Microbiology module
The Microbiology module enables the documentation of the presence of microorganisms in isolates and samples using various diagnostic methods: culture, microscopy, molecular diagnostics, serology (part of immunology) and immunology. In addition, tests that can further characterise the properties of the microorganisms, such as the resistance mechanism or virulence factor, are also described. Phenotypic susceptibility tests including all methods are included as well as predictive susceptibility based on molecular diagnostics. The MRGN classification (multi-resistant gram-negative bacteria) of the Robert Koch Institute can also be represented with this model.
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Medical Research Projects module
The Medical Research Projects module describes characteristics of studies and other medical research projects, i.e. for the investigation of experimental clinical and epidemiological hypotheses through structured data collection and processing, mostly of human subjects. This version of the module supports the recording of attributes for identifying and managing a research project as well as for recording the basic characterising attributes (study register). In addition, structured inclusion and exclusion criteria can be defined, which can be used to decide, at least semi-automatically, whether an individual with their intrinsic characteristics belongs to the target population or not (feasibility).
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Pathology Findings module
The Pathology Findings module describes the general structure of a structured pathology report based on the IHE PaLM (Pathology and Laboratory Medicine) profile APSR 2.0 (Anatomic Pathology Structured Report). These pathology reports are mostly available in text form. The results of clinically requested examinations are collected and documented with a synoptic (summarising) evaluation, such as histological and cytomorphological (tissue and cell morphological) and molecular examinations. The freely formulated examination results can also be supplemented (semantically annotated) by structured coding. It is important to note that each structured code must also be readable as text, but not all text information must be coded. Furthermore, information on the sample, the examination order, image data and the reason for the examination can also be recorded.
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Molecular Genetic Report module
The Molecular Genetic Report module specifies the reporting of variants detected by sequence analysis that are present in a patient's sample material. Genetic tests provide information on causal relationships between structural variants or changes in the genome and potential diseases as well as possible therapies. In addition to the description of the sequence variants and region(s) analysed, the contents of the report may include request information such as the patient's and family members' medical histories and a reference to previously performed tests. The report may also contain information on billing codes and therapeutic and diagnostic implications derived from the variant information.
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Intensive Care Medicine module
The Intensive Care Medicine module specifies ICU data for primary and secondary use. The special nature of this data is not only in the severity of the patient's illness, but also in the fine-grained data collection in special documentation systems and the comparatively high density of fully and partially structured data. Furthermore, intensive care data is of great importance in the context of local and national pandemic management and pandemic-related research.
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Biosample Data module
The Biosample Data module describes both superordinate collections/biobanks and individual samples, including information on their collection, composition, processing and storage. Biosamples are collected, processed and stored in both clinical and population-based biobanks in order to provide high-quality samples for scientific projects. The different collections in a biobank as well as the individual samples must be described in a structured manner to facilitate the retrieval of samples and their appropriate use. Sample-specific data should include information on sample type, quantity, collection, pre-analytical processing and storage. Clinical data on the sample is explicitly not covered by this module, but should be provided via the modules intended for the respective data type.
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Contact:
Do you have any questions or suggestions regarding the further development of the core data set or individual core data set modules? Would you like to get involved in the work on the core data set?
Please contact us by email at office@medizininformatik-initiative.de (keyword: core data set).