Pharmacoepidemiology and drug safety · 2026
A Systematic Process for Assessing Fitness-for-Purpose of Health Outcomes for Computable Phenotyping With Electronic Health Record Data.
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Gatto Nicole M, Cronkite David J, Wartko Paige D, Ball Robert, Carrell David S, Eniafe Rhoda, Desai Rishi, Floyd James S, Lee Terrence, Nelson Jennifer C, Shebl Fatma M, Schoeplein Ryan, Toh Sengwee, Zhang Mingfeng, Dublin Sascha, Hernández-Muñoz José J
Аннотация
PURPOSE: Information from electronic health records (EHRs) may be incorporated into computable phenotype algorithms in efforts to overcome inaccuracies of algorithms based on administrative claims data alone. However, such efforts can be resource-intensive and unsuccessful. Assessing the feasibility of computable phenotyping for a health outcome of interest (HOI) before proceeding is therefore recommended.
METHODS: We developed a systematic fitness-for-purpose (FFP) assessment process to implement concepts outlined in a previously described general framework for computable phenotyping incorporating EHR data. Our process includes verifying the HOI is well-defined, reviewing clinical information about the HOI, identifying existing algorithms and their performance, evaluating HOI clinical and data complexity, and determining an overall FFP conclusion and recommendation. We applied this process to 10 HOIs lacking high-performing claims-based algorithms, selecting HOIs of public health importance that varied in clinical and data complexity, including neutropenia, pericardial effusion, and drug-induced liver injury.
RESULTS: HOIs assessed as having moderate (vs. easy) overall difficulty had characteristics such as the need for natural language processing, integration of multiple laboratory test results, or longitudinal EHR data. HOIs assessed as having high difficulty required using data from multiple EHR sources, ruling out many other potential causes, or relying on low-sensitivity diagnostic tests. Input from experts in EHR data and clinical care was crucial.
CONCLUSION: EHR data have the potential to enhance the accuracy of defining certain HOIs for research and surveillance compared to administrative claims data. The process and tools we created will support others in assessing FFP of HOIs for computable phenotyping.
METHODS: We developed a systematic fitness-for-purpose (FFP) assessment process to implement concepts outlined in a previously described general framework for computable phenotyping incorporating EHR data. Our process includes verifying the HOI is well-defined, reviewing clinical information about the HOI, identifying existing algorithms and their performance, evaluating HOI clinical and data complexity, and determining an overall FFP conclusion and recommendation. We applied this process to 10 HOIs lacking high-performing claims-based algorithms, selecting HOIs of public health importance that varied in clinical and data complexity, including neutropenia, pericardial effusion, and drug-induced liver injury.
RESULTS: HOIs assessed as having moderate (vs. easy) overall difficulty had characteristics such as the need for natural language processing, integration of multiple laboratory test results, or longitudinal EHR data. HOIs assessed as having high difficulty required using data from multiple EHR sources, ruling out many other potential causes, or relying on low-sensitivity diagnostic tests. Input from experts in EHR data and clinical care was crucial.
CONCLUSION: EHR data have the potential to enhance the accuracy of defining certain HOIs for research and surveillance compared to administrative claims data. The process and tools we created will support others in assessing FFP of HOIs for computable phenotyping.