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Dr. Clif Cleaveland

From the moment the Accountable Care Act was ratified in 2010, critics of the law have contended that it gives the federal government authority to dictate how medical care will be dispensed.

The specter of "death panels" staffed by nameless bureaucrats is raised by opponents of the ACA. These would replace the doctor-patient relationship. Specific care would be mandated based on inflexible regulations.

This is nonsense.

The Patient-Centered Outcomes Research Institute was among the first provisions of the ACA to be activated. Its task was to research best available care options for patients and care providers as they confront various health challenges. The panel is advisory and charged with establishing sound science for clinical decision-making. ACA provided vital funding to broaden and speed up research.

For years, the U.S. Preventive Services Task Force ( convenes independent committees to address specific problems in prevention, diagnosis and treatment. Expert panels evaluate scientific evidence to determine safest, most effective approaches for a variety of illnesses. Research related to a specific illness will vary widely in experimental design and quality. Performing detailed analyses of reports from hundreds of research papers in international journals is expensive and tedious. Guidelines derived from the process are published regularly in scientific journals. The recommendations are not binding but illustrate best available practices.

An example of a task force guideline: A 38-year-old woman asks her physician when she should begin periodic mammographies to screen for breast cancer. The guideline recommends biennial mammograms from age 50 to 74, based on the most recent published evidence. The guideline further states that the patient and physician may choose an earlier time to employ screening based upon individual circumstances.

Clinical studies that inform the process can be quite costly, involve multiple hospitals and scientists and extend over many years. These may be financed from grants from the National Institutes of Health, private foundations or pharmaceutical and medical device companies. Rigorous analysis of data may reveal a new approach to treatment or validate an older therapy. Studies that are funded by for-profit companies may not be free of bias.

An application of a clinical study: A 50-year-old man arrives at an emergency room 45 minutes after the onset of severe chest pain. Examination and tests indicate an extensive, acute heart attack. A variety of treatment options can be employed singly or in combination - clot-dissolving medications, other drugs to stabilize his condition, cardiac catheterization for diagnosis and treatment, surgery. Caregivers base treatment upon protocols derived from the most recent study, but which treatment is best in terms of safety and outcome? If there are options with identical outcomes, which is least expensive or more suitable for a community hospital? Which therapy is better for the patient's unique characteristics?

With thousands of conditions to consider and countless options for diagnosis and treatment, caregivers are dependent upon prompt access to what is best in a given circumstance. At the point of care, a guideline provides a consensus of the top standard of care at that moment.

The evaluation process must be as free of bias as possible. Funding must come from neutral sources and engage experts with no commercial or institutional connections. The federal government is the logical sponsor. Because science is always advancing, evaluations require repeated amendments, updates or replacements. There is no way an individual caregiver can keep up with the volume and pace of medical advances without help.

Expanded research into clinical outcomes should include comparisons among drugs used to treat similar conditions. Most new drugs are compared only against placebos and not against older medications which may be much less expensive or safer. Surgical versus non-surgical care for circulatory disease should be compared. Therapies for such common problems as low back pain could be studied. Traditional and alternative therapies for pain relief could be assessed. The list of needs is long.

ACA includes provisions for extending health insurance coverage, controlling costs and improving quality. Outcomes research is crucial for the latter two.

Contact Clif Cleaveland at