Access and validation

Governance details

Documents or webpages that describe the overall governance of the data source and processes and procedures for data capture and management, data quality check and validation results (governing data access or utilisation for research purposes).
Protocol approval is required for use of the data for research purposes, contact GIPAM for more information.
Data Resource Profile: The Multiple Sclerosis Documentation System 3D and AOK PLUS Linked Database (MSDS-AOK PLUS)

Biospecimen access

Are biospecimens available in the data source (e.g., tissue samples)?

No

Access to subject details

Can individual patients/practitioners/practices included in the data source be contacted?

No

Description of data collection

Using the AOK PLUS sickness fund and the Multiple Sclerosis Documentation System MSDS3D from the Center of Clinical Neuroscience (ZKN) in Dresden, Germany, a linked MS-specific database was developed (MSDS-AOK PLUS). Patients treated at ZKN and insured by AOK PLUS were recruited and asked for informed consent. For linkage, insurance IDs were mapped to registry IDs. After the deletion of insurance IDs, an anonymized dataset was provided to a university-affiliated institute, IPAM e.V., for further research applications. The dataset combines a complete record of patient diagnoses, treatment, healthcare resource use, and costs (AOK PLUS) with detailed clinical parameters, including functional performance and patient-reported outcomes (MSDS3D).
Event triggering registration

Event triggering registration of a person in the data source

Insurance coverage start
Practice registration

Event triggering de-registration of a person in the data source

Insurance coverage end
Loss to follow up
Other
Practice deregistration

Event triggering de-registration of a person in the data source, other

Withdrawal of informed consent

Event triggering creation of a record in the data source

Any encounter with the medical system that results in a claim during while the patient receives health insurance from AOK Plus triggers the creation of a record in the administrative claims data. Assuming the patient provides informed consent, a visit at the Center of Clinical Neuroscience (ZKN) in Dresden, Germany triggers the creation of a record in the clinical data.
Data source linkage

Linkage

Is the data source described created by the linkage of other data sources (prelinked data source) and/or can the data source be linked to other data source on an ad-hoc basis?

Yes

Linkage description, pre-linked

Administrative claims from the AOK PLUS sickness fund are linked to clinical data from the Center of Clinical Neuroscience, Dresden (ZKN) Multiple Sclerosis Documentation System (MSDS-3D). Access requires protocol approval from the data owner.

Linkage description, possible linkage

If required, the data could be linked to information extracted from patient charts at other medical offices.
Data management specifications that apply for the data source

Data source refresh

Quarterly

Informed consent for use of data for research

Other

Informed consent, other

Patients treated at ZKN and insured by AOK Plus already provided informed consent for their data to be used for research purposes.

Possibility of data validation

Can validity of the data in the data source be verified (e.g., access to original medical charts)?

Yes

Data source preservation

Are records preserved in the data source indefinitely?

Yes

Approval for publication

Is an approval needed for publishing the results of a study using the data source?

Yes
Common Data Model (CDM) mapping

CDM mapping

Has the data source been converted (ETL-ed) to a common data model?

No