BACKGROUND:Contemporary clinical guidelines recommend the use of intraoperative parathyroid hormone (IOPTH) when treating parathyroid disease, yet the degree to which parathyroid surgeons adhere to this, and other guideline recommendations remains unknown. To evaluate parathyroid surgeon practices when managing primary (PHPT), secondary (SHPT), and tertiary (THPT) hyperparathyroidism. METHODS:A cross-sectional electronic survey characterizing parathyroid surgery practices was conducted according to CHEERS and AAPOR guidance and distributed to four North American surgeon societies from August-November 2024. The survey evaluated surgeon demographics, imaging practices, and surgical adjunct use. The primary outcome was the use of IOPTH. Descriptive and multivariable logistic regression analyses were used to explore parathyroid surgery practices and characteristics predictive of using IOPTH. RESULTS:523 surgeons responded to this survey (response rate: 70.5%, range: 59.9%-85.7%). Most surgeons were from the US and Canada, while 56.3% of respondents were trained in otolaryngology-head and neck surgery. Ultrasonography was the most used modality, while IOPTH was most often used to guide parathyroid surgery [(376/426), 88.3%]. Intraoperative radioguidance and autofluorescence were used infrequently. IOPTH was used by US surgeons [adjusted odds ratio (aOR): 20.1; 95% CI: 1.9, 164.9; p < 0.01] who trained using IOPTH (aOR: 4.7; 95% CI: 1.2, 21.4; p < 0.05). Surveyed surgeons often used the Miami or modified Miami criteria when performing surgery for PHPT, while almost 30% of surgeons reported not using any IOPTH criteria during surgery for SHPT or THPT. CONCLUSIONS:Surgeons adhere to clinical guidelines when managing parathyroid disease, especially with reference to IOPTH in minimally invasive parathyroidectomy. Practice heterogeneity, however, exists with reference to parathyroid imaging and the use of intraoperative adjuncts for parathyroid surgery in parathyroid disease, especially SHPT and THPT.
Objective: To evaluate the effect of facial attractiveness on treatment recommendations for non-melanoma skin cancer of the head and neck. Methods: We conducted a cross-sectional survey of Canadian surgeons and radiation oncologists to assess the effect of facial attractiveness on treatment choices for non-melanoma head and neck skin cancers. Participants rated preference of surgery or radiotherapy (RT) for digitally altered images with lesions at 5 facial subsites. The primary outcome was the association between attractiveness and treatment choice; the secondary outcome was the influence of lesion location. Associations between attractiveness and treatment choice were analyzed with Spearman’s correlation, and site-specific differences were descriptively evaluated. Results: One hundred and eight respondents (17.8% response rate) completed the survey. Surgery was favored across all anatomical subsites. Facial attractiveness was not significantly associated with treatment recommendations at any subsite. At the nasal tip, there was a trend toward recommending surgery for more attractive patients (ρ = 0.13, P = .08). Independent of attractiveness, lesion location appeared to influence treatment recommendations, with the nasal tip more often considered for RT than other subsites. Conclusions: Facial attractiveness did not influence treatment recommendations for non-melanoma head and neck skin cancers. Surgery was preferred across anatomic subsites, but respondents often considered for RT for treating nasal tip non-melanoma skin cancers.
PURPOSE:High-grade major salivary gland cancer is associated with poor prognostic outcomes, but the role for elective neck dissection (END) for improving survival in high-grade N0 major salivary gland cancer is under debate, especially in the context of planned adjuvant therapy. METHODS:We performed a secondary analysis of the SEER cancer database for all patients surgically treated for N0 major salivary gland cancer from 2000 to 2022. Our primary outcome was disease-specific survival (DSS), and our secondary outcome was overall survival. We generated multivariable Cox regression models to evaluate the association of END with survival outcomes. RESULTS:Across the study cohort of 1387 patients, END was independently associated with better DSS (adjusted HR: 0.49, 95% confidence interval (CI): 0.28, 0.83; p < 0.01) in high-grade N0 major salivary gland cancer, but not low-to-intermediate grade N0 major salivary gland cancer (adjusted HR: 0.82, 95% CI: 0.32, 2.08; p = 0.67). END alone (adjusted HR: 0.23, 95% CI: 0.05, 1.07; p = 0.06) or with adjuvant radiotherapy (adjusted HR: 0.42, 95% CI: 0.18, 1.00; p = 0.05) may improve DSS in high-grade T1/T2 N0 disease, while END with adjuvant radiotherapy may be necessary for T3/T4adisease, but these results were inconclusive and require validation. CONCLUSION:Surgeons may consider END in patients with high-grade N0 major salivary gland cancer but opt for regional surveillance in patients with low-to-intermediate grade disease. END with or without adjuvant radiotherapy may be considered in T1/T2 high-grade N0 major salivary gland cancers, but both modalities are likely necessary in T3/T4 disease; however, further confirmatory studies are needed.
ImportanceQuality indicators are used to evaluate the quality of healthcare delivery and as a speciality, otolaryngology-head and neck surgery (OHNS) is beginning to transition toward this empirical understanding of healthcare quality and delivery.ObjectiveTo describe the number and quality of studies that have developed novel quality indicators for any subdiscipline in OHNS.DesignWe performed a database search of MEDLINE (Ovid), EMBASE (Ovid), Web of Science, and Cochrane Database of Systematic Reviews. We did not employ language or study-type restrictions and included studies published from database inception to October 2024.Study SelectionFollowing abstract screening, 184 articles underwent full-text screen. Eligible studies developed quality indicators in any subdiscipline within OHNS. Article screening and full-text review was performed in duplicate.Data Extraction and SynthesisWe extracted study-specific and methodological data in duplicate. Quality appraisal was assessed using the Appraisal of Indicators through Research and Evaluation instrument.ResultsWe identified 10,592 studies, of which 25 studies developed new quality indicators. Quality indicator development studies primarily focused on otology/neurotology, pediatric OHNS, and head and neck surgery. Few studies investigated facial plastics, rhinology and skull base surgery, and laryngology. Most studies employed Delphi consensus methods and patient engagement was rare. Consensus methodology reporting was poor and indicators were often not validated. Outcome indicators were often measured with fewer studies investigation structure or process indicators.ConclusionsQuality indicators may help standardize and improve patient care in OHNS. Future research should focus on structure and process indicators, while improving reporting, optimizing panel composition, and validating quality indicators.
Objective To identify the prognostic value of sarcopenia in surgically treated HNC patients on postoperative morbidity. Design Systematic review and meta-analysis. Information sources, study selection, and methods EMBASE, MEDLINE, SCOPUS, and CINAHL databases were searched from January 1, 1946 to November 4, 2024. Published trials and observational studies reporting the association of sarcopenia and postoperative complications in surgically treated HNC patients were included. Two reviewers independently screened, extracted, and appraised studies using Covidence. Disagreements were resolved through consensus, and/or by consulting a third reviewer. Data were pooled using a random-effects model in RevMan 5.4.1. Results Of 6345 screened studies, 17 out of the 23 included studies had outcomes which were incorporated in the meta-analysis (2884 patients from studies between 1996 and 2024). The meta-analysis revealed a statistically significant association between sarcopenia and all postoperative complications (odds ratio (OR) 2.26, 95 % CI [1.54, 3.33], p < 0.0001), postoperative complications grade 3 (OR 2.34, 95 % CI [1.80, 3.03], p < 0.00001), fistula (OR 2.64, 95 % CI [1.68, 4.16], p < 0.0001), and flap complications (OR 2.77, 95 % CI [1.58, 4.85], p = 0.0004). Subgroup analysis revealed the high risk of bias studies did not significantly bias the results (p = 0.76), but the different measurements of sarcopenia contributed significant heterogeneity (p < 0.00001). The level of evidence is moderate, primarily due to publication bias, for all outcomes, as per GRADE. Conclusions In patients undergoing curative surgery for HNC, preoperative sarcopenia is associated with higher odds of postoperative complications.
Background Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.Methods/design Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding; <50% fail to proceed. Secondary feasibility outcomes include the percentage of enrolled participants with complete data at 6 months trial follow-up (ie, ≥90% proceed; 80–89% modify protocol before proceeding; <80% fail to proceed) and the recruitment rate during the trial (ie, ≥5 patients per month to proceed; 2–4 patients per month to modify protocol before proceeding; <2 patients per month to fail to proceed). We estimate that 60 patients will be needed to achieve the primary feasibility outcome. Descriptive analysis will be conducted for feasibility outcomes. The results of our pilot study will inform the feasibility of a definitive trial, and if no major changes to our protocol are indicated, we will treat this study as a vanguard trial and enrol the 60 pilot patients into the definitive trial.Ethics and dissemination Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.Trial registration number NCT06542315, registered on 6 August 2024.
BackgroundCutaneous head and neck melanoma (cHNM) has a high rate of false-negative sentinel lymph node biopsy (SLNB) and up to a 25% risk of recurrence despite negative SLNB. The aim of this study was to investigate the pattern of melanoma recurrence in patients with cHNM with negative SLNB.MethodsA retrospective cohort study of consecutive cHNM patients at a tertiary care centre from 2014-2022. We included all cHNM patients with negative SLNB. All patients were categorized into Breslow thickness >2 mm and ≤2 mm and extracted information pertaining to histopathological characteristics and the presence and type of disease recurrences. We performed multivariable analysis using logistic and cox regression. We used an alpha of 0.05 and all statistical analyses were performed using R software.ResultsOverall, 167 patients met eligibility criteria and of these, 53.5% patients had cHNM ≤2 mm thick and 46.7% had lesions >2 mm thick. The overall recurrence rate was 29.3%. Multivariable analysis demonstrated that Breslow thickness [aOR: 5.89 (95% CI: 1.37, 32.3), P = 0.02] was associated with distant recurrence. Multivariable cox regression also identified that pathological ulceration [aHR: 3.17 (95% CI: 1.61, 7.66), P = 0.01] predicted time to distant recurrence. The SLNB false omission rate was 3.6% (95% CI: 1.3%, 7.7%).ConclusionSLNB-negative cHNM patients with high-risk pathological features may benefit from adjuvant immunotherapy.
BACKGROUND:Advanced head and neck malignancies with underlying bony involvement often require aggressive oncological resection of large segments of the oral cavity including the mandible. These patients require vascularized donor osseous free tissue transfer to reconstruct significant defects. Traditionally, the donor bone is harvested on its vascular supply and shaped to the defect in a free hand fashion (FHS). However, virtual surgical planning (VSP) has emerged as a method to optimize reconstructive outcomes and decrease operative time. The goals of this study are to assess superiority of VSP to FHS by comparing bony union rates at 12 months, short and long-term complication rates, reconstruction accuracy, quality of life (QOL), functional outcomes, and economic analysis. METHODS:This is a multicenter phase II/III study randomizing four hundred twenty head and neck patients undergoing mandibulectomy in a 1:1 ratio between VSP and FHS. Intention-to-treat analysis will be performed for patients enrolled but unable to undergo VSP-aided reconstruction. The primary endpoint is bony-union rates at 1 year post-operatively. Secondary outcomes include complication rates, QOL, functional outcomes, and economic burden. DISCUSSION:This study will provide an assessment of two different surgical approaches to the reconstructive methods of mandible defects using fibular or scapular free flaps on bony-union rates, complications, QOL and economics. TRIAL REGISTRATION:Clinicaltrials.gov identifier: NCT05429099. Date of registration: June 23, 2022. Current version: 1.0 on March 6, 2024.
Importance:Intraoperative parathyroid hormone (IOPTH) monitoring is recommended by the American Association of Endocrine Surgeons for use during parathyroidectomy for patients with primary hyperparathyroidism (PHPT), but there is no clinician consensus regarding the IOPTH monitoring criteria that optimize diagnostic accuracy. Objective:To evaluate and rank the diagnostic properties of IOPTH monitoring criteria used during surgery for patients with PHPT. Data Sources:A bayesian diagnostic test accuracy network meta-analysis (DTA-NMA) was performed, in which peer-reviewed citations from January 1, 1990, to July 22, 2023, were searched for in MEDLINE, Embase, Web of Science, CENTRAL, and CINAHL. Study Selection:All full-text study designs that evaluated any IOPTH monitoring criteria as a diagnostic test were included in this meta-analysis. Any studies evaluating adult patients diagnosed with PHPT undergoing parathyroidectomy were also included. The reference standard used in this study was normalization of calcium and/or parathyroid hormone levels within 1 year of surgery. Data Extraction and Synthesis:This DTA-NMA was reported in accordance with the applicable Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Two reviewers evaluated all abstracts and full-text articles using a piloted extraction form. A third author resolved any conflicts. There are no published Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) resources for DTA-NMA. The following conventional monitoring criteria were included: Halle, Miami, Rome, Vienna, and PTH normalization, and the following modified criteria were included: Miami and PTH normalization, modified Miami, and modified Vienna. A bayesian hierarchical DTA-NMA model with corresponding 95% credible intervals (CrIs) was used to describe the pooled diagnostic characteristics of the evaluated IOPTH monitoring criteria. Main Outcomes and Measures:Main outcomes included pooled diagnostic test properties, including sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio. Results:A total of 72 studies, which included 19 072 patients, met the inclusion criteria. Sixty-nine studies (95.8%) investigated classic PHPT. In PHPT, the Miami criteria were investigated most often and had the best diagnostic properties (diagnostic odds ratio, 60.00 [95% CrI, 32.00-145.00]) when compared to other conventional criteria. Moreover, the modified Miami criteria, which measures a postexcision IOPTH level 15 minutes or more postexcision of all hyperfunctioning parathyroid tissue, were the overall best criteria (diagnostic odds ratio, 79.71 [95% CrI, 22.46-816.67]). There was a low risk of study bias and no publication bias. Conclusions and Relevance:The results of this meta-analysis suggest that surgeons should use the modified Miami criteria when performing IOPTH-guided surgery for patients with PHPT because these criteria optimize intraoperative diagnostic accuracy by minimizing unnecessary neck exploration and revision surgery rates.
ImportanceIntraoperative parathyroid hormone (IOPTH) monitoring is recommended by the American Association of Endocrine Surgeons for use during parathyroidectomy for patients with primary hyperparathyroidism (PHPT), but there is no clinician consensus regarding the IOPTH monitoring criteria that optimize diagnostic accuracy.ObjectiveTo evaluate and rank the diagnostic properties of IOPTH monitoring criteria used during surgery for patients with PHPT.Data SourcesA bayesian diagnostic test accuracy network meta-analysis (DTA-NMA) was performed, in which peer-reviewed citations from January 1, 1990, to July 22, 2023, were searched for in MEDLINE, Embase, Web of Science, CENTRAL, and CINAHL.Study SelectionAll full-text study designs that evaluated any IOPTH monitoring criteria as a diagnostic test were included in this meta-analysis. Any studies evaluating adult patients diagnosed with PHPT undergoing parathyroidectomy were also included. The reference standard used in this study was normalization of calcium and/or parathyroid hormone levels within 1 year of surgery.Data Extraction and SynthesisThis DTA-NMA was reported in accordance with the applicable Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Two reviewers evaluated all abstracts and full-text articles using a piloted extraction form. A third author resolved any conflicts. There are no published Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) resources for DTA-NMA. The following conventional monitoring criteria were included: Halle, Miami, Rome, Vienna, and PTH normalization, and the following modified criteria were included: Miami and PTH normalization, modified Miami, and modified Vienna. A bayesian hierarchical DTA-NMA model with corresponding 95% credible intervals (CrIs) was used to describe the pooled diagnostic characteristics of the evaluated IOPTH monitoring criteria.Main Outcomes and MeasuresMain outcomes included pooled diagnostic test properties, including sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio.ResultsA total of 72 studies, which included 19 072 patients, met the inclusion criteria. Sixty-nine studies (95.8%) investigated classic PHPT. In PHPT, the Miami criteria were investigated most often and had the best diagnostic properties (diagnostic odds ratio, 60.00 [95% CrI, 32.00-145.00]) when compared to other conventional criteria. Moreover, the modified Miami criteria, which measures a postexcision IOPTH level 15 minutes or more postexcision of all hyperfunctioning parathyroid tissue, were the overall best criteria (diagnostic odds ratio, 79.71 [95% CrI, 22.46-816.67]). There was a low risk of study bias and no publication bias.Conclusions and RelevanceThe results of this meta-analysis suggest that surgeons should use the modified Miami criteria when performing IOPTH-guided surgery for patients with PHPT because these criteria optimize intraoperative diagnostic accuracy by minimizing unnecessary neck exploration and revision surgery rates.
Importance:Myocardial injury after noncardiac surgery (MINS) is associated with increased perioperative mortality; however, the incidence and prognostic impact of MINS after major head and neck surgery remains uncertain. Objective:To determine the incidence and clinical implications of MINS in patients after major head and neck surgery. Design, Setting, and Participants:This cohort study used data from the VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation; 2017) study, an international prospective cohort study that analyzed more than 35 000 patients who had noncardiac surgery. Of those, 648 patients (1.8%) underwent major head and neck surgery requiring at least 1-day hospital admission and screening for MINS via troponin T (TnT) concentrations measured during the first 3 postoperative days. MINS was defined as a high-sensitivity TnT (hsTnT) of 20 to 64 ng/L and absolute change more than 5 ng/L or hsTnT 65 ng/L or greater (ie, fifth-generation assay) and cardiac ischemia. When using fourth-generation assay, MINS was defined as non-hsTNT 0.04 ng/mL or greater and cardiac ischemia. Data analyses were performed from October to December 2024. Main Outcomes and Measures:MINS incidence and its association with 30-day mortality. All clinical outcomes were analyzed using Cox regression models and length of hospital stay (LOHS) was analyzed using multivariable linear regression. Results:Among 648 patients (265 [40.9%] female and 383 [59.1%] male; 376 [58.0%] aged 45 to 64 years), the incidence of MINS after major head and neck surgery was 11.9% (95% CI, 9.39%-14.4%), rising to 23.8% (95% CI, 15.7%-32%) among those aged 75 years or older. MINS occurred more often in patients with medical comorbidities. The proportion of MINS that would have gone undetected without TnT monitoring was 68.8% (95% CI, 57.3%-78.9%). In this cohort, 30-day and 1-year mortality were 1.9% (95% CI, 0.8%-2.9%) and 13.1% (95% CI, 10.5%-15.7%), respectively. MINS was associated with increased 30-day mortality (hazard ratio, 5.51; 95% CI, 1.75-17.36) and prolonged LOHS in patients with MINS with at least 1 ischemic feature (adjusted β, 3.15 days; 95% CI, 1.47-6.76 days). Conclusions and Relevance:This cohort study found that myocardial injury was common among patients undergoing major head and neck surgery, especially those aged 75 years or older and those with comorbidities. Nearly 70% of MINS cases go undetected without TnT monitoring, and MINS may contribute to worse 30-day postoperative mortality and prolonged LOHS. Further prospective validation is needed to evaluate the role of MINS screening in improving clinical outcomes after major head and neck surgery.
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.
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 [β 2.50 (95% confidence interval (CI) 0.200, 3.17); P = .014] and LOHS [β 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.
BACKGROUND:Treatment de-intensification, including transoral robotic surgery (TORS), may outcomes in HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). Early return to work (RTW) improves quality of life in oncology patients. Our objective was to compare the RTW time in OPSCC patients undergoing primary TORS or chemoradiotherapy (CRT). We investigated the role of treatment modality on self-reported swallowing function. METHODS:All patients were adults diagnosed with early-stage (T1-2, N0-2) OPSCC and treated via primary TORS or CRT. We performed 1:1 exact case matching based on tumor stage and subsite. We collected RTW outcomes for all patients. We also reported MD Anderson Dysphagia Index (MDADI) scores up to 24 months from the end of treatment. We performed statistical analyses and comparison of RTW and MDADI outcomes based on treatment group. RESULTS:Overall, 26 patients undergoing primary TORS and 25 undergoing primary CRT were included. We found a significant improvement in RTW in TORS patients compared to CRT (TORS: 54 days (1.8 months), IQR: 30.8; CRT: 164 days (5.4 months), IQR: 109; W=587, p = 9.28e-08) independent of HPV status, tonsillar subsite, and radiotherapy alone. Primary TORS had a 16.2-fold (95 % CI: 5.78-45.5) higher likelihood of returning to work than primary CRT patients. Primary TORS also had better MDADI scores within two years of treatment. CONCLUSIONS:In OPSCC, primary TORS accelerated RTW and improved swallowing when compared to primary CRT. The potential economic advantage of returning to work sooner should be discussed when reviewing treatment options with patients.
Hyperparathyroidism is a common endocrine disorder that occurs secondary to abnormal parathyroid gland functioning. Depending on the type of hyperparathyroidism, surgical extirpation of hyperfunctioning parathyroid glands can be considered for disease cure. Intraoperative parathyroid hormone (IOPTH) monitoring improves outcomes in patients undergoing surgery for primary hyperparathyroidism, but studies are needed to characterize its institutional adoption and its role in surgery for secondary and tertiary hyperparathyroidism, as these entities can be difficult to cure. Hence, we will perform a cross-sectional survey study of surgeon rationale, operational details, and barriers associated with IOPTH monitoring adoption across North America. We will utilize a convenience sampling technique to distribute an online survey to head and neck surgeons and endocrine surgeons across North America. This survey will be distributed via email to three North American professional societies (i.e., Canadian Society for Otolaryngologists-Head and Neck Surgeons, American Head and Neck Society, and American Association of Endocrine Surgeons). The survey will consist of 30 multiple choice questions that are divided into three concepts: (1) participant demographics and training details, (2) details of surgical adjuncts during parathyroidectomy, and (3) barriers to adoption of IOPTH. Descriptive analyses and multiple logistic regression will be used to evaluate the impact of demographic, institutional, and training variables on the use of IOPTH monitoring in surgery for all types of hyperparathyroidism and barriers to IOPTH monitoring adoption. Ethics approval was obtained by the Hamilton Integrated Research Ethics Board (2024-17173-GRA). These findings will characterize surgeon and institutional practices with regards to IOPTH monitoring during parathyroid surgery and will inform future trials aimed to optimize the use of IOPTH monitoring in secondary and tertiary hyperparathyroidism.
Introduction Tall cell subtype papillary thyroid cancer (TCS-PTC) is associated with aggressive disease features and worse patient outcomes. It remains unclear whether adjuvant radioactive iodine (RAI) ablation following thyroidectomy is associated with improved survival in TCS-PTC. The purpose of this review and meta-analysis was to determine whether adjuvant RAI was associated with improved survival in patients with TCS-PTC. Methods We included any study design that investigated survival outcomes in adult patients diagnosed with TCS-PTC who underwent either thyroidectomy following by adjuvant RAI or thyroidectomy alone. We searched MEDLINE, EMBASE, Scopus, and CENTRAL databases from inception with no restrictions. All screening and review stages were performed in duplicate. Risk of bias was evaluated using ROBINS-I and certainty of evidence were evaluated using GRADE. Meta-analysis was performed using a random effects model and we calculated pooled hazard ratios (HRs), where applicable. All analyses were performed in RevMan 5.3 (Cochrane, UK). Results Seven nonrandomized studies were included with 9611 TCS-PTC patients, of which 6296 (65.5%) underwent adjuvant RAI. All studies were at high risk of bias. Based on low certainty evidence, we found that adjuvant RAI was possibly associated with improved overall survival in TCS-PTC (HR = 0.60, 95% confidence interval: 0.42-0.85). This benefit was maintained in studies that performed propensity score matching, but we did not find a significant association with tumor size. Sensitivity analysis to remove studies with potentially overlapping data changed the HR to 0.74 (95% CI: 0.46-1.19) with considerable heterogeneity (I2 = 70%). Based on very low certainty evidence, we were uncertain where adjuvant RAI was associated with cancer-specific or recurrence-free survival. Conclusions Adjuvant RAI may be associated with improved overall survival in TCS-PTC, but future high-quality randomized studies with risk stratification are needed.
Background Randomized-clinical trials (RCTs) are the gold-standard for comparing health care interventions, but can be limited by early termination, feasibility issues, and prolonged time to trial reporting. Adaptive clinical trials (ACTs), which are defined by pre-planned modifications and analyses that occur after starting patient recruitment, are gaining popularity as they can streamline trial design and time to reporting. As adaptive methodologies continue to be adopted by researchers, it will be critical to develop a risk of bias tool that evaluates the unique methodological features of ACTs so that their quality can be improved and standardized for the future. In our proposed methodological review, we will develop a list of risk of bias items and concepts, so that a risk of bias tool specific to ACTs can be developed. Methods and analysis We will perform a systematic database search to capture studies that have proposed or reviewed items pertaining to methodological risk, bias, and/or quality in ACTs. We will perform a comprehensive search of citation databases, such as Ovid MEDLINE, EMBASE, CENTRAL, the Cochrane library, and Web of Science, in addition to multiple grey literature sources to capture published and unpublished literature related to studies evaluating the methodological quality of ACTs. We will also search methodological registries for any risk of bias tools for ACTs. All screening and review stages will be performed in duplicate with a third senior author serving as arbitrator for any discrepancies. For all studies of methodological quality and risk of bias, we will extract all pertinent bias items, concepts, and/or tools. We will combine conceptually similar items in a descriptive manner and classify them as referring to bias or to other aspects of methodological quality, such as reporting. We will plan to generate pertinent risk of bias items to generate a candidate tool that will undergo further refinement, testing, and validation in future development stages. Ethics and dissemination This review does not require ethics approval as human subjects are not involved. As mentioned previously, this study is the first step in developing a tool to evaluate the risk of bias and methodological quality of ACTs. The findings of this review will inform a Delphi study and the development of a risk of bias tool for ACTs. We plan on publishing this review in a peer-reviewed journal and to present these findings at international scientific conferences.
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.
OBJECTIVE:Mucoepidermoid carcinoma of unknown primary (MEC-UP) in the head and neck is a rare presentation of the most common salivary gland cancer. Cancers of unknown primary sites often have poorer prognoses than similar cancers with known primary. Few cases of MEC-UP have been reported; therefore, the objective of this report is an overview of the diagnosis and management of MEC-UP. METHODS:We present two patients with low-grade MEC-UP at a high-volume tertiary care institution in Ontario, and a database search returning 1560 citations of which five studies with seven MEC-UP cases were identified. RESULTS:Review of the limited cases suggest many clinicians use positron emission tomography-computed tomography (PET-CT) in addition to panendoscopy and targeted biopsies with consideration for diagnostic tonsillectomy in diagnostic work-up. CONCLUSION:Like other salivary gland cancers, primary therapeutic surgical resection is recommended with low threshold for adjuvant radiotherapy to regions at high risk for harbouring the primary malignancy, especially in cases of high-grade histopathology.