FoPraNet-BW: An Infrastructure for Clinical Studies in Practice-Based Research Networks in the German Health System.

General practice-based research networks have become an integral tool to gain medical knowledge from primary care in many countries. For this purpose, a scalable IT-infrastructure is presented considering the limiting peculiarities in the German health system and enabling GPs to participate in clinical studies based on their patient population. The infrastructure consists of a central study management server and local clients for each practice. It adopts to the currently limited digital connectivity of GP practices, data protection regulations for clinical data and the needs of the medical staff to manage a clinical study. The infrastructure is in production at the four university hospitals in the state of Baden-Württemberg. Until now three clinical studies with over 70 GPs and 350 Participants are successfully conducted or have been finished. Further clinical studies are in the planning stages.

DESAM-ForNet Portal: A Novel Infrastructure to Integrate Distributed Information from Practice-Based Research Networks in the German Healthcare System.

Currently the German healthcare system does not have a generic structure to answer research questions in primary care through clinical studies. The DESAM-ForNet initiative was founded as an association of German Practice-Based Research Networks (PBRN), to propose an appropriate and feasible solution. Aim is the integration of distributed, consensual information from practices into a single point of contact. To this end, a consensus-based concept for a digital infrastructure was developed in cooperation with all partners involved. Based on a joint requirements analysis the new concept integrates the federal structure of the German health system and the existing research structures.

Implementing Remote Patient Monitoring for Patients During Systemic Cancer Therapy.

Mobile monitoring of outpatients during cancer therapy becomes possible through technological advancements. This study leveraged a new remote patient monitoring app for in-between systemic therapy sessions. Patients' evaluation showed that the handling is feasible. Clinical implementation must consider an adaptive development cycle for reliable operations.

TELEDerm: Implementing store-and-forward teledermatology consultations in general practice: Results of a cluster randomized trial.

BACKGROUND: Although teledermatology has been proven internationally to be an effective and safe addition to the care of patients in primary care, there are few pilot projects implementing teledermatology in routine outpatient care in Germany. The aim of this cluster randomized controlled trial was to evaluate whether referrals to dermatologists are reduced by implementing a store-and-forward teleconsultation system in general practitioner practices. METHODS: Eight counties were cluster randomized to the intervention and control conditions. During the 1-year intervention period between July 2018 and June 2019, 46 general practitioner practices in the 4 intervention counties implemented a store-and-forward teledermatology system with Patient Data Management System interoperability. It allowed practice teams to initiate teleconsultations for patients with dermatologic complaints. In the four control counties, treatment as usual was performed. As primary outcome, number of referrals was calculated from routine health care data. Poisson regression was used to compare referral rates between the intervention practices and 342 control practices. RESULTS: The primary analysis revealed no significant difference in referral rates (relative risk = 1.02; 95% confidence interval = 0.911-1.141; p = .74). Secondary analyses accounting for sociodemographic and practice characteristics but omitting county pairing resulted in significant differences of referral rates between intervention practices and control practices. Matched county pair, general practitioner age, patient age, and patient sex distribution in the practices were significantly related to referral rates. CONCLUSIONS: While a store-and-forward teleconsultation system was successfully implemented in the German primary health care setting, the intervention's effect was superimposed by regional factors. Such regional factors should be considered in future teledermatology research.

Improving cooperation between general practitioners and dermatologists via telemedicine: study protocol of the cluster-randomized controlled TeleDerm study.

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. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00012944 . Registered prospectively on 31 August 2017.

Design, Implementation and Operation of a Reading Center Platform for Clinical Studies.

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.

A generic concept for the implementation of medical image retrieval systems.

This paper presents a technical framework to support the development and installation of system for content-based image retrieval in medical applications (IRMA). A strict separation of feature extraction, feature storage, feature comparison, and the user interfaces is suggested. This allows to reuse implemented components in different retrieval algorithms, which improves software quality, shortens the development cycle for applications, and allows to introduce standardized end-user interfaces. Based on the proposed framework, the IRMA engine has been established, which is currently used to evaluate content-based retrieval methods on a collection of 20,000 medical and 135,000 non-medical images.

A generic concept for the implementation of medical image retrieval systems.

This work presents mechanisms to support the development and installation of content-based image retrieval in medical applications (IRMA). A strict separation of feature extraction, feature storage, feature comparison, and the user interfaces is suggested. The concept and implementation of a system following these guidelines is described. The system allows to reuse implemented components in different retrieval algorithms, which improves software quality, shortens the development cycle for applications, and allows to establish standardized end-user interfaces.

IRMA--content-based image retrieval in medical applications.

The impact of content-based access to medical images is frequently reported but existing systems are designed for only a particular modality or context of diagnosis. Contrarily, our concept of image retrieval in medical applications (IRMA) aims at a general structure for semantic content analysis that is suitable for numerous applications in case-based reasoning or evidence-based medicine. Within IRMA, stepwise processing results in six layers of information modeling (raw data layer, registered data layer, feature layer, scheme layer, object layer, knowledge layer) incorporating medical expert knowledge. At the scheme layer, medical images are represented by a hierarchical structure of ellipses (blobs) describing image regions. Hence, image retrieval transforms to graph matching. The multilayer processing is implemented using a distributed system designed with only three core elements. The central database holds program sources, process-ing schemes, images, features, and blob trees; the scheduler balances distributed computing by addressing daemons running on all connected workstations; and the web server provides graphical user interfaces for data entry and retrieval..