Economic impact analysis of a minimally invasive temperature-controlled radiofrequency device versus nasal surgery for the treatment of nasal airway obstruction in the United States.

OBJECTIVE: To determine the economic impact of a minimally invasive temperature-controlled radiofrequency (TCRF) device for treating nasal airway obstruction (NAO). METHODS: A budget impact model was developed for two scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available treatment option and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of one million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and nasal valve collapse (NVC) as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis. RESULTS: The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3531 through a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. CONCLUSIONS: In patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a treatment option demonstrates the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.

Nasal valve dysfunction is a common cause of nasal airway obstruction (NAO) that has a significant impact on heath and quality of life for affected individuals. Previously, patients were offered temporary measures or a type of surgery called functional rhinoplasty which is a highly complex surgery that can be costly, requires recovery time, and in rare cases, not be successful. Recently, a new minimally invasive treatment alternative for NAO called temperature-controlled radiofrequency (TCRF) that may be performed in a surgery center or a doctor's office has become available. This paper provides the results of budget impact analysis performed to assess whether adding the TCRF procedure in place of surgery as a choice for patients with NAO will result in cost savings to an insurance payer with 1 million covered individuals in the United States over a period of 4 years. Results show that TCRF may result in an average of 9,416 fewer rhinoplasty surgeries, provide an average 4-year cost-savings of $3,531 for every patient that responds to TCRF treatment, and a savings of $20,015,123 over 4 years for the insurance provider. These potential cost savings over 4 years would likely be due to reduced procedure costs and complication rates compared to surgery.

The changing face of rhinology in the NHS: a study of septoplasty, septorhinoplasty and rhinoplasty hospital episode statistics.

INTRODUCTION: In 2011, septorhinoplasty and rhinoplasty were reclassified as procedures of limited clinical value in the NHS. The criteria for funding these operations varies across England. We used hospital episode statistics and freedom of information requests to review the total number of rhinology procedures performed across the previous decade, looking at trends in practice related to time, demographics and commissioning policy. MATERIALS AND METHODS: Hospital episode statistics for 2012-2019 were used to calculate the number of septoplasty, septorhinoplasty, rhinoplasty and reduction rhinoplasty procedures performed in children and adults. Freedom of information requests were also made to all clinical commissioning groups in England asking for number of procedures performed and number of individual funding requests made. RESULTS: A total of 158,031 procedures were performed over this period; the majority were in adult (99.0%) men (65.7%). Septoplasty was the most frequently performed operation; however, the total numbers declined by 5.4% over this period. There was a yearly reduction in the overall number of septorhinoplasty, rhinoplasty and reduction rhinoplasty operations. Four clinical commissioning groups provided a detailed breakdown of data by year and procedure. Those that required individual funding requests for all cases saw septorhinoplasty numbers fall by 81% and 75% over the period. Those that did not, saw numbers increase or remain the same. CONCLUSIONS: We found an overall year-on-year reduction in the number of rhinology operations being performed in the NHS, but variation in trends between different clinical commissioning groups. A reduction in operative activity likely represents the effect of underlying restrictions on commissioning rather than reduced clinical need.

Utilization fraction of rhinoplasty instrument sets: Model for efficient use of surgical instruments.

OBJECTIVES: Recognize the avoidable costs incurred due to overpacking of rhinoplasty instrument trays. Reduce rhinoplasty instrument trays by including only instruments used frequently. Establish methods to reduce trays prepared for other otolaryngologic procedures. METHODS: This is a prospective study. The study evaluates the specific use of instruments opened for rhinoplasty procedures at the New York Eye & Ear Infirmary of Mount Sinai. Instruments were counted in 10 rhinoplasty cases. Usage rate was calculated for each instrument. Additionally, all instruments used in at least 20% of cases were noted. This "20%" threshold was used to create new rhinoplasty tray inventories more reflective of actual instrument usage. Some instruments above the 20% threshold were included in multiples (i.e. two Adson Brown forceps vs. one curved iris scissor). RESULTS: 189 instruments were opened, and 32 instruments were used on average in each rhinoplasty. 55 instruments were used in at least 20% of cases. The 55 "high usage" instruments were used to create new, reduced rhinoplasty tray inventory lists. Based on our analysis, a new rhinoplasty tray inventory was created comprised of 68 instruments, a 64% reduction from 189. CONCLUSION: Instruments are sterilized and packed in gross excess for rhinoplasty procedures. Previously published figures estimate re-sterilization costs of $0.51 to $0.77 per instrument. Reduction in instruments opened from 189 to 68 is expected to lead to cost savings ranging from $62 to $93 per case, yielding a savings between $6200 and $9300 per 100 cases performed. LEVEL OF EVIDENCE: II-3.

Single-Stage Adipofascial Turnover Flap as an Alternate Option for Large Nasal Defects Usually Requiring Two-Stage Forehead Flap.

BACKGROUND: Large nasal defects involving the tip, ala, and/or columella with denuded cartilage have traditionally required a two-stage forehead flap. As many Mohs patients are presenting older with increased medical comorbidities, a single-stage adipofascial turnover flap with a full-thickness skin graft was developed by the senior author as an alternative method. The authors hypothesize that the adipofascial turnover flap would have similar success rates and cost less than the forehead flap. METHODS: A retrospective review of all patients in the senior author's practice who underwent either a forehead flap or adipofascial turnover flap between January of 2016 and February of 2019 was conducted. The two groups were compared regarding success, complications, and cost. RESULTS: There were seven forehead flap patients and 11 patients with adipofascial turnover flaps. Overall complications were three of seven (43 percent) for the forehead flap group and one of 11 (9 percent) for the adipofascial turnover flap group. There was one mortality, one revision for asymmetry, and one with airflow obstruction in the forehead group. The adipofascial turnover flap group had one partial skin graft loss that healed with local wound care only. There were no flap failures in either group, and the cost savings averaged over $22,000 in the adipofascial turnover flap group. CONCLUSIONS: The single-stage adipofascial turnover flap with full-thickness skin grafting is a safe, reliable, and less expensive alternate to the forehead flap. The forehead flap will remain a workhorse in nasal reconstruction, but multiple operations increase cost and may contribute to higher complication rates. The adipofascial turnover flap appears to be an efficacious and reasonable option compared with the forehead flap.

The Health Utility and Valuation of Cosmetic Rhinoplasty.

Importance: The importance of this study is to understand the impact of rhinoplasty as perceived by society and to conceptualize the health utility metric of cosmetic rhinoplasty in relation to other health interventions. Objective: This novel study seeks to measure and quantify the health state utility and valuation of cosmetic rhinoplasty. Design, Setting, Participants: This is a cross-sectional survey administered through public online forums to 161 casual observers in America. Main Outcomes and Measures: Participants were shown pre- and postoperative photographs of six patients who underwent cosmetic rhinoplasty and two patients who did not undergo surgery. Observers were asked to imagine that the external nose in each image was on their own face and rated (1) their health state utility and (2) how much they were willing to pay (WTP) to have the ideal nose. Results: Established metrics of standard gamble and visual analog scale were explored in detail. Using these valuation and health utility data, we calculated WTP per quality-adjusted-life-year (WTP/QALY). The WTP/QALY for cosmetic rhinoplasty is $12,264 per QALY, which is significantly below cost-effective thresholds. Participants were willing to accept 10% risk of death to undergo cosmetic rhinoplasty. Conclusions and Relevance: Calculating WTP/QALY as a metric, we assess and quantify the social importance of rhinoplasty. This is the first study to demonstrate that elective cosmetic rhinoplasty can be a high-value intervention as perceived by society. Furthermore, the high percentage of risk of death that participants are willing to accept for cosmetic rhinoplasty suggests there is a profound psychosocial impact of external nasal deformity. These findings have implications for patients, surgeons, and health policy makers.

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction.

BACKGROUND: Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. AIMS: To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. METHODS/DESIGN: A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation. DISCUSSION: The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. TRIAL REGISTRATION: EudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017.

Comparing the Health Burden of Living With Nasal Deformity in Actual Patients and Healthy Individuals: A Utility Outcomes Score Assessment.

BACKGROUND: Rhinoplasty is a one of the most commonly performed facial surgery aiming at restoring facial aesthetics and improving quality of life. Utility outcome scores are modern, and emerging tools are used to evaluate the burden of a health state on individuals. The study aims to evaluate the impact of living with nasal deformity among real patients and healthy individuals using utility outcome scores. METHODS: A cross-sectional study was conducted at Otolaryngology and Plastic Surgery clinics in a tertiary center. Healthy individuals were recruited from public facilities. A case scenario was developed to reflect an imaginary patient (Nora) with a functional and aesthetic nasal deformity and distributed to participants. Three utility outcomes scores were used: visual analog scale (VAS), time trade-off (TTO), and standard gambling (SG). RESULTS: A total of 407 adult participants were included. Most participants were female (52%). Healthy individuals comprised 71%, and actual patients comprised 29%. Mean VAS score was 0.77 (ie, participants scored Nora's health state as 77%), TTO score was 0.87 (ie, participants were willing to sacrifice 4 years to have Nora's condition corrected), and SD score was 0.91 (ie, participants were willing to take a 9% risk of death to have Nora's condition corrected). Scores differed among actual patients and healthy individuals (P < 0.0001 for VAS and TTO, P = 0.02 for SG). CONCLUSION: Living with a nasal deformity has a significant impact on quality of life. Both patients and healthy individuals are willing to trade a significant number of years to get the condition corrected.

Gender-confirming Rhinoplasty.

Most surgeons who are not routinely treating gender dysphoric patients are more likely to see an isolated rhinoplasty consultation rather than a request for full facial gender confirmation surgery (FGCS). Different from other aspects of FGCS, the surgical basis of rhinoplasty is almost the same as for the cisgender population. Despite technical overlap, the care for patients seeking rhinoplasty for the indication of gender dysphoria vastly differs from that for the cisgender population. This review includes comments on gender norms and outline considerations for the preoperative work-up and operative execution as well as a comprehensive literature review.

Assessment of Casual Observers' Willingness to Pay for Increased Attractiveness Through Rhinoplasty.

IMPORTANCE: Contingent valuation, or willingness to pay, is an established economic concept that has been applied in other areas of medicine and may be useful for understanding the economic forces that determine the cost of cosmetic procedures. OBJECTIVE: To determine the monetary value of changes in attractiveness achieved through rhinoplasty, as perceived by society. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey administered via public online forums to 228 casual observers. MAIN OUTCOMES AND MEASURES: Participants were shown preoperative and postoperative photographs of 12 patients who underwent cosmetic rhinoplasty and 4 patients who did not undergo any surgery. They were asked to rate (1) the change in overall attractiveness of the patients, and (2) the monetary value they would associate with these changes. RESULTS: Completed surveys were obtained from 228 casual observers; 144 were female (63.2%); median age, 25 years (median income bracket, $50 000-$75 000). Multilevel, mixed-effects, linear regression was used to characterize the association between monetary value and change in attractiveness. There was a significant association between the change in attractiveness from a rhinoplasty and its monetary value as perceived by society. The baseline value of a rhinoplasty without any change in attractiveness was $3769.98 (95% CI, $3541.59-$4007.10; P < .001). To increase 1 standard deviation in attractiveness was worth an additional $2353.77 (95% CI, $2197.57-$2512.81; P < .001), while increasing 2 standard deviations in attractiveness was worth an additional $5453.07 (95% CI, $5052.57-$5865.51; P < .001). CONCLUSIONS AND RELEVANCE: There is a significant association between the societally perceived value of cosmetic rhinoplasty and the change in attractiveness after surgery. The average value of a rhinoplasty in our study approximates the actual average cost of cosmetic rhinoplasty, suggesting that willingness to pay may be a useful concept for studying the value of cosmetic procedures. LEVEL OF EVIDENCE: NA.

Quality of Life Gain After Septorhinoplasty: An Analysis of Health Utility and Cost Utility Values Associated with Septorhinoplasty.

PURPOSE: Septorhinoplasty is a common procedure performed in rhinology and facial plastic surgery. Despite this, the health benefits associated with the procedure remain controversial. In this study, a health utility assessment of patients undergoing septorhinoplasty was performed. Health gains associated with the procedure, and the cost at which they were acquired, were also determined. METHODS: Sixty-seven patients undergoing septorhinoplasty at a German tertiary-level hospital were included in the study. Study participants completed the Short Form 36 (SF-36) and satisfaction questionnaires before and 12 months after septorhinoplasty. The Short Form six-dimensional (SF-6D) instrument was used to acquire quality-adjusted life year (QALY) values from SF-36 responses, thus allowing estimation of pre- and post-operative health utilities. Health utility gains after septorhinoplasty were determined and combined with cost data to estimate cost per QALY gained. RESULTS: Patients undergoing septorhinoplasty reported mean pre-operative health utility values of 0.70 pre-operatively and 0.74 post-operatively resulting in health gains of 0.04 QALYs. Patients satisfied with their procedures had significant health utility gains, while dissatisfied patients did not experience any significant gains. The cost of septorhinoplasty to statutory health insurance was €3487.69. When compared to the baseline, the incremental utility ratio for septorhinoplasty was €94,797.30 per QALY gained. CONCLUSIONS: This study successfully estimated the health utilities and gains associated with septorhinoplasty. The findings indicate that the procedure has associated health gains but at a high cost-utility ratio. These values provide a reference point for further much-needed economic evaluations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Nasal Endoscopy Billing Patterns: A Survey of the American Rhinologic Society.

Introduction Nasal endoscopy (NE) is an essential element of office-based clinical rhinology, including the evaluation of chronic rhinosinusitis. Despite the presence of guidelines, variability exists regarding coding and billing for NE especially with regard to inclusion of evaluation and management (E&M) codes and use of the 25 modifier. The goal of this survey was to assess the billing patterns for NE among American Rhinologic Society (ARS) members. Methods An invitation to participate in a web-based survey was electronically sent to all ARS members. Survey participants were queried regarding demographics and billing patterns for NE in several different clinical scenarios using a 5-point Likert-type scale, with a score of 5 representing "always" and a score of 1 representing "never" for billing E&M. Results A total of 93 respondents successfully completed the survey with a range of the number of years since completing training, practice type (50.5% private, 44.1% academic) and completion of a rhinology fellowship (40.9%). Variable responses for billing patterns for distinct clinical scenarios were noted. Higher scores for billing both E&M and NE for the queried clinical scenarios were noted for new patients (mean 4.50) compared to established patients (mean 3.81) and postoperative patients (mean 3.04). Inclusion of a septoplasty as part of the surgery impacted billing an E&M code 28% of the time. Practice type and history of performing a fellowship did not significantly influence billing patterns for NE. Conclusions Significant variability exists among ARS respondents with regard to billing patterns for NE, despite the presence of coding guidelines. Additional teaching of standard coding practices for NE may limit variability among otolaryngologists.

Time, Resident Involvement, and Supply Drive Cost Variability in Septoplasty with Turbinate Reduction.

Objective To determine factors that influence cost variability in septoplasty with inferior turbinate reduction. Study Design Case series with chart review. Setting Tertiary care hospital and affiliated ambulatory surgical center. Subjects and Methods Surgical costs were reviewed for adult patients undergoing septoplasty with inferior turbinate reduction between December 2014 and September 2017. Cases where additional procedures were performed were excluded. Operative supply costs, operative time, room time, and resident involvement were determined. Contribution of these factors to total costs and variability were analyzed. Results The study included 116 patients (mean age, 38 years) and 4 faculty surgeons. Total cost was primarily driven by operative time (74%), with a smaller portion of total cost arising from supplies (26%). Time cost ( P < .0001) and supply cost ( P = .006) varied significantly among surgeons. A resident was involved in 46.6% of cases. When subanalyzed by resident year, no-resident and senior resident (postgraduate years 4 and 5) cases had nearly identical mean times, while junior resident (postgraduate years 1-3) cases had mean times and operative time costs that were 39% greater ( P < .001). Conclusion For septoplasty with inferior turbinate reduction, the greatest driver of cost variation was operative time. Resident involvement correlated with increased time and cost. Supply costs had a much smaller impact. When subanalyzed by resident year, junior resident-involved cases were significantly longer than no-resident cases.

Cost-effectiveness of Early Division of the Forehead Flap Pedicle.

IMPORTANCE: The paramedian forehead flap is considered the gold standard procedure to optimally reconstruct major defects of the nose, but this procedure generally requires 2 stages, where the flap pedicle is divided 3 weeks following the initial surgery to ensure adequate revascularization of the flap from the surrounding recipient tissue bed, which can cost a patient time out of work or away from normal social habits. It has previously been shown that the pedicle may be safely divided after 2 weeks in select patients where revascularization from the recipient bed was confirmed using intraoperative laser fluorescence angiography to potentially save the patient time and money. OBJECTIVE: To demonstrate the cost-effectiveness of takedown of the paramedian forehead flap pedicle after 2 weeks using angiography with indocyanine green (ICG). DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of all patients who underwent 2-week division of the forehead flap after nasal reconstruction. Patient, tumor, defect, and outcomes data were collected. Cost-minimization analysis was performed by comparing the overall costs of 2-week takedown with angiography to a hypothetical patient undergoing 3-week takedown without angiography. INTERVENTION: Two-week division of the forehead flap after nasal reconstruction. MAIN OUTCOMES AND MEASURES: Cost-minimization analysis performed by calculating the total variable costs for a patient in our cohort vs costs to a theoretical patient for whom angiography was not performed and the pedicle was divided at the 3-week mark. RESULTS: A total of 22 patients were included (mean [SD] age, 70.3 [10.0] years; 8 women [36.4%] and 14 men [63.6%]). The selection criteria for 2-week division of the pedicle are a wound bed with at least 50% vascularized tissue present, partial-thickness defects, and absence of nicotine use. All were divided at the 2-week mark with no instances of flap necrosis. One patient had a squamous eccrine carcinoma histology before reconstruction, all other patients had basal cell carcinoma, squamous cell carcinoma, and melanoma. Cost-minimization analysis showed that the use of angiography with ICG results in cost savings of $177 per patient on average. CONCLUSIONS AND RELEVANCE: Two-week takedown of select paramedian forehead flap patients can be performed safely with verification using angiography with ICG. Although this technology inherently adds cost, it is cost-effective, saving a total of $177 per patient. LEVEL OF EVIDENCE: NA.

Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial.

BACKGROUND: Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. METHODS/DESIGN: The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. DISCUSSION: With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty. TRIAL REGISTRATION: Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.

[Inpatient vs. outpatient costs analysis of septumplasty in Germany]. / Potenzialanalyse und Kostenbewertung bei der ambulanten Durchführung der Septumkorrektur.

The septumplasty is realized inpatient and outpatient in different countries. Caused by the pressure of reduction of expenses there is the question of the economic benefit if done outpatient in Germany. A comparison of the inpatient and outpatient gratification will be done. There is a yearly potential of cost reduction of 180 million euro, if the operation would be done as an outpatient procedure. From the hospital view actual there is no economical recommendation doing an outpatient septumplasty caused by the poor outpatient remuneration. That's why an adjustment of the outpatient remuneration should be done. Actual there is no medical or economical recommendation doing the septumplasty as an outpatient procedere.