Vendors must support outcomes research to unlock door to medical imaging's future

McNeil: Rapid studies are needed for new product introductions

Manymedical imaging vendors have shied away from funding outcomesresearch studies, despite the growing importance of such researchin assessing imaging equipment. Some companies are reluctant tocommit the necessary funds during a tight market, while othersbelieve that vendor-sponsored research will be considered self-servingby health-care decision makers.

Vendors can no longer ignore the importance of outcomes research,however, according to Dr. Barbara J. McNeil, a radiologist andhead of the department of health-care policy at Harvard MedicalSchool. Companies must take an active role in sponsoring outcomesstudies to provide the clinical data necessary to support theimaging procedures that justify equipment sales, she said.

McNeil discussed the status of radiology outcomes researchduring the keynote address at Diagnostic Imaging's April conference,Opportunities for the Imaging Industry: Prospects and Challengesin the `90s.

Ironically, the medical imaging industry's success in developinginnovative new products is responsible for some of the attentionnow being given to controlling medical technology more closely.Outcomes research studies began six years ago because policy makerswere concerned that new technologies were being introduced intothe marketplace without assessment of their cost or utility, McNeilsaid.

Imaging procedures like MRI appear to be unnecessarily expensivebecause the unit-cost per procedure is high. But vendors who pursueways to lower the cost per procedure of their equipment are chasingthe wrong rabbit in the race to take advantage of the shift tomanaged care.

The cost of a single imaging procedure is less important thanthe overall cost of an episode of care, in which the use of anexpensive procedure like MRI may be cost-effective if it shortensa hospital stay or obviates an invasive procedure. Manufacturers,therefore, must find ways to demonstrate that their products arenecessary in reducing the cost of an episode of care.

"You have to insinuate your devices or procedures or drugsinto this episode," McNeil said. "That resulting episodeand its associated costs will dominate what happens far more thanwhat you can sell to an individual physician."

Unfortunately, existing research data are inadequate to determinewhether an expensive imaging exam actually lowers the averagecost of an episode of care, McNeil said.

"There are a limited number of circumstances where existingdata will be useful. They are not going to be useful in our specialty,by and large," she said. "We are going to have to bemore creative about how we rapidly collect data, and we will notbe able to use data that have been obtained for other purposes."

Because creating outcomes data from scratch will take years,McNeil stressed the importance of rapid technology assessmentstudies to ease the entrance of new technologies into the market.These studies take much less time than detailed outcomes research,such as the Radiology Diagnostic Oncology Group (RDOG) project,a large-scale outcomes study funded by the National Cancer Institute.In many cases shorter technology assessment studies can includecost analyses that the lengthier studies cannot.

What diagnostic imaging needs first and foremost, McNeil said,are simple descriptors of the accuracy of radiologic procedures.These descriptors should include comparisons of different technologiesand demonstrate that diagnostic tests can provide informationthat is not otherwise available to physicians for patient management.The descriptors should also include information about whetherthe medical imaging test is redundant with laboratory tests orother clinical information.

For example, McNeil and colleagues from Harvard and other universitiesare involved in a study called the Rapid Technology AssessmentActivity, sponsored by the American College of Radiology. Thestudy is designed to last 12 months from inception to publication.The multicenter effort aims to determine the value, in terms ofsensitivity and specificity, of magnetic resonance angiographyin patients with moderate to severe peripheral vascular diseasewho are surgical candidates.

Getting a foot in the door. Imaging vendors should concentrateon funding rapid outcomes studies that can support new productintroductions, according to McNeil.

"When something comes off the line and is being introduced,(rapid technology assessment) is going to be essential for youto get in the door anywhere," McNeil said. "People aregoing to have to have some basic answers, and the only way they'regoing to be able to get them is through rigorous analyses thatare rapid, that help you work with investigators."

Outcomes research can be a double-edged sword, however. Outcomesresearch can justify the utilization of some radiologic proceduresbut will also point out those procedures that are unnecessary,as well as situations in which the procedures produce suboptimalresults.

For example, Blue Cross of Wisconsin changed its reimbursementpolicy for prostate imaging in 1990 based on outcomes data publishedby McNeil and colleagues in the New England Journal of Medicine.Citing the NEJM study, the insurance company elected not to coverclinical staging of prostate cancer using ultrasound and MRI,"because both ultrasound and MRI are not as accurate in stagingas once believed."

Technology assessment and outcomes research studies are beingfunded by the Agency for Health Care Policy Research, which wasestablished in 1987. But because the agency's annual budget isrelatively small -- $160 million -- there is a need for additionalstudies to be conducted, McNeil said.

Perhaps more importantly, AHCPR has been charged with developingguidelines for the practice of medicine. Guidelines for qualitycare, based on whatever data are available, are specifically recommendedin President Clinton's health-care reform bill.

Though Clinton's plan undoubtedly will not pass in its currentform, McNeil believes guidelines will be an integral part of whateverhealth-care reform bill is approved.