How Relevant Is Evidence-Based Medicine to Your Practice?

In his recent editorial "Why We Need to Know the Limitations of Evidence-Based Medicine" (CONSULTANT, August 2006, page 963), Dr Gregory Rutecki questioned whether the findings of randomized controlled trials (RCTs) can be extrapolated to patients in primary care practices, who often have multiple comorbidities. A sampling of the feedback we received appears below, along with Dr Rutecki's responses.
- The Editors

• Why do we insist on patient outcome results rather than accepting, where appropriate, the disease outcome results of certain studies? Why not accept, for example, the results of a trial demonstrating something that makes intuitive sense based on our understanding of physiology? I am aware of the infamous studies that showed that vitamin E was found to have a counterintuitive adverse effect, but in view of the stakes, can we not tolerate a few such missteps?
  -Andrew Gerenyi, MD
    Wexford, Pa

You address the critical tension that must exist between using the available evidence and knowing what to do when data are not available or are equivocal. We do not have RCT evidence for much of what we do in practice every day. Does this mean that even if something works we can't use it because it hasn't been proved in a prospective trial? Absolutely not! We need more evidence than we have at present, but until then, we can do a lot of good in our practices by combining common sense and evidence.

- Gregory W. Rutecki, MD
  Director of Medical Education
  Mount Carmel Health System
  Columbus, Ohio
  Clinical Professor of Medicine
  Ohio State University
  Columbus
  Clinical Professor of Medicine
  Wright State University   Dayton, Ohio

• I am a retired internist with about 40 years in private practice. The mixture of comorbidities in patients is so varied and at times so unusual that I do not believe any "evidence-based" strategy that relies on prospective RCTs can provide a true picture of therapeutic effects. There are too many variables involved to consider participants in the trials typical of patients in everyday primary care practice.- Gabriel A. Covo, MD

You raise an important point regarding the implications of prospective studies for contemporary practice. If "typical" primary care patients--that is, people who have multiple comorbidities--are underrepresented in prospective trials, how relevant and binding can the results be?

You and I agree about the need to focus more attention on this important segment of the population in the future but seem to differ about what has been accomplished to date. I do not think that everything discovered as a result of prospective trials should be considered suspect. Where would we be today without evidence-based medicine? Whether it's aspirin for acute cardiovascular syndromes or important lipid targets in patients with dyslipidemia, we cannot "throw the baby out with the bath water."
- Gregory W. Rutecki, MD

• The present paradigm protects drug companies--because they generally are the only ones able, apart from the federal government, to conduct large randomized trials. This prevents alternative medicine from gaining momentum. If I treat 100 patients with herb X and 90% report significant improvement, evidence-based medicine would say that this is interesting but meaningless. That's baloney. Common sense dictates that something apart from the 30% placebo response is occurring.-Steve Grable, MD  Jacksonville, Fla

I agree with you that pigeonholing every treatment through the gateway of our "Western-scientific" methodology leaves a lot to be desired. A few years ago, my coworkers and I published a survey of primary care physicians' attitudes toward alternative therapies.¹ The doctors we surveyed prescribed alternative therapies that had worked for them or their family. This is not evidence-based medicine, and it's also an admission that RCTs are not all there is to treatment.
- Gregory W. Rutecki, MD

REFERENCE:1. Crock RD, Jarjoura D, Polen A, Rutecki GW. Confronting the communication gap between conventional and alternative medicine: asurvey of physicians' attitudes. Altern Ther Health Med. 1999;5:61-66.

• I practice in a variety of settings: a workers' compensation clinic, an emergency department, a community health organization, and as a team doctor. Thus, I'd be the first to use any shortcuts or evidence-based guidelines, protocols, or nomograms . . . if somehow they applied to the real world.We were told in medical school that medicine is more art than science, and my experience bears that out. Each medical condition is nuanced, involving the complexities of social situations, notions of health, confounders such as other diagnoses, and more and more obesity on top of the presenting complaint. To try to cut through all that with one-size-fits-all trial results is unrealistic even for the simplest conditions.- Ignatius Brady, MD
    Cedar Rapids, Iowa

We are in agreement: one size does not fit all. Hopefully, a solution will be forthcoming, with greater representation of "typical" primary care patients in future trials.
- Gregory W. Rutecki, MD

• Dr Rutecki raises a very important issue: the multi-problem patient in primary care. However, it goes beyond questions of evidence-based medicine. These patients require more time, especially if we are expected to base our management decisions on evidence. Yet, physicians and other allied health care personnel these days are expected to do more and perform better in less time. Are we dealing with the assembly of autos or the care of human lives?- Charles G. Perl, MD
    Fort Lauderdale, Fla

About 4 years ago, I left family medicine to join an independent clinical trials practice. It was the most exciting thing I have ever done. The paradigms of research methodology and pharmacoconstruction are slowly maturing. However, there is minimal participation-active or passive-on the part of those who stand to benefit most from evidence-based medicine, namely patients and those who care for them. I appreciate the many reasons for this lack of involvement. Still, the assembly of a truly representative research population is the seminal task of any clinical trial. In addition to guiding their patients, physicians must also assume a role in constructing and supporting the populations from which the landmark RCTs are born.

- Eileen Mary Gilman, NP-C
    Certified Clinical Research Coordinator
    Norfolk, Va

I agree wholeheartedly. I, too, have been privileged to participate in multiple trials and have realized the number of people who benefited as a result. Even though there are some flaws in the present system-that is, certain trials may lack a robust mix of typical comorbidities-there has also been minimal participation from certain segments of the health care system, including those who most benefit-physicians and patients.

- Gregory W. Rutecki, MD

Primary care physicians are encouraged to use the latest evidence-based diagnostic and therapeutic strategies from prospective randomized, controlled trials in their practice. Most, if not all, these studies exclude participants with comorbidities. In real life, I seldom see patients who have just 1 disease at a time. Thus, I use evidence-based medicine to guide the approach to my patients; however, I review the demographics of the relevant studies (ie, age, sex, race) and see if they apply to my patient. Then I use the “art of medicine” to ultimately diagnose and treat. As a director of medical education, I also teach my students this approach.

- S. Bruce Badaglialacqua, DO    Director, Student Medical Education    Medical Director, Physician Assistant Studies    A.T. Still University, Arizona School of Health Sciences    Mesa, Ariz

Randomized controlled trials (RCTs) should have very little bearing on how we practice medicine. Medicine cannot be practiced "cookbook style," and the causes of medical conditions are almost always multifactorial. Why should we follow medical studies that are composed of data that are usually manipulated in some fashion in order to give a desired response to the initiator or sponsor of the study? The results of these propagandized studies are then sold as facts by pharmaceutical companies. Most doctors go along and put patients on medications that have no real benefit and potentially some serious drawbacks. Physicians need to go back to using their own minds and use their training to find the root causes of patients' problems-and ways to help fix these problems-without the bias of RCTs.

- Steven Horvitz, DO
    Moorestown, NJ

Evidence-based medicine certainly has its limitations-not only because of the quality of the populations used in the studies, but also because of the number of participants in the studies, no matter how large. I think that evidence-based medicine is a great place to start building a base of information, but for deciding how, ultimately, I will treat my patients, I am a true believer in clinically based medicine.

- Louis Beaulieu, FNP
    Kennebunk, Maine