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Chronic Conditions & Duration of Follow-Up

    Basic Details
    Last Updated
    Wednesday, March 6, 2024
    Original Posting Date
    Health Outcome(s)
    duration of follow-up
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Sufficient observable person-time in the indicated population is necessary for conducting drug safety analyses. While the median length of observation time for members in commercial insurance claims databases is typically less than two years, it is unknown if individuals with some chronic conditions have different lengths of observation time in these data sources. The objective of this study was to assess prevalence and duration of follow-up for 24 chronic condition cohorts in the Sentinel Distributed Database (SDD), as defined using the Centers for Medicare and Medicaid Services’ (CMS) Chronic Conditions Data Warehouse condition algorithms. Hypertension and hyperlipidemia had the highest prevalence (26.3% and 23.9%), while all five cancers assessed had low prevalence (0.2 to 1.5%). Median follow-up ranged from 0.8 (lung cancer) to 2.7 years (hyperlipidemia). As this query intended to characterize the data in the SDD, no regulatory actions were taken.