Introduction: Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is also increasingly used off-label in the neonatal intensive care unit. Despite the frequent use of paracetamol, concerns have been raised regarding the high variability in neonatal dosing regimens and the long-term safety of early life exposure. Objective: To investigate the available evidence on the long-term safety of prenatal and neonatal paracetamol exposure. Methods: We conducted a systematic search of the electronic databases Ovid Medline, Ovid Embase and Web of Science from inception to August 2021 for original research studies of any design that described the use of paracetamol in the prenatal or neonatal (within the first four weeks of life) periods and examined the occurrence of neurodevelopmental, atopic or reproductive adverse outcomes at or beyond birth. Results: We identified 1313 unique articles and included 30 studies in the final review. Of all studies, 27 (90%), two (7%) and one (3%) were on the long-term safety of prenatal, neonatal and both prenatal and neonatal exposure, respectively. Thirteen (46%), 11 (39%) and four (15%) studies examined neurodevelopmental, atopic and reproductive outcomes. Eleven (100%), 11 (100%), and three (27%) studies on prenatal exposure reported adverse neurodevelopmental, atopic and reproductive outcomes. Only one study found a possible correlation between neonatal paracetamol exposure and long-term adverse outcomes. Conclusions: The available evidence, although limited, suggests a possible association between prenatal paracetamol exposure and an increased risk of neurodevelopmental, atopic and reproductive adverse outcomes. There is an immediate need for robust data on the long-term safety of paracetamol exposure in the prenatal and neonatal periods.

Introduction: CDK4/6 inhibitors in combination with aromatase inhibitors (AIs) are the standard first-line treatment for hormone receptor-positive (HR+), HER2-negative (HER2−) metastatic breast cancer. Landmark trials have demonstrated a comparable progression-free survival (PFS) across CDK4/6 inhibitors, but the overall survival (OS) outcomes have varied. This study aimed to evaluate the real-world PFS and OS for palbociclib and ribociclib when combined with AIs in patients with HR+/HER2− advanced breast cancer. Materials and Methods: This was a retrospective chart review of adult patients with HR+/HER2− metastatic breast cancer treated at a single academic center between 1 January 2015 and 1 December 2022. The baseline demographics, clinical characteristics, and treatment details were extracted. A Kaplan–Meier analysis was used to estimate the PFS and OS, and differences between the treatment groups were assessed using the log-rank test. Cox proportional hazards models were constructed to adjust for confounding factors. Results: Seventy-five patients were included in the final analysis. The cohort was predominantly female (98.7%) and postmenopausal (77.3%), with 52.0% having de novo stage IV disease. Palbociclib was prescribed to 74.7% of the patients, and ribociclib to 25.3%. The patients receiving ribociclib were significantly younger (57.6 vs. 67.5 years, p = 0.013) and more likely to be premenopausal (42.1% vs. 5.4%, p < 0.001). The real-world median PFS and OS for palbociclib were 20.3 months (95% CI: 14.8–46) and 37.2 months (95% CI: 20.3–not reached [NR]), respectively. For ribociclib, the median PFS and OS were not reached. The Cox proportional hazards models adjusting for age and menopausal status found no significant differences between ribociclib and palbociclib for the PFS (HR = 0.92, p = 0.86) or OS (HR = 0.95, p = 0.92). Conclusion: In this real-world analysis, palbociclib demonstrated a median PFS consistent with the results from landmark trials, although the observed OS was shorter. The ribociclib-treated patients had a numerically longer PFS and OS compared with those treated with palbociclib, but the differences were not statistically significant. The discontinuation rates were similar between the two groups.

Objective: The primary objective was to analyze percutaneous dilatation tracheostomy (PDT) management in the intensive care unit (ICU) by comparison with surgical tracheostomy (ST) outside of the ICU, with respect to: (i) long‐term postoperative outcomes, including rate of follow‐up, return to the emergency department, and major and minor complications; (ii) timing of decannulation, including time to decannulation, decannulation after >30 days, and decannulation at discharge. The secondary objective was to compare perioperative outcomes, including major and minor complications. Methods: A retrospective study from April 2013 to 2024 at a tertiary referral center. Eligible patients included those over 18 years old without PDT contraindications who received PDT in the ICU or ST. Results: Final analysis included 250 patients (125 [50%] PDT; 125 [50%] ST). The mean (SD) age of patients was 60.05 (16.41) years, and 85 (34.0%) were female. Compared with the ST group, the PDT group experienced significantly decreased long‐term follow‐up (41 [39.8%] vs. 115 [95.0%], respectively, p < 0.001), increased emergency department returns (61 [64.2%] vs. 31 [26.1%], p < 0.001), longer time to decannulation (estimated median difference: 11.00 days [95% CI: 7.00 to 15.00, p < 0.001]), increased decannulation after >30 days (23 [34.8%] vs. 13 [12.7%], p < 0.001), and similar postoperative complications (8 [8.4%] vs. 8 [6.8%], p = 0.664). The PDT group experienced significantly more perioperative complications (37 [30.1%] vs. 22 [17.6%], p = 0.021). Conclusion: The decreased long‐term follow‐up, delayed decannulation, and increased complications after PDT highlight potential pitfalls in ICU tracheostomy management, demonstrating the need for refined protocols, appropriate consultant involvement, and improved patient selection. Level of Evidence: 3 Laryngoscope , 135:2306–2313, 2025

Introduction: CDK4/6 inhibitors in combination with aromatase inhibitors (AI) are the standard first-line treatment for hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer. Landmark trials have demonstrated comparable progression-free survival (PFS) across CDK4/6 inhibitors, but overall survival (OS) outcomes have varied. This study aimed to evaluate real-world PFS and OS for palbociclib and ribociclib when combined with AI in patients with HR+/HER2- advanced breast cancer. Materials and Methods: This was a retrospective chart review of adult patients with HR+/HER2- metastatic breast cancer treated at a single academic center between January 1, 2015, and December 1, 2022. Baseline demographics, clinical characteristics, and treatment details were extracted. Kaplan-Meier analysis was used to estimate PFS and OS, and differences between treatment groups were assessed using the log-rank test. Cox proportional hazards models were constructed to adjust for confounding factors. Results: Seventy-five patients were included in the final analysis. The cohort was predominantly female (98.7%) and postmenopausal (77.3%), with 52.0% having de novo stage IV disease. Palbociclib was prescribed to 74.7% of patients, and ribociclib to 25.3%. Patients receiving ribociclib were significantly younger (57.6 vs. 67.5 years, p= 0.013) and more likely to be premenopausal (42.1% vs. 5.4%, p< 0.001). The real-world median PFS and OS for palbociclib were 20.3 months (95% CI: 14.8–46) and 37.2 months (95% CI: 20.3–not reached [NR]), respectively. For ribociclib, the median PFS and OS were not reached. Cox proportional hazards models adjusting for age and menopausal status found no significant differences between ribociclib and palbociclib for PFS (HR = 0.92 , p= 0.86) or OS (HR= 0.95 , p= 0.92). Conclusion: In this real-world analysis, palbociclib demonstrated a median progression-free survival consistent with results from landmark trials, although the observed overall survival was shorter. Ribociclib-treated patients had numerically longer PFS and OS compared with those treated with palbociclib, but the differences were not statistically significant. Discontinuation rates were similar between the two groups.

This case report details a rare and severe presentation of refractory otomastoiditis caused by Mycobacterium abscessus in an immunocompetent pediatric patient who presented with a 1-month history of left ear pain, swelling, and fever unresponsive to antibiotics. Computed tomography imaging was suggestive of coalescent otomastoiditis, and she underwent urgent left mastoidectomy, subperiosteal abscess drainage, and myringotomy with tube insertion, followed by conventional antibiotic management. Despite these interventions, she remained symptomatic and cultures revealed M. abscessus 1 week later. Multidisciplinary management involved serial microdebridement and prolonged multidrug antimicrobial therapy with shared decision-making between otolaryngology, infectious diseases, and international experts. Pharmacological management was complicated by adverse effects including aminoglycoside-induced hearing loss, myelosuppression, and gastrointestinal intolerance requiring drug substitutions. Eighteen months after initial presentation, revision mastoidectomy, canaloplasty, mastoid obliteration, tympanoplasty, and ossiculoplasty were performed for the eradication of residual disease and reconstruction. At follow-up, there was no disease recurrence although left-sided moderate-to-severe mixed hearing loss persisted. This case highlights the importance of early recognition and coordinated medical-surgical interventions in atypical presentations of mastoiditis.

Importance: Expanding the appropriate use of ambulatory surgical care may improve operating room (OR) efficiency. Objective: To demonstrate that pediatric adenoidectomy with laryngeal mask airway (LMA) for select patients in the minor procedure room (MPR) is comparable in safety but more efficient than OR adenoidectomy in a pilot study of 20 patients from July to November 2023. Design: The Institute for Healthcare Improvement Model for Improvement guided this quality improvement project. Safety and efficiency outcomes were prospectively collected for adenoidectomies with LMA in the MPR and compared with retrospective data from similar OR cases with LMA or endotracheal intubation (ETT). Setting: A single tertiary referral center. Participants: Pediatric patients who underwent adenoidectomy from July to November 2023. Interventions: The intervention involved adenoidectomy in the MPR with LMA, as opposed to traditional OR settings. Main Outcome Measures: The main outcome measures included safety (perioperative respiratory adverse events, conversion from LMA to ETT), efficiency (length of hospital stay, wait time for surgery), and patient/provider satisfaction. Results: Final analysis included 55 patients [20 (36%) MPR, 35 (64%) OR]. In the OR, 16 (46%) patients used LMA, the rest used ETT. The median [interquartile range (IQR)] age was 5.5 (3.7-7.3) years, and 22 (41%) patients were female. No major respiratory adverse events occurred in the MPR compared to 1 (3%) event in the OR. One (5%) MPR patient required conversion from LMA to ETT due to limited surgical access. Time-based measures were superior in the MPR, with median hospital stay 91 minutes shorter (158.0; IQR: 143.0-204.0 vs 249.0; IQR: 210.0-278.0). Patient and provider satisfaction were highly rated in the MPR. Conclusions: Pediatric adenoidectomy for select patients in the MPR is a safe and time-efficient alternative to the OR. Relevance: Further exploration of suitable procedures for the MPR may enhance OR resource allocation. Level of Evidence. 3: