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Using the german national medication plan for clinical studies in practice-based research networks
(2024)
The German National Medication Plan (GNMP) can be a valuable and interoperable data source for clinical studies, due to its digital specification and mandatory provisioning for chronically ill patients. Digital transfer of a patients current GNMP from the Patient Data Management System (PDMS) into electronic case report forms would avoid error prone manual data capturing. It is also essential for studies in practice-based research networks (PBRN), where data capturing must have as little impact as possible on everyday practice. The following issues are currently preventing seamless digital integration: There is no standardized interoperable export of the GNMP from PDMS. In the current form, pharmaceutical catalogs are needed to decode the contained pharmaceutical registration numbers. As accessibility to the pharmaceutical catalogs is restricted, there is no generic access to the actual information needed for study data evaluation. In order to conduct studies, feasible workarounds for these issues had to be implemented in the standard operating procedures, tools and participating GP practices. To overcome the GNMP’s current lack of digital interoperability, the proposed solution combines semi-automated data export from PDMS at the GP practice and manual database search at the study center with a semi-automated processing pipeline to balance workload between GP practices, study management and evaluation.
Model-guided Therapy and Surgical Workflow Systems are two interrelated research fields, which have been developed separately in the last years. To make full use of both technologies, it is necessary to integrate them and connect them to Hospital Information Systems. We propose a framework for integration of Model-guided Therapy in Hospital Information Systems based on the Electronic Medical Record, and a taskbased Workflow Management System, which is suitable for clinical end users. Two prototypes - one based on Business Process Modeling Language, one based on the serum-board - are presented. From the experience with these prototypes, we developed a novel personalized visualization system for Surgical Workflows and Model-guided Therapy. Key challenges for further development are automated situation detection and a common communication infrastructure.
Clinical reading centers provide expertise for consistent, centralized analysis of medical data gathered in a distributed context. Accordingly, appropriate software solutions are required for the involved communication and data management processes. In this work, an analysis of general requirements and essential architectural and software design considerations for reading center information systems is provided. The identified patterns have been applied to the implementation of the reading center platform which is currently operated at the Center of Ophthalmology of the University Hospital of Tübingen.
Being able to monitor the heart activity of patients during their daily life in a reliable, comfortable and affordable way is one main goal of the personalized medicine. Current wearable solutions lack either on the wearing comfort, the quality and type of the data provided or the price of the device. This paper shows the development of a Textile Sensor Platform (TSP) in the form of an electrocardiogram (ECG)-measuring T-shirt that is able to transmit the ECG signal to a smartphone. The development process includes the selection of the materials, the design of the textile electrodes taking into consideration their electrical characteristics and ergonomy, the integration of the electrodes on the garment and their connection with the embedded electronic part. The TSP is able to transmit a real-time streaming of the ECG-signal to an Android smartphone through Bluetooth Low Energy (BLE). Initial results show a good electrical quality in the textile electrodes and promising results in the capture and transmission of the ECG signal. This is still a working- progress and it is the result of an interdisciplinary master project between the School of Informatics and the School of Textiles & Design of the Reutlingen University.
This work is a report on practical experiences with the issue of interoperability in German practice management systems (PMSs) from an ongoing clinical trial on teledermatology, the TeleDerm project. A proprietary and established web-platform for store-and-forward telemedicine is integrated with the IT in the GPs’ offices for automatic exchange of basic patient data. Most of the 19 different PMSs included in the study sample lack support of modern health data exchange standards, therefore the relatively old but widely available German health data exchange interface “Gerätedatentransfer” (GDT) is used. Due to the lack of enforcement and regulation of the GDT standard, several obstacles to interoperability are encountered. As a partial, but reusable working solution to cope with these issues, we present a custom middleware which is used in conjunction with GDT. We describe the design, technical implementation and observed hindrances with the existing infrastructure. A discussion on health care interfacing standards and the current state of interoperability in German PMS software is given.
We present an approach for segmenting individual cells and lamellipodia in epithelial cell clusters using fully convolutional neural networks. The method will set the basis for measuring cell cluster dynamics and expansion to improve the investigation of collective cell migration phenomena. The fully learning-based front-end avoids classical feature engineering, yet the network architecture needs to be designed carefully. Our network predicts how likely each pixel belongs to one of the classes and, thus, is able to segment the image. Besides characterizing segmentation performance, we discuss how the network will be further employed.
Background: Internationally, teledermatology has proven to be a viable alternative to conventional physical referrals. Travel cost and referral times are reduced while patient safety is preserved. Especially patients from rural areas benefit from this healthcare innovation. Despite these established facts and positive experiences from EU neighboring countries like the Netherlands or the United Kingdom, Germany has not yet implemented store-and-forward teledermatology in routine care.
Methods: The TeleDerm study will implement and evaluate store-and-forward teledermatology in 50 general practitioner (GP) practices as an alternative to conventional referrals. TeleDerm aims to confirm that the possibility of store-and-forward teledermatology in GP practices is going to lead to a 15% (n = 260) reduction in referrals in the intervention arm. The study uses a cluster-randomized controlled trial design. Randomization is planned for the cluster “county”. The main observational unit is the GP practice. Poisson distribution of referrals is assumed. The evaluation of secondary outcomes like acceptance, enablers and barriers uses a mixed methods design with questionnaires and interviews.
Discussion: Due to the heterogeneity of GP practice organization, patient management software, information technology service providers, GP personal technical affinity and training, we expect several challenges in implementing teledermatology in German GP routine care. Therefore, we plan to recruit 30% more GPs than required by the power calculation. The implementation design and accompanying evaluation is expected to deliver vital insights into the specifics of implementing telemedicine in German routine care.
In this work, a web-based software architecture and framework for management and diagnosis of large amounts of medical data in an ophthalmologic reading center is proposed. Data management for multi-center studies requires merging of standing data and repeatedly gathered clinical evidence such as vital signs and raw data. If ophthalmologic questions are involved the data acquisition is often provided by non-medical staff at the point of care or a study center, whereas the medical finding is mostly provided by an ophthalmologist in a specialized reading center. The study data such as participants, cohorts and measured values are administrated at a single data center for the entire study. Since a specialized reading center maintains several studies, the medical staff must learn the different data administration for the different data center. With respect to the increasing number and sizes of clinical studies, two aspects must be considered. At first, an efficient software framework is required to support the data management, processing and diagnosis by medical experts at the reading center. In the second place, this software needs a standardized user-interface that has not to be trained/taylore /adapted for each new study. Furthermore different aspects of quality and security controls have to be included. Therefore, the objective of this work is to establish a multi purpose ophthalmologic reading center, which can be connected to different data centers via configurable data interfaces in order to treat various topics simultaneously.
