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N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully functional platforms are not yet available.
Here, we present the open source StudyU platform, which includes the StudyU Designer and StudyU app.
With the StudyU Designer, scientists are given a collaborative web application to digitally specify, publish, and conduct N-of-1 trials.
The StudyU app is a smartphone app with innovative user-centric elements for participants to partake in trials published through the StudyU Designer to assess the effects of different interventions on their health.
Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner.
We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, democratize and personalize evidence generation for self-optimization and medicine, and can be integrated in clinical practice.
Background:
Digital therapeutic care apps provide a new effective and scalable approach for people with nonspecific low back pain (LBP). Digital therapeutic care apps are also driven by personalized decision-support interventions that support the user in self-managing LBP, and may induce prolonged behavior change to reduce the frequency and intensity of pain episodes. However, these therapeutic apps are associated with high attrition rates, and the initial prescription cost is higher than that of face-to-face physiotherapy. In Germany, digital therapeutic care apps are now being reimbursed by statutory health insurance; however, price targets and cost-driving factors for the formation of the reimbursement rate remain unexplored.
Objective:
The aim of this study was to evaluate the cost-effectiveness of a digital therapeutic care app compared to treatment as usual (TAU) in Germany. We further aimed to explore under which circumstances the reimbursement rate could be modified to consider value-based pricing.
Methods:
We developed a state-transition Markov model based on a best-practice analysis of prior LBP-related decision-analytic models, and evaluated the cost utility of a digital therapeutic care app compared to TAU in Germany. Based on a 3-year time horizon, we simulated the incremental cost and quality-adjusted life years (QALYs) for people with nonacute LBP from the societal perspective. In the deterministic sensitivity and scenario analyses, we focused on diverging attrition rates and app cost to assess our model's robustness and conditions for changing the reimbursement rate. All costs are reported in Euro (euro1=US $1.12).
Results:
Our base case results indicated that the digital therapeutic care strategy led to an incremental cost of euro121.59, but also generated 0.0221 additional QALYs compared to the TAU strategy, with an estimated incremental cost-effectiveness ratio (ICER) of euro5486 per QALY. The sensitivity analysis revealed that the reimbursement rate and the capability of digital therapeutic care to prevent reoccurring LBP episodes have a significant impact on the ICER. At the same time, the other parameters remained unaffected and thus supported the robustness of our model. In the scenario analysis, the different model time horizons and attrition rates strongly influenced the economic outcome. Reducing the cost of the app to euro99 per 3 months or decreasing the app's attrition rate resulted in digital therapeutic care being significantly less costly with more generated QALYs, and is thus considered to be the dominant strategy over TAU.
Conclusions:
The current reimbursement rate for a digital therapeutic care app in the statutory health insurance can be considered a cost-effective measure compared to TAU. The app's attrition rate and effect on the patient's prolonged behavior change essentially influence the settlement of an appropriate reimbursement rate. Future value-based pricing targets should focus on additional outcome parameters besides pain intensity and functional disability by including attrition rates and the app's long-term effect on quality of life.
SensorHub
(2022)
Observational studies are an important tool for determining whether the findings from controlled experiments can be transferred into scenarios that are closer to subjects' real-life circumstances. A rigorous approach to observational studies involves collecting data from different sensors to comprehensively capture the situation of the subject. However, this leads to technical difficulties especially if the sensors are from different manufacturers, as multiple data collection tools have to run simultaneously. We present SensorHub, a system that can collect data from various wearable devices from different manufacturers, such as inertial measurement units, portable electrocardiographs, portable electroencephalographs, portable photoplethysmographs, and sensors for electrodermal activity. Additionally, our tool offers the possibility to include ecological momentary assessments (EMAs) in studies. Hence, SensorHub enables multimodal sensor data collection under real-world conditions and allows direct user feedback to be collected through questionnaires, enabling studies at home. In a first study with 11 participants, we successfully used SensorHub to record multiple signals with different devices and collected additional information with the help of EMAs. In addition, we evaluated SensorHub's technical capabilities in several trials with up to 21 participants recording simultaneously using multiple sensors with sampling frequencies as high as 1000 Hz. We could show that although there is a theoretical limitation to the transmissible data rate, in practice this limitation is not an issue and data loss is rare. We conclude that with modern communication protocols and with the increasingly powerful smartphones and wearables, a system like our SensorHub establishes an interoperability framework to adequately combine consumer-grade sensing hardware which enables observational studies in real life.