Outcomes research: “a guide to the perplexed”.

Outcomes research is still an embryonic field, one not clearly understood by most physicians and providers of health care. Its scientific foundation includes the disciplines of epidemiology, health services research, biostatistics, psychometrics, pharmacoeconomics and database assessment. Application of an outcomes approach to disease management, compliance and persistency, and its appropriate use in “cost effectiveness” programs by managed care require an active integration of specific methodology into clinical medicine, and the involvement of experienced physicians. In this context, it is important that the differences between traditional efficacy and safety studies and “effectiveness” studies be understood. It is also essential that academicians, health care providers, the pharmaceutical industry and pharmacy benefit management organizations approach outcomes in a rational, scientific and disciplined manner for the field to progress. Likewise, federal agencies such as the FDA and AHCPR need to enhance and integrate their efforts with the private sector. Outcomes research and management programs are most successfully accomplished in an environment where there is also a focus on quality measures and continuous quality improvement. The Merck approach to outcomes research in hypertension will be presented.