Guide to interpreting and evaluating the pharmacoepidemiologic literature.

The purpose of this guide is to provide review criteria for the pharmacoepidemiologic literature. Case-control and cohort studies are the major methodologies used in pharmacoepidemiologic analysis. Evaluation criteria for case-control and cohort studies address proper sample-frame definition, compatibility of cases and controls, drug-exposure validations, unintended-effect ascertainment procedures, and considerations for confounding. Moreover, interpretation of the statistics used in reporting cohort and case-control studies is provided. Further review criteria are given for meta-analysis, an approach to integrating the pharmacoepidemiologic literature.