THE BLOG
01/26/2012 04:23 pm ET Updated Mar 27, 2012

Comparative Effectiveness Research

Physicians are not likely to admit and patients would not be happy to learn that much done in the practice of medicine is based on little more than custom. Historically, the absence of well designed, statistically sound randomized clinical trials, RCTs, has not discouraged the introduction and use of ineffective, costly treatments with significant risks and complications. The status quo plays a large role in the reluctance to question let alone abandon established practices even though we can no longer afford the costs associated with untested and unproven treatments of questionable efficacy.

Recently a move to promote what has come to be known as evidence based medicine has changed the process of examining and testing new therapies before clinical approval and adoption. Many believe the best opportunity to reduce the rate of increase in the cost of medical care is comparative effectiveness research, CER.

CER involves rigorously designed RCTs to evaluate contrasting approaches to the treatment of a specific condition with the goal of identifying the best among them based on objective measurable indices.

While CER can't guarantee definitive accurate conclusions about the effectiveness of a given treatment regimen, without such studies, it is not possible where there are alternatives to justify the use of one rather than another. The current need to control the costs of medical care demands that even medical procedures currently accepted as the standard of care must be validated by well designed RCTs. The fiscal environment will result in payers demanding that all therapeutic regimens be proven to be effective before judging them eligible for reimbursement.

Recently studies have been initiated to evaluate established practices adopted without such substantial proof of effectiveness. Regrettably, many after being subjected to greater scrutiny have been found to be not as effective as originally thought.

The Affordable Care Act, known as Obamacare, has many mechanisms that could, if appropriately implemented, have the effect of limiting practices to those that are supported by CER. This will encourage CER and represents the potential for substantial savings. There are legitimate concerns about just how these issues will be identified and implemented and the text of the legislation leaves some questions about just how this goal could be achieved. The recognition that better effective procedures justified on a cost benefit basis demands the evaluation of treatments, tests, technologies, systems of care delivery all coordinated with payment policies. This involves redesigning many of current practices with regard to reimbursement.

The adoption of CER represents a significant change in the current culture of clinical medicine. Clinicians, administrative officers, and payers will have to be willing participants and accept changes. This will only happen if patients are educated to demand care that has been proven to be effective and the best management of their condition. Absent these changes in our approach to the identification of best practices the cost projections of the ACA cannot be achieved.

It is a fact and may come as an unpleasant surprise that there are large differences in the outcomes of treatment for many diseases that are difficult if not impossible to explain. Simply acknowledging these differences exist is both helpful and useful in pursuing the best of alternatives. Of course, without the assessment of the data pertaining to critical clinical decisions, including the individual preferences for treatment of the physician, decisions about the appropriateness of treatment options and evaluation of outcomes is not possible. Ultimately, treatment decisions are made by patients, relying predominantly on the judgment of their physician, and perhaps secondarily influenced by the policies of their insurance carrier who in many cases is a surrogate for their employer who has chosen to provide a given medical care benefit structure. In the final analysis, the information that the patient needs to make a informed decision is most frequently obtained from the physician whose responsibility it is to present treatment options, their risks and benefits. Patients then can consider their options in the context of their preferences in selecting any procedure from diagnosis to treatment.

CER is not an academic issue. It is brought into sharp focus where a condition can be managed by any number of currently acceptable therapeutic options. This is the case for many common diseases including prostate and breast cancer, coronary artery disease and stroke. Patients should explore the available data with their physician when a choice is to be made among alternatives.

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