Assessment of HL7 FHIR Interoperability Between EHR Systems and the Survivorship Passport v2.0 Platform to Generate Treatment Summaries for Childhood Cancer Survivors in Six Clinics: Preliminary Testing Results.

The Survivorship Passport (SurPass) for childhood cancer survivors provides a personalized treatment summary together with a care plan for long-term screening of possible late effects. HL7 FHIR connectivity of Electronic Health Record (EHR) systems with the SurPass has been proposed to reduce the burden of collecting and organizing the relevant information. We present the results of testing and validation efforts conducted across six clinics in Austria, Belgium, Germany, Italy, Lithuania, and Spain. We also discuss ways in which this experience can be used to reduce efforts for the SurPass integration in other clinics across Europe.

Childhood Cancer Survivorship Passport Challenges in the European Health Data Space.

Innovation in cancer therapy has increased childhood cancer survival rates. However, survivors are still at risk of developing late effects. In the digital transformation of the health sector, the Survivorship Passport (SurPass) can support long-term follow-up care plans. Gaps in seamless connectivity among hospital departments, primary care, combined with the time of health professionals required to collect and fill-in health data in SurPass, are barriers to its adoption in daily clinical practice. The PanCareSurPass (PCSP) project was motivated to address these gaps by a new version of SurPass (v2.0) that supports semi-automatic assembly from organizational Electronic Health Record (EHR) systems of the treatment summary data using HL7 FHIR, to create SurPass, and to link it to regional or national digital health infrastructures in six European countries. In this paper we present the methodology used to develop the SurPass technical implementation strategy with special focus on the European Health Data Space (EHDS). The recently provisionally approved EHDS regulation instruments a digital health data ecosystem with opportunities for cost-effective SurPass implementation across Europe. Moving forward, a European HL7 FHIR SurPass Implementation Guide along with synthetic data sets, and validation tools can enrich the European Electronic Health Record Exchange Format (EEHRxF) with use cases on health & wellness of childhood cancer survivors.

Smart FOX - Enabling Citizen-Based Donation of EHR-Standardised Data for Clinical Research in Austria.

Access to healthcare data for secondary use in clinical research is often restricted due to privacy concerns or business interests, hindering comprehensive analysis across patient pathways. The Smart FOX project seeks to address this challenge by developing concepts, methods, and tools to facilitate citizen/patient-driven donations of health data for clinical research. Leveraging the groundwork, laid by the national Electronic Health Record implementation in Austria (called ELGA), Smart FOX aims to harness structured datasets from ELGA for research purposes through an opt-in approach. With funding secured from the Austrian Research Promotion Agency, the project embarks on innovative solutions encompassing governance frameworks, community engagement, and technical infrastructure. The Smart FOX consortium, comprising key stakeholders across various healthcare-associated domains, will evaluate these efforts through demonstrators focusing on clinical registries, patient-generated data, and recruitment services. The project targets to accompany the development of future data donation infrastructure while ultimately advancing clinical research efficiency and bolstering Austria's preparedness for the European Health Data Space. This paper presents the first systematic evaluation of the technical concept and proposal for the federated system architecture of the Austrian Health Data Donation Space, which is the socio-technical goal of Smart FOX.

Usability of a telehealth-nurse supported home-based walking training for peripheral arterial disease - The Keep Pace! pilot study.

Background: Guidelines recommend walking trainings for peripheral arterial disease (PAD) management. Supervised walking training is superior to walking advise to improve the walking distance. Telehealth service with nurse support may close this gap. Patients and methods: This study introduces a telehealth service, "Keep pace!", which has been developed for patients with symptomatic PAD (Fontaine stage IIa and IIb), enabling a structured home-based walking training while monitoring progress via an app collecting unblinded account of steps and walking distance in self-paced 6-minute-walking-tests by geolocation tracking to enhance intrinsic motivation. Supervision by nurses via telephone calls was provided for 8 weeks, followed by 4 weeks of independent walking training. Patient satisfaction, walking distance and health-related quality of life were assessed. Results: 19 patients completed the study. The analysis revealed an overall high satisfaction with the telehealth service (95.4%), including system quality (95.1%), information quality (94.4%), service quality (95.6%), intention to use (92.8%), general satisfaction with the program (98.4%) and health benefits (95.8%). 78.9% asserted that the telehealth service lacking nurse calls would be less efficacious. Pain-free walking distance (76.3±36.8m to 188.4±81.2m, +112.2%, p<0.001) as well as total distance in 6-minute-walking test (308.8±82.6m to 425.9±107.1m, +117.2%, p<0.001) improved significantly. The telehealth service significantly reduced discomfort by better pain control (+15.5%, p=0.015) and social participation (+10.5%, p=0.042). Conclusions: In conclusion, patients were highly satisfied with the telehealth service. The physical well-being of the PAD patients improved significantly post vs. prior the telehealth program.

IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey.

BACKGROUND: To overcome knowledge gaps and optimize long-term follow-up (LTFU) care for childhood cancer survivors, the concept of the Survivorship Passport (SurPass) has been invented. Within the European PanCareSurPass project, the semiautomated and interoperable SurPass (version 2.0) will be optimized, implemented, and evaluated at 6 LTFU care centers representing 6 European countries and 3 distinct health system scenarios: (1) national electronic health information systems (EHISs) in Austria and Lithuania, (2) regional or local EHISs in Italy and Spain, and (3) cancer registries or hospital-based EHISs in Belgium and Germany. OBJECTIVE: We aimed to identify and describe barriers and facilitators for SurPass (version 2.0) implementation concerning semiautomation of data input, interoperability, data protection, privacy, and cybersecurity. METHODS: IT specialists from the 6 LTFU care centers participated in a semistructured digital survey focusing on IT-related barriers and facilitators to SurPass (version 2.0) implementation. We used the fit-viability model to assess the compatibility and feasibility of integrating SurPass into existing EHISs. RESULTS: In total, 13/20 (65%) invited IT specialists participated. The main barriers and facilitators in all 3 health system scenarios related to semiautomated data input and interoperability included unaligned EHIS infrastructure and the use of interoperability frameworks and international coding systems. The main barriers and facilitators related to data protection or privacy and cybersecurity included pseudonymization of personal health data and data retention. According to the fit-viability model, the first health system scenario provides the best fit for SurPass implementation, followed by the second and third scenarios. CONCLUSIONS: This study provides essential insights into the information and IT-related influencing factors that need to be considered when implementing the SurPass (version 2.0) in clinical practice. We recommend the adoption of Health Level Seven Fast Healthcare Interoperability Resources and data security measures such as encryption, pseudonymization, and multifactor authentication to protect personal health data where applicable. In sum, this study offers practical insights into integrating digital health solutions into existing EHISs.

Towards an Electronic Health Prevention Record Based on HL7 FHIR and the OMOP Common Data Model.

BACKGROUND: Approximately 40% of all recorded deaths in Austria are due to behavioral risks. These risks could be avoided with appropriate measures. OBJECTIVES: Extension of the concept of EHR and EMR to an electronic prevention record, focusing on primary and secondary prevention. METHODS: The concept of a structured prevention pathway, based on the principles of P4 Medicine, was developed for a multidisciplinary prevention network. An IT infrastructure based on HL7 FHIR and the OHDSI OMOP common data model was designed. RESULTS: An IT solution supporting a structured and modular prevention pathway was conceptualized. It contained a personalized management of prevention, risk assessment, diagnostic and preventive measures supported by a modular, interoperable IT infrastructure including a health app, prevention record web-service, decision support modules and a smart prevention registry, separating primary and secondary use of data. CONCLUSION: A concept was created on how an electronic health prevention record based on HL7 FHIR and the OMOP common data model can be implemented.

A Standardized Treatment Pathway for Telehealth-Based Care of Chronic Wounds in Austria.

Chronic wounds present a significant healthcare challenge in Austria as well as in other countries. The interdisciplinary approach to wound treatment involving various caregivers, doctors, and relatives, poses challenges in documentation and information exchange. To overcome these barriers and promote patient-centered care, a new telehealth-supported treatment pathway for chronic wounds has been developed. The primary focus was to regularly update the status of the chronic wound by responding to predefined questions and transmitted images of the chronic wound. This was achieved by an interdisciplinary team of experts in chronic wound care, providing a new perspective for digital implementation in the healthcare system.

Neural Network-Based Prediction of Perceived Sleep Quality Through Wearable Device Data.

BACKGROUND: This study focuses on the development of a neural network model to predict perceived sleep quality using data from wearable devices. We collected various physiological metrics from 18 participants over four weeks, including heart rate, physical activity, and both device-measured and self-reported sleep quality. OBJECTIVES: The primary objective was to correlate wearable device data with subjective sleep quality perceptions. METHODS: Our approach used data processing, feature engineering, and optimizing a Multi-Layer Perceptron classifier. RESULTS: Despite comprehensive data analysis and model experimentation, the predictive accuracy for perceived sleep quality was moderate (59%), highlighting the complexities in accurately quantifying subjective sleep experiences through wearable data. Applying a tolerance of 1 grade (on a scale from 1-5), increased accuracy to 92%. DISCUSSION: More in-depth analysis is required to fully comprehend how wearables and artificial intelligence might assist in understanding sleep behavior.

The Evolution of Telehealth in Heart Failure Management: The Role of Large Language Models and HerzMobil as a Potential Use Case.

The burgeoning domain of telehealth has witnessed substantial transformation through the advent of advanced technologies such as Large Language Models (LLMs). This study examines the integration of LLMs in heart failure management, with a focus on HerzMobil as a pioneering telehealth program. The technical underpinnings of LLMs, their current applications in the medical field, and their potential to enhance telehealth services, have been explored. The paper highlights the benefits of LLMs in patient interaction, clinical documentation, and decision-making processes. Through the HerzMobil case study, improvements in patient self-management and reductions in hospital readmission rates have been observed, showcasing the successful application of telehealth in chronic disease management. The paper also delves into the challenges and ethical considerations of LLM integration, such as data privacy, potential biases, and regulatory compliance, underscoring the need for a balanced approach that prioritizes patient safety and ethical standards.

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses.

Introduction: The potential for secondary use of health data to improve healthcare is currently not fully exploited. Health data is largely kept in isolated data silos and key infrastructure to aggregate these silos into standardized bodies of knowledge is underdeveloped. We describe the development, implementation, and evaluation of a federated infrastructure to facilitate versatile secondary use of health data based on Health Data Space nodes. Materials and methods: Our proposed nodes are self-contained units that digest data through an extract-transform-load framework that pseudonymizes and links data with privacy-preserving record linkage and harmonizes into a common data model (OMOP CDM). To support collaborative analyses a multi-level feature store is also implemented. A feasibility experiment was conducted to test the infrastructures potential for machine learning operations and deployment of other apps (e.g., visualization). Nodes can be operated in a network at different levels of sharing according to the level of trust within the network. Results: In a proof-of-concept study, a privacy-preserving registry for heart failure patients has been implemented as a real-world showcase for Health Data Space nodes at the highest trust level, linking multiple data sources including (a) electronical medical records from hospitals, (b) patient data from a telemonitoring system, and (c) data from Austria's national register of deaths. The registry is deployed at the tirol kliniken, a hospital carrier in the Austrian state of Tyrol, and currently includes 5,004 patients, with over 2.9 million measurements, over 574,000 observations, more than 63,000 clinical free text notes, and in total over 5.2 million data points. Data curation and harmonization processes are executed semi-automatically at each individual node according to data sharing policies to ensure data sovereignty, scalability, and privacy. As a feasibility test, a natural language processing model for classification of clinical notes was deployed and tested. Discussion: The presented Health Data Space node infrastructure has proven to be practicable in a real-world implementation in a live and productive registry for heart failure. The present work was inspired by the European Health Data Space initiative and its spirit to interconnect health data silos for versatile secondary use of health data.

Telemedicine for Ketogenic Dietary Treatment in Refractory Epilepsy and Inherited Metabolic Disease: State of Play and Future Perspectives.

Ketogenic dietary therapies (KDT) are diets that induce a metabolic condition comparable to fasting. All types of KDT comprise a reduction in carbohydrates whilst dietary fat is increased up to 90% of daily energy expenditure. The amount of protein is normal or slightly increased. KDT are effective, well studied and established as non-pharmacological treatments for pediatric patients with refractory epilepsy and specific inherited metabolic diseases such as Glucose Transporter Type 1 Deficiency Syndrome. Patients and caregivers have to contribute actively to their day-to-day care especially in terms of (self-) calculation and (self-) provision of dietary treatment as well as (self-) measurement of blood glucose and ketones for therapy monitoring. In addition, patients often have to deal with ever-changing drug treatment plans and need to document occurring seizures on a regular basis. With this review, we aim to identify existing tools and features of telemedicine used in the KDT context and further aim to derive implications for further research and development.

Scaling up and implementing the digital Survivorship Passport tool in routine clinical care - The European multidisciplinary PanCareSurPass project.

BACKGROUND: Childhood cancer survivors (CCS), of whom there are about 500,000 living in Europe, are at an increased risk of developing health problems [1-6] and require lifelong Survivorship Care. There are information and knowledge gaps among CCS and healthcare providers (HCPs) about requirements for Survivorship Care [7-9] that can be addressed by the Survivorship Passport (SurPass), a digital tool providing CCS and HCPs with a comprehensive summary of past treatment and tailored recommendations for Survivorship Care. The potential of the SurPass to improve person-centred Survivorship Care has been demonstrated previously [10,11]. METHODS: The EU-funded PanCareSurPass project will develop an updated version (v2.0) of the SurPass allowing for semi-automated data entry and implement it in six European countries (Austria, Belgium, Germany, Italy, Lithuania and Spain), representative of three infrastructure healthcare scenarios typically found in Europe. The implementation study will investigate the impact on person-centred care, as well as costs and processes of scaling up the SurPass. Interoperability between electronic health record systems and SurPass v2.0 will be addressed using the Health Level Seven (HL7) International interoperability standards. RESULTS: PanCareSurPass will deliver an interoperable digital SurPass with comprehensive evidence on person-centred outcomes, technical feasibility and health economics impacts. An Implementation Toolkit will be developed and freely shared to promote and support the future implementation of SurPass across Europe. CONCLUSIONS: PanCareSurPass is a novel European collaboration that will improve person-centred Survivorship Care for CCS across Europe through a robust assessment of the implementation of SurPass v2.0 in different healthcare settings.

Instance Selection Algorithms for Predictive Modelling in Telehealth Applications.

Telehealth services are becoming more and more popular, leading to an increasing amount of data to be monitored by health professionals. Machine learning can support them in managing these data. Therefore, the right machine learning algorithms need to be applied to the right data. We have implemented and validated different algorithms for selecting optimal time instances from time series data derived from a diabetes telehealth service. Intrinsic, supervised, and unsupervised instance selection algorithms were analysed. Instance selection had a huge impact on the accuracy of our random forest model for dropout prediction. The best results were achieved with a One Class Support Vector Machine, which improved the area under the receiver operating curve of the original algorithm from 69.91 to 75.88 %. We conclude that, although hardly mentioned in telehealth literature so far, instance selection has the potential to significantly improve the accuracy of machine learning algorithms.

Identifying Accuracy-related Outliers in a 6-Minute Walk Test Application for Monitoring Cardiovascular Disease Patients.

The 6-Minute Walk Test (6-MWT) is frequently used to evaluate functional physical capacity of patients with cardiovascular diseases. To determine reliability in remote care, outlier classification of a mobile Global Navigation Satellite System (GNSS) based 6-MWT App had to be investigated. The raw data of 53 measurements were Kalman filtered and afterwards layered with a Butterworth high-pass filter to find correlation between the resulting Root Mean Square value (RMS) outliers to relative walking distance errors using the test. The analysis indicated better performance in noise detection using all 3 GNSS dimensions with a high Pearson correlation of r = 0.77, than sole usage of elevation data with r = 0.62. This approach helps with the identification between accurate and unreliable measurements and opens a path that allows usage of the 6-MWT in remote disease management settings.Clinical Relevance- The 6-MWT is an important assessment tool of walking performance for patients with cardiovascular diseases. Using a sufficiently accurate application would enable unsupervised and easy remote usage, which could potentially reduce the demand for in-clinic visits and facilitate a more convenient and reliable monitoring method in telehealth settings.

Introduction and Comparison of Novel Decentral Learning Schemes with Multiple Data Pools for Privacy-Preserving ECG Classification.

Artificial intelligence and machine learning have led to prominent and spectacular innovations in various scenarios. Application in medicine, however, can be challenging due to privacy concerns and strict legal regulations. Methods that centralize knowledge instead of data could address this issue. In this work, 6 different decentralized machine learning algorithms are applied to 12-lead ECG classification and compared to conventional, centralized machine learning. The results show that state-of-the-art federated learning leads to reasonable losses of classification performance compared to a standard, central model (-0.054 AUROC) while providing a significantly higher level of privacy. A proposed weighted variant of federated learning (-0.049 AUROC) and an ensemble (-0.035 AUROC) outperformed the standard federated learning algorithm. Overall, considering multiple metrics, the novel batch-wise sequential learning scheme performed best (-0.036 AUROC to baseline). Although, the technical aspects of implementing them in a real-world application are to be carefully considered, the described algorithms constitute a way forward towards preserving-preserving AI in medicine.

Towards a Verification Approach of a Smart Registry for Chronic Heart Failure Patients.

BACKGROUND: The daily increasing amount of health data from different sources like electronic medical records and telehealth systems go hand in hand with the ongoing development of novel digital and data-driven analytics. Unifying this in a privacy-preserving data aggregation infrastructure can enable services for clinical decision support in personalized patient therapy. OBJECTIVES: The goal of this work was to consider such an infrastructure, implemented in a smart registry for heart failure, as a comparative method for the analysis of health data. METHODS: We analyzed to what extent the dataset of a study on the telehealth program HerzMobil Tirol (HMT) can be reproduced with the data from the smart registry. RESULTS: A table with 96 variables for 251 patients of the HMT publication could theoretically be replicated from the smart registry for 248 patients with 80 variables. The smart registry contained the tables to reproduce a large part of the information, especially the core statements of the HMT publication. CONCLUSION: Our results show how such an infrastructure can enable efficient analysis of health data, and thus take a further step towards personalized health care.

Impact of Professional Background on Inter-Annotator Variability and Accuracy During Annotation of Clinical Notes.

BACKGROUND: The aging population's need for treatment of chronic diseases is exhibiting a marked increase in urgency, with heart failure being one of the most severe diseases in this regard. To improve outpatient care of these patients and reduce hospitalization rates, the telemedical disease management program HerzMobil was developed in the past. OBJECTIVE: This work aims to analyze the inter-annotator variability among two professional groups (healthcare and engineering) involved in this program's annotation process of free-text clinical notes using categories. METHODS: A dataset of 1,300 text snippets was annotated by 13 annotators with different backgrounds. Inter-annotator variability and accuracy were evaluated using the F1-score and analyzed for differences between categories, annotators, and their professional backgrounds. RESULTS: The results show a significant difference between note categories concerning inter-annotator variability (p<0.0001) and accuracy (p<0.0001). However, there was no statistically significant difference between the two annotator groups, neither concerning inter-annotator variability (p=0.15) nor accuracy (p=0.84). CONCLUSION: Professional background had no significant impact on the annotation of free-text HerzMobil notes.

Classification of Clinical Notes from a Heart Failure Telehealth Network.

Heart failure is a common chronic disease which is associated with high re-hospitalization and mortality rates. Within the telemedicine-assisted transitional care disease management program HerzMobil, monitoring data such as daily measured vital parameters and various other heart failure related data are collected in a structured way. Additionally, involved healthcare professionals communicate with one another via the system using free-text clinical notes. Since manual annotation of such notes is too time-consuming for routine care applications, an automated analysis process is needed. In the present study, we established a ground truth classification of 636 randomly selected clinical notes from HerzMobil based on annotations of 9 experts with different professional background (2 physicians, 4 nurses, and 3 engineers). We analyzed the influence of the professional background on the inter annotator reliability and compared the results with the accuracy of an automated classification algorithm. We found significant differences depending on the profession and on the category. These results indicate that different professional backgrounds should be considered when selecting annotators in such scenarios.

Barriers and facilitators to implementation of the interoperable Survivorship Passport (SurPass) v2.0 in 6 European countries: a PanCareSurPass online survey study.

PURPOSE: Long-term follow-up (LTFU) care for childhood cancer survivors (CCSs) is essential to improve and maintain their quality of life. The Survivorship Passport (SurPass) is a digital tool which can aid in the delivery of adequate LTFU care. During the European PanCareSurPass (PCSP) project, the SurPass v2.0 will be implemented and evaluated at six LTFU care clinics in Austria, Belgium, Germany, Italy, Lithuania and Spain. We aimed to identify barriers and facilitators to the implementation of the SurPass v2.0 with regard to the care process as well as ethical, legal, social and economical aspects. METHODS: An online, semi-structured survey was distributed to 75 stakeholders (LTFU care providers, LTFU care program managers and CCSs) affiliated with one of the six centres. Barriers and facilitators identified in four centres or more were defined as main contextual factors influencing implementation of SurPass v2.0. RESULTS: Fifty-four barriers and 50 facilitators were identified. Among the main barriers were a lack of time and (financial) resources, gaps in knowledge concerning ethical and legal issues and a potential increase in health-related anxiety in CCSs upon receiving a SurPass. Main facilitators included institutions' access to electronic medical records, as well as previous experience with SurPass or similar tools. CONCLUSIONS: We provided an overview of contextual factors that may influence SurPass implementation. Solutions should be found to overcome barriers and ensure effective implementation of SurPass v2.0 into routine clinical care. IMPLICATIONS FOR CANCER SURVIVORS: These findings will be used to inform on an implementation strategy tailored for the six centres.

Investigation of the time shift between wearable photoplethysmography sensors used for continuous heart rate monitoring.

In this study, we investigated the effect of time shift in heartrate measurement by wearables, which might to be used in telehealth applications for patients suffering from heart failure. Six wearables commercially available on the market were tested in a 14-hour measurement. Each wearable was tested three times by five different test persons. A reference sensor was used to test the accuracy of the wearables. We found that different types of time shifts are common in the sensors we tested: time shifts of full days, time shifts of full hours (most probably due to incorrect or unspecified time zones) and time shifts in the range of seconds to minutes (most likely stemming from averaging, data transmission, etc.). We conclude that time shifts of all manufacturers need to be corrected prior comparison of a photoplethysmography signal with other signals. However, even after correction of the time shift, the reliability of the sensors seems to be too low for application in telehealth settings. Clinical relevance- This study shows that signals from state-of-the-art wearable photoplethysmography heart rate measurements show significant time shifts and marked differences even if time shifts were corrected. This limits their utility for clinical applications.