“I’m not surprised, Curmudge. You tend to forget everything except when it’s time to take a nap. As a patient with a life-threatening disease, I had learned how to learn about my disease by studying review articles, journal articles, and clinical trial results. I had become the local expert on me. So what’s next?”
“In a discussion with your physician you agreed on an evidence-based treatment plan. After following the plan for a couple of months, you were astonished to realize that your condition had not improved. In fact, you even felt worse.”
“What? Not improved! The treatment was evidence based. Clinical trial results indicated that I should have improved. What’s wrong? Did science fail me?”
“No, Julie, science is alive and well. Your problem might be that you are unique and not average. I wrote about this four years ago when I had a different name, Quality Curmudgeon, and you were not yet a member of the team. Readers of Kaizen Curmudgeon probably never saw my original note, so perhaps we should reprint part of the original posting.”
“Do it, Curmudge. By the time I have read it I might not feel cheated by evidence-based medicine.”
The Evidence Behind Evidence-Based Treatments
“Evidence based” is one of today’s health care buzzwords. If a clinician is faced with a patient whose disease may be mitigated by a medication shown to be effective in a large clinical trial, i.e., “evidence based,” he/she can confidently prescribe it and go on to the next patient. This sounds great, but there is more than meets the eye.
Let’s begin with the basics. Assume a pharmaceutical manufacturer’s preliminary studies have, in general, suggested that Compound A at a determined dosage is safe and effective against disease X. The final test is a clinical study in which large numbers of patients with disease X are recruited and divided randomly into two groups. One group is treated with Compound A; the other group is treated with a competing medication or a placebo. At the conclusion of the test, results from both groups are averaged. If the average outcome from the Compound A group is more favorable, the study is written up, peer reviewed and published. Treatment of disease X with Compound A becomes evidence based, and a new “blockbuster” drug is born.
So what’s the problem? The study has shown that the average outcome from a population of hundreds of patients was positive; but it has not answered the clinician’s most important question, “Will it help my patient?” The test population contained some patients with severe symptoms and some with mild symptoms, some with a host of other ailments and some who were otherwise healthy, and some young and some old. Many individual patients were helped by Compound A, but other individuals may have experienced no effect or might even have been harmed. These individual results were obscured by the magnitude of the test population, which on the average demonstrated a favorable outcome.
“I’m sure it won’t make you feel any better, Julie, but if you had been a participant in the trial of this treatment, you would have been part of the population that the treatment didn’t help.”
“Understanding the reason doesn’t make me feel any happier, Curmudge. So what do I do next?”
“I’m afraid that you are going to have to stay sick for another week, Jaded Julie. Then we’ll talk about a possible path forward.”
Affinity’s Kaizen Curmudgeon
Note: An observation on the practice of emergency medicine in a primitive location may be accessed via this link.
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