Prevention guidelines stoke clinical conflict

It took only 24 hours in November 2009 for experts on a federal panel to realize that the public vastly misunderstood new guidance on breast cancer screening.

The recommendation issued by the U.S. Preventive Services Task Force said women younger than 50 didn't need routine mammography screening. But the message that initially spread across the nation was that the panel advised against mammography in younger women.

An uproar ensued overnight.

Lawmakers blasted the guidelines as a form of health care rationing. Physicians raised alarm about missing early stages of the disease. The American College of Radiology asked that the recommendation be rescinded.

The guidance caused such a controversy that Dept. of Health and Human Services Secretary Kathleen Sebelius assured physicians and patients that the task force makes recommendations, but does not set federal policy.

“We didn't think it would be a big deal” because the panel recommended against routine mammography in its 2002 guidance as well [although it was worded differently], said task force Chair Virginia A. Moyer, MD, MPH. She is a pediatrician and professor of pediatrics at Baylor College of Medicine in Houston.

The outcry that followed the 2009 mammography decision is an example of the public's increasingly heightened awareness of task force recommendations that have been issued during the past few years. After more than two decades of the panel's guidance going largely unnoticed by the general public, and even among some in the medical community, nearly every recommendation receives attention from the media and others, said Michael L. LeFevre, MD, MSPH. He is co-vice chair of the task force and a family physician in Columbia, Mo.

“Task force recommendations get a lot more scrutiny than they used to,” said Dr. LeFevre, vice chair of the Dept. of Family and Community Medicine at the University of Missouri School of Medicine.

Likely contributing to the attention was the panel's 2010 decision to make its process more transparent by posting draft recommendation statments on its website and later allowing public comments at nearly every phase of guideline development, he said. That has slowed guideline development by about six months, largely because panel members review the public's comments at varying stages of the process.

Another significant factor is the Affordable Care Act, which requires Medicare and all qualified commercial health plans to cover routine preventive services that the task force gives a grade A or B, Dr. Moyer said. The task force assigns one of five letter grades (A, B, C, D or I) to each of its recommendations. The grades indicate the likely net benefit of the preventive service, with A being the highest.

When the public learned in 2009 about the task force criteria in the ACA, “suddenly people became aware of us,” Dr. Moyer said. “Suddenly, we were in the public eye.”

The change has prompted the task force to be more careful about the way it words recommendations and more accessible to the media for discussions about new guidelines when they are issued, Dr. LeFevre said.

For primary care physicians, greater attention to the task force has led to growing conflict over which prevention guidelines to follow. Some task force recommendations differ from those issued by other medical organizations. Recent examples include task force guidance on mammography, self-breast exams and the prostate-specific antigen test for prostate cancer.

Some doctors say they worry that choosing to follow a new task force recommendation that deviates from common medical practice could increase their liability risk. Physicians also are spending more time explaining prevention guidelines to patients and answering their concerns about how following the recommendations could impact their health.

“I try very hard to tell patients that none of these guidelines are true for everyone. They're very blunt, and each patient needs to determine” what's best for them, said internist Mark S. Roberts, MD, MPP, chair of the Dept. of Health Policy and Management at the University of Pittsburgh. “That takes time, and I can do that because I'm an academician, and I don't get most of my money from seeing patients. But for most doctors, this is really hard.”

When to give guidance

It would take physicians approximately 7.4 hours every workday to fully satisfy all of the task force's prevention guidelines, said a study of the panel's 1996 recommendations that was published in the April 2003 issue of the American Journal of Public Health. Researchers concluded that it's not feasible for physicians to deliver all the services encouraged by the task force.

Limited time is one reason doctors cite for not adhering to the task force's new PSA guidance, said a study of 125 primary care doctors affiliated with Johns Hopkins Community Physicians that was published Nov. 15, 2012, in Cancer. JHCP is a university-affiliated practice of 26 outpatient sites in 11 counties in Maryland.

Phoenix internist Harvey Hsu, MD, said he spends more time now than he ever has in his 13 years of practice discussing with patients the various guidelines.

“It's frustrating that all these guidelines add to my day,” said Dr. Hsu, medical director of Banner Good Samaritan Internal Medicine Center in Arizona. “When [the guidelines] conflict, I spend [even] more time discussing them.”

Other physicians say they save time by disregarding new task force guidance and sticking with what they've been doing for years.

For instance, 37.7% of primary care physicians said they would not change their prostate cancer screening practices following the task force's October 2011 draft guidance that recommended against the PSA test. This paper from the same study of Johns Hopkins-affiliated primary care physicians was published in the April 23, 2012, issue of Archives of Internal Medicine, now JAMA Internal Medicine. The task force's PSA screen recommendation remained unchanged from the draft statement.

Phoenix family physician Doug Campos-Outcalt, MD, MPA, is concerned about that finding.

“Primary care physicians should follow task force guidelines,” said Dr. Campos-Outcalt, liaison to the task force for the American Academy of Family Physicians. If a doctor chooses not to follow them “they're not practicing very good evidence-based medicine.”

He understands that physicians are in a difficult position because some worry that adhering to task force recommendations increases their risk of liability. “That's a legitimate concern,” he said.

Doctors fear that they would follow the task force guidance and not give a patient a PSA test, and then the patient would later be diagnosed with prostate cancer, he said.

“Evidence is pretty good that screening wouldn't make a difference in the patient's outcome,” because many men with prostate cancer don't die of the disease, Dr. Campos-Outcalt said. “But that's not going to sell very well to a jury.”

He recommends that physicians at least inform patients of the panel's recommendation when it is relevant, so they can make an educated decision about their care.

“If a patient still really wants the test, I'm not sure doctors should put up a big fight” to prevent it, Dr. Campos-Outcalt said.

The task force acknowledges that doctors face obstacles in keeping abreast of the panel's ever-evolving guidelines and implementing them. But panel members say the information they issue is critical for primary care because it helps ensure that doctors' preventive methods are not only effective, but also more likely to benefit a patient than cause harm.

“When you take someone who feels fine and subject them to a screening test, there's a chance of making them feel worse,” Dr. Moyer, USPSTF chair, said. “So it's really important that we carefully evaluate how much benefit and harm there is and recommend things be done only when the balance from screening” outweighs the harms.

To save time during office visits, Dr. Moyer suggest that doctors send questionnaires to patients on their health behaviors and other medical information before their scheduled appointment. That could help physicians more easily determine what preventive measures need to be taken with the patient, she said.

There also is a free app available on the task force's website called the electronic Preventive Services Selector, which helps primary care doctors quickly identify clinical preventive services that are appropriate for their patients.

“I'm not saying this is easy,” Dr. Moyer said. But it's doable, she added.

How the task force works

Philadelphia internist Christine Laine, MD, MPH, is among the doctors who regularly follow task force guidance. When the panel updates its stance on cancer screenings and other preventive measures, she revises the care she offers patients.

“The task force is one of a small number of organizations that comes close to meeting requirements of the Institute of Medicine for methodology that defines trustworthy guideline development,” said Dr. Laine, who is editor of Annals of Internal Medicine.

The task force was established in 1984 and is a 16-member panel of volunteers who are experts in prevention and primary care. The experts are appointed by the Agency for Healthcare Research and Quality to four-year terms.

Panel members, many of whom are practicing primary care physicians, assess data on clinical preventive services published in peer-reviewed studies. They evaluate benefits of individual services based on a person's age, gender and risk factors for disease.

The task force does not consider the cost effectiveness of a preventive service or insurance coverage when making its recommendation, said Dr. LeFevre, of the task force. The panel's guidance also is not made by consensus, he said.

“The task force is not issuing their opinion about what they think should be done,” Dr. LeFevre said. “The task force is reviewing the existing science and saying, 'This is what we think the science tells us right now.' ”

Some critics consider the process flawed, because when issuing guidance, the panel doesn't include an expert in that particular medical area. For instance, there wasn't a urologist or prostate cancer expert on the task force when it developed guidelines on cancer screening, said Therese Bartholomew Bevers, MD.

Without such an expert, the task force doesn't “have a true, grounded perspective of what is valued by patients and what they understand might be harms but are willing to accept,” said Dr. Bevers, a family physician and medical director of the Cancer Prevention Center at the University of Texas MD Anderson Cancer Center in Houston.

Panel members disagree with that argument. Dr. Moyer said it would be a conflict of interest to have a person on the panel who is an expert in the area of discussion. She added that during the development process, the panel seeks out advice and information from specialists in that medical area.

“We're not telling urologists what to do with PSA [screening]. That's a different thing,” Dr. Moyer said. “We're developing guidelines for primary care physicians” who see healthy patients.

Criticism of the task force's process has heightened in recent years as the public and medical community grow increasingly aware of the guidelines and how they could affect insurance coverage, health professionals say. Also likely spurring the controversy is the panel's divergent position on some hot-button issues, such as screening for breast cancer and prostate cancer, Dr. Laine said.

She said little attention was paid to the task force's 2012 recommendation that reduced cervical cancer screening or to the 2008 guidance against routine screening for colorectal cancer in people ages 76 to 85.

“Some of these other conditions aren't the pink ribbon, public advocacy type conditions” that breast cancer and prostate cancer are, Dr. Laine said.

When faced with conflicting guidelines, she recommends that physicians look at how the recommendations were developed and follow the highest-quality guidance.

Dr. LeFevre, of the task force, regularly talks to patients about their concerns with new guidance issued by the panel and how it differs from existing recommendations.

“I understand that it's hard [for physicians] to deal with uncertainty and it's much easier to have a clear and consistent message. … I get that,” he said.

The message for primary care physicians is that they can trust that the task force has gone through a rigorous, evidence-based practice, Dr. LeFevre said.

“The recommendations reflect what the science currently tells us.”