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.

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. 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.

[Giant scalp mass]. / Monströser Tumor der Kopfhaut.

A 55-year-old man was referred to our department with bleeding from a painless tumor located at the left parietal region of the head which had been progressively growing for a period of 2 years. Physical examination showed a fist-sized pediculated mass overlying the left parietal region and the auricle. The partly livid and ulcerated surface of the tumor was interspersed with light-yellow chalky material. The mass was totally excised. Infiltration of the skull was not observed. Histopathological examination led to the diagnosis of a giant pilomatricoma. Pilomatricoma is a rare, benign skin neoplasm that originates from hair matrix cells and is most frequently located in the head and neck region.

[Prophylaxis of venous thromboembolism and anticoagulation bridging. Strategies in otorhinolaryngology]. / Thromboembolieprophylaxe und überbrückende Antikoagulation. Strategien in der HNO-Heilkunde.

Various interdisciplinary guidelines recommend that in-patients at risk of venous thromboembolism should receive pharmacologic prophylaxis. Among the anticoagulants low-molecular-weight heparins (LMWH) and fondaparinux can be considered the medications of choice because of the favorable pharmacokinetic properties when compared with unfractionated heparin. Treatment with vitamin K antagonists has to be interrupted in patients undergoing major surgery or invasive procedures. Oral anticoagulation has to be temporarily replaced by short-acting anticoagulants such as LMWH in order to prevent thromboembolic complications (anticoagulation bridging). Although LMWHs have not been approved for this clinical setting their efficacy and safety has been demonstrated in several recent studies. Detailed recommendations for prophylaxis of venous thromboembolism in otorhinolaryngology are lacking although numerous surgical procedures are considered to be associated with a significant risk of thromboembolism. A strategy for pharmacologic prophylaxis of venous thromboembolism and anticoagulation bridging in otorhinolaryngology is proposed.

[Life-threatening differential diagnoses of vertigo and sudden hearing loss]. / Lebensbedrohliche Differenzialdiagnosen des Drehschwindels und des Hörsturzes.

Many patients call the ENT emergency department because of vertigo and sudden hearing loss. The majority of cases are due to peripheral or neurootological reasons. A serious and ongoing problem is that life-threatening ischemic, hemorrhagic and inflammatory diseases of the central nervous system may cause identical symptoms, making it difficult to differentiate between them. On the basis of our own patients with cerebellar ischemia, basilar thrombosis, dissection of the vertebral artery, cerebellar abscess, brain tumor and cholesteatoma and on the basis of expert opinions, typical sets of symptoms in patients with neurootological symptoms of a central cause are defined. To ensure early detection of these rare differential diagnoses, physicians should place particular importance on modern imaging diagnostics and neurological, interdisciplinary cooperation.

Acoustically and electrically evoked responses of the human cortex before and after cochlear implantation.

Multi-channel auditory evoked potentials (AEP) were recorded before and after cochlear implantation (CI) from a patient suffering from severe high frequency hearing loss with residual, but highly fluctuating hearing around 250 Hz. Immediately after CI activation early components of the N1 were present. Later N1 components developed during the use of CI. The unique result of this single case study is the concordance of the cortical AEP pattern obtained by native and artificial peripheral stimulation, which can be regarded as an indicator for the adequate function of the CI.

Transport of heat in caloric vestibular stimulation. Conduction, convection or radiation?

Experiments in temporal bone specimens were carried out under strictly controlled conditions: temperature (37 degrees C) and humidity kept constant; standardized irrigation of the external ear canal by an automated system (in 15 s, 50 ml of water, 11 degrees C above temperature of specimen), thermistor probes of 0.2 mm diameter placed in different parts of the specimens. In the intact temporal bone such an irrigation causes a rise in temperature with a gradient from the external ear canal across the bony bridge to the lateral semicircular canal as expected with heat conduction. After removal of the bony bridge, which is the main route for heat conduction, the rise in temperature in the lateral semicircular canal is greater and faster than in the intact specimen. This effect again is drastically reduced by placing a reflecting shield between tympanic membrane and labyrinth. In the intact middle ear inserting a reflecting shield or filling the cavity with gel also reduces the heat transfer to the labyrinth, although the bony routes for heat conduction are left untouched. The experiments prove that radiation plays an important part in heat transfer in caloric stimulation.

Olfactory function after functional endoscopic sinus surgery for chronic sinusitis.

One hundred and fifteen patients suffering from chronic sinusitis were observed to analyse the prevalence of olfactory dysfunction and the influence of FESS. Pre-operative questionnaires were supplemented by examination of olfactory thresholds and discrimination. Pre-operatively, 58% of the collective were aware or complained of any olfactory deficit. However, the olfactory tests demonstrated that of the collective 52% were hyposmic and 31% anosmic. Eight per cent of the hyposmic patients presented with an isolated reduction of their ability to discriminate odours. Post-operative improvements were found in 70%. Normosmia was post-operatively achieved in 25% of the hyposmic patients, but only in 5% of the anosmic patients. Olfaction changed to the worse in 8% after FESS. Therefore, the prevalence of olfactory dysfunction in chronic sinusitis is pre-operatively higher, and the rate of improvement is lower than generally assumed. The extent of sinus disease as measured by the degree of intranasal polyposis correlates with olfactory dysfunction. Resections of the middle turbinate may have a negative effect on olfaction, due to damage to the olfactory fila or alteration of the normal aerodynamic pattern within the olfactory cleft. However, this hypothesis is based on a few observations and needs to be verified by further investigations.

[Tumors in otorhinolaryngological surgery]. / Die tumoren in der Hals-Nasen-Ohren-Heilkunde.

The most frequent tumors of the head and neck region are squamous cell carcinomas located within the oro- and hypopharynx [37%] or the larynx [36%]. They are clinically associated with chronic hoarseness dysphagia and swelling of the lateral neck. The general physician should pay attention to these initial symptoms, so that most of the tumors can be found noninvasively and at an early stage. Palpation and inspection are sensitive tools for the primary examination of many types of head and neck cancer. In addition, flexible or rigid endoscopy and high-resolution imaging are useful. Modern treatment of early head and neck cancer can be minimally invasive. The laser technique, new biocompatible implants for the reconstruction of postoperative defects and progress in radiotherapy complete the classic management of head and neck cancer.

[Practical aspects of voice prosthesis use after laryngectomy]. / Praktische Aspekte der prothetischen Stimmrehabilitation nach Laryngektomie.

Since the last decade of the last century, surgical voice restoration with the use of voice prostheses has become a standard after total laryngectomy. About 80-90 % of the patients are capable to speak well or even very well with a voice prosthesis. Although severe complications have become rare since special pharynx protectors are in use for the implantation of the voice prostheses, minor problems are quite common. Primarily, these are frequent leakages through the prosthesis caused by fast wear and tear of the material and biofilms on the surface of the prosthesis, granulation tissue around the prosthesis, loss of the prosthesis with either aspiration or ingestion and migration or enlargement of the fistula. This paper explains the application of the most common kinds of voice prostheses and the management of the most frequent problems.

[Ackerman's tumor of the larynx and occupational exposure to asbestos]. / Ackerman-Tumor des Larynx und berufliche Asbestexposition.

The so-called "Ackerman's tumor" is a neoplasm of uncertain dignity. Aim of this paper is to clarify, whether this is an asbestos-induced tumor of the larynx in accordance with German regulations for occupational diseases. A 43-year old male presented the clinical picture of a stenosing laryngeal tumor. A verrucous neoplasm without a proven malignity in the sense of an Ackerman's tumor was diagnosed through several sequential biopsies. Approximately 2 years later a total laryngectomy was performed, because of a squamous cell carcinoma of the larynx. An occupational disease in accordance with 4104 BKV was claimed in connection with an asbestos exposition of 28,3 fibre years (fibres/m3 x years). An Ackerman's tumor is--in accordance with its definition in the German-speaking area--not conclusively malignant, there is no indication of a relation between asbestos and such a tumor in literature, there is no specific benign disorder of the larynx caused by asbestos. This brings us to the conclusion that the Ackerman's tumor of the larynx is no asbestos-induced laryngeal tumor as per German occupational disease regulations.

[Diagnosis and therapy of epistaxis]. / Diagnostik und Therapie der Epistaxis.

Epistaxis is one of the most frequent emergencies in Otorhinolaryngology and occurs in other disciplines, esp. in Oncology, Traumatology and Pediatrics as well. Even the young otorhinolaryngologist should be basically informed about the diagnostic concepts and therapies available for nosebleeding patients. The specialist should be capable to choose between modern and traditional therapeutical options in order to realise a definitive closure of the bleeding source with maximal comfort for the patient and with preservation of functionally important structures. However, even for the specialized rhinologist it can be difficult to overview the tremendous variety of the different therapies and diagnostical procedures. This article is a compressed review of both the traditional guidelines and the more innovative methods concerning epistaxis. Additionally it deals with the vascular anatomy of the nose and the pathophysiology of epistaxis.

[Prevention and therapy of hemorrhage in the HNO region. Specialist and interdisciplinary aspects]. / Blutungen im HNO-Bereich. Fachspezifische und interdisziplinäre Aspekte.

Otolaryngological bleeding is a highly dangerous condition because it is frequently located close to the upper airways. Additionally, it is often unexpected, especially in children, and can injure important nervous structures of the craniocervical region. Over the years, a broad spectrum of algorithms, innovative technologies and therapeutic options have been developed to reduce the incidence of hemorrhages and improve therapy. Nowadays, close cooperation with an hemostaseologist, anesthesiologist and interventional radiologist is necessary for finding the best strategies for the management of bleeding disorders and vascular lesions. This interdisciplinary dialog, combined with an intimate knowledge of the specific otolaryngological techniques, is the precondition for finding an adequate therapy and fulfilling the increasing medico-judicial and economic requirements. We present an overview of the actual and proved concepts for the management of hemorrhage in order to enable the reader to optimize treatment, to increase safety and comfort for the bleeding patient, and to fulfill the medico-judicial and economic requirements.

[Perforation of the esophagus with a mediastinal abscess]. / Osophagusperforation mit Mediastinalabszess. Eine Spätkomplikation der chirurgischen Stimmrehabilitation nach Laryngektomie.

INTRODUCTION: Surgical voice rehabilitation after total laryngectomy is still only a partially solved problem. Because of easy handling and rare complications, the Provox voice prosthesis has become common in voice rehabilitation. CASE REPORT: The 69 year old patient underwent laryngectomy, selective bilateral neck dissection and the implantation of a Provox voice prosthesis because of a glottic squamous cell carcinoma (pT(4), pN(0), M(0)). Postoperative healing ensued without any complications. During adjuvant radiochemotherapy, the patient developed distinctive cervical edema which led to a tilting of the Provox prosthesis. Due to a perforation of the posterior esophageal wall, the patient developed a pronounced mediastinal abscess which was relieved through a transcervical mediastinotomy. Antibiotic therapy led to a partial remission of the symptoms. CONCLUSION: Severe complications may not only occur during the early phase of surgical voice rehabilitation, but also at a much later stage, after completion of the healing process. A voice prosthesis which is too long or generates pressure from a radiogenic edema, cannula and finger pressure used to close the tracheostoma is transmitted through the prosthesis and may lead to a perforation of the posterior esophageal wall. In particular, when the tissue is injured during the course of radiotherapy, this type of complication should be taken into consideration.

[Olfactory neuroblastoma--tumor entity or complex clinical picture?]. / Das Olfaktoriusneuroblastom--Tumorentität oder klinischer Formenkreis?

Clinical and radiological findings in seven cases of olfactory neuroblastoma are reviewed and discussed in the light of the international literature. The report provides further evidence of difficulties related to the predictability of the condition's clinical course, diagnosis, and therapeutic consequences. Moreover, the lack of uniform CCT and NMR features indicates that the discussion about the genesis, the biological action, the terminology, and therapy of these tumors has not yet reached a conclusion.