Diversity of US participants in AstraZeneca-sponsored clinical trials.

BACKGROUND: To develop medicines that are safe and efficacious to all patients, clinical trials must enroll appropriate target populations, but imbalances related to race, ethnicity and sex have been reported. A comprehensive analysis and improvement in understanding representativeness of patient enrollment in industry-sponsored trials are key public health needs. METHODS: We assessed race/ethnicity and sex representation in AstraZeneca (AZ)-sponsored clinical trials in the United States (US) from 2010 to 2022, compared with the 2019 US Census. RESULTS: In total, 246 trials representing 95,372 patients with complete race/ethnicity and sex records were analyzed. The proportions of different race/ethnicity subgroups in AZ-sponsored clinical trials and the US Census were similar (White: 69.5% vs 60.1%, Black or African American: 13.3% vs 12.5%, Asian: 1.8% vs 5.8%, Hispanic: 14.4% vs 18.5%). We also observed parity in the proportions of males and females between AZ clinical trials and US Census (males: 52.4% vs 49.2%, females: 47.6% vs 50.8%). Comparisons of four distinct therapy areas within AZ (Respiratory and Immunology [R&I]; Cardiovascular, Renal, and Metabolism [CVRM]; Solid Tumors; and Hematological Malignancies), including by trial phases, revealed greater variability, with proportions observed above and below US Census levels. CONCLUSION: This analysis provides the first detailed insights into the representativeness of AZ trials. Overall, the proportions of different race/ethnicity and sex subgroups in AZ-sponsored clinical trials were broadly aligned with the US Census. We outline some of AZ's planned health equity initiatives that are intended to continue to improve equitable patient enrollment.

Development of hypothyroidism following hemithyroidectomy: A population-based study.

PURPOSE: Hypothyroidism is a known possibility after hemithyroidectomy, with a highly variable incidence in the literature ranging from 8 to 60 %. Incidence of hypothyroidism after hemithyroidectomy was evaluated with a secondary aim to assess incidence in patients with Hashimoto's disease. MATERIALS & METHODS: A retrospective study using the TriNetX global federated research network was performed. We included patients within the last 15 years that were ≥18 years of age and had Current Procedural Terminology codes for hemithyroidectomy. Patients were excluded if they had a total or completion thyroidectomy at any time, a history of thyroid cancer, were preoperatively either on levothyroxine, diagnosed with hypothyroidism, or had a Thyroid Stimulating Hormone ≥ 4 m[IU]/L. We assessed the 3 month incidence of hypothyroidism postoperatively based on the International Classification of Diseases code, TSH ≥ 4 m[IU]/L, or taking levothyroxine after surgery. RESULTS: 6845 patients met the inclusion criteria. Most of the cohort was female (67 %) and white (63 %). The mean age at surgery for this population was 54 ± 14.8 years. During the 15 years of data, we found the 3-month incidence of hypothyroidism following hemithyroidectomy to be 23.58 %. The median time to develop the disease was 41.8 months. A subgroup analysis of those with Hashimoto's revealed a 3-month incidence of 31.1 % of patients developing hypothyroidism after surgery. CONCLUSIONS: This population-based study gives additional insight into the incidence of hypothyroidism after hemithyroidectomy. This will help improve perioperative patient counseling and management.

Bell's Palsy and COVID-19: Insights from a Population-Based Analysis.

Background: Coronavirus disease 2019 (COVID-19) has been linked to Bell's palsy and facial paralysis. Studies have also shown increased risk of Bell's palsy in unvaccinated COVID-19 patients. Objective: To compare the relationship between Bell's palsy and COVID-19 infection and vaccination. Design: This is a retrospective longitudinal study. Methods: The COVID-19 research network was used to identify patients with facial palsy presenting to 70 health care organizations in the United States. The incidence of Bell's palsy was measured within an 8-week window after COVID-19 test or vaccination event in identified patients. Results: Incidence of facial palsy diagnosis (0.99%) was higher than the background rate within 2 months of COVID-19 infection. When compared with their negative counterparts, patients with COVID-19 infection had significantly higher risk of Bell's palsy (risk ratio [RR] = 1.77, p < 0.01) and facial weakness (RR = 2.28, p < 0.01). Risk ratio was also amplified when evaluating Bell's palsy (RR = 12.57, p < 0.01) and facial palsy (RR = 44.43; p < 0.01) in COVID-19-infected patients against patients who received COVID-19 vaccination. Conclusion: In our patient population, there is a higher risk of developing facial palsy within 2 months of COVID-19 infection versus vaccination. Vaccinated patients are not at higher risk of developing facial palsy.

The Development of Head and Neck Cancer in Patients with the Isolated Complaint of Globus Pharyngeus.

OBJECTIVES: Globus pharyngeus (GP) is a perplexing problem that accounts for 4% of referrals to otolaryngologists. Workup can be extensive and may not be definitive in terms of etiology. The concern that lingers is that of a subtle cancer, which can prolong anxiety and increase testing cost. The aim of this study was to identify the incidence of head and neck cancer (HNC) in patients diagnosed with GP. METHODS: Longitudinal data were captured from two academic institutions, identifying patients with a new diagnosis of globus pharyngeus in 2015. The patient cohort was tracked for at least 4 years to assure follow-up and ability to determine if a HNC developed. Additional demographic data was also collected to determine most common consults, treatments, and testing employed. RESULTS: Excluding patients with previous diagnosis of HNC, 377 patients were identified who presented with GP in 2015 that had at least 4 years of follow-up. Demographics were predominantly women (64.65%), with a mean age of 56.48 years at diagnosis, and the most common provider specialty on the first visit was otolaryngology (39.52%). Four patients ultimately developed HN cancer, for an overall incidence of 1% for the 4-year period of 2015-2019. CONCLUSIONS: Given the long-term follow-up of this population, the overall incidence of developing a head and neck cancer, with a presenting symptom of globus, is low. This is the largest study to date to report the percentage of patients endorsing GP to then subsequently develop HNC. This helps otolaryngologists to reassure patients who have a normal comprehensive exam, flexible endoscopy, and targeted studies. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1147-1154, 2024.

Comparison of the incidence of smell and taste disorders between influenza and COVID-19.

OBJECTIVE: Smell and taste disorders among patients with COVID-19 has become increasingly reported in the literature, however the prevalence varies. Post-infectious respiratory dysfunction has also been linked to influenza. In this study, we aimed to compare the rates of smell and taste disorders between COVID-19 and Influenza in unvaccinated patients. STUDY DESIGN: Retrospective cohort study. SETTING: TriNetX research network. METHODS: Two queries were made on 7/1/2023 to include Influenza without a diagnosis of COVID-19 and a COVID-19 without a diagnosis of Influenza. The queries included patients from January 1 to December 31, 2022 from 102 Healthcare Organizations. The resultant population of patients with ICD-10 codes for COVID-19 and Influenza were matched using demographic characteristics to evaluate the risk of smell disorders. RESULTS: The overall 3-month incidence of smell and taste disorders was 0.73 % in the COVID-19 population and 0.1 % in the influenza population. The 3-month matched risk ratios were 11.1 [95 % CI (8.8,13.8)]; p < 0.001) times higher for disorders of the smell and taste secondary to COVID-19 compared to influenza. CONCLUSIONS: Disorders of the smell and taste are more common among patients with COVID-19 compared to patients with Influenza. Beyond smell loss, patients experience additional nasal and sinus-related rhinological symptoms, pointing to COVID-19's and influenza's wider impact on overall rhinological health. We believe that due to the transient nature of these disorders, they might go underreported.

A Systematic Review of Peritonsillar Abscess Simulators: Enhancing Training and Identifying the Need for Standardization.

OBJECTIVES: To systematically review the literature regarding previously described peritonsillar abscess (PTA) drainage simulation. DATA SOURCES: PubMed, Scopus, Web of Science, Ovid, and Cochrane. REVIEW METHODS: A search of the abovementioned databases was performed in August 2022 using the terms "peritonsillar abscess/quinsy," "incision/drainage/aspiration," and "simulation." No time restrictions were applied. We included studies that clearly described how their PTA models were built and underwent validation from experts and/or evaluation from trainees. Articles describing a model only without any evaluation and reports in languages other than English were excluded. RESULTS: Our search initially yielded 80 articles after duplicate removal, 10 of which met our criteria and were included. Two studies trained participants on both needle aspiration and incision and drainage (I&D), four studies on I&D only, and four on needle aspiration only. 87.5% to 100% of junior residents reported minimal exposure to PTA prior to simulation. Five studies provided some form of validation to their models. The value of the simulators to train participants on skills received better appreciation than their anatomical fidelity. The perceived confidence level of trainees in managing PTA, which was assessed in 7 studies, substantially improved after training. CONCLUSION: PTA simulation improves the confidence of trainees to perform PTA drainage. There is, however, a lack of standardization and evidence regarding transfer validity among PTA simulators. The development of a standardized PTA simulator could allow for more widespread use and increase resident comfort with this procedure in a pre-clinical setting. LEVEL OF EVIDENCE: NA Laryngoscope, 2023.

The Distribution of Eight Antimicrobial Resistance Genes in Streptococcus oralis, Streptococcus sanguinis, and Streptococcus gordonii Strains Isolated from Dental Plaque as Oral Commensals.

It has been proposed that oral commensal bacteria are potential reservoirs of a wide variety of antimicrobial resistance genes (ARGs) and could be the source of pathogenic bacteria; however, there is scarce information regarding this. In this study, three common streptococci of the mitis group (S. oralis, S. sanguinis, and S. gordonii) isolated from dental plaque (DP) were screened to identify if they were frequent reservoirs of specific ARGs (blaTEM, cfxA, tetM, tetW, tetQ, ermA, ermB, and ermC). DP samples were collected from 80 adults; one part of the sample was cultured, and from the other part DNA was obtained for first screening of the three streptococci species and the ARGs of interest. Selected samples were plated and colonies were selected for molecular identification. Thirty identified species were screened for the presence of the ARGs. From those selected, all of the S. sanguinis and S. oralis carried at least three, while only 30% of S. gordonii strains carried three or more. The most prevalent were tetM in 73%, and blaTEM and tetW both in 66.6%. On the other hand, ermA and cfxA were not present. Oral streptococci from the mitis group could be considered frequent reservoirs of specifically tetM, blaTEM, and tetW. In contrast, these three species appear not to be reservoirs of ermA and cfxA.

Examining the relationship between COVID-19 and Bell's palsy: Experience of a single tertiary care center.

BACKGROUND: While the etiology of Bell's palsy (BP) is largely unknown, current evidence shows it may occur secondary to the immune response following a viral infection. Recently, BP has been reported as a clinical manifestation of coronavirus disease (COVID-19). OBJECTIVES: To investigate an association between COVID-19 infection and BP. Additionally, to evaluate the need for COVID-19 testing in patients who present with BP. METHODS: Hospital records of patients who presented to a single tertiary care center with BP in 2020 and 2021 were reviewed for presenting symptoms, demographics, COVID-19 infection and vaccination status. RESULTS: There was no statistically significant difference between patients with BP who had a positive or negative COVID test in terms of sex, BMI, age, race, smoking history or alcohol use. All 7 patients with BP and a positive COVID test were unvaccinated. Of the total cohort of 94 patients, 82 % were unvaccinated at the time of the study. None of the 17 patients who were vaccinated had a positive COVID test. A history of BP showed no statistical significance (10.3 % vs 14.3 %, p-value 0.73). CONCLUSION: We discovered a limited cohort of patients who underwent COVID-19 testing at the time of presentation for BP. Though there have been recent studies suggesting a COVID-19 and BP, we were unable to clearly identify a relationship between COVID-19 and BP. Interestingly, all patients with facial paralysis and COVID-19 were unvaccinated. To further study this relationship, we recommend consideration of a COVID-19 test for any patient that presents with facial paralysis.

Global Economic Burden Associated with Chronic Kidney Disease: A Pragmatic Review of Medical Costs for the Inside CKD Research Programme.

INTRODUCTION: Chronic kidney disease (CKD) is a progressive disease of growing prevalence, posing serious concerns for global public health. While the economic burden of CKD is substantial, data on the cost of CKD is limited, despite growing pressures on healthcare systems. In this review, we summarise the available evidence in 31 countries and regions and compile a library of costing methodology and estimates of CKD management and disease-associated complications across 31 countries/regions within the Inside CKD programme. METHODS: We collected country/region-specific CKD costs via a pragmatic rapid literature review of local literature and engagement with local experts. We extracted cost data and definitions from identified sources for CKD stages G3a-5, kidney failure with replacement therapy by modality, covering haemodialysis, peritoneal dialysis, and kidney transplants, and disease-associated complications in local currency, converted to United States dollars (USD) and inflated to 2022. RESULTS: Annual direct costs associated with CKD management rose by an average factor of 4 in each country/region upon progression from stage G3a to G5. Mean annual costs per patient increased considerably more from early stages versus dialysis (stage G3a, mean: $3060 versus haemodialysis, mean: $57,334; peritoneal dialysis, mean: $49,490); with estimates for annual costs of transplant also substantially higher (incident: $75,326; subsequent: $16,672). The mean annual per patient costs of complications were $18,294 for myocardial infarction, $8463 for heart failure, $10,168 for stroke and $5975 for acute kidney injury. Costing definitions varied widely in granularity and/or definition across all countries/regions. CONCLUSION: Globally, CKD carries a significant economic burden, which increases substantially with increasing disease severity. We identified significant gaps in published costs and inconsistent costing definitions. Cost-effective interventions that target primary prevention and disease progression are essential to reduce CKD burden. Our results can be used to guide cost collection and facilitate better comparisons across countries/regions to inform healthcare policy.

Prognostic significance of time trends in treatment of head and neck squamous cell carcinoma.

PURPOSE: To analyze the impact of demographic, clinical, and management variables on time to treatment initiation (TTI) and overall survival (OS). STUDY DESIGN: Retrospective chart review. MATERIALS AND METHODS: Medical records of patients diagnosed with head and neck cancer from 2018 to 2020 were reviewed. Univariate linear and Cox-regressions identified predictors of TTI and OS. Kaplan Meier (KM) curves assessed the difference in survival by diagnostic year and TTI. RESULTS: 381 patients met eligibility criteria. Median TTI was 35.0 days (IQR: 25.0-49.0). Only 10.8 % of all patients reported any treatment delay, with TTI exceeding 90 days found in 3.7 % of patients. TTI increased with African American race (p = 0.02), ED referrals (p = 0.02), and direct admission status (p = 0.01). When compared to treatment with surgery alone, TTI was shorter in patients undergoing surgery with adjuvant radiation (p = 0.02), adjuvant chemoradiation (p = 0.04), and salvage surgery (p = 0.04). Univariate Cox-regressions found smoking (p = 0.01), direct admission status (p = 0.02), increased duration of symptoms (p = 0.02), placement of PEG tubes (p < 0.01) and tracheostomies (p < 0.01), combination treatment (p < 0.01), and surgery with adjuvant chemoradiation treatment (p = 0.01) to increase mortality risk. Disease characteristics, including tumor size (p < 0.01), presence of nodal disease (p = 0.02), and late-stage disease (p < 0.01), increased mortality risk. TTI and diagnostic year did not impact survival. CONCLUSIONS: Our analysis determined several demographic, referral, and treatment factors impacted TTI. However, increased TTI did not impact survival. Characteristics consistent with advanced disease worsened OS. Despite the pandemic burden, patients diagnosed in 2020 showed no difference in short-term survival compared to prior years.

Pharmacokinetics of Venetoclax Co-Administered with Posaconazole in Patients with Acute Myeloid Leukemia.

The Food and Drug Administration currently approves the combination of hypomethylating agents (HMA), azacytidine or decitabine with venetoclax (VEN) for acute myeloid leukemia (AML) patients aged more than 75 years and for patients unsuitable for intensive chemotherapy. The risk of fungal infection in the early phase of treatment is not negligible; therefore, posaconazole (PCZ) is commonly administered as primary prophylaxis. A drug-drug interaction between VEN and PCZ is well known, but the trend of serum levels of venetoclax when both drugs are overlapped is not clear. In total, 165 plasma samples from 11 elderly AML patients receiving combined treatment with HMA, VEN and PCZ were analyzed by a validated analytical method (high-pressure liquid chromatography-tandem mass spectrometry). Venetoclax trough plasma concentrations were detected during the 3 days of ramp-up as well as on day 7 and day 12 of treatment when the exposure as the area under the plasma concentration-time curve and the accumulation ratio were also calculated. The results were compared with the expected data for 400 mg/dose VEN administered alone-the confirmed high inter-individual variability in pharmacokinetics suggests the need for therapeutic drug monitoring.

Olfactory dysfunction incidence and resolution amongst 608 patients with COVID-19 infection.

PURPOSE: Olfactory dysfunction (OD) is a common presenting sign of coronavirus-19 (COVID-19) infection and remains persistent in up to 7 % of patients one year after diagnosis. However, demographic, socioeconomic, and medical risk factors for persistent OD are not well understood. This study aims to determine risk factors for development and persistence of OD amongst patients with COVID-19 infection. MATERIALS AND METHODS: This prospective, observational questionnaire study was performed at a tertiary-level, academic center. Patients with history of a positive COVID-19 diagnosis were sent an online questionnaire. Patients' self-reported survey responses for OD and resolution were assessed for associations with demographic variables, socioeconomic factors, and clinical data. RESULTS: In total, 608 of 26,094 patients (77.6 % women, mean age 42.7 ± 17.4 years, range 9 months-92 years) completed the survey. OD was reported by 220 (36.2 %) patients, and 139 (63.2 %) patients achieved resolution. Patients with OD were more likely to have other sinonasal and flu-like symptoms, and had a hospitalization rate of 2.7 %. There were no significant differences in age, gender, occupational or residential factors, or medical comorbidities incidence of OD development. Women reported higher rates of persistent OD (88.9 % vs 77.0 %, p = 0.045). The OD recovery rates amongst active and resolved COVID-19 infections was 27.0 % and 70.0 %, respectively (p < 0.001). CONCLUSIONS: There was a low hospitalization rate amongst patients reporting OD. One-third of patients with COVID-19 self-reported OD, and two-thirds of patients achieve OD resolution. Survey respondents with active COVID-19 infection and female gender were more likely to report persistent OD.

Somatic mutations of CADM1 in aldosterone-producing adenomas and gap junction-dependent regulation of aldosterone production.

Aldosterone-producing adenomas (APAs) are the commonest curable cause of hypertension. Most have gain-of-function somatic mutations of ion channels or transporters. Herein we report the discovery, replication and phenotype of mutations in the neuronal cell adhesion gene CADM1. Independent whole exome sequencing of 40 and 81 APAs found intramembranous p.Val380Asp or p.Gly379Asp variants in two patients whose hypertension and periodic primary aldosteronism were cured by adrenalectomy. Replication identified two more APAs with each variant (total, n = 6). The most upregulated gene (10- to 25-fold) in human adrenocortical H295R cells transduced with the mutations (compared to wildtype) was CYP11B2 (aldosterone synthase), and biological rhythms were the most differentially expressed process. CADM1 knockdown or mutation inhibited gap junction (GJ)-permeable dye transfer. GJ blockade by Gap27 increased CYP11B2 similarly to CADM1 mutation. Human adrenal zona glomerulosa (ZG) expression of GJA1 (the main GJ protein) was patchy, and annular GJs (sequelae of GJ communication) were less prominent in CYP11B2-positive micronodules than adjacent ZG. Somatic mutations of CADM1 cause reversible hypertension and reveal a role for GJ communication in suppressing physiological aldosterone production.

Tympanoplasty in the Setting of Complex Middle Ear Pathology: A Systematic Review.

OBJECTIVE: To assess the prognostic factors for anatomic and hearing success after tympanoplasty in the setting of complex middle ear pathology. METHODS: A systematic review was performed in January 2022. English-language articles describing outcome data for tympanoplasty repair variables including underlying pathology, perforation location, smoking status, graft technique, reconstruction material, anatomic success, and hearing success were extracted. Articles were included when tympanosclerosis, retraction pockets, adhesions, cholesteatoma, chronic suppurative otitis media, anterior perforations, and smoking were included. Underlying pathology, perforation location, smoking status, graft technique, reconstruction material, anatomic success, and hearing success were extracted. Any factors analyzed as potential indicators of success were sought out. RESULTS: Data sources included PubMed, OVID, Cochrane, Web of Science, Scopus, and manual search of bibliographies. Ninety-three articles met final criteria, which accounted for 6685 patients. Fifty articles presented data on both anatomic and hearing outcomes, 32 articles presented data on anatomic outcomes only, and 11 articles presented data on hearing outcomes only. This systematic review found that adhesions and tympanosclerosis were prognostic factors for poorer hearing. Additionally, smoking and tympanosclerosis may be predictive of anatomic failure; however, the significance of this finding was mixed in included studies. This analysis is significantly limited by both the heterogeneity within the patients and the lack of controls. CONCLUSION: Adhesions and tympanosclerosis were prognostic factors for poorer hearing. Clearly documented methods and outcomes for the included pathologies could lead to more definitive conclusions regarding prognostic factors for success. LEVEL OF EVIDENCE: 3B.

Incidence and medical complications of COVID-19 in the total laryngectomy population: A population-based study.

OBJECTIVES: Laryngeal and hypopharyngeal cancers treated with total laryngectomy (TL) may provide a unique avenue for COVID-19 to infect cancer patients. The objective of this investigation was to identify incidence of COVID-19 infection and potential complications in TL patients. MATERIALS AND METHODS: Data was extracted from TriNetX COVID-19 research network from from 2019 to 2021 and ICD-10 codes were utilized to query for laryngeal or hypopharyngeal cancer, and outcomes of interest. Cohorts were propensity score-matched based on demographics and co-morbidities. RESULTS: A query of active patients in TriNetX from January 1, 2019 to December 31, 2021 identified 36,414 patients with laryngeal or hypopharyngeal cancer out of the 50,474,648 active patients in the database. The overall COVID-19 incidence in the non-laryngeal or hypopharyngeal cancer population was 10.8% compared to 18.8% (p < 0.001) in the laryngeal and hypopharyngeal cancer group. Those who underwent TL had a statistically significant increased incidence of acquiring COVID-19 (24.0%) when compared to those without TL (17.7%) (p < 0.001). TL patients with COVID-19 had a higher risk of developing pneumonia RR (risk ratio) 1.80 (1.43, 2.26), death 1.74 (1.41, 2.14), ARDS 2.42 (1.16, 5.05), sepsis 1.77 (1.37, 2.29), shock 2.81 (1.88, 4.18), respiratory failure 2.34 (1.90, 2.88), and malnutrition 2.46 (2.01, 3.01) when matched with those COVID-19 positive cancer patients without TL. CONCLUSIONS: Laryngeal and hypopharyngeal cancer patients had a higher rate of acquiring COVID-19 than patients without these cancers. TL patients have a higher rate of COVID-19 compared to those without TL and may be at a higher risk for sequalae of COVID-19.

Transmission risk of COVID-19 infection with office-based flexible laryngoscopy.

Since the beginning of the Coronavirus pandemic, recommendations to ensure safety in clinical practice have fluctuated. Within the Otolaryngology community, a variety of protocols have emerged to assure safety for both patients and healthcare workers while maintaining standard of care practices, especially surrounding aerosolizing in-office procedures. OBJECTIVES: This study aims to describe our Otolaryngology Department's Personal Protective Equipment protocol for both patients and providers during office laryngoscopy and to identify the risk of contracting COVID-19 after implementation of the protocol. METHODS: 18,953 office visits divided between 2019 and 2020 where laryngoscopy was performed were examined and compared to the rate of COVID-19 contraction for both office staff and patients within a 14 day period after the encounter. Of these visits, two cases were examined and discussed; where a patient tested positive for COVID-19 ten days after office laryngoscopy, and one where a patient tested positive for COVID-19 ten days prior to office laryngoscopy. RESULTS: In the year 2020, 8337 office laryngoscopies were performed, 100 patients tested positive within the year 2020, with only these 2 cases of COVID-19 infections occurring within 14 days prior to or after their office visit. CONCLUSION: These data suggest that using CDC-compliant protocol for aerosolizing procedures, such as office laryngoscopy, can provide a safe and effective method for mitigating infectious risk while providing timely quality care for the otolaryngology patient. LEVEL OF EVIDENCE: 3 LAY SUMMARY: During the COVID-19 Pandemic, ENTs have had to balance providing care while minimizing the risk of COVID-19 transmission with routine office procedures such as flexible laryngoscopy. In this large chart review, we show that the risk of transmission is low with CDC-compliant protective equipment and cleaning protocols.

[11C]metomidate PET-CT versus adrenal vein sampling for diagnosing surgically curable primary aldosteronism: a prospective, within-patient trial.

Primary aldosteronism (PA) due to a unilateral aldosterone-producing adenoma is a common cause of hypertension. This can be cured, or greatly improved, by adrenal surgery. However, the invasive nature of the standard pre-surgical investigation contributes to fewer than 1% of patients with PA being offered the chance of a cure. The primary objective of our prospective study of 143 patients with PA ( NCT02945904 ) was to compare the accuracy of a non-invasive test, [11C]metomidate positron emission tomography computed tomography (MTO) scanning, with adrenal vein sampling (AVS) in predicting the biochemical remission of PA and the resolution of hypertension after surgery. A total of 128 patients reached 6- to 9-month follow-up, with 78 (61%) treated surgically and 50 (39%) managed medically. Of the 78 patients receiving surgery, 77 achieved one or more PA surgical outcome criterion for success. The accuracies of MTO at predicting biochemical and clinical success following adrenalectomy were, respectively, 72.7 and 65.4%. For AVS, the accuracies were 63.6 and 61.5%. MTO was not significantly superior, but the differences of 9.1% (95% confidence interval = -6.5 to 24.1%) and 3.8% (95% confidence interval = -11.9 to 9.4) lay within the pre-specified -17% margin for non-inferiority (P = 0.00055 and P = 0.0077, respectively). Of 24 serious adverse events, none was considered related to either investigation and 22 were fully resolved. MTO enables non-invasive diagnosis of unilateral PA.

Temporal Bone Resection for Squamous Cell Carcinoma of the Lateral Skull Base: Systematic Review and Meta-analysis.

OBJECTIVE: Temporal bone squamous cell carcinoma (TBSCC) is rare and often confers a poor prognosis. The aim of this study was to synthesize survival and recurrence outcomes data reported in the literature for patients who underwent temporal bone resection (TBR) for curative management of TBSCC. We considered TBSCC listed as originating from multiple subsites, including the external ear, parotid, and external auditory canal (EAC), or nonspecifically from the temporal bone. DATA SOURCES: PubMed, Cochrane Library, Embase, and manual search of bibliographies. REVIEW METHOD: A systematic literature review conducted in December 2020 according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Survival data were collected from 51 retrospective studies, resulting in a pooled cohort of 501 patients with TBSCC. Compared to patients undergoing lateral TBR (LTBR), patients undergoing subtotal (SBTR) or total (TTBR) TBR exhibited significantly higher rates of stage IV disease (P < .001), positive surgical margins (P < .001), facial nerve involvement (P < .001), and recurrent disease (P < .001). A meta-analysis of 15 studies revealed a statistically significant 97% increase in mortality in patients who underwent STBR or TTBR. On multivariate analysis, recurrent disease was independently associated with worse overall survival (P < .001). On univariate analysis, facial nerve involvement was also associated with decreased overall survival (P < .001). CONCLUSION: Recurrent disease was associated with risk of death in patients undergoing TBR. Larger prospective multi-institutional studies are needed to ascertain prognostic factors for a wider array of postoperative outcomes, including histology-specific survival and recurrence outcomes.

A Pediatric Lateral Submental Mass: A Rare Presentation of Dermoid Cyst.

Dermoid cysts are benign cutaneous neoplasms that contain germ cells from the ectoderm and mesoderm. Approximately 70% are diagnosed during childhood before the age of 5. Although they can present throughout the body, the prevalence is 7% for those arising from the head and neck. These lesions present primarily as midline masses and are classified as sublingual, submental, or overlapping depending on their relationship with the muscles of the floor of mouth. A 10-year-old female presented with a 2-week history of right submental swelling. She denied pain, dysphagia, odynophagia, or respiratory distress. Physical examination showed nontender fullness of the submental region without erythema or induration and no palpable cervical lymphadenopathy. Ultrasound showed an oval-shaped cystic mass measuring 4.8 × 4.0 × 2.6 cm. After a course of clindamycin, a computed tomography was obtained which showed a right 4.5 × 4.0 × 2.6 cm fluid filled lesion, within the right lateral floor of mouth. Intraoral resection was performed and the mass was freed from the geniohyoid and mylohyoid. Histopathology was consistent with a dermoid cyst. Submental masses have a broad differential, but rarely are they dermoid cysts if they arise lateral to the midline. With appropriate diagnosis and total surgical excision, patients and their families can be reassured in similar cases.