Minimally Invasive Surgery in the United States, 2022: Understanding Its Value Using New Datasets.

INTRODUCTION: While minimally invasive surgery (MIS) has transformed the treatment landscape of surgical care, its utilization is not well understood. The newly released Nationwide Ambulatory Surgery Sample allows for more accurate estimates of MIS volume in the United States-in combination with inpatient datasets. MATERIALS AND METHODS: Multiple nationwide databases from the Healthcare Cost and Utilization Project (HCUP) were used: the Nationwide Ambulatory Surgery Sample and National Inpatient Sample. The volume of MIS and robotic procedures were calculated from 2016 to 2018. An online query system, HCUPNet, was queried for inpatient stays from 1993 to 2014. RESULTS: In 2017, 9.8 million inpatient major operating room procedures were analyzed, of which 11.1% were MIS and 2.5% were robotic-assisted, compared with 9.6 million inpatient operating room procedures (11.2% MIS and 2.9% robotic-assisted) in 2018. There were 10.6, 10.6, and 10.7 million ambulatory procedures in 2016, 2017, and 2018, respectively. Ambulatory MIS procedures showed an increasing trend across years, representing 16.9%, 17.4%, and 18%, respectively. HCUPNet data revealed an increase in inpatient MIS cases from 529,811 (8.9%) in 1993 to 1,443,446 (20.7%) in 2014. CONCLUSIONS: This study is the first to estimate national MIS volume across specialties in both inpatient and ambulatory hospital settings. We found a trend toward a higher proportion of MIS and robotic cases from 1997 to 2018. These data may help contribute to a more comprehensive understanding of MIS value within surgery and highlight limitations of current databases, especially when categorizing robotic cases on a national scale.

Cost-effectiveness analysis comparing in-office posterior nasal nerve ablation to surgical therapies.

BACKGROUND: Recently, in-office posterior nasal nerve ablation (PNA) devices have offered a new tool to treat refractory chronic rhinitis, but their cost-effectiveness relative to traditional interventions such as vidian neurectomy (VN) and posterior nasal neurectomy (PNN) remains unexplored. OBJECTIVE: To compare the cost-effectiveness of these interventions in patients with refractory chronic rhinitis. METHODS: A decision tree with embedded Markov models was created to compare the cost-effectiveness of PNN, VN, and PNA, measured in quality-adjusted life years (QALYs) over a 30-year time horizon with a $100,000/QALY willingness-to-pay threshold. One- and two-way sensitivity analyses were completed. RESULTS: Sensitivity analysis found that in-office PNA became cost-effective compared to VN when patients undergoing PNA were less than 20 % more likely than VN to have symptoms recur; this value was assumed to be twice as likely in the base case. In the base case, however, VN and in-office PNA were more effective and less expensive than PNN, while VN was cost-effective when compared to in-office PNA (incremental cost-effectiveness ratio $11,616.24/QALY). Other assumptions were not found to considerably impact incremental cost-effectiveness. CONCLUSION: Although highly limited by currently available data, PNA may be cost-effective compared to VN as long-term outcomes on the durability of its effects emerge. These data should not be used by payers considering coverage or utilization since long-term data is still nascent. However, that as new technologies emerge for rhinitis, it will be important to monitor longer-term outcomes to identify high value care, but based on limited data PNA devices may meet this standard.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Tracheostomy Complications in the Emergency Department: A National Analysis of 38,271 Cases.

BACKGROUND: Greater than 100,000 tracheotomies are performed annually in the USA, yet little is known regarding patients who present to the emergency department (ED) with tracheostomy complications. OBJECTIVES: To characterize patient and hospital characteristics, outcomes, and charges associated with tracheostomy complications and to identify predictors of admission and mortality. METHODS: The 2009-2011 Nationwide Emergency Department Sample (NEDS) was queried for patients with a principle diagnosis of tracheostomy complication. A descriptive analysis was performed and multivariable logistic regression was used to identify predictors of admission and mortality. RESULTS: A total of 69,371 nationwide visits to the ED had tracheostomy complication as an associated ICD-9 diagnosis, of which 55.2% (n = 38,293) carried a primary diagnosis of tracheostomy complication. Unspecified tracheostomy complications were most common (61.4%), followed by mechanical complications (31.3%), and lastly by tracheostomy infections (7.3%). Pediatric patients were significantly more likely to have tracheostomy infections than adults (p < 0.0001). A total of 35.5% of patients with tracheostomy complications were admitted to the hospital, and death occurred with 1.4% of visits. Patients from higher-income ZIP codes had increased odds of admission (adjusted odds ratio [OR]: 1.35; p = 0.0009), as did patients with tracheostomy infections (OR: 4.425; p < 0.0001). Patients with tracheostomy infections (OR: 3.14; p = 0.0062) and unspecified tracheostomy complications (OR: 2.00; p = 0.0076) had increased odds of mortality. CONCLUSION: These findings may help improve overall outcomes amongst patients with tracheostomies by preventing unnecessary ED admissions and improving healthcare provider preparedness and awareness.

Patient preferences regarding the communication of biopsy results in the general otolaryngology clinic.

OBJECTIVES: To determine the preferred methods of communicating biopsy results for patients in our comprehensive otolaryngology clinic, and to examine factors associated with preferring remote vs. in-person communication of results. STUDY DESIGN: Cross-sectional study. SETTING: Academic comprehensive otolaryngology clinic. SUBJECTS AND METHODS: A survey instrument was administered to 107 consecutive adult otolaryngology patients undergoing head and neck fine needle aspiration biopsy from March 1, 2017 to April 30, 2018 assessing their health literacy using the Brief Health Literacy Score and their preferred method of notification of biopsy results (in-person vs. remote). RESULTS: 69% of patients preferred remote notification of their biopsy results (either by telephone or via an online portal). 54% of patients prioritized clear explanation of the results as the most important factor when communicating a malignant result. Adequate health literacy was associated with lower odds of preferring in-person notification (adjusted odds ratio 0.11, 95% CI 0.03 to 0.39). Patients who prioritized clear explanation of the results were more likely to prefer in-person notification (adjusted OR 4.13, 95% CI 1.31 to 14.88). CONCLUSIONS: A significant proportion of patients in our comprehensive otolaryngology clinic undergoing fine needle aspiration biopsy preferred remote communication of their biopsy results. Patients most valued clear explanations from the provider and prompt receipt of the result when communicating malignant results. This highlights the need for individualized results communication plans, for patients undergoing biopsy.

Serum elevation of B lymphocyte stimulator does not increase regulatory B cells in glioblastoma patients undergoing immunotherapy.

Regulatory B cells that secrete IL-10 (IL-10(+) Bregs) represent a suppressive subset of the B cell compartment with prominent anti-inflammatory capacity, capable of suppressing cellular and humoral responses to cancer and vaccines. B lymphocyte stimulator (BLyS) is a key regulatory molecule in IL-10(+) Breg biology with tightly controlled serum levels. However, BLyS levels can be drastically altered upon chemotherapeutic intervention. We have previously shown that serum BLyS levels are elevated, and directly associated, with increased antigen-specific antibody titers in patients with glioblastoma (GBM) undergoing lymphodepletive temozolomide chemotherapy and vaccination. In this study, we examined corresponding IL-10(+) Breg responses within this patient population and demonstrate that the IL-10(+) Breg compartment remains constant before and after administration of the vaccine, despite elevated BLyS levels in circulation. IL-10(+) Breg frequencies were not associated with serum BLyS levels, and ex vivo stimulation with a physiologically relevant concentration of BLyS did not increase IL-10(+) Breg frequency. However, BLyS stimulation did increase the frequency of the overall B cell compartment and promoted B cell proliferation upon B cell receptor engagement. Therefore, using BLyS as an adjuvant with therapeutic peptide vaccination could promote humoral immunity with no increase in immunosuppressive IL-10(+) Bregs. These results have implications for modulating humoral responses in human peptide vaccine trials in patients with GBM.

A Systematic Review of Race and Ethnicity in Hepatitis C Clinical Trial Enrollment.

The African American/Black population in the United States (US) is disproportionately affected by hepatitis C virus (HCV) and has lower response rates to current treatments. This analysis evaluates the participation of African American/Blacks in North American and European HCV clinical trials. The data source for this analysis was the PubMed database. Randomized controlled clinical trials (RCT) on HCV treatment with interferon 2a or 2b between January 2000 and December 2011 were reviewed. Inclusion criteria included English language and participants 18 years or older with chronic HCV. Exclusion criteria included non-randomized trials, case reports, cohort studies, ethnic specific studies, or studies not using interferon-alfa or PEG-interferon. Of the 588 trials identified, 314 (53.4%) fit inclusion criteria. The main outcome was the rate of African American/ Black participation in North American HCV clinical trials. A meta-analysis comparing the expected and observed rates was performed. Of the RCT's that met search criteria, 123 (39.2%) reported race. Clinical trials in North America were more likely to report racial data than European trials. Racial reporting increased over time. There was a statistically significant difference among the expected and observed participation of African Americans in HCV clinical trials in North America based on the prevalence of this disease within the population. The burden of HCV among African Americans in North America is not reflected in those clinical trials designed to treat HCV. Research on minority participation in clinical trials and how to increase minority participation in clinical trials is needed.

Prehabilitation in our most frail surgical patients: are wearable fitness devices the next frontier?

PURPOSE OF REVIEW: Frailty is the concept of accumulating physiologic declines that make people less able to deal with stressors, including surgery. Prehabilitation is intervention to enhance functional capacity before surgery. Frailty and prehabilitation among transplant populations and the role of wearable fitness tracking devices (WFTs) in delivering fitness-based interventions will be discussed. RECENT FINDINGS: Frailty is associated with increased complications, longer length of hospital stay and increased mortality after surgery. Frail kidney transplant patients have increased delayed graft function, mortality and early hospital readmission. Frail lung or liver transplant patients are more likely to delist or die on the waitlist. Prehabilitation can mitigate frailty and has resulted in decreased length of hospital stay and fewer postsurgical complications among a variety of surgical populations. Increasingly, WFTs are used to monitor patient activity and improve patient health. Interventions using WFTs have resulted in improved activity, weight loss and blood pressure. SUMMARY: Frailty is a measurable parameter that identifies patients at risk for worse health outcomes and can be mitigated through intervention. Prehabilitation to reduce frailty has been shown to improve postsurgical outcomes in a variety of populations. WFTs are being integrated in healthcare delivery for monitoring and changing health behavior with promising results.

Reduction in olfactory dysfunction prevalence among patients with diabetes taking metformin.

KEY POINTS: Metformin treatment is associated with reduced olfactory dysfunction (OD) in diabetic patients Metformin may possess potential protective effects on olfaction beyond glycemic control.

Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses.

OBJECTIVES: This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured. DESIGN: Systematic review of systematic reviews (umbrella review). DATA SOURCES: Cochrane Database of Systematic Reviews. ELIGIBILITY CRITERIA: Systematic reviews attempt to compare surgical to drug interventions. DATA EXTRACTION: We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review. SYNTHESIS: The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger's test and excess significance were assessed. RESULTS: Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance. CONCLUSIONS: Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.

Molecular patterns and mechanisms of tumorigenesis in HPV-associated and HPV-independent sinonasal squamous cell carcinoma.

Mechanisms of tumorigenesis in sinonasal squamous cell carcinoma (SNSCC) remain poorly described due to its rare nature. A subset of SNSCC are associated with the human papillomavirus (HPV); however, it is unknown whether HPV is a driver of HPV-associated SNSCC tumorigenesis or merely a neutral bystander. We hypothesized that performing the first large high-throughput sequencing study of SNSCC would reveal molecular mechanisms of tumorigenesis driving HPV-associated and HPV-independent SNSCC and identify targetable pathways. High-throughput sequencing was performed on 64 patients with HPV-associated and HPV-independent sinonasal carcinomas. Mutation annotation, viral integration, copy number, and pathway-based analyses were performed. Analysis of HPV-associated SNSCC revealed similar mutational patterns observed in HPV-associated cervical and head and neck squamous cell carcinoma, including lack of TP53 mutations and the presence of known hotspot mutations in PI3K and FGFR3. Further similarities included enrichment of APOBEC mutational signature, viral integration at known hotspot locations, and frequent mutations in epigenetic regulators. HPV-associated SNSCC-specific recurrent mutations were also identified including KMT2C , UBXN11 , AP3S1 , MT-ND4 , and MT-ND5 . Mutations in KMT2D and FGFR3 were associated with decreased overall survival. We developed the first known HPV-associated SNSCC cell line and combinatorial small molecule inhibition of YAP/TAZ and PI3K pathways synergistically inhibited tumor cell clonogenicity. In conclusion, HPV-associated SNSCC and HPV-independent SNSCC are driven by molecularly distinct mechanisms of tumorigenesis. Combinatorial blockade of YAP/TAZ and vertical inhibition of the PI3K pathway may be useful in targeting HPV-associated SNSCC whereas targeting MYC and horizontal inhibition of RAS/PI3K pathways for HPV-independent SNSCC. One Sentence Summary: This study solidifies HPV as a driver of HPV-associated SNSCC tumorigenesis, identifies molecular mechanisms distinguishing HPV-associated and HPV-independent SNSCC, and elucidates YAP/TAZ and PI3K blockade as key targets for HPV-associated SNSCC.

Testosterone levels influence mouse fetal Leydig cell progenitors through notch signaling.

Leydig cells are the steroidogenic lineage of the mammalian testis that produces testosterone, a key hormone required throughout male fetal and adult life for virilization and spermatogenesis. Both fetal and adult Leydig cells arise from a progenitor population in the testis interstitium but are thought to be lineage-independent of one another. Genetic evidence indicates that Notch signaling is required during fetal life to maintain a balance between differentiated Leydig cells and their progenitors, but the elusive progenitor cell type and ligands involved have not been identified. In this study, we show that the Notch pathway signals through the ligand JAG1 in perivascular interstitial cells during fetal life. In the early postnatal testis, we show that circulating levels of testosterone directly affect Notch signaling, implicating a feedback role for systemic circulating factors in the regulation of progenitor cells. Between Postnatal Days 3 and 21, as fetal Leydig cells disappear from the testis and are replaced by adult Leydig cells, the perivascular population of interstitial cells active for Notch signaling declines, consistent with distinct regulation of adult Leydig progenitors.

Recurrent Nasopharyngeal Carcinoma and the Role of Surgery.

Recurrent nasopharyngeal carcinoma (rNPC) presents unique challenges as reirradiation comes with significant treatment-related morbidity in swallowing, middle ear function, and large-vessel integrity. Advances in endoscopic technology have made surgery for rNPC an increasingly viable option for select patients and may play a role in providing a better quality of life to patients with this challenging disease. In carefully selected patients, endoscopic and open surgical approaches may provide comparable disease control while mitigating long-term treatment-related morbidity.

Chronic interleukin-13 expression in mouse olfactory mucosa results in regional aneuronal epithelium.

BACKGROUND: Olfactory dysfunction is highly associated with chronic rhinosinusitis with nasal polyps (CRSwNP), and the severity of loss has been linked with biomarkers of type 2 inflammation. The ability of dupilumab to rapidly improve the sense of smell prior to improvement in polyp size suggests a direct role of IL-4/IL-13 receptor signaling in the olfactory epithelium (OE). METHODS: We created a transgenic mouse model in which IL-13 is inducibly expressed specifically within the OE. Gene expression analysis and immunohistology were utilized to characterize the effect of IL-13 on the structure of the OE. RESULTS: After induction of olfactory IL-13 expression, there is a time-dependent loss of neurons from OE regions, accompanied by a modest inflammatory infiltrate. Horizontal basal cells undergo morphologic changes consistent with activation and demonstrate proliferation. Mucus production and increased expression of eotaxins is observed, with marked expression of Ym2 by sustentacular cells. DISCUSSION: Chronic IL-13 exposure has several effects on the OE that are likely to affect function. The neuronal loss is in keeping with other models of allergic type 2 nasal inflammation. Future studies are needed to correlate cellular and molecular alterations in olfactory cell populations with findings in human CRSwNP, as well as to assess olfactory function in behavioral model systems.

Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews.

Objectives: To examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons, and whether surgery or the drug intervention was favored. Design: Systematic review of systematic reviews (umbrella review). Data sources: Cochrane Database of Systematic Reviews (CDSR). Eligibility criteria and synthesis of results: Using the search term "surg*" in CDSR, we retrieved systematic reviews of surgical interventions. Abstracts were subsequently screened to find systematic reviews that aimed to compare surgical to drug interventions; and then, among them, those that included any randomized controlled trials (RCTs) for such comparisons. Trial results data were extracted manually and synthesized into random-effects meta-analyses. Results: Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs with data) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% confidence intervals, the surgical intervention was favored in 38/103 (37%), and the drugs were favored in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favor of surgery, and 2 (9%) were in favor of drugs. Conclusions: Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomized evidence is rare. More randomized trials comparing surgery to drug interventions are needed. Protocol registration: https://osf.io/p9x3j.

Cost comparison between open thyroid lobectomy and radiofrequency ablation for management of thyroid nodules.

BACKGROUND: There is an increasing array of treatment options for addressing clinically significant thyroid nodules, including radiofrequency ablation (RFA). While effective, the cost compared to alternative approaches has not been well elucidated. METHODS: This study involved a retrospective chart review, focusing on variable direct cost (VDC) of each procedure, from April 2016 to January 2020. We analyzed costs for 53 open lobectomies and 16 RFA procedures. RESULTS: Cost effectiveness depended on the simulated cost of the RFA probe. In comparison to open lobectomy, the VDC to perform RFA was $597 (19%) cheaper when the simulated probe cost was $1500 and $403 (13%) more expensive for a probe cost of $2500. Statistical significance was achieved for both these differences. CONCLUSIONS: If cost per RFA probe can be less than $2100-the break-even dollar amount between open lobectomy and RFA-there would be considerable cost savings for treating thyroid nodules.

Otolaryngology Considerations of Pituitary Surgery: What an Endocrinologist Should Know.

Endoscopic endonasal skull base surgery is the preferred surgical approach for the management of pituitary adenomas. Perioperative management of pituitary lesions requires multidisciplinary care and typically includes a dual surgeon team consisting of a neurosurgeon and an otolaryngologist. The involvement of the otolaryngologist allows for a safe surgical approach with excellent intraoperative visualization of the tumor to enable an effective resection of the tumor by the neurosurgeon. Detection and treatment of sinonasal pathology is essential prior to surgery. Patients may experience sinonasal complaints following endoscopic transsphenoidal surgery, although this is typically temporary. Sinonasal care in the postoperative period can expedite recovery to baseline. Here we discuss the perioperative factors of endoscopic pituitary surgery that endocrinologists should be aware of, ranging from preoperative patient selection and optimization to postoperative care, with a particular emphasis on anatomic and surgical factors.

Surgeon Volume and Laryngectomy Outcomes.

OBJECTIVE: To examine the relationship between surgeon volume and operative morbidity and mortality for laryngectomy. DATA SOURCES: The Nationwide Inpatient Sample was used to identify 45,156 patients who underwent laryngectomy procedures for laryngeal or hypopharyngeal cancer between 2001 and 2011. Hospital and surgeon laryngectomy volume were modeled as categorical variables. METHODS: Relationships between hospital and surgeon volume and mortality, surgical complications, and acute medical complications were examined using multivariable regression. RESULTS: Higher-volume surgeons were more likely to operate at large, teaching, nonprofit hospitals and were more likely to treat patients who were white, had private insurance, hypopharyngeal cancer, low comorbidity, admitted electively, and to perform partial laryngectomy, concurrent neck dissection, and flap reconstruction. Surgeons treating more than 5 cases per year were associated with lower odds of medical and surgical complications, with a greater reduction in the odds of complications with increasing surgical volume. Surgeons in the top volume quintile (>9 cases/year) were associated with a decreased odds of in-hospital mortality (OR = 0.09 [0.01-0.74]), postoperative surgical complications (OR = 0.58 [0.45-0.74]), and acute medical complications (OR = 0.49 [0.37-0.64]). Surgeon volume accounted for 95% of the effect of hospital volume on mortality and 16%-47% of the effect of hospital volume on postoperative morbidity. CONCLUSION: There is a strong volume-outcome relationship for laryngectomy, with reduced mortality and morbidity associated with higher surgeon and higher hospital volumes. Observed associations between hospital volume and operative morbidity and mortality are mediated by surgeon volume, suggesting that surgeon volume is an important component of the favorable outcomes of high-volume hospital care. Laryngoscope, 133:834-840, 2023.