Structure and establishment of the German Cochlear Implant Registry (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

Automatic electrode scalar location assessment after cochlear implantation using a novel imaging software.

As of today, image-based assessment of cochlear implant electrode array location is not part of the clinical routine. Low resolution and contrast of computer tomography (CT) imaging, as well as electrode array artefacts, prevent visibility of intracochlear structures and result in low accuracy in determining location of the electrode array. Further, trauma assessment based on clinical-CT images requires a uniform image-based trauma scaling. Goal of this study was to evaluate the accuracy of a novel imaging software to detect electrode scalar location. Six cadaveric temporal bones were implanted with Advanced Bionics SlimJ and Mid-Scala electrode arrays. Clinical-CT scans were taken pre- and postoperatively. In addition, micro-CTs were taken post-operatively for validation. The electrode scalar location rating done by the software was compared to the rating of two experienced otosurgeons and the micro-CT images. A 3-step electrode scalar location grading scale (0 = electrode in scala tympani, 1 = interaction of electrode with basilar membrane/osseous spiral lamina, 2 = translocation of electrode into scala vestibuli) was introduced for the assessment. The software showed a high sensitivity of 100% and a specificity of 98.7% for rating the electrode location. The correlation between rating methods was strong (kappa > 0.890). The software gives a fast and reliable method of evaluating electrode scalar location for cone beam CT scans. The introduced electrode location grading scale was adapted for assessing clinical CT images.

Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification program and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification program and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification program for quality control in CI care was successfully implemented in Germany.

[Structure and establishment of the German Cochlear Implant Registry]. / Struktur und Einrichtung des Deutschen Cochlea-Implantat-Registers (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

[Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany. German version]. / Konzeption und Implementierung eines Zertifizierungssystems zur Qualitätssicherung der Cochlea-Implantat-Versorgung in Deutschland.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification system and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification system and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification system for quality control in CI care was successfully implemented in Germany.

Association between malformation type, location and functional deficits in lymphatic malformations of the head and neck in children.

PURPOSE: Lymphatic malformations (LM) are congenital malformations of the lymphatic system, mainly located in the head and neck area. They can be staged based on location according to de Serres and based on different morbidity items using the Cologne Disease Score (CDS), a clinical staging system. In many cases, functional impairment greatly affects the life of patients suffering from lymphatic malformations. The present study aims to analyze a cohort of pediatric patients with LM. METHODS: A retrospective analysis of 144 pediatric patients with head and neck LM was performed. Location, type of malformation (microcystic, macrocystic, mixed), scoring according to two different scoring systems and therapy were analyzed. Kruskal-Wallis test was used to analyze the difference in CDS between the patient groups and Dunn's test was used for post-hoc pairwise comparison. RESULTS: The average age at presentation was 6.1 years. The most common sites were neck (47%), cheek/parotid gland (26%), tongue (17%) and orbit (8%). Macrocystic malformations dominated the lateral neck, while microcystic malformations were predominantly localized in the tongue and floor of mouth. Macrocystic malformations (mean CDS 9.44) were associated with significantly better CDS than microcystic (mean CDS 7.11) and mixed (mean CDS 5.71) malformations (p < 0.001). LM in stage V according to de Serres had the lowest values (mean CDS: 4.26). The most common therapeutic procedures were conventional surgical (partial) resection, laser therapy and sclerotherapy with OK-432. CONCLUSIONS: There is an association between malformation type, location according to de Serres and CDS in children with LM of the head and neck. Patients with microcystic and mixed malformations in stage V had lowest CDS levels.

Keyword-augmented and semi-automatic generation of FESS reports: a proof-of-concept study.

INTRODUCTION: Surgical reports are usually written after a procedure and must often be reproduced from memory. Thus, this is an error-prone, and time-consuming task which increases the workload of physicians. In this proof-of-concept study, we developed and evaluated a software tool using Artificial Intelligence (AI) for semi-automatic intraoperative generation of surgical reports for functional endoscopic sinus surgery (FESS). MATERIALS AND METHODS: A vocabulary of keywords for developing a neural language model was created. With an encoder-decoder-architecture, artificially coherent sentence structures, as they would be expected in general operation reports, were generated. A first set of 48 conventional operation reports were used for model training. After training, the reports were generated again and compared to those before training. Established metrics were used to measure optimization of the model objectively. A cohort of 16 physicians corrected and evaluated three randomly selected, generated reports in four categories: "quality of the generated operation reports," "time-saving," "clinical benefits" and "comparison with the conventional reports." The corrections of the generated reports were counted and categorized. RESULTS: Objective parameters showed improvement in performance after training the language model (p < 0.001). 27.78% estimated a timesaving of 1-15 and 61.11% of 16-30 min per day. 66.66% claimed to see a clinical benefit and 61.11% a relevant workload reduction. Similarity in content between generated and conventional reports was seen by 33.33%, similarity in form by 27.78%. 66.67% would use this tool in the future. An average of 23.25 ± 12.5 corrections was needed for a subjectively appropriate surgery report. CONCLUSION: The results indicate existing limitations of applying deep learning to text generation of operation reports and show a high acceptance by the physicians. By taking over this time-consuming task, the tool could reduce workload, optimize clinical workflows and improve the quality of patient care. Further training of the language model is needed.

Efficacy of sirolimus in children with lymphatic malformations of the head and neck.

PURPOSE: Children with extensive lymphatic malformations of the head and neck often suffer from functional impairment and aesthetic deformity which significantly affect the quality of life and may be life-threatening. Treatment with sirolimus has the potential to improve symptoms and downsize lymphatic malformations. This systematic review summarizes the current information about sirolimus treatment of lymphatic malformations of the head and neck in children, its efficacy and side effects. METHODS: A systematic search of the literature regarding studies on sirolimus treatment of children with lymphatic malformations of the head and neck was performed in PubMed, Embase, and Google Scholar up to July 2021 with the search terms "lymphatic malformation", "lymphangioma", "cystic hygroma", "low-flow malformation", "sirolimus", "rapamycin", "mTOR inhibitor" and "children". RESULTS: In all, 28 studies including 105 children from newborn to 17 years treated with sirolimus for lymphatic malformations of the head and neck were analyzed. The most frequent initial dose was 0.8 mg/m2 per dose, twice daily at 12-h interval. The target blood level differed between studies, 10-15 ng/mL and 5-15 ng/mL were most often used. More than 91% of the children responded to sirolimus treatment which lasts from 6 months to 4 years. Typical side effects were hyperlipidemia, neutropenia and infections. METHODS: Sirolimus could be an effective treatment for children with large complicated lymphatic malformations of the head and neck. As not all patients will benefit from treatment, the decision to treat sirolimus should be made by a multidisciplinary team.

A randomized phase II study comparing the efficacy and safety of the glyco-optimized anti-EGFR antibody tomuzotuximab against cetuximab in patients with recurrent and/or metastatic squamous cell cancer of the head and neck - the RESGEX study.

BACKGROUND: The aim of the RESGEX study was to compare the efficacy and safety of the anti-epidermal growth factor receptor (anti-EGFR) antibody tomuzotuximab against cetuximab both in combination with chemotherapy in patients with recurrent and/or metastatic squamous cell cancer of the head and neck in the first-line treatment. PATIENTS AND METHODS: In this phase II trial 240 patients were equally randomized for six cycles to receive either tomuzotuximab (initial dose 990 mg then 720 mg) weekly and cisplatin 100 mg/m2 and fluorouracil (5-FU; 1000 mg/m2/day, days 1-4) every 3 weeks or cetuximab (400 mg/m2 subsequent 250 mg/m2) weekly with the same chemotherapeutic backbone followed by antibody maintenance treatment. The primary endpoint was progression-free survival. RESULTS: Median progression-free survival was 6.5 months [95% confidence interval (CI) 5.9-7.9 months] in the tomuzotuximab group and 6.2 months (95% CI 5.8-7.3 months) in the cetuximab group (P = 0.86). The median overall survival (OS) estimate was 11.6 months (95% CI 9.5-17.2 months) in the tomuzotuximab group and 13.8 months (95% CI 12.3-16.4 months) in the cetuximab group (P = 0.96). In an exploratory analysis a small subgroup of p16-positive patients had a significantly longer OS compared with p16-negative patients (hazard ratio 1.860, 95% CI 1.09-3.16, P = 0.02). CONCLUSIONS: The glyco-engineered antibody tomuzotuximab failed to demonstrate improved efficacy with a chemotherapeutic backbone in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. It remains a so far unanswered question whether such antibody would partner better with different drugs such as checkpoint inhibitors.

[The nasal and pharyngeal swab techniques during the COVID-19-pandemic - the ENT-perspective - SARS-CoV-2, Coronavirus, nasal swab, pharyngeal swab, complications]. / Der Nasen- oder Rachenabstrich in der COVID-19-Pandemie ­ Aspekte für den HNO-Arzt/die HNO-Ärztin ­ SARS-CoV-2, Coronavirus, Nasenabstrich, Rachenabstrich, Komplikationen.

Since the beginning of the SARS-CoV-2 pandemic, swabs or other samples have increasingly been taken from the upper aero-digestive tract, since high viral loads exist here, especially in the early stages of the disease. As diagnostic options, swabs from the anterior nose, from the nasopharynx, from the oropharynx or the extraction of throat rinse water or saliva are possible. The laboratory methods available are antigen tests that can be read in a few minutes or more lengthy RT-PCR methods in a lab. Swabs are carried out by physicians, medical staff, laypeople and in the self-test, in each case according to prior instructions. Many of these factors therefore have an influence on the informative value and the sensitivity of the entire diagnostic process. The PCR laboratory method is more sensitive than the antigen method; the swabs from the nasopharynx are considered the most valid smear site; correct execution of a test can be achieved even with non-professional individuals with good instructions. Complications with such swabs are reported very rarely, given the assumed number of procedures performed. Short-term nosebleeds after traumatic smears can be assumed without publications about it being found. Broken parts of swabs had to be removed by an ENT doctor. There are only very few reports on injuries to the skullbase with CSF-leaks, including 2 times with anomalies such as meningoceles. The choice of a suitable diagnostic medium depends on many parameters such as availability, the timing of the result, a smear test by knowledgeable staff or a self-test, and a number of other practical considerations.

Screening for distress, related problems and perceived need for psycho-oncological support in head and neck squamous cell carcinoma (HNSCC) patients: a retrospective cohort study.

BACKGROUND: In different cancer entities, several studies have shown the adverse effects of cancer on mental health, psychological well-being and the increased risk of high emotional distress in cancer patients. This study aims to analyze psychosocial distress levels and their relationship between sociodemographic parameters and selected items on the Distress Thermometer (DT) Problem List in head and neck squamous cell carcinoma (HNSCC) patients. PATIENTS AND METHODS: We assessed a total of 120 HNSCC patients using the Distress Thermometer (DT) Problem List. Distress scores (DTS) of 90 patients were available. A DTS of ≥ 5 on the visual analogue scale represents clinically relevant distress. Data analysis consisted of descriptive statistics, comparison of mean values for different DTS subcategories and correlation between DTS scores and parameters of tumor classification, sociodemographic variables and selected problems. RESULTS: Distress was present in 57.7% of the sample, with a total of 52 patients with a DTS  ≥ 5. The mean DTS was 4.7 (SD 2.4). Patients with newly diagnosed HNSCC had significantly higher DTS. Distress levels were significantly associated with sadness, general worries, anxiety, nervousness, sleeping disorders, mouth sores and fever. Out of the total sample, 6 patients and out of these 6 individuals, 5 patients with a DTS ≥ 5 requested referrals to psycho-oncological service. CONCLUSION: High distress levels were common in HNSCC patients but only few patients desired psycho-oncological care. Addressing patients' supportive care needs in routine clinical practice is essential to meet unmet needs of HNSCC patients and thus improve cancer care.

[Effects of the SARS-CoV­2 pandemic on the otolaryngology university hospitals in the field of research, student teaching and specialist training]. / Auswirkungen der SARS-CoV­2-Pandemie auf die universitäre Hals-Nasen-Ohren-Heilkunde im Bereich der Forschung, Lehre und Weiterbildung.

BACKGROUND: From spring 2020, SARS-CoV­2 began to spread worldwide, with what is now known as the first wave of the pandemic, starting in March 2020. This resulted in restructuring and shift of resources at many hospitals. The aim of our work was to detect the effects of the pandemic on the german Oto-Rhino-Laryngology (ORL) university hospitals in terms of research, student teaching and further specialist training. MATERIAL AND METHODS: The chairmen of the 39 ORL university hospitals in Germany were asked about the effects of the pandemic on research, student teaching and ORL specialist training (residency) in the period from March to April 2020 using a structured online survey. RESULTS: All 39 chairmen took part in the survey. Of these, 74.4% (29/39) stated that their research activities had deteriorated as a result of the pandemic. In 61.5% (24/39) pandemic-related research issues were addressed. All hospitals reported a restriction for in-house teaching and 97.5% (38/39) introduced new digital teaching methods. During the observation period, 74.4% of the chairmen did not see ORL specialist training (residency)at risk. CONCLUSION: Our results provide an insight into the heterogeneous effects of the pandemic. The fast processing of pandemic-related research topics and the introduction of innovative digital concepts for student teaching impressively demonstrates the great innovative potential and the ability of the ORL university hospitals to react quickly in order to maintain their tasks in research, student teaching and ORL specialist training in the best possible way even during the pandemic.

Depression, anxiety, fatigue, and quality of life in a large sample of patients suffering from head and neck cancer in comparison with the general population.

BACKGROUND: Treatment of head and neck cancer (HNC) often leads to visible and severe functional impairments. In addition, patients often suffer from a variety of psychosocial problems, significantly associated with a decreased quality of life. We aimed to compare depression, anxiety, fatigue and quality of life (QoL) between HNC patients and a large sample of the general population in Germany and to examine the impact of sociodemographic, behavioral and clinical factors on these symptoms. METHODS: We assessed data of HNC patients during the aftercare consultation at the Leipzig University Medical Center with a patient reported outcome (PRO) tool named "OncoFunction". Depression, anxiety, fatigue and QoL were assessed using validated outcome measures including the PHQ-9, the GAD-2, and the EORTC QLQ-C30 questionnaire. RESULTS: A total of 817 HNC patients were included in our study and compared to a sample of 5018 individuals of the general German population. HNC patients showed significantly higher levels of impairment in all dimensions assessed. Examination of association between depression, anxiety, fatigue and QoL and clinical as well as sociodemographic variables showed significant relationships between occupational status, ECOG-state, body mass index and time since diagnosis. CONCLUSIONS: HNC patients suffer significantly from psychological distress. The used questionnaires are suitable for the use in daily routine practice and can be helpful to increase the detection of depression, anxiety and fatigue and therefore can improve HNC aftercare.

[Regional distribution of the cochlear implant (CI) centers in Germany]. / Regionale Verteilung der Cochlea-Implantat (CI)-versorgenden Einrichtungen in Deutschland.

The treatment of patients with severe hearing loss or deafness with a cochlear implant (CI) represents a standard in Germany today. However, there is hardly any data on the current number of clinical CI centers (CI clinics) and their geographical distribution. The patient self-help organization, German Cochlear Implant Society (DCIG), and the German Society for Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC) have therefore initiated a survey to determine the regional distribution, the range of services, the consideration of existing quality standards and cooperation with patient self-help organizations of the individual clinical CI centers.For this purpose, a total number of 170 ENT departments or their directors (37 professors and 133 chief physicians), respectively, were contacted by e-mail and provided with a questionnaire. The survey took place from October 2019 to February 2020.Of the 170 departments contacted, 71 (41.8 %) took part in the survey. Of these, 70 departments (98.6 %) confirmed to perform CI surgeries. Thus, 41.8 % of all clinics contacted reported to perform CI surgeries (70 of 170 clinics), while this information was not available from 99 clinics. All 70 clinical CI centers (100 %) reported to conduct CI surgeries on adults, 60 centers (85.7 %) also on children (< 18 years). 36 departments (51.4 %) reported that the total number of CI surgeries at their facility in 2018 was more than 50. In 64 departments (91.4 %), the recommendations of the DGHNO-KHC on CI care (according to the White Paper CI care 2018) were followed. A collaboration between the department and patient self-help organization was confirmed by 67 institutions (95.7 %). The geographical distribution of the clinical CI centers showed a heterogeneous distribution pattern between the individual federal states and also within the respective federal state.The work presented here is a first assessment of the situation with regard to the regional distribution of clinical CI centers in Germany. A clustering of CI centers was noticeable in metropolitan areas, sometimes with several facilities in one city. The predominant attention to quality-related aspects, such as the consideration of the DGHNO-KHC white paper and the cooperation with patient self-help, is gratifying. The limitations of the study result from limited participation in the survey (41.8 % of the contacted clinics).

[Effects of the SARS-CoV-2 pandemic on the otorhinolaryngology university hospitals in the field of medical care]. / Auswirkungen der SARS-CoV-2-Pandemie auf die universitäre Hals-Nasen-Ohrenheilkunde im Bereich der Krankenversorgung.

INTRODUCTION: Since December 2019, the SARS-CoV-2 virus has been rapidly spreading worldwide. In Germany, an exponential increase in the number of infections was registered at the beginning of March 2020 and led to a call of the Ministry of Health to create more capacity for intensive medical treatment in hospitals. The aim of the present study was to determine the effects of the SARS-CoV-2 pandemic on Oto-Rhino-Laryngology (ORL) university hospitals regarding patient care. MATERIALS AND METHODS: An online survey was sent out to all chairmen of the 39 ORL university hospitals in Germany. The answers to the questions referred to the defined period from March 15th to April 15th 2020 and were carried out using the online survey tool "SurveyMonkey". 87 questions focused on general information, health care, and structural effects in the respective institution. RESULTS: All chairmen of the 39 university hospitals in Germany participated in the survey. The collected data prove the considerable impact on organizational, structural and medical aspects of patient care. For example, the surveyed clinics reported a decrease in outpatient cases by 73.8 % to 26.2 ±â€Š14.2 % and in surgical treatments by 65.9 % to 34.1 ±â€Š13.9 %. In contrast, emergency treatment remained unchanged or even increased in 80 % of the facilities and surgical treatment of emergency patients remained unchanged or even increased in more than 90 %. Emergency outpatient and surgical treatment of patients was provided throughout the pandemic in all facilities. In total, about 35 000 outpatients and about 12 000 surgical cases were postponed. As a result of the acute structural changes, the potential danger of falling below current treatment standards was seen in individual areas of patient care. DISCUSSION: The assessment of the impact of the SARS-CoV-2 pandemic is heterogeneous. The majority of the chairmen are critically aware of the risk of falling below current medical treatment standards or guidelines. In the phase of an exponential increase in the number of infections, significant changes in treatment processes had to be accepted for understandable reasons. However, with the currently significantly reduced number of infections, falling below treatment standards and guidelines should not be allowed to remain constant and tolerated. SUMMARY: This study shows a differentiated picture with regard to the effects of the SARS-CoV-2 pandemic on outpatient, inpatient and operative patient care at the ORL university hospitals in Germany and illustrates the importance of these institutions for ensuring patient care during this critical phase.

[Organ preservation in advanced laryngeal/hypopharyngeal carcinoma: lessons from the DeLOS-II trial]. / Organerhalt beim fortgeschrittenen Larynx­/Hypopharynxkarzinom: Erfahrungen aus der DELOS-II-Studie.

Patients with locoregionally advanced laryngeal and hypopharyngeal squamous cell carcinomas (LHSCC) comprise two broad groups: those who are candidates for functional larynx preservation (LP) with avoidance of ablative surgery and those who are not. Currently, treatment depends on the patient's needs and wishes, the experience and recommendation of the surgeon, the philosophy of the institution, etc. The milestone VA trial established non-surgical LP in advanced LHSCC in the 1990s using induction chemotherapy (IC) with PF (cisplatin, P, plus 5­fluorouracil, F) followed by irradiation (IC + RT) as an appropriate alternative treatment to total laryngectomy (TL). Even though the findings of the VA trial were verified by the EORTC 24891 trial, a debate persists regarding the best protocol for balancing survival and laryngectomy-free survival (LFS) with acceptable late toxicity and good functional outcome. In advanced LHSCC without surgical options for larynx preservation, only IC + RT or primary concurrent platin-based chemoradiotherapy (CRT) are accepted treatment options aiming to preserve a functional larynx. In the US, cisplatin-based CRT is exclusively recommended as the best curative protocol. With regards to long-term survival with functional organ preservation and persistently high failure rates, there is current discussion on the necessity of improving patient selection based on the current literature and the recently published data of the DeLOS-II trial.