Proceedings of the Meeting of the Radiology Research Association

Vol 5, No 10, October 1998

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Proceedings of the Meeting of the Radiology Research Association March 1998 "Control the research, control the technology" was the theme at the recent symposium sponsored by the Radiology Research Association at the Association of University Radiologists (AUR) meeting on March 26, 1998. While a great deal of research has been done in radiology departments, much of it has been descriptive. Radiology has benefited from the technology explosion that has brought new imaging modalities to the clinical arena. As these new modalities were developed, it was essential to describe the manifestations of disease seen with those imaging modalities. Our field is now maturing, and we must use these powerful tools to look at more basic questions of disease pathophysiology and to understand how results of radiologic examinations contribute to patient care and the ultimate clinical outcome. The Academy of Radiology Research (ARR) arose from the efforts of Drs Baum, Bragg, Maynard, Putman, and others, as well as the active support of the AUR, the American Roentgen Ray Society (ARRS), the Radiological Society of North America (RSNA), the American College of Radiology (ACR), and many subspecialty radiology societies. With the recruitment of Ed Nagy as executive director, the ARR has become an effective organization in making a cogent argument for more direct support for radiology research. The Academy has gained the attention of Congress and helped establish a new Imaging Program at the National Institutes of Health (NIH). Dan Sullivan, MD, was recruited from the University of Pennsylvania to become an associate director of the National Cancer Institute (NCI) and head the new Imaging Program. The NCI is the largest of the 18 institutes at the NIH. It consists of six divisions, three intramural and three extramural, and submits its own (bypass) budget. The goals of the Diagnostic Imaging Program are to coordinate imaging research within the NCI, to manage the grant portfolio, and to initiate new requests to application (RFAs). Most grants submitted to the Diagnostic Imaging Pro-

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gram will be assigned to one of two study sections. The Diagnostic Radiology Study Section has a clinical sciences emphasis and is chaired by Robert Grossman, MD. The Diagnostic Imaging Study Section has a basic science emphasis and is chaired by Steven Fritz, PhD. When submitting grants to the NIH, it is important for investigators to designate the study section theN would like to review their grant application. Otherwise, the grant may be routed to a study section with little, if any, radiology input. In an effort to enhance communication with the imaging community, Dr Sullivan has started an e-mail newsletter and plans to place advertisements in Academic Radiology. Investigators submitting new RO1 grant applications may be eligible for accelerated executive review if they score near, but not under, the payline. Investigators may also appeal a study section review if the investigator believes that the review was inappropriate. The budget of the NIH is increasing and is projected to have further increases over the next several years. In fiscal year 1997, a total of $113 million in grants was awarded to radiology departments for imaging studies. This is an increase of $8 million, or 7.6%, compared with fiscal year 1996. The total amount of NIH funding for imaging research in all departments is approximately $200 million. The largest share of these grants come from the Diagnostic Imaging Program of the NCI. NIH funding is a competitive process. Successful applicants have often benefited from specific training, grantsmanship seminars, and mentoring. The quality of the grant submission may also be improved by the study section reviews, as the success rate on reapplications is much higher than first-time applications. There are two new grant initiatives that are of interest to radiologists. RFA CA 97 020 is for cooperative trials in diagnostic imaging. The grant awardee is expected to create a network to perform multiinstitutional clinical trials in imag-

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ing related to cancer. The second new announcement is for exploratory and/or developmental grants for diagnostic cancer imaging. This will use an R21 mechanism and will be reviewed on innovation rather than the extent of preliminary data. Grants will be made for $100,000 per year for 2 years. Imaging priorities established by the Diagnostic Imaging Program include functional imaging, pattern recognition, and image enhancement, as well as image-guided diagnosis and therapy. These priorities reflect what is most important to oncologists and patients. There are seven Working Group Task Forces. These include screening and early detection, in vivo molecular imaging, emerging technologies, technology development, image-guided treatment, evaluation]approval process for new technologies, and training. The development of a strong radiology research program must begin with our trainees. Jannette Collins, MD (University of Wisconsin), reported that research is required in only 21% of radiology residencies. It is much more likely that research is required in other specialties. For instance, research is required in 64% of residency programs in obstetrics and gynecology. Success in producing successful investigators from our radiology residencies may require a specific course in research, as well as other programs to foster and reward research efforts. Dr Collins recommended that research be strongly encouraged and that electives of several months in duration be offered to interested residents. However, these research electives should require a research plan, identification of any space and equipment that may be needed, and a mentor. Residents should be given additional funds to present the results of this work, and faculty should be rewarded for their mentoring support. Residents could also be rewarded for their research activities by providing other benefits such as inviting them to dinner with visiting faculty. Residents should be encouraged to attend the annual meeting of the AUR, and their expenses should be funded. Both incoming and outgoing chief residents could be sponsored to attend the meeting of the American Association of Academic Chief Residents in Radiology. In addtion to the AUR, both the RSNA and the ARRS support research by

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residents through funded prizes, scholarships, and educational programs. Residents must be encouraged and supported to participate in these programs. Dr Philip Alderson (Columbia University) reminded us that the practice of radiology is interesting and rewarding. To entice residents to stay in academic medical centers, they must be enthusiastic about those aspects of an academic practice that are different from private practice. These include the ability to practice one's chosen subspecialty; the opportunity to teach; the interaction with medical students, residents, and fellows; and, most important, involvement in research. Today's research is tomorrow's clinical practice. It was pointed out by David Levin, MD (Thomas Jefferson University), that our entire knowledge base in radiology has been established by research, and that most of this has been unfunded work. "Unfunded research" is, of course, a misnomer, as the time allotted to faculty and the resources used are provided by the department. With the emphasis on cost containment and the diminished reimbursement per case, it is increasingly difficult to find the resources to support this work. As our clinical work increases in an effort to compensate for decreased reimbursement, it becomes difficult to find time for research. In an effort to generate additional revenues to support research, the radiology department at Thomas Jefferson University has become entrepreneurial by providing services on contract for several off-campus organizations. The need for efficiency is also affecting our subspecialized way of practicing radiology. To be more efficient, faculty must work in more than one division. Common exceptions include nuclear medicine, vascular/interventional radiology, neuroradiology, and pediatric radiology. Incentives for faculty productivity must be significant in order to be effective. Disincentives include a fixed salary and the tenure system as currently practiced in many of our university programs. The most critical time in a faculty member' s career is the beginning. Junior faculty have little experience in the field and often do not appreciate the problems in need of investigation. Thus, junior faculty must be nurtured by providing o

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them with more academic time than generally is afforded more senior faculty. Furthermore, it is essential for them to work in an atmosphere in which research is valued and to have the support of an academic mentor. To have a viable research program, it is essential to have an infrastructure that includes people with skills in biostatis" tics, epidemiology, and outcomes research. Since there is intense competition for research dollars, successful faculty members need structured training in research methods and other disciplines pertinent to their projects. They must often be supported for 3-5 years before they can become self-supporting with external funding, An effective research program requires time protected from clinical and administrative responsibilities. A survey by Ron Arenson, MD (University of California at San Francisco), compared the amount of work done by radiology faculty as measured by relative value units (RVUs) with NIH funding. It was not surprising that there was an inverse relationship between RVUs per faculty and NIH funding. Health outcomes as described by Bob Bree, MD (University of Michigan), and Curt Langlotz, MD, PhD (University of Pennsylvania), are defined as outcomes of medical conditions that affect the length or quality of a patient's life. A helpful mnemonic is "the 5 D's": death, disease, disability, discomfort, and dissatisfaction. Depending on the imaging test being studied, we may focus on different parts of this spectrum. For example, an outcome study of transvenous intrahepatic portosystemic shunt (TIPS) procedures might use death as the main outcome measure. Death rates are an appropriate outcome measure because they are clinically important, easily quantifiable, and likely to be affected by TIPS procedures. On the other hand, a study examining the effect of spine imaging on the outcome of back pain might focus on disability and discomfort, as measured by functional-status outcome scores. To find the appropriate focus for outcomes research, it is helpful to imagine the encounter between the patient and the referring physician. The referring physician asks the following question: Which imaging test is best for my patient? Research that addresses this question both can be a suitable starting point for those interested in getting started with

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health services and outcomes research and can ultimately help improve patient outcomes. Outcomes research in diagnostic radiology poses several challenges relative to outcomes research of therapeutic modalities. There are several reasons for the additional difficulty: Diagnostic outcome studies must enroll a broader spectrum of patients.--Therapeutic trials have the luxury of enrolling only patients who have the disease for which the treatment is designed. Trials of diagnostic tests must include all patients being evaluated for suspected disease (many of whom may not have the disease in question). The magnitude of outcome benefits of imaging will be smaller than the outcome b'enefits of therapy.--Because many patients enrolled in diagnostic outcomes studies will not have the disease for which the therapy is effective, the benefits of imaging will be small. This result can be proved mathematically. There are some patients at the extremes of disease likelihood for whom imaging tests are not optimal.--Patients who almost certainly have the disease have better outcomes if they are treated without testing. Patients without the disease often have better outcomes if nothing is done. All of these patients may be enrolled in an outcomes trial because it may be difficult to identify them prospectively. A large temporal~causal distance exists' between the testing decision and the patient outcome.--Reasons for this distance include (a) the variability of imaging accuracy among radiologists, (b) the lack of knowledge about how imaging test results should influence therapeutic decision making, and (c) the low or variable effectiveness of available treatments. Because of the complexities listed above, there is simply no substitute for formal training in epidemiology and biostatistics, particularly for those interested in the planning and execution of large-scale prospective clinical trials. Formal training can help radiologists interpret the existing literature, "speak the language" of expert methodologic collaborators, and anticipate the clinical data needed for the design and planning of prospective trials. A good first step would be to attend one of the refresher courses or other meetings that focus on these topics. For example, a refresher course

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and a minicourse devoted to health services research will be held at the RSNA this year. The Society for Health Services Research in Radiology holds its annual meeting this fall, and in 1998 it will meet consecutively with the Society for Medical Decision Making, a scientific organization devoted to this type of research throughout medicine. Despite the methodological complexities, there are severn good ways for those just getting started to contribute to the field. Here are a few examples: Prediction rule development.---To provide clinically relevant results, prospective outcomes studies must categorize patients according to their pretest risk of underlying disease. Valid measures of disease likelihood can be developed and validated through smaller retrospective studies that are of appropriate scope for a new investigator. Feature analysis studies.--Before an imaging technology can be assessed in a multi-institutional outcomes trial, consensus image interpretation methods must be developed. Thus, there is a need for studies that examine the accuracy of various combinations of image features (rather than the typical study that examines the accuracy of radiologists), These feature analysis studies are of appropriate scope for young investigators and can provide a prescription for consistent and optimal image interpretation by radiologists participating in a multi-institutional outcome trial.

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Data synthesis and modeling.--Before embarking on expensive prospective outcomes studies, it is essential to understand the patient groups that are most likely to benefit from imaging. Techniques such as meta-analysis and decision modeling provide important insights that assist the design of prospective trials. Because these data synthesis methods do not require the collection of primary patient data, they can be accomplished with limited resources by those young investigators with an understanding of mathematical models and an ability to evaluate critically the published literature. In summary, large-scale, prospective outcomes trials for diagnostic imaging will most likely be organized and coordinated by those investigators with formal training or substantial experience. Those interested in learning more about such studies could consider serving as a local coordinator for a multi-institutional study. In addition, there are several research methods that are of appropriate scope for the junior investigator and that advance the cause of outcomes research. These methods include prediction rule development, feature analysis studies, and data synthesis and modeling. N. Reed Dunnick, MD University of Michigan Ann Arbor, Mich

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