Facts, Fallacies, and Politics of Comparative Effectiveness Research: Part I. Basic Considerations

While the United States leads the world in many measures of health care innovation, ithas been suggested that it lags behind many developed nations in a variety of healthoutcomes. It has also been stated that the United States continues to outspend all otherOrganisation for Economic Co-operation and Development (OECD) countries by a widemargin. Spending on health goods and services per person in the United States, in2007, increased to $7,290 – almost 2½ times the average of all OECD countries. Risinghealth care costs in the United States have been estimated to increase to 19.1% of grossdomestic product (GDP) or $4.4 trillion by 2018. The increases are illustrated in bothpublic and private sectors.Higher health care costs in the United States are implied from the variations in themedical care from area to area around the country, with almost 50% of medical carebeing not evidence-based, and finally as much as 30% of spending reflecting medicalcare of uncertain or questionable value. Thus, comparative effectiveness research (CER)has been touted by supporters with high expectations to resolve most ill effects of healthcare in the United States and provide high quality, less expensive, universal health care.CER is defined as the generation and synthesis of evidence that compares the benefits andharms of alternate methods to prevent, diagnose, treat, and monitor a clinical conditionor to improve the delivery of care. The efforts of CER in the United States date back tothe late 1970’s even though it was officially born with the Medicare Modernization Act(MMA) and has been rejuvenated with the American Recovery and Reinvestment Act(ARRA) of 2009 with an allocation of $1.1 billion.CER has been the basis for health care decision-making in many other countries.According to the International Network of Agencies for Health Technology Assessments(INAHTA), many industrialized countries have bodies that are charged with healthtechnology assessments (HTAs) or comparative effectiveness studies. Of all the availableagencies, the National Institute for Health and Clinical Excellence (NICE) of the UnitedKingdom is the most advanced, stable, and has provided significant evidence, thoughbased on rigid and proscriptive economic and clinical formulas.While CER is making a rapid surge in the United States, supporters and opponents areexpressing their views. Part I of this comprehensive review will describe facts, fallacies,and politics of CER with discussions to understand basic concepts of CER.Key words: Comparative effectiveness research, evidence-based medicine, Instituteof Medicine, National Institute for Health and Clinical Excellence, interventional painmanagement, interventional techniques, geographic variations, inappropriate care.