Sunday, December 2, 2012

Healthcare: Protocols and Evidence-Based Medicine vs. Intuition

Healthcare in the United States faces critical challenges. Science and engineering have provided great advances in knowledge about the human body and its conditions, and provided numerous new treatments for illnesses. These advances have not simplified the job for dispensers of healthcare; rather, they have made it more complex—perhaps too complex for isolated individuals to deal with. Atul Gawande, a surgeon and writer, provided this perspective in a commencement address at Stanford University.
"Half a century ago, medicine was neither costly nor effective. Since then, however, science has combated our ignorance. It has enumerated and identified, according to the international disease-classification system, more than 13,600 diagnoses—13,600 different ways our bodies can fail. And for each one we’ve discovered beneficial remedies—remedies that can reduce suffering, extend lives, and sometimes stop a disease altogether. But those remedies now include more than six thousand drugs and four thousand medical and surgical procedures. Our job in medicine is to make sure that all of this capability is deployed, town by town, in the right way at the right time, without harm or waste of resources, for every person alive. And we’re struggling. There is no industry in the world with 13,600 different service lines to deliver."

Gawande was making the case for utilizing a systematic approach to medicine, such as using protocols with checklists and other aids to ensure that proper steps were being taken and nothing was overlooked.

"Diagnosis and treatment of most conditions require complex steps and considerations, and often multiple people and technologies. The result is that more than forty per cent of patients with common conditions like coronary artery disease, stroke, or asthma receive incomplete or inappropriate care in our communities."

Gawande was referring to situations where a known set of procedures are to be followed, but avoidable mistakes are made. To put the importance of this in perspective, the number of people who die from infections and other avoidable mishaps in hospitals each year is about 200,000. We have discussed Gawende’s presentation in more detail in Medical Care Is a System—It Should Be Subject to System Design and Analysis.

Gawande also touches on a second aspect of the exploding complexity of healthcare: the role of the individual physician.

"Why does anyone receive suboptimal care?....This can no longer be a profession of craftsmen individually brewing plans for whatever patient comes through the door. We have to be more like engineers building a mechanism whose parts actually fit together, whose workings are ever more finely tuned and tweaked for ever better performance in providing aid and comfort to human beings."

David Leonhardt provided an article in the New York Times that addressed this issue and posed it properly as whether or not we should be determining evidence-based procedures or depending on doctors’ intuition for diagnosis and treatment. The traditional method is the latter.

Evidence-based methods utilize data on various methods of diagnosis or treatment as well as the eventual outcomes. With a large enough data set most effective approaches will emerge. A group of experts evaluates the data and makes a tentative recommendation in the form of a protocol to be followed to attain best results. This is clearly an iterative process that has to be updated as more data becomes available. Physicians are expected to use this as a guide but need not follow it slavishly if there are counter indications that suggest a better approach. The deviations and outcomes are to be reported and become part of the data set.

Decisions based on physician intuition are educated guesses. In many instances these are quite satisfactory, but as was argued above, the field is just too complex to expect any one individual to always have at their command all the information needed.

Leonhardt uses the experience of Brent James, chief quality officer at Intermountain Healthcare, a network of hospitals and clinics in Utah and Idaho, as an example of how the evidence-based methods are developed and applied. The history described by James began with one doctor trying to make sense of how to treat a particular condition over 20 years ago. Individual doctors were taking different approaches and there was no way to know which methods worked best. It was basically a plea to standardize on parts of the procedure that were well established so that focus could be provided on the aspects that were more important. Other doctors gradually began to collaborate and a protocol was developed. This particular condition being studied had a patient survival rate of 10% in a national study. Under the protocol at Intermountain the survival rate was 40%.

This experience led the Intermountain system to utilize the same approach for the treatment of other conditions and to distribute the developed protocols throughout the network.

"Intermountain has reduced the number of preterm deliveries, as well as the number of babies who must spend time in the neonatal-intensive-care unit. So-called adverse drug events, which include overdoses and allergic reactions, were cut in half in the mid-1990s. A protocol for dealing with one broad category of pneumonia cut its mortality rate by 40 percent over several years. The death rate for coronary-bypass surgery was cut to 1.5 percent, from the national average of about 3 percent. Medicare data on heart-failure and pneumonia patients show that Intermountain has significantly lower-than-average readmission rates. In all, James estimates that the changes have saved thousands of lives a year across Intermountain’s network. Outside experts consider that estimate to be fair."

When James was asked about critics of his approach who think it is too restrictive and can be bettered by the individual physician he provided this response.

"The human mind can sometimes do a better job of piecing together amorphous bits of information — diagnosing a disease, for example — than even the most powerful computer. On the other hand, human beings can also be unduly influenced by just a few experiences, like the treatment of an especially memorable patient. As a result, different doctors frequently end up coming up with different answers to the same question. Cardiologists in Davenport, Iowa, are quick to insert stents; cardiologists in Iowa City and Sioux City are not. They can’t both be right. Some people with heart disease are getting the best treatment, and some are not. The same is true of debilitating back pain, various cancers and even pregnancy."

Leonhardt references Jerome Groopman, a Harvard doctor, as a prominent critic of evidence-based methods and protocols. Groopman claims the approach is too limited in application and too limiting to the physician who often can do better on his own. He recognizes the problem the mind has with biased memories and claims that this difficulty can be overcome.

"To Groopman, a fundamental problem with ‘systems analysis,’ as he calls it, is that it discourages doctors from considering a wide-enough array of possible treatments. He also worries that if doctors are judged based on how well they follow a protocol, they may follow it even when they are correctly skeptical of it. Groopman says that the proper solution to misdiagnosis instead lies with individual doctors. If they are taught the ways in which their instincts can lead them astray, and if they reflect on their previous mistakes, they can avoid some of the pitfalls of intuition. They can become more self-aware."

Fortunately, data is accumulating on the efficacy of the data-based and the intuitive approaches.

"The researchers say that Groopman is right to highlight examples of human judgment being just as good as data. There are many of them. Still, the overall record of decision-making approaches that are based mostly on intuition is far weaker than the record of decisions based mostly on data. To give just one example, an article in the journal Psychological Assessment, analyzing dozens of studies that compared clinical judgments with data-based diagnoses, found that clinical judgments were better in only a few instances. The two approaches were equally accurate about half of the time, but the data-based diagnoses substantially outperformed human judgment in nearly half of the studies. And with data collection becoming ever cheaper, Kahneman says that the number of occasions in which an intuitive approach beats a systemic one is getting smaller all the time."

This summary seems to indicate that the data-based approach and the subsequent protocols are superior when the data base is sufficiently robust and inclusive to allow accurate conclusions to be drawn. That makes sense.

Groopman’s suggestion that it is better to let doctors learn from their mistakes rather than be directed to learn from the mistakes of others is ridiculous.

The fact that evidence-based approaches are controversial at all is absurd.

We will never have a cost-effective system that provides quality care and avoids killing large numbers of patients until we begin to use the knowledge and skills of the individual physician in the most efficient manner. We are not there yet.

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