Primary care practice-based research comes of age

Physician-researchers are struggling with data management, privacy and funding issues to find the answers they seek.

By Victoria Stagg Elliott — Posted July 4, 2005

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Lance Reynoso, MD, a family physician at St. Mary's Hospital in Grand Junction, Colo., has lots of questions.

He knows, for example, what the hemoglobin A1c number should be for his patients with diabetes. But he isn't sure that using it as a target is always worthwhile.

He also knows how to interpret lab results but wonders about the best way to communicate the information to his patients and convince them to take necessary action.

"I don't care if scientists have found out how many mitochondria divide in a hair," he said. "There are so many unanswered questions when patients come in that we have to look at."

These kinds of uncertainties are what motivated Dr. Reynoso to be involved in the Colorado Research Network or CaReNet. This group is a local, practice-based research network and one of a growing number of such entities, which enlist primary care physicians to turn real-world practice experiences into a lab that can lead to real world solutions.

Growing pains

The concept of PBRNs emerged in the past 30 years and picked up steam in the last decade. At least 111 networks were operating at the end of 2003, an increase from just 28 in 1994.

With the bump in numbers has come more credibility. These networks increasingly are being viewed as vital sources of scientific data. But most experts feel that they are now also dealing with lots of growing pains.

For this reason, the Agency for Healthcare Research and Quality published a supplement in the May/June Annals of Family Medicine featuring multiple papers exploring future challenges. This collection is the first of what the agency hopes will be a series of educational efforts examining the development of these kinds of research networks -- whether funded by the agency or not.

"There's no way we can provide [financial] support for them all, but we wanted to get out some education in an accessible format," said David Lanier, MD, who wrote the lead editorial and is the associate director of AHRQ's Center for Primary Care, Prevention, and Clinical Partnerships.

Among the trials these PBRNs face, according to the AHRQ supplement, is the fact that they are struggling to determine the best way to manage data produced over the many decades that patients might interact with a primary care practice -- a timeline different from the few months or years encompassed by most clinical trials.

"These are pretty large data sets," said Tillman Farley, MD, director of Salud Family Health Centers in Lupton, Colo., who is also involved in CaReNet.

Data management is further complicated by the requirements of the Health Insurance Portability and Accountability Act. Most experts say the law itself is not necessarily a barrier, but the way it is interpreted can be, and negotiating the particulars requires very careful planning.

Networks also must gain approval from numerous institutional review boards rather than just the one, as is the norm in academic settings.

"Going through one is bad enough," Dr. Lanier said. "Going through 12 or more is very bad."

In addition, funding is not always easy to come by. AHRQ, which bankrolls much of this type of research, has a much smaller budget than the National Institutes of Health, and leveraging support from other sources can be difficult because the research in question might lead to better care but may not have much commercial appeal.

"We're not like biotech companies," said Wilson Pace, MD, author of two of the papers and a University of Colorado professor of family medicine. "We don't get venture capital coming in."

Finally, these networks are struggling with the question of how to train doctors to be good researchers, in addition to being good physicians.

"If you say a practice is a lab, how do you train physicians to be quality researchers because they're not going to take a statistics and methods course? That's tough," said T. Michael Harrington, MD, chair of the Dept. of Community and Family Medicine at the University of Alabama School of Medicine at Birmingham and director of the Alabama PBRN.

Becoming learning communities

Those who run PBRNs, though, say they are becoming more than just labs. They are becoming learning communities for physicians and engines for quality improvement.

"What we are trying to do is create a new culture which says we need research as part of your every day life," Dr. Pace said.

But whatever the future holds, it's clear that this phenomenon is gaining more respect. Translational research is the centerpiece of the NIH Roadmap to Medical Research published in September 2003. The American Medical Association has also repeatedly issued policies calling for adequate funding for this kind of science.

"It's the beginning of a revolution in how we think about medical research," said James W. Mold, MD, MPH, author of one of the papers and director of the research division in the Dept. of Family and Preventive Medicine at the University of Oklahoma Health Sciences Center, Oklahoma City. "And the crucial issue for networks right now is financial viability during this period of transition to a new model."

These networks are also being replicated throughout primary care and beyond into other medical specialties. In 1994, the 28 networks in existence were almost entirely made up of family physicians. This primary care specialty is still dominant, but pediatrics and internal medicine have both gotten in on the act. These networks are also starting to spring up in specialty care.

"If imitation is the sincerest form of flattery, we're being flattered," Dr. Lanier said.

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Growth spurt

The number of practice-based research networks increased significantly in the past decade.

  • 28 PBRNs operated in 1994, made up almost exclusively of family physicians.
  • 111 PBRNs operated in 2004, most with family physicians, but also networks of pediatricians, internists and other specialists.

Source: Annals of Family Medicine, May/June

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External links

Contemporary Challenges for Practice-Based Research Networks, Annals of Family Medicine, Supplement, May/June (link)

"Translating Biomedical Research Into Clinical Practice," American Medical Association Board of Trustees report, June 2004 (link)

National Institutes of Health's roadmap to medical research (link)

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