Medical Device Daily Washington Editor

WASHINGTON – Ranging from better targeting of therapies to how physicians use these therapies, the National Advisory Council for the Agency for Healthcare Research and Quality (AHRQ: Rockville, Maryland) reviewed a wide range of the organization's studies and discussed how to disseminate this information to the public.

The director of AHRQ, Carolyn Clancy, MD, emphasized in her opening remarks the importance of the new efforts in personalized medicine, saying that it is opening doors to “a lot of incredibly exciting developments“ in targeted therapies. She added that the Secretary of Health & Human Services, Michael Leavitt, is taking a “holistic view“ of such advances and that he is very interested in promoting “rapid access“ to personalized medicine.

Among the key points in this overview session:

Measuring physician practice: Clancy reported that the Ambulatory Care Quality Alliance, a collaboration started in 2004 by the American Academy of Family Physicians (Leawood, Kansas), the American College of Physicians (Philadelphia), America's Health Insurance Plans (Washington), and AHRQ had set up six pilot sites – in Arizona, California, Indiana, Massachusetts, Minnesota and Wisconsin – in an effort to measure and report on physician practice.

Goals of the alliance are to bolster healthcare quality and patient safety by setting standards for “measuring performance at the physician level,“ collecting physician data in “the least burdensome way“ and reporting the data to physicians and consumers with the hope of improving outcomes.

Dealing with GERD: In news rather disappointing to surgical instrument makers, Clancy said the first AHRQ comparative effectiveness review concluded that “drugs can be as effective as surgery“ in the management of gastro-esophageal reflux disease (GERD). AHRQ determined that for those with uncomplicated GERD, “proton-pump inhibitors are as effective as surgery and more effective than H2 antagonists,“ although she acknowledged that proton-pump inhibitors, such as Nexium and Prevacid, exhibit more side effects than the H2 antagonists. One of the reasons that surgery did not fare better in that study is that “about 65% continue to use medication“ after surgery for GERD.

Breast abnormality assessment: Clancy also noted that the agency completed another comparative effectiveness review, this one to establish the relative efficacy of non-invasive tests and biopsy for breast abnormalities.

Among the devices in question were MRI, ultrasonograpy, positron-emission tomography and scintimammography. Clancy remarked that many of these miss “about 4% to 9%“ of cancers in women “who have average risk for the disease.“

The AHRQ report for this comparative effectiveness survey stated that the invasiveness of biopsies makes the reduction of their use “desirable“ and poses the question of how accurate a test has to be “before it becomes an acceptable and appropriate alternative.“ The results suggest that with a “negative predictive value of 98%,“ MRI “would miss 38 cases of breast cancer in exchange for avoiding 962 biopsies.“ The comparative numbers for ultrasound, PET, and scintimammography were 50/950, 76/924 and 93/907, respectively.

AHRQ points out that “a potential limitation of the available studies is the high prevalence of breast cancer in the patients enrolled in them,“ suggesting that the enrollees were not representative of women overall who present with suspicious findings after a screening exam.

The document also noted that the studies used in compiling the numbers did not include “women with probably benign lesions,“ adding that “it is possible that non-invasive imaging could be used to accurately detect suspicious cases in this population.“

The report concluded that given a standard for a 98% predictive threshold, based on a level set by the Ontario Ministry of Health, “all four of the diagnostic tests evaluated in this report fall short.“

Among the subjects of other comparative treatment studies that are under way are cancer, ischemic heart disease, arthritis and non-traumatic joint disorders.

Clarifying results: Some of the key program components for comparative effectiveness reviews are relevance, transparency and timeliness. AHRQ seeks to “identify unintended consequences, good or bad,“ but she added that one of the difficulties was in “making the findings clear for different audiences.“

Clancy stated that AHRQ contacts device and drug makers when a comparative effectiveness study is concluded, inquiring as to whether the company has any data that the agency might not possess.

She told Medical Device Daily that the time for AHRQ's review of a newly approved product “varies“ and depends on “systematic reviews of published studies,“ so device makers must depend on the publication of such material to contest any claims of comparative efficacy published by AHRQ.

Clancy also stated that the frequency of an update “depends on the amount of new evidence available. If new study findings are published, the team will evaluate whether or not these new findings would have an impact“ on the agency's conclusions.

As for the subjects of the comparativeness studies, she noted that the agency examined topics “and considered prevalence, was it costly, [whether it is] disproportionably represented in a population, and was there a potential for impact?“ At present, there are no comparative studies currently underway for sustained recurrent ventricular tachycardia or fibrillation.

Improving communication: In an effort to improve the overall communication effort at AHRQ, Clancy said the agency continues to “work very closely with the lay media“ to provide information that is useable by non-professional audiences.

However, in a discussion that followed, Judith Hibbard, PhD, of the Department of Planning, Public Policy and Management at the University of Oregon (Eugene) remarked that policy makers cannot always be certain what risk/benefit information on drugs and medical devices “really means to a patient.“

In discussing the options a physician might present to a patient, Paul Wallace, MD, the executive director of the Care Management Institute , said that doctors may tend to steer toward known sources of information on drugs and devices that are not necessarily the latest information because of perceived reliability.

“We think these knowledge-seeking behaviors are linear, when they're anything but,“ he said, adding that he was aware of data suggesting that when a physician is thrust into the role of a patient, their knowledge-seeking behavior tends to mimic that of lay patients, including reliance on anecdotal sources.