PurposeOff-label drugs are being used in laryngology. Prescribing of a medicinal product is a decision taken within the relationship between a patient and his/her treating health care provider (HCP). The purpose of this article is to discuss the medicolegal aspects of off-label drug use, to provide recommendations for obtaining informed patient consent for off-label treatment and to propose the place and role of scientific societies and specialist boards in shaping good practices in this area. The final aim is to present recommendations concerning off-label usage and propose special clauses in informed patients consent.MethodsThe literature was reviewed regarding off-label applications in laryngology. Practical information on off-label use in various EU countries was collected.ResultsRegistration data and pharmacokinetics of cidofovir, bevacizumab, Gardasil®, hyaluronic acid and mitomycin are provided. Off-label prescribing is not prohibited by EU law. Informed consent to treatment with an off-label drug exists in all EU countries. The risk that a court will accept liability of a HCP in case of off-label prescribing is higher than in case of on-label prescribing. If a HCP is held liable for the outcome of a medical treatment, the approval by the competent authorities and professional guideline is a strong defense.ConclusionA patient’s precise, explicit consent for the procedures including off-label drugs administration is mandatory. The second prerequisite is defining a need for creating based on recommendations by national or international scientific societies.

PurposeChemotherapy induced ototoxicity (e.g. by cisplatin) is a regularly occurring although underreported challenge in clinical practice. Several reviews of ototoxicity monitoring throughout clinical trials reveal difficulty in estimating the incidence due to the use of different scales and classification systems. In this communication, we introduce a scale to improve the assessment of ototoxicity during routine cancer care incorporating patient reported outcomes.MethodsCombining and updating the existing ototoxicity scales to develop a new and universally applicable grading scale.ResultsThe developed scale includes all types of ototoxicity (hearing loss as well as tinnitus) and combines audiogram measurements with patient reported outcomes.ConclusionUsing a single scale for assessing and grading ototoxicity in routine care as well as in clinical trials may improve the current understanding of the actual incidence and actual patient burden of this toxicity. In addition, it could enhance the opportunities for intervention and/or aural rehabilitation.

PurposeThis study aimed to explore the capabilities of advanced large language models (LLMs), including OpenAI’s GPT-4 variants, Google’s Gemini series, and Anthropic’s Claude series, in addressing highly specialized otolaryngology board examination questions. Additionally, the study included a longitudinal assessment of GPT-3.5 Turbo, which was evaluated using the same set of questions one year ago to identify changes in its performance over time.MethodsWe utilized a question bank comprising 2,576 multiple-choice and single-choice questions from a German online education platform tailored for otolaryngology board certification preparation. The questions were submitted to 11 different LLMs, including GPT-3.5 Turbo, GPT-4 variants, Gemini models, and Claude models, through Application Programming Interfaces (APIs) using Python scripts, facilitating efficient data collection and processing.ResultsGPT-4o demonstrated the highest accuracy among all models, particularly excelling in categories such as allergology and head and neck tumors. While the Claude models showed competitive performance, they generally lagged behind the GPT-4 variants. A comparison of GPT-3.5 Turbo’s performance revealed a significant decline in accuracy over the past year. Newer LLMs displayed varied performance levels, with single-choice questions consistently yielding higher accuracy than multiple-choice questions across all models.ConclusionWhile newer LLMs show strong potential in addressing specialized medical content, the observed decline in GPT-3.5 Turbo’s performance over time underscores the necessity for continuous evaluation. This study highlights the critical need for ongoing optimization and efficient API usage to improve LLMs potential for applications in medical education and certification.

ObjectivesTo investigate the correlation between laryngopharyngeal reflux (LPR) and psychological distress in a sample of adult Italian patients.MethodsLPR was assessed using the Reflux Symptom Index (RSI), Reflux Finding Score (RFS), and 24-hour impedance-pH monitoring. Psychological distress was evaluated with the following clinical tools: the Hospital Anxiety and Depression Scale (HADS), the Hamilton Anxiety Rating Scale (HAM-A), the Hamilton Depression Rating Scale (HAM-D), the Impact of Event Scale-Revised (IES-R), the Insomnia Severity Index (ISI), and the Perceived Stress Scale-10 (PSS-10). Associations between RSI, RFS, and psychological scores were analyzed.ResultsA total of 45 patients with LPR (Study Group, SG) and 29 healthy volunteers (Control Group, CG) were included in the study. Psychological assessments revealed significant differences between the CG and SG, except for the ISI. The HAM-A score was 6.79 ± 6.5 in the CG versus 9.53 ± 5.8 in the SG (p = 0.025), with similar results for the HADS (p = 0.029). For the HAM-D, mean scores in both groups were below the threshold for mild depressive symptoms, though SG scores were just below the cut-off (CG: 4.86 ± 5.1; SG: 6.89 ± 4.1; p = 0.010). The PSS-10 indicated mild to moderate perceived stress, with significantly higher scores in the SG (CG: 13.90 ± 5.5; SG: 21.62 ± 8.1; p = 0.000). RSI scores were positively correlated with HAM-D, HADS, and HAM-A scores.ConclusionsPsychological distress is significantly higher in LPR patients compared to healthy controls. These preliminary findings suggest that psychological factors should be considered in the management of LPR.

PurposeInflammations of the upper respiratory tract (URT) are common both in adults and children and they are generally treated using aerosol therapy with mucolytic medications and steroids. When these inflammations affect children, the treatment must be rapid and resolutive to prevent complications. Steroids present some contraindications, i.e. alteration of smell, that must be considered especially in children. Therefore, alternative treatments that have similar efficacy but limited adverse effects should be considered. This study aims at evaluating the efficacy of Adelmidrol to treat inflammation of the URT in children.MethodsCase-Control study. Control group used standard treatment for URT inflammation (mucolytics and steroids); treatment groups were treated by Adelmidrol spray. Sixty children (age range 2.5–4.5 years) were randomly assigned to (i) control group, (ii) treatment group 1 (TG1)- Adelmidrol nasal spray only and (iii) treatment group 2 (TG2), in which Adelmidrol was administered in both nasal and oral spray solution. The URT and the tympanic membrane were evaluated at T0, T1 (30 days) and T2 (90 days). The treatments were performed for 90 consecutive days.ResultsAt the end of the treatment, TG2 (combination of nasal and oral sprays) had the best outcomes both on URT findings (χ²: p = 0.0004) and tympanic membrane conditions (χ²: p = 0.03). TG1 showed similar outcome of CG.ConclusionsThese preliminary results in our group of 60 children showed that Adelmidrol had the same efficacy of standard treatment when used as nasal spray only and was better than the standard treatment when used combining nasal and oral sprays. The molecule seems to offer the same benefit of standard treatment without side effects. If confirmed on a larger sample, the use of Adelmidrol could be suggested as an alternative to traditional treatment for the inflammation of URT in children.

ObjectivesThe aim of the current study was to evaluate the functional sinonasal outcomes after rescue flap versus double nasoseptal flap in endoscopic endonasal pituitary surgery.MethodsThis randomized clinical trial was conducted over 1.5 years over 60 patients who underwent endoscopic trans-sphenoid surgery for macroadenomas (more than 2 cm.). the patients were randomly allocated into 2 groups: the rescue flap group, (n = 30) and the double nasoseptal flap group (n = 30). Functional sinonasal outcomes were evaluated in both groups in terms of sinonasal outcome test (SNOT-22), crusting, adhesions, and olfaction.Resultsthe sinonasal outcome test (SNOT-22), as well as the olfaction scores were significantly better in the double flap group compared to the rescue flap group. Crusting and adhesions occurred more frequently in the rescue flap group. The nasal stage operative time was significantly longer in the double flap group than the rescue flap group.ConclusionEndoscopic pituitary surgery can adversely affect the sinonasal functions. Double nasoseptal flap technique allows posterior septectomy with bilateral septal mucosa preservation. Although it requires longer operative time than the rescue flap technique, better functional sinonasal outcomes and olfaction scores are achieved.

PurposeThe aim of this study is to determine the presence of hyperacusis in gifted children and evaluate its effect on quality of life.MethodsThe study included 47 children between the ages of 7 and 12 who did not have hearing loss, who were diagnosed as gifted by scoring 120 or more on the Weschler Intelligence Scale for Children-IV (WISC-IV) and who did not have any accompanying disabilities, and 27 age and gender matched children with normal intelligence.The ‘Pediatric Hyperacusis Questionnaire Parent Form(P-HQ)’ was applied to the children for hyperacusis assessment, and the ‘Quality of Life Inventory for Children (PedsQL)’ was applied for quality of life.ResultsWhen the pediatric hyperacusis questionnaire parent form scores were compared between the groups, a statistically significant difference was obtained (p =.000).In the quality of life assessment made using the quality of life scale for children, a statistically significant difference was obtained between the groups in the sub-parameters of the test; physical health total score (p =.000),emotional functioning score (p =.032),social functioning score (p =.007),school functioning score (p =.000) and scale total score (p =.000).ConclusionOur study results showed that gifted children mostly complain of hyperacusis and that this complaint increases as their intelligence level increases.We believe that hyperacusis and its effect on quality of life should not be ignored in gifted children.Whenever possible, gifted children should be evaluated for hyperacusis and sensory sensitivities.We think that individualized therapy planning is necessary for the difficulties caused by sensory sensitivities that affect quality of life. Our findings revealed the necessity of hyperacusis assessment and therapy when working with gifted individuals.

ObjectiveScientometric analysis helps to understand the research trends and identify top contributors, publishers, trends, and research topics. Laryngopharyngeal reflux has been a topic of interest in research and clinical practice. The literature on laryngopharyngeal reflux is evolving and a scientometric analysis will help us understand the trends better. The present study aimed to analyze published data to identify trends, top contributors, top institutions and countries, growth of publications, keywords and keyword co-occurrence.MethodsThe present study aims to analyze the evolution of Laryngopharyngeal reflux research using a scientometric analysis approach for publications from the Scopus database using keywords related to laryngopharyngeal reflux. Documents related to laryngopharyngeal reflux were identified for further analysis. Microsoft Excel and VosViewer were used to perform bibliometric analysis.ResultsA total of 7,327 hits were obtained, and after applying filter, 5637 studies were retained for further analysis. The results revealed an increase in publications on LPR, which surged after the early 2000s. The Unites States had the maximum research output, and the Journal of Voice had the highest number of publications. The keyword co-occurrence analysis helped identify five research themes on laryngopharyngeal reflux.ConclusionThe findings reveal a rising trend in laryngopharyngeal reflux, especially in recent years. The presence of international collaborations and a high volume of research will help bridge gaps, enable capacity building and improve understanding of LPR.