Objective: To review the fundamental concepts used in clinical economic analysis and establish a simple model to systematically evaluate the quality of pharmacoeconomic studies.
Data sources: A MEDLINE search was used to identify pertinent pharmacoeconomic literature, including reviews.
Study selection: Selected literature evaluating the methodology of health economics studies was used.
Conclusions: The number of studies presenting a pharmacoeconomic evaluation has increased progressively; however, the quality of the studies has not improved in parallel. The existence of different types of pharmacoeconomic studies does not justify their arbitrary use and the achievement of valid conclusions must be based on sound knowledge of the concepts employed, as well as on use of the most adequate tool in each instance. By evaluating pharmacoeconomic studies systematically, the more common errors (i.e., in planning the study or interpreting the results) can be detected and thus prevented. The checklist we present has 12 sections, each of which includes several subsections. After evaluating the corresponding subsections, each section is labeled as "correct," "acceptable," "doubtful," "incorrect," or "not applicable." From this qualitative evaluation, aspects that have been dealt with correctly and those needing improvement will become apparent. Also, the checklist permits the user to verify whether the results have been correctly obtained and, therefore, whether the conclusions are valid. The use of a checklist for evaluating pharmacoeconomic studies may be useful for researchers, journal editors, and the audience when performing, receiving, reading, or accepting a clinical economic study.