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.

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.

Methods and reference data for middle ear transfer functions.

Human temporal bone specimens are used in experiments measuring the sound transfer of the middle ear, which is the standard method used in the development of active and passive middle ear implants. Statistical analyses of these experiments usually require that the TB samples are representative of the population of non-pathological middle ears. Specifically, this means that the specimens must be mechanically well-characterized. We present an in-depth statistical analysis of 478 data sets of middle ear transfer functions (METFs) from different laboratories. The data sets are preprocessed and various contributions to the variance of the data are evaluated. We then derive a statistical range as a reference against which individual METF measurements may be validated. The range is calculated as the two-sided 95% tolerance interval at audiological frequencies. In addition, the mean and 95% confidence interval of the mean are given as references for assessing the validity of a sample group. Finally, we provide a suggested procedure for measuring METFs using the methods described herein.

[Coupling of active middle ear implants-biomechanical aspects]. / Ankopplung aktiver Mittelohrimplantate ­ biomechanische Aspekte.

Active middle ear implants or implantable hearing aids are used to treat sensorineural or combined hearing loss. Their coupling to the middle ear structures has a large impact on the success of rehabilitation. Practical issues such as the coupling site, influence of middle ear status, and forward and backward excitation of the inner ear are discussed in the context of biomechanics. For this purpose, experimental studies, model simulations, and current literature data are evaluated. The explanations are intended to contribute to a better understanding of certain procedures in hearing rehabilitation with active implants.

[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.

[Active hearing implants in chronic otitis media]. / Aktive Hörimplantate bei chronischer Otitis media.

In patients with inadequate hearing improvement after tympanoplasty and failure of conventional hearing aid fitting, active hearing implants provide an alternative treatment option. Active middle ear implants function as a vibromechanical bypass of the stiffness and damping effect of a poorly oscillating tympanic membrane and the (reconstructed) ossicular chain. The selection of the hearing system depends on the maximum output levels of the hearing system and the anatomical conditions in mostly multiply operated ears. The development of variable coupling elements for active middle ear implants led to an extension of the indications to include not only purely sensorineural hearing loss but also mixed and conductive hearing loss in patients, as the transducer can now be coupled to the (mobile) stapes or the round window membrane. The article provides an overview of current clinical study results and recommendations on the indications for active hearing implants in patients with chronic otitis media.

[From reconstruction to function : Hands-on training in tympanoplasty using real-time feedback]. / Von der Rekonstruktion zur Funktion : Tympanoplastik-Training mit Real-Time-Feedback.

BACKGROUND: Surgery of the middle ear requires a very high level of fine motor skills. Due to the increased potential for complications in middle ear operations, it is appropriate to acquire these skills beforehand by operating on a model. OBJECTIVE: How satisfactory is the training on suitable models? Are the skills acquired from working on a model transferable to intraoperative situations? Will the type of model and its use for training influence ear surgery in the future? MATERIAL AND METHODS: Available publications and own experiences with the Dresden tympanoplasty model (DTM) are analyzed and discussed. RESULTS: Although middle ear surgery makes very high demands on the surgeon and there is a significant risk for severe complications to the ear as a sense organ, there are currently very few options to train surgeons in advance. The DTM is a validated training model, which is capable of closing this gap. Due to the possibility of using a real-time feedback variation of the model, the understanding for reconstruction quality and intraoperative acoustic stress can be improved. The translation of the real-time feedback idea into actual middle ear surgery can improve reconstruction quality in the future. CONCLUSION: Training on suitable models is indispensable, especially when training as a surgeon to carry out middle ear operations. Adding another sense perception to the internal and external quality assessment of tympanoplasty by inclusion of the real-time feedback option, can optimize learning and operating processes.

[The situation of education in ENT-residency-training in Germany]. / Die Weiterbildungssituation in der HNO-Heilkunde in Deutschland.

BACKGROUND: As a starting point for developing concrete suggestions for optimizing specialty training in German ENT departments, the present study analysed the current status of residency training in order to identify weaknesses. METHODS: Residents at German ENT departments were invited to participate in an online survey. The questionnaire comprised 78 individual questions. RESULTS: The questionnaire was answered by 223 ENT residents. Educational deficits such as a lack of regular feedback from supervisors, only moderately rated mediation of specialist competencies, capriciousness of the trainers in charge regarding the organisation of training, and time and personnel shortages were identified. Some of the mandatory recommendations of the specialty training regulations, including determination of concrete training goals during regular meetings or the use of a logbook, have only been implemented in limited cases. Demands for development of more external training opportunities (job shadowing/rotation) and an external objective review of the residency training (e.g., by a representative of the German Society of Otorhinolaryngology, Head and Neck Surgery, DGHNOKHC) in the sense of quality assurance are discussed. CONCLUSION: Implementation of structured and standardized ENT residency training in Germany, for which DGHNOKHC reviewal is also possible, can generate a basis for more effective compulsory residency training.

[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.

[Spectroscopic investigation of the middle ear mucosa]. / Spektroskopische Untersuchung der Mittelohrschleimhaut.

BACKGROUND: The middle ear mucosa (MEM) plays a central role in the middle ear due to its function of providing regular ventilation. To date, assessment of the state of the MEM is only possible subjectively by the surgeon. An objective characterization of the state of the MEM is desirable. OBJECTIVE: The aim of this study was to enable objective characterization of the MEM and test infrared (IR) spectroscopy as a possible diagnostic tool for clinical use. MATERIALS AND METHODS: During middle ear surgery, 48 MEM samples were collected and divided into four groups according to clinical appearance: group I: normal MEM; group II: sclerotic MEM; group III: inflammatory thickened MEM; group IV: granulated MEM. After collection, samples were analyzed by IR spectroscopy to identify characteristic IR spectra. RESULTS: In the supervised analysis of the selected images, the biochemical differences representing the decisive factors for classification into groups I to IV were characterized. The differences in amide bands, carbohydrates, lipids, and proteins permit reliable separation of the clinical categories. CONCLUSION: Spectroscopic investigations enable objective characterization of the MEM. Conclusions regarding biochemical differences make it possible to weigh up treatment options. Routine use of IR spectroscopy in the operating theater requires histopathological comparison and an extended dataset with reference values of the individual groups.

[Learning curve of the ENT mirror examination : Goal-oriented curriculum planning for psychomotor learning]. / Lernkurve der HNO-Spiegeluntersuchung : Zielgerichtete Lehrveranstaltungsplanung zu einer psychomotorischen Fertigkeit.

BACKGROUND: Learning complex psychomotor sequences requires a high number of training sessions to achieve precise execution. In the current student curriculum there are only few study sessions available to achieve this level of competence. OBJECTIVE: The objective of the current study was to record the learning curve of psychomotor proficiency using the example of the ENT mirror examination. Particular focus was on the number of practice sessions needed to achieve safe execution of the examination and the learning success as assessed in partial investigations. MATERIALS AND METHODS: During a 5­day period of their ENT block internship, students were taught and practiced the correct ENT mirror examination. At the end of each internship day, the learning progress of a total of 48 students was statistically evaluated by a checklist-based assessment. RESULTS: In the full study and in the partial studies, a significant increase in points was shown over the days, which proved a growing learning curve of the students. The students required at least five training sessions (each 45 min) for safe execution (Bloom taxonomy level 3) and six training sessions for routine execution (Bloom taxonomy level 4; Nationaler kompetenzorientierter Lernzielkatalog Medizin, NKLM, level 3a). CONCLUSION: Looking at the ENT mirror examination, an improvement in psychomotor skills was shown with an increasing number of practice sessions. This study is therefore representative as an example of resource-optimized curriculum planning based on the previously defined level of competence that students should have attained by the end of a course.

[Use and acceptance of the ORL logbook for final year students in German university and academic teaching hospitals]. / Einsatz und Akzeptanz des PJ­HNO­Basis-Logbuchs an deutschen Universitätskliniken und akademischen Lehrkrankenhäusern.

BACKGROUND: The current German medical licensing system from 2013 dictates the mandatory keeping of logbooks for final year students. A field-specific logbook for the practical year was created by the national otorhinolaryngology (ORL) society in 2012, which has been in use since then in all academic teaching and university hospitals nationwide. OBJECTIVE: After this time interval it seemed appropriate to evaluate this logbook for its usefulness by associate lecturers and students. The objectives were whether the actual learning targets could be considered relevant, suitable and feasible concerning department location, practical and clinical education for medical students. MATERIAL AND METHODS: A total of 165 associate lecturers of all registered national ORL departments were asked to participate using a 2-step evaluation. The logbook was evaluated by 77 lecturers in general and 17 lecturers also evaluated each of the 78 learning targets. Out of the 24 final year students from the Universities of Freiburg and Dresden who were contacted, 16 evaluated the logbook. RESULTS: Analysis demonstrated that the ORL logbook was used in 55% without alterations to the content and in 36% a medical faculty-specific logbook was used. The lecturers' judgement revealed no significant differences between the two logbooks. They approved the 78 learning targets with a majority vote of between 60-100%. Only 3 learning targets (otoacoustic emission, rhinomanometry and sonography) showed approval of less than 60%, associated with a request for modifications. Students evaluated the ORL logbook as being significantly better than the faculty's version concerning practical education. CONCLUSION: The results demonstrated the nationwide acceptance of the ORL logbook by lecturers and students. The amount of critical learning targets which will have to be changed is moderate. This evaluation confirmed the relevance and balance of the ORL logbook content in the practical year training and the possibility of use independent of the location of ORL departments.

[Georgia, a country of diverse aid from Germany in the ENT field]. / Georgien, ein Land vielfältiger Hilfen aus Deutschland auf dem HNO-Gebiet.

Following a long-term tradition, several teams of German ENT specialists are currently working in different Georgian clinics on a charitable basis. The current paper describes the structures of the medical and health insurance systems in this southern Caucasian country. The course of medical education for physicians in Georgia is portrayed and differences to the German situation which explain why young Georgian colleagues have difficulties when moving to Germany are highlighted. The paper describes the typical stay of a German ENT specialist in Georgia and also points out how these physicians are in turn supported in their charitable work by medical devices and equipment sent from Germany. Finally, the input that German colleagues can contribute to improving the situation in the Georgian health care system is discussed from the perspective of German ENT specialists and future goals of the cooperation between German and Georgian physicians are summarized.

[Social reimbursement-the Spanish-German ENT Society's (SDGHNO) Latin America project]. / Soziale Rückvergütung ­ das Projekt "Lateinamerika" der Spanisch-Deutschen HNO-Gesellschaft (SDGHNO).

Nowadays, social projects are usually oriented in such a way that after a given period of time, they can either support themselves independently or even allow a pecuniary reimbursement. In the latter case, experts speak of a profit-oriented reimbursement. On the other hand, there is so-called social reimbursement, which in contrast to the abovementioned form is not profit oriented, but, for example, considers its task fulfilled by the fact of successful knowledge transfer. The Spanish-German Society for ENT Medicine and Head and Neck Surgery (SDGHNO) launched the Latin America project in 2001 under the patronage of the then President Prof. Dr. Wolfgang Draf (Fulda). The goal of the SDGHNO was and is to create a professional as well as cultural platform for Spanish- and German-speaking ENT doctors. This platform can and should be used for professional purposes, e.g., for knowledge transfer. Since the beginning of its existence, the Latin America project has thus brought numerous scientific events into being and created specific contacts which have lasted until today or have even been continued and further developed. Particularly successful examples are Chile, Colombia, and Peru. This is a vivid example of social reimbursement, because the participating German-speaking members/speakers carried out their tasks on an entirely voluntary basis. Thus, the SDGHNO did not bear any travel, catering, or accommodation costs. The activities of the SDGHNO within the framework of the Latin America project are explained.

[State of the art of quality-of-life measurement in patients with chronic otitis media and conductive hearing loss]. / Aktueller Stand der Lebensqualitätsmessung bei Patienten mit chronischer Otitis media und Schallleitungsschwerhörigkeit.

The evaluation of results after middle ear reconstruction has been mainly based on functional parameters. In clinical practice as well as in otological research, the pure tone audiogram represents the gold standard in the assessment of the postoperative outcome. In order to assess the patient's subjective outcome, outcome analyzes focus increasingly on the health-related quality of life (HRQOL). However, the evaluation of HRQOL requires reliable and validated measuring instruments. A modest number of validated questionnaires for determination of the disease-specific HRQOL in patients with chronic otitis media and/or conductive hearing loss are currently available. Three of seven available questionnaires were developed and validated in the German-speaking countries, the Zurich Chronic Middle Ear Inventory 21 (ZCMEI-21), the Chronic Otitis Media Outcome Test 15 (COMOT-15) and the Stapesplasty Outcome Test 25 (SPOT-25). In this review, all seven available disease-specific measuring instruments as well as the generic questionnaires, which were used in previous clinical trials, are explained and current findings of quality-of-life research in patients with chronic otitis media and/or conductive hearing loss are presented.