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Networks Aim to Bridge Gap Between Clinical Research, Medical Practice

Charles Marwick

Obtaining the benefits from clinical research in everyday medical practice must involve practicing physicians, and ways have to be found to encourage research in general medical practices, both for the physicians’ and patients’ benefit, concluded a panel of experts convened by the Institute of Medicine’s Clinical Research Roundtable.

At a recent workshop, the group examined ways to bridge the gap between clinical research findings and their application in medical practice. Putting these findings into practice inevitably involves research. In this sense, clinical research does not stop with academic research; it is a seamless process that continues in medical practice.

Practice-based research may effectively bridge the gap between formal research studies and clinical practice, suggested Kurt Stange, M.D., a workshop participant. "A great deal of research is performed in the academic environment, which is really an unusual environment. Then we wonder why that research doesn’t translate into the world of everyday practice," said Stange, who is a practicing family physician and a professor of family medicine at Case Western Reserve University, Cleveland. "So, our idea is to make the medical practitioner the research laboratory. The result is that there’s not a translational problem because the research is being done in the area in which it is applied."



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Dr. Kurt Stange

 
However, he continued, there are some serious concerns that face practice-based research. "It’s a stress on the practice. There’s basically no slack in the system, and there are administrative burdens," he said. To that extent, practicing physicians who are asked to conduct clinical research will view it as "just one more thing to add to their practice, [and] it’s not going to fly," he said.

From the clinicians’ point of view, there are a lot of competing influences, said Edward Campion, M.D., senior deputy editor at the New England Journal of Medicine. Physicians face a stream of messages from the media and expectations from patients, not to mention the demands of payers and government regulations, and fear of legal implications. Implementation of one more research advance is seen by clinicians as one more burden, he said at the workshop. "The real challenge to the research community is to find some way of becoming allies with clinicians to effect changes that will make practice not only better but make it easier to delivery quality care," he said. "It’s not a small challenge."

Meanwhile, a considerable amount of clinical research is already being done in the clinic, pointed out Kenneth Getz, president of CenterWatch, Boston, a health care organization. "Fifty percent of industry-sponsored research is conducted in clinical settings—40,000 clinical trials in 8,000 different locations," he said. He noted that a large percentage of those doing these studies are part-time investigators and community based physicians, who do perhaps one trial every 2 or 3 years.

In the field of cancer prevention, the National Cancer Institute’s Community Clinical Oncology Program provides resources to community physicians so they can participate in NCI-sponsored clinical trials. There are more than 50 CCOP centers set up throughout the country to work with practice-based physicians.

More Than Clinical Trials

However, clinical research is not limited to clinical trials. It includes observational studies, cost-effectiveness studies, and translational studies, said Myron Genel, M.D., associate dean for government and community affairs at Yale University, New Haven, Conn., and a Roundtable member. Such studies are uniquely suited to medical practice.

A number of organizations have taken steps to develop practice-based research networks, enlisting physicians’ services to investigate issues that occur in the health care system.

There about 60 of these networks around the country, and the number is growing, said Stange. He noted that practice-based research is hardly new; he cited the promoting of such research by the Royal College of General Practitioners in Britain.

At the workshop and in an interview, Stange described such a network of primary care physicians in northeastern Ohio, part of a larger movement in the development of practice-based research networks that focuses on improving preventive service delivery.

What began as an interest in helping clinicians improve their preventive services turned into a large observational study called STEPUP—Study to Enhance Prevention by Understanding Practice. "We looked at how care is actually provided, how practices are actually organized, and the place of prevention among all the other competing demands of general practice," Stange said.

"We discovered a surprising variation in practices. This means that a one-size-fits-all approach is unlikely to be effective," he continued. "Intervention works best when it is tailored to the individual practice, counseling being the main focus of the intervention. What’s important in practice-based research is that physicians have a voice in it."

From there, the group designed a randomized trial for 80 medical practices of ways to deliver cancer prevention services. Doctors were given a menu of options that had been shown could be effective in improving their delivery of cancer preventive services, Stange said. At the end of 12 months, Stange and his group found a statistically significant increase of between 31% and 42% in the use of preventive services by the intervention group compared with the control group ( Am J Prev Med 2001;21:20-28[Medline]).

Maintaining Success

But what is even more important, Stange said, is that this intervention rate has now been maintained for 24 months. The key to this success was that the delivery of preventive services was individualized to meet practice needs, he said.

A similar network is being developed by the American Association of Family Physicians. "This is a new endeavor, based on our conviction that science and research needs to be at the core of what we do," said John Hickner, M.D., director of the AAFP’s practice based network, in Lansing, Mich. "There’s a cultural revolution taking place in family medicine right now, but research has not been a large component. My contention is that over the next 5 to 10 years family physicians will become more interested in the generation of new knowledge to improve care."

The network has 202 members in 32 states, and Hickner said that the plan is to expand the network to 300 doctors by the end of the year with an ultimate goal of enlisting 1,000 physicians. Specific projects include managing diabetes, a randomized trial into controlling problem drinking, studies in post partum depression, and a randomized trial of smoking cessation efforts.

Hickner noted that, besides the AAFP, there are other physician groups engaged in research. He mentioned psychiatrists, gastroenterologists, and dermatologists. "The word is getting out. It’s happening. There are other networks out there. We’re not alone," he said.

The Agency for Healthcare Research and Quality has given some infrastructure support and planning grants for these networks. Nevertheless, a number of the workshop participants pointed to the need for adequate funding. "We need to put some money into this so as to figure out what is worthwhile," Hickner said.

The roundtable’s discussions are available on their Web site at http://www.iom.edu/crr.


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