Archive for November, 2015

PSA Police?

Sunday, November 29, 2015 // Uncategorized

Screening for prostate cancer is controversial for reasons outlined in this article from the Wall Street Journal, but now it is taking a new turn. The government is becoming more aggressive in determining what high quality care is. Before they would not pay for certain tests or medications that were unapproved. Now, they will actually penalize doctors. This goes way beyond educating the public. It interferes with shared decision making by patients and their doctors.

Doctors Could be Penalized for Ordering This Test
Wall Street Journal

November 20, 2015

By Melinda Beck

Medicare officials are considering a measure that would penalize doctors who order routine prostate-cancer screening tests for their patients, as part of a federal effort to define and reward quality in health-care services.

The proposal, which hasn’t been widely publicized, has prompted a flurry of last-minute comments to the Centers for Medicare and Medicaid Services, including more than 200 in the past two days, virtually all in opposition. The official comment period began Oct. 26 and ends Friday.

Many of those commenting said the measure would discourage doctors from discussing the pros and cons of screening for prostate-specific antigen (PSA) with their patients and allowing them to decide, as several major medical groups recommend.

“PSA screening is a very controversial topic. The debate is ongoing and people feel very strongly about it, one way or another,” said David Penson, chair of public policy and practice support for the American Urological Association, which urged CMS to reject the proposal. “To make it a quality measure would say, ‘You’re a poor quality doctor if your patients get this test.’ ”

The proposed measure is part of continuing federal efforts to develop ways to identify and reward value in health care. The Obama administration has said it plans to tie 50% of Medicare payments to such quality measures by 2018.

Since 2012, the U.S. Preventive Services Task Force has recommended against routine screening for prostate cancer for men of any age on the grounds that the benefits don’t outweigh the harms.

Studies have shown that screening reduces the risk of death from prostate cancers only minimally, if at all, because most grow so slowly they effectively are harmless.

Yet many men diagnosed with prostate cancer undergo surgery and radiation, which can have lifelong side effects.

Meanwhile, about 28,000 U.S. men die annually from aggressive prostate cancers, often despite getting regular PSA tests and fast treatment.

Both the rate of PSA testing, and diagnoses of early-stage prostate cancer, have declined significantly in the U.S. in recent years, according to studies published in the Journal of the American Medical Association this week. But whether treating fewer cancers early results in more deaths from late-stage prostate cancer later won’t be known for many years.

A CMS official said that as currently drafted, the proposed measure addresses only “non-recommended PSA screenings”—that is, “men who get PSA screening when, under current clinical guidelines, it is not recommended for them.” She said it wouldn’t restrict needed or medically necessary PSA tests.

“Physicians can still order PSA tests if they feel the test is recommended or if the patient requests it,” she said.

The proposal lists some categories of men who would be excluded from the measure, including those with a history of prostate cancer or enlarged prostate, prior elevated PSA levels, or those taking certain medications for prostate issues. It doesn’t mention men at high risk for prostate cancer due to family history or African-American heritage. Some experts say the benefits of screening may outweigh the harms for such patients.

Wanda Flier, president of the American Academy of Family Physicians, which is working with CMS on other quality measures, said it planned to urge the agency to adopt a more flexible measure for PSA screening that would allow for shared decision-making between a patient and physician based on individual circumstances.

“Our goal, as we move to value-based care, is to get to a system that is based on evidence and individual circumstances and not create harm to the patient or undue economic harm to the country,” she said.

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Blood Pressure: How Low Do You Go?

Sunday, November 15, 2015 // Uncategorized

retro This article got a lot of press and a lot of patient’s questions when the study was ended prematurely several months ago.  I couldn’t answer patient’s questions on the news release because the study hadn’t been published.  Now it has been on November 9th and the results only apply to high risk patients who are being treated for  hypertension.

Bottom line:Treating to a lower blood pressure goal in high risk individuals may be of benefit, but it comes at a potential cost.

Here is the summary from Journal Watch.

SPRINT: Intensive Blood Pressure Control Tied to Lower Adverse CV Events

By Allan S. Brett, MD

Dr. Brett is editor-in-chief of NEJM Journal Watch General Medicine, from which this summary was adapted. See full coverage at the link below.

Treating to a systolic blood pressure target of 120 mm Hg lowered the incidence of adverse cardiovascular events in a high-risk population, according to the SPRINT study published in the New England Journal of Medicine and presented at the American Heart Association’s annual meeting.

Researchers enrolled roughly 9400 patients (age 50 or older) with a systolic BP of 130 to 180 mm Hg and high cardiovascular risk but without diabetes or stroke. Patients were randomized to either intensive or standard treatment (systolic BP targets, 120 or 140 mm Hg, respectively). The researchers were permitted discretion in choosing drug regimens.

The trial was terminated early after a median follow-up of 3.3 years, during which participants’ average systolic BPs were 121.5 mm Hg and 134.6 mm Hg in the intensive- and standard-treatment groups, respectively. The primary composite outcome (myocardial infarction, non-MI acute coronary syndrome, stroke, heart failure, or CV-related death) occurred in 5.2% of intensive-treatment patients and 6.8% of standard-treatment patients. Two individual components of the composite outcome were significantly lower with intensive treatment — heart failure (1.3% vs. 2.1%) and CV-related death (0.8% vs. 1.4%). All-cause mortality also was significantly lower with intensive treatment (3.3% vs. 4.5%).

Several serious adverse events were significantly more common with intensive than with standard treatment: incidences of hypotension, syncope, and electrolyte abnormalities were each about 1 percentage point higher, and incidence of acute kidney injury was about 2 percentage points higher. Among patients without CKD at baseline, the incidence of a >30% decline in glomerular filtration rate was significantly greater with intensive treatment (3.8% vs. 1.1%).

SPRINT has demonstrated that aiming for a systolic BP of 120 mm Hg can lower the rate of adverse cardiovascular events; to prevent 1 event, 61 patients had to be treated for 3.3 years. Keep in mind that SPRINT was limited to middle-aged and older patients at above-average CV risk and that diabetic patients were excluded. Whether the decline in GFR associated with intensive treatment represents a harmless hemodynamic effect or more-serious renal injury is unclear.

Clinicians must understand that BP measurements in this study were based on the average of the three readings, taken automatically at 5-minute intervals with no clinician in the room. This method yields substantially lower readings than does a single measurement by a clinician. If SPRINT is applied without attention to proper BP measurement, substantial overtreatment — with a higher rate of adverse events — likely will occur.

Finally, note that the average achieved systolic BP in the intensive-treatment group (121.5 mm Hg) remained higher than the 120 mm target. This likely represents judicious balancing by treating clinicians who tried to approximate the 120 mm goal while avoiding side effects and excessive polypharmacy.

 

retro SPRINT: Intensive Blood Pressure Control Tied to Lower Adverse CV Events

By Allan S. Brett, MD

Dr. Brett is editor-in-chief of NEJM Journal Watch General Medicine, from which this summary was adapted. See full coverage at the link below.

Treating to a systolic blood pressure target of 120 mm Hg lowered the incidence of adverse cardiovascular events in a high-risk population, according to the SPRINT study published in the New England Journal of Medicine and presented at the American Heart Association’s annual meeting.

Researchers enrolled roughly 9400 patients (age 50 or older) with a systolic BP of 130 to 180 mm Hg and high cardiovascular risk but without diabetes or stroke. Patients were randomized to either intensive or standard treatment (systolic BP targets, 120 or 140 mm Hg, respectively). The researchers were permitted discretion in choosing drug regimens.

The trial was terminated early after a median follow-up of 3.3 years, during which participants’ average systolic BPs were 121.5 mm Hg and 134.6 mm Hg in the intensive- and standard-treatment groups, respectively. The primary composite outcome (myocardial infarction, non-MI acute coronary syndrome, stroke, heart failure, or CV-related death) occurred in 5.2% of intensive-treatment patients and 6.8% of standard-treatment patients. Two individual components of the composite outcome were significantly lower with intensive treatment — heart failure (1.3% vs. 2.1%) and CV-related death (0.8% vs. 1.4%). All-cause mortality also was significantly lower with intensive treatment (3.3% vs. 4.5%).

Several serious adverse events were significantly more common with intensive than with standard treatment: incidences of hypotension, syncope, and electrolyte abnormalities were each about 1 percentage point higher, and incidence of acute kidney injury was about 2 percentage points higher. Among patients without CKD at baseline, the incidence of a >30% decline in glomerular filtration rate was significantly greater with intensive treatment (3.8% vs. 1.1%).

SPRINT has demonstrated that aiming for a systolic BP of 120 mm Hg can lower the rate of adverse cardiovascular events; to prevent 1 event, 61 patients had to be treated for 3.3 years. Keep in mind that SPRINT was limited to middle-aged and older patients at above-average CV risk and that diabetic patients were excluded. Whether the decline in GFR associated with intensive treatment represents a harmless hemodynamic effect or more-serious renal injury is unclear.

Clinicians must understand that BP measurements in this study were based on the average of the three readings, taken automatically at 5-minute intervals with no clinician in the room. This method yields substantially lower readings than does a single measurement by a clinician. If SPRINT is applied without attention to proper BP measurement, substantial overtreatment — with a higher rate of adverse events — likely will occur.

Finally, note that the average achieved systolic BP in the intensive-treatment group (121.5 mm Hg) remained higher than the 120 mm target. This likely represents judicious balancing by treating clinicians who tried to approximate the 120 mm goal while avoiding side effects and excessive polypharmacy.

Why We Chose This as Our Top Story:

André Sofair, MD, MPH: This well-designed study reiterates the importance of individualized blood pressure control. It demonstrates that in certain high-risk patients, more aggressive BP targets may be warranted.

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Blog Is Back! Should Doctor’s Go Bare?

Wednesday, November 4, 2015 // Uncategorized

I was having technical difficulties that prevented me from blogging for the past month.  Fortunately, these have been resolved.

The white coat is a time honored symbol of the medical profession. Medical schools have a  White Coat Ceremony where they are given their white coats. I gave up white coats 12 years ago because I felt that they intimidated some patients possibly contributing to “White Coat Syndrome” and because I also felt that they could, like doctor’s ties, transmit disease.  More people have been advocating recently that doctors abandon this tradition.

Should Doctors Go Bare? Infection Control Debate Rages

Hospital-acquired infections and the rise of drug-resistant organisms has put new focus on whether requiring doctors to go “bare below the elbows” (BBE) would help infection control. BBE means no long sleeves, no neckties, no wristwatches, no jewelry other than a wedding band, and generally that physicians will wear scrubs.

The practice was adopted in the UK in 2008. But it appears to be a tough sell in the US. At a debate today at IDWeek 2015 in San Diego, two physicians squared off in a friendly—and highly entertaining—debate.

Michael Edmond, MD, MPH, MP,of the University of Iowa Hospitals and Clinics said his hospital is going BBE January 1, 2016.  He took the “yes” side of the debate. Neil Fishman, MD, of Penn Medicine in Philadelphia, PA, took the “no” side and closed his debate with a hip-hop style rap.

Edmond began by citing studies that showed how dirty and microbe-contaminated lab coats could get. Though some surveys have shown patients prefer to see their doctors in coats and ties, “Patients preferences vary” and the survey techniques may bias the answers, he said.

Edmond said he was convinced that BBE would help infection control since staph and other organisms persist on clothing, lasting over a month on white coats, particularly if they are polyester not cotton.

One survey showed the iconic white coats are laundered infrequently, with about half the physicians in one survey saying they washed them once a month. “Quite appallingly, 20% said they had never washed them,” Edmond said.

Though there have not yet been any random controlled studies showing that patients treated by physicians wearing white coats and ties had higher rates of preventable infections that those treated by BBE physicians the concept “has biologic plausibility,” Edmond said. Further, trying BBE has “no risk, except to some people’s egos” and minimal cost.

Nonsense said Fishman. “There is no evidence that BBE works,” he said. With all the headaches and challenges physicians and hospital face “You want us to be fashion police too?” Fishman presented a slide show that featured hairy forearms, tattooed forearms, and arms of men with plaque psoriasis, suggesting that baring forearms could be unprofessional and even hazardous.

And what about the “commit to sit” doctrine that encourages physicians to talk to patients at eye level, not tower above them. “Will going bare below the knee be next?” he asked. Edmond, showing photo of a filthy white coat he said belonged to a coworker, said it was simply common sense to think BBE would be safer and cleaner. “Your mother would tell you that,” Edmond said.

Fishman responded with quotes from a UK physician who charged that the BBE practice of wearing scrubs had led to a “less robust view of infection control” in which physicians began to neglect hand-washing and acquired “a slovenly personal appearance.” Other complaints were that doctors never knew what time it was and had “no place to put their stuff,” he said.

In a straw poll after the debate, the audience sided 58% to 42% with Fishman, who at one point showed a slide of himself in a white coat, his arm around the shoulders of a life-sized cutout of Pope Francis, a recent visitor to Philadelphia. The pontiff was wearing white vestments, Fishman pointed out.

Ending the debate on a more serious note, Edmond challenged Fishman to compare his hospital’s infection data with Edmond’s after the Iowa hospital ho has started its BBE policy. He is confident there will be fewer hospital-aquired infections, he said.

Editor’s note: An earlier version of this story misstated Dr. Edmond’s institutional affiliation.

– See more at: http://www.hcplive.com/conference-coverage/idweek-2015/should-doctors-go-bare-infection-control-debate-rages?utm_source=Informz&utm_medium=HCPLive&utm_campaign=Trending_News_10-12-15#sthash.UsEBkxH0.dpuf

By the way, in spite of not having a white coat, some patient’s blood pressure  runs higher in the office than it does at home.

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