Diabetes Mellitus Interagency Coordinating Committee Focuses on Comparative Effectiveness Research at April 2010 Meeting
Comparative effectiveness research (CER) was the topic for the Diabetes Mellitus Interagency Coordinating Committee (DMICC) meeting on April 30, 2010. CER compares the effectiveness of treatments and strategies to improve health.
As speakers at the DMICC meeting noted, CER is not a new approach to research—the National Institutes of Health (NIH) and other federal agencies have been conducting and supporting CER for decades. However, a recent Federal Government emphasis on CER, along with funding through the American Recovery and Reinvestment Act of 2009, has stimulated interest in new CER projects to produce evidence to enhance medical decisions made by patients and their medical providers.
The Recovery Act included $1.1 billion for CER, including $400 million for the NIH, $400 million for the Office of the Secretary of Health and Human Services, and $300 million for the Agency for Healthcare Research and Quality (AHRQ). Much of the funding has been allocated for specific projects.
Judith Fradkin, M.D., director, Division of Diabetes, Endocrinology, and Metabolic Diseases for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), chaired the DMICC meeting and presented information about diabetes CER at the NIDDK. Other speakers included Michael Lauer, M.D., National Heart, Lung, and Blood Institute (NHLBI); Christine Chang, M.D., and Barbara Bartman, M.D., AHRQ; Hylton Joffe, M.D., and Hui Talia Zhang, M.D., Sc.D., U.S. Food and Drug Administration; and James Rollins, M.D., Ph.D., Centers for Medicare & Medicaid Services. The speakers addressed diabetes CER at their respective agencies.
Multiple definitions of CER exist. The Institute of Medicine's 2009 report Initial National Priorities for Comparative Effectiveness Research defined CER as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels." The report is available at www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx .
Lauer said that although the current interest in CER is exciting, CER itself is not new. He described a clinical trial in the early 1880s in which a Scottish surgeon compared the commonly used treatment of bloodletting with other treatments. The trial found that bloodletting increased death risk tenfold. Nevertheless, bloodletting continued to be popular among leading physicians for more than 100 years. Lauer gave some modern examples of accepted therapies that were later found to be harmful or useless and noted that excessive belief in logic, strong personalities, excessive reliance on observational data, and habit all contribute to the use of such discredited treatments. CER has always been controversial, in part because its findings can be a threat to sellers of costly goods and services that are shown to be of no benefit.
Fradkin highlighted several landmark studies that have employed CER methods to shed light on treatment approaches for people with prediabetes and diabetes, including the Diabetes Control and Complications Trial (DCCT), the Diabetes Prevention Program (DPP), the United Kingdom Prospective Diabetes Study, and the NHLBI's Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The ACCORD study and other large studies have examined intensive control of blood glucose, also called blood sugar, levels; blood pressure; and lipids, but many questions remain unanswered. One important area in which CER is needed is diabetes medications. Nine classes of drugs have been approved for type 2 diabetes treatment, but data are needed to guide health care providers in decisions about add-on medications when monotherapy with first-line agent metformin does not succeed in controlling blood glucose levels. Comparative head-to-head studies of the various drugs and drug classes with longer follow-up than in studies done for drug approval are needed to provide the missing data.
More information about the DMICC and its work can be found in the publication Diabetes Mellitus Interagency Coordinating Committee: Coordinating the Federal Investment in Diabetes Programs to Improve the Health of Americans, available online at www.diabetescommittee.gov.
The NIDDK has easy-to-read booklets and fact sheets about diabetes, including fact sheets about the DCCT and the DPP. For more information or to obtain copies, visit www.diabetes.niddk.nih.gov.
NIH Publication No. 10-4562
Page last updated: December 5, 2011