“If all else fails, we could try science.”

There was a bold and thoughtful article in the New England Journal of Medicine this past week that received no notice in mainstream media but deserved to. It offered valuable insights into the importance of evidence-based clinical guidelines — that are really based on the evidence — and why this is a vital issue for us, as well as our doctors.

How readily will doctors be to object to guidelines — such as for obesity, diabetes, and heart disease management — that they don’t agree are sound or to be in the best interests of their individual patients? Or are the costs of doing so too great? This article offered revealing insights into the dilemmas faced by doctors under growing pressures to comply with the clinical guidelines being issued by third parties, such as government agencies or insurance companies.

Doctors are finding their medical care being monitored and evaluated by how well they comply with these performance measures. Failing to conform, costs doctors reimbursement and referrals, and increasingly means risking malpractice charges. Called P4P measures (pay-for-performance), these are being instituted under the guise of quality improvement and improving patient outcomes.

But do they?

The series on P4P (here, here, here and here) has revealed that these measures aren’t always the result of impartial examinations of the evidence nor do they necessarily translate into better care and clinical outcomes. In fact, most are considerably more controversial than commonly presented in the media. There are even multiple and different “evidence-based” guidelines for the very same disease, depending on which professional organization or insurer issues them. Concerns have been raised that because they are one-size-fits-all care algorithms created from statistical data on populations, and frequently issued by third party payers with financial incentives, they are not always best for individual patients and their unique personal situations and wishes.

The latest issue of American Medical News underscored the problem of clinical practice guidelines, each of which only addresses a single disease, as being “woefully inadequate” for caring for real patients and real life situations. People rarely just have a single disease, as a study just published in the Journal of General Internal Medicine (online link not available) found. It was led by Dr. Eve Kerr, M.D., MPH, associate director for the VA Ann Arbor Health Services Research and Development Center for Clinical Management Research and associate professor of internal medicine at the University of Michigan Medical School in Ann Arbor. Examining 1,900 seniors with diabetes, they found 92% had at least one other chronic health problem, with half having three or more additional diseases. Each condition has competing demands and caring for the whole patient means weighing numerous issues. According to an editorial by Dr. Pugh, M.D., “we need to take care of the whole person, not just their heart, knee or pancreas, and to truly let that person be the decision-maker with the care team providing information and support.” P4P measures don’t enable these types of clinical judgments.

Clinical guidelines were once be clinical guides for physicians, to assist them in managing their individual patients, but now they “have grown teeth,” said Dr. Mark Vonnegut, M.D., a pediatrician in Quincy, MA, and the insurer withholds money for every metric not met. “Having teeth means these programs come down as edicts; they may or may not have a scientific basis or be applicable to our practice or population, but we must either go along with them or go out of business,” he said.

Writing in the current issue of the New England Journal of Medicine, he laments that: “We have gone from doing the right thing for the patient no matter what, to doing the right thing for the patient as long as it doesn't hurt our hospital or practice or the insurance company too much.”

His article, “Is Quality Improvement Improving Quality? A View from the Doctor's Office,” goes on to express concerns about the effects these measures will have on medical care. Dr. Vonnegut asks: Do we really want doctors who are motivated by getting good scores from insurers and earning performance bonuses? Or will these overcome the capacity for critical thinking and reliance on empirical data? All of the time he spends documenting his compliance with P4P measures for asthma or obesity and other initiatives, he says, is time he’s not spending taking care of his patients. But the bigger concern may be in how these measures risk discriminating against people most in need of care, as those paying for healthcare become more concerned with managing costs. As he writes:

At this point, the notion that any of these programs actually improves the quality of care is speculative and debatable. With the health-maintenance-organization (HMO) model of health care delivery, it quickly became clear that it was advantageous to take care of people who didn't need much care. Avoiding unemployed and poor people was generally a good idea, because they tend to have more problems. There was a great deal of talk about preventive care, but what really happened, as far as I could see, was that successful HMOs were able to siphon off billions of dollars and become the corporations they are today by taking care of young, healthy, employed, middle-class people....

The consequences of third-party payers who are also managing clinical performance means “the incentives for getting rid of sick and poor patients will be stronger than ever,” he said:

I can't help suspecting that underneath all these quality-improvement and pay-for-performance initiatives lies yet another scheme that will work out very well for insurers and very badly for providers and patients. The tens of thousands of dollars I'm going to lose out on for failing to achieve my electronic-prescribing or obesity-management goals has certainly caught my attention, but it's not the big prize.

The big prize, he says, will come from making doctors increasingly dependent on trying to meet these quality and cost-containment goals, while distracting them from patient care. Moreover, overhead will go through the roof. Practices such as his already require a full-time nurse and secretary dedicated to dealing with these initiatives. He added:

Meanwhile, U.S. doctors today have less and less to say about the care of their patients. All the complex lessons they learned in medical school are being swept aside for template care.... And if these so-called quality-improvement programs turn out to be elaborate cost-shifting schemes, many sick people will be deprived of medical care, and the overall costs for all of us will go up.

At a minimum, we should be working harder to determine whether these programs really will improve care before adopting what is a very radical and far-reaching change in the way medical care evolves and is delivered. If we adopt a multitude of quality measures that have not been validated, we are very likely to end up with more quality problems than we started with. We all went to medical school — if all else fails, we could try science.