Bias from outcome misclassification in immunization schedule safety research

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.

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