Cost-effectiveness analysis of molecular testing for cytologically indeterminate thyroid nodules.

BACKGROUND: Thyroid nodules affect up to 65% of the population. Although fine needle aspirate (FNA) cytology is the gold standard for diagnosis, 15-30% of results are indeterminate. Molecular testing may aid in the diagnosis of nodules and potentially reduce unnecessary surgery. However, these tests are associated with significant costs. The objective of this study was to evaluate the cost-effectiveness of Afirma, a commercially available molecular test, in cytologically indeterminate thyroid nodules. METHODS: The base case was a solitary thyroid nodule with no additional high-risk features and an indeterminate FNA. Decision tree analysis was performed from the single payer perspective with a 1-year time horizon. Costing data were collected through micro-costing methodology. A probabilistic sensitivity analysis was performed. The primary outcome was the incremental cost effectiveness ratio (ICER) of cost per thyroid surgery avoided. RESULTS: Over 1 year, mean cost estimates were $8176.28 with 0.58 effectiveness for the molecular testing strategy and $6016.83 with 0.07 effectiveness for current standard management. The ICER was $4234.22 per surgery avoided. At a willingness-to-pay (WTP) threshold of $5000 per surgery avoided, molecular testing is cost-effective with 63% certainty. CONCLUSION: This cost-effectiveness analysis suggests utilizing Afirma for indeterminate solitary thyroid nodules is a cost-effective strategy for avoiding unnecessary thyroid surgery. With a $5000 WTP threshold, molecular testing has a 63% chance of being the more cost-effective strategy. The cost effectiveness varies based on the cost of the molecular test and the value of Afirma for patients with indeterminate thyroid nodules depends on the WTP threshold to avoid unnecessary thyroid surgery.

Economic Evaluation of Dupilumab Versus Endoscopic Sinus Surgery for the Treatment of Chronic Rhinosinusitis With Nasal Polyps.

BACKGROUND: Dupilumab is a novel monoclonal antibody that recently received US Food and Drug Administration approval for the treatment of chronic rhinosinusitis with nasal polyps. Endoscopic sinus surgery (ESS) has been the mainstay of treatment for patients refractory to initial medical therapy. Data comparing the cost-effectiveness of these treatments are scarce. The objective of this study is to compare the cost-effectiveness of dupilumab and ESS treatment for patients with chronic rhinosinusitis with nasal polyps refractory to medical therapy. METHODS: A cohort-style Markov decision tree economic evaluation with 10-year time horizon was performed. The two comparative treatment strategies were dupilumab therapy or ESS followed by postoperative maintenance therapy. Patients with response to treatment continued with either maintenance or dupilumab therapy; patients with no response underwent ESS. The primary outcome measure was incremental cost per quality-adjusted life-year calculated from Sino-Nasal Outcome Test (SNOT-22) scores. Sensitivity analyses were performed including discounting scenarios and a probabilistic sensitivity analysis. RESULTS: The dupilumab strategy cost $195,164 and produced 1.779 quality-adjusted life-years. The ESS strategy cost $20,549 and produced 1.526 quality-adjusted life-years. This implies an incremental cost of $691,691 for dupilumab for every 1-unit increase in quality-adjusted life-year compared with ESS. Probability sensitivity analysis indicated that ESS was more cost-effective than dupilumab in all iterations. CONCLUSIONS: While dupilumab and ESS may demonstrate similar clinical effectiveness, ESS remains the most cost-effective treatment option and should remain the standard of care for patients with chronic rhinosinusitis with nasal polyps refractory to medical therapy.

Quality Indicators for the Diagnosis and Management of Acute Bacterial Rhinosinusitis.

BACKGROUND: Acute bacterial rhinosinusitis (ABRS) is a highly prevalent disease that is treated by a variety of specialties, including but not limited to, family physicians, emergency physicians, otolaryngology-head and neck surgeons, infectious disease specialists, and allergy and immunologists. Unfortunately, despite high-quality guidelines, variable and substandard care continues to be demonstrated in the treatment of ABRS. OBJECTIVE: This study aimed to develop ABRS-specific quality indicators (QIs) to evaluate the diagnosis and management that reduces symptoms, improves quality of life, and prevents complications. METHODS: A guideline-based approach, proposed by Kötter et al., was used to develop QIs for ABRS. Candidate indicators (CIs) were extracted from 4 guiding documents and evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Each CI and its supporting evidence was summarized and reviewed by an expert panel based on validity, reliability, and feasibility of measurement. Final QIs were selected from CIs utilizing the modified RAND/University of California at Los Angeles appropriateness methodology. RESULTS: Twenty-nine CIs were identified after literature review and evaluated by our panel. Of these, 5 CIs reached consensus as being appropriate QIs, with 1 requiring additional discussion. After a second round of evaluations, the panel selected 7 QIs as appropriate measures of high-quality care. CONCLUSION: This study proposes 7 QIs for the diagnosis and management of patients with ABRS. These QIs can serve multiple purposes, including documenting the quality of care; comparing institutions and providers; prioritizing quality improvement initiatives; supporting accountability, regulation, and accreditation; and determining pay for performance initiatives.

Socioeconomic status impacts postoperative productivity loss and health utility changes in refractory chronic rhinosinusitis.

BACKGROUND: Social determinants of health can have a substantial impact on treatment outcomes. Prior study has shown that socioeconomic status influences the likelihood of improvement in quality-of-life (QOL) following endoscopic sinus surgery (ESS). However, the impact of socioeconomic factors on changes in productivity loss and health utility after ESS remains unknown. METHODS: Adult patients (≥18 years of age) with chronic rhinosinusitis (CRS) who underwent ESS were prospectively enrolled into a multi-institutional cohort study. Productivity losses were calculated using the human capital approach and monetized using U.S. government-estimated wage rates. Health utility values (HUVs) were derived from the Medical Outcomes Study Short-Form-12 survey using University of Sheffield algorithms. Independent socioeconomic factors of interest included: age, gender, ethnicity, insurance status, educational attainment, and household income categorized via the Thompson-Hickey model. RESULTS: A total of 229 patients met inclusion criteria, and 163 (71%) provided postoperative follow-up. All subjects reported significant, within-subject improvement in both mean monetized productivity loss (p < 0.001) and HUV postoperatively (p < 0.001). Using paired sample statistics, patients with lowest income (≤$25,000/year) and with Medicare insurance did not report significant improvement in productivity loss (p ≥ 0.112) or HUV (p ≥ 0.081), although sample size limitations may have contributed to this finding. Patients in higher income tiers ($25,001 to $100,000/year and $100,001+/year) and those with employer-provided/private health insurance reported significant postoperative improvements in productivity loss and HUV (all p ≤ 0.003). CONCLUSION: Socioeconomic factors, including income and insurance provision, may impact improvements in productivity loss and HUV following ESS. Further research to validate these findings, ascertain mechanisms behind these results, and improve these outcomes is warranted.

Socioeconomic factors impact quality of life outcomes and olfactory measures in chronic rhinosinusitis.

BACKGROUND: Healthcare disparities related to socioeconomic factors may adversely impact disease states and treatment outcomes. Among patients with chronic rhinosinusitis (CRS), the impact of socioeconomic factors on outcomes following endoscopic sinus surgery (ESS) remains uncertain. METHODS: Adult patients with refractory CRS were prospectively enrolled into an observational, multi-institutional cohort study between March 2011 and June 2015. Socioeconomic factors analyzed included household income, insurance status, years of education completed, race, age, and ethnicity. Income was stratified according to the Thompson and Hickey model. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Brief Smell Identification Test (BSIT) were completed preoperatively and postoperatively. RESULTS: A total of 392 patients met inclusion criteria. Higher age and male gender were associated with better mean preoperative SNOT-22 scores (both p < 0.02), whereas Medicare insurance status and male gender were associated with worse preoperative mean BSIT scores (both p < 0.02). Postoperatively, higher household income ($100,001+/year) and lower age were associated with a greater likelihood of improving at least 1 minimal clinically important difference (MCID) on SNOT-22 scores (OR = 2.40 and 1.03, respectively, both p < 0.05), while no factors were associated with increased odds of achieving a MCID on BSIT scores. CONCLUSIONS: Preoperative olfactory function and postoperative quality of life (QOL) improvement were associated with metrics of socioeconomic status in patients with CRS electing ESS. The odds of experiencing a clinically meaningful QOL improvement were more than twice as likely for patients with the highest household income level compared to other income tiers. Further investigation is warranted to identify barriers to postoperative improvement.

Quality indicators for the diagnosis and management of chronic rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) has been identified as a high-priority disease category for quality improvement. To this end, this study aimed to develop CRS-specific quality indicators (QIs) to evaluate diagnosis and management that relieves patient discomfort, improves quality of life, and prevents complications. METHODS: A guideline-based approach, proposed in 2012 by Kötter et al. was used to develop QIs for CRS. Candidate indicators (CIs) were extracted from 3 practice guidelines and 1 international consensus statement on the diagnosis and management of CRS. Guidelines were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Each CI and its supporting evidence was summarized and reviewed by an expert panel based on validity, reliability, and feasibility of measurement. Final QIs were selected from CIs utilizing the modified RAND Corporation-University of California, Los Angeles (RAND/UCLA) appropriateness methodology. RESULTS: Thirty-nine CIs were identified after literature review and evaluated by our panel. Of these, 9 CIs reached consensus as being appropriate QIs, with 4 requiring additional discussion. After a second round of evaluations, the panel selected 9 QIs as appropriate measures of high-quality care. CONCLUSION: This study proposes 9 QIs for the diagnosis and management of patients with CRS. These QIs can serve multiple purposes, including documenting the quality of care; comparing institutions and providers; prioritizing quality improvement initiatives; supporting accountability, regulation, and accreditation; and determining pay-for-performance initiatives.

Airway management changes associated with rising radiologic incidence of external laryngotracheal injury.

BACKGROUND: Traumatic laryngeal injuries are uncommon life-threatening injuries that require prompt, rational management of a potentially precarious airway. It is unclear whether the current incidence of laryngotracheal injury is due to enhanced injury detection or increased occurrence. The objective of this study was to evaluate the relations between diagnostic imaging with both initial airway management and surgical treatment in patients with external laryngotracheal injuries (ELTIs) in Alberta. METHODS: In this large-scale population-based analysis, we used regional health databases containing inpatient admissions, emergency department visits and trauma service activations employing International Classification of Diseases diagnostic codes to identify all ELTIs diagnosed from Apr. 1, 1995, to Dec. 31, 2011, in adults (age ≥ 16 yr). We evaluated health records and diagnostic imaging for injury features, airway management, operative interventions and hospital length of stay (LOS). RESULTS: Eighty-nine patients met the inclusion criteria. The incidence of ELTIs increased over time, paralleling a rise in detection during the period incorporating greater computed tomography (CT) use (p = 0.002). Endotracheal tube intubation was performed in 8/30 cases (27%) in the pre-CT era, compared to 38/59 cases (64%) in the post-CT era (p = 0.001); the use of surgical intervention remained consistent. The largest contributors to increased endotracheal tube placements were the emergency department and emergency medical services. No change in survival was detected, but mean LOS among patients admitted for minor, isolated ELTIs increased by 2.3 (95% confidence interval 0.14-4.8) days (p = 0.06), mostly for patients admitted under critical care for mechanical ventilation. CONCLUSION: Management of ELTIs shifted from predominantly conservative airway monitoring to endotracheal tube intubation over the study period in spite of no clinically significant change in injury severity or operative intervention frequency. The location of endotracheal tube placement suggests less comfort with ELTI among first-responder and emergency personnel.

CONTEXTE: Les lésions traumatiques du larynx sont des blessures rares qui peuvent être mortelles et nécessitent une prise en charge rapide et efficiente, en raison de l'état potentiellement précaire des voies respiratoires. On ignore si l'incidence actuelle des lésions laryngo-trachéales est attribuable à une amélioration de la détection ou à une augmentation de la fréquence réelle. Cette étude avait pour but d'évaluer le lien entre l'imagerie diagnostique, et la prise en charge initiale des voies respiratoires ainsi que le traitement chirurgical chez des patients ayant subi des lésions laryngo-trachéales externes (LLTE) en Alberta. MÉTHODES: Dans le cadre de cette analyse de grande envergure basée sur une population, nous avons interrogé des bases de données régionales sur les hospitalisations, les consultations aux services d'urgence et la prestation de services de traumatologie. Nous nous sommes servis des codes diagnostiques de la Classification statistique internationale des maladies pour repérer tous les cas de LLTE diagnostiqués entre le 1er avril 1995 et le 31 décembre 2011 chez des adultes (16 ans et plus). Nous avons examiné les dossiers de santé et les résultats d'imagerie diagnostique pour en extraire des données sur les caractéristiques des lésions, la prise en charge des voies respiratoires, les interventions chirurgicales et la durée de séjour à l'hôpital. RÉSULTATS: Au total, 89 patients répondaient aux critères d'inclusion. L'incidence des LLTE a augmenté au fil du temps; en parallèle, l'utilisation répandue de la tomographie par ordinateur a entraîné une augmentation de la détection de ces lésions (p = 0,002). Une intubation trachéale a été réalisée chez 8/30 patients (27 %) pendant la période prétomographie, et chez 38/59 patients (64 %) pendant la période post-tomographie (p = 0,001); le recours à la chirurgie est demeuré constant. L'augmentation du nombre d'intubations est principalement attribuable aux interventions effectuées par le personnel ambulancier et par les services d'urgence. Aucun changement du taux de survie n'a été enregistré; toutefois, la durée de séjour moyenne des patients hospitalisés en raison de LLTE mineures et isolées a augmenté de 2,3 jours (intervalle de confiance à 95 % : 0,14-4,8; p = 0,06), surtout pour les patients admis aux soins intensifs pour recevoir une ventilation mécanique. CONCLUSION: Durant la période à l'étude, la prise en charge des LLTE est passée d'un suivi essentiellement conservateur des voies respiratoires à la prépondérance de l'intubation trachéale, bien qu'aucun changement significatif n'ait été observé quant à la gravité des lésions ou à la fréquence des interventions chirurgicales. Le contexte où ont lieu les intubations laisse croire que le personnel ambulanciers et les premiers intervenants sont moins à l'aise de prendre en charge les LLTE.

The cost of being clean: A cost analysis of nasopharyngoscope reprocessing techniques.

OBJECTIVE: Nasopharyngoscopes are an essential instrument to otolaryngologists; reprocessing them in a high-value manner is paramount. Although several different techniques for reprocessing exist, all methods yield similar effectiveness. Given equivalent effectiveness outcomes, a cost analysis of four nasopharyngoscope reprocessing techniques was performed. STUDY DESIGN: Cost-minimization analysis. METHODS: Four techniques were evaluated: 1) an automated reprocessor using peracetic acid (Steris System 1; Steris Canada Inc., Mississauga, Canada), 2) an automated reprocessor using ortho-phthalaldehyde (OPA) (Cidex OPA; Advanced Sterilization Products, Johnson and Johnson Inc., Markham, Canada), 3) a manually performed accelerated hydrogen peroxide bath (Revital-Ox; Steris Canada Inc.), and 4) a chlorine dioxide wipe (Tristel Trio Wipes System; Tristel plc, Cambridgeshire, U.K.). The costing perspective was a third-party payer that was adjusted to 2014 Canadian dollars. The base-case scenario used an annual volume of 4,153 reprocessing events in a tertiary care setting, and a scenario analysis assessed the impact of volume and capital expense. RESULTS: The cost per reprocessing event for the Steris (Steris Canada Inc.) automated endoscope reprocessing, Cidex OPA (Advanced Sterilization Products), Revital-Ox (Steris Canada Inc.), and Tristel Trio Wipes (Tristel plc) were $20.58, $14.20, $9.57, and $13.14, respectively. Scenario analysis demonstrated the Tristel Trio Wipes System (Tristel plc) was the least expensive method in practices with low reprocessing volumes (a threshold of less than 6 events per day, or 22 per week), whereas the Revital-Ox (Steris Canada Inc.) system was least expensive at higher volumes and became substantially more so as volumes increased. CONCLUSION: A manual accelerated hydrogen peroxide bath offers the least costly approach to nasopharyngoscope reprocessing. The convenience and portability of the Tristel Trio (Tristel plc) system may be a good alternative for low reprocessing volumes, or when rapid turnaround is necessary. LEVEL OF EVIDENCE: NA. Laryngoscope, 128:64-71, 2018.

What drives productivity loss in chronic rhinosinusitis? A SNOT-22 subdomain analysis.

OBJECTIVES/HYPOTHESIS: Previous studies have shown declines in productivity due to chronic rhinosinusitis (CRS) are correlated with disease-specific quality-of-life (QOL) measures. However, it is unclear which symptom domains contribute primarily to productivity loss. This investigation sought to assess the association between CRS-specific QOL subdomain impairment and productivity loss. STUDY DESIGN: Prospective, multi-institutional, observational cohort study. METHODS: There were 198 patients with refractory CRS enrolled between August 2012 and June 2015. Baseline QOL measures were obtained across five subdomains of the 22-item SinoNasal Outcome Test (SNOT-22). Lost productivity time was determined from patient-reported measures of annual absenteeism, presenteeism, and lost leisure time, and then monetized using annual daily wage rates from the 2012 US National Census and 2013 Department of Labor statistics. RESULTS: Productivity losses correlated with impairments in both SNOT-22 psychological dysfunction (Spearman correlation coefficient [Rs] = 0.428, P < .001), and sleep dysfunction domain scores (Rs = 0.355, P < .001). Higher SNOT-22 total scores also significantly correlated with increased monetized productivity losses (Rs = 0.366, P < .001). The mean annual productivity cost was $11,820/patient, whereas patients with comorbid immunodeficiency ($23,285/patient), tobacco use ($23,195/patient), and steroid dependency ($18,910/patient) reported higher than average annual productivity costs. Multivariate linear regression found maximum annual productivity costs in adjusted psychological ($13,300/patient, P < .001) and sleep dysfunction ($9,275/patient, P < .001) domains. CONCLUSIONS: Impairments in sleep and psychological SNOT-22 domains correlate with productivity losses. Patients with comorbid immunodeficiency, smoking, and steroid dependency had higher than average productivity losses. Targeted management of psychological and sleep dysfunction in combination with standard symptom control may improve patient-centered care and reduce the annual economic burden of CRS. LEVEL OF EVIDENCE: 2c. Laryngoscope, 128:23-30, 2018.

Economics of Chronic Rhinosinusitis.

PURPOSE OF REVIEW: The objective of this article is to provide an updated review of the economic burden of chronic rhinosinusitis (CRS) and discuss how both medical and surgical interventions impact direct and indirect costs related to CRS. By understanding the economics of CRS, clinicians may improve the patient-centeredness of their care and help distinguish between low and high value interventions. RECENT FINDINGS: Direct costs related to CRS are primarily driven by outpatient physician visits, prescription medical therapy, and endoscopic sinus surgery (ESS). CRS produces large indirect costs and these costs often vary based on the severity of the patients CRS-specific QoL impairment. The overall direct cost related to CRS is estimated to range between $10 and $13 billion per year in the USA. The overall indirect cost related to CRS-related losses in work productivity is estimated to be in excess of $20 billion per year. In the appropriate patients with refractory CRS, ESS provides significant reductions in both direct and indirect costs; however, continued medical therapy alone may be a high value intervention in select patients who have lower severity in their baseline QoL and work productivity.

Medical therapy, refractory chronic rhinosinusitis, and productivity costs.

PURPOSE OF REVIEW: The purpose of this review is to address the most recent advances in the medical therapy for chronic rhinosinusitis (CRS), define recalcitrant and refractory CRS, and discuss the productivity costs associated with CRS. RECENT FINDINGS: Recent studies evaluating anti-IL-4 receptor α antibodies and calcium channel blockers have demonstrated promising early results during management of CRS. Recent appropriateness criteria have been developed to assist clinicians with defining which patients have 'refractory' CRS and may be considered candidates for endoscopic sinus surgery. Productivity costs appear to be associated with disease severity and can be reduced with appropriate interventions. SUMMARY: Topical corticosteroid therapy and high volume saline irrigation continue to be the cornerstone to medical therapy, whereas use of systemic corticosteroids and antibiotics depends on CRS phenotype and presence of acute exacerbation. More research is needed before routine use of novel immunomodulatory therapies such as anti-IL5, anti-IgE, anti-IL4, and calcium channel blockers. Clinicians should apply an appropriate definition for refractory CRS when discussing role of sinus surgery. Assessing the degree of work productivity impairment can assist in treatment decision-making and may help predict treatment outcomes.

Association of olfactory dysfunction in chronic rhinosinusitis with economic productivity and medication usage.

BACKGROUND: Chronic rhinosinusitis (CRS) has significant impacts upon productivity, economic metrics, and medication usage; however, factors that are associated with these economic outcomes are unknown. METHODS: We evaluated olfactory dysfunction in 221 patients with CRS using the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) and the 40-item Smell Identification Test (SIT) and assessed whether an association existed between these olfactory metrics and healthcare utilization, productivity, and medication usage over the preceding 90 days. RESULTS: After adjusting for CRS-associated comorbidities, objective measures of disease, demographics, and CRS-specific quality of life (QOL), patients with lower QOD-NS scores (worse patient-reported olfaction) had more missed days of normal productivity and employment, worse productivity levels, more hours of missed employment due to physician visits, more time caring for sinuses, greater distance traveled to medical appointment, more days of oral steroid use, and higher odds of being on disability insurance. Clinical olfaction, as measured by SIT, was associated with greater distance traveled to medical appointment and higher odds of being on disability insurance, but did not correlate with other productivity measures. CONCLUSION: Impaired olfactory-specific QOL is associated with significantly worse economic and productivity metrics and increased medication usage even after adjusting for CRS-specific comorbidities, objective measures of disease, demographics, and severity of CRS-specific QOL. Future studies are warranted to determine if targeting the impaired olfactory-specific QOL noted in patients with CRS results in improved productivity and economic outcomes.

A Cost-effectiveness Analysis of Early vs Late Tracheostomy.

Importance: The timing of tracheostomy in critically ill patients requiring mechanical ventilation is controversial. An important consideration that is currently missing in the literature is an evaluation of the economic impact of an early tracheostomy strategy vs a late tracheostomy strategy. Objective: To evaluate the cost-effectiveness of the early tracheostomy strategy vs the late tracheostomy strategy. Evidence Acquisition: This economic analysis was performed using a decision tree model with a 90-day time horizon. The economic perspective was that of the US health care third-party payer. The primary outcome was the incremental cost per tracheostomy avoided. Probabilities were obtained from meta-analyses of randomized clinical trials. Costs were obtained from the published literature and the Healthcare Cost and Utilization Project database. A multivariate probabilistic sensitivity analysis was performed to account for uncertainty surrounding mean values used in the reference case. Results: The reference case demonstrated that the cost of the late tracheostomy strategy was $45 943.81 for 0.36 of effectiveness. The cost of the early tracheostomy strategy was $31 979.12 for 0.19 of effectiveness. The incremental cost-effectiveness ratio for the late tracheostomy strategy compared with the early tracheostomy strategy was $82 145.24 per tracheostomy avoided. With a willingness-to-pay threshold of $50 000, the early tracheostomy strategy is cost-effective with 56% certainty. Conclusions and Relevance: The adaptation of an early vs a late tracheostomy strategy depends on the priorities of the decision-maker. Up to a willingness-to-pay threshold of $80 000 per tracheostomy avoided, the early tracheostomy strategy has a higher probability of being the more cost-effective intervention.

Health utility values for patients with recurrent acute rhinosinusitis undergoing endoscopic sinus surgery: a nested case control study.

BACKGROUND: Health utility scores quantify an individual's valuation of particular health states and are vital components of health economic studies and cost-effectiveness research. We sought to characterize health utility values for patients with recurrent acute rhinosinusitis (RARS) both before and after endoscopic sinus surgery (ESS), as well as compare health utility to chronic rhinosinusitis without nasal polyposis (CRSsNP). METHODS: Patients with RARS (n = 20) and CRSsNP (n = 20) undergoing ESS were enrolled as part of a longitudinal, observational, prospective cohort. Case patients diagnosed with RARS were age- and gender-matched to controls with CRSsNP using a nested case-control design at a 1:1 ratio. Health utility was measured using the Medical Outcomes Study Short Form-6D (SF-6D) survey. RESULTS: Patients with RARS were followed for an average of 14.0 ± 6.1 (mean ± standard deviation) months compared to an average of 14.4 ± 5.3 months for CRSsNP controls (p = 0.779). Mean preoperative SF-6D health utility scores were statistically comparable between RARS (0.71 ± 0.14) and CRSsNP (0.66 ± 0.12; p = 0.341). Both patients with RARS and CRSsNP reported significant postoperative improvement in SF-6D scores from 0.71 ± 0.14 to 0.79 ± 0.13 (p = 0.031) and from 0.66 ± 0.12 to 0.77 ± 0.13 (p = 0.004), respectively. No difference in last postoperative SF-6D scores were found between RARS and CRSsNP (p = 0.583) or in the average magnitude of postoperative improvement (0.08 ± 0.16 vs 0.11 ± 0.13; p = 0.620). CONCLUSION: Patients with RARS and CRSsNP report significant impairment in health utility as measured by the SF-6D. ESS significantly improves health utility in patients with RARS and CRSsNP to near normative values. These data will help inform future economic analysis and cost-effectiveness research.

Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery.

OBJECTIVE: Propel is a bioabsorbable drug-eluting sinus implant inserted following an endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). The objective of this study was to estimate the budget impact of incorporating Propel post-ESS for CRS patients from a self-insured employer or third-party payer perspective. METHODS: An Excel-based budget impact model was developed. Estimates of the prevalence of CRS, rates of ESS, and effectiveness outcomes, along with direct and indirect costs from CRS were obtained from published literature. A total population of 1.5 million members was hypothesized for the analysis. All cost data were adjusted to October 2015 US dollars using the Medical Care Component of the Consumer Price Index. The cost and clinical/economic characteristics of Propel were compared to other treatments commonly used to minimize post-operative complications. The primary outcome was the incremental budget impact reported using per-member-per-month (PMPM) costs. Scenario-based, probabilistic, and one-way sensitivity analyses were performed to gauge the robustness of the results and identify the parameters with the most influence on the results. RESULTS: For a US self-insured employer or a commercial health plan of 1.5 million members, the incremental PMPM impact of incorporating Propel was estimated to range from -$0.003 to $0.036, respectively, for all members in the health plan. Sensitivity analyses identified the cost of Propel, probability of polyposis recurrence requiring medical intervention, probability of adhesion formation requiring surgical intervention, and the treatment costs for polyposis as the primary parameters influencing the results. CONCLUSION: This study has demonstrated the use of Propel following ESS procedures has a negligible impact on the budget of a US self-insured employer or payer. The upfront cost of Propel was offset by savings associated with reduced probability for polyp recurrence, adhesion formation, and their subsequent treatment.

Defining appropriateness criteria for endoscopic sinus surgery during management of uncomplicated adult chronic rhinosinusitis: a RAND/UCLA appropriateness study.

INTRODUCTION: Appropriate indications for endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) are currently poorly defined. The lack of clear surgical indications for ESS likely contributes to the large geographic variation in surgical rates and contributes to reduced quality of care. The objective of this study was to define appropriateness criteria for ESS during management of adult patients with uncomplicated CRS. METHODS: The RAND/UCLA appropriateness methodology was performed. An international, multi-disciplinary panel of 10 experts in CRS was formed and completed two rounds of a modified Delphi ranking process along with a face-to-face meeting. RESULTS: A total of 624 clinical scenarios were ranked, 312 scenarios each for CRS with and CRS without nasal polyps. For adult patients with uncomplicated CRS with nasal polyps, ESS can be appropriately offered when the CT Lund-Mackay score is ≥ 1 and there has been a minimum trial of a topical intranasal corticosteroid plus a short-course of systemic corticosteroid with a post-treatment total SNOT-22 score ≥ 20. For adult patients with uncomplicated CRS without nasal polyps, ESS can be appropriately offered when the CT Lund-Mackay score is ≥ 1 and there has been a minimum trial of a topical intranasal corticosteroid plus either a short-course of a broad spectrum/culture-directed systemic antibiotic or the use of a prolonged course of systemic low-dose anti-inflammatory antibiotic with a post-treatment total SNOT-22 score ≥ 20. CONCLUSION: This study has developed and reported of list of appropriateness criteria to offer ESS as a treatment option during management of uncomplicated adult CRS. The extent or technique of ESS was not addressed in this study and will depend on surgeon and patient factors. Furthermore, these criteria are the minimal threshold to make ESS a treatment option and do not imply that all patients meeting these criteria require surgery. The decision to perform ESS should be made after an informed patient makes a preference-sensitive decision to proceed with surgery. Applying these appropriateness criteria for ESS may optimize patient selection, reduce the incidence of unwarranted surgery, and assist clinicians in providing high quality, patient-centered care to patients with CRS.

Productivity costs decrease after endoscopic sinus surgery for refractory chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: The primary objective of this pilot study was to define the change in productivity costs following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). Secondary objectives were to identify CRS-related characteristics that may influence the degree of productivity improvement after ESS. STUDY DESIGN: Prospective, multi-institutional, observational cohort study. METHODS: The human capital approach was used to define productivity costs. Annual absenteeism, presenteeism, and lost leisure time were quantified to define annual lost productive time (LPT). LPT was monetized using the annual daily wage rates obtained from the 2012 US Census and the 2013 US Department of Labor statistics. RESULTS: Twenty-seven patients with refractory CRS who underwent ESS were followed for a mean of 15 months (range, 8-25 months). Following ESS, there were improvements in annual absenteeism (22 days reduced to 3 days), annual presenteeism (41 days reduced to 19 days), and annual household days lost (12 days reduced to 6 days). Overall, the preoperative productivity costs were reduced after ESS ($9,190 vs. $3,373, respectively; P < .001). CONCLUSIONS: Daily productivity is negatively impacted by the presence of CRS. The outcomes from this study provide the first insights into the reduced productivity costs associated with receiving ESS for refractory CRS. Future studies with larger sample sizes will need to validate the results from this pilot study. LEVEL OF EVIDENCE: 2c Laryngoscope, 126:570-574, 2016.

Disparities in grant funding for Chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: The objective of this study was to identify the level of grant funding for chronic rhinosinusitis (CRS) with the purpose of elucidating if disparities exist compared to other common chronic diseases. STUDY DESIGN: Review of four major health research grant agencies from the United States (National Institutes of Health), Canada (Canadian Institute of Health Research), and United Kingdom (National Institute of Health Research and Medical Research Council). METHODS: Research operating grants awarded in the fields of CRS, asthma, diabetes, and dementia were identified using database-specific search strategies. Searches were limited to the previous 10 years (2004-2014). Comparator chronic diseases were chosen to have similar prevalence rates and low mortality risk. Research efficiency was calculated as the monetary value of grants awarded per paper published. RESULTS: There is a large disparity in the number of grants awarded for research in CRS (n = 196; $74,774,384), asthma (n = 13,226; $8,358,861,941), diabetes (n = 54,902; $47,282,739,735), and dementia (n = 34,569; $16,709,900,125). In terms of research efficiency, CRS researchers received eight to 12 times less financial support per paper published compared to those in our comparator conditions. CONCLUSIONS: This study has demonstrated that over the last 10 years, CRS is disproportionately underfunded (∼$75 million) compared to other similarly prevalent chronic diseases such as asthma (∼$8.3 billion), diabetes (∼$47.2 billion), and dementia (∼$16.7 billion). We feel this justifies further research into identifying and reducing barriers to obtaining grant support for CRS. LEVEL OF EVIDENCE: NA.

Patient-reported outcome measures for adult chronic rhinosinusitis: A systematic review and quality assessment.

BACKGROUND: With a focus on patient-centered care, there is increasing policy interest in patient-reported outcome measures (PROMs) to inform improvements in health care delivery. Given the importance of understanding patient-reported outcomes during the management of chronic rhinosinusitis (CRS), PROMs will play an essential role in informing and tailoring the right intervention to the right patient. OBJECTIVE: The objective of this systematic review was to identify and assess the quality of PROMs being used for adults with CRS. METHODS: A systematic review of Ovid MEDLINE (R) (1947-May 2015), Embase, and the Cochrane databases was performed using the following key terms: ["chronic" AND "*sinusitis"] AND [PROM OR patient reported outcome measure* OR quality of life OR questionnaire OR survey OR valid* OR develop*]. An unlimited truncation strategy (placement of *) was used to capture all variations of terms used. The quality of each PROM was assessed and reported using standardized criteria from the COnsensus-based Standards for the selection of health status Measurement INstruments checklist. RESULTS: A total of 15 PROMs validated for use in adult patients with CRS were identified. Fourteen instruments were specific to adults with CRS, and one was a generic quality-of-life instrument (EuroQol five-dimensional questionnaire [EQ-5D]). There was significant variation in the quality of development and reporting of psychometric properties. Overall, the highest quality validated PROMs for adults with CRS were (1) the 22-item Sinonasal Outcome Test (19 points), (2) the Questionnaire of Olfactory Disorders (14 points), (3) the Sinusitis Control Test (14 points), and (4) the EQ-5D (13 points). Most of the PROMs were developed for research purposes such as determining changes in health-related quality of life or symptoms after an intervention as opposed to improving clinical decision making. CONCLUSIONS: Based on quality assessment, the 22-item Sinonasal Outcome Test, the Questionnaire of Olfactory Disorders, and the Sinusitis Control Test provided the highest quality CRS-specific PROMs, whereas the EQ-5D provided the highest quality generic quality-of-life instrument. Future CRS PROMs will need to incorporate clinical domains that assess common comorbid diseases along with patient values and preferences to improve clinical decision making.

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

IMPORTANCE: It is estimated that lost productivity related to chronic rhinosinusitis (CRS) costs society in excess of $13 billion per year in the United States. Given this tremendous cost to society, it is important to evaluate the effect of current interventions on improving this productivity loss. OBJECTIVE: To define the change in productivity costs in patients with refractory CRS who select continued medical therapy. DESIGN, SETTING, AND PARTICIPANTS: Observational cohort study. Thirty-eight patients with a guideline-based diagnosis of CRS whose initial appropriate medical therapy failed were enrolled from 4 tertiary-level rhinology clinics. The study was conducted from December 6, 2010, to April 23, 2013, and data analysis was performed from December 6, 2010, to June 1, 2015. INTERVENTIONS: Continued medical therapy for CRS. MAIN OUTCOMES AND MEASURES: The human capital approach was applied to quantify productivity costs. Absenteeism, presenteeism, and lost leisure time were quantified to define annual lost productive time, which was measured at enrollment (baseline) and at a minimum of 6 months after treatment. Lost productive time was monetized using the annual daily wage rates obtained from the 2012 US National Census and the 2013 US Department of Labor statistics. RESULTS: Thirty-eight patients with refractory CRS who selected continued medical therapy had a mean (SD) baseline annual productivity cost of $3464 ($4900) per patient. After continued medical therapy for a mean of 12.8 (4.8) months, productivity costs were $2730 ($3720) (before vs after continued medical therapy productivity cost, P = .74). Mean annual absenteeism was reduced from 5 (12) days to 2 (8) days (P = .02). Mean annual presenteeism (17 [27] days reduced to 15 [23] days; P = .93) and mean annual household days lost (7 [7] days reduced to 6 [6] days; P = .51) were maintained at baseline levels. There were no significant differences in productivity outcomes based on endoscopy, the 22-item Sinonasal Outcome Test score, age, or polyp status (all P ≥ .11). CONCLUSIONS AND RELEVANCE: Patients with refractory CRS often make treatment decisions based on the degree of quality-of-life and productivity impairment. Outcomes from this study suggest that productivity in patients with refractory CRS who have minor reductions in baseline productivity can remain stable with continued medical therapy. Physicians can use this information to inform appropriate patients with CRS of their expected outcomes from continued medical therapy.