as a minority of patients incur significantly greater cost than average.
Inpatient Care In total, 283 patients had an inpatient admission due to CRS or related respiratory conditions as described above, and an additional 39 patients had an admission on or after the surgery with a diagnosis or procedure associated with a complication of the ESS. Of the 283 patients, 55 had more than 1 visit, for a total of 412 visits. For AEs, patients only presented once, for a total of 39 visits. Payments for inpatient visits followed an exponential distribution with an arithmetic mean cost of $7286.54 (exponential mean, $7261.88). Key diagnoses and timing of inpatient visits are shown in Figure 1A, B.
Outpatient Care Exclusive of Adverse Events and Index Procedure Figure 2 provides a graphic representation of weekly payments and utilizations per patient.
Year –2 before surgery. From weeks –104 to –52, the average number of outpatient events per patient per week (PPPW) remained flat at an average of 0.046 procedures (95% CI, 0.045-0.048) at an average payment of $8.49 (95% CI, $7.90-$9.08) PPPW. This level of health care use was maintained up to approximately week –26 (6 months prior to surgery). From 6 months to 3 weeks preoperatively. At week –26 (6 months preoperativeky), the number of events and payments was at $8.84 (95% CI, $6.64-$11.05) and 0.064 procedures (95% CI, 0.0573-0.0756) PPPW. A gradual increase in
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Table 3. Combination of Sinuses Accessed during Endoscopic Sinus Surgery and the Frequency of the Different Combinations.a Procedures Performed During the Surgery Ethmoid and maxillary All 4 sinuses Maxillary only Ethmoid and maxillary and frontal Ethmoid and sphenoid and maxillary Ethmoid only Maxillary and frontal Frontal and ethmoid Sphenoid only Frontal only Frontal and sphenoid and ethmoid Sphenoid and ethmoid Sphenoid and maxillary Maxillary and frontal and sphenoid Frontal and sphenoid
No. (%) of All Surgeries (n = 9105) 3500 1424 1218 1199 832 284 113 110 91 81 67 61 57 52 16
No. (%) of Procedures Performed Bilaterally
(38.4) (15.6) (13.4) (13.2) (9.1) (3.1) (1.2) (1.2) (1.0) (0.9) (0.7) (0.7) (0.6) (0.6) (0.2)
1445 (41.3) 554 (38.9) 322 (26.4) 389 (32.4) 270 (32.5) 73 (25.7) 37 (32.7) 26 (23.6) 13 (14.3) 22 (27.2) 11 (16.4) 14 (23.0) 12 (21.1) 14 (26.9) 4 (25.0)
a
Ethmoid procedures included Current Procedural Terminology (CPT) codes 31254 and 31255, maxillary procedures included CPT codes 31256 and 31267, frontal procedures were defined by CPT code 31276, and sphenoid procedures included CPT codes 31287 and 31288.
Figure 2. Total outpatient cost (US$) and number of visits or procedures, by week, excluding cost of surgery (time 0). ESS, endoscopic sinus surgery.
PPPW reached $78.90 (95% CI, $73.65-$84.14) and 0.46 (95% CI, 0.43-0.49), respectively.
Figure 1. (A) Inpatient visits before, at the time of, and after ESS surgery (2-year period). Inpatient visits due to management of adverse events are shown in red. (B) diagnoses for inpatient visits. CRS, chronic rhinosinusitis; ESS, endoscopic sinus surgery.
From 3 weeks preoperatively to index surgery. A significant subsequent surge in services was observed from week –3 to week –1, at an average increase of $80.90 PPPW, reaching 0.78 procedures (95% CI, 0.75-0.81) and $240.71 (95% CI, $263.23-$218.20) PPPW the week prior to surgery. (Index procedure payments are described in the prior section.)
health care use was then observed, both in number of procedures and payment per patient. The rate of increased cost was fairly constant at an average $3.12 PPPW. At week –3 (1 month prior to surgery), the total cost and utilization
Postoperative period. From day 1 to 5 weeks postoperatively, health care use declined rapidly, at an average rate of decline of –$48.54 PPPW. A slower rate of decline was then observed (average rate of decline, $4.52) from weeks 6 to 13. By 13 weeks postoperatively, health care utilization
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Table 4. Key Procedures and Visits by Main Categories and Time Point. No. of Outpatient Events per Patient per 6-Month Period Procedure Allergen immunotherapy Chest radiology Computed tomography radiology Diagnostic endoscopy, including debridement General evaluation and management Microbiology and laboratory services
6 Months Prior to Surgery
First 6 Months After Surgery
7 to 12 Months After Surgery
0.06 0.06 0.83 0.55 2.31 1.03
0.05 0.01 0.06 1.85 1.01 0.58
0.03 0.01 0.06 0.32 0.65 0.33
Figure 3. Frequency of prescriptions per patient and time points. (A) All drugs and (B) each drug category separately.
reached a plateau and remained stable to the end of the study period (1103 weeks), ranging from $5.78 to $21.29 PPPW. Outpatient services by category were also analyzed before and after surgery. General evaluation and management, as well as laboratory services and allergen immunotherapy, declined postoperatively, whereas endoscopy with or without debridement increased. Imaging (mostly computed tomography [CT]) was significant preoperatively as 83% patients had a CT before surgery, whereas only 6% had postoperative CTs. Table 4 lists the key procedures by patient and by 6-month increments before and after surgery.
Drug Utilization Prescription counts and costs are shown graphically from weeks –52 to 152 in Figure 3A.
Year –2 to 6 months prior to surgery. From weeks –104 to –52, the average number of prescription remained relatively flat between 0.02 and 0.03 prescriptions PPPW and an average payment of $2.44 (95% CI, $2.32-$2.56) PPPW. From 6 months to 3 weeks preoperatively. At week –26, the number of prescriptions per patient was 0.05 (95% CI,
0.045-0.055) and the payment was $3.56 (95% CI, $2.80$4.32). A steady increase in prescription utilization was then observed at an average rate of increase from weeks 226 to –5 of $ 0.46 PPPW. At the 5-week preoperative time point, the weekly per-patient prescription utilization was $12 (95% CI, $11.14-$13.99) and 0.17 prescriptions (95% CI, 0.16-0.19). From weeks –5 to –3, the utilization remained flat.
From 3 weeks preoperatively to index surgery. As observed previously with outpatient procedures, from weeks –3 to index surgery, the rate of increase in prescription use increased significantly, at a rate of $2.78 PPPW, reaching $17.36 (95% CI, $16.10-$18.62) and 0.40 prescriptions (95% CI, 0.39-0.41) per patient the week prior to surgery. Postoperative period. Postoperatively, the decline in utilization was fairly linear for the first 13 weeks, declining at a rate of $1.49 PPPW and reaching $3.35 (95% CI, $2.76$3.95) and 0.049 prescriptions (95% CI, 0.044-0.054) per patient at week 13 postoperatively. From week 13 onwards, prescription utilization remained flat, ranging from $2.04 to $4.86 PPPW.
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Table 5. Proportion of All vs Revision Patients with Comorbidities.a Relative Risk Patients with Ratio of Revision in 2-Year Revision Follow-up Surgery (95% CI) Period, % Comorbidity All Patients, % Asthma Polyps Allergy Aspirin Depression Diabetes Prior surgery
23.3 29.5 53.3 7.3 9.9 9.8 6.0
31.8 39.2 60.1 9.1 11.0 12.4 16.4
1.53 (1.29-1.81) 1.54 (1.31-1.81) 1.32 (1.12-1.55) 1.28 (0.97-1.68) 1.12 (0.87-1.44) 1.30 (1.02-1.65) 3.07 (2.50-3.76)
Abbreviation: CI, confidence interval. a Relative risk ratios for revision surgery were calculated for all comorbidities.
Prescription utilization by prescription type. Antibiotics were the first category to show increased utilization around week –28. Increase in steroid use was mostly noticeable starting week –12. All drug categories showed a similar pattern of linear increase up to week –3 and then further, rapid escalation leading to surgery. Decline in drug utilization was particularly rapid for antibiotics and pain medication and slower for steroids (Figure 3B).
Adverse Events Adverse events were experienced by a total of 348 patients, with 39 requiring inpatient treatments (see Inpatient Care section above). Hemorrhage was found in 290 patients (22 with inpatient visits), 21 patients had a cerebrospinal fluid (CSF) leak (8 with inpatient visits), and 59 patients had orbital complications (6 with inpatient visits). Average outpatient payment of complications ranged from $1622.28 for treatments of hemorrhage to $4486 for treatment of CSF leak, whereas average inpatient costs ranged from $3908 (orbital complication) to $21,844 (CSF leak).
Revisions A total of 671 revisions were identified in 572 distinct patients, with 72 patients experiencing multiple revisions. The relative risk ratio for revision surgery was greatest for patients who had a history of prior sinus surgery (relative risk ratio, 3.07; 95% CI, 2.50-3.76), as shown in Table 5.
Discussion This study was designed to understand health care utilization before and after sinus surgery as well as patient presentation and outcomes following surgery, in an all-comer population with CRS. The linear increase of health care needs from 6 months to 3 weeks prior to surgery suggests that the disease may be progressive and more difficult to treat, with increasing utilization related to continuous attempts by treating physicians to manage the CRS exacerbation using medical management.
Around week –3, a decision to proceed with surgery may have led to significant escalation in health care use, reflective of patient preparation for surgery and including treatments such as preparatory imaging and provision of perioperative medications. There is a debate about the overall role of sinus surgery as to whether it plays much of a role in long-term utilization of health care resources or has a long-term impact on quality of life in comparison to medical management.15-17 Similar to other studies,15 our data suggest that the overall health care resource utilization earlier than 6 to 9 months prior to surgery and after a few months following surgery is similar. If utilization were measured at only these time frames, then there could be a logical argument that sinus surgery has no impact on health care resources. In contrast, if utilization were measured within a short time before surgery and compared with after, there would be a strong argument that sinus surgery has a substantive impact on health care utilization.18 Our data would in essence support both of these premises. There is a clear escalation of overall resource utilization beginning approximately 6 months before surgery, strongly suggesting worsening disease, to the point that surgery is needed to get the patient, and the resources used, back to their chronic baseline. (In our study, cost and frequency of care were not analyzed separately based on care provider [eg, primary vs otolaryngologist]; as such, a subanalysis could not be completed accurately with the current methodology.) The demographics of our cohort are representative of those from other CRS publications, where average age was shown to be in the 40- to 50-year age range.19,20 Rates of aspirin intolerance were within the range of previously published studies. The diagnostic codes used for aspirin intolerance—while appropriate to identify patients allergic to aspirin—were not specific to aspirin. However, as queries were conducted in the context of CRS, and based on the alignment of our rate of aspirin intolerance to that published by others, it is conceivable that most patients identified by our diagnostic codes indeed had aspirin intolerance. Rates of asthma, polyposis, and depression were slightly lower than those previously published.19,21 These differences may be due to (1) our analysis reports rates of diagnosed conditions, which may be different from that of conditions self-reported by the patient or checked for by a physician as part of a clinical trial, and (2) rates of some conditions (eg, polyposis) may be underreported. As for prior surgery, only 6% patients in our cohort had a surgery in the 2 years prior to the index surgery. This finding is within the range of expected repeat surgeries based on studies evaluating rates of reoperation following ESS.20,22 Recent guidelines have provided some insightful recommendations for medical management of patients with CRS, recommending maximal medical therapy for approximately 12 weeks prior to surgery.23 In our study, the ramp-up of both drugs and visits was observed starting at about 6 months before surgery, as would be expected based on current practices.
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Surprisingly, only approximately 90% of patients in our cohort had preoperative CT scans. Similarly low rates of imaging have been previously reported by Hopkins et al20 from the UK Sinus Surgery Audit. The rate of revision surgery was similar to that reported by others.24 In our study, we also identified patients at risk for repeat surgery. It is interesting that beyond the welldefined risk factors such as asthma or polyps, having prior surgery within 2 years of the index procedure constituted the greatest risk of having a new surgery. Key limitations of this study include possible underreporting of diagnoses or procedures. All data were collected from the database, and while the MarketScan database undergoes significant validation, some procedures or diagnoses may not be consistently reported and therefore would not be captured in the analysis.
Conclusions This study was designed to understand payments and effectiveness of ESS in an all-comer patient population, based on health care utilization. Overall, patients with CRS experience constant health care needs, mostly outpatient. Drug use, while at a low quarterly rate, is also maintained continuously in this challenging patient population. The surgical event was observed after a clear escalation of both inpatient and outpatient health care resource utilization, suggesting that worsening and more difficult to medically manage disease leads to a decision to proceed with surgery. Postoperatively, payments and utilization resumed within approximately 13 weeks to levels observed 26 weeks prior to surgery. Author Contributions Michael S. Benninger, overall study conception and design, thorough review of analytical results, co-drafting of manuscript and clinical interpretations, final approval of the submitted version; Chantal E. Holy, contribution to study design, data acquisition and analytics, co-drafting of manuscript, final approval of the submitted version.
Disclosures Competing interests: Chantal E. Holy is an employee of Acclarent. Sponsorships: None. Funding source: Acclarent/J&J paid for the license to access the MarketScan database.
Supplemental Material Additional supporting information may be found at http://oto.sagepub .com/content/by/supplemental-data
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