Medical Management of Headache and Facial Pain in CRS: A Systematic Review and Meta-Analysis.

OBJECTIVES: This study aims to characterize the effect of medical therapy on headache and facial pain/pressure among patients with chronic rhinosinusitis (CRS). DATA SOURCES: CINAHL, PubMed, and Scopus. METHODS: CINAHL, PubMed, and Scopus were searched from inception through April 10th, 2024, for English language articles reporting headache or facial pain/pressure outcomes in CRS patients. Inclusion was restricted to studies reporting results of the medical treatment of CRS in nonsurgical cohorts. Primary outcome measures included the sino-nasal outcome test (SNOT) and the visual analogue scale (VAS). Meta-analyses of continuous measures (mean), mean difference (Δ), and proportions (%) were conducted. RESULTS: The initial search yielded 2429 unique articles. After a full-text review of 272 articles, 17 studies reporting outcomes for 2269 patients were included in the meta-analysis. The mean patient age was 48.6 years (range 18.0-86.0; 95% CI: 46.5 to 50.6), among which 55.4% (95% CI: 51.5 to 59.4) were male and 82.9% (95% CI: 68.8 to 93.4) had nasal polyposis. SNOT facial pain/pressure scores improved by 1.1 points (95% CI: -1.7 to -0.5; relative reduction 40.4%) with non-biologic therapies and 1.0 point (95% CI: -1.4 to -0.6; relative reduction 54.6%) with biologic therapies. On an 11-point scale, VAS headaches scores improved by 1.8 units (95% CI: -3.3 to -0.3; 42.1% relative reduction) in CRSwNP patients and 1.0 unit (95% CI: -1.7 to -0.3; 54.0% relative reduction) in CRSsNP patients. CONCLUSIONS: Our findings suggest medical therapy significantly reduces facial pain and pressure in the CRS population. Laryngoscope, 2024.

Topical steroids for chronic rhinosinusitis without nasal polyps: A systematic review and meta-analysis.

BACKGROUND: Evidence supporting topical steroids for the treatment of chronic rhinosinusitis without nasal polyposis (CRSsNP) is unclear. Recent trials describe alternative topical steroid delivery modalities, including rinses and exhalation delivery system (EDS), necessitating a re-examination of the current literature. METHODS: Cochrane Library, CINAHL, PubMed, and Scopus databases were searched from inception to February 13, 2024 for placebo-controlled randomized control trials on topical steroids used to treat CRSsNP, including topical spray, nasal irrigation, sinonasal catheter, and EDS modalities. Primary outcome measures included total symptom scores (TSS) (Δ) and response rates (odds ratio). RESULTS: Ten trials (N = 751) were included for meta-analysis, with a mean age of 47.5 years (range: 18-80 years; 95% confidence interval [CI]: 43.9-51.2 years). Topical steroids delivered by any method significantly improved TSS in CRSsNP patients (Δ0.4; 95% CI: 0.3-0.6; p < 0.0001). When stratified by allergy status, CRSsNP patients without allergy had significantly improved TSS when treated with EDS (Δ0.4; 95% CI: 0.1-0.7; p = 0.01), but not with topical spray (Δ0.04; 95% CI: -0.9 to 1.0; p = 0.94). Patients treated with EDS or sinonasal catheter responded significantly better compared to placebo (odds ratio [OR]: 3.4; 95% CI: 1.9-6.0; p < 0.0001; OR: 12.4; 95% CI: 1.8-83.8; p < 0.01), whereas patients treated with topical spray had no significant difference (OR: 1.8; 95% CI: 0.9-4.0; p = 0.12). CONCLUSIONS: Topical steroids are effective in treating CRSsNP, especially when delivered via EDS or sinonasal catheter. Future trials comparing steroid delivery mechanisms using validated outcome measures in CRSsNP populations are needed.

Orbital decompression surgery among Medicare beneficiaries in the post-teprotumumab era.

KEY POINTS: Utilization of orbital decompressions (ODS) increased (CAGR: +3.2%) from 2000 to 2019. FDA approved teprotumumab in January 2020; ODS utilization decreased (CAGR: -14.9%) from 2019 to 2022. In 2022, total spending was substantially higher for teprotumumab ($325 million) than surgery ($580,000).

Salvage surgery for recurrent or residual hypopharyngeal squamous cell carcinoma: A systematic review.

BACKGROUND: This systematic review aggregates the data of studies that include site-specific analyses of patients undergoing salvage surgery for residual or recurrent hypopharyngeal squamous cell carcinoma. METHODS: The primary outcomes are disease-free, disease-specific, and overall survival (DFS, DSS, and OS, respectively). Secondary outcomes include complications and postoperative feeding requirements. RESULTS: Fifteen studies met the inclusion criteria with a total of 442 patients. Two-year DFS is reported from 30.0 to 50.0% and 5-year DFS ranges from 15.0 to 57.1%. Five-year DSS ranges from 28.0 to 57.1%. Two-year OS ranges from 38.8 to 52.0% and 5-year OS ranges from 15.5 to 57.1%. Complications include pharyngocutaneous fistula (0.0-71.4%), carotid artery rupture (2.9-13.3%), and stomal stenosis (4.2-20.0%). Complete oral feeding achieved following surgery ranges from 61.9 to 100.0%, while complete gastrostomy tube dependence ranges from 0.0 to 28.6%. CONCLUSIONS: Salvage surgery for residual or recurrent hypopharyngeal squamous cell carcinoma has a relatively high complication rate and should be offered to patients with the understanding of a guarded prognosis.

Surgical management of headache and facial pain/pressure in chronic rhinosinusitis: A systematic review and meta-analysis.

BACKGROUND: Headache and facial pain are common symptoms of chronic rhinosinusitis (CRS). However, given the numerous etiologies that can cause these symptoms, the impact of sinus surgery is not well characterized. METHODS: A systematic review was performed by searching the literature from inception through June 6, 2023. English-language articles reporting outcomes for facial pain/pressure or headache following endoscopic sinus surgery were selected for inclusion. Meta-analyses were performed using random and fixed effect models on continuous measures (mean), mean difference (Δ), and proportions (%). RESULTS: A total of 26 articles reporting on 2839 patients were selected for inclusion. The mean patient age was 44.0 ± 3.9 (range 16.0-84.0), with an average symptom duration of 5.3 ± 2.8 years. Among these patients, 56.5% (95% confidence interval [CI]: 52.3-60.6) were male and 77.0% (95% CI: 56.6-92.3) had nasal polyposis (NP). Patients with and without NP reported substantial reductions in both 22-item sino-nasal outcome test facial pain/pressure (with NP: -1.4 [95% CI: -1.6 to -1.2; relative reduction 59.1%]; without NP: -1.5 [95% CI: -1.9 to -1.1; relative reduction 60.9%]) and visual analogue scale (VAS) headache (with NP: -2.5 [95% CI: -2.8 to -2.1; relative reduction 67.2%]; without NP: -2.8 [95% CI: -4.7 to -1.0; relative reduction 42.7%]). Symptom reductions were greater in the without NP versus with NP group; VAS facial pain/pressure: Δ0.4 (95% CI: 0.2-0.6; p = 0.0006) and VAS headache: Δ0.4 (95% CI: 0.1-0.7; p = 0.02). CONCLUSIONS: Our findings suggest that CRS patients, regardless of polyp status, benefit from significant reductions in facial pain/pressure and headache following surgical therapy.

The Inflation Reduction Act: Implications for Medicare spending and access to biologic therapies for chronic rhinosinusitis with nasal polyposis and asthma.

KEY POINTS: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022.

KEYPOINTS: Between 2007 and 2022, the FDA received 119 US-based reports mentioning budesonide nasal irrigation. Most reports were submitted by patients and alerted FDA to off-label usage of budesonide. Notable adverse events reported to the FDA included headache, dyspnea, and blurred vision.

Trends in Response Rate to US News & World Report Best Hospitals Reputation Survey, 2015 to 2023.

Reputation score has been shown to be the strongest predictor of ranking in the US News & World Reports (USNWR) Best Hospitals report. However, the extent to which physicians participate in the underlying USNWR reputation survey is not well-characterized. We conducted a retrospective cross-sectional study of USNWR public methodology reports from 2015 to 2023 to characterize trends in physician response rates by specialty, region, and Doximity membership. Overall response rates declined between 2015 (24.0%) and 2023 (8.9%). In 2023, rates ranged from 4.7% (psychiatry) to 13.9% (otolaryngology). Otolaryngology had the highest response rate among all specialties between 2017 and 2023. Within otolaryngology, both response rates (25.0% to 13.9%) and count (2106 to 1724 physicians) declined between 2015 and 2023. Among Doximity members, response rates were consistently higher for otolaryngologists in the Northeast and Midwest compared to other regions. Though hospital rankings often influence where patients seek care, our findings suggest USNWR reputation scores may not be reliable or representative.

Utility of a LangChain and OpenAI GPT-powered chatbot based on the international consensus statement on allergy and rhinology: Rhinosinusitis.

KEY POINTS: We created a LangChain/OpenAI API-powered chatbot based solely on International Consensus Statement of Allergy and Rhinology: Rhinosinusitis (ICAR-RS). The ICAR-RS chatbot is able to provide direct and actionable recommendations. Utilization of consensus statements provides an opportunity for AI applications in healthcare.

Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program.

Importance: The US Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have different statutory authorities; FDA evaluates safety and effectiveness for market authorization of medical devices while CMS determines whether coverage is "reasonable and necessary" for its beneficiaries. CMS has recently enacted policies automatically providing supplemental reimbursement for new, costly devices authorized after designation in FDA's Breakthrough Devices Program (BDP) and in June 2023 issued notice for a new Transitional Coverage for Emerging Technologies pathway, accelerating coverage for Breakthrough devices. Observations: Aiming to incentivize innovation, FDA awards Breakthrough designations early in device development to expedite market authorization and can accept greater uncertainty in benefit and risk, contingent on postmarket evidence generation. Since 2020, Breakthrough designation has effectively automatically qualified devices to receive supplemental Medicare reimbursement after CMS waived a long-standing requirement that devices demonstrate "substantial clinical improvement" for beneficiaries. Using publicly available information, 3 examples of cardiovascular devices illustrate that the BDP may allow for FDA authorization based on less rigorous evidence, such as single-arm trials focused on surrogate end points with short-term follow-up whose participants are often not representative of Medicare beneficiaries. In 1 case, Breakthrough designation allowed a 30% decrease in enrollment of a trial used to support approval. Initial positive findings for some devices have remained unverified, and in 1 case even partially nullified, by postmarket studies. Manufacturers have also used Breakthrough designations to set the price of devices to facilitate additional pass-through payments, leading to higher short-term and long-term costs to CMS and health care systems. Conclusions and Relevance: The BDP may qualify new, costly devices for higher and automatic Medicare reimbursement despite evidence not being representative of CMS beneficiaries and persistent uncertainty of benefit and risk. To ensure the best evidence is generated to inform clinical care, FDA could apply more selectivity to BDP eligibility, specify objective criteria for revoking Breakthrough designation when appropriate, and ensure timely postmarket evidence generation, whereas CMS could independently review clinical evidence, advise manufacturers about standards for coverage review, and make supplemental payments and long-term device reimbursement contingent on clinical outcome benefit and postmarket evidence generation.

Smell and Taste Loss Associated with COVID-19 Infection.

OBJECTIVE: The aim of this study was to quantify the impact of COVID-19 on olfactory and gustatory function in US adults. METHODS: From the 2021 Adult National Health Interview Survey, demographic and survey-specific module data concerning COVID-19 diagnoses, testing and disease severity, and data quantifying disturbances and eventual recovery of smell and taste were extracted. Sample weights were applied to obtain nationally representative statistics. The overall rate of COVID-19 infection was determined, and those diagnosed with COVID-19 were analyzed with respect to disease severity, smell and taste disturbance, and respective recoveries. RESULTS: In 2021, 35.8 million or 14% of the adult population (95% CI 13.5-14.7%; mean age, 43.9 years; 53.8% female) had been diagnosed with COVID-19. Among those, 60.5% (58.6-62.5%) and 58.2% (56.2-60.1%) reported accompanying losses  in smell or taste, respectively; there was a significant association between overall COVID-19 symptom severity and smell (p < 0.001) and taste disturbance (p < 0.001). Following infection, 72.2% (69.9-74.3%), 24.1% (22.2-26.2%), and 3.7% (3.0-4.6%) of the patients experienced complete, partial, and no smell recovery, respectively. Recovery rates for gustatory function paralleled olfaction, with 76.8% (74.6-78.9%), 20.6% (18.7-22.7%), and 2.6 (1.9-3.4%) reporting complete, partial, and no recovery of taste, respectively. When sensory disturbance was present, severity of overall symptomatology was negatively associated with smell and taste recovery (p < 0.001 for each). CONCLUSION: The majority of adults infected with COVID-19 in 2021 experienced olfactory or gustatory dysfunction with a non-negligible population reporting incomplete or no near-term sensory recovery. Our results are useful for providers counseling patients and suggest that interventions lessening overall COVID-19 symptom burden may prevent prolonged sensory dysfunction. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2357-2361, 2023.

Rates of Antidepressant, Anxiolytic, and ADHD Medication Use Among Patients Undergoing ESS.

Patients with chronic rhinosinusitis (CRS) are estimated to have psychiatric comorbidity at a higher rate than the general population; however, self-report of depression diagnoses or symptoms often underestimates true prevalence in many populations. In the present study, a cohort of 2279 patients undergoing endoscopic sinus surgery (ESS) were matched to an equal number of non-CRS control subjects by age, sex, race and health status. Overall, the rate of antidepressant/anxiolytic utilization among ESS patients was 22.1%versus 11.3% for controls (P < .001, OR = 2.23, 95% CI 1.90-2.63). The rate of ADHD medication utilization among ESS patients was 3.6%versus 2.0% for controls (P = .001, OR = 1.85, 95% CI 1.28-2.68). This study suggests that patients undergoing ESS exhibit significantly higher rates of antidepressant and ADHD medication utilization relative to a matched control population.

Variations in Payer-Negotiated Prices for Head and Neck Reconstructive Surgery.

OBJECTIVE: Little is known about pricing for reconstructive procedures of the head and neck. As of January 2021, the Centers for Medicare and Medicaid Services requires hospitals to disclose payer-negotiated prices for services, offering new insight into prices for privately insured patients. STUDY DESIGN: Cross-sectional analysis. SETTING: Turquoise database. METHODS: Payer-negotiated facility fees for 41 reconstructive surgeries were grouped by procedure type: primary closure, skin grafts, tissue rearrangement, locoregional flaps, or free flaps. Prices were normalized to account for local labor costs, then calculated as percent markup in excess of Medicare reimbursement. The mean percent markup between procedure groups was compared by the Kruskal-Wallis test. Subset analyses were performed to compare mean percent markup using a Student's t test. We also assessed price variation by calculating the ratio of 90th/10th percentile mean prices both across and within hospitals. RESULTS: In total, 1324 hospitals (85% urban, 81% nonprofit, 49% teaching) were included. Median payer-negotiated fees showed an increasing trend with more complex procedures, ranging from $379.54 (interquartile range [IQR], $230.87-$656.96) for Current Procedural Terminology (CPT) code 12001 ("simple repair of superficial wounds ≤2.5 cm") to $5422.60 ($3983.55-$8169.41) for CPT code 20969 ("free osteocutaneous flap with microvascular anastomosis"). Median percent markup was highest for primary closure procedures (576.17% [IQR, 326.28%-1089.34%]) and lowest for free flaps (99.56% [37.86%-194.02%]). Higher mean percent markups were observed for rural, for-profit, non-Northeast, nonteaching, and smaller hospitals. CONCLUSION: Wide variation in private payer-negotiated facility fees exists for head/neck reconstruction surgeries. Further research is necessary to better understand how pricing variation may correlate with out-of-pocket costs and quality of care.

Trends in price, spending, and utilization of omalizumab among Medicare beneficiaries.

KEY POINTS: Between January 2005 and January 2023, the average selling price of omalizumab increased by nearly 60%. Between 2016 and 2021, Medicare Part B and D spending on omalizumab totaled over $3.7 billion. Between 2016 and 2021, Medicare Part B and D utilization of omalizumab increased by approximately 30%.