[The adaptive use of the Freiburg mono-syllabic speech test in noise with a few number of test-lists]. / Die adaptive Messung des Freiburger Einsilbertests im Störschall mit einer verringerten Anzahl an Testlisten.

BACKGROUND: Considering the different calibration and masking of the noise, the adaptive Freiburg monosyllabic speech test in noise (aFBE-S) and the Oldenburg sentence test in noise (OLSA-S) were shown to be comparable with respect to the accuracy of both tests in a previous study. However, the time requirement of the aFBE-S was significantly greater than that of the OLSA-S due to the adaptive measurement method. The purpose of this study is to theoretically determine whether the aFBE-S can be used with fewer test lists, given the low scatter of results, and to compare the results with those of the OLSA-S. METHODS: Using the results of 40 otologically healthy subjects who had already been tested in randomized order with the OLSA-S and aFBE-S, the mean difference of the 95 % confidence interval (95 % CI) of the signal-to-noise ratio for 50% speech understanding (S/N50) of the aFBE-S was calculated for three, four, and five test lists instead of 7.5. In addition, the time required for the reduced number of test lists was determined and the results were examined in comparison with those of the OLSA-S. RESULTS: In each case, no significant difference between the difference mean of the 95 %-CI of the S/N50 of the original aFBE-S, the aFBE-S shortened to 3, 4, or 5 test lists and the OLSA-S could be found. The time required for the aFBE-S with a reduced number of test lists was significantly less than for the OLSA-S in each case. CONCLUSION: The aFBE-S is not inferior with a reduced number of test lists in comparison to the OLSA-S. This would allow to use the shortened aFBE-S theoretically.

High-Dose Glucocorticoids for the Treatment of Sudden Hearing Loss.

BACKGROUND: Systemic glucocorticoids are commonly used for primary therapy of idiopathic sudden sensorineural hearing loss (ISSNHL). However, the comparative effectiveness and risk profiles of high-dose over lower-dose regimens remain unknown. METHODS: We randomly assigned patients with sudden hearing loss of greater than or equal to 50 dB within 7 days from onset to receive either 5 days of high-dose intravenous prednisolone at 250 mg/d (HD-Pred), 5 days of high-dose oral dexamethasone at 40 mg/d (HD-Dex), or, as a control, 5 days of oral prednisolone (Pred-Control) at 60 mg/d followed by 5 days of tapering doses. The primary outcome was the change in hearing threshold (pure tone average) in the three most affected contiguous frequencies from baseline to day 30. Secondary outcomes included speech understanding, tinnitus, communication competence, quality of life, hypertension, and insulin resistance. RESULTS: A total of 325 patients were randomly assigned. Mean change in 3PTAmost affected hearing threshold from baseline to 30 days was 34.2 dB (95% CI, 28.4 to 40.0) in the HD-Pred group, 41.4 dB (95% CI, 35.6 to 47.2) in the HD-Dex group, and 41.0 dB (95% CI, 35.2 to 46.8) in the Pred-Control group (P=0.09 for analysis of variance). There were more adverse events related to trial medication in the HD-Pred (n=73) and HD-Dex (n=76) groups than in the Pred-Control group (n=46). CONCLUSIONS: Systemic high-dose glucocorticoid therapy was not superior to a lower-dose regimen in patients with ISSNHL, and it was associated with a higher risk of side effects. (Funded by the Federal Ministry of Education and Research [BMBF]; EudraCT number, 2015­002602­36.)

[Fundamentals and practice of the application of nasal packing in sinonasal surgery]. / Grundlagen und Praxis der Anwendung von Nasentamponaden in der endonasalen Chirurgie.

BACKGROUND AND OBJECTIVES: This paper presents an overview on nasal packing materials which are available in Germany. The current literature is analyzed whether there are robust criteria regarding use nasal packing after sinonasal surgery, whether there are fundamental and proven advantages or disadvantages of products, and what this means in clinical practice. MATERIALS AND METHODS: Selective literature analysis using the PubMed database (key words "nasal packing", "nasal tamponade", "nasal surgery", "sinonasal surgery", or "sinus surgery"), corresponding text books and resulting secondary literature. RESULTS AND CONCLUSIONS: Because of systematic methodological shortcomings, the literature does not help in the decision-making about which nasal packing should be used after which kind of sinonasal surgery. In fact, individual approaches for the many different clinical scenarios are recommended. In principle, nasal packing aims in hemostasis, should promote wound healing, and should not result in secondary morbidity. Nasal packing materials should be smooth (non-absorbable materials), inert (absorbable materials), and should not exert excessive pressure. Using non-absorbable packing entails the risk of potentially lethal aspiration and ingestion. For safety reasons inpatient control is recommended as long as this packing is in situ. With other, uncritical packing materials and in patients with special conditions, outpatient control could be justified.

[On the state of intersectoral treatment in otolaryngology in Germany - Results of a survey]. / Zum Stand der intersektoralen Behandlung in der HNO-Heilkunde in Deutschland ­ Ergebnisse einer Umfrage.

BACKGROUND: The German Healthcare System is currently subject of significant structural changes. Due to politic influences it is obvious that more and more even complex diagnostic and therapeutic procedures will be performed in an office setting or as day treatments. This is due to the high rate of hospital treatments in Germany compared to other OECD countries. A revision of the healthcare system will include both, ambulatory and hospital treatments, which will only be possible with some new structures for this "intersectoral" treatment. Currently there are no data available on the status, possibilities and structure of the "intersectoral" treatment in ENT in Germany. METHODS: To get an overview on the possibilities for an "intersectoral" treatment in ENT in Germany a survey was conducted. Each chariman of an ENT clinic/Department and all ENT specialists in private practice were contacted and got a questionnaire. The evaluation was performed differently for chairmen of an ENT department, ENT specialists in private practice without and with a ward for inpatients in hospitals. RESULTS: 4,548 questionnaires were mailed. Out of them 493 were filled and came back (10.8%). The return rate in the group of ENT Department chairmen was with 52.9% even higher. "Intersectoral" for physicians in hospitals means that they are usually working with a personal authorization by the local Association of Statutory Health Insurance Physicians, ENT specialists in private practice usually with a ward for inpatient authorization in a hospital. Appropriate structures for an intersectoral organization of patients´s treatment are currently missing. Both, ENT Department chairmen and ENT specialists in private practice declared the current remuneration system for ambulatory and day surgery as completely inaedequate and is urgently to be revised. Beside this, ENT Department chairmen declared problems with the emergency care of patients with complications operated on outside the hospital, problems with the continuing education of residents and with information transfer. They request that hospital specialists should be allowed to work in the contractual medical care of outpatients without a restriction. ENT specialists in private practice mentioned positively the good cooperation possibilities with hospital physicians, knowledge sharing, and wide ranges of indications in the ENT Departments. Negative points could be possible worse information sharing when there is no distinct contact person in the ENT Departments, a possible competitive situation between ENT Departments and specialists in private practice, and sometimes long waiting times for the patients. DISCUSSION: The German health care system is currently facing a radical reform with the overcoming of traditional rigid and inflexible sectors in outpatient care and inpatient hospital care. To achieve this, the intersectoral patient treatment should play the key role. "Intersectoral" means that the whole process of patient care from diagnosis to therapy is closely interlinked and can also be managed by the same physicians, no matter whether they are working as spcialists in an ENT-Department in a hospital or in private practice. However, currently there are no appropriate structures available to achieve this goal. Beside creating structural conditions for intersectoral treatment the current remuneration system for outpatient procedures and dayclinic treatments must be renewed in a way to cover all the costs. Further conditions are the development of good cooperation models between ENT Departments and specialists in private practice, and the possibility for hospital ENT physicians to work in the contractual medical care of outpatients without a restriction. Intersectoral patient care must take the quality management, the continuing education of residents and the patient safety under consideration.

[Clinical trials as a central part of patient-centered clinical research]. / Klinische Studien als zentraler Bestandteil patientenorientierter Forschung.

As the continuation and implementation of findings from basic (pre­)clinical research, clinical trials make a significant contribution to medical research. They form the central building block of translational medicine and thus make a decisive contribution to bringing medical knowledge into general care. This helps to make possible a healthcare system that is aligned to the needs of patients and functions efficiently in the long term. Based on the specific objective, clinical trials must comply with national, but increasingly also with European and international regulatory requirements. In academia in particular, expertise in a variety of fields is required in order to make investigator-driven clinical trials a success. This expertise can be provided by a clinical trial center based within the institution conducting the trial.

[Webinars for ENT specialists in Germany during the Lockdown phase of the COVID-19 pandemic 2020/2021]. / Webinare für HNO-Fachärzte in Deutschland während der Lockdown-Phase der COVID-19-Pandemie 2020/2021.

INTRODUCTION: During the COVID-19 pandemic, webinars are one of the few opportunities to continue CME training to a large majority of ENT doctors. However, experiences with the quality of this digital form of education is still limited. METHODOLOGY: In this study, six webinars for ENT specialists during the second lockdown in Germany (January to March 2021, provider Zoom) were evaluated. The quality control was performed by participants and speakers using special quality questions. School grades (1-6) were used for the evaluation. Answers were statistically evaluated. RESULTS: On average, 1108 participants attended the six webinars. 330 ENT doctors answered the surveys. The return of the questionnaires was 30.2%, that of the speakers 100%. Eight of the nine questions asked received school grades better than 2.0 on average. The speakers needed an average of 12.8 hours to prepare the webinar. The cost per webinar was about 3.50 €. CONCLUSIONS: Webinars have become an effective form of CME-training for ENT doctors in Germany. They can be organized quickly for a large number of participants, are less expensive and environmentally benefical. Webinars might have an important place in CME-training in the future.

[The ENT patients' perspective on otorhinolaryngology, head and neck surgery - a Germany-wide survey]. / Die Perspektive der Patienten auf die HNO-Heilkunde ­ eine deutschlandweite Befragung.

BACKGROUND: Patient orientation in the decision-making process for the best treatment, but patient participation in research projects, are more required. METHODS: In a multi-center prospective cross-sectional study, ENT patients completed a layman-friendly questionnaire with questions on patient orientation, evidence-based medicine, need for research, and health literacy. The survey was performed during an ENT awareness week in June 2021 in 27 ENT practices, 18 ENT clinics and 14 university ENT departments. RESULTS: 2023 patient responses (46% female; 49% 46-75 years old; 40% in ENT practice) were evaluated. The most commonly reported ENT diseases were sensory disorders (16.8%), or tumors (12.7%), Shared decision-making was the favored process for treatment decisions (43.5%). Sufficient time to talk was cited as the most important element of the relationship (15.8%). Most participants felt well informed about treatment steps (42.4%). For electronic searches, general search engines were primarily used (50.3%). Three-quarters of participants (73.7%) had never participated in a study before. About two-thirds (62.8%) could not imagine doing so in the future. Factors such as gender, age, schooling, or location of the survey were associated with different response behaviors. DISCUSSION: The desire for patient orientation is also high among ENT patients and frequently implemented by ENT doctors in practice and clinic. Especially, patients with lower education level should be more involved in the planning of studies in order to provide opportunities for participation in accordance with the recommendations of the funding institutions.

[Clinical trials as a central part of patient-centered clinical research]. / Klinische Studien als zentraler Bestandteil patientenorientierter Forschung.

As the continuation and implementation of findings from basic (pre-)clinical research, clinical trials make a significant contribution to medical research. They form the central building block of translational medicine and thus make a decisive contribution to bringing medical knowledge into general care. This helps to make possible a healthcare system that is aligned to the needs of patients and functions efficiently in the long term. Based on the specific objective, clinical trials must comply with national, but increasingly also with European and international regulatory requirements. In academia in particular, expertise in a variety of fields is required in order to make investigator-driven clinical trials a success. This expertise can be provided by a clinical trial center based within the institution conducting the trial.

[Unmet medical need in otorhinolaryngology: A challenge for otorhinolaryngologists and head and neck surgeons]. / Unmet medical need in der Hals-Nasen-Ohren-Heilkunde: Die HNO-Ärztinnen und HNO-Ärzte sind gefordert.

BACKGROUND: Otorhinolaryngologists and head and neck surgeons are predestined to scientifically analyze and prioritize the medical needs in ENT medicine under the umbrella of the German Society of Otolaryngology, Head and Neck Surgery (DGHNO-KHC). This medical need assessment is important for targeting research and development of medical innovations to improve ENT patients' care with these needs and to trigger respective research and innovation funding programs at an early stage. METHODS: This is to recommend that the DGHNO-KHC and its working groups and task forces in their specialty disciplines address the issue. The goal is a comprehensive medical need assessment for the fields of otolaryngology as well as head and neck surgery. The parameterization of medical needs is based on the unmet medical need (UMN) concept. Criteria for prioritization should follow the method of multi-criteria decision analysis (MCDA). RECOMMENDATION: The working groups of the DGHNO-KHC familiarize themselves with the concept of UMN. Subsequently, suggestions on ENT diseases with UMN in diagnostics and therapy will be collected considering the medical evidence. The suggestions are evaluated in a standardized way according to MCDA and a ranking is established. The results will be published and used to make research funding institutions aware of UMN in otorhinolaryngology, head and neck surgery. DISCUSSION: The work will contribute to the further development of the UMN concept and will also be able to provide a basis to investigate the evidence of the concept to define the UMN. Through this work, the DGHNO-KHC will be perceived as an important scientific player for the development of need-driven medical innovations in Germany.

[Considerations for the Performance and Quality Assurance of Outpatient Surgery in Otorhinolaryngology, Head and Neck Surgery in Germany]. / Erwägungen zur Durchführung und Qualitätssicherung ambulanter Operationen im HNO-Bereich in Deutschland.

BACKGROUND: German health policy has propagated an expansion of outpatient surgeries and procedures and initiated the discussion about this. Otorhinolaryngology, head and neck surgery offers opportunities to provide currently inpatient procedures on an outpatient basis. METHODS: The German Society of Otorhinolaryngology, Head and Neck Surgery, and the German Professional Association of Otorhinolaryngologists established working groups to assess and evaluate the ENT-specific aspects of shifting services to the outpatient setting. The working groups were given the task of developing and considering organizational, structural and personnel definitions of quality assurance. RECOMMENDATION: Facts were determined in detail, which exclude an ambulatory operation in the ENT-specialty. This was based on both surgery-related and patient-related facts. Finally, operations were named which can be performed as outpatient operations. DISCUSSION: An evaluation was performed from the ENT specialist's perspective. A prerequisite for outpatient treatment is a reorganization of remuneration. The current DRG and EBM system do not provide a satisfactory framework for this, and the EBM does not allow for the economic provision of surgical interventions in otorhinolaryngology, head and neck surgery. The development of an appropriate financing model is as imperative for a successful implementation as the integration and financing of further training of ENT physicians.

[Possibilities to predict the success of an individual hearing aid fitting using the APHAB]. / Möglichkeiten der Vorhersage des Erfolgs einer Hörgeräteversorgung mittels des APHAB-Fragebogens.

BACKGROUND: Since 2012, the APHAB is part of the quality agreement for statutory insured patients in hearing aid fitting (HAF). So far, individual results could be interpreted by using percentile curves only, but not for the improvement quotient and the cumulated benefit. The presented study should close this gap. Moreover, it should be clarified if an individual constancy within percentile exists. METHODS: Using the data of 6861 hearing aid fitted patients from a database, we calculated the benefit by improvement quotient and cumulated benefit for different age-classes and percentile-groups and presented by a heatmap. Individual constancy of percentile would be calculated using Spearman's rank correlation. RESULTS: The average benefit was 21.41. The average of the improvement quotient was 41.01. It was significantly higher (44.36 %) in subjects younger than the average (27.26 years ± 11.86) than in the elderly (37.66 %). It decreased in cases of lower APHAB-scores before HAF concerning the percentile-group, ranging from 23.22 % to 52.07 %. Spearman's rank coefficient for the APHAB benefit was 0.285, Cohen's effect size was small. The correlation between the APHAB-score before HAF and the cumulated benefit was 0.582 and the improvement quotient was 0.270. CONCLUSIONS: An individual constancy within percentile before and after HAF was not detectable. Nevertheless, some relationships of the improvement quotient and the age resp. percentile-groups could be demonstrated. The benefit of HAF was less in older subjects with lower APHAB-scores and best in young subjects with higher APHAB-scores before HAF.

[Correlation between the APHAB questionnaire and the Freiburg monosyllabic test without + with noise]. / Korrelationen zwischen dem APHAB-Fragebogen und dem Freiburger Einsilbertest ohne und mit Störschall.

BACKGROUND: Questionnaires, e. g. the APHAB, and speech-audiometry are the most used elements in measuring the success of hearing aid fitting (HAF). This study investigates the correlations between the results of the Freiburg monosyllabic word test without and with noise (FBE, FBE-S) and the results of the APHAB before and after HAF. METHODS: Data of the FBE, the FBE-S, and the APHAB, generated within HAF of 156 subjects were analyzed. After exclusion of a normal distribution of the data, Spearman's correlation and Cohen's effect size were determined. RESULTS: 73 (46.8 %) of the 156 subjects were females, and 83 (53.2 %) males. No significant correlation could be found between the EC-, the RV-, and the cumulative ECBNRV-subscale and the benefit of HAF in the FBE and FBE-S (EC: ease of communication, BN: background noise, RV: reverberation). Most of the remaining coefficients of correlation had a weak positive effect size. A middle positive effect size could only be demonstrated for 6 combinations, for the EC-subscale mostly. CONCLUSION: The not strong effect sizes could assume that the results in speech-audiometry and the APHAB are not independent and complementing each other as parameters of hearing loss and benefit in HAF. The effect size could be explained by individually different possibilities for the compensation of hearing loss.

Hypoglossal nerve stimulation for obstructive sleep apnea: updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.

Since the first statement of the German Society of Oto-Rhino-Laryngology, hypoglossal nerve stimulation (HNS) is meanwhile an established treatment option for obstructive sleep apnea (OSA). There are three HNS systems available in Germany which differ in their technical details of the underlying comparable basic principle. For the unilateral HNS with respiratory sensing, several comparative studies, high-volume register analysis and long-term reports exist. The continuous HNS without respiratory sensing does not require a sleep endoscopy for indication. For the bilateral continuous HNS as the single partially implantable device, a feasibility study exists. For indication, the assessment of positive airway pressure failure by sleep medicine is crucial, and the decision for HNS should be made in discussion of other treatment options for at least moderate OSA. The implantation center holds primarily responsibility among the interdisciplinary sleep team and is primary contact for the patient in problems. This depicts why structural processes are required to secure outcome quality and minimize the complications. The aftercare of HNS patients can be provided interdisciplinary and by different medical institutions, whereat, minimal reporting standards to document outcome and usage are recommended.

Webinar-based continuing medical education in otorhinolaryngology during the COVID-19 pandemic in Germany: a longitudinal study.

OBJECTIVE: Reliance on webinars for continuing medical education (CME) has increased since the onset of the COVID-19 pandemic. Here, we aimed to evaluate the teaching methods used in these webinars. DESIGN: Retrospective, longitudinal study. SETTING: 20 CME-approved webinars, conducted March-December 2020 in Germany, and lasting 2.25 hours each. PARTICIPANTS: Otorhinolaryngologists pursuing CME credits. INTERVENTIONS: Postwebinar participant assessments of the speaker, effects on practical work, desired scientific content, technical quality, interactions, attention and future training behaviour. RESULTS: On average, 780 participants joined each webinar. The mean survey response rate was 35% (n=282). When asked how well the speaker had mastered the content, 38% responded 'very well', 44% responded 'well', 14% indicated 'satisfactory' and 4% chose 'sufficient'. The frequency of webinars was considered appropriate by 92%, too high by 4% and too low by 4% of participants. The measured attention of the participants was 90%. After the COVID-19 pandemic lockdown, 68% of participants preferred online teaching. The average costs per participant were €3.50 (about $4.25 or £3.15) per webinar. CONCLUSIONS: Although the pandemic context likely influenced the results, we conclude that periodic ear, nose and throat webinar training during COVID-19 in 2020 was an effective alternative delivery method. We found high attention rates, high levels of participant satisfaction and low costs. Evaluations and re-evaluations will be necessary to adapt teaching concepts successfully and ensure high levels of teaching and learning efficiency.

Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): study protocol for a randomized non-inferiority trial.

BACKGROUND: Tonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. For decades, tonsillectomy was the surgical treatment of choice for recurrent acute tonsillitis. Tonsillotomy was used in some countries as an alternative to tonsillectomy only for the treatment of obstructive sleep apnea in young children. In recent years, an increase of tonsillotomy also to treat recurrent acute tonsillitis can be observed. Therefore, the German Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether tonsillotomy offers advantages compared to tonsillectomy. The meta-analysis of the IQWiG including studies until 2016 revealed that the long-term benefits and harms of tonsillotomy compared to tonsillectomy are unclear. Consequently, the G-BA performed a European call for a clinical trial. A consortium of the German Professional Association of ENT-surgeons (BVHNO), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), and the Jena University Hospital were finally selected to perform the TOTO study. METHODS: TOTO is a multicenter, 1:1 two-arm, randomized non-blinded non-inferiority trial. Four hundred fifty-four patients ≥ 3 years of age will be randomly allocated to undergo either tonsillotomy or tonsillectomy as surgical treatment of recurrent acute tonsillitis. All participants will be followed up for a total of 24 months. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. DISCUSSION: TOTO is designed to evaluate the effectiveness and efficiency of tonsillectomy versus tonsillectomy for the management of patients with recurrent acute tonsillitis. Tonsil disease and surgery have a major impact on preschool and school children as well as on economically active young adults, with individual and societal costs through loss of school visits, earnings, and productivity. If tonsillotomy is at least as effective as tonsillectomy but with reduced morbidity, this would reduce costs to the healthcare system and society. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020823 . Registered on 04 September 2020.