Optimal Rate for Partial Chart Review

• Activity Number: 43
• Type: Contributed
• Date/Time: Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Section on Statistics in Epidemiology
• Author(s): Lei Qian*+ and Jeffrey Slezak and Steven Jacobse
• Companies: Kaiser Permanente and Kaiser Permanente and Kaiser Permanente
• Keywords: vaccine safety ; PPV ; sampling ; chart validation

Abstract

Automated databases from managed care organizations (MCOs) are a primary resource for monitoring the post-licensure safety of vaccines. Since these data are not originally collected for research purpose, automated outcomes based on ICD-9 codes subject to error, manual medical chart review of a positive signal has become a standard procedure for vaccine safety studies. The percent of cases sampled for chart review is often driven by resource availability and has rarely been discussed in contents of the estimation precision. We used both simulations and theoretical method to study the precision of the resulting estimate given a range of expected positive predictive values (PPV), numbers of automated cases, and sampling proportions for chart validation. A guideline for sampling strategy based on our findings will provide.