Eyassu, Daniel G.

Importance Standard adjuvant therapy for human papillomavirus–associated oropharyngeal squamous cell carcinoma (HPV-OPSCC) is radiation therapy 60 Gy with or without cisplatin delivered in 30 fractions during 6 weeks. A phase 3 randomized clinical trial demonstrated decreased toxic effects and improved patient-reported outcomes with de-escalated adjuvant radiation therapy (DART) compared with standard therapy; however, outcomes for patients treated in the clinical practice setting following trial adoption remain unknown. Objective To compare characteristics and oncologic outcomes of patients treated with DART during clinical trials (on study) and in clinical practice settings (off study) and report progression-free survival (PFS) by risk category. Design, Setting, and Participants This retrospective cohort study included patients treated with DART in the MC1273 and MC1675 trials and in clinical practice after study completion at a multisite tertiary care center. Patients with surgically resectable HPV-OPSCC who underwent margin-negative resection between August 20, 2013, and March 21, 2023, and were treated with DART were included in the analysis. Those with prior head and neck cancer, pT0 or pT4 disease, unknown HPV status, metastatic disease at presentation, synchronous primary tumors, induction chemotherapy, or treatment at an outside institution were excluded. Data were analyzed from July 1, 2024, to July 18, 2025. Interventions DART consisting of 30 to 36 Gy in 1.5- to 1.8-Gy fractions twice daily with docetaxel 15 mg/m 2 on days 1 and 8. Main Outcomes and Measures Progression-free survival as measured via Kaplan-Meier analysis. Results A total of 282 patients were included in the analysis: 176 (62.4%) in the on-study group and 106 (37.6%) in the off-study group (252 [89.4%] male; mean [SD] age, 59.1 [9.3] years). Both groups were predominantly male (157 [89.2%] and 95 [89.6%], respectively) and consisted mostly of never smokers (118 [67.0%] and 62 [58.5%], respectively). Pathologic features were similar between groups except for nodal stage (pN1: 155 [88.1%] on study vs 102 [96.2%] off study; pN2: 21 [11.9%] on study vs 4 [3.8%] off study; P = .02). The median follow-up times were 5.2 years (95% CI, 5.2-5.8 years) in the on-study group and 2.2 years (95% CI, 1.9-2.4 years) in the off-study group. Two-year PFS was similar (93% [95% CI, 88%-97%] on study vs 93% [95% CI, 88%-99%] off study). For patients with pN1 and no extranodal extension (ENE), 2- and 5-year PFS were 97% (95% CI, 93%-100%) and 96% (95% CI, 92%-100%), respectively. Patients with pN1 and ENE had a 2- and 5-year PFS of 93% (95% CI, 89%-98%) and 87% (95% CI, 81%-94%), respectively. Conclusions and Relevance In this retrospective cohort study of patients receiving DART on and off study, oncologic outcomes were similar between the 2 groups. Fewer patients with pN2 received DART off study, given the interim results of MC1675. Patients with pN1 and no ENE treated with DART had excellent 2- and 5-year PFS, supporting DART as a compelling treatment option in well-selected patients. An additional study that is currently underway will evaluate biomarker risk-stratified treatment of patients with pN1 and ENE receiving DART.

Importance Adverse events in otolaryngology–head and neck surgery (OHNS) are inconsistently reported. The Clavien-Dindo Classification has been modified and validated in several surgical subspecialties but has yet to be validated in OHNS. Objective To create and validate a modified Clavien-Dindo Classification for OHNS that reflects the severity and duration of harm for complications experienced by patients undergoing OHNS. Design, Setting, and Participants This is a multicenter survey study of subject matter experts (SMEs) from OHNS subspecialties from academic institutions within the US. A literature review identified publications reporting surgical complications in OHNS in the English language between January 2019 and April 2020. Complications were summarized and used to inform a modified Clavien-Dindo Classification. Feedback from internal SMEs was incorporated. Thirty-five clinical vignettes were created, and an electronic survey was sent to SMEs at outside institutions. Each SME was randomly assigned to 1 of 4 groups to evaluate 8 to 9 vignettes. The survey was conducted in September 2023, and data were analyzed from February to May 2024. Exposure Participation in the electronic survey. Main Outcomes and Measures Vignette scores were assessed and the Comprehensive Complication Index (CCI) calculator was used to assess cumulative morbidity. The scale is based on the grading by the Clavien-Dindo Classification and reflects overall morbidity on a scale from 0 (no complication) to 100 (death). Variability of the CCIs between reviewers, the primary outcome, was summarized with the SD. The percentage of reviewers with a high (≥26.2) or low (<26.2) CCI within a vignette was reported. Reliability was summarized using Krippendorff α. Results Of 106 SMEs, 43 (response rate, 40.6%) completed at least 1 vignette. Eighteen of 35 vignettes (51.4%; 95% CI, 34.9%-68.0%) had unanimous high CCI, and 8 of 35 vignettes (22.9%; 95% CI, 8.9%-36.8%) had unanimous low CCI (overall categorical agreement, 74.3%; 95% CI, 59.8%-88.8%). On average, the Krippendorff α was 0.74, indicating moderate reliability. A total of 21 850 OHNS complications were reviewed and categorized as surgical or medical with 12 including subcategorization for specificity. Each category was then assigned a modified OHNS Clavien Dindo classification grade. Conclusions and Relevance In this survey study of OHNS experts, a modified OHNS Clavien-Dindo Classification was developed and validated using case vignettes. The modified Clavien-Dindo Classification provided a granular subcategorization for each complication category and grade, duration of harm, and an overall summary complication score (CCI). Results suggest the modified OHNS Clavien-Dindo Classification reliably differentiated between high-grade and low-grade OHNS complications and could be utilized for assessing surgical outcomes.

Background: Surgical registries have been widely adopted in high-income countries to improve patient outcomes. However, similar data-driven initiatives are still scarce in low- and middle-income countries (LMICs). Aims: This study aimed to address the challenges of implementing a perioperative registry for otolaryngology-head and neck surgery (OHNS) in Mekelle, Ethiopia, and to assess strategies for ensuring its long-term sustainability. Methods: The registry was developed using REDCap, through a collaborative effort between otolaryngologists in the United States and Ethiopia, ensuring its relevance to the local context. On-site training sessions were conducted for 13 OHNS residents and four senior surgeons to facilitate their use of the registry. A Wi-Fi router was installed in the operating room to enable real-time data entry. Continuous support was provided through remote communication between the local team and the U.S. research team. Sustainability strategies focused on fostering local ownership, integrating the registry into existing workflows, and maintaining continuous data monitoring. Results: Despite facing challenges like intermittent internet connectivity and issues with workflow integration, the local team successfully integrated the registry into routine clinical and surgical practices. Key strategies included providing dedicated Wi-Fi routers, modifying registry fields for improved efficiency, and emphasizing the registry’s value to the institution. Ongoing collaboration between the local team and the U.S. team enabled continuous optimization and data collection. Conclusion: The successful implementation of this perioperative registry underscores the importance of engaging local stakeholders and integrating sustainable workflows. This initiative serves as a model for other LMICs seeking to establish surgical registries that enhance data-driven decision-making at both the patient and institutional levels.

AbstractThis study compares delays in otolaryngologic care between patients in Mekelle, Ethiopia and Harare, Zimbabwe using the Three Delays model. Patient surveys conducted among 46 patients in Zimbabwe during October 2022 and 105 patients in Ethiopia during June 2023 revealed a significantly higher prevalence of delays in seeking and reaching care in Ethiopia. This was in the aftermath of the Tigray War, which damaged the region's health care infrastructure and diminished the trust of patients. In Zimbabwe, there was poor awareness among patients and nonotolaryngologist providers of otolaryngology disease and care capacity leading to delays in seeking and reaching care. Patients in both countries faced delays in receiving appropriate care due to resource limitations, with Ethiopia's constraints worsened by the recent war and Zimbabwe's by consistent health care underfunding. The longest delays were observed in head and neck oncology care. These findings provide a foundation for understanding otolaryngologic care delays in these low‐ and middle‐income countries.

AbstractObjective(s)To evaluate the otolaryngology surgical capacity in Harare, Zimbabwe by analyzing procedural volumes across four hospitals, one private and three public, from 2019 to 2022.MethodsA retrospective review of hand‐written surgical case logs was conducted at Harare Eye, Ear, Nose, and Throat Institute (HEENT), Parirenyatwa Group of Hospitals (PGH), Sally Mugabe Children's Hospital (SMCH), and Sally Mugabe Adult's Hospital (SMAH). Patient age and surgical intervention for all otolaryngology surgeries performed in the operating room from 2019 to 2022 were recorded. Procedures were categorized into six groups: head and neck malignancy, laryngeal surgery, oropharyngeal surgery, otologic surgery, rhinology/sinus surgery, and other. Data were analyzed using descriptive statistics to identify trends in surgical volume and types of procedures across hospitals.ResultsA total of 2626 procedures were recorded: 1470 at HEENT, 377 at PGH, 625 at SMCH, and 154 at SMAH. Of these, 39.5% were performed on pediatric patients and 60.5% on adult patients. The most common procedures were adenotonsillectomy/adenoidectomy/tonsillectomy (38.9%), diagnostic endoscopies (10.4%), and endoscopic sinus surgery (8.3%). HEENT performed the highest volume and widest range of procedures. HEENT had higher surgical volumes across all groups of procedure, except for laryngeal surgery.ConclusionThis study found disparities in otolaryngology surgical capacity between a private hospital, HEENT, and three public tertiary hospitals—SMCH, SMAH, and PGH, the largest hospital in the country—in Harare, Zimbabwe. Additionally, it highlights areas for targeted interventions in capacity building. This study establishes a foundation for understanding otolaryngologic surgical capacity in the country, supporting international collaboration, guiding future research, and serving as a model for similar assessments in other LMICs.Level of evidenceLevel VI.

Introduction: External ear malformations represent a spectrum of congenital anomalies that may involve the external auditory canal (EAC), tympanic membrane (TM), or associated structures. A rare anomaly, the EAC skin wedge, results from incomplete canalization during embryologic development. This report presents the clinical presentation, diagnostic evaluation, and surgical management of this condition. Objective: To detail the successful surgical management of an isolated EAC skin wedge and demonstrate the applicability of argon laser in treating these congenital anomalies. Methods: A 13-month-old female presented with recurrent otitis media and mild bilateral conductive hearing loss. Physical examination revealed a fan-like skin wedge spanning the EAC to the TM. Imaging with temporal bone computed tomography confirmed the extent of the anomaly. Under general anesthesia, the skin wedge was ablated using an argon laser, followed by antibiotic-soaked packing to prevent scarring and recurrence. Follow-up audiometry and endoscopic evaluations assessed outcomes. Results: The procedure was well-tolerated, with no intraoperative complications. At 3 weeks and 3 months postoperatively, no recurrence of the skin wedge was observed, and audiometry normalized. The patient demonstrated improved middle ear ventilation and resolution of conductive hearing loss. Conclusions: This case demonstrates the successful use of argon laser in the management of a rare congenital EAC anomaly. Argon lasers offer precise ablation and excellent hemostasis, making them a valuable option for similar cases. This report emphasizes the importance of tailored surgical approaches for rare pediatric ear malformations.

AbstractObjectiveThis study aims to document and analyze the challenges and outcomes of performing complex airway surgery in a low‐resource, post‐war setting in Mekelle, Ethiopia.MethodsThis prospective case series examines clinical data from five patients who underwent airway reconstruction surgeries and one patient who underwent total laryngectomy at Ayder Comprehensive Specialized Hospital in Mekelle. Data included patient demographics, airway stenosis etiology and severity, operative details, postoperative outcomes, complications, and hospital length of stay. Ethical approval was obtained from institutional review boards at Mayo Clinic and Mekelle University.ResultsThe study included six patients aged 9–62 years, with surgeries comprising three cricotracheal resections, two tracheal resections, and one laryngectomy. Three reconstructions were for war‐related injuries. Challenges included power outages during surgeries, limitations in medical supplies and equipment, and inadequate perioperative care. Despite these, three patients requiring tracheostomies were successfully decannulated within a year. However, complications such as restenosis, infections, and the need for reintubation were common.ConclusionAirway surgeries in a low‐resource, post‐war setting face significant hurdles, including perioperative care quality, resource limitations, and infrastructure issues. Successful outcomes require multidisciplinary training tailored to local contexts, investments in hospital infrastructure and reliable electricity, and proper perioperative nutrition. This study highlights the need for comprehensive interventions to improve surgical care in such settings.Level of evidence: IV.