Variability in Cochlear Implantation Outcomes in a Large German Cohort With a Genetic Etiology of Hearing Loss.

OBJECTIVES: The variability in outcomes of cochlear implantation is largely unexplained, and clinical factors are not sufficient for predicting performance. Genetic factors have been suggested to impact outcomes, but the clinical and genetic heterogeneity of hereditary hearing loss makes it difficult to determine and interpret postoperative performance. It is hypothesized that genetic mutations that affect the neuronal components of the cochlea and auditory pathway, targeted by the cochlear implant (CI), may lead to poor performance. A large cohort of CI recipients was studied to verify this hypothesis. DESIGN: This study included a large German cohort of CI recipients (n = 123 implanted ears; n = 76 probands) with a definitive genetic etiology of hearing loss according to the American College of Medical Genetics (ACMG)/Association for Molecular Pathology (AMP) guidelines and documented postoperative audiological outcomes. All patients underwent preoperative clinical and audiological examinations. Postoperative CI outcome measures were based on at least 1 year of postoperative audiological follow-up for patients with postlingual hearing loss onset (>6 years) and 5 years for children with congenital or pre/perilingual hearing loss onset (≤6 years). Genetic analysis was performed based on three different methods that included single-gene screening, custom-designed hearing loss gene panel sequencing, targeting known syndromic and nonsyndromic hearing loss genes, and whole-genome sequencing. RESULTS: The genetic diagnosis of the 76 probands in the genetic cohort involved 35 genes and 61 different clinically relevant (pathogenic, likely pathogenic) variants. With regard to implanted ears (n = 123), the six most frequently affected genes affecting nearly one-half of implanted ears were GJB2 (21%; n = 26), TMPRSS3 (7%; n = 9), MYO15A (7%; n = 8), SLC26A4 (5%; n = 6), and LOXHD1 and USH2A (each 4%; n = 5). CI recipients with pathogenic variants that influence the sensory nonneural structures performed at or above the median level of speech performance of all ears at 70% [monosyllable word recognition score in quiet at 65 decibels sound pressure level (SPL)]. When gene expression categories were compared to demographic and clinical categories (total number of compared categories: n = 30), mutations in genes expressed in the spiral ganglion emerged as a significant factor more negatively affecting cochlear implantation outcomes than all clinical parameters. An ANOVA of a reduced set of genetic and clinical categories (n = 10) identified five detrimental factors leading to poorer performance with highly significant effects ( p < 0.001), accounting for a total of 11.8% of the observed variance. The single strongest category was neural gene expression accounting for 3.1% of the variance. CONCLUSIONS: The analysis of the relationship between the molecular genetic diagnoses of a hereditary etiology of hearing loss and cochlear implantation outcomes in a large German cohort of CI recipients revealed significant variabilities. Poor performance was observed with genetic mutations that affected the neural components of the cochlea, supporting the "spiral ganglion hypothesis."

Diagnostic Yield of Targeted Hearing Loss Gene Panel Sequencing in a Large German Cohort With a Balanced Age Distribution from a Single Diagnostic Center: An Eight-year Study.

OBJECTIVES: Hereditary hearing loss exhibits high degrees of genetic and clinical heterogeneity. To elucidate the population-specific and age-related genetic and clinical spectra of hereditary hearing loss, we investigated the sequencing data of causally associated hearing loss genes in a large cohort of hearing-impaired probands with a balanced age distribution from a single center in Southwest Germany. DESIGN: Genetic testing was applied to 305 hearing-impaired probands/families with a suspected genetic hearing loss etiology and a balanced age distribution over a period of 8 years (2011-2018). These individuals were representative of the regional population according to age and sex distributions. The genetic testing workflow consisted of single-gene screening (n = 21) and custom-designed hearing loss gene panel sequencing (n = 284) targeting known nonsyndromic and syndromic hearing loss genes in a diagnostic setup. Retrospective reanalysis of sequencing data was conducted by applying the current American College of Medical Genetics and Genomics/Association for Molecular Pathology guidelines. RESULTS: A genetic diagnosis was established for 75 (25%) of the probands that involved 75 causal variants in 35 genes, including 16 novel causal variants and 9 medically significant variant reclassifications. Nearly half of the solved cases (47%; n = 35) were related to variants in the five most frequently affected genes: GJB2 (25%), MYO15A, WFS1, SLC26A4, and COL11A1 (all 5%). Nearly one-quarter of the cases (23%; n = 17) were associated with variants in seven additional genes (TMPRSS3, COL4A3, LOXHD1, EDNRB, MYO6, TECTA, and USH2A). The remaining one-third of single cases (33%; n = 25) were linked to variants in 25 distinct genes. Diagnostic rates and gene distribution were highly dependent on phenotypic characteristics. A positive family history of autosomal-recessive inheritance in combination with early onset and higher grades of hearing loss significantly increased the solve rate up to 60%, while late onset and lower grades of hearing loss yielded significantly fewer diagnoses. Regarding genetic diagnoses, autosomal-dominant genes accounted for 37%, autosomal-recessive genes for 60%, and X-linked genes for 3% of the solved cases. Syndromic/nonsyndromic hearing loss mimic genes were affected in 27% of the genetic diagnoses. CONCLUSIONS: The genetic epidemiology of the largest German cohort subjected to comprehensive targeted sequencing for hereditary hearing loss to date revealed broad causal gene and variant spectra in this population. Targeted hearing loss gene panel analysis proved to be an effective tool for ensuring an appropriate diagnostic yield in a routine clinical setting including the identification of novel variants and medically significant reclassifications. Solve rates were highly sensitive to phenotypic characteristics. The unique population-adapted and balanced age distribution of the cohort favoring late hearing loss onset uncovered a markedly large contribution of autosomal-dominant genes to the diagnoses which may be a representative for other age balanced cohorts in other populations.

Metadata Correction: Patient Empowerment During the COVID-19 Pandemic by Ensuring Safe and Fast Communication of Test Results: Implementation and Performance of a Tracking System.

[This corrects the article DOI: 10.2196/27348.].

Patient Empowerment During the COVID-19 Pandemic by Ensuring Safe and Fast Communication of Test Results: Implementation and Performance of a Tracking System.

BACKGROUND: Overcoming the COVID-19 crisis requires new ideas and strategies for online communication of personal medical information and patient empowerment. Rapid testing of a large number of subjects is essential for monitoring and delaying the spread of SARS-CoV-2 in order to mitigate the pandemic's consequences. People who do not know that they are infected may not stay in quarantine and, thus, risk infecting others. Unfortunately, the massive number of COVID-19 tests performed is challenging for both laboratories and the units that conduct throat swabs and communicate the results. OBJECTIVE: The goal of this study was to reduce the communication burden for health care professionals. We developed a secure and easy-to-use tracking system to report COVID-19 test results online that is simple to understand for the tested subjects as soon as these results become available. Instead of personal calls, the system updates the status and the results of the tests automatically. This aims to reduce the delay when informing testees about their results and, consequently, to slow down the virus spread. METHODS: The application in this study draws on an existing tracking tool. With this open-source and browser-based online tracking system, we aim to minimize the time required to inform the tested person and the testing units (eg, hospitals or the public health care system). The system can be integrated into the clinical workflow with very modest effort and avoids excessive load to telephone hotlines. RESULTS: The test statuses and results are published on a secured webpage, enabling regular status checks by patients; status checks are performed without the use of smartphones, which has some importance, as smartphone usage diminishes with age. Stress tests and statistics show the performance of our software. CTest is currently running at two university hospitals in Germany-University Hospital Ulm and University Hospital Tübingen-with thousands of tests being performed each week. Results show a mean number of 10 (SD 2.8) views per testee. CONCLUSIONS: CTest runs independently of existing infrastructures, aims at straightforward integration, and aims for the safe transmission of information. The system is easy to use for testees. QR (Quick Response) code links allow for quick access to the test results. The mean number of views per entry indicates a reduced amount of time for both health care professionals and testees. The system is quite generic and can be extended and adapted to other communication tasks.

ENT Residents Benefit from a Structured Operation Planning Approach in the Training of Functional Endoscopic Sinus Surgery.

Background and Objectives: Preoperative planning utilizing computed tomographies (CT) is of utmost importance in functional endoscopic sinus surgery (FESS). Frequently, no uniform documentation and planning structures are available to residents in training. Consequently, overall completeness and quality of operation planning may vary greatly. The objective of the present study was to evaluate the impact of a structured operation planning (SOP) approach on the report quality and user convenience during a 4-day sinus surgery course. Materials and Methods: Fifteen participant were requested to plan a FESS procedure based on a CT scan of the paranasal sinuses that exhibited common pathological features, in a conventional manner, using a free text. Afterwards, the participants reevaluated the same scans by means of a specifically designed structured reporting template. Two experienced ENT surgeons assessed the collected conventional operation planning (COP) and SOP methods independently with regard to time requirements, overall quality, and legibility. User convenience data were collected by utilizing visual analogue scales. Results: A significantly greater time expenditure was associated with SOPs (183 s vs. 297 s, p = 0.0003). Yet, legibility (100% vs. 72%, p < 0.0001) and overall completeness (61.3% vs. 22.7%, p < 0.0001) of SOPs was significantly superior to COPs. Additionally, description of highly relevant variants in anatomy and pathologies were outlined in greater detail. User convenience data delineated a significant preference for SOPs (VAS 7.9 vs. 6.9, p = 0.0185). Conclusions: CT-based planning of FESS procedures by residents in training using a structured approach is more time-consuming while producing a superior report quality in terms of detailedness and readability. Consequently, SOP can be considered as a valuable tool in the process of preoperative evaluations, especially within residency.

A Big Data Perspective on the Genomics of Hearing Loss. / Big data in der Diagnostik genetischer Schwerhörigkeit.

The completion of the human genome, the most fundamental example of big data in science and medicine, is the remarkable product of multidisciplinary collaboration and is regarded as one of the largest and most successful undertakings in human history. Unravelling the human genome means not only identifying the sequence of its more than 3.2 billion nucleotide bases, but also understanding disease-associated variations and applying this knowledge to patient-tailored precision medicine approaches. Genomics has moved at a remarkable pace, with much of the propelling forces behind this credited to technological developments in sequencing, computing, and bioinformatics, that have given rise to the term "big genomics data." The analysis of genetics data in a disease context involves the use of several big data resources that take the form of clinical genetics data repositories, in silico prediction tools, and allele frequency databases. These exceptional developments have cultivated high-throughput sequencing technologies that are capable of producing affordable high-quality data ranging from targeted gene panels to exomes and genomes. These new advancements have revolutionized the diagnostic paradigm of hereditary diseases including genetic hearing loss.Dissecting hereditary hearing loss is exceptionally challenging due to extensive genetic and clinical heterogeneity. There are presently over 150 genes involved in non-syndromic and common syndromic forms of hearing loss. The mutational spectrum of a single hearing loss associated-gene can have several tens to hundreds of pathogenic variants. Moreover, variant interpretation of novel variants can pose a challenge when conflicting information is deposited in valuable databases. Harnessing the power that comes from detailed and structured phenotypic information has proven promising for some forms of hearing loss, but may not be possible for all genetic forms due to highly variable clinical presentations. New knowledge in both diagnostic and scientific realms continues to rapidly accumulate. This overwhelming amount of information represents an increasing challenge for medical specialists. As a result, specialist medical care may evolve to take on new tasks and facilitate the interface between the human genetic diagnostic laboratory and the patient. These tasks include genetic counselling and the inclusion of genetics results in patient care.This overview is intended to serve as a reference to otolaryngologists who wish to gain an introduction to the molecular genetics of hearing loss. Key concepts of molecular genetic diagnostics will be presented. The complex processes underlying the identification and interpretation of genetic variants in particular would be inconceivable without the enormous amount of data available. In this respect, "big data" is an indispensable prerequisite for filtering genetic data in specific individual cases and making it clear and useful, especially for clinicians in contact with patients.

Attitudes Toward e-Health: The Otolaryngologists' Point of View.

INTRODUCTION: Online communication and the number of e-health applications have noticeably increased. However, little is known about the otolaryngologists' use behavior and their attitudes toward the potential of e-health. The aims of the study were to evaluate the documentation, information, and communication technologies used by otolaryngologists and to get a better understanding of their attitudes toward the potential of e-health for cross-sectoral patient care. METHODS: A survey was developed and tested by otolaryngologists, healthcare-information technology experts, and health services researchers. A total of 334 otolaryngologists in private practice were asked to participate in this cross-sectional study. In total, 234 of them took part in the study, and 157 returned completed questionnaires. Statistical analysis was performed by using crosstabs, including chi-square tests, and multivariate logistic regressions. Results and Materials: Digital technologies are widely used by otolaryngologists (e.g., 89.6% use an electronic health record). However, the majority of intersectoral communication is still based on analogue techniques (e.g., fax use in 63.7%). From the otolaryngologists' perspectives, the potential of e-health for intersectoral care is mostly in appointment scheduling, further referrals to hospitals, and automated appointment reminders. The physicians' attitudes toward e-health are associated with their Internet use behavior in daily life (odds ratio = 4.30, confidence interval 1.11-16.64, p = 0.035) but not with their demographics. DISCUSSION: The otolaryngologists are well prepared and have an overall positive attitude toward e-health for deeper use in cross-sectoral care. Therefore, e-health in otolaryngology needs more attention and resources for further studies, especially with a focus on quality and safety of care.

Manual Compression versus Vascular Closing Device for Closing Access Puncture Site in Femoral Left-Heart Catheterization and Percutaneous Coronary Interventions: A Retrospective Cross-Sectional Comparison of Costs and Effects in Inpatient Care.

OBJECTIVES: To compare complication rates, length of hospital stay, and resulting costs between the use of manual compression and a vascular closing device (VCD) in both diagnostic and interventional catheterization in a German university hospital setting. METHODS: A stratified analysis according to risk profiles was used to compare the risk of complications in a retrospective cross-sectional single-center study. Differences in costs and length of hospital stay were calculated using the recycled predictions method, based on regression coefficients from generalized linear models with gamma distribution. All models were adjusted for propensity score and possible confounders, such as age, sex, and comorbidities. The analysis was performed separately for diagnostic and interventional catheterization. RESULTS: The unadjusted relative risk (RR) of complications was not significantly different in diagnostic catheterization when a VCD was used (RR = 0.70; 95% confidence interval [CI] 0.22-2.16) but significantly lower in interventional catheterization (RR = 0.44; 95% CI 0.21-0.93). Costs were on average €275 lower in the diagnostic group (95% CI -€478.0 to -€64.9; P = 0.006) and around €373 lower in the interventional group (95% CI -€630.0 to -€104.2; P = 0.014) when a VCD was used. The adjusted estimated average length of stay did not differ significantly between the use of a VCD and manual compression in both types of catheterization. CONCLUSIONS: In interventional catheterization, VCDs significantly reduced unadjusted complication rates, as well as costs. A significant reduction in costs also supports their usage in diagnostic catheterization on a larger scale.

The potential of eHealth in otorhinolaryngology-head and neck surgery: patients' perspectives.

The use of modern information and communication technologies (ICT) in daily life has significantly increased during the last several years. These essential online technologies have also found their way into the healthcare system. The use of modern ICT for health reasons can be summarized by the term 'eHealth'. Despite the potential importance of eHealth in the field of otorhinolaryngology (ORL), there is little understanding of patients' attitudes towards the deeper integration of these technologies into intersectoral care. The aim of this study was to gain a better understanding of patients' attitudes towards the use of modern ICT for intersectoral communication and information transfer in the field of ORL. Therefore, a structured interview was developed by an interdisciplinary team of otorhinolaryngologists, public health researchers, and information technology (IT) specialists. Overall, 211 ORL patients were interviewed at the Department of Otorhinolaryngology-Head and Neck Surgery, Tuebingen University Hospital, Germany, and 203 of these patients completed the interview. This study revealed ORL patients' perspectives on the potential of eHealth, especially for appointment scheduling, appointment reminders, and intersectoral communication of personal medical information. Furthermore, this study provides evidence that data security and the impacts of eHealth on the physician-patient relationship and on treatment quality warrant special attention in future research.

Compliance of Clinical Pathways in Elective Laparoscopic Cholecystectomy: Evaluation of Different Implementation Methods.

BACKGROUND: Clinical pathways aim to standardize perioperative and postoperative care of surgical procedures and are shown to result in a significant optimization associated with cost reduction. The aim of this study was to establish the impact of two different implementations forms of clinical pathways on the pathway compliance and resulting costs. METHODS: Data of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: using a clinical pathway in the form of a paper-based checklist, or a clinical pathway integrated into the paper-based medical treatment and nursing documentation. Outcome measures were compliance of the clinical pathway and total costs per case. RESULTS: The compliance was significantly higher using integrated pathways compared to paper-based checklists (n = 117 of 123, 95 % vs 54 of 118, 46 %; p < 0.001). Mean total costs (€2206 vs €2458, p = 0.027) and length of hospital stay (2.13 vs 2.77 days, p < 0.001) were significantly reduced by the integrated clinical pathway compared to checklists. Further, the variation of costs per case and variation of length of hospital stay were significantly smaller with integrated clinical pathway (±€440 vs ±€538, p = 0.039 and ±0.53 vs ±0.68 days, p < 0.001, respectively). No difference regarding postoperative complication was observed (n = 3 vs. 4 events; p = 0.67). CONCLUSION: Integrated clinical pathways display a significant higher compliance compared to checklists resulting in reduced total costs, shorter hospital stay and a smaller variation of cost, making it a useful tool in process controlling and planning.

A case of recurrent respiratory papillomatosis with malignant transformation, HPV11 DNAemia, high L1 antibody titre and a fatal papillary endocardial lesion.

BACKGROUND: Recurrent respiratory papillomatosis (RRP) is a rare disease, which is characterised by the growth of papillomavirus-induced papillomas within the respiratory tract. Malignant transformation occurs in less than 1% of the cases. CASE PRESENTATION: We report a case of human papillomavirus (HPV) type 11-associated juvenile-onset RRP (JORRP) initially diagnosed at the age of two years. Remarkably high copy numbers of HPV11 DNA and antibody titres targeting the capsid protein L1 were detected in the patient's serum. The patient developed squamous cell carcinomas in both lungs and extraordinarily an HPV11 DNA-positive papillary endocardial lesion in the left atrium of the heart, which caused thromboembolic events leading to the patient's death at 19 years old. CONCLUSION: We here report a severe case of JORRP hallmarked by HPV11 DNAemia and very high antibody titres directed against the major viral capsid protein L1. Furthermore, the extent of malignant transformation and the discovery of a very rare fatal endocardial lesion highlight the unpredictability of JORRP and the complexity of its clinical management.

A Generative Pretrained Transformer (GPT)-Powered Chatbot as a Simulated Patient to Practice History Taking: Prospective, Mixed Methods Study.

BACKGROUND: Communication is a core competency of medical professionals and of utmost importance for patient safety. Although medical curricula emphasize communication training, traditional formats, such as real or simulated patient interactions, can present psychological stress and are limited in repetition. The recent emergence of large language models (LLMs), such as generative pretrained transformer (GPT), offers an opportunity to overcome these restrictions. OBJECTIVE: The aim of this study was to explore the feasibility of a GPT-driven chatbot to practice history taking, one of the core competencies of communication. METHODS: We developed an interactive chatbot interface using GPT-3.5 and a specific prompt including a chatbot-optimized illness script and a behavioral component. Following a mixed methods approach, we invited medical students to voluntarily practice history taking. To determine whether GPT provides suitable answers as a simulated patient, the conversations were recorded and analyzed using quantitative and qualitative approaches. We analyzed the extent to which the questions and answers aligned with the provided script, as well as the medical plausibility of the answers. Finally, the students filled out the Chatbot Usability Questionnaire (CUQ). RESULTS: A total of 28 students practiced with our chatbot (mean age 23.4, SD 2.9 years). We recorded a total of 826 question-answer pairs (QAPs), with a median of 27.5 QAPs per conversation and 94.7% (n=782) pertaining to history taking. When questions were explicitly covered by the script (n=502, 60.3%), the GPT-provided answers were mostly based on explicit script information (n=471, 94.4%). For questions not covered by the script (n=195, 23.4%), the GPT answers used 56.4% (n=110) fictitious information. Regarding plausibility, 842 (97.9%) of 860 QAPs were rated as plausible. Of the 14 (2.1%) implausible answers, GPT provided answers rated as socially desirable, leaving role identity, ignoring script information, illogical reasoning, and calculation error. Despite these results, the CUQ revealed an overall positive user experience (77/100 points). CONCLUSIONS: Our data showed that LLMs, such as GPT, can provide a simulated patient experience and yield a good user experience and a majority of plausible answers. Our analysis revealed that GPT-provided answers use either explicit script information or are based on available information, which can be understood as abductive reasoning. Although rare, the GPT-based chatbot provides implausible information in some instances, with the major tendency being socially desirable instead of medically plausible information.

Embracing digital health: German otolaryngology patients' usage and prospects of digital information and communication technologies for cross-sectoral care.

Objective: The usage of digital information and communication technologies in European healthcare is growing. Unlike numerous technological possibilities, the present use of these technologies and perspectives towards them in relation to otolaryngology care have so far been of less interest. This study evaluates the utilisation of and attitudes towards digital information and communication technologies in cross-sectoral otolaryngology care among German patients. Methods: A structured interview-based study was conducted at the outpatient facility of a tertiary hospital in Germany. It focused on chief complaints, current use of digital technologies, estimated benefits of increased digital technology use in otolaryngology care, and sociodemographic data. The detailed statistical analysis employed Chi-squared tests and multivariate logistic regression. Results: A total of 208 otolaryngology patients completed the interview. Digital communication technologies exhibited a high penetration rate (91.8%) and were regularly used in daily life (78.7%) and for health reasons (73.3%). Younger age (p ≤ 0.003) and higher education levels (p ≤ 0.008) were significantly correlated with the increased digital communication technology use. The overall potential of eHealth technologies was rated significantly higher by younger patients (p ≤ 0.001). The patients' chief complaints showed no significant influence on the current and potential use of these technologies for cross-sectoral otolaryngology care. Conclusion: Regardless of their chief complaints, German otolaryngology patients regularly use digital information and communication technologies for health reasons and express interest in their further use for cross-sectoral care. To enhance digital patient communication in otolaryngology, attention should be given to treatment quality, usability, data security and availability and financial remuneration for service providers.

The potential of eHealth for cancer patients-does COVID-19 pandemic change the attitude towards use of telemedicine services?

BACKGROUND: Internet penetration worldwide has increased rapidly over the recent years. With this growth, modern information and communication technologies (ICT) have become increasingly important. They do not only change daily life but also patient-physician interaction and health related information search, which can be summarized as electronic Health (eHealth). eHealth was already known before the emergence of the coronavirus disease 2019 (COVID-19), but this pandemic substantially challenged health systems, physicians and hospitals so profoundly that new services and methods of patient-physician interaction had to be implemented rapidly. This study investigates the attitude of cancer patients towards eHealth and the potential impact of COVID-19 on its use. METHODS AND FINDINGS: The study was a multicentered study carried out at the university hospitals Bonn and Aachen. Patients were asked to answer a structured questionnaire in the time span between September 2019 and February 2021. Due to the COVID-19 pandemic, no patients were addressed between March 2020 and July 2020. The questionnaire focused on socio-demographic data, the dissemination of internet-enabled devices, the patients' attitude towards eHealth and the use of modern ICT in daily life and for health-related information search. In total, 280 patients have filled the questionnaire of which 48% were female and 52% were male. Men have a slightly more positive attitude towards the overall potential of eHealth than women which was shown by a significant influence for receiving medical information via e-mail. Hematological-oncological patients with a higher education level reported a significantly higher willingness to send personal health information to their physician and health insurance. A frequency of medical consultation of more than 5 times during the previous year has a significantly positive impact regarding the use of online communication, online video consultation and treatment quality. Younger patients have more concerns about data security than older patients. The study shows a different attitude towards the influence of eHealth on the patient-physician relationship in different therapy situations. While there were no significant changes in patients' attitude towards eHealth after the start of the COVID-19 pandemic, there was a trend towards an increasingly embracing attitude in patients, who answered the questionnaire during COVID-19 pandemic situation. CONCLUSIONS: Overall, cancer patients had a positive attitude towards eHealth and the dissemination of internet-enabled devices was high. The study shows that the potential of eHealth is high among hematological-oncological patients. Further eHealth technologies and especially telemedically supported care processes should be implemented to improve patient-physician interaction and cross-sectoral care. COVID-19 pandemic led to a fast initiation and acceleration of new structures and routines for physicians, hospitals and patients. These new processes should be used to promote digitalization in hematological and oncological telemedicine. To successfully implement new eHealth technologies, future research should focus on patients' concerns about data privacy and data availability especially in the context of exchange of medical information in cross sectoral and interdisciplinary care processes.

New shift models for doctors in a large German University Neurosurgery Department: how they comply with the European Working Time Directive 3 years after implementation.

BACKGROUND: Due to the European Working Time Directive (EWTD) and a new collective agreement for doctors working at University hospitals in 2006 new shift models had to be designed in the Department of Neurosurgery of the University Hospital Tübingen, Germany. The aim of the study was to show the fit of the models regarding the average weekly working time limits (aWTL), the daily maximum of 10-h working time (10-h dWT), and the staff expenditures 3 years after implementation. METHODS: The new shift model was implemented in 2008, and hence planning and documentation were done electronically. Adherence to the work schedules was measured, and aWTL adherence rates were compared. The relative number of 10-h dWT violations in 2009 and 2010 was analysed. Staff costs relative to performance before and after implementation were calculated and tested using analysis of variance (ANOVA). Four other departments without alteration of shift models served as a control group in cost trend analysis. RESULTS: In 2010 all doctors in the Department of Neurosurgery were able to stay within the limit of 54 h/week; one doctor without opt-out exceeded the 48 h/week limit (50.1 h/week). The median per capita rate of 10-h dWT violations in 2009 was 20.3 % of all eligible working days and further declined to 10.7 % in 2010 (p < 0.001). Staff costs per case-weight point did not change significantly (2007: 339.88€, 2009: 307.99€, 2010: 322.54€; p = 0.22) in neurosurgery or in the control group (2007: 633.72€, 2009: 637.06€, 2010: 690.30€; p = 0.67). CONCLUSIONS: After implementation of the new shift model, current monitoring and properly matching modifications led to long-term stability in complying with the EWTD regulations without increasing costs for staff expenditures.

"We Want Good Education for All of Us" - A Participatory Quality Improvement Approach.

Introduction: In ever changing conditions, medical faculties must face the challenge of preparing their medical students as best as possible for the demands of their future work. This requires involving all stakeholders, especially medical students in the constant redefinition of medical curricula. Using the idea of "Communities of Practice" as conceptual framework, this study looks at semester spokespeople as an example for participatory quality management. Methods: We conducted focus-group interviews with semester spokespeople at a German Medical Faculty. Data was recorded, transcribed, and analysed using MAXQDA. The interviews were analysed using meaning condensation method. Results: Eleven out of 48 semester spokespeople took part. We found seven topics that fell within three main categories: (1) role of the semester spokesperson, (2) role of the fixed meeting, and (3) contact and commitment. Communities of Practice principles could be aligned to topics and categories. Discussion: The idea of semester spokespeople based on the concept of Communities of Practice are useful in the quality management processes of a medical school and lead to greater involvement of medical students, identifying their needs. The reciprocal commitment among all stakeholders fosters mutual understanding and collaboration. Future studies could investigate the underlying motivational factors of dedicated students and how to transfer these characteristics to a larger cohort.

Interaction Empowerment in Mobile Health: Concepts, Challenges, and Perspectives.

In its most trending interpretation, empowerment in health care is implemented as a patient-centered approach. In the same sense, many mobile health (mHealth) apps are being developed with a primary focus on the individual user. The integration of mHealth apps into the health care system has the potential to counteract existing challenges, including incomplete or nonstandardized medical data and lack of communication, especially in the intersectional context (eg, patients, medical forces). However, concerns about data security and privacy, regional differences in regulations, lack of accessibility, and nontransparent apps hinder the successful integration of mHealth into the health care system. One approach to address this is to rethink the interpretation of empowerment. On that basis, we here examine existing approaches of individual empowerment and subsequently analyze a different view of empowerment in digital health, namely interaction empowerment. Such a change of perspective could positively influence intersectoral communication and facilitate secure data and knowledge sharing. We discuss this novel viewpoint on empowerment, focusing on more efficient integration and development of mHealth approaches. A renewed interpretation of empowerment could thus buffer current limitations of individual empowerment while also advancing digitization of the health system.

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study.

As the Corona Disease 2019 (COVID-19) caused by SARS-CoV-2 persists, vaccination is one of the key measures to contain the spread. Side effects (SE) from vaccination are one of the reasons for reluctance to vaccinate. We systematically investigated self-reported SE after the first, second, and booster vaccinations. The data were collected during the TüSeRe: exact study (Tübinger Monitoring Studie zur exakten Analyse der Immunantwort nach Vakzinierung). Employees of health and research institutions were invited to participate. Study participants were asked to fill out an online questionnaire and report their SE after each dose of SARS-CoV-2 vaccination. A total of 1046 participants (mean age: 44 ± 12.9 years; female, n = 815 (78%); male, n = 231 (22%)) were included in the analysis. Local and systemic SE were more frequent after receiving the vector-based vaccine ChAdOx1 nCoV-19 in the first vaccination. However, local and systemic SE were more common after receiving mRNA vaccines (BNT162b2, mRNA-1273) in the second vaccination. Compared to the BNT162b2 vaccine, more SE have been observed after receiving the mRNA-1273 vaccine in the booster vaccination. In multivariate analysis, local and systemic side effects were associated with vaccine type, age and gender. Local and systemic SE are common after SARS-CoV-2 vaccines. The frequency of self-reported local and systemic SE differ significantly between mRNA and vector-based vaccines.

Multimodal Sensor-Based Identification of Stress and Compulsive Actions in Children with Obsessive-Compulsive Disorder for Telemedical Treatment.

In modern psychotherapy, digital health technology offers advanced and personalized therapy options, increasing availability as well as ecological validity. These aspects have proven to be highly relevant for children and adolescents with obsessive-compulsive disorder (OCD). Exposure and Response Prevention therapy, which is the state-of-the-art treatment for OCD, builds on the reconstruction of everyday life exposure to anxious situations. However, while compulsive behavior pre-dominantly occurs in home environments, exposure situations during therapy are limited to clinical settings. Telemedical treatment allows to shift from this limited exposure reconstruction to exposure situations in real life. In the SSTeP KiZ study (smart sensor technology in telepsychotherapy for children and adolescents with OCD), we combine video therapy with wearable sensors delivering physiological and behavioral measures to objectively determine the stress level of patients. The setup allows to gain information from exposure to stress in a realistic environment both during and outside of therapy sessions. In a first pilot study, we explored the sensitivity of individual sensor modalities to different levels of stress and anxiety. For this, we captured the obsessive-compulsive behavior of five adolescents with an ECG chest belt, inertial sensors capturing hand movements, and an eye tracker. Despite their prototypical nature, our results deliver strong evidence that the examined sensor modalities yield biomarkers allowing for personalized detection and quantification of stress and anxiety. This opens up future possibilities to evaluate the severity of individual compulsive behavior based on multi-variate state classification in real-life situations. Clinical Relevance- Our results demonstrate the potential for efficient personalized psychotherapy by monitoring physiological and behavioral changes with multiple sensor modalities in ecologically valid real-life scenarios.