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Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
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FAIR data sharing: The roles of common data elements and harmonization.

R D Kush1, D Warzel2, M A Kush3

  • 1Elligo Health Research and Catalysis, USA.

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Summary

Common data elements (CDEs) have failed to improve clinical research data sharing and interoperability due to a lack of standardization and common use. Recommendations are provided to enhance data sharing and adhere to Findable, Accessible, Interoperable, Reusable (FAIR) principles.

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Area of Science:

  • Clinical Research Informatics
  • Health Data Standards
  • Biomedical Data Interoperability

Background:

  • Robust data sharing is crucial in clinical research and healthcare, but achieving interoperability and semantic interoperability remains challenging.
  • The Findable, Accessible, Interoperable, Reusable (FAIR) principles are recommended for valuable data exchange.
  • Lack of standardized data exchange, domain-relevant content, and accessible metadata hinders interoperability, limiting data value and FAIR adherence.

Purpose of the Study:

  • To explore the reasons behind the low adoption of common data elements (CDEs) in clinical research.
  • To analyze the limitations of CDEs and other clinical research standards in solving data sharing and interoperability problems.
  • To offer recommendations for improving CDE adoption and enabling responsible data sharing.

Main Methods:

  • Review of existing literature and initiatives related to CDEs and clinical data standards.
  • Analysis of the structure and implementation of CDEs, particularly within the National Institutes of Health (NIH).
  • Exploration of challenges in semantic interoperability and adherence to FAIR principles.

Main Results:

  • CDEs have not achieved widespread adoption or interoperability due to project-specific definitions, lack of common use, and inconsistent linking to controlled terminologies.
  • NIH CDEs are a conglomerate developed in silos, lacking overarching harmonization and causing confusion for researchers.
  • The selection of different CDEs for the same variable across studies exacerbates data comparison issues.

Conclusions:

  • CDEs and current clinical research standards have largely failed to deliver on the promise of widescale interoperability and data sharing.
  • Rectifying the situation requires overarching harmonization, consistent linking to controlled terminologies, and promotion of common identifiers for CDEs.
  • Implementing these recommendations is essential for responsible data sharing, adherence to FAIR principles, and the realization of Learning Health Systems.