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USPSTF Scrutiny, Controversy
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Task Force Faces Scrutiny, Controversy
[After USTSTF recommendations]....."a 10% drop in the mammography rate among women, ages 40 to 49, immediately after the USPSTF announced the recommendation. Thereafter, mammography rates in that age group stabilized, but 2 years later remained 5% lower than the rates prior to the recommendation.......Regarding the PSA decision, influence on PSA testing rates has yet to be documented in published studies, but the evidence "is out there and PSA testing has decreased......has seen a draft recommendation to end PSA screening tests in the Veterans Affairs Health System......one VA center had been instructed to stop ordering routine PSA tests and to delete any pending orders for tests".
from Jules: The USPSTF may put baby boomers at risk for morbidity & mortality due to HCV & in at the same time cost the healthcare system & the federal & state budgets quite a lot, their recent HCV screening draft recommendation de-prioritizing HCV screening for baby-boomers fails to recognize & address "high-risk" patients within the 'baby-boomer' group, that is, individuals who have had HCV for 20-30 years & have advanced HCV disease who are thus at risk for liver cancer, end-stage liver disease & death if not screened & receiving care, and they fail to discuss the recent studies finding HCV screening baby boomers cost-effective. This review below does not discuss the HCV USPSTF draft recommendations, which were recently made public for comment and is still under review by the USPSTF, but reviews controversy surrounding their history of other recent health recommendations, breast cancer & prostate cancer screening. Despite a large outpouring from the wider HCV community including the CDC the USPSTF unless they alter their draft recommendations are putting those with HCV but having not been screened & thus remaining undiagnosed at grave risk for serious disease consequences & death. There was bitter disappointment at the draft recommendations in the wider HCV community among advocacy groups, researchers, industry, CDC, NIH and clinicians because the draft recommendations only gave a 'C' grade to screening baby boomers which apparently would relegate screening this group to perhaps not receiving support by insurers thus increasing chances that clinics & hospitals would choose not to screen this group. To their credit the USPSTF gave a "B" grade to HCV screening for those with a history of injection drug use (IDUs), which apparently is a high enough grade to receive support from insurers. But they fail to recognize that clinicians & and patients alike often fail to discuss or admit IDU since it's a stigmatizing admission. With a "C" grade clinics & hospitals can choose to screen baby boomers & a number of clinics & hospitals are in fact conducting wide HCV screening programs for all baby boomers in their system, but so far it appears this is a small minority of clinics & hospitals choosing to do this. The problem is that it is estimated that 70-80% of individuals with HCV in the USA remain undiagnosed & obviously if one is not diagnosed they cannot receive care for HCV. CDC data says about 70% of those undiagnosed are from the baby boomer generation, born between 1945 & 1965. The dilemma for individuals with HCV but not diagnosed from this age group is they have had HCV for 20-30 years and therefore are at risk for advancing disease, and as studies have shown we are in the USA facing increased numbers of cases for advanced disease among this group - who are at risk for developing cirrhosis, liver cancer and death due to the disease. ......"birth-cohort screening of all patients born between 1945 and 1965 is cost-effective.....There is a large cohort of aging patients who were infected between 1960 and 1980,3 with a resultant increase in the current number of patients with compensated cirrhosis (CC) and, subsequently, endstage liver disease (ESLD). Between 1996 and 2006 the proportion of patients with HCV-related cirrhosis increased from 9% to 19%, and the prevalence of decompensated cirrhosis increased from 5% to 11%.4 The prevalence of hepatocellular carcinoma (HCC) and HCV-related mortality has also increased considerably"....
http://www.natap.org/2012/HCV/121812_03.htm
http://www.natap.org/2010/HCV/031110_02.htm.....
"our findings suggest that the CH-C (chronic hepatitis C) that we have become familiar with during the last 30 years is much different than the hepatitis C we will come to know during the next decade or 2......Currently, only a small proportion of those with CH-C are aware of their infection and, of these, just 10% to 27% are offered treatment.......the proportion of cases with advanced fibrosis will continue to rise during the next 2 decades (Cirrhosis accounted for just 5% of all cases (diagnosed and undiagnosed) of CH-C in 1989, 10% in 1998, and 20% in 2006, the proportion with cirrhosis is projected to reach 24.8% in 2010, 37.2% in 2020, and 44.9% in 2030).....HCC in persons older than the age of 65 years with HCV infection has doubled during the last several years....(The model suggests that decompensation became more common after 1995 and is currently estimated to be present in 11.7% of persons with cirrhosis (Figure 4). The proportion of cirrhotics with decompensation is expected to continue to rise at least through 2030).....it is critical to identify infected persons and treat their disease before advanced fibrosis or liver failure ensues......It is in the immediate best interest of patients, providers, insurers, and governments to promote guidelines and encourage better screening for infection and early antiviral treatment.68 Without such a proactive policy, it is likely that we will spend a considerable amount of resources during the next 2 or 3 decades dealing with liver failure in our elderly population."
http://www.natap.org/2012/HCV/120612_01.htm....
"Our analyses identified the 1941-1960 US birth cohort with HCV related disease as generating the greatest demand for LTx (liver transplantation).....within this birth cohort of individuals with HCV related liver disease we found a dramatic increase in the rate of new registrants for LTx due to HCC. Interestingly, our observed and projected analyses suggest that older patients (³60 years) with HCC will increasingly contribute to the proportion HCV infected liver transplant candidates, unless current patterns of care change dramatically.....Over the coming decade, the projected increase in demand for LTx from an aging HCV infected population will challenge the liver transplant community to reconsider current treatment paradigms...... This birth cohort, born between 1940 and 1965, passed through their high-risk period (ages 20 to 35) during the period of high incidence of HCV infection (1970 to 1989)."
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/36647?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2012-12-29&eun=g92748d0r&userid=92748&email=julev@aol.com&mu_id=5092023
Year in Review
By Charles Bankhead, Staff Writer, MedPage Today
Published: December 28, 2012
As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened since we published the first 2012 piece on the United States Preventive Services Task Force (USPSTF) recommendation against PSA testing for prostate cancer in otherwise healthy men on May 21.
Virginia Moyer, MD, laughed out loud at an analogy that the USPSTF is like a parent telling an insistent kid "no," when it makes a recommendation that runs counter to what many physicians support.
"Maybe so," said Moyer, chair of the task force and a pediatrician at Baylor College of Medicine in Houston. "I think probably part of the issue is that people really don't have a good understanding [of the USPSTF], and maybe we're a victim of our own success."
"Way back when the task force got started, prevention wasn't really part of the doctor visit," she explained. "Most physicians weren't very interested in it; it was generally not something that was covered by insurance; and the result was that when people went to see their doctors, prevention was ignored."
Creation of the USPSTF helped change the status of prevention. The task force was charged with giving primary care physicians "good information" about prevention and to make recommendations about preventive services "that actually work."
"That sort of philosophy, of getting prevention that works into the primary care office, seems to have worked extremely well," Moyer said. "The American public now really believes in prevention, to the extent that it is awfully hard to give up things that you think might be working in the way of prevention."
But not all preventive services are beneficial, Moyer pointed out. "Think about it: If you come into your doctor's office for a check up and you feel fine and don't have symptoms, then if the doctor does a screening test, the best thing that can happen to you is that you don't get any worse," she said. "However, all the other things that can happen to you actually make you feel worse."
There needs to be a recognition that prevention and preventive services can come with potential harm, and that harm has to be balanced with potential benefits, she added.
Moyer said the task force has become quite adept at striking that balance, although some observers -- including many physicians -- might argue with that assessment.
USPSTF in the Limelight
Controversy surrounding the PSA decision actually started to roil in 2009, when circumstances created a "perfect storm" for the USPSTF to get a lot of unaccustomed attention.
As Moyer recounted, political debate and bickering about the Affordable Care Act (ACA) had shifted into high gear. In addition, discussion and posturing related to mid-term elections had already begun, and the ACA provision to provide coverage for any service or test that received a grade A or B from the task force focused unprecedented attention on the USPSTF.
"Prior to that time, no one paid attention to the task force," Moyer said. "We often felt like we were toiling in obscurity."
As events unfolded, a recommendation related to mammography screening for women, ages 40 to 49, was the first one out of the gate. The USPSTF recommended that mammography screening be an individual decision between a woman and her physician, as opposed to a mandated exam.
The recommendation set in motion a blizzard of controversy and critical comment that has yet to abate.
Unaccustomed to the media spotlight, task force members were caught off-guard by the reaction to the mammography decision, said Moyer, who was on a 1-year break from the USPSTF at the time. But by the time the PSA recommendation came out, the outcry from supporters of PSA screening was expected.
The push back included the American Urological Association (ASH), which voiced strong opposition to the recommendation, as did individual urologists. William Catalona, MD, a leader in research that led to the development of PSA tests, has been an especially vocal critic.
Though technically not an arm of the government, task force decisions "certainly do carry the weight of the government," said Catalona, of Northwestern University in Chicago. "There is enormous prestige for this to come from a 'US government-appointed agency.'"
The PSA recommendations also drew criticism from medical specialists who noted that the USPSTF does not include physicians from specialties affected by the decisions.
"Not a single person on that panel was a urologist, a radiation oncologist, or a medical oncologist, who commonly treat prostate cancer patients," Catalona said. "This panel really lacked the specialty expertise in the early management of prostate cancer and the treatment of prostate cancer."
Moyer countered that the USPSTF makes "recommendations for preventive services in the primary care setting. All of us are in primary care, so in fact, we are speaking to our peers in primary care."
'We Really Aren't Talking to Urologists'
The panel continues to receive letters and emails concerning the PSA recommendation, some of which question the absence of a urology representative on the PSA panel.
"We really aren't talking to urologists," Moyer said . "Urologists don't see people who don't have any symptoms, who just want to know if they might be at risk for prostate cancer. That's something that happens in the primary care office. Urologists use PSA testing for a variety of reasons, many of which are entirely appropriate, and are something that urologists should be thinking about."
Phoenix-based family physician Doug Campos-Outcalt, MD, who has worked with the USPSTF for several years, seconded Moyer's statements about primary care physicians as the intended audience for recommendations.
"Urologists follow the recommendations of their specialty societies," said Campos-Outcalt, an American Academy of Family Physicians liaison to the USPSTF. "I can't imagine why they would be so interested in recommendations from the task force, unless they're concerned about getting fewer referrals."
Critics of task force decisions also include people who "have made it their life's work to keep people from suffering the disease that their husband or family member died from," Campos-Outcalt continued.
"Whether or not there is evidence that a particular intervention is effective is not something they are particularly interested in, or would know how to evaluate. All they see is that the task force is not recommending it for first-dollar coverage, and that upsets them," he said.
Prevention, Not Deprivation
The bottom line for USPSTF decisions is the extent to which the recommendations influence primary care practice. In that respect, the data have just begun to emerge.
At the Breast Cancer Symposium earlier this year, investigators reported almost a 10% drop in the mammography rate among women, ages 40 to 49, immediately after the USPSTF announced the recommendation. Thereafter, mammography rates in that age group stabilized, but 2 years later remained 5% lower than the rates prior to the recommendation.
Regarding the PSA decision, influence on PSA testing rates has yet to be documented in published studies, but the evidence "is out there and PSA testing has decreased," said Catalona. "I hear from patients who are in HMOs or similar healthcare organizations, and when they go to their doctors, their doctors say 'We don't do PSA testing anymore. Word has come down from on high that we're not supposed to order PSA tests anymore.'"
"I think there really has been a substantial reduction in PSA testing," he added.
Catalona has seen a draft recommendation to end PSA screening tests in the Veterans Affairs Health System. He shared an email from a colleague who said house staff at one VA center had been instructed to stop ordering routine PSA tests and to delete any pending orders for tests.
Looking ahead to decisions not yet reached, Moyer expressed a desire for better understanding about the task force and its responsibilities.
"We are a group of primary care providers," she said. "We are experts in prevention, experts in understanding scientific literature. Our sole purpose is to improve the health of Americans. We are not out to save money, because improving health often costs money, but health is worth it."
When the task force makes a recommendation against a procedure or test, their goal is not to deprive the public, she emphasized. "It's because the science says that doing that thing is more likely to result in harm than benefit, and we don't wish to harm the American public."
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USPSTF Says 'No' to PSA Testing
Year in Review
By Charles Bankhead, Staff Writer, MedPage Today
Published: December 28, 2012
Our Year in Review series highlights the major medical news stories of 2012. One of the year's controversies centered on the United States Preventive Services Task Force recommendation against PSA screening for prostate cancer in otherwise healthy men. Here is the original story, published on May 21. In a companion article, you'll find out what has happened since then.
Healthy men should no longer have PSA measurements as a screening test for prostate cancer, according to a final recommendation from the United States Preventive Services Task Force (USPSTF).
The so-called grade D recommendation applies to men of all ages, but does not apply to the use of PSA testing for monitoring patients after a prostate cancer diagnosis or treatment.
Calling prevention of prostate cancer deaths the primary goal of screening, the task force cited a lack of evidence that PSA testing has an impact on that goal.
"There is convincing evidence that the number of men who avoid dying of prostate cancer because of screening after 10 to 14 years is, at best, very small," members of the task force said in an article published online in Annals of Internal Medicine. "There is adequate evidence that the benefit of PSA screening and early treatment ranges from 0 to 1 prostate cancer deaths avoided per 1,000 men screened."
On the other hand, convincing evidence of potential harms related to PSA testing does exist. Psychological harm occurs almost immediately when men receive a false-positive test result (estimated to account for 80% of all positive PSA tests when cutoff values of 2.5 to 4.0 μg/L are used).
"Men who have a false-positive test result are more likely to have additional testing, including one or more biopsies, in the following year than those who have a negative test," the task force panel wrote. "Over 10 years, approximately 15% to 20% of men will have a PSA test result that triggers a biopsy, depending on the PSA threshold and testing interval used."
Data from a recent randomized trial showed that a third of men who have PSA-prompted prostate biopsies have pain, fever, bleeding, infection, transient urinary problems, and other issues that require physician follow-up. About 1% of prostate biopsies cause adverse events that result in hospitalization, according to the USPSTF panel.
The comments and conclusions came as no surprise. The USPSTF recommended against PSA testing as a prostate cancer screening tool in a draft guideline released in the fall of 2011.
Despite its position against PSA screening, the panel acknowledged that some men will still want the test and some physicians will continue to offer it.
"The decision to initiate or continue PSA screening should reflect an explicit understanding of the possible benefits and harms and respect the patients' preferences," the panel wrote.
The recommendation drew quick responses, two of which appeared as commentaries that accompanied the journal article. In one of the commentaries, the co-authors began by noting that the task force panel that made the recommendation included no urologists or cancer specialists.
"We, an ad hoc group that includes nationally recognized experts in the surgical and radiological treatment of prostate cancer, oncologists, preventive medicine specialists, and primary care physicians, believe that the USPSTF has underestimated the benefits and overestimated the harms of prostate cancer screening," Marc Rendell, MD, of Creighton University in Omaha, Neb., and co-authors wrote in their introduction.
The USPSTF based its recommendation largely on data from two large trials of PSA screening for prostate cancer. One trial showed no difference in prostate cancer mortality between screened and unscreened men. The other showed an adjusted reduction in mortality risk of 29% among screened men, which the USPSTF translated into too few lives saved to offset the potential harms of screening.
Rendell and co-authors cited what they considered several flaws in the USPSTF recommendation and the process that led to the recommendation:
· Failure to consider that procedures and associated complications occur in unscreened patients
· Focusing on mortality and ignoring the illness associated with living with cancer
· Inadequate consideration of potential benefits in high-risk populations
· Failure to consider epidemiologic data showing a 40% reduction in prostate cancer mortality and 75% reduction in diagnosis of late-stage prostate cancer since the introduction of PSA testing
· Applying the recommendation without regard to age could increase the number of advanced cancers at diagnosis
Noting the potential economic implications of the task force recommendations, Rendell and co-authors wrote, "We believe that elimination of reimbursement for PSA testing would take us back to an era when prostate cancer was often discovered at advanced and incurable stages."
The American Cancer Society (ACS) also weighed in on the issue, and generally supported the USPSTF decision.
"It is my hope that the current USPSTF recommendation ends mass screening," ACS scientific officer Otis Brawley, MD, wrote in another commentary published along with the recommendation. "Although recommending against routine screening, the Task Force does leave room for it within the physician-patient relationship."
"We must heed science when making clinical and policy decisions about PSA-based prostate cancer screening," Brawley added. "The harms are well-proven, whereas the evidence of benefit is weak. Even if one accepts that true benefits exist, the documented harms are likely greater than those small benefits."
"Despite this, some will continue to forcefully advocate PSA-based screening because of a blind faith in early detection. We need to practice medicine on the basis of evidence and not on the basis of faith," he said.
The American Urological Association (AUA) also responded. At the group's annual meeting in Atlanta, AUA vice chair of the health policy council David Penson, MD, said the recommendation was not unexpected but was nonetheless disappointing.
"The real impact has to do with the healthcare reform act," said Penson, of Vanderbilt University in Nashville, Tenn. "Coverage for preventive services is tied to the grade that a service is given. Unfortunately, if you get a grade D, then Medicare is not going to cover the service without a copay, and that could really affect access for some patients who might decide they want to have screening."
Penson said he does not consider the USPSTF decision the "end of the road" for PSA testing. The AUA, other healthcare societies, and patient advocacy groups will continue their efforts to ensure that patients who want PSA testing will be able to get it.
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