Abstract
OBJECTIVES: Real-world data (RWD) analyses primarily rely on structured clinical documentation collected through routine clinical care or driven by medical billing requirements. Patient-reported outcome measures (PROMs), integrated into electronic health records (EHRs), are an additional data source that could offer valuable insights into a patient's perspective and contribute to a more comprehensive understanding of health outcomes in RWD studies. This study aims to characterize agreement between PROMs symptoms and structured clinical documentation of these symptoms by clinicians in EHRs. MATERIALS AND METHODS: A cross-sectional study of 913 244 adult primary care annual physical visits between January 1, 2019 and December 31, 2023. We compared differences in prevalence and agreement of patient-reported symptoms (PRS) and structured clinician documentation (CD) across 15 respiratory, gastrointestinal, cardiometabolic, and neuropsychiatric symptoms. RESULTS: Patient-reported symptom prevalence were significantly higher compared to CD across most symptoms including joint pain (33% PRS vs 12%), headaches (17% PRS vs 8.8% CD), and sleep disturbance (24% PRS vs 10% CD). Clinicians documented anxiety (11% PRS vs 23% CD) and depression (6.6% PRS vs 15.4% CD) symptoms using structured code at higher rates than patients reported them. Agreement between symptom self-report and clinician-documented structured codes was low to moderate (κ: 0.06-0.39). DISCUSSION: Primary care patients self-report symptoms up to ten times more frequently than clinicians document them with structured codes in the EHR. CONCLUSION: This work demonstrates the value and feasibility of incorporating PRSs in RWD studies to reduce misclassification and more holistically capture a patient's health.