Surgical salvage of human papillomavirus-positive oropharyngeal cancer: Secondary analysis of a randomized controlled trial.

BACKGROUND: Survival outcomes are generally better for human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPV+ OPSCC) than other forms of head and neck cancer. However, less is known about oncologic outcomes, late adverse events, and gastrostomy tube dependence associated with salvage surgery after the failure of definitive chemoradiation in patients with HPV+ OPSCC. METHODS: A secondary analysis of the Radiation Therapy Oncology Group 1016 randomized trial, which compared radiotherapy plus cetuximab to radiotherapy plus cisplatin in patients with HPV+ OPSCC, was performed. The oncologic and adverse event outcomes for patients who underwent salvage surgery were examined. RESULTS: Among the 805 patients who were assigned to treatment and were eligible for analysis, 198 developed treatment failure. Salvage surgery was required for 61 patients (7.6%), with 33 patients undergoing salvage surgery after locoregional failure (LRF) and 28 patients undergoing salvage neck dissection within the 20 weeks after treatment. Patients with LRF who underwent salvage surgery experienced improved overall survival in comparison with patients with LRF who did not undergo surgery (45% vs. 17% at 5 years after treatment; hazard ratio, 0.41; 95% confidence interval [CI], 0.23-0.74). Surgical salvage after LRF was associated with similar frequencies of late grade 3/4 dysphagia in comparison with LRF without surgery (24% [95% CI, 13%-41%] vs. 20% [95% CI, 12%-32%]; p = .64) and with similar gastrostomy tube dependence at 2 years (29% [95% CI, 15%-49%] vs. 13% [95% CI, 5%-28%]; p = .12). CONCLUSIONS: Salvage surgery in patients with HPV+ OPSCC is associated with favorable survival and adverse event outcomes.

Association of State-Imposed Restrictions on Gabapentin with Changes in Prescribing in Medicare.

BACKGROUND: Between August 2016 and July 2018, three states classified gabapentin as a Schedule V drug and nine states implemented prescription drug monitoring program (PDMP) regulation for gabapentin. It is highly unusual for states to take drug regulation into their own hands. The impact of these changes on gabapentin prescribing is unclear. OBJECTIVE: To determine the effect of state-imposed regulation on gabapentin prescribing for Medicare Part D enrollees from 2013 to 2018. DESIGN: Population-based difference-in-difference(DID) analysis study utilizing the Medicare Part D Prescriber Public Use File. PARTICIPANTS: All eligible Medicare Part D prescribers excluding those outside of the fifty states and the District of Columbia were included in our analysis. Prescriber data and key sociodemographic variables were organized by state and year. States with a gabapentin schedule change or PDMP regulation enacted before 2019 were included in the intervention group. For the Schedule V DID analysis, a control group of the ten highest opioid-prescribing states was used. INTERVENTIONS: States with gabapentin schedule changes or PDMP regulation before January 1, 2019, were included and compared to control states that did not implement these policies. MAIN MEASURES: Total days' supply of gabapentin per enrollee per year was the primary outcome variable. KEY RESULTS: The mean total days' supply of gabapentin per enrollee increased 41% from 19.71 to 27.81 total days' supply per enrollee per year between 2013 and 2018. After adjustment, Schedule V gabapentin regulation resulted in a reduction of 8.37 total days of gabapentin prescribed per enrollee (95% confidence interval of - 10.34 to - 6.39). In contrast, PDMP regulation resulted in a reduction of 1.01 total days of gabapentin prescribed per enrollee (95% confidence interval of - 1.74 to - 0.29). CONCLUSIONS: Classifying gabapentin as a Schedule V drug results in substantial reduction in total days prescribed whereas PDMP regulation results in modest reduction.

Surgical Fires Involving Alcohol-Based Preparation Solution, 1991-2020.

BACKGROUND: Alcohol-based skin preparations were first approved for surgical use in 1998 and have since become standard in most surgical fields. The purpose of this report is to examine incidence of surgical fires because of alcohol-based skin preparation and to understand how approval and regulation of alcohol-based skin preparations impacted trends in fires over time. METHODS: We identified all reported surgical fires resulting in patient or staff harm from 1991 through 2020 reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. We examined incidence of fires because of these preparations, trends after approval and regulation, and common causes. RESULTS: We identified 674 reports of surgical fires resulting in harm to patients and surgical personnel, in which 84 involved an alcohol-based preparation. The time-adjusted model shows that from 1996 through 2006, there was a 26.4% increase in fires followed by a 9.7% decrease from 2007 to 2020. The decrease in fires was most rapid for head and neck and upper aerodigestive tract surgeries. Qualitative content analysis revealed improper surgical site preparation as well as close proximity of surgical sites to an oxygen source as the most common causes of fires. CONCLUSION: Since FDA approval, alcohol-based preparation solutions have been associated with a significant percentage of surgical fires. Warning label updates from 2006 to 2012 coupled with increased awareness efforts of associated risks of alcohol-based surgical solutions likely contributed to the decrease in fires. Improper surgical site preparation technique and close proximity of surgical sites to oxygen continue to be risk factors for fires. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:607-613, 2024.

Surgical Fire in the United States: 2000-2020.

BACKGROUND: Despite fire prevention protocols and perioperative staff training, surgical fires continue to cause patient harm, disability, and death. METHODS: We identified surgical fires that were reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database between 2000 and 2020 that resulted in patient or surgical personnel harm. Quantitative and descriptive content analyses were performed on free-text responses to identify contributing factors of surgical fire patient and personnel harm events. RESULTS: We identified 565 surgical fire events resulting in patient or surgical personnel harm over a 20-year study period (median 25 events/year; range, 8-53). Surgical fires were significantly more likely to occur during upper aerodigestive tract (unadjusted odds ratio 15.96; 95% confidence interval, 11.93-21.34) and head and neck (unadjusted odds ratio 5.47; confidence interval 4.14-7.22) procedures compared with abdomen and pelvis procedures. Upper aerodigestive tract and head and neck procedures had the highest incidence of life-threatening injury (41% and 21%, respectively). An electrosurgical device was the ignition source in 82% of events. Content analysis revealed 7 common categories identified as root causes of surgical fires: preparation of surgical site (n = 55, 29%); device malfunction (n = 51, 26%), surgical accident (n = 47, 24%), medical judgement (n = 44 reports, 23%), equipment care and handling (n = 18, 9%), patient factors (n = 10, 5%), and communication (n = 3, 2%). CONCLUSION: Surgical fires resulting in harm to patient and surgical personnel continue to occur. The common themes identified in this study will prepare and empower surgeons and surgical personnel to prevent surgical fires in the future.

Incidence of Head and Neck Cancer With Lung Cancer Screening: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVES/HYPOTHESIS: To evaluate the incidence of head and neck cancers (HNC) in high-risk current and/or former smokers with screening low-dose computed tomography (LDCT) chest versus chest x-ray (CXR). STUDY DESIGN: Second analysis of randomized clinical trial. METHODS: We performed a secondary analysis examining the incidence of HNC in the National Lung Screening Trial. This was a randomized trial comparing LDCT versus CXR screening for lung cancer detection in high-risk individuals (30 pack-year smokers who currently smoke or quit within the last 15 years, aged 55-74). We compared the incidence of HNC in participants screened with LDCT versus CXR. We performed subgroup analyses in participants with mucosal HNC (oral cavity, oropharynx, larynx, hypopharynx, nasal/sinus cavity, or nasopharynx) or nonmucosal HNC (thyroid or salivary gland) and examined survival in the two screening arms. RESULTS: This trial enrolled 53,452 participants with a median follow-up of 6.2 years after randomization. The incidence of HNC was 111.8 cases per 100,000 person-years in the LDCT group versus 87.1 cases per 100,000 person-years in the CXR group (rate ratio 1.30, 95% confidence interval [CI] 1.05-1.61). There were 11.7 deaths from HNC per 100,000 person-years in the LDCT group and 12.9 deaths per 100,000 person-years in the CXR group (hazard ratio 0.80, 95% CI 0.42-1.52). CONCLUSIONS: Participants screened with LDCT had a modestly higher incidence of HNC. As uptake and adherence of lung cancer screening guidelines improve, clinicians should recognize that incidental findings from screening may lead to increased detection of HNC. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1609-1614, 2022.

Development of a self-directed sinonasal surgical anatomy video curriculum: Phase 1 validation.

BACKGROUND: Sinusitis is a common outpatient diagnosis made by physicians and is a reason for referral to otolaryngologists. A foundation in basic sinonasal anatomy is critical in understanding sinus pathophysiology and avoiding complications. Our objective in this study was to develop and to validate a self-directed surgical anatomy video for medical students. METHODS: Two multimedia videos were developed highlighting sinonasal anatomy. In Video 1 we included audio narration and radiologic imaging. Video 2 incorporated highlighted images from a sinus surgery video. An assessment was developed to test sinonasal anatomy landmarks, spatial recognition of structures, and their clinical relevance. An expert panel of rhinologists scored face and content validity of the curriculum videos and assessment. Factor analysis was used to separate questions into face and content validity domains, and a one-sample t test was performed. RESULTS: The panel scored face validity (Videos 1 and 2: 4.4/5) and content validity (Video 1: 4.5/5, 0.83; Video 2: 4.3/5, 0.75) significantly higher than a neutral response. There were no statistical differences for face or content validity between videos. The assessment was rated suitable (29%) or very suitable (57%) for testing basic sinonasal surgical anatomy, and the majority (71%) of respondents agreed (14%) or strongly agreed (57%) that the assessment thoroughly covered the sinus anatomy content with which medical students should be familiar. CONCLUSION: We have developed two videos and an assessment that highlight and test sinonasal anatomy. Future studies will aim to identify whether the use of a self-directed video curriculum improves sinonasal anatomy awareness and whether incorporation of surgical endoscopic videos augments training.

Cochlear Implantation and Facial Nerve Synkinesis in an Infant with Hypoplastic Internal Auditory Canals - A Case Report.

Sensorineural hearing loss (SNHL) is a common finding in cases of the congenital internal acoustic canal (IAC) stenosis. Previous reports reveal a relationship between IAC stenosis and facial palsy as well as vestibular dysfunction. This case identifies a patient with bilateral profound SNHL, bilateral IAC stenosis, and temporary unilateral facial palsy who went on to receive bilateral cochlear implants (CI). The facial nerve synkinesis that was found in this patient with hypoplastic IACs occurred after a cochlear implant activation. The synkinesis was ipsilateral to prior transient facial palsy after salmonella infection. Patients with IAC stenosis and cochlear nerve hypoplasia may respond well to cochlear implantation, but caution should be used when considering CI with an emphasis on counseling for possible facial nerve complications.