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Clin. Cardiol. 25, 1-2 (2002)
Key words: guidelines, clinical trials
Is anybody out there reading all of these guidelines? They seem to be everywhere. The American College of Cardiology/ American Heart Association has its set of guidelines. The European Society of Cardiology has its set of guidelines, and I am sure other professional cardiovascular societies are developing their sets of guidelines. Sixteen are currently in print and available for download from the American College of Cardiology website. These guidelines are written for blood pressure control, lipid control, risk-factor modification, acute coronary syndromes, heart failure, valvular heart disease, percutaneous coronary interventions, angiography, echo, exercise testing, pacemakers and implantable cardiac defibrillators, atrial fibrillation, stable angina, perioperative evaluation for noncardiac surgery, radionuclide imaging, and much more. I, for one, am overwhelmed with some of these 80-100 page documents. Sensory overload! I certainly agree that they are scholarly pieces assembled by individuals who have searched the literature and come to consensus opinions based on medical literature, practice experience, and, one hopes, common sense. Despite this learned approach, I seriously doubt that the guidelines as they now appear are being read in their entirety by anyone but those who wrote them. In this editorial, I will focus my comments in a general way on guidelines for noninterventional therapy.
What Are Guidelines?
I suspect that some persons (private payers, Medicare, etc.) may interpret guidelines as "minimal standards." I strongly disagree with this. Guidelines are just that: "guidelines." The dictionary defines guidelines as a strategy, a plan, a guiding principle, or a course of action. The Institute of Medicine defines guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances."
It should not be considered poor practice or, at worst, malpractice, if guidelines are not followed in every patient, since there may be many circumstances in which the "guideline" does not apply to the individual patient. However, if guidelines are not followed, the reason should be documented by the physician. It needs to be emphasized that not all patients respond the same way to any particular form of therapy, as everyone knows. Even if a drug has a beneficial effect on survival or other endpoints in a clinical trial, many of the patients in that clinical trial did well in the placebo arm and several of those receiving the drug did poorly. The trick is to determine which group your patient falls into. Pharmacogenetics and pharmacogenomics may be the answer in the future.1
Not all patients receive guideline-recommended drugs for a number of reasons:
Judgment is still necessary. Clinical judgments are based on whatever evidence exists, plus experience. This is the essence of clinical guidelines. Medicine is not so simple that recipes can be used for all patients with a certain clinical condition.
Practice Pattern Surveys
In recent years, professional societies and even governments have surveyed physicians for their practice patterns. I sometimes wonder about the accuracy of these surveys, in which the surveyors have determined that certain drugs, such as beta blockers and ACE inhibitors, are not used as frequently as they should be. Survey data on the use of drugs do not always take special circumstances into consideration. For example, in a clinical trial, the patient population is highly selective. Rarely do these patients have multisystem disease and none has contraindications to the agent being tested. In contrast, in clinical practice, patients often have multisystem co-morbid diseases, for example, lung, renal, liver, or brain disease, and so forth, and many have contraindications to the agent tested in the clinical trials. Perhaps the survey numbers are correct, but there may be extenuating circumstances since clinical practice patients may not be the same as clinical trial practice patients. The latter group have all received the agent in question because it is being tested in the trial, and also because there is no contraindication to its use. I guess the bottom line is that we do need advice and guiding principles on how to practice medicine; but we must remember that there are no generic patients. Often, clinical trials that are wonderful in themselves are really not confirmatory of each other because patients or drug doses, and so forth, are not identical. The majority of patients do pretty well without any new treatment, and clinical trials, as wonderful as they are, may have no applicability to the individual patient.
Changing Clinical Practice
Another point that bears examination is the rush to change guidelines, and thus clinical practice, based on a single clinical trial that has been presented at a national or international scientific meeting but has not yet been published in a peer-reviewed journal. Often, the initial enthusiasm of the investigators obscures details of the study that have important bearing on patient selection for the agent being tested. I am all in favor of changing guidelines for clinical practice, so long as trial results are confirmed by other clinical trials. My own approach is to let these clinical trials percolate a bit, and when appropriate details are made known in peer-reviewed journals, to include them in the updated "guidelines."
Brevity Please
Finally, guideline writers--please be merciful to those of us who think guidelines do have some importance. Remember that our standard textbooks are loaded with information. Guideline writers should not try to rewrite the textbooks but rather add important, timely, new information in a simple format.
C. Richard Conti, M.D., M.A.C.C.
Editor-in-Chief
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