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Clinical Effectiveness Research from the eyes of a Neurosurgeon.

We have a guest blog post today from Doctors for America member, Dr. Phil Levitt from Palm Beach County, Florida.
My name is Phil Levitt. I’m a retired neurosurgeon who spent 5 of my 30 years in practice as a community hospital chief of staff. During that time, I spent many hours learning about how medical research evolves into treatment recommendations and strategies for the delivery of care. I sat on two hospital boards and two medical executive committees and innumerable lesser committees involved in health care policy at a grassroots level. I have a feel for how the far reaching changes likely to occur in medicine will play out in the community hospital setting. Community hospitals are the places where the majority of Americans get their inpatient care.

A newer approach to improving your health care is comparative effectiveness research. I say “newer” because it has been around for a few years on a small scale. The present administration in Washington has expanded it greatly and is attempting to organize the research and set priorities. The government wants to know which forms of diagnostic and therapeutic procedures are actually effective and which aren’t, so it can stop paying for the ones that clearly are not and encourage the use of those found to be best. Ideally it would be a win-win situation for both the patient and the payor. Better treatment would prevent further illness and expense. It applies to medicines, rehabilitative devices, operations and invasive procedures not done in an operating room, diagnostic tests, behavioral change strategies like smoking cessation, preventive care and delivery system strategies. All of this can be found in the Federal Coordinating Council for Comparative Effectiveness Research Report to the President and the Congress dated June 30, 2009. This report was mandated by the stimulus package legislation passed in February, 2009.

The private insurers and Medicare and Medicaid have been looking at whether high cost operations are effective for decades. I’ll give two examples. In my specialty of neurosurgery there was an elegant operation to prevent stroke developed by a great innovative genius of our specialty, Dr. Gazi Yassargil of the University Hospital in Zurich, Switzerland. He had so advanced the safety and efficacy of neurosurgery by employing the operating microscope, that he was universally revered by neurosurgeons. The surgery involved connecting an artery in the scalp to an artery in the brain to supplement the blood flow from narrowed or blocked brain arteries. Each vessel was only a millimeter (1/25 of an inch) in diameter so it took hours of work in the lab for neurosurgeons to develop the necessary skills.

His operation was put to a test. Here in the U.S., hundreds of patients were enrolled. One half received aspirin and the other got the operation. Both groups had the same frequency of stroke. As a result, the insurers, private and government, stopped paying for the operation. Nobody complained except the neurosurgeons who criticized the methodology of testing, but to no avail. No one cried about interference with the doctor patient relationship. In another example, an important Veterans Administration control study compared the effectiveness of angioplasty and medical treatment with medical therapy alone in the prevention of heart attack or death in patients with stable cardiac pain. As in the stroke study, the two groups did the same.

There are now hundreds of millions of dollars set aside as part of the Federal economic stimulus bill for doing dozens of studies similar to the ones mentioned above, an unprecedented amount. Scientific panels will take the results and write clinical guidelines which doctors will be asked to consider in their decision making. This will fill a huge knowledge gap. Although there are presently guidelines for most things in medicine, it has been estimated that only a third are based on hard scientific evidence. Some have been written by drug companies and favor the products of those companies.

Clinical effectiveness research will go a step further than traditional clinical trials to make the results more relevant to the real world setting of your doctor’s office by looking into differences in response to treatment among racial, gender, ethnic, and age groups. This aspect of the research has been incorporated into the official definition of clinical effectiveness research. Several groups, racial and ethnic minorities and women among them, have often been underrepresented in medical research. The authors of the report ask, “What is the best pain management regimen for disabling arthritis in an elderly African-American woman with heart disease?” This is a good question since several of the NSAIDs once used for arthritis were shown to induce heart problems. A racial difference doesn’t come to mind but the question takes into consideration studies that show differences in susceptibilities to a variety of chronic conditions and responses to medications between racial, gender and age groups. One size does not fit all.

There are big caveats to all of this. however. A medical utopia is an unlikely outcome of all this spending and research. The problem of what to do for an individual patient will not invariably be solved by referring to the results of clinical effectiveness research. This is partly because definitive, unequivocal results and recommendations have not been obtained from some of the best designed and performed scientific studies. That is the nature of research. Sometimes well done studies contradict each other resulting in dramatic shifts in guidelines. In the last three years, those for regulating blood sugar in diabetics have changed from advising rigid control to much looser control when it was found in a well controlled prospective study that in some patients tight control was harmful. I think that an important lesson about  flexibility in guidelines and the limitations of studies was learned.

The best safety mechanism is leaving health care decisions in the hands of the doctor and patient acting in concert. Consistent with this, the report to the President and Congress says, “CER {clinical effectiveness research} should not be used as a sole criterion for denying or awarding care or as justification for making care choices based on cost without consideration of effectiveness, safety, and convenience for an individual patient.” Even so, it will become less likely that a patient will get an operation costing tens of thousands of dollars when an aspirin, say, has been proven to be just as effective.

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