Digitization of Follow-Up Care in Orthopedic and Trauma Surgery With Video Consultations: Health Economic Evaluation Study From a Health Provider's Perspective.

BACKGROUND: Recommendations for health care digitization as issued with the Riyadh Declaration led to an uptake in telemedicine to cope with the COVID-19 pandemic. Evaluations based on clinical data are needed to support stakeholders' decision-making on the long-term implementation of digital health. OBJECTIVE: This health economic evaluation aims to provide the first German analysis of the suitability of video consultations in the follow-up care of patients in orthopedic and trauma surgery, investigate the financial impact on hospital operations and personnel costs, and provide a basis for decisions on digitizing outpatient care. METHODS: We conducted a randomized controlled trial that evaluated video consultations versus face-to-face consultations in the follow-up care of patients in orthopedic and trauma surgery at a German university hospital. We recruited 60 patients who had previously been treated conservatively or surgically for various knee or shoulder injuries. A digital health app and a browser-based software were used to conduct video consultations. The suitability of telemedicine was assessed using the Telemedicine Satisfaction Questionnaire and the EQ-5D-5L questionnaire. Economic analyses included average time spent by physician per consultation, associated personnel costs and capacities for additional treatable patients, and the break-even point for video consultation software fees. RESULTS: After 4 withdrawals in each arm, data from a total of 52 patients (telemedicine group: n=26; control group: n=26) were used for our analyses. In the telemedicine group, 77% (20/26) of all patients agreed that telemedicine provided for their health care needs, and 69% (18/26) found telemedicine an acceptable way to receive health care services. In addition, no significant difference was found in the change of patient utility between groups after 3 months (mean 0.02, SD 0.06 vs mean 0.07, SD 0.17; P=.35). Treatment duration was significantly shorter in the intervention group (mean 8.23, SD 4.45 minutes vs mean 10.92, SD 5.58 minutes; P=.02). The use of telemedicine saved 25% (€2.14 [US $2.35]/€8.67 [US $9.53]) in personnel costs and increased the number of treatable patients by 172 annually, assuming 2 hours of video consultations per week. Sensitivity analysis for scaling up video consultations to 10% of the hospital's outpatient cases resulted in personnel cost savings of €73,056 (US $ 80,275.39) for a senior physician. A total of 23 video consultations per month were required to recoup the software fees of telemedicine through reduced personnel costs (break-even point ranging from 12-38 in the sensitivity analysis). CONCLUSIONS: Our study supports stakeholders' decision-making on the long-term implementation of digital health by demonstrating that video consultations in the follow-up care of patients in orthopedic and trauma surgery result in cost savings and productivity gains for clinics with no negative impact on patient utility. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023445; https://drks.de/search/en/trial/DRKS00023445.

COVID-19 related decline in cancer screenings most pronounced for elderly patients and women in Germany: a claims data analysis.

PURPOSE: This study aimed to analyze the utilization of cancer screenings in Germany before and during the COVID-19 pandemic in 2020. The objective of the analysis was to identify the population at particular risk and to derive recommendations for the future use of resources to prevent long-term deteriorations in health outcomes. METHODS: The analysis was conducted based on claims data of all preventive health services for 15,833,662 patients from the largest statutory health insurance fund in Germany. Utilization of general female cancer screening, general male cancer screening, general health checkup, colorectal cancer screening stool test, colorectal cancer screening consultation, colonoscopy, skin cancer screening, and mammography screening was compared before (2017-2019) and during (2020) the pandemic. RESULTS: Data of a total of 42,046,078 observed screenings showed that the utilization of the individual screenings developed differently, but that the overall utilization decreased significantly by 21.46% during the COVID-19 pandemic (p < 0.001). At the same time, no catch-up effects were detected for total screenings throughout the entire year 2020. The highest decline in screenings was found for the elderly (p < 0.001) and women (p < 0.001). CONCLUSION: Because the elderly are at higher risk for cancer, the omission of early detection might lead to higher treatment costs, reduced quality of life, and higher mortality. In addition, women's medical care in particular has been negatively affected, for example, by the interruption of mammography screenings and the lack of catch-up effects. Therefore, resources must be targeted to reduce burdens on health outcomes and public health in the long term.

Economic and Environmental Impact of Digital Health App Video Consultations in Follow-up Care for Patients in Orthopedic and Trauma Surgery in Germany: Randomized Controlled Trial.

BACKGROUND: Following the Riyadh Declaration, digital health technologies were prioritized in many countries to address the challenges of the COVID-19 pandemic. Digital health apps for telemedicine and video consultations help reduce potential disease spread in routine health care, including follow-up care in orthopedic and trauma surgery. In addition to the satisfaction, efficiency, and safety of telemedicine, its economic and environmental effects are highly relevant to decision makers, particularly for the goal of reaching carbon neutrality of health care systems. OBJECTIVE: This study aims to provide the first comprehensive health economic and environmental analysis of video consultations in follow-up care after knee and shoulder interventions in an orthopedic and trauma surgery department of a German university hospital. The analysis is conducted from a societal perspective. We analyze both economic and environmental impacts of video consultations, taking into account the goal of carbon neutrality for the German health care system by 2030. METHODS: We conducted a prospective randomized controlled trial comparing follow-up care with digital health app video consultations (intervention group) to conventional face-to-face consultations in the clinic (control group). Economic impact included the analysis of travel and time costs and production losses. Examination of the environmental impact comprised the emissions of greenhouse gases, carbon monoxide, volatile hydrocarbons, nitrogen oxides, and particulates, and the calculation of environmental costs. Sensitivity analysis included calculations with a higher cost per ton of carbon dioxide equivalent, which gives equal weight to the welfare of present and future generations. RESULTS: Data from 52 patients indicated that, from the patients' point of view, telemedicine helped reduce travel costs, time costs, and production losses, resulting in mean cost savings of €76.52 per video consultation. In addition, emissions of 11.248 kg of greenhouse gases, 0.070 kg of carbon monoxide, 0.011 kg of volatile hydrocarbons, 0.028 kg of nitrogen oxides, and 0.0004 kg of particulates could be saved per patient through avoided travel. This resulted in savings of environmental costs between €3.73 and €9.53 per patient. CONCLUSIONS: We presented the first comprehensive analysis of economic and environmental effects of telemedicine in the follow-up care of patients in orthopedic and trauma surgery in Germany. Video consultations were found to reduce the environmental footprint of follow-up care; saved travel costs, travel time, and time costs for patients; and helped to lower production losses. Our findings can support the decision-making on the use of digital health during and beyond the COVID-19 pandemic, providing decision makers with data for both economic and environmental effects. Thanks to the pragmatic design of our study, our findings can be applied to a wide range of clinical contexts and potential digital health applications that substitute outpatient hospital visits with video consultations. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023445; https://tinyurl.com/4pcvhz4n.

Motion Artifact Reduction in Electrocardiogram Signals Through a Redundant Denoising Independent Component Analysis Method for Wearable Health Care Monitoring Systems: Algorithm Development and Validation.

BACKGROUND: The quest for improved diagnosis and treatment in home health care models has led to the development of wearable medical devices for remote vital signs monitoring. An accurate signal and a high diagnostic yield are critical for the cost-effectiveness of wearable health care monitoring systems and their widespread application in resource-constrained environments. Despite technological advances, the information acquired by these devices can be contaminated by motion artifacts (MA) leading to misdiagnosis or repeated procedures with increases in associated costs. This makes it necessary to develop methods to improve the quality of the signal acquired by these devices. OBJECTIVE: We aimed to present a novel method for electrocardiogram (ECG) signal denoising to reduce MA. We aimed to analyze the method's performance and to compare its performance to that of existing approaches. METHODS: We present the novel Redundant denoising Independent Component Analysis method for ECG signal denoising based on the redundant and simultaneous acquisition of ECG signals and movement information, multichannel processing, and performance assessment considering the information contained in the signal waveform. The method is based on data including ECG signals from the patient's chest and back, the acquisition of triaxial movement signals from inertial measurement units, a reference signal synthesized from an autoregressive model, and the separation of interest and noise sources through multichannel independent component analysis. RESULTS: The proposed method significantly reduced MA, showing better performance and introducing a smaller distortion in the interest signal compared with other methods. Finally, the performance of the proposed method was compared to that of wavelet shrinkage and wavelet independent component analysis through the assessment of signal-to-noise ratio, dynamic time warping, and a proposed index based on the signal waveform evaluation with an ensemble average ECG. CONCLUSIONS: Our novel ECG denoising method is a contribution to converting wearable devices into medical monitoring tools that can be used to support the remote diagnosis and monitoring of cardiovascular diseases. A more accurate signal substantially improves the diagnostic yield of wearable devices. A better yield improves the devices' cost-effectiveness and contributes to their widespread application.

Assessing Telemedicine Efficiency in Follow-up Care With Video Consultations for Patients in Orthopedic and Trauma Surgery in Germany: Randomized Controlled Trial.

BACKGROUND: Telemedicine can help mitigate important health care challenges, such as demographic changes and the current COVID-19 pandemic, in high-income countries such as Germany. It gives physicians and patients the opportunity to interact via video consultations, regardless of their location, thus offering cost and time savings for both sides. OBJECTIVE: We aimed to investigate whether telemedicine can be implemented efficiently in the follow-up care for patients in orthopedic and trauma surgery, with respect to patient satisfaction, physician satisfaction, and quality of care. METHODS: We conducted a prospective randomized controlled trial in a German university hospital and enrolled 60 patients with different knee and shoulder conditions. For follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients' and physicians' subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires. RESULTS: On the basis of data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58, SD 0.643) than with in-clinic consultations (mean 1.64, SD 0.569), although the difference was not statistically significant (P=.69). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47, SD 0.516 vs mean 1.32, SD 0.557; P=.31). Further analysis indicated that telemedicine can be applied to broader groups of patients and that patients who have prior experience with telemedicine are more willing to use telemedicine for follow-up care. CONCLUSIONS: Telemedicine can be an alternative and efficient form of follow-up care for patients in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with in-person consultations in the clinic. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023445; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023445.

COVID-19 pandemic and waiting times in outpatient specialist care in Germany: an empirical analysis.

BACKGROUND: International healthcare systems face the challenge that waiting times may create barriers to accessing medical care, and that those barriers are unequally distributed between different patient groups. The disruption of healthcare systems caused by the COVID-19 pandemic could exacerbate this already strained demand situation. Using the German healthcare system as an example, this study aims to analyze potential effects of the COVID-19 pandemic on waiting times for outpatient specialist care and to evaluate differences between individual patient groups based on their respective insurance status and the level of supply. METHODS: We conducted an experiment in which we requested appointments by telephone for different insurance statuses in regions with varying levels of supply from 908 outpatient specialist practices in Germany before and during the COVID-19 pandemic. Data from 589 collected appointments were analyzed using a linear mixed effect model. RESULTS: The data analysis revealed two main counteracting effects. First, the average waiting time has decreased for both patients with statutory (mandatory public health insurance) and private health insurance. Inequalities in access to healthcare, however, remained and were based on patients' insurance status and the regional level of supply. Second, the probability of not receiving an appointment at all significantly increased during the pandemic. CONCLUSIONS: Patient uncertainty due to the fear of a potential COVID-19 infection may have freed up capacities in physicians' practices, resulting in a reduction of waiting times. At the same time, the exceptional situation caused by the pandemic may have led to uncertainty among physicians, who might thus have allocated appointments less frequently. To avoid worse health outcomes in the long term due to a lack of physician visits, policymakers and healthcare providers should focus more on regular care in the current COVID-19 pandemic.

Cost Effectiveness of Voretigene Neparvovec for RPE65-Mediated Inherited Retinal Degeneration in Germany.

Purpose: Voretigene Neparvovec-rzyl (VN) is the first available treatment for biallelic RPE65 mutation-associated inherited retinal degeneration, which is usually associated with infancy-onset severe visual impairment and complete blindness during the third life decade. We aim to estimate the cost effectiveness of VN in Germany considering medication costs of €410,550 per eye and potential indirect cost offsets by higher labor force participation. Methods: We developed an individual patient sampling model to simulate patients over their lifetime. In a Monte Carlo analysis, 1000 simulations are performed. Cycle length of the two-state Markov model is 1 year. For each cycle, visual field and best-corrected visual acuity are tracked, compared with natural progression and converted to quality of life. Direct and indirect costs are recorded and the incremental cost-utility ratio is calculated. Results: In the base case scenario, VN provides 4.82 additional quality-adjusted life-years over a patient's lifetime at an incremental cost-utility ratio of €156,853 per additional quality-adjusted life-year gained. Sensitivity analyses show the robustness of the results when altering treatment effect duration, discounting of quality-adjusted life-years and costs, direct costs, and natural progression. Conclusions: Under a lifetime perspective, VN proves to be cost effective for the German statutory health insurance system despite high initial treatment costs. Because VN has important implications for future gene therapies, cost-utility analyses have high economic relevance from a societal perspective. Translational Relevance: Our research analyzes the value of a gene augmentation therapy in clinical care in terms of quality of life gains for patients with blindness from retinal degeneration.

Accuracy of mHealth Devices for Atrial Fibrillation Screening: Systematic Review.

BACKGROUND: Mobile health (mHealth) devices can be used for the diagnosis of atrial fibrillation. Early diagnosis allows better treatment and prevention of secondary diseases like stroke. Although there are many different mHealth devices to screen for atrial fibrillation, their accuracy varies due to different technological approaches. OBJECTIVE: We aimed to systematically review available studies that assessed the accuracy of mHealth devices in screening for atrial fibrillation. The goal of this review was to provide a comprehensive overview of available technologies, specific characteristics, and accuracy of all relevant studies. METHODS: PubMed and Web of Science databases were searched from January 2014 until January 2019. Our systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses. We restricted the search by year of publication, language, noninvasive methods, and focus on diagnosis of atrial fibrillation. Articles not including information about the accuracy of devices were excluded. RESULTS: We found 467 relevant studies. After removing duplicates and excluding ineligible records, 22 studies were included. The accuracy of mHealth devices varied among different technologies, their application settings, and study populations. We described and summarized the eligible studies. CONCLUSIONS: Our systematic review identifies different technologies for screening for atrial fibrillation with mHealth devices. A specific technology's suitability depends on the underlying form of atrial fibrillation to be diagnosed. With the suitable use of mHealth, early diagnosis and treatment of atrial fibrillation are possible. Successful application of mHealth technologies could contribute to significantly reducing the cost of illness of atrial fibrillation.

Cost-effectiveness of Interferon-free therapy for Hepatitis C in Germany--an application of the efficiency frontier approach.

BACKGROUND: The approval of direct-acting antivirals for Interferon-free treatment revolutionized the therapy of chronic Hepatitis C infection. As of August 2014, two treatment regimens for genotype 1 infection received conditional approval in the European Union: Sofosbuvir and Ribavirin for 24 weeks and Sofosbuvir and Simeprevir with or without Ribavirin for 12 weeks. We aim to analyze the cost-effectiveness of both regimens in Germany. METHODS: We set up a Markov model with a lifetime horizon to simulate immediate treatment success and long-term disease progression for treatment-naive patients. The model analyzes both short-term and long-term costs and benefits from the perspective of the German Statutory Health Insurance. We apply the efficiency frontier method, which was suggested by German Institute for Quality and Efficiency in Health Care for cost-effectiveness analysis in Germany. RESULTS: The efficiency frontier is defined by dual therapy and first generation direct-acting antiviral Boceprevir, yielding a maximum of € 1,447.69 per additional percentage point of sustained virologic response gained. Even without rebates, Sofosbuvir/Simeprevir is very close with € 1,560.13 per additional percentage point. It is both more effective and less expensive than Sofosbuvir/Ribavirin. CONCLUSIONS: In addition to higher sustained virologic response rates, new direct-acting antivirals save long-term costs by preventing complications such as liver cirrhosis, hepatocellular carcinoma and ultimately liver transplants, thereby offsetting part of higher drug costs. Our findings are in line with the guidance published by German Society for Gastroenterology, Digestive and Metabolic Diseases, which recommends Sofosbuvir/Simeprevir for Interferon ineligible or intolerant patients.

Cost per responder of TNF-α therapies in Germany.

Tumor necrosis factor α (TNF-α) inhibitors ranked highest in German pharmaceutical expenditure in 2011. Their most important application is the treatment of rheumatoid arthritis (RA). Our objective is to analyze cost per responder of TNF-α inhibitors for RA from the German Statutory Health Insurance funds' perspective. We aim to conduct the analysis based on randomized comparative effectiveness studies of the relevant treatments for the German setting. For inclusion of effectiveness studies, we require results in terms of response rates as defined by European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria. We identify conventional triple therapy as the relevant comparator. We calculate cost per responder based on German direct medical costs. Direct clinical comparisons could be identified for both etanercept and infliximab compared to triple therapy. For infliximab, cost per responder was 216,392 euros for ACR50 and 432,784 euros for ACR70 responses. For etanercept, cost per ACR70 responder was 321,527 euros. Cost was lower for response defined by EULAR criteria, but data was only available for infliximab. Cost per responder is overestimated by 40% due to inclusion of taxes and mandatory rebates in German drugs' list prices. Our analysis shows specific requirements for cost-effectiveness analysis in Germany. Cost per responder for TNF-α treatment in the German setting is more than double the cost estimated in a similar analysis for the USA, which measured against placebo. The difference in results shows the critical role of the correct comparator for a specific setting.