Develop Data Protection Analytical Approaches for Medical Big Data Analysis - Use the Comparative Effectiveness of Ophthalmologic Biologic Agents as an Example

BACKGROUND: With advances in technology and informatics methods, using population-based claims database such as Taiwan’s National Health Insurance Research Databases (NHIRD) to generate high quality real-world evidence has become more feasible. However, common challenges including (1) invalid diagnosis codes, (2) unavailable information such as disease severity, and (3) unmeasured confounders largely limit the analyses. The use of external information, such as hospital-based electronic health records (EHR), and conduct a multi-databases study could be a possible solution to address the limitations, facilitating high quality analysis to evaluate effectiveness and risk of medication. However, because of concerns about data security, analytical approaches without compromising privacy and related ethical issues are required. OBJECTIVE: We propose three analytical models without cross-linkage of data for multi-database studies, of each addresses aforementioned corresponding three challenges in analyses using claims database. METHOD: We propose a three-year research project and focus on the comparative effectiveness and safety of ophthalmologic biologics in patients with two major macular diseases, including age-related macular degeneration (AMD) and diabetic macular edema (DME), respectively. We use Chang Gung Research Database and National Cheng Kung University hospital electronic health records as external information to adjust the estimations from the NHIRD. We will develop a validated algorithm for identifying macular disease cases, create proxy measures accounting for macular disease severity, and perform propensity score calibration to deal with unmeasured confounders from the NHIRD. SIGNIFICANCE: The proposed analytical models could apply to future multi-databases and big data analyses to facilitate high quality evaluations without compromising data privacy. This three-year project enables to establish real-world evidences on comparative effectiveness and safety of ophthalmologic biologics in Taiwan, which could be strong grounds for clinical practices or policy decisions making.