Tools for health care decision making: observational studies, modeling studies, and network meta-analyses.

Comparative effectiveness research incorporates study designs extending beyond the randomized controlled trial (RCT) [1], which is the touchstone for demonstrating therapeutic efficacy. The litany of RCT flaws is often recited: not real world, not real patients, not real settings, not available, not timely, and not affordable. Although not every RCT is well designed, there are established narratives and tools to aid health care decision makers in appraising and interpreting them. The Comparative Effectiveness Research Collaborative Initiative is a collective effort among the Academy of Managed Care Pharmacy, the National Pharmaceutical Council, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to provide tools for decision makers to assess studies that use nonexperimental methods important to comparative effectiveness research. To this end, ISPOR Good Practices Task Forces have developed tools to assess 1) prospective and retrospective observational studies, 2) modeling studies, and 3) network meta-analysis studies.