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Research Limitations in Cardiac Treatment

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Not Much Evidence Supports Heart Disease Treatment Recommendations

Where does your cardiologist look for advice on treating patients? I hope not just the latest published recommendations, since a leading team of cardiologists has recently called into question whether there is much research behind these recommendations. The study revealed that published recommendations on treatment for heart disease are often based on opinion rather than rigorous and controlled randomized clinical trials.

This is yet another example of why medicine should be considered an art rather than a science, observes consumer health advocate Charles B. Inlander, founding president of the nonprofit People’s Medical Society, a consumer advocacy organization responsible for key improvements in the quality of US health care. In his view, this latest development underlines the need for more solid evidence supporting which treatments work and which do not — evidence that may, in fact, be forthcoming if the federal government’s new comparative effectiveness research initiative takes effect. The research initiative theoretically should be beneficial as it recommends direct study-to-study comparisons of the efficacy of different methods of care.

NOT MANY EARN AN “A”

Over the past 20+ years, the American College of Cardiology (ACC) and the American Heart Association (AHA) have issued broad cardiac care guidelines, which have added up to a total of 7,196 specific recommendations. These recommendations are given a grade of A, B or C depending on the level and quality of the research supporting them, published along with the study, so the doctors are aware of them. An A is awarded to recommendations based on evidence generated from multiple controlled trials… a B is given for evidence that comes from just one randomized study or from non-randomized trials… and a C means recommendations are backed by expert opinion but little or no scientific evidence.

At the Duke Clinical Research Institute in North Carolina, cardiologist Pierluigi Tricoci, MD, MHS, PhD, and his colleagues catalogued these recommendations. They found that while the total number of recommendations increased by 48% from 1984 to 2008, the trend was toward publishing more of them with lower levels of supporting evidence. In particular…

  • Just 11% of current recommendations received a grade of A, while 48% got a C.
  • Recommendations for treatment of heart failure and unstable angina (chest pain that strikes when heart blood vessels are blocked) were among those that received the highest number of A recommendations. Yet even in these “grade A” cases, Dr. Tricoci notes that fewer than 30% of the recommendations got an A.

Keep in mind that this study involved only recommendations for cardiac care, and did not measure the care patients actually received. Individual physicians make their own decisions on whether or not to follow what’s recommended for a particular patient or problem. That said, it is still a major concern that so-called expert guidelines are derived from what is often limited research. Adding to the problem is the fact that most major clinical trials are funded by the pharmaceutical or medical device industries searching for opportunities to bring new profit-generating drugs and devices to market. They have no motivation to answer fundamental clinical questions about the relative effectiveness of medicines, devices, practices and procedures already in use because there is no additional revenue to be generated, and it can be risky to “lose to the competition” on a head-to-head trial.

Results of this study were published in the February 25, 2009, issue of the Journal of the American Medical Association.

THE HEART OF THE MATTER

Comparative effectiveness is a standard we can expect to hear more about going forward — studies are already in the planning stages at US government agencies. These future trials will theoretically help us all — doctors and patients alike — fill in current gaps in evidence and determine which cardiovascular and other medical treatments are the safest and most effective.

According to Inlander, this is needed in every aspect of medicine, not just cardiology. Too often we go too long using drugs or doing procedures that ultimately do not prove to work, but doctors think they are effective or say they are effective, because “everyone is using or doing it.”

So, how do you go about ensuring that you are getting the best possible care? If you have heart disease, or any other chronic disease for that matter, Inlander once again strongly recommends that you become knowledgeable about your illness and actively involved with your own health care decisions from the very beginning. Follow these strategies…

  • See only doctors who are board-certified and have demonstrated experience and expertise with your condition. While board certification does not assure competence, you know that these physicians are pursuing on-going training and education.
  • When such information is available, check outcome rates of hospitals and ratings of doctors. Check board certification online and any actions against the doctor at your state medical licensing board.
  • Ask your doctor to explain the basis for the treatment recommendation, as well as for not choosing a different one.
  • Be sure to get second or even third opinions concerning your diagnosis and treatment.
  • Keep in mind that drugs aren’t the only solution. You can help control heart disease by making simple, healthy lifestyle choices — maintain a normal weight, follow a healthy diet, get regular exercise and take steps to control stress.
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Source: Charles B. Inlander, a consumer advocate and health care consultant based in Fogelsville, Pennsylvania. He is founding president of the nonprofit People’s Medical Society, a consumer advocacy organization credited with key improvements in the quality of US health care in the 1980s and 1990s, and author of 20 books, including Take This Book to the Hospital with You (St. Martin’s). Pierluigi Tricoci, MD, MHS, PhD, Duke Clinical Research Institute, Duke University, Durham, North Carolina. Date: July 27, 2009 Publication: Bottom Line Health
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