American Academy of Ophthalmology Web Site: www.aao.org
Clinical Update: Eye on Eye Medicine, Part One
The Studied Eye: Community Research Comes of Age
For many ophthalmologists, the decision to enter private practice instead of pursue an academic career was not an easy one. For those who chose the former but still hear the call of research, it's not too late. The growth of clinical trials based in ordinary health care settings now allows some private practice ophthalmologists to enjoy the best of both worlds: community-based research.
In contrast to large, institutionally based trials, community-based studies are designed to enlist the patients of MDs in private practice and local health clinics. In this model, the data collected by a small-town eye doctor who enrolls only a few patients is just as important as that amassed by a researcher at a large academic center. Practice size and geographic location are not obstacles to participation. In fact, many community-based clinical researchers serve on their network's protocol development committees, help write papers and speak at meetings.
To Treat a Community, Go to It
The National Eye Institute has pioneered some large, multicenter community-based trials. Over the years, these collaborative arrangements have produced dividends in ophthalmic conditions such as herpetic eye disease, cornea transplantation, diabetic retinopathy and amblyopia. Physicians involved in the studies say that having office-based ophthalmologists participate in clinical research offers many benefits, not the least of which is providing a real-world perspective to study designs and outcomes.
Find Him in His Community
More patients become available. Roy W. Beck, MD, PhD, director of the Jaeb Center for Health Research in Tampa, Fla., has been involved in coordinating clinical research networks for the NEI since the mid-1980s. "I became interested in doing projects that involved community-based private offices in part because it can provide a different population of patients than is seen only in universities," he said. "It also has the potential to bring a larger number of sites and patients into a study."
Diversity improves the data. Donald F. Everett, MA, program director for collaborative clinical research at the NEI, agreed. "One of the criticisms of academic-based studies is that the patients who are enrolled are the types who end up in the large tertiary academic medical centers and who may or may not be a good reflection of the general patient population." He added that community-based research also allows researchers to recruit Hispanic and African-American patients and other populations they might not have had access to otherwise. "By having more clinical centers involved, with more diverse populations, we think we get better results in terms of being able to treat the general population."
Dr. Beck sees a long-term benefit as well. "In the end, it's the community-based practices that are going to have to implement whatever recommendations come out of clinical trials. It's a real advantage to be doing the studies in the setting where the results will need to be implemented."
The Current Opportunities
The two large NEI-supported networks that are actively recruiting new sites are the Pediatric Eye Disease Investigator Group (PEDIG) and the Diabetic Retinopathy Clinical Research (DRCR) network. Dr. Beck oversaw the formation of the PEDIG network in 1998 and the DRCR network in 2002.
"Not much pediatric research was going on at the time," he said. "Much of the care for children with eye problems"”primarily strabismus and amblyopia"”takes place in the community. So there were a large number of relatively common pediatric eye conditions that had never been well studied."
A boon for pediatrics. The PEDIG network now has about 70 centers, approximately three-quarters of which are community-based private offices. Dr. Beck said the group has completed roughly 13 studies, including several major studies in amblyopia. Seven studies are under way, and four new protocols are starting this year.
Diabetes, too. The DRCR network comprises about 150 centers, approximately two-thirds of which are private practices. Like PEDIG, the DRCR network has multiple studies under way at any given time. Three new protocols are starting this year. These research networks are open to any ophthalmologist who has the relevant credentials: retina specialists for the DRCR network and pediatric ophthalmologists for the PEDIG studies. Network physicians choose their level of involvement. Some may participate in one or two protocols, whereas others may opt to be involved in as many projects as possible.
The Nuts and Bolts of Generating Data
Ophthalmologists who join these networks go through a formalized, Web-based general training program on clinical research. The program addresses issues such as how to work with research subjects and consent forms. Each protocol then requires additional specialized Web-based training for the physician and support staff. Training is funded or provided by the NEI, which helps ensure that all research is conducted in the same manner.
Study coordinator. Every office-based research center has a coordinator who performs administrative tasks, such as keeping track of appointments, maintaining records and filing reports.
Study assistants. In addition, if specific ophthalmic tests are required, the individuals who will perform the testing are trained and certified. Dr. Beck said the PEDIG and DRCR groups now use computerized visual acuity testing, and each center is supplied a computer that runs a specific testing program, again funded by the NEI.
Data delivery. "We supply all the centers with touch screen tablet computers that can be set up to be wireless so they can be taken from room to room," Dr. Beck explained. The computers are linked to the study's database in Tampa and provide real-time interactive instructions as the doctor examines each patient.
"As doctors input data, the computer tells them what to do next," Dr. Beck added. "This is another way we can maintain quality control when we have a hundred centers and practices. We're checking the data at the exact time it is being collected."
Clinician check-in. The networks hold at least one or two investigator meetings each year, plus side meetings at specialty group conferences.
Challenges and Rewards
Scott M. Friedman, MD, a private practice retina specialist in Lakeland, Fla., is an active participant in the DRCR network and an enthusiastic proponent of community-based clinical trials. "You learn something new every day," he said, "and we're getting good information on how to treat patients with diabetes. The only way you can do that is with these randomized clinical trials."
Physicians must make some time. But being in a clinical study does alter your normal practice, Dr. Friedman cautioned. "You have to make room in your schedule to see the study patients. Some people set aside clinical trial days, when they see only study patients, but I tend to just fit them into my normal schedule. We've also found it helpful to have a separate clinical research area a little off to the side."
Patients must make some commitment. He noted that careful screening of potential study participants is critical to keeping the dropout rate low. "They need to understand up front that participation will require more frequent visits for the duration of the study."
Even so, it can be challenging for patients to stick to the protocol. Work obligations, illness or travel may make it difficult for some patients to keep appointments. As a result, the physician and office staff sometimes need to be flexible by staying late or coming in early.
Always abreast of the news. David I. Silbert, MD, a pediatric ophthalmologist in Lancaster, Penn., is part of the PEDIG network and believes that being involved in the research studies has been beneficial for him as well as his patients. "Being in the study, I really know what's going on in pediatric ophthalmology. I know about new options, and I'm exposed to things I never would have been exposed to otherwise." His orthoptist is now on the planning committee for the network's Bangerter filter study.
"It's useful and it helps us learn and gain more information," Dr. Friedman added. "So I'm willing to do whatever I have to do to make the system work, whether that's staying late, coming in early or at unusual times, hiring new employees or attending meetings. It all pays off in the end."
Editors Note: "The Studied Eye" is the first installment in a seven-part EyeNet series on contemporary issues in ophthalmology. From now through November, "Eye on Eye Medicine" will take a close look at topics as diverse as the standing of ophthalmology in modern medical education, the state of the science of pain control and the emergence of popular physician chat rooms. This series will explore the larger social and professional context of medicine today, and how the issues facing medicine generally are affecting ophthalmology in particular.