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    Saturday, May 16, 2009


    Thus if the new Obama money on the health care scene will do more comparative studies to make sure current guidelines are appropriate, that’s great.

    What we need most are evidence based outcome studies showing the benefits of quality metrics on mortality/morbidity in concert with the application of such studies rather than experts getting together to hammer out compromised clinical practice guidelines as exists today.

    Groups representing African-American, Hispanic or elderly patients argue that they will be underrepresented in future clinical trials. Whether this is true or not, the whole point of comparative effectiveness is to move medical practice beyond the limits of ordinary randomized trials, by looking at a broader range of evidence that includes the actual experience of patients undergoing treatment. Comparative effectiveness is to see what works in practice, rather than over generalizing from a few unrepresentative studies.

    However as I see it there is another bugaboo. Policymakers and research funders, such as the National Institutes of Health, often assume that the final steps in the translation of clinical research — the decision to act on new medical evidence and its implementation in routine care — are seamless and automatic. We clinicians know that changing the behavior of physicians and patients is difficult. Many of the assumptions regarding the most important aspect of such research — the ultimate implementation of its findings into health care — have had little empirical support.

    The dominant White House voice on health policy is Peter Orszag, the budget chief who champions "comparative effectiveness research" -- studying the patterns of clinical practice to determine which drugs and treatments work best and therefore necessary and which treatments are un-necessary and therefore non re-imburseable.

    The Obama Administration thinks it can use "comparative effectiveness research" analysis to weed out wasteful or unnecessary care. They say that by paying more "if the treatment has been shown to be effective and necessary and a little less if not," as Mr. Orszag recently was quoted, that un-necessary treatment will stop. He cites Dartmouth data that shows health-care spending varies wildly between regions, often with little or no correlation to “health outcomes.” Does anyone really believe that un-necessary treatment will eventually be reimbursed at all?

    And haven’t we’ve seen “comparative effectiveness” before?

    Under managed care in the 1980’s and 90’s, doctors and hospitals had to undergo prior "utilization review" by HMOs to reduce “unnecessary” hospitalizations, surgeries, tests, prescriptions etc. This cost-effectiveness gatekeeping was supposed to have disciplined health spending. “What happened next to this version of the dream is known to all,” says the WSJ. Administrative hassles led to a consumer backlash, with patients feeling they were getting inferior care in return for insurer profits. The political class eventually forced the HMOs to dilute or end most of their cost-control strategies.

    Will the same course of events happen again?

    It is for this reason that a shift is needed from the "science of recommendation to a science of implementation."

    The creation of a CER initiative focused on developing and disseminating effectiveness reviews is an essential, but not yet a sufficient, step toward the routine provision of safe, high-quality health care to all Americans.

    We also need evidence-based methods for discovering and describing how the findings of clinical trials and CER can be efficiently implemented and incorporated into routine practice.

    An implementation research and development program designed for this purpose could fulfill three important objectives.

    • It could accelerate the translation of evidence into everyday care.
    • It could enhance the opportunities for doctors and patients to define value (balancing expected benefits with costs) on the basis of their understanding of local contexts and constraints.
    • It could allow providers and patients to communicate with researchers and policymakers about clinically important issues earlier in the research process.

    Local factors such as infrastructure, existing processes, the degree of buy-in by clinicians and administrators, and the costs associated with change may vary widely among hospitals and regions.

    The Federal Coordinating Council must therefore remain mindful that the primary goal of CER is to enhance the translation of new medical discoveries into safe and high-quality health care for all Americans.

    This goal can be achieved only if our investment in CER includes a commitment to implementation research.

    This has not yet been done.

    But a step in the right direction was taken by Sen. Arlen Specter, D-PA, who recently introduced legislation that would authorize the establishment of the Cures Acceleration Network (CAN). Under the bill, a new $2 billion agency would provide funds to translate research discoveries from the bench to the bedside, and would operate as an independent agency; it would not be part of HHS. The CAN would make awards outside of the traditional funding stream to accelerate the development of cures and treatments including but not limited to drugs, devices and behavioral therapies. The CAN would have a flexible expedited review process to get monies into the hands of the grantees as quickly as possible. These development funds would complement the research dollars provided to the NIH and would not compete or take monies away from the NIH.

    Let’s hope bills like these don’t get stalled.

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