Analysing Practice Guidelines For Heart Disease Treatment

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A study just published by Tricoci, et al., in the Journal of the American Medical Association points out the importance of funding clinical research, including comparative effectiveness research to determine the best ways to diagnose and treat heart disease, the number one killer of Americans. The paper is a valuable and important message to the new Administration, Congress and the nation about the need to invest more in science, medical evidence and clinical comparative effectiveness.

The American College of Cardiology (ACC) and the American Heart Association (AHA) use clinical research findings in developing treatment guidelines for heart disease and fully support the call for increased national funding of research.

The ACC/AHA clinical practice guidelines offer guidance to help healthcare providers determine the best treatment options for their patients. These guidelines are developed after careful analysis of the strongest clinical trial evidence available at the time. In some cases, however, evidence is limited or not available, so some recommendations are based on the consensus agreement of a panel of leading experts in the field of heart disease care. Once drafted, the guidelines go through substantial peer review and content review by clinicians and scientists at the highest levels of each organization. The published guidelines represent a product of academic and clinical commentary from a large group of the best minds in the field and go through extensive peer-review process before publication.

As these guidelines are put into practice, important progress is being made. Coronary heart disease deaths rates have fallen by more than 30 percent over the past decade.

“Despite limitations of the current evidence base, we can see that guideline-driven care has resulted in real progress in our fight against heart disease,” said Tim Gardner, M.D., president of the American Heart Association. “However, that fight is far from over with more than 445,000 people still dying of heart disease each year.”

“There are gaps in the evidence base for patient care, gaps that could be eliminated if more clinical research were funded, especially comparative effectiveness research that specifically compares one kind of diagnostic procedure or treatment with another,” said W. Douglas Weaver, M.D., president of the American College of Cardiology. “Improving our evidence base can lead to even greater improvements in treatment and in saving lives.”

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Gardner and Weaver note that the paper by Tricoci, et al., raises several important issues in its careful analysis of the ACC’s and AHA’s decades-long approach to clinical guideline development:

• The recommendations in guidelines should always be placed in the context of a healthcare provider’s knowledge of each patient’s clinical situation and the patient’s values and wishes.

• Because of the extent of the clinical trial literature on cardiovascular disorders, individual healthcare providers find it difficult to keep current with the evidence and to weigh the impact of new data in relation to the previous body of knowledge. Nonetheless, they must make decisions. Expert consensus can be very helpful, even critical, in these circumstances.|

• The article points out that there has been no reduction in the number of recommendations based on levels of evidence lower than A. If all, or even the majority of research over the course of this analysis had been directed at comparative effectiveness of previous evidence, the analysis would have shown an increase in the levels of evidence over time. The decrease in evidence levels occurred because the primary focus of research was directed at finding novel approaches and testing new diagnostic and therapeutic procedures and/or agents.

• Researchers who have relationships with industry – particularly those that result from the design of or the conduct of clinical trials – are often among the most knowledgeable about the procedures or agents being studied. However, writing groups and review groups must include an adequate number of individuals without the potential for bias that such relationships create. Details about the methods for managing such relationships and the transparency of the ACC/AHA Guidelines process are described, including the disclosure of relationships, abstention of those with relationships from voting or reviewing, and the requirement that writing groups be chaired by individuals with no relevant relationships with industry.

“The guidelines we have developed to-date are based on the best evidence we have available to us and they are working,” Weaver said. “We will continue to pursue the knowledge needed to maintain and improve our progress in saving lives.”

“Can we do better? Certainly, actually in several ways,” Gardner said. “We can do a better job of communicating those best practices to providers and ensuring they are used when they are the right treatment for the patient. And we can continue to advocate for adequate funding and other improvements in our clinical research infrastructure. We can continue to make an important difference.”

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