Methodologic Challenges to Studying Patient Safety and Comparative Effectiveness

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Abstract
Studies of patient safety and comparative effectiveness entail unique methodologic challenges. These studies may be sus- ceptible to systematic error, including selection bias, exposure misclassification, and outcome misclassification. They may also be vulnerable to random error, or confounding by a variable such as another drug, a disease, or the drug indication itself. Finally, special logistical issues can arise, including data access problems, difficul- ties in conveying the need for studies of certain interventions, and obstacles to gaining institutional review board approval. This article provides a conceptual overview of these methodologic issues.