Accuracy of Salivary Circulating Tumor Human Papillomavirus DNA in Detecting Oropharyngeal Cancer: A Systematic Review and Meta-Analysis.

Importance: Circulating tumor human papillomavirus DNA (ctHPV DNA) has shown potential as a biomarker capable of improving outcomes in patients with HPV-related oropharyngeal (OP) cancer. It can be isolated from plasma or saliva, with the latter offering reduced invasiveness and theoretic reduction of lead time. Objective: To perform a systematic review and meta-analysis on the accuracy of salivary ctHPV DNA for detecting HPV-associated OP cancer. Data Sources: Cochrane Library, Embase, PubMed, and Web of Science databases were searched from inception through October 2023. Study Selection: All patients who underwent salivary ctHPV DNA testing at presentation for possible or diagnosed HPV-related OP cancer were included. Non-English and review publications were excluded. Two authors independently voted on article inclusion with a third resolving conflicting votes. Data Extraction and Synthesis: Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines, multiple authors independently abstracted data and assessed bias of included articles. Bivariate random-effects meta-analysis was performed with I2 to assess for study heterogeneity. Main Outcomes and Measures: Sensitivities, specificities, positive likelihood ratios (PLR), negative likelihood ratios (NLR), and diagnostic odds ratios (DOR) with 95% CIs alongside area under the curve (AUC) of a summary receiver operating characteristic (SROC) curve were calculated. The initial analysis took place throughout December 2023. Results: Of 440 initially identified articles, 6 met inclusion criteria and demonstrated moderate heterogeneity (I2 = 36%) with low risk of bias and low applicability concerns. Overall, 263 total patients were included with a median (range) age of 58 (39-86) years, and 228 (87%) were male patients. Per updated prognostic staging criteria, localized tumors (ie, stages 1 or 2) comprised most cancers at 139 (77%), whereas advanced ones (ie, stages 3 or 4) comprised the remaining 41 (23%). Pooled sensitivity, specificity, PLR, NLR, and DOR values were 64% (95% CI, 36%-85%), 89% (95% CI, 46%-99%), 11.70 (95% CI, 0.37-77.00), 1.21 (95% CI, 0.08-7.00), and 139.00 (95% CI, 0.05-837.00), respectively. The AUC of the SROC curve was 0.80. Conclusions and Relevance: This study supports salivary ctHPV DNA as an acceptably specific test in detecting HPV-associated OP cancer that would benefit from testing in clinical trials prior to real-time implementation.

Quantifying the effect of shoulder size on operation duration: an analysis of stapes surgery outcomes.

OBJECTIVE: To investigate the effect of body mass index on hearing outcomes, operative time and complication rates following stapes surgery. METHOD: This is a five-year retrospective review of 402 charts from a single tertiary otology referral centre from 2015 to 2020. RESULTS: When the patient's shoulder was adjacent to the surgeon's dominant hand, the average operative time of 40 minutes increased to 70 minutes because of a significant positive association between higher body mass index and longer operative times (normal body mass index group (<25 kg/m2) r = 0.273, p = 0.032; overweight body mass index group (25-30 kg/m2) r = 0.265, p = 0.019). Operative times were not significantly longer upon comparison of low and high body mass index groups without stratification by laterality (54.9 ± 19.6 minutes vs 57.8 ± 19.2 minutes, p = 0.127). CONCLUSION: There is a clinically significant relationship between body mass index and operating times. This may be due to access limitations imposed by shoulder size.

Comparing adverse events associated with LigaSure and Harmonic devices in head and neck surgery.

OBJECTIVE: To characterize adverse events, provide a safety profile, and understand patient outcomes after complications arising from LigaSure and Harmonic use in the head and neck region. METHODS: Retrospective analysis of adverse events from the Manufacturer and User Facility Device Experience (MAUDE) between January 2013 and 2023. RESULTS: A total of 158 LigaSure and 159 Harmonic events were extracted. There were significantly more reports of Harmonic device overheating (6.9% vs. 0.6%, p = 0.003) and spontaneous self-activation (4.4% vs. 0%, p = 0.032). Although intra-operative and post-operative complications were similar among both groups, there were significantly more intra-operative bleeding events for LigaSure as compared to Harmonic (8.2% vs. 0.0%, p = 0.001). CONCLUSION: Understanding technical complications and adverse events attributable to LigaSure and Harmonic devices enables the development of clinically relevant risk mitigation strategies. Surgeons should avoid improper use by remaining vigilant of device functionality and temperature changes.

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

BACKGROUND: The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials. METHODS: Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases. RESULTS: Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56-213) and 2 (0-5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent (n = 52) of studies. A higher fragility index correlated with higher sample size (r = 0.514, p < 0.001), number of events (r = 0.449, p < 0.001) and statistical significance via p-value (r = -0.367, p < 0.001). CONCLUSION: Head and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.

Does labyrinthectomy have an impact on hearing in the contralateral ear during long-term follow-up?

OBJECTIVE: To quantify contralateral hearing outcomes after labyrinthectomy for unilateral Ménière's disease (MD). STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Labyrinth removal for the management of MD or translabyrinthine (TLAB) acoustic neuroma resection between 2008 and 2012. MAIN OUTCOME MEASURE: Long-term hearing changes via pure tone averages (PTA). RESULTS: Upon comparison of low-frequency PTA (250, 500, 1000 Hz), MD patients experienced a greater degree of hearing loss during the follow-up period when compared to the TLAB lab group (7.54 ± 2.11 dB vs 2.39 ± 1.10 dB, p = 0.035). This difference as attributable to 12 (28.6 %) MD patients experiencing a ≥30 dB increase in low-frequency PTA, whereas none (0.0 %) of the TLAB surpassed this threshold. CONCLUSIONS: At 10 years post-labyrinthectomy there is a heightened risk for MD patients to develop low-frequency sensorineural hearing loss. Clinicians should monitor for audiometric changes through regular testing in the decade following labyrinth removal.

Simultaneous Cochlear Implantation and Salvage Translabyrinthine Resection of Vestibular Schwannoma after Radiotherapy.

OBJECTIVE: To report on the novel use of simultaneous cochlear implantation (CI) during salvage translabyrinthine resection of vestibular schwannoma (VS) after failed stereotactic radiosurgery (SRS). PATIENT: A 52-year-old woman presented with a medium-sized right VS. She experienced continued tumor growth despite previous SRS, resulting in medial extension beyond the internal auditory canal into the cerebellopontine angle. Associated symptoms included asymmetrical right moderate to severe sensorineural hearing loss, poor word recognition, tinnitus, and dizziness. INTERVENTION: Simultaneous CI with translabyrinthine VS resection. MAIN OUTCOME MEASURE: CI-aided pure-tone averages. RESULTS: After 4 months of device use, CI-aided speech audiometry revealed hearing thresholds in the normal range, with a four-tone pure-tone, average of 16.3 dB. Speech perception with consonant-nucleus-consonant testing in the CI-only condition was 46%, representing a 12% improvement compared with preoperatively. Tinnitus and dizziness burden were subjectively reduced. CONCLUSIONS: Despite challenges inherent to second procedures after radiotherapy failure, successful CI outcomes can be achieved. The current study demonstrates the feasibility of simultaneous CI during salvage VS resection after SRS. A larger study should be undertaken to further substantiate these preliminary findings.

Twelve-Month Outcomes of Simultaneous Translabyrinthine Resection and Cochlear Implantation.

OBJECTIVE: Audiometric outcomes at 12 months following simultaneous translabyrinthine (TL) resection of vestibular schwannoma (VS) and cochlear implantation (CI). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral center. METHODS: Adult patients undergoing TL resection of sporadic, unilateral VS ≤ 2 cm were prospectively enrolled. Preoperative testing included binaural AZBio in noise and quiet and unilateral Consonant-Nucleus-Consonant (CNC). Tinnitus Handicap Index (THI) and Speech, Spatial, and Qualities of Hearing (SSQ) questionnaires were also completed. Patients underwent TL resection with simultaneous CI. The preoperative test battery was repeated at 1, 3, 6, and 12 months after activation. Statistical analysis was performed to characterize short-term outcomes (preoperative to 3 months), longer-term outcomes (3-12 months), and overall changes during the preoperative to 12-month period. RESULTS: AZBio, CNC, and THI improved at 3 months with no significant changes thereafter and showed durable improvement at 12 months compared to preoperative testing. While SSQ did not improve at 12 months, a subset of patients showed either recovery or improvement of SSQ-spatial subscores. Patients with cerebellopontine angle tumors had poorer performance, although the impact of tumor size and location could not be deduced based on the small sample size. CONCLUSION: Patients undergoing simultaneous CI and TL resection of VS had durable improvements in speech perception and tinnitus severity 12 months following surgery. Subjective improvements in localization were not observed. Additional studies are needed to determine which VS patients are optimal candidates for CI.

Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons.

BACKGROUND: Informed consent requires preoperative discussion of surgical risks, complications, and alternative treatment options. Allegations of incomplete informed consent are common in the field of otolaryngology. OBJECTIVES: Analyze outcomes and case variables in cases of alleged informed consent failure involving otolaryngologists. METHODS: A legal research database containing state and federal case records from across the United States was retrospectively reviewed for malpractice claims involving informed consent and otolaryngology. RESULTS: Among the 128 informed consent cases identified, 72.6% resulted in favorable verdicts for otolaryngologists. Functional endoscopic sinus surgery (FESS) was the most common source of informed consent litigation in the field of otolaryngology, with an incidence four-fold higher than the next most litigated procedure of uvulopalatopharyngoplasty (21.9% vs 5.4%). The top four factors cited in FESS-related cases were CSF leak (10), inadequate discussion of alternative therapies (4), diplopia (3), and meningitis (3). Cases resulting in a transient injury were significantly less likely to result in a payment from a plaintiff verdict or settlement (9.1%) as compared to payment-rates among cases involving permanent complications (34.6%) (p = 0.005). CONCLUSIONS: Failure to obtain informed consent is an important factor in medical malpractice litigation. This report identifies specific, actionable recommendations aimed at protecting sinus surgeons from liability and ensuring that patients are better informed.

Patient Sentiments Influencing Management Strategy for Single-sided Deafness.

OBJECTIVE: Assess opinions that influence treatment choice for single sided deafness (SSD). STUDY DESIGN: Retrospective chart review. SETTING: Tertiary neurotology referral center. PATIENTS: Patients with SSD were recruited between December 2020 and February 2021. Included patients were self-selected by voluntary completion of the study questionnaire. MAIN OUTCOME MEASURES: Tinnitus Handicap Inventory (THI), Hearing Handicap Inventory for Adults (HHIA), and a questionnaire containing 25 areas of inquiry relevant to management strategy decision making. RESULTS: In comparison to the surgical management group, patients opting for nonsurgical amplification were significantly more concerned about device visibility (p = 0.005, 1.32 ±â€Š0.22 versus 2.67 ±â€Š0.37), undergoing surgery (p = 0.017, 1.64 ±â€Š0.23 versus 2.89 ±â€Š0.51), and the thought of harboring an implanted device (p = 0.003, 1.46 ±â€Š0.22 versus 2.82 ±â€Š0.35). Patients with a major hearing handicap (grade 2-4) placed significantly less emphasis on out-of-pocket costs (p = 0.049, 2.38 ±â€Š0.17 versus 2.94 ±â€Š0.21) and were less concerned about experiencing discomfort from the device (p = 0.033, 3.13 ±â€Š0.11 versus 3.56 ±â€Š0.16) or ease of device use (p = 0.040, 3.20 ±â€Š0.13 versus 3.63 ±â€Š0.13) when compared with the minor handicap group. CONCLUSIONS: Lingering concerns about device visibility, undergoing surgery, and harboring an implanted device underscore the need for thorough patient counseling during SSD device selection consultations. These efforts should aim to address esthetic and surgical risk concerns while emphasizing the potential for improvements in quality of life.

Hearing Outcomes With a Novel Total Ossicular Replacement Prosthesis.

INTRODUCTION: A total ossicular replacement prosthesis (TORP) is used to reconstruct the ossicular chain in the absence of the stapes suprastructure. The Wildcat prosthesis is a novel TORP that eliminates the need for a separate footplate shoe prosthesis and aims to improve ease-of-use and stability. This study evaluates hearing outcomes using the Wildcat prosthesis. STUDY DESIGN: Case series with chart review. SETTING: Tertiary neurotology referral center. METHODS: Retrospective chart review of 64 patients undergoing ossicular chain reconstruction using the Wildcat TORP. Hearing outcomes after surgery were assessed with air conduction pure-tone average, bone conduction pure-tone average, air-bone gap (ABG), speech recognition threshold , and word recognition score as primary outcome measures. The stability of hearing outcomes was evaluated on subsequent long-term follow-up. RESULTS: At mean short-term follow-up of 4.4 ±â€Š2.7 months, ABG improved from 31.0 ±â€Š13.0 dB preoperatively to 22.5 ±â€Š10.0 dB (p < 0.001) with 51.6% achieving ABG less than 20 dB. No significant difference in any primary outcome measures was found when analyzing outcomes by initial versus revision surgery, use of cartilage graft, or type of mastoidectomy. The only exception was a smaller reduction in ABG of 4.2 dB for patients with canal wall down mastoidectomy compared with a 13.7 dB ABG closure in patients with canal wall up mastoidectomy (p = 0.039). CONCLUSION: Total ossicular chain reconstruction using the Wildcat demonstrates versatility in challenging cases to provide hearing outcomes that are comparable to published data using TORPs.

Pre-existing Vestibular Symptoms Are Associated With Acute Vestibular Symptoms After Gamma Knife Therapy for Vestibular Schwannoma.

OBJECTIVE: To identify pretreatment variables associated with the development of acute vestibular symptoms after Gamma Knife (GK) treatment for Vestibular Schwannoma (VS). STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Patients treated with GK radiosurgery for VS between March 2007 and March 2017 were considered for this study. Patients with neurofibromatosis type II, previous VS surgery, follow-up less than 6 months, or the lack of T2 magnetic resonance imaging (MRI) sequences from the day of treatment were excluded. MAIN OUTCOME MEASURES: The presence of acute vestibular symptoms arising within 6 months after GK was the main outcome variable. Tumor, patient, and treatment characteristics were gathered from the medical record. RESULTS: In total, 98 patients met inclusion criteria. The incidence of acute vestibular symptoms occurring within 6 months after GK treatment was 46.9%. Post-GK vestibular symptoms were reported at a significantly higher frequency among subjects who had reported vestibular symptoms before their treatment (p = 0.001). Tumor size was not associated with a propensity to develop acute vestibular symptoms (p = 0.397). The likelihood of receiving a referral to vestibular rehabilitation services was not significantly different among patients with larger versus smaller tumor size, as defined by 1.6 cm and 1.4 cm thresholds (p = 0.896, p = 0.654). CONCLUSIONS: Inquiries aimed at revealing a history of vestibular complaints may prove useful in counseling patients on the likelihood of experiencing acute vestibular symptoms after treatment of Vestibular Schwannoma with Gamma Knife therapy.

A Protective Cap: Fundal Fluid Cap Facilitates a Reduction in Inner Ear Radiation Dose in the Radiosurgical Treatment of Vestibular Schwannoma.

OBJECTIVE: Assess inner ear radiation dose magnitude as it relates to fundal cap length and hearing outcomes in the radiosurgical treatment of vestibular schwannoma. STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Patients treated with Gamma Knife radiosurgery for vestibular schwannoma between March 2007 and March 2017 were considered for this study. Exclusion criteria included pretreatment pure-tone average (PTA) >90 dB, neurofibromatosis type II, history of previous surgical resection, and follow-up less than 1 year. MAIN OUTCOME MEASURE: (s): Hearing function was assessed by maintenance of class A/B hearing level and maintenance of baseline hearing (≤20 dB change in PTA following Gamma Knife radiosurgery). RESULTS: Lower radiation doses delivered to the inner ear were associated with longer fundal cap lengths: mean cochlear dose (r = -0.130; p = 0.184), mean labyrinth dose (r = -0.406; p < 0.001), max cochlear dose (r = -0.326; p = 0.001), and max labyrinth dose (r = -0.360; p < 0.001). Kaplan-Meier analysis with log-rank testing revealed that patients with a mean labyrinth dose < 3 Gy achieved higher rates of preserving baseline hearing (≤20 dB change in PTA) following radiosurgery, compared to patients with a mean labyrinth dose ≥3 Gy (p < 0.001). A fundal fluid cap length of 2.5 mm was associated with the 3 Gy mean labyrinth dose threshold. CONCLUSIONS: We report that fundal cap presence facilitated the creation of treatment plans with a lower dose delivered to the labyrinth. By affording this dose reduction, a fundal cap may be associated with a slight improvement in hearing outcomes.

Fundal Fluid Cap Is Associated With Hearing Preservation in the Radiosurgical Treatment of Vestibular Schwannoma.

OBJECTIVE: To evaluate the relationship between fundal fluid and hearing outcomes after treatment of vestibular schwannoma (VS) with Gamma Knife radiosurgery (GKRS). STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Patients treated with GKRS for vestibular schwannoma between March 2007 and March 2017 were considered for this study. Exclusion criteria included pretreatment pure-tone average (PTA) >90 dB, neurofibromatosis type II, history of previous surgical resection, and follow-up less than 1 year. MAIN OUTCOME MEASURE(S): Hearing function was assessed both by preservation of serviceable hearing and by preservation of baseline hearing (≤20 dB change in PTA) after GKRS. Hearing preservation comparisons were made between groups of patients with and without a fundal fluid cap. RESULTS: Patients with a fundal cap had significantly higher rates of baseline hearing preservation (≤20 dB change in PTA) according to Kaplan-Meier survival analysis of all 106 patients (p = 0.006). By the 3rd year posttreatment, 70.9% of patients with a fundal cap had maintained a ≤20 dB change in PTA, while only 43.6% of patients without a fundal fluid cap achieved this outcome (p = 0.004). CONCLUSIONS: Fundal fluid present on pretreatment magnetic resonance imaging is predictive of improved baseline hearing preservation rates in patients undergoing GKRS for vestibular schwannoma when considering all patients with PTA ≤90 dB. Fundal fluid cap presence may serve as a favorable prognostic indicator to help set hearing expectations and guide patient selection efforts.

Surgical Explantation of Bone-Anchored Hearing Devices: A 10-year Single Institution Review.

OBJECTIVE: To identify clinical variables associated with the decision to surgically discontinue bone-anchored hearing device function. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary neurotology referral center. SUBJECTS AND METHODS: This study examines surgical interventions performed on existing bone-anchored hearing devices at a single institution from 2008 to 2018. Patient characteristics, indications for implantation, and complications prompting surgical intervention were assessed. RESULTS: Seventy-seven cases were included in this study. Among patients in the younger cohort (<37 years old), 100% (13 of 13) of those discontinuing their device had a contralateral normal-hearing ear. Conversely, 0% (0 of 14) of the younger patients with bilateral hearing loss surgically discontinued their devices. Within the older cohort (≥37 years old), female patients (P = .002) and those with an increased body mass index (P = .035) were more likely to surgically discontinue their devices. Multivariate analysis revealed that a contralateral normal-hearing ear (P = .001) and infection without soft tissue overgrowth of the abutment (P = .026) were the strongest predictors of device discontinuation, after adjusting for potential confounders. CONCLUSION: Surgical discontinuation is associated with several clinical variables. Targeted interventions that are viable alternatives to removal, such as device relocation, should be presented to younger patients with a contralateral normal-hearing ear who experience persistent complications. Patients with persistent infection in the absence of soft tissue overgrowth would especially benefit from enhanced counseling on proper hygiene.