Socioeconomic Status, Length of Stay, and Postoperative Complications in Oral Cavity Squamous Cell Carcinoma.

Background: Despite universal healthcare in Canada, low socioeconomic status (SES) has been associated with worse survival in oral cavity squamous cell carcinoma (OCSCC) patients. However, the relationship between SES and outcomes during the acute postoperative period is poorly defined. Hamilton, Ontario, presents a unique population with widely varying SES within the same geography. The objective of this study was to examine the relationship between SES, length of hospital stay (LOHS), and postoperative complications in OCSCC. Methods: Newly diagnosed OCSCC patients receiving primary surgical treatment from 2010 to 2014 were identified within a prospectively collected database. Inclusion criteria included age >18 years old, pathological diagnosis of oral cavity cancer, and primary surgical treatment with curative intent. Patients were excluded if they were undergoing palliative treatment or had previous head and neck surgery/radiotherapy. Postal codes were used to identify neighborhood-level socioeconomic variables via 2011 Canada Census data. Income quartiles were defined from groups of neighboring municipalities based on Canada Census definitions. Demographic, social, pathological, staging, and treatment data were collected through chart review. Results: One hundred and seventy-four patients were included in the final analysis. OCSCC patients with lower SES were more likely to be younger (P = .041), male (P = .040), have significant tobacco and alcohol use (P = .001), higher Charlson Comorbidity Index (CCI; P = .014), lower levels of education (P = .001), and have lower employment levels (P = .001). Lower SES patients had higher clinical tumor (P = .006) and clinical nodal (P = .004) staging and were more likely to receive adjuvant therapy (P = .001) and G-tubes (P = .001). Multivariable regression analysis showed that low SES was a statistically significant predictor of postoperative complications [ß 2.50 (95% confidence interval (CI) 0.200, 3.17); P = .014] and LOHS [ß 2.03 (95% CI 1.06, 2.99); P = .0001]. Tobacco and alcohol use, clinical tumor, and nodal stage, CCI, and planned adjuvant therapy were also statistically significant predictors of postoperative complications and LOHS (P < .05). Conclusion: Patients with lower SES have more advanced OCSCC disease with increased comorbidities that owes itself to more acute postoperative complications and LOHS within this study population. Patients with low SES should be identified as patients that require more support during their cancer treatment.

Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

IMPORTANCE: Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. OBJECTIVE: Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. EVIDENCE REVIEW: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. FINDINGS: Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. CONCLUSION AND RELEVANCE: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

The protective role of postoperative radiation therapy in low and intermediate grade major salivary gland malignancies: A study of the Canadian Head and Neck Collaborative Research Initiative.

BACKGROUND: The objective of this study was to examine the utility of postoperative radiation for low and intermediate grade cancers of the parotid and submandibular glands. METHODS: The authors conducted a retrospective, Canadian-led, international, multi-institutional analysis of a patient cohort with low or intermediate grade salivary gland cancer of the parotid or submandibular gland who were treated from 2010 until 2020 with or without postoperative radiation therapy. A multivariable, marginal Cox proportional hazards regression analysis was performed to quantify the association between locoregional recurrence (LRR) and receipt of postoperative radiation therapy while accounting for patient-level factors and the clustering of patients by institution. RESULTS: In total, 621 patients across 14 tertiary care centers were included in the study; of these, 309 patients (49.8%) received postoperative radiation therapy. Tumor histologies included 182 (29.3%) acinic cell carcinomas, 312 (50.2%) mucoepidermoid carcinomas, and 137 (20.5%) other low or intermediate grade primary salivary gland carcinomas. Kaplan-Meier LRR-free survival at 10 years was 89.0% (95% confidence interval [CI], 84.9%-93.3%). In multivariable Cox regression analysis, postoperative radiation therapy was independently associated with a lower hazard of LRR (adjusted hazard ratio, 0.53; 95% CI, 0.29-0.97). The multivariable model estimated that the marginal probability of LRR within 10 years was 15.4% without radiation and 8.8% with radiation. The number needed to treat was 16 patients (95% CI, 14-18 patients). Radiation therapy had no benefit in patients who had early stage, low-grade salivary gland cancer without evidence of nodal disease and negative margins. CONCLUSIONS: Postoperative radiation therapy may reduce LLR in some low and intermediate grade salivary gland cancers with adverse features, but it had no benefit in patients who had early stage, low-grade salivary gland cancer with negative margins.

Attitudes Toward and Acceptability of Medical Marijuana Use Among Head and Neck Cancer Patients.

OBJECTIVE: This study aims to understand the attitudes toward marijuana in HNC patients. METHODS: A 17-question questionnaire regarding medical marijuana (MM) was distributed to HNC patients at a tertiary cancer center. RESULTS: 63 HNC patients completed the questionnaire. Patients that had used or were using marijuana described benefit with symptoms of headache, pain, nausea, and loss of appetite. 83% of all patients considered marijuana as treatment for cancer related pain and 67% as treatment for cancer related anxiety. About 70% of patients actively undergoing cancer treatment believed marijuana medications would help with symptoms during treatment. CONCLUSIONS: By understanding how HNC patients perceive MM, HNC teams may be able to prescribe and educate their patients on MM.

Post-operative survival in head and neck cancer patients with elevated troponins.

OBJECTIVES: The strenuous demands of head and neck cancer surgery (HNS) place patients at increased risk of myocardial injury. Troponin positivity (TP) post-operatively is a predictor of increased complications and mortality. The present study is the first to investigate the effects of TP on potential delays in adjuvant treatment and disease-specific survival. DESIGN, SETTING, PARTICIPANTS AND MAIN OUTCOME MEASURES: All patients undergoing HNS from 2014 to 2016 had troponins measured at a single academic centre. Relevant patient data was extracted on retrospective chart review. The main outcome measures were the impact of TP on timing of adjuvant treatment and disease-specific survival. RESULTS: Of 166 patients, 26 (15.6%) developed TP post-operatively. There was no significant difference between cohorts for baseline characteristics except for age. Overall and disease-specific survival for TP patients were respectively 45.9% and 57.4% at 3 years. There was no significant difference between cohorts for overall and disease-specific survival, and time to adjuvant therapy. CONCLUSION: No significant association was found between TP and overall and disease-specific survival, and time to adjuvant therapy.

Inter-Rater Reliability of Thyroid Ultrasound Risk Criteria: A Systematic Review and Meta-Analysis.

OBJECTIVE: The most commonly employed diagnostic criteria for identifying thyroid nodules include Thyroid Imaging and Reporting Data System (TI-RADS) and American Thyroid Association (ATA) guidelines. The purpose of this systematic review and meta-analysis is to determine the inter-rater reliability of thyroid ultrasound criteria. METHODS: We performed a library search of MEDLINE (Ovid), EMBASE (Ovid), and Web of Science for full-text articles published from January 2005 to June 2022. We included full-text primary research articles that used TI-RADS and/or ATA guidelines to evaluate thyroid nodules in adults. These included studies must have calculated inter-rater reliability using any validated metric. The Quality Appraisal for Reliability Studies (QAREL) was used to assess study quality. We planned for a random-effects meta-analysis, in addition to covariate and publication bias analyses. This study was performed in accordance with Preferred Reporting Items for a Systematic Review and Meta-analysis guidelines and registered prior to conduction (International prospective register of systematic reviews-PROSPERO: CRD42021275072). RESULTS: Of the 951 articles identified via the database search, 35 met eligibility criteria. All studies were observational. The most commonly utilized criteria were ACR Thyroid Imaging and Reporting Data System (TI-RADS) and/or ATA criteria, while the majority of studies employed Κ statistics. For ACR TI-RADS, the pooled Κ was 0.51 (95% confidence interval [CI]: 0.42, 0.57; n = 7) while for ATA, the pooled Κ was 0.52 (95% CI: 0.37, 0.67; n = 3). Due to the small number of studies, covariate or publication bias analyses were not performed. CONCLUSION: Ultrasound criteria demonstrate moderate inter-rater reliability, but these findings are impacted by poor study quality and a lack of standardization. Laryngoscope, 133:485-493, 2023.

Intraoperative parathyroid hormone monitoring in parathyroidectomy for hyperparathyroidism: a protocol for a network meta-analysis of diagnostic test accuracy.

Intraoperative parathyroid hormone (iPTH) monitoring is standard-of-care in the surgical management of hyperparathyroidism. It involves real-time determination of circulating PTH levels to guide parathyroid gland excision. There exists several iPTH monitoring criteria, such as the Miami criteria, and a lack of standardization in the timing of post-parathyroid gland excision samples. We present a protocol of a systematic review and network meta-analysis of diagnostic test accuracy to identify the iPTH criteria and post-gland excision timepoint that best predicts surgical cure in hyperparathyroidism. The database search strategy will be developed in conjunction with a librarian specialist. We will perform a search of Medline (Ovid), EMBASE (Ovid), CINAHL, Cochrane Collaboration, and Web of Science from 1990-present. Studies will be eligible if they include adult patients diagnosed with hyperparathyroidism who undergo parathyroidectomy with iPTH monitoring. We will only include studies that report diagnostic test properties for iPTH criteria and/or post-excision sampling timepoints. All screening, full-text review, data extraction, and critical appraisal will be performed in duplicate. Critical appraisal will be performed using QUADAS-2 instrument. A descriptive analysis will present study and critical appraisal characteristics. We will perform evaluation of between-study heterogeneity using I2 and Cochrane Q and where applicable, we will perform sensitivity analysis. Our network meta-analysis will include Bayesian hierarchical framework with random effects using multiple models. Ethics approval is not required. This proposed systematic review will utilize a novel Bayesian network meta-analysis model to help standardize iPTH monitoring in hyperparathyroidism, thereby optimizing patient outcomes and healthcare expenditures.

Multidisciplinary Practice Variations of Anti-Thrombotic Strategies for Free Tissue Transfers.

Background: Venous thrombosis, the leading cause of free flap failure, may have devastating consequences. Many anti-thrombotic agents and protocols have been described for prophylaxis and treatment of venous thrombosis in free flaps. Methods: National surveys were distributed to microsurgeons (of both Plastics and ENT training) and hematology and thrombosis specialists. Data were collected on routine screening practices, perceived risk factors for flap failure, and pre-, intra-, and post-operative anti-thrombotic strategies. Results: There were 722 surveys distributed with 132 (18%) respondents, consisting of 102 surgeons and 30 hematologists. Sixty-five surgeons and 9 hematologists routinely performed or managed patients with free flaps. The top 3 perceived risk factors for flap failure according to surgeons were medical co-morbidities, past arterial thrombosis, and thrombophilia. Hematologists, however, reported diabetes, smoking, and medical co-morbidities as the most important risk factors. Fifty-four percent of physicians routinely used unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) as a preoperative agent. Surgeons routinely flushed the flap with heparin (37%), used UFH IV (6%), or both (8%) intra-operatively. Surgeons used a range of post-operative agents such as UFH, LMWH, aspirin, and dextran while hematologists preferred LMWH. There was variation of management strategies if flap thrombosis occurred. Different strategies consisted of changing recipient vessels, UFH IV, flushing the flap, adding post-operative agents, or a combination of strategies. Conclusions: There are diverse practice variations in anti-thrombotic strategies for free tissue transfers and a difference in perceived risk factors for flap failure that may affect patient management.

Contexte: La thrombose veineuse, principale cause de l'échec des volets libres, peut avoir des conséquences catastrophiques. De nombreux agents et protocoles antithrombotiques ont été décrits pour la prévention et le traitement de la thrombose veineuse dans les volets libres. Méthodes: Des enquêtes nationales ont été distribuées à des chirurgiens spécialistes de microchirurgie (ayant à la fois une formation en chirurgie plastique et ORL) et à des spécialistes en hématologie et thrombose. Les données collectées ont porté sur les pratiques usuelles de sélection, les facteurs de risque perçus d'échec des volets, ainsi que sur les stratégies antithrombotiques pré-, per- et postopératoires. Résultats: Sur les 722 enquêtes distribuées, il y a eu 132 répondants (18 %) consistant en 102 chirurgiens et 30 hématologistes. Soixante-cinq chirurgiens et neuf hématologues réalisent ou gèrent régulièrement des patients avec des volets libres. Les trois plus importants facteurs de risque perçus d'échec du volet, selon les chirurgiens, étaient les comorbidités médicales, un antécédent de thrombose artérielle et la thrombophilie. De leur côté, les hématologues ont indiqué que le diabète, le tabagisme et les comorbidités médicales étaient les facteurs de risque les plus importants. Cinquante-quatre pour cent des médecins utilisent régulièrement de l'héparine non fractionnée ou de l'héparine de bas poids moléculaire (HBPM) comme agent préopératoire. Les chirurgiens rincent régulièrement le volet à l'héparine (37 %), utilisent de l'héparine non fractionnée par voie IV (6 %) ou les deux (8 %) en peropératoire. Les chirurgiens utilisent un éventail d'agents postopératoires, tels que l'héparine non fractionnée, l'HBPM, l'aspirine et le dextran tandis que les hématologues préfèrent l'HBPM. Des variations dans les stratégies de gestion ont été observées en cas de survenue d'une thrombose du volet. Différentes stratégies ont consisté à changer les vaisseaux receveurs, administrer de l'héparine non fractionnée IV, rincer le volet, ajouter des agents postopératoires, ou combiner ces stratégies. Conclusions: Il y a différentes variations dans la pratique de stratégies antithrombotiques pour les transferts de tissus libres et une différence dans les facteurs de risque perçus d'échec du volet qui peuvent avoir des répercussions sur la gestion des patients.

Bilateral Vocal Cord Paralysis Secondary to Leptomeningeal Metastases With Unknown Primary Malignancy: A Case Report and Review of the Literature.

Bilateral vocal cord paralysis (BVCP) most commonly occurs secondary to iatrogenic injury and/or malignancy, but can also be a consequence of central nervous system (CNS) pathology. We report a case of BVCP secondary to leptomeningeal consequence in the context of unknown primary malignancy. The aim of this report is to promote awareness for BVCP caused by rare CNS pathology and highlight the importance of complete neoplastic and paraneoplastic workups in new-onset BVCP with unclear etiology. Here, we present a case report and review of the literature. A 68-year-old female presented with new-onset BVCP in the context of progressive dysphagia in addition to rectal and urinary incontinence. She underwent an awake tracheostomy. Her infectious and paraneoplastic workups did not identify a cause for her BVCP. Her brain MRI demonstrated enhancement of multiple cranial nerves, spine MRI demonstrated leptomeningeal enhancement, and cerebrospinal fluid (CSF) cytology was positive for metastatic adenocarcinoma. Her functional status was poor and she was deemed ineligible for chemotherapy and transitioned to palliative care. She died three months following her hospital admission. Leptomeningeal metastasis is a rare cause of new-onset BVCP. Airway management remains a critical component in BVCP. The sudden onset of BVCP in the context of generalized neurologic symptoms or cranial nerve deficits should prompt complete neoplastic and paraneoplastic investigation.

Ultrasonography and Fine-Needle Aspiration in Indeterminate Thyroid Nodules: A Systematic Review of Diagnostic Test Accuracy.

OBJECTIVES/HYPOTHESIS: Sonographic risk criteria may assist in further prognostication of indeterminate thyroid nodules (ITNs). Our aim was to determine whether sonographic criteria could further delineate the post-test probability of malignancy in ITNs. STUDY DESIGN: Meta-analysis of diagnostic test accuracy. METHODS: A systematic review of Web of Science, MEDLINE, EMBASE, and CINAHL was performed from inception to April 15, 2021. Eligible studies included those which reported ultrasonographic evaluations with the American Thyroid Association (ATA) or the Thyroid Imaging Reporting and Data System (TIRADS) in adult patients with ITNs. ATA or TIRADS were scored as low (negative) or high (positive) malignancy risk using a previously validated binary classification. Primary outcomes included pooled sensitivity, specificity, likelihood ratios, and diagnostic odds ratio for all sonographic criteria. Studies were appraised using Quality Assessment of Diagnostic Accuracy Studies and the data were pooled using bivariate random-effects models. RESULTS: Seventeen studies were included in the analysis. For Bethesda III, ATA had a specificity (0.90, 95% confidence interval (CI): 0.74-0.94), but a sensitivity of 0.52 (95% CI: 0.25-0.77). Conversely, K-TIRADS had the highest sensitivity (0.78, 95% CI: 0.62-0.89) with a specificity of 0.53 (95% CI: 0.31-0.74). Furthermore, American College of Radiology and EU TIRADS had specificities of 0.60 (95% CI: 0.36-0.80) and 0.81 (95% CI: 0.73-0.87) with sensitivities of 0.70 (95% CI: 0.37-0.90) and 0.38 (95% CI: 0.20-0.60), respectively. There were few studies with Bethesda IV nodules. CONCLUSIONS: Though dependent on malignancy rates, Bethesda III nodules with low-suspicion TIRADS features may benefit from clinical observation, whereas nodules with high-suspicion ATA features may require molecular testing and/or surgery. LEVEL OF EVIDENCE: NA Laryngoscope, 132:242-251, 2022.

Diagnostic Test Accuracy of Ultrasonography vs Computed Tomography for Papillary Thyroid Cancer Cervical Lymph Node Metastasis: A Systematic Review and Meta-analysis.

Importance: The use of ultrasonography (US) vs cross-sectional imaging for preoperative evaluation of papillary thyroid cancer is debated. Objective: To compare thyroid US and computed tomography (CT) in the preoperative evaluation of papillary thyroid cancer for cervical lymph node metastasis (CLNM), as well as extrathyroidal disease extension. Data Sources: MEDLINE and Embase were searched from January 1, 2000, to July 18, 2020. Study Selection: Studies reporting on the diagnostic accuracy of US and/or CT in individuals with treatment-naive papillary thyroid cancer for CLNM and/or extrathyroidal disease extension were included. The reference standard was defined as histopathology/cytology or imaging follow-up. Independent title and abstract review (2515 studies) followed by full-text review (145 studies) was completed by multiple investigators. Data Extraction and Synthesis: PRISMA guidelines were followed. Methodologic and diagnostic accuracy data were abstracted independently by multiple investigators. Risk of bias assessment was conducted using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool independently and in duplicate. Bivariate random-effects model meta-analysis and multivariable meta-regression modeling was used. Main Outcomes and Measures: Diagnostic test accuracy of US and CT of the neck for lateral and central compartment CLNM, as well as for extrathyroidal disease extension, determined prior to study commencement. Results: A total of 47 studies encompassing 31 942 observations for thyroid cancer (12 771 with CLNM; 1747 with extrathyroidal thyroid extension) were included; 21 and 26 studies were at low and high risk for bias, respectively. Based on comparative design studies, US and CT demonstrated no significant difference in sensitivity (73% [95% CI, 64%-80%] and 77% [95% CI, 67%-85%], respectively; P = .11) or specificity (89% [95% CI, 80%-94%] and 88% [95% CI, 79%-94%], respectively; P = .79) for lateral compartment CLNM. For central compartment metastasis, sensitivity was higher in CT (39% [95% CI, 27%-52%]) vs US (28% [95% CI, 21%-36%]; P = .004), while specificity was higher in US (95% [95% CI, 92%-98%]) vs CT (87% [95% CI, 77%-93%]; P < .001). Ultrasonography demonstrated a sensitivity of 91% (95% CI, 81%-96%) and specificity of 47% (95% CI, 35%-60%) for extrathyroidal extension. Conclusions and Relevance: The findings of this systematic review and meta-analysis suggest that further study is warranted of the role of CT for papillary thyroid cancer staging, possibly as an adjunct to US.

A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer.

Background: The traditional management of papillary thyroid cancer (PTC) is thyroidectomy (total or partial removal of the thyroid). Active surveillance (AS) may be considered as an alternative option for small, low risk PTC. AS involves close follow-up (including regularly scheduled clinical and radiological assessments), with the intention of intervening with surgery for disease progression or patient preference. Methods: This is a protocol for a prospective, observational, long-term follow-up multi-centre Canadian cohort study. Consenting eligible adults with small, low risk PTC (< 2cm in maximal diameter, confined to the thyroid, and not immediately adjacent to critical structures in the neck) are offered the choice of AS or surgery for management of PTC. Patient participants are free to choose either option (AS or surgery) and the disease management course is thus not assigned by the investigators. Surgery is provided as usual care by a surgeon in an institution of the patient's choice. Our primary objective is to determine the rate of 'failure' of disease management in respective AS and surgical arms as defined by: i) AS arm - surgery for progression of PTC, and ii) surgical arm - surgery or other treatment for disease persistence or progression after completing initial treatment. Secondary outcomes include long-term thyroid oncologic and treatment outcomes, as well as patient-reported outcomes. Discussion: The results from this study will provide long-term clinical and patient reported outcome evidence regarding active surveillance or immediate surgery for management of small, low risk PTC. This will inform future clinical trials in disease management of small, low risk papillary thyroid cancer. Registration details: This prospective observational cohort study is registered on clinicaltrials.gov (NCT04624477), but it should not be considered a clinical trial as there is no assigned intervention and patients are free to choose either AS or surgery.

Association of Tracheostomy With Outcomes in Patients With COVID-19 and SARS-CoV-2 Transmission Among Health Care Professionals: A Systematic Review and Meta-analysis.

Importance: Approximately 5% to 15% of patients with COVID-19 require invasive mechanical ventilation (IMV) and, at times, tracheostomy. Details regarding the safety and use of tracheostomy in treating COVID-19 continue to evolve. Objective: To evaluate the association of tracheostomy with COVID-19 patient outcomes and the risk of SARS-CoV-2 transmission among health care professionals (HCPs). Data Sources: EMBASE (Ovid), Medline (Ovid), and Web of Science from January 1, 2020, to March 4, 2021. Study Selection: English-language studies investigating patients with COVID-19 who were receiving IMV and undergoing tracheostomy. Observational and randomized clinical trials were eligible (no randomized clinical trials were found in the search). All screening was performed by 2 reviewers (P.S. and M.L.). Overall, 156 studies underwent full-text review. Data Extraction and Synthesis: We performed data extraction in accordance with Meta-analysis of Observational Studies in Epidemiology guidelines. We used a random-effects model, and ROBINS-I was used for the risk-of-bias analysis. Main Outcomes and Measures: SARS-CoV-2 transmission between HCPs and levels of personal protective equipment, in addition to complications, time to decannulation, ventilation weaning, and intensive care unit (ICU) discharge in patients with COVID-19 who underwent tracheostomy. Results: Of the 156 studies that underwent full-text review, only 69 were included in the qualitative synthesis, and 14 of these 69 studies (20.3%) were included in the meta-analysis. A total of 4669 patients were included in the 69 studies, and the mean (range) patient age across studies was 60.7 (49.1-68.8) years (43 studies [62.3%] with 1856 patients). We found that in all studies, 1854 patients (73.8%) were men and 658 (26.2%) were women. We found that 28 studies (40.6%) investigated either surgical tracheostomy or percutaneous dilatational tracheostomy. Overall, 3 of 58 studies (5.17%) identified a small subset of HCPs who developed COVID-19 that was associated with tracheostomy. Studies did not consistently report the number of HCPs involved in tracheostomy. Among the patients, early tracheostomy was associated with faster ICU discharge (mean difference, 6.17 days; 95% CI, -11.30 to -1.30), but no change in IMV weaning (mean difference, -2.99 days; 95% CI, -8.32 to 2.33) or decannulation (mean difference, -3.12 days; 95% CI, -7.35 to 1.12). There was no association between mortality or perioperative complications and type of tracheostomy. A risk-of-bias evaluation that used ROBINS-I demonstrated notable bias in the confounder and patient selection domains because of a lack of randomization and cohort matching. There was notable heterogeneity in study reporting. Conclusions and Relevance: The findings of this systematic review and meta-analysis indicate that enhanced personal protective equipment is associated with low rates of SARS-CoV-2 transmission during tracheostomy. Early tracheostomy in patients with COVID-19 may reduce ICU stay, but this finding is limited by the observational nature of the included studies.

Virtual Reality for Vestibular Rehabilitation: A Systematic Review.

INTRODUCTION: Vertigo is a debilitating symptom, leading to increased healthcare utilization and lost patient productivity. Vestibular rehabilitation is used to manage the symptomatic manifestations of vestibular disease. However, vestibular rehabilitation is limited by accessibility and time commitment. Recently, virtual reality has been described as a vestibular rehabilitation tool that may circumvent these barriers to treatment. Despite this, the efficacy of virtual reality for vestibular rehabilitation remains unclear. This study aims to review and summarize the current literature on the effectiveness of virtual reality-based vestibular rehabilitation. METHODS: A systematic review of the MEDLINE, EMBASE, and Alternative and Complementary Medicine databases was conducted for prospective studies describing virtual reality-based vestibular rehabilitation. RESULTS: Our search identified 382 unique articles. Six randomized controlled trials and four other studies were ultimately included. Study sample sizes ranged from 13 to 70 participants and varied in diagnoses from any unilateral peripheral vertigo to specific pathologies. Different virtual reality interventions were used. Comparator groups ranged from supervised vestibular rehabilitation to independent Cawthorne-Cooksey exercises. Outcomes consisted of validated questionnaires, objective clinical tests, and measurements of balance or reflexes. CONCLUSION: The studies reviewed in this study are preliminary evidence to suggest the benefit of virtual reality-based vestibular rehabilitation. However, these studies are limited by their inclusion criteria, heterogeneity, comparator design, and evidence-based clinical outcomes. Further research should address these limitations.

Rate of Second Primary Head and Neck Cancer With Cannabis Use.

Objective To determine whether there is an association between cannabis use and developing a second primary cancer in head and neck cancer patients, as well as determining the prevalence of cannabis use amongst head and neck cancer patients. Study design This retrospective cohort study investigated patients from the Hamilton Region Head and Neck Cancer Database who were enrolled prospectively between 2011 and 2015, with follow-up data up to November 2018. Patients were contacted to confirm current cannabis and tobacco smoking status. Setting All patients were enrolled from a single tertiary cancer center in Hamilton, Ontario. Subjects and methods Consecutive patients with a newly diagnosed head and neck cancer were prospectively enrolled between 2011 to 2015. Cannabis users and controls were compared using standard modes of comparison. The odds ratio from a multivariable logistic regression model was then determined. Results A total of 513 patients were included in this study: 59 in the cannabis group and 454 in the control group. In terms of baseline characteristics, there was no significant difference between cannabis users and controls except that cannabis users were more likely to develop primary oropharyngeal cancer (p=0.0046). Two of 59 (3.4%) cannabis users developed a second primary cancer, in comparison to 23 of 454 (5.1%) non-cannabis users. The odds ratio for cannabis use on the second primary cancer was 0.19 (95% CI [0.01-3.20], p=0.25). Conclusion This study suggests that cannabis use behaves differently than tobacco smoking, as the former may not be associated with field cancerization.

A Retrospective Cohort and Systematic Review of Non-Operative Management of Exposed Calvaria Post-Radiotherapy.

Scalp defects with exposed calvaria that have previously been irradiated present a unique reconstructive challenge. Patients with previously radiated scalp defects often have few reconstructive options due to poor health or personal choice. The aim of this study was to evaluate the results of non-operative management for patients with prior radiotherapy to the scalp who developed exposed calvaria. The outcomes of interest were major and minor complications related to exposed calvaria with a time frame of follow-up of greater than one year or death from any cause. A retrospective chart review was performed to identify patients with prior radiotherapy and surgery for skin cancer to the scalp who subsequently developed exposed calvaria. Data from four surgeons from 2008 to 2019 was collected. Next, a systematic review of PubMed, EMBASE, Cochrane Library, and CINAHL was conducted to identify articles in which non-operative management was utilized for exposed calvaria post-radiotherapy. Nineteen patients were identified who received radiotherapy either before developing recurrent malignancy requiring operation or requiring radiation postoperatively because of close or involved margins and who subsequently developed exposed calvaria. Six of these patients had an additional attempt at local flap or skin grafting that failed. All patients had an American Society of Anesthesiologists score of three or four. All were managed with local wound care. Ten patients had near-complete healing with wound care alone. Eight patients are still alive from one to six years after the presentation. One patient, who remains alive, developed an intracranial abscess requiring long-term antibiotics but was medically compromised by concomitant myelodysplastic syndrome, mantle cell lymphoma on chemotherapy, atrial fibrillation on anticoagulation, and heart failure. Three patients developed new malignancies requiring re-operation with watchful waiting. Two of the three cases resulted in failure to control disease, but control of malignancy occurred in one case with resection of recurrent cancer and exposed bone.  The systematic review of the literature yielded three studies that met the inclusion criteria. None of the studies encountered cases of meningitis, encephalitis, or death due to the non-operative treatment of exposed calvaria post radiation. Coverage of the calvaria with well-vascularized tissue is the reconstructive goal in the majority of circumstances. This case series and systematic review found that non-operative management of exposed calvaria post-radiotherapy can be an option for patients who are either not candidates for aggressive surgical treatment or who refuse surgery.

Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial.

BACKGROUND: Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. METHODS: This is a multicenter phase II study randomizing one hundred and forty patients with T1-2 N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50-60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. DISCUSSION: This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.

The Usefulness of the Thyroid Imaging Reporting and Data System in Determining Thyroid Malignancy.

OBJECTIVES/HYPOTHESIS: To determine the effect of a modified Thyroid Imaging and Reporting Data System (TIRADS) in predicting malignancy in surgically treated nodules. STUDY DESIGN: Retrospective review. METHODS: This study was carried out at a tertiary care center from July 2016 to July 2017. Patients were included if they had a thyroid nodule that had an ultrasound assessment with subsequent fine-needle aspiration biopsy (FNAB) as well as surgical resection. Patients were excluded if they had previous head and neck surgery. Patients were stratified into those who had a formal modified TIRADS report by the radiologist versus those who had an ultrasound report without TIRADS reporting. FNAB results were reported as per Bethesda Thyroid Cytology Criteria, and the final pathology report was nominalized as malignant or benign. RESULTS: One hundred twenty-four consecutive patients who met the inclusion criteria listed above were included within the study. Thirty one patients (25%) had a modified TIRADS report from the radiologist, whereas 93 patients (75%) did not. There was no statistical significance between the two groups in terms of: gender (P = .24), age (P = .77), FNAB results (P = .95), final surgical pathology (P = .90), or incidental findings of malignancy (P = .09). Comparative analysis showed no statistically significant difference between the two groups in terms of the concordance of FNAB and a final pathological diagnosis of malignancy (P = .91). CONCLUSIONS: Despite the known diagnostic utility of the TIRADS in relation to FNAB results and its widespread use, this study shows that the overall detection of malignancy is not statistically different in those who received a modified TIRADS report. LEVEL OF EVIDENCE: 3 Laryngoscope, 130: 2087-2091, 2020.

Elevated Troponin: A Marker for Noncardiac Complications After Resection of Head and Neck Cancers.

OBJECTIVE: To examine if troponin positivity (TP) in patients who undergo head and neck cancer mucosal resections (HNS) predicts noncardiac complications (NCC). BACKGROUND: Major HNSs are arduous operations that place stress on the patient's hemodynamic system. TP after noncardiac surgery previously has been shown in up to 25% of patients, which may signal cardiac complications (CC) or NCC. Although CC after HNS has been observed, no study has investigated the relationship of TP to NCC. METHODS: All patients who underwent HNS at a tertiary-care cancer center from July 2014 to July 2016 were included and underwent postoperative troponin measurements as part of an institutional cardiac protocol. Comparative and multivariate regression analysis were used to compare TP and troponin-negative (TN) patients for NCC. RESULTS: One hundred seventy-two patients underwent HNS. Of those, 15% developed TP during the postoperative period. There was no significant difference between TP and TN for gender, tumor-node-metastasis staging, Charlson comorbidity index, and smoking status. Risk of NCC in TP was 73.1% versus 28.1% in TN (P < 0.001). A significant difference (P < 0.05) in wound complications, length of hospital stay (LOHS), and incidence of pneumonia was found between both groups. Nonparametric testing confirmed significant difference in pneumonia (Z = -3.469, P = 0.001) and LOHS (-3.110, P = 0.002). Multivariate regression analysis confirmed a significant difference in LOHS independent of CC (R2 = 0.122, P < 0.0001). CONCLUSION: TP is not an uncommon occurrence after HNS and is associated with statistically significant increases in wound complications, LOHS, and pneumonia. However, the overall significance of these findings remains unclear, and further research is warranted to determine if outcomes may be improved by closely monitoring these patients for TP. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2148-2152, 2020.