The Experience of Physicians in Pharmacogenomic Clinical Decision Support Within Eight German University Hospitals

Hinderer, Marc; Boeker, Martin; Wagner, Sebastian; Binder, Harald; Ückert, Frank; Newe, Stephanie; Hülsemann, J. L.; Neumaier, Michael; Schade‐Brittinger, Carmen; Acker, Till; Prokosch, Hans‐Ulrich; Sedlmayr, Brita

doi:10.2217/pgs-2017-0027

Cited by 14 publications

(13 citation statements)

References 43 publications

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“… # Identified design requirements Barriers and challenges Studies R1 Security and privacy • Secure storage of the PGx data • Unauthorised access to PGx data • Preserving patient privacy and confidentiality when outsourceing data [ 29 – 47 ] R2 Accessibility • Limited data sharing • Time lag to receive the results • Lack of infrastructure and standardised processes for storing, accessing PGx data •And reporting results efficiently • Communicate results to patients [ 29 , 40 , 43 , 44 , 48 – 59 ] R2 Interoperability • Difficulties of integrating PGx data with the EHR • Low degree of connectivity between different PGx resources • Lack of a link between several software-systems • Integrating PGx testing into existing services [ 29 , 43 , 45 – 48 , 50 , 52 – 55 , 58 – 61 ] R4 Traceability • Lack of transparency • Uncertainty of about the appropriate level of oversight • Lack of patient engagement in care decision making • Future use of patient PGx data • Who could have access to PGx data? [ 42 , 44 , 59 , 61 , 62 ] R5 Legal Compliance • Autonomy and informed consent issues • Risk of discrimination • Misuse of patient data • Legal uncertainty • Lack of accountability regarding PGx data ownership [ 30 , 33 , 35 – 38 , 50 , 61 , …”

Section: Resultsmentioning

confidence: 99%

A blockchain-based framework to support pharmacogenetic data sharing

et al. 2022

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The successful implementation of pharmacogenetics (PGx) into clinical practice requires patient genomic data to be shared between stakeholders in multiple settings. This creates a number of barriers to widespread adoption of PGx, including privacy concerns related to the storage and movement of identifiable genomic data. Informatic solutions that support secure and equitable data access for genomic data are therefore important to PGx. Here we propose a methodology that uses smart contracts implemented on a blockchain-based framework, PGxChain, to address this issue. The design requirements for PGxChain were identified through a systematic literature review, identifying technical challenges and barriers impeding the clinical implementation of pharmacogenomics. These requirements included security and privacy, accessibility, interoperability, traceability and legal compliance. A proof-of-concept implementation based on Ethereum was then developed that met the design requirements. PGxChain’s performance was examined using Hyperledger Caliper for latency, throughput, and transaction success rate. The findings clearly indicate that blockchain technology offers considerable potential to advance pharmacogenetic data sharing, particularly with regard to PGx data security and privacy, large-scale accessibility of PGx data, PGx data interoperability between multiple health care providers and compliance with data-sharing laws and regulations.

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Section: Resultsmentioning

confidence: 99%

A blockchain-based framework to support pharmacogenetic data sharing

et al. 2022

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“…To address this issue, e.g., the MIRACUM consortium (Medical Informatics in Research and Care in University Medicine) has established a solution which focuses on the provision of IT and bioinformatics support for translation and visualization of data analyzed in MTBs. As part of this use case, they work on a generic, open-source framework that supports the analysis, interpretation and visualization of both clinical and *omics data [20]. Moreover, the HiGHmed consortium of the German Medical Informatics Initiative is developing a common cross-institutional reference architecture based on relevant standards such as IHE, openEHR and FHIR.…”

Section: B Tumor Boardsmentioning

confidence: 99%

Towards Distributed Healthcare Systems – Virtual Data Pooling Between Cancer Registries as Backbone of Care and Research

Appenzeller

Bartholomäus

Breitschwerdt

et al. 2021

2021 IEEE/ACS 18th International Conference on Computer Systems and Applications (AICCSA)

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Cancer registries offer a systematic approach for the collection, storage, and management of data on persons with cancer and related diseases. Much hope in research and healthcare in general is depending on such register-based analyses in order to comprehensively consider the features of a highly diverse population. Next to the data collection the cancer registries are responsible for data protection. To fulfill legal regulations, access to data has to be controlled in a strict way leading to sometimes bureaucratic and slow processes. The situation is especially complicated in Germany, since cancer data is distributed over numerous federal cancer registries. A research team has to negotiate a separate contract with each cancer registry, if a nationwide data evaluation has to be performed.In a joint effort of cancer registries, technical, medical, and economical experts we propose a different solution for cooperative data processing. Our approach aims for combining data in a virtual pool based on the selection criteria of individual requests from researchers. To achieve our goal, we adapt the Fraunhofer Medical Data Space as enabling technology. The architecture we propose will allow us to pool data of multiple partners regulated by data access policies. In doing so, each of the data sources can introduce its own rules and specifications on how data is used. Additionally, we add a digital consent management that will allow individual patients to decide how their data is used. Finally, we show the high potential of the cooperative analysis of distributed cancer data supported by the proposed solution in our approach.

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“…In the MIRACUM conceptual phase, we have already performed an in-depth analysis of the clinician experiences and attitudes towards genome-guided therapy support [ 46 ] as well as analysis of activities, processes and IT solutions at all MIRACUM sites [ 47 ] to gain a comprehensive understanding of the requirements and the processes involved in MTBs across these institutions. Further, a comprehensive literature review was performed to learn from experiences of previous research towards the integration of pharmacogenomics testing and molecular-guided therapy decisions in clinical care environments [ 48 ].…”

Section: Use Casesmentioning

confidence: 99%

MIRACUM: Medical Informatics in Research and Care in University Medicine

Prokosch¹,

Acker²,

Bernarding³

et al. 2018

Methods Inf Med

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109

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Summary Introduction: This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. Similar to other large international data sharing networks (e.g. OHDSI, PCORnet, eMerge, RD-Connect) MIRACUM is a consortium of academic and hospital partners as well as one industrial partner in eight German cities which have joined forces to create interoperable data integration centres (DIC) and make data within those DIC available for innovative new IT solutions in patient care and medical research. Objectives: Sharing data shall be supported by common interoperable tools and services, in order to leverage the power of such data for biomedical discovery and moving towards a learning health system. This paper aims at illustrating the major building blocks and concepts which MIRACUM will apply to achieve this goal. Governance and Policies: Besides establishing an efficient governance structure within the MIRACUM consortium (based on the steering board, a central administrative office, the general MIRACUM assembly, six working groups and the international scientific advisory board), defining DIC governance rules and data sharing policies, as well as establishing (at each MIRACUM DIC site, but also for MIRACUM in total) use and access committees are major building blocks for the success of such an endeavor. Architectural Framework and Methodology: The MIRACUM DIC architecture builds on a comprehensive ecosystem of reusable open source tools (MIRACOLIX), which are linkable and interoperable amongst each other, but also with the existing software environment of the MIRACUM hospitals. Efficient data protection measures, considering patient consent, data harmonization and a MIRACUM metadata repository as well as a common data model are major pillars of this framework. The methodological approach for shared data usage relies on a federated querying and analysis concept. Use Cases: MIRACUM aims at proving the value of their DIC with three use cases: IT support for patient recruitment into clinical trials, the development and routine care implementation of a clinico-molecular predictive knowledge tool, and molecular-guided therapy recommendations in molecular tumor boards. Results: Based on the MIRACUM DIC release in the nine months conceptual phase first large scale analysis for stroke and colorectal cancer cohorts have been pursued. Discussion: Beyond all technological challenges successfully applying the MIRACUM tools for the enrichment of our knowledge about diagnostic and therapeutic concepts, thus supporting the concept of a Learning Health System will be crucial for the acceptance and sustainability in the medical community and the MIRACUM university hospitals.

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The Experience of Physicians in Pharmacogenomic Clinical Decision Support Within Eight German University Hospitals

Abstract: Physicians in German hospitals require additional education of both genetics and pharmacogenomics. They need to be provided with access to relevant pharmacogenomic CDSS.

Cited by 14 publications

References 43 publications

A blockchain-based framework to support pharmacogenetic data sharing

A blockchain-based framework to support pharmacogenetic data sharing

Towards Distributed Healthcare Systems – Virtual Data Pooling Between Cancer Registries as Backbone of Care and Research

MIRACUM: Medical Informatics in Research and Care in University Medicine

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