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.

Through the looking glass: how do marked dolphins use mirrors and what does it mean?

Mirror-guided self-inspection is seen as a cognitive hallmark purportedly indicating the existence of self-recognition. Only a few species of great apes have been reported to pass a standard mark test for mirror self-recognition in which animals attempt to touch a mark. In addition, evidence for passing the mark test was also reported for Asian elephants, two species of corvids, and a species of cleaner fish. Mirror self-recognition has also been claimed for bottlenose dolphins, using exposure of marked areas to a mirror as evidence. However, what counts as self-directed behaviour to see the mark and what does not has been debated. To avoid this problem, we marked the areas around both eyes of the animals at the same time, one with visible and the other with transparent dye to control for haptic cues. This allowed the animal to see the mark easily and us to investigate what side was exposed to the mirror as an indicator for mark observation. We found that the animals actively chose to inspect their visibly marked side while they did not show an increased interest in a marked conspecific in the pool. These results demonstrate that dolphins use the mirror to inspect their marks and, therefore, likely recognise a distinction between self and others.

Quality control in cochlear implant therapy: clinical practice guidelines and registries in European countries.

PURPOSE: The treatment with a cochlear implant (CI) is the gold standard in therapy of patients with profound hearing loss or deafness. Successful hearing rehabilitation with a CI is a complex, multi-stage process. In medicine, "Clinical Practice Guidelines" (CPG) are widely accepted for the standardization of such processes. These are supplemented by medical registries in which data regarding the treatment can be collected and evaluated. The aim of this paper is to identify currently existing CI-related CPGs and registries in Europe. METHODS: Between 01/2021 and 06/2021, 42 countries on the European continent, including the United Kingdom, Russia and Turkey, were screened using an internet search (search engine: Google) and a key word search in the Pubmed database. Search terms were the respective country name combined with the following terms: "Cochlear Implant", "CI", "Cochlear implant clinical practice guideline", "CI Guideline", "Cochlear Implant Registry", "CI Registry", "Ear nose throat society". The internet search was conducted in English as well as in the corresponding national language. The objective was to identify a CI-related CPG or registry. RESULTS: A CPG was found in 16 of 42 (38%) countries. In terms of population, this accounts for 645 million out of 838 million people (77%). A registry existed in 4 of the 42 (10%) countries assessed. This corresponds to 102 million out of 838 million (12%) people. In total, 4 out of 42 countries (10%) had both a CPG and a registry. CONCLUSION: Our work shows numerous efforts in Europe to standardize CI care at the national level. While most people in Europe already live in countries with a CPG, this is not the case for CI registries. European-wide consensus on CPGs or registries does not yet exist. The present study thus provides a first assessment of the distribution of CI-related CPGs and registries.

[Development of the publication activity at the German university hospitals for Otorhinolaryngology, Head and Neck Surgery during the SARS-CoV-2-pandemic in 2020]. / Entwicklung der Publikationsleistung der Universitätskliniken für Hals-Nasen-Ohrenheilkunde, Kopf- und Hals-Chirurgie während der SARS-CoV-2-Pandemie im Jahr 2020 in Deutschland.

INTRODUCTION: The SARS-CoV-2 pandemic has led to profound limitations in patient care and student teaching at the University Hospitals of Otorhinolaryngology (ORL). In contrast, the impact on research has been variable. To classify the pandemic-related effect on research, the development of the number of scientific publications of the German ORL university hospitals before and during the pandemic was analyzed. MATERIAL AND METHODS: The publication performance between 2015 and 2020 of the 39 current chairmen was surveyed using a literature search (Pubmed). All entries relating to the chairmen of the university hospital as first, last or co-author were included. The absolute and relative development of each author's publication performance was determined and evaluated using nonparametric statistical methods. RESULTS: A total of 2420 publications could be documented. From 2015 to 2019, an average of 368 publications were published per year. In 2020, this number increased by 57.9 % to 581 publications. While the number of monthly publications remained constant between 2015 and 2019, a significant increase was seen from May 2020 up to a maximum of 74 publications in September 2020. In 2020, 34 articles (5.9 %) had a thematic relation to the SARS-CoV-2 pandemic, with 7 of these papers (20.6 %) resulting from cross-site publications. CONCLUSION: In 2020, the number of scientific publications was raised to more than 1.5 times the usual annual publications. This increase was clearly related in time to the reduction of elective patient care during the SARS-CoV-2 pandemic starting in mid-March 2020. Probably, free time capacities enabled this increased publication output. Our results confirm the great scientific potential of the ORL university hospitals, which has been successfully implemented despite the pandemic.

Prevalence of obstructive sleep apnoea syndrome following oropharyngeal cancer treatment: A prospective cohort study.

OBJECTIVES: To evaluate the prevalence of obstructive sleep apnoea syndrome (OSAS) in a population of patients treated for an advanced oropharyngeal cancer (AJCC Stage III or IV), depending on treatment strategy, and to evaluate its impact on quality of life. DESIGN: Prospective cohort study. SETTING: University Teaching Hospital of La Conception, Marseille, France. PARTICIPANTS: Fifty-one disease-free patients were included. Forty-one patients received a combined chemoradiotherapy, while 10 patients were treated by surgery followed by chemoradiotherapy. MAIN OUTCOME MEASURES: Every patient underwent a formal sleep consultation and was asked to complete the Epworth Sleepiness Scale and EORTC QLQ C-30 and the EORTC H&N 35 questionnaires. A home overnight respiratory polygraphy was performed in every subject. RESULTS: The mean time between the end of cancer treatment and the OSAS analysis was 54.04 months [20; 84]. An OSAS was found in 25.49% of our patients. There was no significant difference between patients treated with either surgery (30%) or CRT (24.39%), P=.79. The EORTC QLQ C-30 questionnaire showed a significant difference between positive and negative OSAS groups in the Global Health Status Scale (50.64 vs 67.11, P=.02) and in the fatigue item (35.04 vs 17.25, P=.03). CONCLUSIONS: Our population with advanced oropharyngeal cancer, whatever the treatment strategy it may be, was at risk of developing OSAS with negative impact on quality of life. A routine screening and treatment of OSAS seems necessary to improve the quality of life of patients treated for advanced oropharyngeal cancer.

Is having quality as an item on the executive board agenda associated with the implementation of quality management systems in European hospitals: a quantitative analysis.

OBJECTIVE: To assess whether there is a relationship between having quality as an item on the board's agenda, perceived external pressure (PEP) and the implementation of quality management in European hospitals. DESIGN: A quantitative, mixed method, cross-sectional study in seven European countries in 2011 surveying CEOs and quality managers and data from onsite audits. PARTICIPANTS: One hundred and fifty-five CEOs and 155 quality managers. SETTING: One hundred and fifty-five randomly selected acute care hospitals in seven European countries (Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey). Main outcome measure(s) Three constructs reflecting quality management based on questionnaire and audit data: (i) Quality Management System Index, (ii) Quality Management Compliance Index and (iii) Clinical Quality Implementation Index. The main predictor was whether quality performance was on the executive board's agenda. RESULTS: Discussing quality performance at executive board meetings more often was associated with a higher quality management system score (regression coefficient b = 2.53; SE = 1.16; P = 0.030). We found a trend in the associations of discussing quality performance with quality compliance and clinical quality implementation. PEP did not modify these relationships. CONCLUSIONS: Having quality as an item on the executive board's agenda allows them to review and discuss quality performance more often in order to improve their hospital's quality management. Generally, and as this study found, having quality on the executive board's agenda matters.

HLA genes associated with autoimmunity and progression to disease in type 1 diabetes.

Insulin dependent diabetes mellitus (type I DM) is caused by an autoimmune process which culminates in destruction of pancreatic beta cells with resultant loss of insulin production. Preceding the clinical diagnosis of type I DM is a preclinical stage characterized by autoantibodies to insulin, glutamic acid decarboxylase (GAD) and a tyrosine phosphatase-like molecule (IA-2). We have studied both HLA class I and class 2 allele distributions in diabetic probands and autoantibody positive individuals in members of 452 families recruited for the Australian type I diabetes DNA repository. The results demonstrate that progression to autoimmunity as measured by the appearance of autoantibodies is strongly associated with the class 2 alleles DRB1*03 and DRB*04 and with DRB1*03/04 heterozygosity. In contrast, the progression to clinical disease appears associated with class I alleles A24, A30 and B18 while A1, A28, B14 and B56 appear negatively associated. The class 2 alleles appear to have a minimal role in the progression from autoantibody positivity to clinical disease. These results are consistent with the view that CD4+ T cells responding to peptides in the context of class 2 molecules are responsible for initiating autoantibody production, while the destruction of islet cells leading to clinical expression of the disease is the function of CD8+ T cells recognizing relevant peptides in the context of class I molecules.

Nasal mucosal blood flow in patients with diabetes mellitus.

Fifty patients with diabetes mellitus of varying duration were divided into two groups according to whether they were on treatment with insulin or not. Nasal mucosal blood flow was investigated and the results were compared with a reference material from healthy subjects, and were also related to the degree of retinopathy. Patients with diabetes mellitus had normal mucosal blood flow. There was no correlation between the duration of diabetes and nasal blood flow, nor was there any correlation between the degree of retinopathy and nasal blood flow. Diabetes mellitus does not seem to be accompanied by changes in blood flow in the nasal mucosa.