Comparative studies in radiology, until now a rare occurrence, will become common and could help define practice under an implementation proposal for a new comparative effectiveness research program approved this year in Congress.
Eleven of 100 high priority comparative effectiveness research (CER) projects announced by the Institute of Medicine July 2 relate to diagnostic imaging. When completed, the studies are intended to offer fresh insight into the relative clinical effectiveness of various imaging modalities for evaluations of cancer, of the value of obstetric ultrasound in normal pregnancies, and whether imaging performed by radiologists is significantly more clinically valuable than procedures read by nonradiologists.
The list mostly calls for head-to-head comparisons of competing medical approaches to diagnosis and therapy. Studies from the list that are funded with the $1.1 billion appropriated by Congress under the economic stimulus bill could provide definitive answers to questions that now lead to wide variations in practice across the country.
Until now, imaging researchers have shied away from such practical comparisons because of high costs and complicated infrastructure demands, said Constantine Gatsonis, head of the Biostatistics Center for the American College of Radiology Imaging Network (ACRIN) and one of 23 members of a committee that helped write the priority list. He hopes that the 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 in an interview.
During the 2008 election campaign, then-candidate Barack Obama promised to back 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.
CER DEFINED
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.
Dr. James Thrall, chair of the ACR board of chancellors, predicted that research based on the announced priorities will help radiologists eliminate wasteful practices. The results will also help strengthen the ACR appropriateness criteria.
“Better comparative effectiveness information will help us become more certain in our recommendations about what imaging is appropriate,” 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 into four groups to indicate their priority ranking (see below).
Many imaging-related themes on the list have already been covered by the ACRIN, according to Dr. Mitchell Schnall, ACRIN executive director. Its comparative studies include digital with film screen mammography, chest radiography with CT for lung cancer screening, optical colonoscopy with CT colonography, and a planned comparison of CT with 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 play 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.
POTENTIAL BENEFIT
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 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 the SNM's PET utilization task force, and interdisciplinary workshops to define how to do CER properly.
The IOM report serves 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 said he expects the CER priorities to engineer a shift in emphasis from studies designed to satisfy the curiosity of individual medical researchers toward 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.”
