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Measuring alignment between the ADRC UDS data elements, FDA, and EHR data standards.

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Alzheimer's Disease Research Center Uniform Data Set (UDS) data shows high compatibility with Clinical Data Interchange Standards Consortium (CDISC) standards (94%) and potential for electronic health record (EHR) extraction via Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) (45%). This research supports data sharing across ADRC research, EHRs, and industry.

Keywords:
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Area of Science:

  • Biomedical Informatics
  • Health Data Standards
  • Neuroscience Research Data Management

Background:

  • Alzheimer's Disease Research Centers (ADRCs) utilize the Uniform Data Set (UDS).
  • Electronic Health Records (EHRs) commonly employ Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR).
  • Industry research often uses Clinical Data Interchange Standards Consortium (CDISC) standards.

Purpose of the Study:

  • To compare and measure the alignment between ADRC UDS, HL7 FHIR, and CDISC standards.
  • To assess the feasibility of harmonizing Alzheimer's disease research data with clinical and industry standards.
  • To identify areas for improving data standards harmonization in Alzheimer's disease and related dementias (ADRD) research.

Main Methods:

  • A systematic mapping process was employed to align ADRC UDS data elements with HL7 FHIR and CDISC standards.
  • Two independent mappers assessed the data element alignment.
  • Expert adjudication resolved any discrepancies identified during the mapping process.

Main Results:

  • Forty-five percent of the 5959 UDS data elements mapped to the FHIR standard, suggesting potential for EHR data extraction.
  • Ninety-four percent of UDS data elements mapped to CDISC standards, indicating high compatibility with industry data requirements.
  • The study identified specific areas for enhancing data standards harmonization.

Conclusions:

  • The harmonization of ADRC UDS data with CDISC and FHIR standards is feasible.
  • CDISC standards demonstrated superior alignment with ADRC UDS data compared to FHIR.
  • FHIR shows potential for improvement as its resources mature and standardization is enhanced, facilitating data sharing across ADRC research, EHRs, and industry.