USPSTF Guidelines: Two Years Later the Fallout Continues

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 - Female doctor and patient
Screening mammography works. However, that was not the message promulgated by the U.S. Preventive Services Task Force (USPSTF) in November 2009. The updated guidelines eliminated screening for women younger than age 50 and older than age 74 and suggested biannual screening for women ages 50 to 74. The revision provoked an uproar among radiologists and confusion among women and primary care providers.

Nearly two years after the release of the controversial guidelines, Health Imaging & IT examines their impact on radiology practices, screening mammography volume and women's health. We spoke with breast imagers across the country to determine how they are contending with the new modus operandi in mammography screening.

The volume effect

"Screening mammography volumes are down from 10 to 30 percent across the country," confirms Michael N. Linver, MD, director of mammography at X-Ray Associates of New Mexico in Albuquerque, which has seen screening volume drop 10 to 20 percent since November 2009. Similarly, Scott & White Radiology in Temple, Texas, reports a 25 percent drop-off in screening volumes, shares Debra L. Monticciolo, MD, president of Society of Breast Imaging and breast imaging section chief at Scott & White Radiology.

In fact, Monticciolo believes that the negative impact on screening volume has increased with time. "We saw more of a change in the second year. Women participated in screening in the first year because they were unsure about the guidelines. Now, we are seeing a larger effect."

A survey presented in May at the annual meeting of the American Roentgen Ray Society confirmed the impact of the guidelines on referring physician recommendations. When researchers at the University of Colorado School of Medicine in Denver surveyed 303 primary care physicians about screening practices before and after the release of the guidelines, they found statistically significant decreases in ordering patterns for women ages 40 to 49, according to Jayme Takahashi, MD, a radiology resident at University of Colorado School of Medicine.

Prior to the 2009 guidelines, for patients ages 40 to 49, 56 percent of physicians recommended annual screening mammography, 33 percent recommended biannual screening and 11 percent advised against screening. After the guidelines were revised, 20 percent recommended annual screening, 18 percent recommended biannual screening and 8 percent advised against screening for women in this age group.

Lara A. Hardesty, MD, section chief of breast imaging of University of Colorado Hospital in Denver, devised a related study and examined the effect of guidelines on women seeking mammograms.

Researchers mined institutional mammography databases to calculate the number of women presenting for screening mammograms in the nine months preceding the release of the guidelines (February 2009 to November 2009) and the nine months following the release (November 2009 to August 2010) among women in two age categories: ages 40 to 49 and 50 and older.

Before the guidelines were released, 1,327 women in the age 40 to 49 cohort presented for screening mammography. In the nine months following the release, the number dropped to 1,122, a statistically significant decrease of 15.4 percent. Volume stayed roughly the same for women older than age 50.

The drop is tied to confusion among referring physicians and women. "The guidelines hint that physicians shouldn't be advocating for screening [and suggest] they should wait for patients to initiate the discussion," says Monticciolo. "Anecdotally, women are deciding not to get screened because they interpret the guidelines to mean that they do not need a mammogram until age 50," adds Daniel B. Kopans, MD, director of breast imaging at Massachusetts General Hospital in Boston. Others, says Linver, are confused or trusting enough to defer to the guidelines.

What's more, primary care physicians may be in a bind. "Primary care physicians don't understand the pros and cons of screening," explains Kopans. "They see only two to four women with breast cancer each year. They have to deal with more questions about false positives. Hypertension, heart failure and pneumonia are much bigger problems for them."

But the challenges for primary care physicians extend far beyond clinical understanding and patient care. "What I've heard from my colleagues in primary care is that they feel they need more data from radiologists as to why they should not follow the USPSTF guidelines. Otherwise, they encounter pressure from their groups to follow the guidelines. In other words, if we are going to tell them 'no, no, no, disregard the guidelines,' we need to tell them why," offers Hardesty.

There are a few pieces of positive news. In July, the American College of Obstetrician and Gynecologists, which had held to USPSTF recommendations, shifted course and issued revised guidelines recommending annual screening mammography beginning at age 40. In addition, data detailing the negative impact of USPSTF guidelines are becoming available and volumes may be nudging up.

On June 1, the FDA reported that the number of mammograms performed in the last 12 months reached nearly 39 million, which is greater than that before the USPSTF recommendations.  However, this is a three-year aggregate, so it's difficult to pinpoint trends.  "I am hearing from radiologists that the number of mammograms went down immediately following the USPSTF recommendations, but has rebounded to the levels previous," notes Shawn Farley, spokesperson for the American College of Radiology.

Data, data, data

"To show mortality caused by the guidelines, it's going to take five to 10 years and no one wants to let that happen," Hardesty says. However, ongoing data as reported from the Swedish Two-County Trial lend credence to radiologists' concerns.

Published in the July issue of Radiology, the study confirmed initial results published in 1985, which showed a 30 percent reduction in mortality among women invited to screening. In contrast, the task force attributed a 15 percent mortality reduction among women ages 40 to 49 invited to screening mammography.

The researchers stressed that only 45 percent of prevented breast cancer deaths were observed in the first 10 years and that most prevented deaths would have occurred, in the absence of screening, after the first 10 years of follow-up.

This finding has two major implications, writes Laszlo Tabar, MD, from the departments of mammography, surgery and pathology at Falun Central Hospital in Sweden, and colleagues. Some breast cancers would remain asymptomatic for several years and would take some years after symptoms appear to lead to death, and "long-term follow-up is necessary for considerably more than 10 years to estimate the absolute effect on clinical outcome."

In addition, the researchers acknowledged the differences between the study design and clinical practice in the U.S., where two-view mammography and shorter intervals represent the standard of care. They suggested that two-view mammography and shorter intervals could have yielded a larger impact on breast cancer mortality.

Upon publication of the results, the ACR issued a statement saying the USPSTF should withdraw its 2009 guidelines and support annual screening, beginning at the age of 40.

Other studies have focused on the clinical ramifications of the guidelines.

For example, a 10-year retrospective study conducted at the University of Missouri in Columbia and presented at the annual meeting of the American Society of Breast Surgeons found that screening mammography detected smaller tumors with less nodal metastasis than were identified through clinical breast exams among women ages 40 to 49 years.

In the mammography group, the mean tumor size was 20 mm in diameter, while non-mammographically identified tumors were 30 mm, a highly significant difference in size. The study also found that the frequency of lymph node involvement in the clinically-detected group was about twice that of mammographically detected patients.

The researchers estimated the five-year disease-free survival rate at 94 percent for the group receiving mammograms and 78 percent for those who did not receive the screening exams.

Meanwhile, Mallory Kremer, MD, medical student at the school of medicine at Case Western Reserve University in Cleveland, and colleagues conducted an electronic chart review of all women ages 40 to 49 undergoing image-guided core needle biopsies at Case Western Medical Center between 2008 and 2009. The researchers divided women into screened and unscreened cohorts, defining unscreened women as those presenting with a symptomatic complaint, who had not participated in screening mammography 12 months prior to presentation.

The 511 biopsies indicated 108 primary breast cancers, with 71 found in screened patients and 37 occurring in unscreened patients.

There was a greater proportion of DCIS in the screened cohort, with approximately one-third of cancers in the screened group classified as DCIS versus less than 5 percent in the unscreened group. Among women diagnosed with invasive cancers, nearly half of the screened patients presented at stage 1. In contrast, one-quarter of unscreened women were diagnosed with stage 1 cancer. In addition, screened women had a higher probability of being detected with a smaller tumor and node-negative disease.

A recent study from Emory University in Atlanta amplifies these findings among African American women, who are at increased risk for early breast cancer, by comparing the impact of the USPSTF guidelines with the American Cancer Society guidelines endorsing annual screening.

The researchers extracted tumor sizes from the records of 84 patients with stage 1 to 3 breast cancers diagnosed in 2008 and applied tumor volume doubling times as if various guidelines had been followed. "We found that almost 30 percent of the patient population would have been diagnosed at a later stage under USPSTF guidelines, which could substantially impact patient survival," offers Carl D'Orsi, MD, director of breast imaging research at Emory University School of Medicine.

Kremer notes that in addition to improving outcomes, earlier detection also allows women to avoid more intense treatment, a consideration that the task force seems to have overlooked.

"The task force was overly concerned about overdiagnosis and overtreatment. We are trying to figure out which cancers are lethal and which may not be, but it doesn't negate the fact that the only way to save lives is to find breast cancer earlier," Kopans says.

What's more, earlier diagnosis is more economical. "The costs for treating advanced disease are more than $200,000, which is much more than screening mammography. If the task force really figured the actual costs of screening compared with not screening they would realize they could save money as well as lives if we screened yearly beginning at age 40," asserts Linver.

Meanwhile, the debate continues. A study published July 28 in the British Medical Journal comparing countries that implemented screening mammography at different time periods claimed that improvements in treatment rather than screening are behind the decline in breast cancer mortality. Breast imagers responded by pinpointing flaws in the study. One point is certain—the firestorm shows no signs of abating.

Rads' new role—educators?

Following the release of the guidelines, some breast imagers immediately embraced the advocacy role, and committed to educating their colleagues in primary care through any means necessary. Kopans, for example, has delivered lectures at Boston-area hospitals and national meetings, emphasizing the science of data supporting screening mammography.

Linver has employed a comprehensive approach, mailing 3,000 letters to referring physicians, lecturing physician groups and archiving his lectures as webinars for colleagues in breast imaging. He also reaches out to physicians to share local breast screening success stories, particularly when the patient is younger. "I'll remind them that this is making a difference."

The Albuquerque radiologist was one of the first in the country to launch a patient education campaign. "We mailed 60,000 one-page letters to our patients, telling them why we thought the guidelines were wrong and supporting it with data from our own practice." The costs for both mailing campaigns was approximately $25,000.

Other practices, such as Scott & White Radiology, are following in his footsteps. "We're telling patients coverage is here and that the American Cancer Society recommends screening. However, this adds to costs at a time when volume is down. We're spending money to tell them something that we've known for years," says Monticciolo.

Meanwhile, other radiologists are mining free, or relatively-free, resources, penning op-ed pieces for local papers, speaking to women's groups and appearing on local talk shows.

Professional organizations also are lending a helping hand. For example, the American College of Radiology,  the Society of Breast Imaging  and the American Society of Breast Disease have launched the Mammography Saves Lives campaign, which features television and radio public service announcements (PSAs) to educate women in their 40s about the value of screening mammography. The PSAs have aired nearly 30,000 times since the program launched.

Such campaigns can pay off, offers Jim Koehler, president of Armada Medical Marketing in Denver. In December 2009, Invision Sally Jobe, a network of Denver outpatient imaging centers, contracted with Armada to launch a marketing campaign to demonstrate its expertise in women's imaging. The campaign correlated with a slight bump in women's imaging volumes over the previous year, at a time when most hospitals and imaging centers experienced fairly hefty declines, confirms Koehler.

The ultimate approach

Nearly two years after the release of the USPSTF guidelines, breast imagers remain up in arms and, to a degree, at a loss. After vigorous educational campaigns, Linver may take his response to the next level. "I'm considering suing the government for depraved indifference. They admit that women's lives will be lost. The court of law may be the only recourse at this point. A lawsuit would provide a public venue to debate the issue and bring it back into the public eye."

The issue, unfortunately, may not see resolution in the near future. While radiology experts continue to prove and promote the benefits of screening, epidemiologists and other stakeholders are debating its efficacy, attempting to reduce the screening pool and denigrating the exam.