HIS modelling and simulation based cost-benefit analysis of a telemedical system for closed-loop diabetes therapy.

OBJECTIVES: INCA (Intelligent Control Assistant for Diabetes) is an EU funded project aimed at improving diabetes therapy by creating a personal closed-loop system interacting with telemedical remote control. This study aims at identifying and applying suitable methods for a cost-benefit analysis from the perspective of the payor for health services. METHODS: For cost analysis MOSAIK-M was used, a method and tool for health information systems analysis and design. Two MOSAIK-M models were created describing conventional insulin pump based diabetes care (CSII), and INCA based diabetes care. Both models were parameterized with costs and simulated to determine yearly costs of diabetes management and treatment for a patient with no diabetes related complications. Probability of developing complications and their duration were determined based on the Archimedes model. It was parameterized with results of a clinical study concerning HbA1c-value changes using the INCA system compared with conventional CSII. The simulation results in form of years of disease within a 30-year time frame were multiplied with corresponding treatment costs. RESULTS: Yearly costs of conventional insulin CSII for a diabetes type 1 patient are euro 5908 (German health care system). Using INCA based on the clinical study setting would raise yearly costs by euro 2233. 24% of the INCA costs are generated by the continuous blood glucose measurement device, 5% by IT devices and services. Considering also diabetes related complications in a 30-year time frame and HbA1c value reductions from 7.9 and 7.6% (conventional CSII) to 7.5 and 7.3% (INCA) reduces the additional costs of INCA to euro 2102 and euro 2162. CONCLUSIONS: The approach produces an estimation of a lower bound for cost savings concerning the treatment of diabetes related complications in a 30-year time frame. These savings alone do not prove cost efficiency of the INCA approach. Further work is needed to improve the approximation and to include indirect and intangible costs.

An e-consent-based shared EHR system architecture for integrated healthcare networks.

OBJECTIVES: Virtual integration of distributed patient data promises advantages over a consolidated health record, but raises questions mainly about practicability and authorization concepts. Our work aims on specification and development of a virtual shared health record architecture using a patient-centred integration and authorization model. METHODS: A literature survey summarizes considerations of current architectural approaches. Complemented by a methodical analysis in two regional settings, a formal architecture model was specified and implemented. RESULTS: Results presented in this paper are a survey of architectural approaches for shared health records and an architecture model for a virtual shared EHR, which combines a patient-centred integration policy with provider-oriented document management. An electronic consent system assures, that access to the shared record remains under control of the patient. A corresponding system prototype has been developed and is currently being introduced and evaluated in a regional setting. CONCLUSION: The proposed architecture is capable of partly replacing message-based communications. Operating highly available provider repositories for the virtual shared EHR requires advanced technology and probably means additional costs for care providers. Acceptance of the proposed architecture depends on transparently embedding document validation and digital signature into the work processes. The paradigm shift from paper-based messaging to a "pull model" needs further evaluation.

Simulation based cost-benefit analysis of a telemedical system for closed-loop insulin pump therapy of diabetes.

BACKGROUND: INCA (Intelligent Control Assistant for Diabetes) is a project funded by the EU with the objective to improve diabetes therapy by creating a personal closed loop system interacting with telemedical remote control. Cost-benefit analyses of such systems are needed to decide on the introduction of telemedical systems such as the INCA system to routine care. OBJECTIVE: To identify and apply suitable methods for a cost-benefit analysis from the perspective of the payor for health services (i.e. a health insurance company). METHODS: For the cost analysis MOSAIK-M was used, a method and tool that supports health information systems analysis and design. Two MOSAIK-M models were created during the INCA project. Both, the "As is"-model of conventional insulin pump based diabetes care, and the "To be"-model of the INCA system were parameterised with cost values. With both models a period of one year was simulated to determine the yearly costs of diabetes management and treatment for a patient who does not suffer from diabetes related complications yet. The HbA1c-value was chosen as effectiveness parameter for diabetes therapy. To determine the probability of developing complications and their probable duration the Archimedes-Model was used. It was parameterised with selected HbA1c-values anticipating the effect of INCA. The simulation results in form of years of disease within a 30-years time frame were multiplied with corresponding treatment costs from the KoDiM study. RESULTS: The yearly costs of conventional insulin pump treatment for a 19 year old diabetes type 1 patient with no complications are 5,907 euro (German health care system). Using the INCA system would raise the yearly costs by 7,348 euro. Almost all (98.53%) of the additional costs are generated by the continuous blood glucose measurement device. HbA1c-decreases from 7% (conventional treatment) to 6.5%, 6%, and 5.8 % would produce yearly savings (benefit) concerning the treatment of complications of 100.50 euro, 189.20 euro and 221.82 euro. CONCLUSIONS: The selected approach produces an estimation of a lower bound for cost savings. Further work is needed to improve the approximation and to include indirect and intangible costs. The INCA approach would be cost efficient from the chosen perspective, only if the costs of system operation were notably lowered.

An eConsent-based System Architecture Supporting Cooperation in Integrated Healthcare Networks.

OBJECTIVES: The economical need for efficient healthcare leads to cooperative shared care networks. A virtual electronic health record is required, which integrates patient related information but reflects the distributed infrastructure and restricts access only to those health professionals involved into the care process. Our work aims on specification and development of a system architecture fulfilling these requirements to be used in concrete regional pilot studies. METHODS: Methodical analysis and specification have been performed in a healthcare network using the formal method and modelling tool MOSAIK-M. The complexity of the application field was reduced by focusing on the scenario of thyroid disease care, which still includes various interdisciplinary cooperation. RESULTS: Result is an architecture for a secure distributed electronic health record for integrated care networks, specified in terms of a MOSAIK-M-based system model. The architecture proposes business processes, application services, and a sophisticated security concept, providing a platform for distributed document-based, patient-centred, and secure cooperation. A corresponding system prototype has been developed for pilot studies, using advanced application server technologies. The architecture combines a consolidated patient-centred document management with a decentralized system structure without needs for replication management. An eConsent-based approach assures, that access to the distributed health record remains under control of the patient. CONCLUSION: The proposed architecture replaces message-based communication approaches, because it implements a virtual health record providing complete and current information. Acceptance of the new communication services depends on compatibility with the clinical routine. Unique and cross-institutional identification of a patient is also a challenge, but will loose significance with establishing common patient cards.