Abstract
Objective
We sought to evaluate preoperative and postoperative productivity losses and quality of life (QOL) impairment reported by patients with recurrent acute rhinosinusitis (RARS) as compared to patients with chronic rhinosinusitis without nasal polyposis (CRSsNP).
Study Design
Prospective, multi-institutional, nested case-control
Methods
Participants with RARS (n=20) and CRSsNP (n=20) undergoing endoscopic sinus surgery (ESS) were enrolled as part of a prospective cohort study. For comparison, participants diagnosed with RARS cases were age/gender matched to control participants diagnosed with CRSsNP using a 1:1 ratio.
Results
RARS and CRSsNP participants were followed for ~14 months postoperatively. Productivity losses were reported as the number of days missed from normal productive activities out of the previous 90 days. RARS participants reported similar baseline productivity losses (12.6[27.1]) as participants with CRSsNP (11.7[20.9]; p=0.314). Postoperatively, improvement in productivity losses was similar between RARS participants and CRSsNP controls (−6.7[20.0] vs −9.8[19.1]; p=0.253). Preoperative and postoperative disease specific QOL measures (SinoNasal Outcomes Test-22 & Rhinosinusitis Disability Index) were similar between the two groups. RARS participants reported a significant decrease in days of previous antibiotic (p=0.009) and nasal decongestant (p=0.004) use following ESS while participants with CRSsNP reported a significant decrease in antibiotic (p=0.002) and oral corticosteroid use (p=0.002).
Conclusion
RARS patients report baseline productivity losses and disease-specific QOL impairment to levels that parallel those with CRSsNP. Patients with RARS report improvement in QOL following ESS in all disease-specific QOL measures and in several medication measures. Productivity losses and postoperative improvements are similar between patients with RARS and CRSsNP.
MeSH Key Words: Sinusitis, outcome assessment, patient outcome assessment, case-control studies, medical therapy management
INTRODUCTION
Recurrent acute rhinosinusitis (RARS) is a distinct clinical entity affecting 1:3000 adults per year in the United States.1 In contrast to chronic rhinosinusitis (CRS), patients with RARS experience resolution of sinus specific symptoms between episodes of acute bacterial rhinosinusitis. Despite symptom relief between disease exacerbations it is now recognized that patients with RARS report diminished quality of life (QOL) to levels that often parallel their CRS counterparts.2
Current guidelines have established a threshold of 4 episodes of acute bacterial rhinosinusitis per year as a diagnostic indication of RARS.3,4 These diagnostic criteria are used by many clinicians to determine when a patient may become a candidate for endoscopic sinus surgery (ESS). Health economic modeling investigations, however, have offered alternate criteria by reporting a cost-benefit threshold for ESS at 5 infections per year.5 Given the relative paucity of treatment outcomes data following ESS for patients with RARS,2,6,7 more information is needed to truly discern the benefit of ESS in these patients. While direct costs (eg. medication use, health care utilization) of RARS have been measured,1,8 indirect costs associated with productive activities such as days missed from work/school/volunteering are less well described. Accurate societal cost estimates must incorporate both direct and indirect costs associated with these treatments.9,10
The primary objective of this study was to assess the impact of RARS on patient reported productivity. RARS cases were matched with CRS controls to frame the results in the context of the known impact that CRS has on productivity. We hypothesized that RARS patients electing ESS would report significant improvement in daily productivity measures. A secondary goal was to evaluate preoperative and postoperative QOL and medication use to provide a broader context of the overall impact of RARS.
MATERIALS and METHODS
Patient Population and Inclusion Criteria
Patients were recruited and prospectively enrolled into a continuing, multi-site, observational, cohort study of adult patients with RARS and CRS. Preliminary findings from this investigation have been previously published.11–13 The Institutional Review Board (IRB) at each enrollment location governed all investigational protocols and adult informed consent procedures. Enrollment sites consisted of sinus and skull base surgery centers within academic, tertiary hospital systems including Oregon Health & Science University (OHSU; Portland, OR, eIRB#7198), Stanford University (Palo Alto, CA, IRB#4947), the Medical University of South Carolina (Charleston, SC, IRB #12409), and the University of Calgary (Calgary, Alberta, Canada, IRB#E-24208), with central coordination conducted at OHSU. All study patients were reminded that study consent was voluntary and the standard of care surrounding ESS was unchanged due to study participation.
All study participants elected adjunctive ESS as the subsequent treatment option for alleviation of symptoms after failure of previous medical management including, but not limited to, at least one course (≥14 days) of broad spectrum or culture-directed antibiotic therapy (CRSsNP cohort) and at least one course of either topical corticosteroids (≥21 days) or a 5 day course of oral corticosteroid therapy. For comparison, case participants diagnosed with RARS were age (within 2 years) and gender matched to control participants diagnosed with CRS without nasal polyposis (CRSsNP) using a 1:1 ratio for the nested case-control design. Case subjects were selected from CRSsNP subjects (n=337) enrolled within the same prospective cohort. Both case and control participants were prospectively diagnosed with RARS and CRSsNP, respectively, as defined by criteria outlined by the 2007 and 2015 Adult Sinusitis guidelines published by the American Academy of Otolaryngology.3,4
During the initial preoperative enrollment appointment, study participants were asked to provide detailed demographic information, as well as social and medical history cofactors including, but not limited to: age, gender, race, asthma, nasal polyposis, depression, allergy, aspirin sensitivity, current tobacco and alcohol use, ciliary dyskinesia, corticosteroid dependency, immunodeficiency, autoimmunity, and diabetes mellitus. Participants were followed up to 18 months after ESS and completed survey evaluations postoperatively at 6 month intervals, either during physician-directed clinical appointments or via follow-up mailings.
Clinical Measures of Disease Severity
Computed Tomography (CT)
High resolution CT imaging was utilized to evaluate preoperative sinonasal disease severity using images in both sagittal and coronal planes. Images were also staged by the enrolling physician in accordance with the Lund-Mackay bilateral scoring system (score range: 0–24) which quantifies the severity of image opacification in the maxillary, ethmoidal, sphenoidal, ostiomeatal complex, and frontal sinus regions.14
Nasal Endoscopy
Paranasal sinuses were evaluated at baseline and following ESS using rigid fiberoptic endoscopes (SCB Xenon 175, Karl Storz, Tuttlingen, Germany). Endoscopic exams were staged by the enrolling physician at each site using the bilateral Lund-Kennedy scoring system (score range: 0–20) which quantifies visualized pathologic states within the paranasal sinuses including the severity of polyposis, discharge, edema, scarring, and crusting.15 Higher scores on both staging systems indicate worse disease severity.
Olfactory Function
Preoperative and postoperative olfactory function was evaluated using the Brief Smell Identification Test (BSIT). The BSIT is a validated 12-item, non-invasive test of olfactory function that uses microencapsulated odorant strips which are activated with a standard #2 pencil in a ‘scratch ‘n sniff’ format.16 Participants are instructed to identify each odorant using a method of forced choice (score range: 0–12). Scoring of all BSIT evaluations was completed by a study coordinator at each site. Higher total scores represent better olfactory status whereas both male and females can be categorized as having “normal” (score ≥9) or “abnormal” (score <9) olfactory function.
Endoscopic Sinus Surgery
Surgical extent was directed by the discretion of each enrolling physician and reflected sinus disease progression on an individual patient basis. ESS consisted of either unilateral or bilateral maxillary antrostomy, partial or total ethmoidectomy, sphenoidotomy, frontal sinusotomy (Draf I, IIa, IIb, or III), partial or complete middle turbinate resections, with septoplasty and/or inferior turbinate reductions. Image guidance was used when deemed appropriate. All surgical cases were followed with postoperative therapeutic regimens including daily nasal saline rinses and subsequent medical therapy as necessary.
Disease-specific Quality of Life
Study participants completed two patient-based, QOL surveys during both preoperative evaluation and at all subsequent follow-up time points, as part of a larger total battery of evaluative instruments.
Sinonasal Outcome Test (SNOT-22)
The SNOT-22 is a validated survey developed to evaluate symptom severity in CRS (©2006, Washington University, St. Louis, MO).17,18 Individual item scores are measured using patient selected responses on a Likert scale where higher scores indicate worse symptom severity as follows: 0= “No problem”; 1=”Very mild problem”; 2=”Mild or slight problem”; 3=”Moderate problem”; 4=”Severe problem”; 5=”Problem as bad as it can be”. Previous exploratory factor analysis of SNOT-22 scores, using this cohort, identified 5 distinct subdomains.19 Subdomains include rhinologic symptoms (score range: 0–30), extra-nasal rhinologic symptoms (score range: 0–15), ear and/or facial symptoms (score range: 0–25), psychological dysfunction (score range: 0–35), and sleep dysfunction (score range: 0–25). Higher subdomain and SNOT-22 scores (score range: 0–110) represent worse QOL and symptom severity.
Rhinosinusitis Disability Index (RSDI)
The RSDI is a 30-item survey instrument comprised of 3 subdomains to assess the impacts of rhinosinusitis on a participants physical (score range: 0–44), functional (score range: 0–36), and emotional (score range: 0–40) status.20 Higher subdomain and total RSDI scores (score range: 0–120) represent worse QOL and greater impact of rhinosinusitis symptoms on patients’ daily function.
Measures of Medication Utilization and Lost Productivity
Preoperative and postoperative outcome evaluations also included questions of past days of medication use (days out of the previous 90) including: antibiotics, systemic corticosteroids, topical corticosteroid drops, topical corticosteroid sprays, antihistamines, decongestants, leukotriene modifiers, and saline irrigations. Lost productivity was operationalized in both cases and controls as participants were asked to recall the number of days (out of the previous 90 days) that were missed or impacted due to sinus related symptoms (eg. missed work days, school days, or volunteer time).
Exclusion Criteria
Patients with immunodeficiency, ciliary dysfunction, and autoimmune disease were excluded due to potential heterogeneity of disease processes and variations in subsequent treatment. Patients with steroid dependent diseases were excluded due to potential confounding of reported postoperative medication use following endoscopic sinus surgery. Patients were excluded if less than 6 months had lapsed since ESS procedures and any participants failing to provide study related QOL evaluations within the preceding 18 months were considered lost to follow-up and were also excluded from the final analyses.
Data Management and Statistical Analyses
Study data was stripped of all protected health information and coded using a unique study identification number to ensure confidentiality before being transferred to OHSU. All study data was manually entered into a relational database (Microsoft Access, Microsoft Corp., Redmond, WA) and statistical analyses were conducted using commercially available software (SPSS v.22, IBM Corp., Armonk, NY). Preoperative cofactors, clinical measures of disease severity, measures of surgical extent, QOL scores, and days of medication use and lost productivity were evaluated descriptively while data normality was verified for all continuous measures. Last available RSDI and SNOT-22 item scores were used to operationalize each postoperative evaluation due to previously reported stability of postoperative scores between 6, 12, and 18 month follow-up.12,21 The Mann Whitney U and chi-square testing was utilized to compare all independent continuous measures and prevalence measures between cases and controls when appropriate. Wilcoxon signed rank testing was used to evaluate matched pairings over time. All statistical comparisons assumed a 0.050 error probability.
RESULTS
Study Cohort and Sinus Surgery Characteristics
A total of 20 participants, meeting all inclusion and exclusion criteria, undergoing ESS for RARS were enrolled between July, 2011 and June, 2014. Patients were subsequently matched to 20 participants undergoing ESS for CRSsNP between May, 2011 and March, 2014. Participants with RARS were followed for an average of 14.0 SD [6.1] months compared to an average of 14.4[5.3] months for control subjects with CRSsNP (p=0.779). Both RARS cases and CRSsNP controls had a mean age of 35.3[9.1] years and were comprised of 6 males (30%) and 14 females (70%). Further comparisons of participant characteristics, comorbid conditions, and clinical measures of disease severity are described in Table 1 while the prevalence of unilateral and bilateral surgical procedures is described in Table 2.
Table 1.
Characteristics, comorbid conditions, and clinical measures of disease severity of matched RARS case and CRSsNP control subjects (n=40)
| RARS (N=20) | CRSsNP (n=20) | ||||
|---|---|---|---|---|---|
| Characteristics: | Mean [SD] | N (%) | Mean [SD] | N (%) | p-value |
| Caucasian/white | 19 (95%) | 16 (80%) | 0.151 | ||
| Asian | 1 (5%) | 1 (5%) | >0.999 | ||
| Hispanic / Latino | 0 (0%) | 1 (5%) | >0.999 | ||
| Asthma | 4 (20%) | 2 (10%) | 0.661 | ||
| Allergy (mRAST/skin prick) | 11 (55%) | 7 (35%) | 0.204 | ||
| Nasal polyposis | 0 (0%) | 0 (0%) | >0.999 | ||
| Aspirin sensitivity | 0(0%) | 1 (5%) | >0.999 | ||
| Septal deviation | 17 (85%) | 8 (40%) | 0.008 | ||
| Turbinate hypertrophy | 12 (60%) | 3 (15%) | 0.008 | ||
| Depression | 3 (15%) | 5 (25%) | 0.695 | ||
| Tobacco use | 0 (0%) | 2 (10%) | 0.487 | ||
| Alcohol use | 14 (70%) | 8 (40%) | 0.057 | ||
| Diabetes mellitus (Type I/II) | 1 (5%) | 0 (0%) | >0.999 | ||
| Clinical measures of disease severity: | |||||
| Lund-Mackay CT scores | 4.8 [4.2] | 8.5 [5.7] | 0.030 | ||
| Lund-Kennedy endoscopy scores | 2.5 [1.7] | 4.3 [3.5] | 0.108 | ||
| BSIT olfactory scores | 10.2 [1.5] | 9.6 [1.7] | 0.421 | ||
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; mRAST, modified radioallergosorbent testing; CT, computed tomography; BSIT, Brief Smell Identification Test.
Table 2.
The prevalence of unilateral and bilateral surgical procedures
| RARS (n=20) | CRSsNP (n=20) | ||||
|---|---|---|---|---|---|
| Surgical procedures: | Left side N (%) |
Right side N (%) |
Left side N (%) |
Right side N (%) |
p-value |
| Previous (revision) sinus surgery | 0 (0%) | 11 (55%) | <0.001 | ||
| Maxillary antrostomy | 20 (100%) | 19 (95%) | 16 (80%) | 16 (80%) | 0.029 |
| Partial ethmoidectomy | 16 (80%) | 15 (75%) | 5 (25%) | 4 (20%) | <0.001 |
| Total ethmoidectomy | 3 (15%) | 3 (15%) | 12 (60%) | 11 (55%) | <0.001 |
| Sphenoidotomy | 2 (10%) | 1 (5%) | 12 (60%) | 11 (55%) | <0.001 |
| Middle turbinate resection | 0 (0%) | 1 (5%) | 3 (15%) | 4 (20%) | 0.057 |
| Inferior turbinate reduction | 12 (60%) | 12 (60%) | 4 (20%) | 4 (20%) | <0.001 |
| Septoplasty | 18 (90%) | 8 (40%) | 0.002 | ||
| Frontal sinusotomy Draf I | 1 (5%) | 0 (0%) | 1 (5%) | 1 (5%) | >0.999 |
| Frontal sinusotomy Draf IIa | 0 (0%) | 0 (0%) | 7 (35%) | 8 (40%) | <0.001 |
| Frontal sinusotomy Draf IIb | 0 (0%) | 0 (0%) | 2 (10%) | 1 (5%) | 0.241 |
| Frontal sinusotomy Draf III* | 0 (0%) | 0 (0%) | >0.999 | ||
| Image guidance | 1 (5%) | 9 (45%) | 0.008 | ||
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; Wherein right and left side frequencies are reported separately, p-values reflect differences between summarized total sides for RARS and CRSsNP.
indicates bilateral surgical procedure by definition.
Subjects with RARS were found to have a significantly higher prevalence of septal deviation and turbinate hypertrophy while control participants with CRSsNP had significantly worse CT scores. No other differences in patient characteristics or average clinical measures of disease severity were found between RARS and CRSsNP groups. Subjects with RARS were found to have significantly less previous sinus surgeries, less overall total ethmoidectomies, sphenoidotomies, frontal sinusotomies, and image guidance use (Table 2) compared to subjects with CRSsNP. Conversely, subjects with RARS were found to undergo greater frequencies of maxillary anstrostomy, partial ethmoidectomy, inferior turbinate reduction, and septoplasty procedures as part of their surgical treatment.
Preoperative QOL Outcome Measures
Differences between preoperative mean SNOT-22 and RSDI total and domain scores were compared between RARS and CRSsNP group (Table 3). No significant differences were reported between matched participants with RARS and CRSsNP for any preoperative QOL outcome measure (p≥0.086).
Table 3.
Comparisons between preoperative mean SNOT-22 and RSDI scores between RARS case and CRSsNP control subjects (n=40)
| RARS (n=20) | CRSsNP (n=20) | ||||
|---|---|---|---|---|---|
| Outcome measures: | Mean [SD] | Range | Mean [SD] | Range | p-value |
| SNOT-22 total scores | 49.1 [19.0] | [17 – 89] | 52.4 [17.8] | [21 – 79] | 0.583 |
| Rhinologic symptoms | 14.3 [5.1] | [5 – 25] | 14.6 [5.7] | [6 –27] | >0.999 |
| Extra-nasal rhinologic symptoms | 7.9 [3.4] | [2 – 14] | 7.6 [2.7] | [0 – 12] | 0.820 |
| Ear and/or facial symptoms | 9.6 [4.7] | [2 –19] | 9.6 [5.2] | [0 – 21] | 0.968 |
| Psychological dysfunction | 14.4 [7.7] | [1 – 31] | 17.3 [8.3] | [0 –27] | 0.114 |
| Sleep dysfunction | 13.4 [6.8] | [3 –25] | 13.4 [7.5] | [0 –25] | >0.999 |
| RSDI total score | 41.1 [22.7] | [4 – 104] | 49.4 [19.0] | [10 – 81] | 0.127 |
| Physical subdomain | 17.6 [9.2] | [0 – 39] | 19.6 [6.0] | [6 – 27] | 0.327 |
| Functional subdomain | 14.1 [7.8] | [1 – 35] | 16.5 [7.4] | [4 – 30] | 0.301 |
| Emotional subdomain | 9.4 [7.3] | [0 – 30] | 13.4 [8.5] | [0 – 26] | 0.086 |
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; SNOT-22, 22-Item SinoNasal Outcome Test; RSDI, Rhinosinusitis Disability Index; SD, standard deviation.
Preoperative Medication Use and Lost Productivity
Differences between preoperative mean days of medication usage and lost productivity days were compared between RARS and CRSsNP group (Table 4). Case participants with RARS were only found to report significantly more average days of antihistamine use compared to CRSsNP controls. Days of lost productivity were comparable between subjects with RARS and CRSsNP.
Table 4.
Comparisons between preoperative days of medication use and lost productivity between RARS case and CRSsNP control subjects (n=40)
| RARS (n=20) | CRSsNP (n=20) | ||||
|---|---|---|---|---|---|
| Medication days (out of previous 90): | Mean [SD] | Range | Mean [SD] | Range | p-value |
| Antibiotics | 15.3 [17.4] | [0 – 56] | 19.3 [16.6] | [0 – 60] | 0.314 |
| Systemic corticosteroids | 5.1 [9.0] | [0 – 30] | 9.0 [10.5] | [0 – 40] | 0.086 |
| Topical corticosteroid drops | 4.5 [20.1] | [0 – 90] | 19.3 [36.3] | [0 – 90] | 0.301 |
| Topical corticosteroid sprays | 45.9 [38.5] | [0 – 90] | 32.3 [40.0] | [0 – 90] | 0.331 |
| Antihistamines | 38.2 [42.2] | [0 – 90] | 11.9 [27.9] | [0 – 90] | 0.040 |
| Decongestants | 33.9 [35.1] | [0 – 90] | 16.9 [29.1] | [0 – 90] | 0.072 |
| Leukotriene modifiers | 5.5 [20.4] | [0 – 90] | 3.0 [10.4] | [0 – 45] | 0.989 |
| Saline irrigations | 50.1 [38.8] | [0 – 90] | 44.2 [36.5] | [0 – 90] | 0.640 |
| Lost productivity days (out of previous 90) | 12.6 [27.1] | [0 – 90] | 11.7 [20.9] | [0 – 80] | 0.314 |
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; SD, standard deviation.
Postoperative Medication Use and Lost Productivity
Differences between postoperative mean days of medication usage and lost productivity days were compared between subjects with RARS and CRSsNP (Table 5). Subjects with RARS were found to report significantly higher mean days on oral steroids than patients with CRSsNP. No differences were found for the remaining classes of medication use or lost productivity days.
Table 5.
Comparison of mean improvements in medication use and lost productivity days between RARS cases and CRSsNP controls
| RARS | CRSsNP | ||
|---|---|---|---|
| Mean [SD] | Mean [SD] | p-value | |
| Antibiotics | −11.7 [17.0] | −15.2 [17.4] | 0.445 |
| Systemic corticosteroids | −2.9 [7.9] | −8.4 [10.1] | 0.020 |
| Topical corticosteroid drops | 4.5 [35.5] | 2.1 [49.4] | 0.678 |
| Topical corticosteroid sprays | −5.4 [35.2] | −7.7 [25.0] | 0.659 |
| Antihistamines | −5.8 [26.5] | 6.7 [27.4] | 0.231 |
| Decongestants | −21.1 [29.8] | −6.5 [21.4] | 0.114 |
| Leukotriene modifiers | 9.2 [40.7] | 3.8 [14.4] | 0.779 |
| Saline irrigations | −6.6 [43.8] | −13.3 [41.3] | 0.758 |
| Lost productivity days | −6.7 [20.0] | −9.8 [19.1] | 0.253 |
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; SD, standard deviation.
Following ESS, patients with RARS were found to have a significant decrease in reported days of previous antibiotic and decongestant use. While there was average improvement in lost productivity days, this improvement did not reach statistical significance (p=0.064). In the CRSsNP cohort, significant reductions in average days of antibiotic use (p=0.001), systemic corticosteroid use (p=0.001), and lost productivity days (p=0.002) were reported (Table 6).
Table 6.
Improvement in the mean days of medication use and lost productivity (out of previous 90) for both independent RARS case (n=20) and CRSsNP control (n=20) groups.
| Preoperative | Postoperative | ||
|---|---|---|---|
| RARS: | Mean [SD] | Mean [SD] | p-value |
| Antibiotics | 15.3 [17.4] | 3.6 [9.0] | 0.009 |
| Systemic corticosteroids | 5.1 [9.0] | 2.1 [6.9] | 0.113 |
| Topical corticosteroid drops | 4.5 [20.1] | 9.0 [27.7] | 0.564 |
| Topical corticosteroid sprays | 45.9 [38.5] | 40.5 [42.4] | 0.574 |
| Antihistamines | 38.2 [42.2] | 32.4 [40.5] | 0.326 |
| Decongestants | 33.9 [35.1] | 12.8 [27.3] | 0.004 |
| Leukotriene modifiers | 5.5 [20.4] | 14.7 [32.8] | 0.281 |
| Saline irrigations | 50.1 [38.8] | 43.9 [41.1] | 0.414 |
| Lost productivity days | 12.6 [27.1] | 5.9 [20.0] | 0.064 |
| CRSsNP: | |||
| Antibiotics | 19.3 [16.6] | 4.1 [11.3] | 0.001 |
| Systemic corticosteroids | 9.0 [10.5] | 0.6 [1.8] | 0.001 |
| Topical corticosteroid drops | 19.3 [36.3] | 21.3 [37.4] | 0.953 |
| Topical corticosteroid sprays | 32.3 [40.0] | 21.4 [35.9] | 0.137 |
| Antihistamines | 11.9 [27.9] | 18.5 [35.7] | 0.416 |
| Decongestants | 16.9 [29.1] | 10.4 [27.4] | 0.182 |
| Leukotriene modifiers | 3.0 [10.4] | 6.8 [22.0] | 0.276 |
| Saline irrigations | 44.2 [36.5] | 30.9 [33.8] | 0.152 |
| Lost productivity days | 11.7 [20.9] | 1.9 [4.8] | 0.002 |
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; SD, standard deviation.
Postoperative QOL Outcome Measures
Differences between preoperative mean SNOT-22 and RSDI total and domain scores over time were compared between subjects with RARS and CRSsNP (Table 7). Participants with RARS were found to have significant improvements across all mean QOL measures including SNOT-22 and RSDI scores. Similarly, patients with CRSsNP were found to exhibit significant improvement in all mean QOL measures. Neither group was found to exhibit improvement in Lund-Kennedy endoscopy scores (RARS, p=0.248; CRSsNP, p=0.119) nor BSIT olfaction scores (RARS, p=0.831; CRSsNP, p=0.811). When comparing patients with RARS to matched CRSsNP controls, both groups improved significantly over time and to approximately the same average magnitude in all QOL measures, endoscopy scores, and BSIT scores (all p≥0.301).
Table 7.
Comparison of mean preoperative and postoperative QOL and clinical measure of disease severity scores over time for both independent RARS case (n=20) and CRSsNP control (n=20) groups.
| Outcome Measures: | Preoperative | Postoperative | |
|---|---|---|---|
| RARS: | Mean [SD] | Mean [SD] | p-value |
| SNOT-22 total scores | 49.1 [19.0] | 23.9 [16.6] | 0.001 |
| Rhinologic symptoms | 14.3 [5.1] | 7.1 [5.6] | 0.002 |
| Extra-nasal rhinologic symptoms | 7.9 [3.4] | 4.1 [3.8] | 0.003 |
| Ear and/or facial symptoms | 9.6 [4.7] | 4.9 [3.6] | 0.003 |
| Psychological dysfunction | 14.4 [7.7] | 6.5 [6.1] | 0.002 |
| Sleep dysfunction | 13.4 [6.8] | 6.8 [5.3] | 0.004 |
| RSDI total score | 41.1 [22.7] | 17.9 [18.1] | 0.001 |
| Physical subdomain | 17.6 [9.2] | 8.1 [8.0] | 0.001 |
| Functional subdomain | 14.1 [7.8] | 5.8 [6.9] | 0.001 |
| Emotional subdomain | 9.4 [7.3] | 4.0 [5.5] | 0.008 |
| Lund-Kennedy endoscopy scores | 2.5 [1.7] | 2.3 [2.2] | 0.248 |
| BSIT olfactory scores | 10.2 [1.5] | 10.2 [2.5] | 0.831 |
| CRSsNP: | |||
| SNOT-22 total scores | 52.4 [17.8] | 24.7 [20.2] | <0.001 |
| Rhinologic symptoms | 14.6 [5.7] | 7.6 [6.2] | 0.001 |
| Extra-nasal rhinologic symptoms | 7.6 [2.7] | 3.2 [3.1] | <0.001 |
| Ear and/or facial symptoms | 9.6 [5.2] | 5.4 [4.8] | 0.004 |
| Psychological dysfunction | 17.3 [8.3] | 7.4 [7.6] | <0.001 |
| Sleep dysfunction | 13.4 [7.5] | 6.1 [6.1] | 0.001 |
| RSDI total score | 49.4 [19.0] | 21.1 [21.2] | <0.001 |
| Physical subdomain | 19.6 [6.0] | 9.2 [8.9] | <0.001 |
| Functional subdomain | 16.5 [7.4] | 7.2 [8.7] | 0.001 |
| Emotional subdomain | 13.4 [8.5] | 4.8 [7.0] | 0.001 |
| Lund-Kennedy endoscopy scores | 4.3 [3.5] | 3.5 [3.2] | 0.119 |
| BSIT olfactory scores | 9.6 [1.7] | 9.9 [1.3] | 0.811 |
RARS, recurrent acute rhinosinusitis; CRSsNP, chronic rhinosinusitis without nasal polyposis; SNOT-22, 22-Item SinoNasal Outcome Test; RSDI, Rhinosinusitis Disability Index; SD, standard deviation; BSIT, Brief Smell Identification Test.
DISCUSSION
Recurrent acute rhinosinusitis represents an important subset of patients with rhinosinusitis, yet this disease entity remains relatively understudied and poorly understood. The overall burden of disease in RARS has been primarily measured by CRS disease-specific QOL outcomes, though recent studies have incorporated measures of health care utilization, medication use, and productivity into this paradigm.5,22 Productivity is a measure of indirect cost and commonly reported as days missed from work or reduced work performance due to a health condition.9 This study was designed to specifically evaluate these measures of disease burden at baseline and to quantify the improvement following ESS.
Productivity was compared between RARS patients and CRSsNP controls due to the known substantial detrimental effects CRS has on patient productivity levels. Recent investigation performed by Rudmik et al. characterized productivity losses in patients with CRS and found an average annual absenteeism of 24.6 work days missed per year, resulting in an annual productivity cost of $10,077.07 per patient.9 Endoscopic sinus surgery may help negate some of these costs for CRS patients, as several studies have reported significant improvements in time missed from productive activities following surgical intervention.23,24 However, there is limited data examining productivity in patients with RARS. Battacharya was the first to report significant improvement in missed workdays following ESS in a cohort of 19 patients who failed maintenance medical management.7 In the current study, patients with RARS were found to have comparable measures of preoperative productivity loss as patients with CRSsNP indicating no greater level of productivity loss burden in patients with RARS attributable to their disease process. Similarly, productivity gains following ESS were not statistically different between patients with RARS and CRSsNP controls (p=0.253). While improvement in mean lost days of productivity did not reach statistical significance following ESS (p=0.064), there was greater than 50% reduction in mean time missed from productive activities for RARS patients.
Patients enrolled in the current study were matched by age and gender to examine for any potential differences in productivity and QOL between the two groups while controlling for those two patient factors. Given the chronicity of CRS as compared to the intermittent nature of RARS, we suspected that average reported productivity losses would be greater in the CRS cohort. Both baseline and postoperative QOL and productivity measures were similar between cases and controls, suggesting a greater daily impact of the RARS disease process on productivity than initially thought.
Using both the RSDI and SNOT-22 survey instruments, the current study found significant improvement in QOL in patients with RARS following ESS. These data both support and augment the literature regarding postoperative QOL outcomes in patients with RARS. Poetker et al. evaluated postoperative QOL using the RSDI in 14 patients with RARS and found significant postoperative improvement in the RSDI total scores and within the physical and functional subdomains with an average of 8 months of follow-up.2 In their study, no improvement was found in the emotional subdomain. With a larger sample size and a longer follow-up period, the current study identified postoperative improvement in the total RSDI score as well as in all subdomains. Bhattacharyya et al. noted a statistically significant improvement in the rhinosinusitis symptom inventory (RSI) with a minimum of 12 months of follow-up data.7 Our data complement these findings with a similar length of postoperative follow-up using a different set of well-validated and widely used QOL indices which measure additional aspects of the patients’ experience.
Patients with RARS are commonly prescribed antibiotics for episodes of acute sinusitis, resulting in increased healthcare costs. The reduction in postoperative antibiotic use found in the current study suggests that over time there may be an economic benefit via reduced health care utilization8. It is important to note, however, that the use of oral antibiotics for patients with RARS has recently been called into question. Kaper et al.’s 2013 systematic review of RARS literature found no evidence available to support the effectiveness of short-course antibiotic therapy for recurrent acute episodes of sinusitis25. Future study will be needed to further delineate the role of antibiotic therapy in RARS patients.
To accurately assess the economic burden of chronic illness, both direct (eg. medication use/health care use/surgical costs) and indirect costs (eg. productivity, lost wages, travel costs) should be accounted for. Previous economic analysis has integrated variations of these measures, albeit with limited data as few published studies have incorporated these measures. The results presented in the current study encompass both of these domains and may help to support future economic analysis.
Several limitations must be considered when interpreting the results of this study. Literature surrounding treatment outcomes for RARS is frequently limited by sample size, and the current study is no exception. This is a reflection of the challenges associated with studying RARS patients, as they do not necessarily require tertiary rhinology care or strict long-term follow-up. Future study should include prospective analysis of a larger cohort to verify findings from the current study. In this study, productivity and medication use were measured by patient recall over the past 90 days. Given that RARS is an episodic disease process, there are inherent limitations in the form of recall bias, as patients may have been asymptomatic during the period in which follow-up evaluations took place and been unable to accurately recall missed days of work, exact medication use, or normal productivity. We feel this risk is minimized as current recall recommendations support 3 month evaluations.10,26,27 Despite these factors, this study is strengthened by its prospective, case-controlled, multi-institutional nature and provides a measure of insight into productivity losses associated with refractory RARS.
CONCLUSION
Baseline productivity and QOL are diminished in patients with RARS to severity levels that parallel their CRSsNP counterparts. Patients with RARS report improvement in QOL following ESS in all disease-specific QOL measures and in several medication measures. Productivity losses and postoperative gains are similar between patients with RARS and CRSsNP.
Acknowledgments
Timothy L. Smith, Jess C. Mace, and Jeremiah A. Alt are supported by a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD), one of the National Institutes of Health, Bethesda, MD (R01 DC005805; PI/PD: TL Smith) which supported this investigation. Public clinical trial registration (www.clinicaltrials.gov) ID# NCT01332136. This funding organization did not contribute to the design or conduct of this study; collection, management, analysis, or interpretation of the data; preparation, review, approval or decision to submit this manuscript for publication. Timothy L. Smith and is a consultant for IntersectENT, Inc (Menlo Park, CA) which is not affiliated with this investigation.
Footnotes
Conflicts of Interest: None to report
Financial Disclosures: There are no financial disclosures for Toby O. Steele, E. Bradley Strong, or Kara Y. Detwiller.
REFERENCES
- 1.Bhattacharyya N, Grebner J, Martinson NG. Recurrent acute rhinosinusitis: epidemiology and health care cost burden. Otolaryngol Head Neck Surg. 2012;146(2):307–312. doi: 10.1177/0194599811426089. [DOI] [PubMed] [Google Scholar]
- 2.Poetker DM, Litvack JR, Mace JC, Smith TL. Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008;22(3):329–333. doi: 10.2500/ajr.2008.22.3177. [DOI] [PubMed] [Google Scholar]
- 3.Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2) Suppl:S1–S39. doi: 10.1177/0194599815572097. [DOI] [PubMed] [Google Scholar]
- 4.Rosenfeld RM, Andes D, Bhattacharyya N, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007;137(3) Suppl:S1–S31. doi: 10.1016/j.otohns.2007.06.726. [DOI] [PubMed] [Google Scholar]
- 5.Leung R, Almassian S, Kern R, Conley D, Tan B, Chandra R. Patient level decision making in recurrent acute rhinosinusitis: a cost-benefit threshold for surgery. Laryngoscope. 2013;123(1):11–16. doi: 10.1002/lary.23504. [DOI] [PubMed] [Google Scholar]
- 6.Costa ML, Psaltis AJ, Nayak JV, Hwang PH. Medical therapy vs surgery for recurrent acute rhinosinusitis. Int Forum Allergy Rhinol. 2015 doi: 10.1002/alr.21533. [DOI] [PubMed] [Google Scholar]
- 7.Bhattacharyya N. Surgical treatment of chronic recurrent rhinosinusitis: a preliminary report. Laryngoscope. 2006;116(10):1805–1808. doi: 10.1097/01.mlg.0000231786.10969.3f. [DOI] [PubMed] [Google Scholar]
- 8.Bhandarkar ND, Mace JC, Smith TL. Endoscopic sinus surgery reduces antibiotic utilization in rhinosinusitis. Int Forum Allergy Rhinol. 2011;1(1):18–22. doi: 10.1002/alr.20005. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014;124(9):2007–2012. doi: 10.1002/lary.24630. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Zhang W, Bansback N, Anis AH. Measuring and valuing productivity loss due to poor health: A critical review. Soc Sci Med. 2011;72(2):185–192. doi: 10.1016/j.socscimed.2010.10.026. [DOI] [PubMed] [Google Scholar]
- 11.Steele TO, Mace JC, Smith TL. Does comorbid anxiety predict quality of life outcomes in patients with chronic rhinosinusitis following endoscopic sinus surgery? Int Forum Allergy Rhinol. 2015 doi: 10.1002/alr.21543. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.DeConde AS, Mace JC, Alt JA, Rudmik L, Soler ZM, Smith TL. Longitudinal improvement and stability of the SNOT-22 survey in the evaluation of surgical management for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2015;5(3):233–239. doi: 10.1002/alr.21458. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Alt JA, Smith TL, Schlosser RJ, Mace JC, Soler ZM. Sleep and quality of life improvements after endoscopic sinus surgery in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014;4(9):693–701. doi: 10.1002/alr.21364. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993;31(4):183–184. [PubMed] [Google Scholar]
- 15.Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. 1997;117(3 Pt 2):S35–S40. doi: 10.1016/S0194-59989770005-6. [DOI] [PubMed] [Google Scholar]
- 16.Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT) Laryngoscope. 1996;106(3 Pt 1):353–356. doi: 10.1097/00005537-199603000-00021. [DOI] [PubMed] [Google Scholar]
- 17.Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447–454. doi: 10.1111/j.1749-4486.2009.01995.x. [DOI] [PubMed] [Google Scholar]
- 18.Piccirillo JF, Merritt MG, Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20) Otolaryngol Head Neck Surg. 2002;126(1):41–47. doi: 10.1067/mhn.2002.121022. [DOI] [PubMed] [Google Scholar]
- 19.DeConde AS, Bodner TE, Mace JC, Smith TL. Response shift in quality of life after endoscopic sinus surgery for chronic rhinosinusitis. JAMA Otolaryngol Head Neck Surg. 2014;140(8):712–719. doi: 10.1001/jamaoto.2014.1045. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997;123(11):1175–1179. doi: 10.1001/archotol.1997.01900110025004. [DOI] [PubMed] [Google Scholar]
- 21.Soler ZM, Smith TL. Quality-of-life outcomes after endoscopic sinus surgery: how long is long enough? Otolaryngol Head Neck Surg. 2010;143(5):621–625. doi: 10.1016/j.otohns.2010.07.014. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Leung R, Kern RC, Conley DB, Tan BK, Chandra RK. Establishing a threshold for surgery in recurrent acute rhinosinusitis: a productivity-based analysis. Otolaryngol Head Neck Surg. 2012;146(5):829–833. doi: 10.1177/0194599811434709. [DOI] [PubMed] [Google Scholar]
- 23.Smith TL, Kern RC, Palmer JN, et al. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study. Int Forum Allergy Rhinol. 2011;1(4):235–241. doi: 10.1002/alr.20063. [DOI] [PubMed] [Google Scholar]
- 24.Stankiewicz J, Tami T, Truitt T, et al. Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2011;1(1):38–45. doi: 10.1002/alr.20008. [DOI] [PubMed] [Google Scholar]
- 25.Kaper NM, Breukel L, Venekamp RP, Grolman W, van der Heijden GJ. Absence of evidence for enhanced benefit of antibiotic therapy on recurrent acute rhinosinusitis episodes: a systematic review of the evidence base. Otolaryngol Head Neck Surg. 2013;149(5):664–667. doi: 10.1177/0194599813505841. [DOI] [PubMed] [Google Scholar]
- 26.Revicki DA, Irwin D, Reblando J, Simon GE. The accuracy of self-reported disability days. Med Care. 1994;32(4):401–404. doi: 10.1097/00005650-199404000-00008. [DOI] [PubMed] [Google Scholar]
- 27.Severens JL, Mulder J, Laheij RJ, Verbeek AL. Precision and accuracy in measuring absence from work as a basis for calculating productivity costs in The Netherlands. Soc Sci Med. 2000;51(2):243–249. doi: 10.1016/s0277-9536(99)00452-9. [DOI] [PubMed] [Google Scholar]