Quality and safety

The Prescribing Fiesta for Atypical Antipsychotic Drugs

February 3rd, 2011 | No Comments | Source: MedPageToday

When the so-called “atypical antipsychotic” drugs became available for the treatment of schizophrenia, physicians began prescribing them like crazy because they did not cause debilitating extrapyramidal side effects like their predecessors. As we described previously, relentless and occasionally unscrupulous marketing campaigns by drug makers also drove utilization of the newer agents.

madeinchina 300x225 The Prescribing Fiesta for Atypical Antipsychotic DrugsUnfortunately, the atypical agents turned out to have a nasty side-effect profile of their own. They promote obesity and diabetes, increase the risk of cardiovascular events, precipitate tics and increase mortality in elderly patients with dementia, among other things.

The weight gain/diabetes problem is particularly severe in children—a demographic in which these agents are rarely indicated. In one study for example, the drugs caused youths between the ages of 4 and 19 to gain between 10 and 19 pounds on average in just 11 weeks.

What’s New?
Recently, G. Caleb Alexander and colleagues at the University of Chicago reviewed historical trends in the use of atypical antipsychotics and published their findings in Pharmacoepidemiology and Drug Safety. It’s a largely confirmatory study, and the picture they paint is not pretty.

Caleb’s team queried nationally representative data from IMS Health’s National Disease and Therapeutic Index to characterize prescribing behavior for antipsychotic drugs in outpatient settings. (more…)

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Screening CT Scans Reduce Lung Cancer Mortality. A Little. Now What?

November 8th, 2010 | 2 Comments | Source: Commentary

According to the results of a large study, chest CT scans performed annually as a lung cancer screening test can reduce the risk of lung cancer death by 20% in current and former heavy smokers.

lungcancer Screening CT Scans Reduce Lung Cancer Mortality. A Little. Now What?To reach these conclusions, federally funded scientists performed a multi-center trial in which they enrolled 53,000 people between the ages 55 and 74 that had at least a 30 pack-year history of smoking. Participants were randomized to receive either a chest x-ray or a CT scan at trial entry and then again one year, and 2 years thereafter. Ex-smokers that had quit within the last 15 years were enrolled as well.

The enrollees were followed for up to 5 years. There were 354 lung cancer deaths in the group that was randomized to receive CT scans, and 442 deaths in those receiving chest x-rays. The difference was large enough to prompt the study’s overseers to halt the study before its planned completion date, and to publicize the findings even before the write-up appeared in a peer reviewed journal.

Lung cancer kills nearly 160,000 people per year in the US. That’s more than the combined annual deaths from breast, colorectal, prostate and pancreatic cancers combined. 

Previous studies had ruled-out chest x-rays as useful screening tests for the scourge, because they caught the disease too late. Not surprisingly therefore, many scientists hailed the news as a major advance in lung cancer screening.

“This is the first time that we have seen clear evidence of a significant reduction in lung cancer mortality with a screening test in a randomized controlled trial,” the National Cancer Institute’s Christine Berg told the New York Times.

Statements like this seem premature to me. Chest CT scans cost between $300-1,000 per test. There are nearly 90 million Americans who smoke or used to smoke. A widespread screening program using this technology would cost tens of billions of dollars per year in direct costs alone.

CTscanner Screening CT Scans Reduce Lung Cancer Mortality. A Little. Now What?That’s not counting the indirect costs. In the present study, fully 25% of the subjects who were randomized to receive a CT scan were found to have a false positive result (an abnormality that turned out not to be cancer). Many of these false positive results undoubtedly triggered additional scans, lung biopsies and even thoracic surgery which drive up the overall costs of the screening program many times over.

It’s not clear that our overburdened health system can accomodate the cost escalations implied by a widespread CT scan-based screening program for lung cancer.

Beyond this, CT scans, even the newer “Spiral” scans, are associated with modest levels of radiation exposure in their own right. The cumulative effects of this can actually cause cancer.

And that 20% mortality reduction? That statistic can, in itself, be deceiving. According to Jaan Sidorov’s calculations over at Disease Management Care Blog, the absolute cancer death percentages in last Friday’s study were 1.3% for subjects receiving the CT scan and 1.7% in those receiving chest x-rays. The absolute difference in death rates was therefore about 4 in a thousand. More than 98% of both groups didn’t die of lung cancer during the study period, and the direct cost per life saved was $180,000. That’s an awful lot of CT scans, and an awful lot of money to achieve that reduction in absolute risk. (more…)

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Docs Push Back Against Performance Reports

August 24th, 2010 | No Comments | Source: Wall Street Journal

Private health insurance companies have long since required patients to pay higher out-of-pocket fees when they see physicians who are not in the insurers’ contracted physicians network. In a more recent development, they have begun to rank physicians according to quality and cost parameters and offer enrollees lower out-of-pocket charges if they see physicians who fare better on these parameters.

certifiedgreatdrugaward 300x300 Docs Push Back Against Performance ReportsIn such programs for example, a doctor shown to order fewer imaging tests that are of questionable value would rank in a higher category.

Physicians have always objected to these practices. A March article in the New England Journal of Medicine brought the issue to a boil by showing that these tiered rating systems misclassified 22% of all doctors.

The study prompted provider organizations to release a letter protesting the payer’s practices. “Physicians’ reputations are being unfairly tarnished using unscientific methodologies and calculations,” the letter claimed.

“There are serious flaws in health insurers’ programs to try to rate individual physicians,” AMA President Cecil Wilson added in an interview with the Wall Street Journal.

The provider organizations implored payers to reevaluate their ranking programs.

Payers’ reactions to the letter were lukewarm. For example, Cigna told the Journal that its doctor-rating program already addressed issues raised in the study by focusing on physician groups rather than individuals. Besides that, “Some physicians do provide higher-quality or more-efficient care, and it makes sense to provide modest incentives for choosing that care,” said Dick Salmon, the company’s VP for network quality.

A spokesperson for WellPoint responded it has “taken a thorough, thoughtful approach in introducing measures of physician quality and cost effectiveness” and that the effort is “collaborative with the physician community.”

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US News Hospital Ratings Largely Subjective

June 28th, 2010 | No Comments | Source: Annals of Int'l Medicine, Medscape

US News & World Report’s influential “top 50” list of US hospitals is driven by subjective reputations of the institutions rather than objective measures of hospital quality, according to a study by Ashwini Sehgal of Case Western Reserve University.

scientificratingsystem 144x300 US News Hospital Ratings Largely SubjectiveTo establish subjective reputations of US hospitals, US News surveys 250 board-certified physicians from around the country. US News also uses objective data including nurse-to-patient ratios, availability of specific medical technology, risk-adjusted mortality for Medicare patients, and teaching status.

In analyzing the relative contributions of subjective vs. objective measures in determining which hospitals made the coveted list, Sehgal “found little relationship between rankings and objective quality measures for most specialties.”

Specifically, he found a strong correlation between a hospital’s rank in the US News list and the hospital’s “reputation score” as measured in the survey. By contrast, a hospital’s rank was variably correlated with the objective scores used by US News.

For example, the top five heart and heart-surgery hospitals based on reputation score alone were the same as those of the US News top five heart hospitals (Cleveland Clinic, Mayo Clinic–Rochester, Johns Hopkins University, Massachusetts General Hospital, and the Texas Heart Institute).

“Because reputation score is determined by asking approximately 250 specialists to identify the five best hospitals in their specialty, only nationally recognized hospitals are likely to be named frequently,” Sehgal told MedScape. “Users should understand that the relative standings of US News & World Report’s top 50 hospitals largely indicate national reputation, not objective measures of hospital quality.”

“Being well-known may be the result of many factors that are unrelated to the quality of day-to-day care,” commented Harlan Krumholz of the Yale University School of Medicine.

The write-up is in the Annals of Internal Medicine.

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P4P Improves Diabetes Care

March 24th, 2010 | No Comments | Source: Am. J. Managed Care, MedPageToday

Diabetic patients treated by physicians who received pay-for-performance incentives received better care and had better clinical outcomes than those whose physicians were not involved in the program, according to researchers at IMS Health.

Thisissodemeaning 200x300 P4P Improves Diabetes CareTo reach these conclusions, Judy Chen and colleagues looked at the records of diabetic patients who received care from the Hawaii Medical Services Association, a large PPO between 1999 and 2006. HMSA had 19,600 diabetic at study onset and about 32,000 by 2006.

HMSA offered its physicians the opportunity to earn bonuses ranging between 1.5% and 7.5% of their base fees if they met quality-of-care targets including the use of HbA1c and LDL cholesterol testing for their diabetic patients. Beginning in 2001, participating physicians could earn nearly $6,000 in bonuses if their adherence to specified care requirements improved versus the previous year.

The provider organization defined high-quality care as receiving at least 2 tests for HbA1c and one test for LDL cholesterol in a given year.

Chen’s group found that physicians who were enrolled in the P4P program delivered high quality care 16% more frequently than physicians who were not so enrolled. The patients of physicians who participated in P4P for at least 3 consecutive years were also found to be 25% less likely to be hospitalized.

“This study showed a robust, consistent, significant, and positive association between increased receipt of appropriate laboratory monitoring of A1c and LDL cholesterol levels and decreased hospitalization rates,” Chen’s group wrote.

The proportion of diabetic patients seen by physicians enrolled in the P4P plan jumped from 79% in 1999 to 95% in 2006.

The write up is in the American Journal of Managed Care.

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Never Events Not Always Preventable

March 23rd, 2010 | No Comments | Source: MedPageToday

Patient risk factors like advanced age increase the likelihood of some so-called “never events” in hospitals, according to a report in last month’s Archives of Surgery. The findings do not support Medicare’s current policy of denying payments associated with treatments for such events.

didntusechecklist 300x297 Never Events Not Always PreventableTo reach this conclusion, Donald Fry and colleagues analyzed 890,000 surgeries in 1,368 hospitals using the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample. They studied abdominal hysterectomy, aorto-femoral bypass, colon resection, coronary artery bypass grafting and total hip replacement.

The researchers looked for associations between patient factors like comorbidities, age and gender and 8 “never event” complications, including C. difficile, MRSA, and surgical site infections, catheter-associated vascular and urinary tract infections, mediastinitis after CABG, decubitus ulcers and post-operative pneumonia.

They found that patient age and comorbid conditions like renal failure and weight loss were associated with a much higher risk of many of these “never event” complications.

The odds ratios ranged from 1.8 for unscheduled admission as a predictor for C. difficile enterocolitis to 16.4 for malnutrition and weight loss as a risk factor for intravascular device infection.

“Calling these complications never events and refusing to pay for their treatment may advantage high-quality caregivers, but it also will penalize providers that care for the most vulnerable patients or that perform procedures with higher-than-average risk,” Fry’s group wrote.

Medicare’s “never events” list was implemented 2 years ago. It includes obvious mistakes like transfusing the wrong blood type and wrong-site surgeries.

But the list also features complications that may not be preventable. In addition to those mentioned above, the list includes falls in the hospital, inadequate blood glucose control, pulmonary embolism and drug-induced delerium.

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Antibiotics and Earaches

March 18th, 2010 | No Comments | Source: Wall Street Journal

More than 75% of kids have at least one ear infection before age 5 and earaches are among the most common reasons why kids visit pediatricians. But doctors don’t agree how earaches should be treated.

anothernameinthedatabase 300x199 Antibiotics and EarachesGuidelines promulgated by the American Academy of Pediatrics and the American Academy of Family suggest that many kids will get better without antibiotics.

A recent study in the British Medical Journal even hinted that kids who receive antibiotics might be at greater risk for recurrent infections.

Nevertheless, US doctors prescribe them for more than 80% of the children they diagnose with earaches, according to a study in Pediatrics.

“I’m not looking at a study, I’m looking at a patient,” William Corporon a Kansas-based family practitioner told the Wall Street Journal. Corporan prescribes antibiotics when he diagnoses a bacterial ear infection.

Antibiotic-prescribing doctors believe the drugs help kids recover faster, though they admit the marginal gain is a day or less, at best. They also doubt the veracity of clinical trials on the subject, because they include kids that don’t have bacterial ear infections.

Meanwhile, many parents are not comfortable leaving an ear infection untreated, and others want the quickest possible recovery so their kids can get back to school or day care. In a survey of PCPs for example, 65% said parents’ requests for antibiotics was the most important factor leading to the prescription.

Allan Lieberthal, a pediatrician at Kaiser and chairman of an AAP group tasked to update guidelines on the subject says 80% of children will improve within a few days without antibiotics, while 90% will get better with the antibiotic. Lieberthal typically gives parents a prescription they can fill after 48 hours if the kid still has a fever or pain.

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CT Scans Pose Cancer Risk

January 13th, 2010 | No Comments | Source: Archives Int. Medicine, LA Times, NY Times

The radiation produced by CT scans performed in 2007 will cause 29,000 cancers and kill 14,500 Americans, according to a study published in the Archives of Internal Medicine

Dontlooknow 300x199 CT Scans Pose Cancer RiskTo reach this conclusion, Amy Berrington de Gonzalez and colleagues from the National Cancer Institute used a computer simulation to estimate the impact of the 70 million or so CT scans that were performed in the US that year (only 3 million were performed in 1980).

The scientists estimated that about a third of the future cancers will occur in people who were between the ages of 35 and 54 when they received their CT, and 15% of them will develop in people who were children or teens when the scan was performed.

About two-thirds of the new cancers will develop in women, since they are more vulnerable to radiation.

“There is a significant amount of radiation with these CT scans, more than what we thought, and there is a significant number of cancers,” Rita Redberg, the editor of the Archives of Internal Medicine, told the LA Times.

“While certainly some of the scans are incredibly important and life saving, it is also certain that some of them were not necessary,” Redberg added.

CT scans provide pristine images by combining data from multiple x-ray images. They can also expose patients to up to 400 times more DNA-damaging radiation than conventional chest x-rays. 

In another study, Rebecca Smith-Bindman and colleagues from UCSF found that radiation exposure varies almost 13-fold for different kinds of CT studies, from about 2 millisieverts for a routine head CT scan to 31 millisieverts for a scan of the abdomen and pelvis.

The average American receives about 3 millisieverts of radiation per year, a level not considered to be a health risk.

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Antibiotic Misuse Costs $20b Per Year

November 24th, 2009 | No Comments | Source: Clinical Infectious Diseases

Inappropriate use of antibiotics and consequent antibiotic-resistant infections waste $20 billion per year, according to a study published in Clinical Infectious Diseases.

heregocurecancer 300x200 Antibiotic Misuse Costs $20b Per YearTo reach this conclusion, Rebecca Roberts and colleagues at Cook County (Stroger) Hospital quantified antibiotic resistant infections (ARIs), total costs, length of stay, length of ICU stay, surgeries and mortality rates for 1,391 high-risk adult patients that were hospitalized in the year 2000. 

The scientists found that 188 (13.5%) patients developed an ARI. The medical costs attributable to ARIs ranged from $18,588 to $29,069 per patient. In these patients, length of stay was 6.4–12.7 days longer than in those who did not develop ARIs. Excess mortality in the ARI group was 6.5%.

Common ARIs include methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), as well as many other bacteria that are becoming resistant to common antibiotics.

“Significant health and economic benefits could be realized through effective interventions to reduce antimicrobial-resistant and healthcare-associated infections,” said Roberts in a press release.

Stuart Levy, a senior author on the paper added that his study “demonstrates the enormous cost savings that could be realized for both the health care system and to individuals and their families…these costs will continue to increase if we don’t practice a more prudent usage of antibiotics.”

Levy added that more studies are needed to determine how much could be saved at a national level if we took steps to slow the rise of resistant infections, especially those acquired in hospital settings.

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Check Your Neck

August 21st, 2009 | No Comments | Source: NY Times

Many believe that healthy people should examine themselves regularly or submit to cancer screening because early detection saves lives.

nowweregettinsomewhere 200x300 Check Your NeckThat’s likely true for women, who should begin cervical cancer (Pap) screening by the age of 21, and for adults 50 years or older, who should get colonoscopy.

And it’s probably true for women at least 40 years old, for whom many suggest it’s wise to get mammograms annually to screen for breast cancer.

But that’s about it, at least according to today’s best evidence.

Which brings us to a well-meaning but ultimately dangerous PR campaign by the Light of Life Foundation to raise awareness about thyroid cancer.

“Confidence kills. Thyroid cancer doesn’t care how healthy you are,” read ads in People magazine, Sports Illustrated and elsewhere.  “Ask your doctor to check your neck.”

Thyroid cancer kills about 1,600 Americans per year. In other words, it’s responsible for about 0.3% of all cancer deaths in this country.

And there’s not a shred of evidence that routine neck exams cut the risk of death from thyroid cancer, according to Barnett Kramer, an associate director for disease prevention at NIH.

Most thyroid cancers grow slowly and are curable surgically no matter when they’re found, and the remaining ones are so aggressive that early detection doesn’t’ improve outcomes anyway, according to Kramer. 

A routine thyroid screening program would trigger thousands of unnecessary ultrasounds and needle biopsies not to mention thyroidectomies that risk damaging the vocal cords.

And there’s no guarantee that cursory palpations of the gland by busy PCPs would detect more than a small percentage of the tumors anyway.

Healthy people should consult with their physicians about cancer screening. And they should contact their physicians if new symptoms develop or if their health status changes in any way.

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