Ann-Kristin Kock-Schoppenhauer’s research while affiliated with University of Lübeck and other places

Background In Germany, around 2.250 children and adolescents are diagnosed with cancer each year. Despite generally positive long-term survival rates, many patients must cope with late effects of the disease and its treatment. This highlights the need for a well-structured, long-term approach addressing both physical and mental health issues. Currently, the German healthcare system lacks such comprehensive structures. Our study aims to evaluate the effectiveness of a structured, multidisciplinary long-term approach compared to conventional “treatment as usual” (TAU). Methods A prospective, multicenter study with ten pediatric university clinics in Germany will be conducted. The cluster-randomization takes place at the clinic level. Children and adolescents who completed their cancer treatment at least five years ago and their parents will be eligible to participate. While the control group (CG) receives TAU, the intervention group (IG) participates in a structured program. This program includes risk-based medical treatment and psychosocial interventions tailored to each patient’s individual needs within a two-month timeframe. The primary outcome is the improvement of self-efficacy. Secondary outcomes are satisfaction with health care, improvement of health-related quality of life (HRQoL), reduction of mental health problems, and improvement of transition readiness. Discussion This approach has the potential to optimize the health care for individuals who survived cancer during childhood or adolescence. It addresses the challenges of overuse, underuse, and misuse of health care resources. By considering both medical and psychosocial factors and promoting increased self-efficacy, independent from parental involvement, it may facilitate a smoother transition to adult medicine and enhance adherence to lifelong aftercare. If proven successful, this approach will contribute to the integration of multidisciplinary strategies into standard healthcare practice. Trial registration German Clinical Trials Register DRKS00029269. Registered on December 23, 2022.

Introduction: The reuse of clinical data from clinical routine is a topic of research within the field of medical informatics under the term secondary use. In order to ensure the correct use and interpretation of data, there is a need for context information of data collection and a general understanding of the data. The use of metadata as an effective method of defining and maintaining context is well-established, particularly in the field of clinical trials. The objectives of this paper is to examine a method for integrating routine clinical data using metadata. Methods: To this end, clinical forms extracted from a hospital information system will be converted into the FHIR format. A particular focus is placed on the consistent use of a metadata repository (MDR). Results: A metadata-based approach using an MDR system was developed to simplify data integration and mapping of structured forms into FHIR resources, while offering many advantages in terms of flexibility and data quality. This facilitated the management and configuration of logic and definitions in one place, enabling the reusability and secondary use of data. Discussion: This work allows the transfer of data elements without loss of detail and simplifies integration with target formats. The approach is adaptable for other ETL processes and eliminates the need for formatting concerns in the target profile.

Introduction: Conducting clinical studies is an integral part of the clinical research repertoire of university hospitals. A wealth of organizational competences must always be available in a central location and in an up-to-date form for appropriate administration. Information such as the number of ongoing studies, and the number of enrolled participants is required for tasks related to e.g. sponsor quality management and KPIs. A registry for clinical trials can answer these questions and enhance the exchange of information. Methods: Requirements for an in-house registry for clinical trials were defined in a multidisciplinary task force. The requirements included interfaces and key abilities to create customized reports to fulfill the obligation to provide evidence. Results: The study registry is productive since May 2020 and internal interfaces have been implemented to ensure consistency between systems and the documented studies. Manually recorded data is enhanced by interfaces to primary registers. The comprehensive data set in the study register enables the creation of individual queries at any time for a variety of questions. Discussion: The UKSH study register has already demonstrated its usefulness in various applications and several projects. The extensive data set and the modular realization allows many current and future requirements to be met.

This paper explores the challenges and lessons learned during the mapping of HL7 v2 messages structured using custom schema to openEHR for the Medical Data Integration Center (MeDIC) of the University Hospital, Schleswig-Holstein (UKSH). Missing timestamps in observations, missing units of measurement, inconsistencies in decimal separators and unexpected datatypes were identified as critical inconsistencies in this process. These anomalies highlight the difficulty of automating the transformation of HL7 v2 data to any standard, particularly openEHR, using off-the-shelf tools. Addressing these anomalies is crucial for enhancing data interoperability, supporting evidence-based research, and optimizing clinical decision-making. Implementing proper data quality measures and governance will unlock the potential of integrated clinical data, empowering clinicians and researchers and fostering a robust healthcare ecosystem.

The integration of tumor-related diagnosis and therapy data is a key factor for cancer-related collaborative projects and research projects on-site. The Medical Data Integration Center (MeDIC) of the University Hospital Schleswig-Holstein, resulting from the Medical Informatics Initiative and Network University Medicine in Germany, has agreed on an openEHR-based data management based on a centralized repository with harmonized annotated data. Consequently, the oncological data should be integrated into the MeDIC to interconnect the information and thus gain added value. A uniform national data set for tumor-related reports is already defined for the cancer registries. Therefore, this work aims to transform the national oncological basis data set for tumor documentation (oBDS) so that it can be stored and utilized properly in the openEHR repository of the MeDIC. In a previous work openEHR templates representing the oncological basis data set were modeled. These templates were used to implement a processing pipeline including a metadata repository, which defines the mappings between the elements, a FHIR terminology service for annotation and validation, resulting in a tool to automatically build openEHR compositions from oBDS data. The prototype proved the feasibility of the referred mapping, integration into the MeDIC is straightforward and the architecture introduced is adaptable to future needs by design.

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.

Importance There is a lack of trials examining the effect of counseling interventions for child, adolescent, and younger adult (CAYA) cancer survivors. Objective To assess lifestyle habits and the psychosocial situation of CAYAs to determine the efficacy of needs-based interventions in the CARE for CAYA program (CFC-P). Design, Setting, and Participants The CFC-P was conducted as a multicenter program in 14 German outpatient clinics, mainly university cancer centers. Recruitment began January 1, 2018; a randomized clinical trial was conducted until July 15, 2019; and intervention was continued as a longitudinal cohort study until March 31, 2021. Data preparation was conducted from April 1, 2021, and analysis was conducted from August 14, 2021, to May 31, 2022. Herein, predefined confirmatory analyses pertain to the RCT and descriptive results relate to the overall longitudinal study. Data analysis was based on the full analysis set, which is as close as possible to the intention-to-treat principle. Intervention A comprehensive assessment determined needs in physical activity, nutrition and psychooncology. Those with high needs participated in 1 to 3 modules. In the RCT, the IG received 5 counseling sessions plus newsletters, while the control group CG received 1 counseling session. Main Outcomes and Measures The primary outcome was the change in the rate of CAYAs with high needs at 52 weeks. Secondary outcomes were feasibility, modular-specific end points, satisfaction, quality of life, and fatigue. Results Of 1502 approached CAYAs aged 15 to 39 years, 692 declined participation. Another 22 CAYAs were excluded, resulting in 788 participants. In the randomized clinical trial, 359 CAYAs were randomized (intervention group [IG], n = 183; control group [CG], n = 176), and 274 were followed up. In the RCT, the median age was 25.0 (IQR, 19.9-32.2) years; 226 were female (63.0%) and 133 male (37.0%). After 52 weeks, 120 CAYAs (87.0%) in the IG and 115 (86.5%) in the CG still had a high need in at least 1 module (odds ratio, 1.04; 95% CI, 0.51-2.11; P = .91). Both groups reported reduced needs, improved quality of life, reduced fatigue, and high satisfaction with the CFC-P. Conclusions and Relevance In this randomized clinical trial, the implementation of a lifestyle program in this cohort was deemed necessary, despite not meeting the primary outcome. The interventions did not alter the rate of high needs. The results may provide guidance for the development of multimodal interventions in the follow-up care of CAYAs. Trial Registration German Clinical Trial Register: DRKS00012504

BACKGROUND Reaching a significant amount of interoperability between proprietary healthcare systems is an ubiquitous task in medical informatics, where communication servers are traditionally used for referring and transforming data from source to target systems. The Mirth Connect Server, which is an open-source communication server, offers in addition to the exchange functionality, also functions for the simultaneous manipulation of data. In recent times, the standard Fast Healthcare Interoperability Resources (FHIR) is becoming more and more prevalent in the German healthcare system. This standard specifies its own standardized mechanisms for transforming data structures in the form of StructureMaps and the FHIR Mapping Language. OBJECTIVE In this study, a generic approach will be developed, which allows to apply these formalized mapping rules defined by the FHIR Mapping Language in an exchangeable manner. A transformation engine is required to execute the mapping rules. METHODS FHIR natively defines resources to support conversion of instance data, the FHIR resource StructureMap. This resource encodes all information required to transform data from a source system into a target system. In our approach, this information is defined in an implementation-independent manner using the FHIR Mapping Language. Once the mapping has been defined, executable Mirth channels are automatically generated from the resources containing the mapping in form of JavaScript. These channels can be deployed to the Mirth Connect Server. RESULTS The resulting tool is called FML2Mirth, a Java-based transformer that derives Mirth channels from a given mapping based on the underlying StructureMaps that contain the detailed rules. The implementation of the translate functionality is guaranteed by the integration of a terminology server and to achieve conformity with existing profiles, validation via the FHIR validator is built in. The system is evaluated for its practical use by transforming LDTv.2 laboratory results into MIO lab reports according to NASHIP specifications and into to the HL7 Europe Laboratory Report. It is shown that the system can generate complex structures, but LDTv.2 lacks some information to fully comply with the specification. CONCLUSIONS The tool for the auto-generation of Mirth channels was successfully presented. Initial tests have shown that it is feasible to use the complex structures of the mapping language in combination with a terminology server to transform instance data. Although the Mirth Server and FHIR are well established in the field of medical informatics, the combination offers space for more research, especially with regard to the FHIR Mapping Language. At the same time, it can be stated that the Mapping Language still has implementation short comings that can be compensated by Mirth Connect as a base technology. CLINICALTRIAL N/A