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Expect higher standards in research.

Peer-reviewed research should provide clear guidance to clinical practice. However, there is considerable information that we as physicians have a right to expect from peer-reviewed research but are not getting. This deficiency makes it harder for us to practice evidence-based medicine.

We are not paying enough attention to research methods, either as investigators or as skeptical consumers of the literature.

A great deal of what we do in medicine depends on the results of randomized, controlled trials. Unfortunately, many of the researchers performing trials today fail to ask important questions before beginning their studies.

For example, researchers need to ask themselves what they think will happen in the study and articulate their ideas as clearly stated hypotheses. Also, they need to determine what would constitute a clinically significant result. It is not enough to report that an outcome is statistically significant. Physicians need to know if the information they read in a journal is meaningful enough to change the way they practice.

The Food and Drug Administration could help to improve the information that is reported by changing its requirements for drug approval. Currently, the FDA requires two positive trials. That means two trials where the experimental drug differs from the control at a P value of less than .05, a relatively easy result to obtain if enough subjects are included in the trial and the sample of subjects is sufficiently "purified" to keep noise out of the data. The agency could ask for more information that gets to the question of clinical relevance. It could even begin to base its approval decisions on such information.

But even absent a change in government policy, there are some relatively simple definitions that researchers could use to judge success. One such measure is the number needed to treat. This measure allows the clinician to see how many patients would have to be treated to see one additional positive outcome. If the number needed to treat is three or four, it's a pretty powerful intervention; if it's 500, you would have to seriously question if it is worth changing your practice to include this intervention. Number needed to treat is a useful way to evaluate treatment or to compare the potency of treatments.

Another useful measure is the number needed to harm. This number is not only important to the physician in assessing risk, but it is a good way to inform patients of the chance for side effects and adverse events.

And comparing the number needed to treat with the number needed to harm is a fairly easy way for physicians to get an overall picture of the risk-benefit profile of a treatment.

The first step to bolstering the information that goes from bench to the bedside or from research report to practice is to urge journal editors to insist that information on clinical significance be included before agreeing to publish a study. The drug industry needs to step up as well. They could do their part by designing their studies to provide better information on benefits, risks, and clinical significance.

Evidence-based medicine is a great idea that has gained widespread acceptance among doctors, but it will not become a reality unless that evidence is presented in a usable way.

Getting this useful translation of the evidence is the best way to foster clear communication with patients and their families. It will also give physicians the tools to compare different drugs or studies--an essential element in today's ever-changing medical environment.

DR. KUPFER is professor and chairman of psychiatry at the University of Pittsburgh and coauthor of the book "To Your Health: How to Understand What Research Tells Us About Risk."

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Title Annotation:GUEST EDITORIAL
Author:Kupfer, David
Publication:Internal Medicine News
Geographic Code:1USA
Date:Nov 1, 2005
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