Development of Robust Comprehensive Code Lists to Ensure Consistency Across Global Real-World Evidence Studies
Author(s)
Aaron Kamauu, MD, MS, MPH1, Craig G Parker, MD MS2, Amanda Shields, BA3, Leanne Larson, MHA4, Michael Buck, PhD2;
1Navidence Inc., Bountiful, UT, USA, 2Navidence Inc., Salt Lake City, UT, USA, 3Navidence Inc., Chapel Hill, NC, USA, 4Univ of South Carolina - Beaufort, WIlmette, IL, USA
1Navidence Inc., Bountiful, UT, USA, 2Navidence Inc., Salt Lake City, UT, USA, 3Navidence Inc., Chapel Hill, NC, USA, 4Univ of South Carolina - Beaufort, WIlmette, IL, USA
OBJECTIVES: Code lists (value sets) provide a basis for computable operational definitions (CODefs) used in cohort selection, case ascertainment, cohort characterization, and outcomes assessment for real-world evidence (RWE) research. However, significant consistency challenges arise, largely due to different coding systems across geographic regions and often no single reference source containing a comprehensive list of codes/medications for a given clinical concept. We demonstrate a framework using multiple sources and clinical input for CODef development to enable effective global RWE programs, with both comprehensive and consistent value sets.
METHODS: A robust process was used to develop comprehensive value sets across multiple code systems: 1. Identify the clinical concepts needed for the RWE study; 2. Review multiple global/regional reference sources (eg, general, clinical, medical coding); 3. Aggregate codes/medications across the multiple sources to generate an initial comprehensive value set; 4. Conduct medical review to confirm the value set; 5. Map to relevant code systems (e.g., ICD-10-CM, ICD-10-WHO, SNOMED CT, RxNorm, ATC-5, HCPCS) and link together; 6. Organize linked value sets by relevant indication and therapeutic area.
RESULTS: A few examples: For Antidepressant Therapies (step #1): 43 references (step #2) identify the 7 drug classes that collectively include 104 total meds after medical review (steps #3 & 4) - 69 ATC-5, 68 RxNorm, and 13 HCPCS codes (step #5), which is part of the Depression indication library (step #6). Antidiabetic Therapies: 38 references for 10 drug classes of 146 meds - 119 ATC-5, 112 RxNorm, and 20 HCPCS codes. Atherosclerotic Cardiovascular Diseases: 6 references for 9 distinct medical conditions - 793 ICD-10-CM, 60 ICD-10-WHO, and 422 SNOMED-CT US codes. Further examples and details will be presented.
CONCLUSIONS: This methodology demonstrates the creation of comprehensive value sets that ensure consistency across code systems for global RWE studies, which allow for appropriate comparison of scientific results/evidence across studies.
METHODS: A robust process was used to develop comprehensive value sets across multiple code systems: 1. Identify the clinical concepts needed for the RWE study; 2. Review multiple global/regional reference sources (eg, general, clinical, medical coding); 3. Aggregate codes/medications across the multiple sources to generate an initial comprehensive value set; 4. Conduct medical review to confirm the value set; 5. Map to relevant code systems (e.g., ICD-10-CM, ICD-10-WHO, SNOMED CT, RxNorm, ATC-5, HCPCS) and link together; 6. Organize linked value sets by relevant indication and therapeutic area.
RESULTS: A few examples: For Antidepressant Therapies (step #1): 43 references (step #2) identify the 7 drug classes that collectively include 104 total meds after medical review (steps #3 & 4) - 69 ATC-5, 68 RxNorm, and 13 HCPCS codes (step #5), which is part of the Depression indication library (step #6). Antidiabetic Therapies: 38 references for 10 drug classes of 146 meds - 119 ATC-5, 112 RxNorm, and 20 HCPCS codes. Atherosclerotic Cardiovascular Diseases: 6 references for 9 distinct medical conditions - 793 ICD-10-CM, 60 ICD-10-WHO, and 422 SNOMED-CT US codes. Further examples and details will be presented.
CONCLUSIONS: This methodology demonstrates the creation of comprehensive value sets that ensure consistency across code systems for global RWE studies, which allow for appropriate comparison of scientific results/evidence across studies.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
MSR65
Topic
Methodological & Statistical Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas