Medical imaging given priority on comparative effectiveness research list

Diagnostic imaging is the focus of 11 of 100 priority research projects identified in an Institute of Medicine report released Tuesday that promises to revolutionize how the clinical efficacy and cost-effectiveness of emerging medical technologies and treatment regimens are determined in the U.S.

Included on the list is a comparison of the effectiveness of diagnostic imaging performed by nonradiologists and radiologists.

A 23-member committee, including Constantine Gatsonis, head of the Biostatistics Center for the American College of Radiology Imaging Network (ACRIN), developed the list of priority topics at the request of Congress as part of the $1.1 billion effort to improve the quality and efficiency of healthcare through comparative effectiveness research outlined in the 2009 economic recovery legislation. Development of the list was sponsored by the Department of Health and Human Services.

During the 2008 election campaign, then-candidate Barack Obama promised to back comparative effectiveness research (CER) along with universal healthcare insurance access and electronic medical records as key components of comprehensive healthcare reform. The government is taking steps to fulfill those promises.

The committee defined CER as the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. It recommended randomized controlled trials as appropriate for 49 of the 100 projects. Literature reviews, prospective registries, and cohort studies were in also included as possible study methods.

The priority list covers 29 research areas affecting various age and ethnic groups. Twenty-four projects pertain to special populations.

Many analysts were surprised by the IOM's rapid response. The report comes less than six months after the Obama inauguration and while the Congressional healthcare debate is under way.

"This report lays the foundation for an ongoing enterprise to provide the evidence that health-care providers need to make better decisions and achieve better results," said IOM committee cochair Sheldon Greenfield, Ph.D., executive director of the Health Policy Institute at the University of California, Irvine in a release.

Greenfield urged the HHS to ensure that the results are translated into practice to make the most of them.

Dr. James Thrall, chair of the American College of Radiology board of chancellors, predicted that research based on the announced priorities will help radiologists eliminate wasteful practices. The results will also help strengthen ACR appropriateness criteria.

"Better comparative effectiveness information will help us become more certain about our recommendations about what imaging is appropriate," he said in an interview.

Gatsonis is encouraged by the head-to-head nature of the imaging-related priorities. He noted that imaging researchers have recently shied away from such practical comparisons because of high costs and complicated infrastructure demands. He hopes that the priority list will lead to a resurgence of such work.

"If you do comparative studies and you show that one modality is diagnostically more accurate than another modality, that is an important type of study to do," he said.

Another CER committee member, Dr. Sean Tunis, director of the Center for Medical Technology Policy in Baltimore, said the 100 priorities may serve as a magnet for private and public funding. Until actual research begins, Tunis expects the list will encourage public skepticism about existing and emerging medical technologies that have not been rigorously evaluated.

Recommended projects were organized in quartiles to indicate their priority ranking. Imaging related projects include the following:

First quartile

• Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, and pharmacologic treatment (imaging is essential for surgical planning for this procedure).
• Compare the effectiveness of management strategies for ductal carcinoma in situ (DCIS).
• Compare the effectiveness of imaging technologies in diagnosing, staging, and monitoring patients with cancer including PET, MRI, and CT.

Second quartile

• Compare the effectiveness of film-screen or digital mammography alone and mammography plus MRI in community practice-based screening of breast cancer in high-risk women of different ages, risk factors, and race or ethnicity.
• Compare the effectiveness of new screening technologies, such as fecal immunochemical tests and CT colonography, and usual care (fecal occult blood tests and colonoscopy) in preventing colorectal cancer.
• Compare the effectiveness and outcomes of care with obstetric ultrasound studies and care without the use of ultrasound in normal pregnancies.

Third quartile

• Compare the effectiveness of traditional risk stratification for coronary heart disease and noninvasive imaging using coronary artery calcium and carotid intima media thickness measures and other approaches on coronary heart disease outcomes.
• Compare the effectiveness of formulary management practices and usual practices in controlling hospital expenditures for products other than drugs, including medical devices (surgical hemostatic products, radiocontrast, interventional cardiology devices, and others).
• Compare the effectiveness of traditional and new imaging modalities, such as routine imaging, MRI, CT, and PET, when ordered for neurological and orthopedic indications by primary care practitioners, emergency department physicians, and specialists.

Fourth quartile

• Compare the effectiveness of CT angiography and conventional angiography in assessing coronary stenosis in patients at moderate pretest risk of coronary artery disease.
• Compare the effectiveness of diagnostic imaging performed by nonradiologists and radiologists.

Many imaging-related themes on the list have already been covered by ACRIN, according to Dr. Mitchell Schnall, executive director of the network. Its comparative studies include digital versus film-screen mammography, chest radiography versus CT for lung cancer screening, optical colonoscopy versus CT colonography, and a planned comparison of CT and MR for imaging hepatocellular carcinoma.

"This is something that has always been on our radar screen. But when we see it displayed so prominently as a national priority, we want to pay extra special attention to it," he said.

Though it is too early to pitch for specific projects, Schnall expressed interest in the priority covering the diagnosis, staging, and monitoring of cancer patients with PET, MRI, and CT because of ACRIN's experience with cancer-related imaging applications. Gatsonis noted that this priority is so broad that it will probably spawn numerous projects.

CER could help nuclear physicians strengthen their base in the medical literature covering PET, according to Dr. Michael Graham, SNM president. In particular, it could improve upon numerous PET cost-effectiveness studies that have never gained acceptance within the technology assessment community.

"That is what we have to deal with if we are going to see these modalities (PET and SPECT) used appropriately," he said.

Graham is planning on a coordinated approach among molecular imaging researchers to compete for research projects that emerge from the priorities. He envisions a role for the SNM Clinical Trials Network, planning through SNM's PET utilization task force, and interdisciplinary workshops to define how to do CER properly.

The IOM report serves as an important inflection point in the evolution of evidence-based medicine, Tunis said. The former chief medical officer for the Centers for Medicare and Medicaid Services expects the CER priorities to engineer a shift in emphasis from studies that satisfy the curiosity of individual medical researchers to work specifically geared for policy-making.

"It is one thing to talk about comparative effectiveness, as we have for several years. It is another thing to have a list of 100 specific priorities," he said. "These are the things that decision-makers really need to know with certainty."