Person module

The core dataset (CDS) module Person contains basic information about a person in the context of the healthcare system. The specification defines the data models that allow the recording of information on patients or probands within the MII using the HL7-FHIR IT standard. This includes attributes for identification, i.e. unique IDs such as health insurance numbers, organisation-internal patient identifiers from the local identity management of the sites or identifiers for test subjects within studies. Furthermore, demographic information such as name, date of birth, gender and address are included. These attributes can be used for external record linkage and to identify and link patient data from different sources. This can be relevant for personalised, cross-institutional analyses. Demographic information enables descriptive analyses by region, gender and age. In addition, the CDS-module “Person” contains information on vital status and, if applicable, the cause of death coded with ICD-10. The contents of other core data set modules refer to the Person module.

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Case module

The Case module records the contacts of patients in healthcare facilities. Contacts include information on patient visits along the entire treatment process, such as inpatient stays, outpatient visits and virtual, telemedicine contacts. Inpatient contacts can be assigned to a hospital, within a hospital to corresponding wards and departments, and below that to an operating theatre (OR) or specific functional departments for carrying out diagnostic or therapeutic measures. As part of this, the specialist discipline or department can also be documented using the specialist department code of the German Hospital Federation (DKG). The Case module also records the times and periods in which a contact took place, who was involved, which main or secondary diagnoses were relevant during a contact and which procedures were carried out. The Case module refers to the modules Person, Diagnosis and Procedure of the core dataset in order to link the clinical data of those core dataset modules to the treatment case.

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Consent module

The basis for the provision of patient data in the MII for secondary data use is the MII Broad Consent. This is a standardised informed consent form for the scientific reuse of patient data collected in the context of medical care. The Broad Consent was developed by the MII's Consent Working Group and agreed with the responsible data protection officers.

This technical implementation of the MII Broad Consent is based on the generic HL7 specifications and has been adapted to the requirements of the MII.

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Diagnosis module

The Diagnosis module describes the diagnoses of patients in the healthcare system and the characteristics of these diagnoses. The use of various terminology systems for coding diagnosis information is supported. This includes the official classification for coding diagnoses in Germany ICD-10-GM as well as the use of the comprehensive healthcare terminology SNOMED CT for semantic interoperability in the electronic exchange of diagnostic data. Furthermore, the module contains specifications for the coding of rare diseases using Orpha codes and the coding of tumour diseases using the International Classification of Diseases for Oncology ICD-O-3. The terminology systems for diagnoses are complemented by extensive data elements for the contextualisation of a diagnosis, such as the determination of the affected body part of a disease, the times and periods of occurrence or subsidence of the disease-specific symptoms as well as the determination and documentation date of a diagnosis. A diagnosis is assigned to a patient via a reference to the Person module.

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Procedure module

The Procedure module describes treatments and measures that patients have undergone during healthcare. The operation and procedure code (OPS) is used to code operations and medical procedures in inpatient care, outpatient surgery and selected drug therapies. The procedure codes from the comprehensive SNOMED CT terminology can also be used for coding. In addition, the module contains data elements to map structured information on anatomical target body sites of procedures, to record the intention to perform and also to record the date of performance and documentation. The connection with the question of who a procedure was performed on is realised by reference to the Person module.

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Laboratory test results module

Laboratory tests are performed for almost all hospital in-patients. The test results are usually stored centrally. The following items of information for each patient and case should be transferred to the corresponding data integration centre (DIC) each time a laboratory test is conducted:

  • The test/analysis designation, with unique test identifier (using the LOINC standard coding system)
  • The date the test was conducted
  • The result (measured value) with standardised unit of measurement
  • Interpretation: indication whether result represents a pathological value (recommended)
  • Type of scale (optional)
  • Reference range (recommended)
  • Source laboratory (optional)

It is also possible to model other clinical tests, microbiological tests and vital signs that go beyond the scope of conventional clinical/chemical and haematological laboratory data.

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Medication module

The Medication module enables the documentation of medication orders and administration as well as medication plans. Prescribing and administering pharmaceuticals are core processes of routine healthcare and take place at all MII sites. However, the proportion of digitally documented prescriptions and administrations varies between the sites in terms of the degree of structuring, the populations and medications covered. Medication data is of central importance for a variety of issues, for example in pharmacovigilance or as an inclusion/exclusion criterion for study collectives.

The following types of medication documentation can be distinguished:

  • Medication in hospital (mainly inpatient/partial inpatient)
  • Admission and discharge medication
  • Outpatient medication
  • Self-medication (OTC)
  • Medication in the context of clinical studies
  • Medication documentation for the nationally standardised medication plan

Medication details can range from the simple documentation of the administration of a medicinal product to the detailed, structured recording of individual doses with coding of the active ingredient, pharmaceutical form, route of administration and dose in accordance with internationally established standards.

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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 (keyword: core data set).