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Introduction People with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care providers and enhancing self-management skills. This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysis The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. The main process outcomes are fidelity, dose, feasibility and context. Context will be analysed through semistructured interviews and focus groups using the Consolidated Framework of Implementation Research. To elucidate potential facilitators and barriers to implementation and to gain deeper insights into the efficacy outcome data, quantitative and qualitative process data will be integrated at an interpretative level using mixed methods. In addition to process evaluation, potential indirect mechanisms of impact will be measured.Ethics and dissemination Ethical approval for this study was obtained from the responsible state medical ethics committees in Hesse and Hamburg, Germany. Results will be communicated to the funding body and disseminated through scientific publications.Trial registration This study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.

Objective Digital health applications are digital medical products (e.g. apps and web applications) that are prescribed by healthcare service providers and reimbursed by health insurances. Before digital health applications can be prescribed, manufacturers must fulfill the requirements of the approval process. The aim of this study is to identify the challenges faced by digital health applications manufacturers in the German fast-track process. Methods Use of a questionnaire-based online survey with 10 digital health applications manufacturers from March to October 2023. The survey design is based on the German digital health application regulation and the digital health application guideline. Data collection via LimeSurvey and HubSpot and data visualization in bar charts. Results Digital health applications manufacturers see the fast-track process as a challenge, especially in terms of demonstrating positive care effects and compliance with regulatory standards. Challenges include conducting clinical trials, negotiating pricing and improving market acceptance even with innovative approaches. Views on the profitability and relevance of the digital health application model are varied, with concerns over pricing and market strategies predominating. Conclusions The fast-track approval of digital health applications in Germany is a significant barrier to innovation and market entry. Collaboration between stakeholders is essential to optimizing processes while ensuring safety and accessibility for patients. However, even with the limitations, the results provide insights for future research and policy refinements that are necessary to improve the implementation of digital health applications in healthcare.

Because of their resilience, Time-of-Flight (ToF) cameras are now essential components in scientific and industrial settings. This paper outlines the essential factors for modeling 3D ToF cameras, with specific emphasis on analyzing the phenomenon known as “wiggling”. Through our investigation, we demonstrate that wiggling not only causes systematic errors in distance measurements, but also introduces periodic fluctuations in statistical measurement uncertainty, which compounds the dependence on the signal-to-noise ratio (SNR). Armed with this knowledge, we developed a new 3D camera model, which we then made computationally tractable. To illustrate and evaluate the model, we compared measurement data with simulated data of the same scene. This allowed us to individually demonstrate various effects on the signal-to-noise ratio, reflectivity, and distance.

Abstract Introduction The Global Initiative for Asthma (GINA)-defined criteria for asthma control include questions about daytime symptoms, limitation of activity, nocturnal symptoms, need for reliever treatment and patients’ satisfaction. Patients with nocturnal symptoms like wheezing and cough often suffer from lower sleep quality and impaired daytime performance. The lack of an appropriate method for standardized and objective monitoring of respiratory symptoms leads to difficulties in asthma management. The aim of this study is to present a new method for automated wheeze and cough detection during sleep and to assess the actual level of asthma control by the Asthma Control Test (ACT). Methods Respiratory symptoms like wheezing and cough were recorded with the LEOSound-Monitor for one night in 55 asthmatic patients in their individual domestic setting. Patients were asked to assess their level of asthma subjectively with the ACT. The study consisted of 37 women and 18 men, with a mean age of 41 years, and a mean BMI of 27 kg/m2. Most of the patients had been taking an ICS/LABA combination and would resort to a SABA as their rescue medication. Results 60% of the participants were classed as having controlled, and 40% were classed as having partially- or uncontrolled asthma. During sleep wheezing was found in 8 of the 55 asthma patients (14.5%) and coughing was found in 30 patients (54.5%). The median ACT score in wheezing-patients was 14, while in non-wheezing patients it was 21. Uncontrolled asthma was found in 6 of the 8 wheezing-patients. Coughing versus non-coughing patients did not show a significant difference in the ACT-score (20, 22 respectively). Conclusion Wheezing is a sign of uncontrolled asthma. The ACT-score in wheezing patients is worse compared to patients without wheezing. LEOSound proofed to be a useful tool in providing an objective evaluation of respiratory symptoms, like coughing and wheezing. In clinical practice, this may allow an improvement in asthma therapy.

Background The clinical diagnosis of pneumonia is usually based on crackles at auscultation, but it is not yet clear what kind of crackles are the characteristic features of pneumonia in children. Lung sound monitoring can be used as a “longtime stethoscope”. Therefore, it was the aim of this pilot study to use a lung sound monitor system to detect crackles and to differentiate between fine and coarse crackles in children with acute pneumonia. The change of crackles during the course of the disease shall be investigated in a follow-up study. Patients and methods Crackles were recorded overnight from 22:00 to 06:00 h in 30 children with radiographically confirmed pneumonia. The data for a total of 28 800 recorded 30-s epochs were audiovisually analysed for fine and coarse crackles. Results Fine crackles and coarse crackles were recognised in every patient with pneumonia, but the number of epochs with and without crackles varied widely among the different patients: fine crackles were detected in 40±22% (mean±sd), coarse crackles in 76±20%. The predominant localisation of crackles as recorded during overnight monitoring was in accordance with the radiographic infiltrates and the classical auscultation in most patients. The distribution of crackles was fairly equal throughout the night. However, there were time periods without any crackle in the single patients so that the diagnosis of pneumonia might be missed at sporadic auscultation. Conclusion Nocturnal monitoring can be beneficial to reliably detect fine and coarse crackles in children with pneumonia.

Computer applications in medicine are very important. However, there are differences in quality of such software, which periodically led to discussions about safety, regulation, and registration of software applications. Today, the admission procedure of medical products is highly regulated, and this applies also for mobile medical apps. The clinical evaluation is one important aspect of the admission procedure, especially due to the latest regulatory changes of the guideline MedDev 2.7/1 revision 4. The requirements have increased, and uncertainty grows in medical app development companies. The aim of this paper was the development of a process orientated guide, that gives an overview of the needed steps of a clinical evaluation of mobile medical apps and that could help to give a rough estimation about the necessary effort. The guide was developed, based on the relevant literature and legal texts. The clinical evaluation can be conducted in five substeps: “Planning and Scoping”, “Literature Research”, “Literature Assessment”, “Clinical Data Analysis” and “Reporting”. Prospectively, this guide will be evaluated by developers and adjusted, as soon as Medical Device Regulation is legally binding.

Knee acoustic emissions provide information about joint health and loading in motion. As the reproducibility of knee acoustic emissions by vibroarthrography is yet unknown, we evaluated the intrasession and interday reliability of knee joint sounds. In 19 volunteers (25.6 ± 2.0 years, 11 female), knee joint sounds were recorded by two acoustic sensors (16,000 Hz; medial tibial plateau, patella). All participants performed four sets standing up/sitting down (five repetitions each). For measuring intrasession reliability, we used a washout phase of 30 min between the first three sets, and for interday reliability we used a washout phase of one week between sets 3 and 4. The mean amplitude (dB) and median power frequency (Hz, MPF) were analyzed for each set. Intraclass correlation coefficients (ICCs (2,1)), standard errors of measurement (SEMs), and coefficients of variability (CVs) were calculated. The intrasession ICCs ranged from 0.85 to 0.95 (tibia) and from 0.73 to 0.87 (patella). The corresponding SEMs for the amplitude were ≤1.44 dB (tibia) and ≤2.38 dB (patella); for the MPF, SEMs were ≤13.78 Hz (tibia) and ≤14.47 Hz (patella). The intrasession CVs were ≤0.06 (tibia) and ≤0.07 (patella) (p < 0.05). The interday ICCs ranged from 0.24 to 0.33 (tibia) and from 0 to 0.82 (patella) for both the MPF and amplitude. The interday SEMs were ≤4.39 dB (tibia) and ≤6.85 dB (patella) for the amplitude and ≤35.39 Hz (tibia) and ≤15.64 Hz (patella) for the MPF. The CVs were ≤0.14 (tibia) and ≤0.08 (patella). Knee joint sounds were highly repeatable within a single session but yielded inconsistent results for the interday reliability.

Abstract This paper examines the short-run immigration effects on prices for owner-occupied housing and rents in Switzerland, exploiting regional variation at the level of 106 local labor markets (“Mobilité Spatiale” regions) and 26 cantons, respectively. We propose two empirical strategies that exploit the Agreement on the Free Movement of Persons (AFMP) with the European Union (EU), enacted in 2002, as an exogenous shock to immigration. The first approach uses the AFMP reform within an instrumental variable approach, instrumenting current regional inflows of immigrants based on the historical distribution of immigrants across regions. The second conducts an event study of housing price changes before and after the reform, distinguishing between regions with historically high, medium, and low immigration from EU-15 countries. The analysis based on data at the level of local labor markets for the years 1985–2016 suggests that immigration triggered off by the AFMP reform has substantially raised prices of single-family homes and of owner-occupied apartments. Before the reform, immigration has not affected house prices. Estimates based on cantonal data for the years 1998–2016 suggest that immigration has raised rental prices even more than prices of owner-occupied housing.

Human papillomavirus (HPV) is responsible for almost all of the 570,000 new cases of cervical cancer and approximately 311,000 deaths per year. HPV vaccination is an integral component of the World Health Organization's (WHO) global strategy to fight the disease. However, high vaccine prices enforced through patent protection are limiting vaccine expansion, particularly in low- and middle-income countries. By limiting market power, patent buyouts could reduce vaccine prices and raise HPV vaccination rates while keeping innovation incentives. We estimate the global patent buyout price as the present discounted value (PDV) of the future profit stream over the remaining patent length for Merck's HPV vaccines (Gardasil-4 and 9), which hold 87% of the global HPV vaccine market, in the range of US$ 15.6-27.7 billion (in 2018 US$). The estimated PDV of the profit stream since market introduction amounts to US$ 17.8-42.8 billion and the estimated R&D cost to US$ 1.05-1.21 billion. Thus, we arrive at a ratio of R&D costs to the patent value of the order of 2.5-6.8%. We relate this figure to typical estimates of the probability of success (POS) for clinical trials of vaccines to discuss if patent protection provides Merck with extraordinarily strong price setting power.