Author + information
- Alfred A. Bove, MD, PhD, FACC, ACC President⁎
- ↵⁎Address correspondence to:
Alfred A. Bove, MD, PhD, FACC, American College of Cardiology, 2400 N Street NW, Washington, DC 20037
The raging debate on health care reform involves, among other things, a new topic called “comparative effectiveness.” The American Recovery and Reinvestment Act of 2009 invested $1.1 billion in comparative effectiveness research (CER), indicating that there are a number of people in government who think that this effort will have a significant impact on medical practice.
The original discussions about comparative effectiveness revolved around reducing cost by examining various medical therapies and tests to determine which produced the lowest cost while preserving the same outcome in care. This approach has often been used in evaluating consumer goods to determine which provide the best value for the cost. This idea is not lost on spending for medical care. The reason for the studies was obviously to lower health care costs, but it quickly became apparent that using cost as the basis for selecting the value of a therapy or test could compromise quality of care. This is particularly true because of the wide variation in patients based on age, ethnicity, sex, and so on, where one therapy might be the best for one type of patient, but not for others. A number of organizations, including the American College of Cardiology, developed principles for CER (1) and stated clearly that comparisons of various therapies or tests would be appropriate, but only if measures of clinical value were used as comparators. The organizations that are tasked with reviewing the research proposals and distributing the funds (National Institutes of Health, Agency for Healthcare Research and Quality) are cognizant of the difference between a cost-based study and a clinically-based study and are prepared to fund CER in a wide variety of topics.
To identify relevant topics, the Institute of Medicine assembled a group of experts in health care to develop a list of priorities for CER (2). In it, they listed the first 100 topics in 4 quartiles of priority. Cardiovascular disease is listed as a high priority for CER. The highest quartile includes atrial fibrillation as the only cardiology-related comparative effectiveness question in need of urgent research funds. The specific comparison recommended for comparative effectiveness was between medical therapy for atrial fibrillation and ablation therapy. This is indeed an unanswered question in cardiology practice, and a well-designed study that identified those patients who would benefit most from ablation would be welcome information. Although we do not have direct comparisons under the rubric of comparative effectiveness, many of the clinical trials that provide the basis for guidelines and practice standards in fact compare various therapies or tests and provide guidance on the relative clinical value of the therapies or tests being discussed. Cost, however, has not been a part of guideline development, and it is likely that future guidelines will provide some discussion of cost as well as relative efficacy when discussing treatments or tests. Because the effectiveness of our therapies, and to some extent cost, is incorporated into all of our clinical decisions, having real data on many of these choices should improve care.
Soon to be announced will be proposals to conduct CER to answer a variety of questions regarding the best way to treat diseases and deliver health care. We have had the opportunity to meet with the National Institutes of Health and Agency for Healthcare Research and Quality directors to gain some insight into how the process of CER will go. It is clear that CER proposals will undergo peer review and the usual critique that we are familiar with in the grant application process. So, like any grant application, the projects must be focused, carefully thought out, and well supported by literature review and, optimally, prior related research. The addition of over $1 billion to the research pool will provide many opportunities for obtaining research funding for these projects. With so many questions that arise in a typical clinical day in cardiology, there is nearly an infinite number of comparisons of therapy that can be studied to improve practice efficiency and clinical outcomes.
And what about cost? Should we ignore all cost considerations when deciding on tests or therapies for an individual patient? Generally, we tend to ignore cost, and seek the best therapy for each patient based on anticipated clinical benefit. But this concept cannot be extended to all therapies. Cardiac transplant is an example. If an end-stage heart failure patient is considered for transplant, the case must be presented to a committee of physicians, nurses, social workers, and financial representatives who must determine if the cost of the transplant is supported by insurance and if the patient will be able to afford the complexity of medications needed after transplant. We have seen post-transplant patients die because they could not afford their medications and were too embarrassed to ask for money to buy them. There are many situations in medicine in which cost does become an issue in deciding on therapy. With data from CER studies, both clinical outcome and cost choices will be supported by data so that decisions can be better informed.
We understand that health care is becoming unaffordable for many individuals and families. Spending excess money on care, therefore, does have an impact on others who are not covered when there are inadequate funds for the collective health care of the country. We have a responsibility to be stewards of our health care system. This includes being aware of excess costs when making decisions on care, particularly when a high-cost test or procedure has no incremental clinical benefit over other less expensive procedures.
My personal sense is that this kind of information will improve quality of care and efficiency, and if done well, will lower costs. It is essential that cost does not become the principle focus of CER. Application of comparative effectiveness data should be through guidelines and practice standards that are carefully reviewed by a committee of peers to be certain that the information is applied appropriately. The research is not expected to produce useful information for 4 or 5 years. By then, many of us will be using electronic information systems for day-to-day patient care, and comparative effectiveness data, guidelines, and other information will be built into these systems to provide point-of-care decision tools to aid in providing high quality care.
- American College of Cardiology Foundation
- Drozda J.P.,
- Bufalino V.J.,
- Fasules J.W.,
- et al.
- Committee on Comparative Effectiveness Research Prioritization, Institute of Medicine