Roderic Pettigrew, MD, PhD, is director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH). He states his organization’s goal simply: developing technology that can detect disease early, even at the molecular level, long before physical symptoms begin to appear.
“We want to achieve the earliest possible detection so the disease can be treated at its earliest stage,” he says. “In addition, in the past, those processes have been separate: You detect; later, you decide how to treat. We are focused on merging diagnosis and treatment in a single setting, with the ultimate goal of preventing disease.”
Pettigrew defines imaging broadly as the science of observation, and he is not alone in his perception of imaging as a clinical tool that far exceeds the confines of what is known today as radiology. Hedvig Hricak, MD, PhD, chair of the department of radiology at Memorial Sloan-Kettering Cancer Center (MSKCC), New York, New York, and a past president of the RSNA, takes a similarly open view. “Rather than being owned by one specialty, integrated diagnostics will be a collaborative effort. Large amounts of data (generated by each of the involved specialists) will be integrated, with the help of analytical computers, in order to provide the most comprehensive and detailed overview of a certain pathology or disease,” she predicts.
The dovetailing of clinical specialties will be made possible by advanced IT—technology so powerful that it will make today’s informatics systems look like filing cabinets by comparison, Hricak says. “In health-care centers today, we use computers largely for storing patient data,” she says. “Tomorrow, we will use them as intelligent systems that think with us to help us integrate large quantities of information productively.”
Models for this productive integration of clinical data are already being developed in leading institutions around the country. Hricak and her colleagues at MSKCC have a collaborative agreement with IBM to work with the Watson artificial-intelligence system in a clinical setting; on the opposite coast, the University of California–Los Angeles (UCLA) recently formed a Radiology Pathology Center headed by Dieter Enzmann, MD, chair of radiology for Ronald Reagan UCLA Medical Center in Los Angeles.
“A lot of imaging is ordered for either the detection of cancer or the monitoring of cancer treatment,” Enzmann says. “To round out the data, we need something in addition to the imaging phenotype. As molecular therapies become more sophisticated, the clinician choosing between these therapies needs molecular information. Just being aware of a tumor’s size and where it is may not be enough to determine the proper therapy or to follow that therapy.”
While physically integrating the two specialties was comparatively simple—pathologists were located with radiologists in an imaging center—the informatics side of the equation presents a bigger challenge, Enzmann says. “What we are trying to do is create an integrated report from different databases in different departments, and those databases aren’t currently designed to communicate with one another,” he notes. “Then, there is the question of how referring physicians should interact with the integrated report. The goal is to make it easy to use, understandable, and interactive. It’s a work in progress.”
At the University of Florida College of Medicine, Anthony Mancuso, MD, chair of the department of radiology, and Christopher Sistrom, MD, MPH, PhD, CIO in the department of radiology, are collaborating on a conceptual model of diagnostic imaging that maps clinical scenarios and imaging procedures in a 2D matrix. “It’s a way of picturing the domain of imaging. It’s a big space, with millions of plausible cells; any one radiologist might be able to know only a small cluster of cells in the matrix. This is a huge domain that requires a team to figure out,” Sistrom explains.
Daniel Sullivan, MD, professor of radiology at Duke University, heads another such initiative, the Quantitative Imaging Biomarker Alliance (started by the RSNA in 2007). It brings together academic researchers, device manufacturers, and information from clinical trials and clinical practice to develop quantitative measures for imaging. “We can’t get good studies if we just use subjective interpretations of imaging tests,” Sullivan notes. “We need objective measures. For radiology to be relevant in the future, as medicine becomes more of a science and less of an art, we have to rely more on quantitative results that are consistent and standardized.” He continues, “That’s the goal. We want to keep radiology relevant in the era of modern, molecular-based medicine.”
Collaborating to Thrive
Maintaining that relevance could well mean redefining the profession of radiology entirely. Hricak does not mince words when it comes to the importance of further research into imaging’s impact on outcomes. “Radiology is facing economic challenges that make policymaking more complex than ever, and informed policymaking requires evidence-based knowledge that can only be derived from research,” she says.
Udo Hoffmann, MD, a cardiac radiologist at Massachusetts General Hospital in Boston, has firsthand experience with Hricak’s point. As the lead researcher behind the groundbreaking ROMICAT and ROMICAT II trials,1,2 Hoffmann has done work validating the diagnostic and prognostic value of coronary CT angiography (CCTA) in the triage of emergency-department patients with chest pain.
“The important question, for a new technology such as CCTA, is how it works in clinical practice,” Hoffmann notes. “The big debate was whether CT imaging was justified or those resources were being spent unnecessarily. Now, we know that when you have CT, you are much better able to differentiate between patients who have no disease and those who do have disease—and you can spend your resources on the latter group.” Hoffmann and his team’s research has moved using CCTA in the emergency department to rule out myocardial infarction into the mainstream, he says. “It gets the attention of clinicians across medicine now,” he notes. “Integrated diagnostics means symptom-based evaluation—in this case, for chest pain—that integrates imaging into the care episode, with physicians who work together, as a team, to determine an effective treatment.”
This is the goal at UCLA, where Enzmann’s vision of the future is one in which a more accurate and complete diagnosis is a prerequisite value proposition for participation in bundled payment models. “The accountable-care organization needs an accurate diagnosis, and that may mean more than just imaging,” he says. “One of the complaints about medical care is the lack of integration and communication. On the diagnostic side, radiology and pathology can organize themselves to make the diagnostic component of the patient experience highly integrated.” Sullivan shares that vision. “Radiology and pathology will become integrated,” he says. “It is unrealistic to think that a single imaging test would be specific enough, in a predictive way, to be the sole factor for choosing one therapy over another. It would have to be a combination of information from a variety of diagnostic tests, some of which we would traditionally think of as pathology tests.”
Emerging Clinical Techniques
To comprehend the role that pathology and other disciplines outside radiology can play in diagnosis, it is imperative to understand the emerging clinical techniques that are transforming the field of imaging. “Investigating life processes at the microscopic scale opens up a lot of room for new innovations. When you think on that level, integrated diagnostics makes absolute sense. If we think of diagnostics as the science and field of medical observation, it’s radiology and pathology—looking for patterns, shapes, orientations, sites, dynamics, and functional changes—and mapping what occurred and what it occurred in relation to,” Pettigrew explains.
Hricak’s vision for the future involves what she calls preemptive medicine: care that begins at such an early stage that even the term preventive falls short of describing it. “The role that imaging will play in preemptive medicine remains uncertain,” she says, “but it may include the use of molecular imaging, allowing us to visualize cellular function to assess alterations that lead to cancer, or the use of interventional radiology to deliver highly targeted preemptive treatments to the location of the disease.”
At the NIBIB, Pettigrew and his teams are developing nanotechnology that does just that. Trojan-horse nanoparticles carry therapeutic molecules directly to tumor cells, breaking down once they have penetrated these cells and releasing therapeutic agents to destroy them from the inside (with minimal impact on healthy cells). “These therapeutics work in conjunction with the targeting agents and the imaging agents, so you can determine where the particle is going, whether it reached the target, and what the response is,” Pettigrew says. “Having the imaging component allows one to make that observation.”
Pettigrew sees imaging coming together, in the future, with cellular and molecular biology (as well as pathology) to implement these highly personalized and site-specific therapies. “You have a growing convergence of these specialists who are experts in the scientific subtleties of image interpretation with those who understand molecular biology and genetics, and they can work to achieve health-care approaches that are optimized on a patient-by-patient, disease-by-disease basis,” he says. He adds, “Radiology converges with all of the natural sciences to become diagnostic medicine. It really takes all of those disciplines to understand and to use the information you have gained in order to fashion a therapeutic approach.”
Innovation is by no means limited to molecular imaging, however. David Bluemke, MD, PhD, director of radiology and imaging sciences for the NIH Clinical Center (Bethesda, Maryland) and a senior investigator at the NIBIB, describes MRI tractography, which measures neurological function. The NIH-sponsored Human Connectome Project is working to create a complete map of structural and functional neural connectivity. “This initiative seeks to determine the normal neural circuits in the healthy brain,” Bluemke says. “Tractography is especially important in relationship to neurosurgery and removal of brain tumors, as well as in assessment of neurodegenerative disease and brain trauma,” he continues. “One of the more discrete and earlier applications is to use it prior to brain surgery: You have essential connections between different portions of the brain, and they can be spared, during surgery, to avoid leaving the patient with severe deficits.”
Bluemke says that tractography also has implications for improving the understanding of neurodegenerative diseases and disorders of the central nervous system. “We can determine how the disease is affecting certain portions of the brain and can look at connections between where the signals in the brain are originating and their ultimate destination and function,” he says.
Hricak also sees a growing role for the informatics tools that aid diagnosticians, particularly computer-aided detection software. “Computer-aided detection tools will become increasingly necessary to help radiologists deal with the ever-growing amounts of data generated by sophisticated imaging techniques,” she predicts.
Rather than displacing radiologists, Hricak believes that these tools will help radiologists spend more time in consultative roles. “The hallmark of our profession will be to deliver simplicity out of complexity,” she says. “To do this, we will need not only to be technologically savvy, but to cultivate a deep understanding of disease processes and an eagerness to be full participants in clinical care.”
Economics of Integration
No discussion of the future direction of imaging is complete without a vision of the business models that will enable the profession to evolve. It is self-evident that imaging is facing an imperative to become both more collaborative and more consultative, but that dream might not sound achievable to radiologists already beleaguered by reimbursement cuts and turf battles. These challenges are not likely to subside soon. “In fee-for-service medicine, some providers will make money, even if an imaging test is inappropriate,” Sistrom says. “In the new world, inappropriate tests will be unacceptable. You definitely won’t make money, and you are going to harm your patient population to the extent that it will cost you more somewhere else.”
Sistrom continues, “Even marginal (appropriate, but not necessary) tests will have to be rationed in the bundled-payment or capitated environments. In this new world of health-care payment, the organization needs to do all of the imaging that is necessary and none of the inappropriate imaging—and it has to do it within a budget.”
For that reason, Enzmann envisions a future of varied business models for radiology. “The previous approach, that of the general radiology practice, won’t be enough, in terms of strategic positioning,” he predicts. “Radiology will wind up with different business models. One will be focused on operational efficiencies: a teleradiology-type model that manages just imaging studies—very efficiently and at a low cost. The integrated-diagnostics approach is a higher-end business model in which radiologists will provide these other consultative services.”
Enabling organizations to use that business model will be advanced informatics tools, including computerized decision support to aid clinicians in choosing appropriate exams. This will free the time of both referring physicians and radiologists, thus leaving more time for consultation and patient care. “The new paradigm is order-entry decision support, which gives you the ability to analyze utilization on a physician-by-physician, quarter-by-quarter basis. You can see whether there are physicians who are ordering more inappropriate tests, and you can give feedback,” Mancuso says. “That requires sophisticated, risk-adjusted, and hierarchical analysis of the utilization data. If you want other clinicians to change their behavior, they have to know you are being fair.”
For the additional services that radiologists can provide to be more consultative, Mancuso and Sistrom have no shortage of ideas. Their vision of the radiology round trip includes consultation at the time of ordering, consultation on optimal modality protocols, and the development of a scenario-specific report that truly enables the ordering physician to take the next step in decision making.
Sullivan concurs: “Radiologists need to be paying attention to what information their referring physicians need,” he says. “Increasingly, treating physicians have more therapeutic options available to them, and they have a lot of questions about which are most important or relevant. Radiologists need to hear what questions treating physicians have and focus on helping them choose the best therapeutic options.”
Hoffmann is optimistic that new payment models will actually encourage radiologists to play a more consultative, integrated role. “Integrated care is driven by how things are reimbursed,” he says. “If the reimbursement for the patient is based on a care episode, it becomes more critical that all the pieces work together. Radiologists will need to be willing and able to connect with patients and to see themselves as an active part of patient care.”
Further Research Required
Moving the specialty along this path will require a much deeper investment in research. “Research involving new imaging technology is often seen as especially costly—and, therefore, risky,” Hricak says. “Such innovative research, however, is essential to making optimal use of the tools at our disposal. Although it may seem counterintuitive, in these difficult times, greater expenditures on science, technological innovation, and clinical research are called for, as they will fuel economic growth and increase the precision and efficiency of health care.”
As Hricak indicates, radiologists will probably have to prioritize this research themselves, as the economic crisis has led to a decline in federal funding. “The NIH landscape has changed dramatically, over the past three years or so,” Bluemke notes. “Before, one in four or five grants would be funded; now, grant funding is less than one in 10.”
Further, he observes, radiologists in practice have been so focused on efficiency and productivity that making time for research has fallen by the wayside. “For radiology, the background, training, and full-time dedication are sometimes not quite as intense as in other fields,” he says. “It’s partly because of all the clinical activities in radiology: There are tremendous amounts of imaging being done, and a lot of clinical translational researchers are halftime workers. It’s difficult to do a halftime world-class discipline.”
Bluemke believes one solution to this problem would be the development of more grants for clinical trainees in radiology. “We really have not invested heavily in research for clinical trainees, compared with other specialties,” he says. “You need a strong base of trainees, and to mentor those individuals, you need a strong senior staff—and those mentors are increasingly busy with clinical activities. It’s a catch-22, and the only way to solve it is through dedicated effort to making research training for more individuals a priority.”
Comparative-effectiveness research based on quantitative imaging measures is equally critical, Sullivan says. “The goal is to determine what effect different diagnostic tests have on patient outcome,” he says. That investment will pay big dividends in the future, Hoffmann predicts. “In general, integrated care has tremendous potential to be more cost effective, but it’s an initial investment—a downpayment on the future of care,” he says. “For some of these projects, it may be hard, initially, to show an impact on health. It is better to look at integrated care as an investment in future management of the patient.”
Pettigrew’s vision for future patient management takes a philosophical turn as he analogizes integrated diagnostics with the functioning of the human body. “Biology, chemistry, electrical engineering, and physics—the disease inside the person involves all of these fields,” he says. “There are no lines drawn between them inside the patient. We know the convergence of the sciences will happen because it already exists: It lives within all of us.”
Cat Vasko is associate editor of Radiology Business Journal.