A Nationwide Chronic Disease Management Solution via Clinical Decision Support Services: Software Development and Real-Life Implementation Report.

BACKGROUND: The increasing population of older adults has led to a rise in the demand for health care services, with chronic diseases being a major burden. Person-centered integrated care is required to address these challenges; hence, the Turkish Ministry of Health has initiated strategies to implement an integrated health care model for chronic disease management. We aim to present the design, development, nationwide implementation, and initial performance results of the national Disease Management Platform (DMP). OBJECTIVE: This paper's objective is to present the design decisions taken and technical solutions provided to ensure successful nationwide implementation by addressing several challenges, including interoperability with existing IT systems, integration with clinical workflow, enabling transition of care, ease of use by health care professionals, scalability, high performance, and adaptability. METHODS: The DMP is implemented as an integrated care solution that heavily uses clinical decision support services to coordinate effective screening and management of chronic diseases in adherence to evidence-based clinical guidelines and, hence, to increase the quality of health care delivery. The DMP is designed and implemented to be easily integrated with the existing regional and national health IT systems via conformance to international health IT standards, such as Health Level Seven Fast Healthcare Interoperability Resources. A repeatable cocreation strategy has been used to design and develop new disease modules to ensure extensibility while ensuring ease of use and seamless integration into the regular clinical workflow during patient encounters. The DMP is horizontally scalable in case of high load to ensure high performance. RESULTS: As of September 2023, the DMP has been used by 25,568 health professionals to perform 73,715,269 encounters for 16,058,904 unique citizens. It has been used to screen and monitor chronic diseases such as obesity, cardiovascular risk, diabetes, and hypertension, resulting in the diagnosis of 3,545,573 patients with obesity, 534,423 patients with high cardiovascular risk, 490,346 patients with diabetes, and 144,768 patients with hypertension. CONCLUSIONS: It has been demonstrated that the platform can scale horizontally and efficiently provides services to thousands of family medicine practitioners without performance problems. The system seamlessly interoperates with existing health IT solutions and runs as a part of the clinical workflow of physicians at the point of care. By automatically accessing and processing patient data from various sources to provide personalized care plan guidance, it maximizes the effect of evidence-based decision support services by seamless integration with point-of-care electronic health record systems. As the system is built on international code systems and standards, adaptation and deployment to additional regional and national settings become easily possible. The nationwide DMP as an integrated care solution has been operational since January 2020, coordinating effective screening and management of chronic diseases in adherence to evidence-based clinical guidelines.

A reinforcement learning based algorithm for personalization of digital, just-in-time, adaptive interventions.

Suboptimal health related behaviors and habits; and resulting chronic diseases are responsible for majority of deaths globally. Studies show that providing personalized support to patients yield improved results by preventing and/or timely treatment of these problems. Digital, just-in-time and adaptive interventions are mobile phone-based notifications that are being utilized to support people wherever and whenever necessary in coping with their health problems. In this research, we propose a reinforcement learning-based mechanism to personalize interventions in terms of timing, frequency and preferred type(s). We simultaneously employ two reinforcement learning models, namely intervention-selection and opportune-moment-identification; capturing and exploiting changes in people's long-term and momentary contexts respectively. While the intervention-selection model adapts the intervention delivery with respect to type and frequency, the opportune-moment-identification model tries to find the most opportune moments to deliver interventions throughout a day. We propose two accelerator techniques over the standard reinforcement learning algorithms to boost learning performance. First, we propose a customized version of eligibility traces for rewarding past actions throughout an agent's trajectory. Second, we utilize the transfer learning method to reuse knowledge across multiple learning environments. We validate the proposed approach in a simulated experiment where we simulate four personas differing in their daily activities, preferences on specific intervention types and attitudes towards the targeted behavior. Our experiments show that the proposed approach yields better results compared to the standard reinforcement learning algorithms and successfully capture the simulated variations associated with the personas.

An expandable approach for design and personalization of digital, just-in-time adaptive interventions.

Objective: We aim to deliver a framework with 2 main objectives: 1) facilitating the design of theory-driven, adaptive, digital interventions addressing chronic illnesses or health problems and 2) producing personalized intervention delivery strategies to support self-management by optimizing various intervention components tailored to people's individual needs, momentary contexts, and psychosocial variables. Materials and Methods: We propose a template-based digital intervention design mechanism enabling the configuration of evidence-based, just-in-time, adaptive intervention components. The design mechanism incorporates a rule definition language enabling experts to specify triggering conditions for interventions based on momentary and historical contextual/personal data. The framework continuously monitors and processes personal data space and evaluates intervention-triggering conditions. We benefit from reinforcement learning methods to develop personalized intervention delivery strategies with respect to timing, frequency, and type (content) of interventions. To validate the personalization algorithm, we lay out a simulation testbed with 2 personas, differing in their various simulated real-life conditions. Results: We evaluate the design mechanism by presenting example intervention definitions based on behavior change taxonomies and clinical guidelines. Furthermore, we provide intervention definitions for a real-world care program targeting diabetes patients. Finally, we validate the personalized delivery mechanism through a set of hypotheses, asserting certain ways of adaptation in the delivery strategy, according to the differences in simulation related to personal preferences, traits, and lifestyle patterns. Conclusion: While the design mechanism is sufficiently expandable to meet the theoretical and clinical intervention design requirements, the personalization algorithm is capable of adapting intervention delivery strategies for simulated real-life conditions.

A Semantic Transformation Methodology for the Secondary Use of Observational Healthcare Data in Postmarketing Safety Studies.

Background: Utilization of the available observational healthcare datasets is key to complement and strengthen the postmarketing safety studies. Use of common data models (CDM) is the predominant approach in order to enable large scale systematic analyses on disparate data models and vocabularies. Current CDM transformation practices depend on proprietarily developed Extract-Transform-Load (ETL) procedures, which require knowledge both on the semantics and technical characteristics of the source datasets and target CDM. Purpose: In this study, our aim is to develop a modular but coordinated transformation approach in order to separate semantic and technical steps of transformation processes, which do not have a strict separation in traditional ETL approaches. Such an approach would discretize the operations to extract data from source electronic health record systems, alignment of the source, and target models on the semantic level and the operations to populate target common data repositories. Approach: In order to separate the activities that are required to transform heterogeneous data sources to a target CDM, we introduce a semantic transformation approach composed of three steps: (1) transformation of source datasets to Resource Description Framework (RDF) format, (2) application of semantic conversion rules to get the data as instances of ontological model of the target CDM, and (3) population of repositories, which comply with the specifications of the CDM, by processing the RDF instances from step 2. The proposed approach has been implemented on real healthcare settings where Observational Medical Outcomes Partnership (OMOP) CDM has been chosen as the common data model and a comprehensive comparative analysis between the native and transformed data has been conducted. Results: Health records of ~1 million patients have been successfully transformed to an OMOP CDM based database from the source database. Descriptive statistics obtained from the source and target databases present analogous and consistent results. Discussion and Conclusion: Our method goes beyond the traditional ETL approaches by being more declarative and rigorous. Declarative because the use of RDF based mapping rules makes each mapping more transparent and understandable to humans while retaining logic-based computability. Rigorous because the mappings would be based on computer readable semantics which are amenable to validation through logic-based inference methods.

An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies.

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information.

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies.

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.

Adverse drug event notification on a semantic interoperability framework.

Adverse drug events (ADEs) are common, costly and one of the most important issues in contemporary pharmacotherapy. Current drug safety surveillance methods are largely based on spontaneous reports. However, this is known to be rather ineffective. There is a lack of automated systems checking potential ADEs on routine data captured in electronic health records (EHRs); present systems are usually built directly on top of specific clinical information systems through proprietary interfaces. In the context of the European project "SALUS", we aim to provide an infrastructure as well as a tool-set for accessing and analyzing clinical patient data of heterogeneous clinical information systems utilizing standard methods. This paper focuses on two components of the SALUS architecture: The "Semantic Interoperability Layer" (SIL) enables an access to disparate EHR sources in order to provide the patient data in a common data model for ADE detection within the "ADE Detection and Notification Tool" (ANT). The SIL in combination with the ANT can be used in different clinical environments to increase ADE detection and reporting rates. Thus, our approach promises a profound impact in the domain of pharmacovigilance.