IOM Report Envisions National Program for Evaluating Scientific Evidence

The federal government should create a new program with the authority to set priorities for evaluating clinical services and conduct systematic reviews of scientific evidence to determine what works in health care, according to a new report released by the Institute of Medicine, or IOM. That program also should develop (or endorse) rigorous standards for clinical practice guidelines and promote preferential use of those standards-based guidelines to health care providers, payers and others.

"We need a way to synthesize data about the effectiveness of health care products and services in a standardized, objective fashion that will be considered reliable and trustworthy by all decision makers," said Barbara McNeil, M.D., Ph.D., Ridley Watts Professor and head of the department of health care policy at Harvard Medical School and chair of the committee that wrote the report, in a press release. "A system coordinated by a single, national entity that can prioritize and coordinate these evaluations would enable us to sort the wheat from the chaff and make sense of it all."

The report says Congress should direct HHS to create a single entity or program with the authority and the capacity "to ensure production of credible, unbiased information about what is known and not known about clinical effectiveness." The program also should have the authority to:

In addition, the program should create a system for prioritizing research based on the most pressing needs facing the nation, not on the availability of research funding, the report says.

"Researchers conduct research on whatever topic they get funded for or are interested in," said Arthur Levin, M.P.H., director of the Center for Medical Consumers, New York, and one of the authors of the report, in an interview with AAFP News Now. "We are trying to make sure that the research that gets done meets the most pressing needs of our health care system and society."

The IOM study, "Knowing What Works in Health Care: A Roadmap for the Nation," does not call for the creation of a new government agency. Instead, it recommends the establishment of a program within the federal government to coordinate the standardization of clinical studies and other activities. The standards promoted by the program would not have the force of law, but it is hoped they would become widely used and accepted by providers and other stakeholders.

"We clearly came down on the side of not letting the system go on as it is," said Levin. "But we also didn't come down on the side of creating a new government bureaucracy."

The study looked at how various agencies and organizations review clinical studies and materials and how they determine which information should be adopted by the nation's health care system, said Levin. He described the current system as a "free for all," which lacks universal standards or criteria. For example, "there is nothing out there that says you have to use a standard grading system" for evaluating the strength of evidence, said Levin "In fact, nobody does. A lot of organizations who make clinical recommendations will tell you the grade of evidence behind it, but they use different grading systems so there is no comparability."

According to Levin, the report notes that there are more than 240 guidelines on the "right way" to treat hypertension. "That makes no sense," said Levin. "That doesn't mean there is only one way to do it, but there certainly cannot be hundreds of 'best practices' to treat hypertension based on the same body of evidence."

By adopting the report's recommendations, the federal government would bring "trust and openness to the health care system," ultimately improving patient care, said Levin. The report specifically suggests how conflicts of interest should be addressed if public trust is to be earned.

Not surprisingly, the report has generated interest during the current presidential election year.

"We spend twice as much as any other country on health care, and we are not getting the results for our money," said Levin. "So the need to increase the value or efficiency of our health care system becomes critical, particularly when some of the candidates are talking about bringing some or all of the uninsured population into insured status."