Real-World Use of Controlled Terminologies, Ontologies, and Vocabularies for Evidence Generation Across a Large International Observational Network: Challenges and Lessons Learned From a Mixed Method Study - Report - MDSpire
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Utilization of Standardized Terminologies, Ontologies, and Vocabularies for Evidence Generation in a Global Observational Network: Insights and Challenges from a Mixed Methods Analysis

  • By

  • Anna Ostropolets

  • Vlad Korsik

  • Tatsiana Skuhareuskaya

  • Aleh Zhuk

  • Maryia Khitrun

  • Alexander Davydov

  • Dmitry Dymshyts

  • Christian Reich

  • George Hripcsak

  • Patrick Ryan

  • September 15, 2026

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Utilization of Standardized Terminologies for Evidence Generation in a Global Network

Background

The integration of observational data from diverse sources is crucial for understanding patient care and treatment outcomes, particularly for complex clinical questions. However, variations in data acquisition and coding present significant challenges in generating reliable evidence. Standardized terminologies and ontologies play a vital role in addressing these discrepancies and facilitating interoperability across international networks.

Data Highlights

No numerical or trial data provided in the source material.

Key Findings

  • Observational data networks can provide insights into patient care that randomized clinical trials may not capture.
  • Common Data Models (CDMs) and data harmonization are essential for addressing variations in data coding.
  • The OHDSI collaborative has implemented standardized vocabularies to support data interoperability across 544 sources in 54 countries.
  • Standardized vocabularies include coordinated ontologies and controlled vocabularies to enhance data analytics.
  • Different countries utilize various coding systems, which are mapped to a standard within the OMOP CDM for consistent analysis.

Clinical Implications

Standardized vocabularies can improve the quality and consistency of data used in observational studies.

Conclusion

Standardized terminologies and ontologies are critical for enhancing the interoperability of observational data networks.

Related Resources & Content

  1. Hripcsak G, Schuemie MJ, Madigan D, Ryan PB, Suchard MA, Yearb Med Inform, 2021 -- Drawing reproducible conclusions from observational clinical data with OHDSI
  2. Brown BB, Patel C, McInnes E, Mays N, Young J, Haines M, BMC Health Serv Res, 2016 -- The effectiveness of clinical networks in improving quality of care and patient outcomes: a systematic review
  3. Schneeweiss S, Brown JS, Bate A, Trifirò G, Bartels DB, Clin Pharmacol Ther, 2020 -- Choosing among common data models for real-world data analyses
  4. Reich C, Ostropolets A, Ryan P, et al., J Am Med Inform Assoc, 2024 -- OHDSI Standardized Vocabularies-a large-scale centralized reference ontology for international data harmonization
  5. Journal of Medical Internet Research — Standardizing Clinical Laboratory Terminology for Enhanced Semantic Interoperability Through a Large Language Model-Based Approach: A Methodological Investigation
  6. Drug Safety — Connecting Disparate Information Sources to Create a Unified Knowledge Base on Medications and Relevant Health Outcomes
  7. Drugs - Real World Outcomes — Approaches to Overcome Existing Obstacles in Generating Real-World Evidence in Japan
  8. npj Digital Medicine — Enhanced Transferability of Predictions from Electronic Health Records Across Different Countries and Coding Frameworks Using Large Language Models
  9. Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices | FDA
  10. Data Quality Framework for EU medicines regulation: application to Real-World Data
  11. CBER-CDER Data Standards Program 2025 Annual Assessment
  12. DARWIN EU P4-C2-013, P4-C2-014, and P4-C2-021 St
  13. An Assessment of the Sentinel System
  14. PCORnet® Common Data Model - PCORnet®
  15. July 2026 SNOMED CT International Edition release available - Product Release Announcements - SNOMED Forums
  16. Releases · OHDSI/Vocabulary-v5.0 · GitHub

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