An NIH study of treatments for high blood pressure, called the ALLHAT trial, shows some of the strengths and limitations of comparative effectiveness research to improve patient care. More...
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Will government-supported comparative effectiveness research (CER) come between doctors and patients in making treatment decisions? The jury, I think, is still out.
We all can agree, as stated in a recent blog post by the Center for American Progress (CAP), that the goal of CER is to "permit patients and their health providers to make better decisions about care based on evidence."
Yet at the same time, many providers and patients are concerned that a new CER program poses a real risk of constraining the doctor's ability to tailor care to the needs of the individual. As stated in recent NPR commentary from Anne Brewster, an internist and instructor at Harvard Medical School, "Physicians may agree with the end goal, but many of us worry about the methods and unintended consequences. Comparative effectiveness research sounds sensible. Of course we need more studies to define best practices. But I find myself afraid that the results will be used by policy makers, hospital administrators, and lawyers to further limit my autonomy by setting hard and fast rules about what is “right”. Clinical situations are always nuanced, never black and white. Perhaps it is semantic, but I want to feel that CER will empower rather than constrain me."
This sentiment echoes concerns raised recently in a Wall Street Journal op-ed by Drs. Jerome Groopman and Pamela Hartzbrand from Harvard Medical School. “Data from clinical studies provide averages from populations and may not apply to individual patients," they explained. "Clinical studies routinely exclude patients with more than one medical condition and often the elderly or people on multiple medications. Conclusions about what works and what doesn't work change much too quickly for policymakers to dictate clinical practice.” As a result, “bureaucrats could well write regulations mandating treatment measures that violate patient autonomy.”
In this case, the answer will come down to how policymakers structure a government-run CER program. The CAP posting states, incorrectly, that “nothing in any of the developing pieces of [health care] legislation would mandate coverage or recommend any reimbursement requirements." This is not the case. And it will be one of the key determinants in whether CER ends up empowering or constraining providers and patients.
The House health reform bill, H.R. 3200, in fact would create a new agency within the Department of Health and Human Services (HHS) that is explicitly empowered to conduct cost-based research and make policy recommendations based on the results. The bill also creates a parallel HHS agency to use the research to define and implement "best practices." As Dr. Brewster stated, this poses a significant risk of policies that set rules firmly and quickly as to what is "right."
Yet lawmakers still have a chance to create a patient-centered CER program that avoids this pitfall. CER legislation introduced by Rep. Kurt Schrader (D-Ore.) in the House (H.R. 2502) and Sens. Baucus (D-Mont.) and Conrad (D-N.D.) in the Senate (S. 1213) offers a sound approach that focuses research on the needs of patients. This measure recently was approved as part of the Senate Finance Committee's action on health reform.
In order to ensure that CER is not misused in ways that come between the doctor and patient in making treatment decisions, we're urging lawmakers to support H.R. 2502 and S. 1213 as part of health care reform.