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Researcher knows common flaws in CER studies, dangers of result's misuse

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A recent article by Jerome Groopman, M.D, provides some valuable, first-hand insight as to what can go wrong when policy makers “give teeth” to comparative effectiveness research (CER) studies by translating results into “best practices.” Groopman’s understanding of the limitations of CER and the complexities of delivery high quality care to each patient, lead him to caution against blunt application of CER in ways that do not give physicians the ability to deviate from CER-based recommendations in order to deliver care that is optimal for the individual. This article is a must read for anyone interested in making use of CER to improve patient care.

Groopman, a medical researcher and long time staff writer for The New Yorker, uses his own experience (he was once part of a “misconceived” ‘best practice CER trial) to partially explain the many “repeated failures of expert panels to identify and validate ‘best practices.’"

To exemplify the point, Groopman first discusses several of these failures, including, among others:

  • Medicare’s supposed "best practice" recommendation directing physicians to “tightly control blood sugar levels in critically ill patients in intensive care.” This faulty advice resulted in a “higher likelihood of death” when compared to alternate methods.
  • A Medicare recommendation having to do with hip and knee replacements which was later revealed to have “no effect on the rate of complications from the operation or on the clinical outcomes of cases treated.”
  • An expert panel’s recommendation claiming that all patients with pneumonia “receive antibiotics within four hours of arrival at the emergency room.” This application of this bad recommendation caused a number of adverse results. The recommendation was soon rescinded.

Groopman describes these examples to make the case for more flexible approaches to improving quality and value in health care. "Your doctor should not be paid less if she follow a course of treatment that she can defend as reasonable, even if she deviates from officially issued guidelines,” Groopman writes. “To prevent policy planners from going down the slippery slope of coercion, there should, in Sunstein's view, but safety rails. Whatever the proposal put forward, he has written, people must retain 'freedom of choice' and be able to oppose the more objectionable kinds of government intervention."

Groopman echoes some of the main points that the Partnership to Improve Patient Care (PIPC) has made all through the course of the health care debate and that I have made in previous blogs: That due to the diversity of patients, medical care must be specific to the needs of each individual patient. This means that decision making power must stay between patient and physician, as physicians can often detect cases in which a patient’s needs are different than those of an average patient experiencing the same symptoms.

Examining reasons for “the failure of experts to recognize when they overreach,” Groopman notes that “once we depart from such mechanical procedures [such as proper insertion of an intravenous catheter] and impose a single ‘best practice’ on a complex malady, our treatment is too often inadequate.”

After extension discussion of the recent controversy over USPSTF mammography guidelines, Groopman concludes: “The care of patients is complex, and choices about treatment involve difficult tradeoffs. That the uncertainties can be erased by mandates from experts is a misconceived panacea, a ‘focusing illusion.’” The solution, Groopman said, is flexibility in creation of incentives to maintain that ability of physicians to tailor care based on the values and preferences of the individual patient.