Bias from outcome misclassification in immunization schedule safety research.

ABSTRACT:

Purpose

The Institute of Medicine recommended conducting observational studies of childhood immunization schedule safety. Such studies could be biased by outcome misclassification, leading to incorrect inferences. Using simulations, we evaluated (1) outcome positive predictive values (PPVs) as indicators of bias of an exposure-outcome association, and (2) quantitative bias analyses (QBA) for bias correction.

Methods

Simulations were conducted based on proposed or ongoing Vaccine Safety Datalink studies. We simulated 4 studies of 2 exposure groups (children with no vaccines or on alternative schedules) and 2 baseline outcome levels (100 and 1000/100 000 person-years), with 3 relative risk (RR) levels (RR = 0.50, 1.00, and 2.00), across 1000 replications using probabilistic mo

SUBMITTER: Newcomer SR 

PROVIDER: S-EPMC5800415 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature