Imaging is increasingly pervasive in modern medicine; according to a 2011 study¹ published in Radiology, the use of CT scans in emergency-department visits has risen 16% per year since 1995, and the report estimated that the modality could have been used in 20% of emergency-department visits in 2011. Remarkably little research has been performed to validate certain applications of advanced imaging, however.
“There’s a real lack of evidence for diagnostics, especially as to whether they are comparatively effective,” according to Larry Kessler, MD, professor and chair of the department of health services at the University of Washington School of Public Health. Kessler presented “Community-based Comparative Effectiveness Study of Advanced Imaging in Breast Cancer” as one of four parts of “Comparative Effectiveness Research for Radiology: Reports From the Field” on November 28, 2011, at the annual meeting of the RSNA in Chicago, Illinois. “When new imaging methods come out every month, the question is, ‘Do they change patient management or outcomes?’ There’s next to no information about that,” he says.
Kessler and his team are currently conducting two comparative-effectiveness research projects centered on imaging and cancer: one on breast-cancer diagnosis and one on lung-cancer staging. The three-year projects launched in fall 2009 and will conclude in fall 2012. Kessler explains that both studies began with an analysis of the available research.
“If you look at the literature, you’ll discover a number of studies suggesting that there’s really no evidence for the way MRI is currently being used in the diagnosis of breast cancer,” he says. “With lung cancer, people who have a pathologically confirmed diagnosis are being imaged like crazy, and our stakeholders say this imaging is really biting them in the pocketbook, so we’re looking at whether that’s justified.”
Working with these stakeholders, including the providers and the payors, is critical to the success of comparative-effectiveness research, Kessler says. “The payors are very interested in this information. We asked them to generate data that would help us begin to examine this, and their involvement has been critical,” he says.
Both projects have leveraged payor data from every beneficiary of the local medical plans who was diagnosed with either lung or breast cancer from 2002 through 2009. “We use their claims records to create the datasets and perform analysis on the trends in imaging and whether they are affecting the patients, in terms of outcomes,” Kessler says.
Show Me the Funding
Though results of both studies will be unavailable until the end of the study period, both projects are progressing well, thanks to stakeholder engagement and adequate funding from the National Institutes of Health. As Constantine Gatsonis, PhD, chair of the department of biostatistics at Brown University, reported in “The State of the Art in Comparative Effectiveness Research for Diagnostic Imaging: An Introduction” during the same four-part RSNA presentation, funding for radiology comparative-effectiveness research became available in 2009 following an Institute of Medicine report that named “the effectiveness of diagnostic imaging performed by radiologists and nonradiologists”² as one of 100 priorities in comparative-effectiveness research.
Gatsonis notes that this report influenced the focus on patient-centered care and outcomes seen in health-reform legislation, suggesting that comparative-effectiveness research will be a vital component of health-care policymaking in the years to come. Kessler concurs. Comparative-effectiveness research “is a natural opportunity for those of us who are interested in health policy,” he says. “It’s critical to figure out whether the addition of resources is justified and to add to the evidence base.”
That might sound like bad news for radiology, which is already under siege from Medicare and private payors when it comes to appropriateness of imaging and to reimbursement. Kessler and Gatsonis both emphasize, however, that the use of comparative-effectiveness research can lead to powerful justifications of imaging’s value.
Comparative-effectiveness research “calls for illuminating the path between diagnoses and outcomes,” Gatsonis says; as an example, he cites the National Oncologic PET Registry, which led to the CMS decision to cover FDG-PET for nearly all cancer patients. For this reason, Gatsonis and other presenters urge radiologists