AI-Assisted Expert Computable Operation Definition (CODef) Development for Real-World Research

Author(s)

Michael Buck, PhD, Craig G Parker, MD, MS, Aaron W C Kamauu, MD, MS, MPH.
Navidence, Salt Lake City, UT, USA.
OBJECTIVES: As regulatory agencies look to require computable operational definitions (CODefs) as part of submissions from life sciences companies, it is essential to have ways to create and maintain this content quickly and accurately.
METHODS: The process to develop code list/value sets that accurately represent clinical concepts for multiple EHR, claims and life science data sets can be very time consuming. We developed a novel three-step process to assist expert medical informaticists using Artificial Intelligence (AI): 1. Leveraging Claude.ai we processed and created a concept list from the National Comprehensive Cancer Network (NCCN) Gastric Cancer guidelines. 2. Leveraging Claude.ai we linked the concepts to common terminologies, like ICD-10-CM, LOINC, CPT, and RxNorm. 3. Assisted by Perplexity.ai a non-physician informaticist verified the accuracy of the concept and terminology mappings.
RESULTS: For CPT procedures, we had 101 distinct concepts mapped to 86 distinct code terms with 54 concepts missing a mapped term and 24 concepts with incorrect terms for gastric cancer. For ICD-10-CM diagnoses, we had 9 distinct concepts mapped to 11 distinct terms with no concepts missing a mapping and all 9 verified as correct. For RxNorm medications, we had 81 distinct concepts mapped to 33 distinct terms with 9 concepts missing a mapped term and all terms with correct codes/text, except 12 with hallucinated RxNorm codes but correct medication text. For LOINC labs, we had 3 distinct concepts mapped to 33 distinct terms with 0 concepts missing a mapped term and all terms with correct codes/text except 1 with a hallucinated LOINC code but correct lab text.
CONCLUSIONS: AI was able to accelerate an expert human informaticist’s ability to create and maintain value sets (for diagnoses, medications, and labs) for CODefs quickly and accurately and which are compliant with expectations from regulators / stakeholders.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

RWD14

Topic

Health Policy & Regulatory, Health Technology Assessment, Real World Data & Information Systems

Topic Subcategory

Data Protection, Integrity, & Quality Assurance, Reproducibility & Replicability

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×