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P09.02 A Clinical Evaluation Algorithm to Define Clinical Utility of Lung Nodule Diagnosis in a Multi-Collaborator Setting Using Real World Data

      Introduction

      New biomarkers for the diagnosis of indeterminate lung nodules (IPN) suspicious for lung cancer are being developed regularly. Clinically useful new diagnostic tests for IPN requires improvement in post-test risk classification to reduce subsequent testing or time to diagnosis. Therefore, measuring the activity to a diagnosis is needed. In a collaboration between Lahey Hospital and Medical Center (LHMC), representing a large screening only population, Vanderbilt University Medical Center (VUMC), a tertiary referral center with incidental and screening discovered nodules, and OneFlorida Clinical Research Consortium, a statewide network with incidental nodules, we defined an algorithm to combine real world data (RWD) from electronic health records (EHR) to measure the clinical activity necessary to diagnose an IPN. We adapted the algorithm to local environments and defined referral pattern biases for others who wish to define clinical utility using RWD.

      Methods

      RWD was transformed to the Observation Medical Outcomes Partnership (OMOP) common data model. An EHR-based algorithm was coded. IPN cohorts were identified using a published algorithm or by existing registries. Chart reviews were conducted to determine the gold standard of clinical activity and to define the time to diagnosis. IPN size 6-30mm and patients aged 40-80 years were included. Clinical activity consisting of CT and PET imaging, bronchoscopies, surgeries and SBRT was identified by ICD-9/10, CPT, or site-specific procedural and diagnostic codes. Differences between algorithm and chart review results by site were measured and systematic differences in activity were investigated using correlation and Wilcoxon sign-rank tests.

      Conclusion

      We successfully developed an EHR-based algorithm to capture clinical evaluation activity to diagnose IPN. The algorithm was most accurate in a screening population. Systematic underreporting of CT Imaging arose among incidentally discovered nodules. Researchers seeking to determine clinical activity in IPN diagnosis must consider the method of nodule discovery when using RWD.

      Keywords

      Lung nodules, clinical evaluation, Real World Data