Wednesday, September 21, 2011

Best Practices

Your Medical Mind: How to Decide What Is Right for You by Jerome Groopman and Pamela Hartzband, as its title indicates, discusses medical decision making, and how individuals should make decisions with respect to their treatment incorporating information and advice from medical professionals. Following the discussion of a study in which patients and doctors made different decisions about preferred treatments because the patients on average were more risk adverse than the doctors, the authors write:

Patients should be aware that there can be differing views among specialists about who should be treated for various conditions. For example, expert committees in Europe and the United States crafted different guidelines about when to treat high blood pressure. The group of American experts believed that the benefits outweighed the risks from treatment for mild elevation of blood pressure and wrote guidelines that advise medication for patients like Alex Miller. But in Europe, an expert committee with access to the same scientific data formulated different guidelines that don't advise treatment for mild elevation of blood pressure. In Europe, Alex and others like him would not be encouraged to take medication. Different groups of experts can disagree significantly about what is "best practice." Dr. Rodney Hayward, a widely respected researcher on health care at the University of Michigan, recently wrote in the New England Journal of Medicine that "the assessment of whether the benefit is great enough to warrant the risk of harm — i.e., the decision of where the threshold for intervention should lie — is necessarily a value judgment." 
Why is it subjective, a value judgment, rather than a matter of a clear black-and-white answer? Because, Hayward continues, for many treatments there exists a substantial "gray area of indeterminate net benefit." 
Hayward mentions cholesterol levels as one example of such a gray area. We examined the "net benefit" of treatment in Susan Powell's deliberation about taking a statin medication. "Net benefit" means the potential gains from the treatment minus the downsides. After seeing all the data, particularly the "number needed to treat," she didn't believe the net benefit was worth it, given the risks statins entail. In effect, Susan set a different cutoff for herself from the one some experts would apply, not because she was "health illiterate" or "irrational," but because she has a different subjective assessment from that of the experts who wrote the recommendations. We agree strongly with Hayward that within the substantial gray area of indeterminate net benefit, "physicians should defer to an individual patient's preferences in choosing whether or not to intervene." 
How do recommendations for "best practice" come about? Committees of specialists are convened to draw up guidelines that aim to identify "best practice" for a certain medical condition. The principle is that guidelines should be drawn from the "best" evidence and craft ed by the "best" scientific experts in the field. These guidelines are a key component of so-called evidence-based medicine, the idea that clinical practice should be based solely on the results of scientific studies. The recommendations are presented not only to physicians, but directly to patients, in informational brochures, on the Internet, and in the media. Guidelines therefore have become one of the most powerful forces on patient decisions, since the very language used to describe their content is "best" practice. Advocates of guidelines assert that both doctors and patients should accept their recommendations as the default option. Some physicians and health policy planners conclude that patients who deviate from expert recommendations aren't adequately informed or are "irrational."
Doctors and patients certainly should consult guidelines since they provide considerable background information about disorders and treatment options. But, it's important to recognize that guidelines aren't strictly "scientific." They incorporate biases and subjective judgments. Experts select which clinical studies to use and which to discard when they formulate their recommendations. Further, all studies have limitations. They provide results from statistical averages of selected groups of study subjects. These averages may not be applicable to a particular patient. Even the most rigorous, inclusive studies cannot address all the variables of age, gender, genetics, lifestyle, diet, and concurrent medical conditions that make us individuals and often influence how effective a particular treatment will be or what sorts of side effects we might experience. Many studies exclude the elderly or those who have coexisting common medical problems. When making their final recommendations about the need for treatment, experts also apply their subjective judgment about how much risk is worth taking in order to obtain a certain benefi t. Concerns have also been raised by the Institute of Medicine about potential conflicts of interest, since some experts who write guidelines are consultants to drug and device companies or private insurers. Finally, guideline committees have an imperative for consensus and present their recommendations with one voice. As a result, their conclusions usually fail to mention dissenting opinions that may have arisen among committee members. 
It's also important for patients to realize that guidelines aren't engraved in stone; they can change quickly. A survey of one hundred recommendations from expert committees found that within a year 14 percent were reversed, within two years 23 percent were changed, and fully half were overturned at five and a half years. The American College of Physicians, representing internists in the United States, stated in 2010 that all of its guidelines, if not rewritten, should be automatically suspended after five years. This isn't only because new and better data become available, but also because the composition of expert committees may change, and with this change, subjective judgments of "utility" or value may shift . Consider the guidelines that recommended the use of estrogen in virtually all postmenopausal women to prevent heart disease and dementia. These guidelines were overturned by new information from the Women's Health Initiative trial. Yet some experts remain critical of this study and still endorse parts of the earlier guidelines, believing that for some women the "value" of hormone replacement may be enough to risk the downsides.
Compare "best practices" in medical practice with those in international development. In medicine, new drugs or new techniques are accepted only after large scale case-control studies showing efficacy. There are peer reviewed medical journals that publish individual studies and review articles summarizing many studies. There is the Cochrane Library that maps the status of research on key medical topics. Physicians undergo long formal education and internships and residencies before allowed to specialize, and are subjected to peer review when in practice and required to participate in continuing education and periodic re-certification. "Best practice" judgments are based on thousands of cases.

In international development, individual practitioners usually learn on the job and have severely limited experience with development cases as compared to physicians with medical cases. There are few serious statistical studies of development interventions, and arguably there are greater differences among the situations in which development projects are undertaken than there are among a doctor's patients suffering from the same medical problem. If recommended "best medical practices" should be taken with a grain of salt, then "best development practices" should be regarded with a jaundiced eye.

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