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The Vitals - May 2016

Patients Might Not Need to Fast Before Cholesterol Testing

COPENHAGEN, DENMARK – If you’ve had it with cranky patients who come in for a blood draw after missing breakfast and their morning coffee, new research will come as good news.

An international study involving more than 300,000 patients in Denmark, Canada, and the United States, published online recently in the European Heart Journal, suggests that fasting is no longer necessary for blood tests that check cholesterol levels. Until now, cholesterol and triglycerides have been measured in patients with empty stomachs in all countries except Denmark, where non-fasting blood sampling has been used since 2009.

"This will improve patients’ compliance to preventive treatment aimed at reducing number of heart attacks and strokes, the main killers in the world," suggested Borge Nordestgaard, MD, DMSc, of Herlev Hospital at the University of Copenhagen.

Nordestgaard pointed out that, in Denmark, patients, healthcare providers, and laboratories all have benefitted from the simplified procedure.

The recommendations were based on extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions. Results indicate that the maximal mean changes at one to six hours after habitual meals are not clinically significant for a range of cholesterol measures.

“In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease,” according to the joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine involving 21 medical experts from Europe, Australia, and North America.

The authors recommend that fasting sampling be considered when non-fasting triglycerides are more than 5 mmol/L (440 mg/dL). Here is how the consensus statement recommends that laboratory reports should flag abnormal concentrations:

  • triglycerides ≥2 mmol/L (175 mg/dL), compared to fasting samples, where abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL),
  • total cholesterol ≥5 mmol/L (190 mg/dL),
  • LDL cholesterol ≥3 mmol/L (115 mg/dL),
  • calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL),
  • calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL),
  • HDL cholesterol ≤1 mmol/L (40 mg/dL),
  • apolipoprotein A1 ≤1.25 g/L (125 mg/dL),
  • apolipoprotein B ≥1.0 g/L (100 mg/dL), and
  • lipoprotein(a) ≥50 mg/dL (80th percentile).

The statement notes that life-threatening concentrations require separate referral when triglycerides are greater than 10 mmol/L (880 mg/dL) for the risk of pancreatitis; when LDL cholesterol is less than 13 mmol/L (500 mg/dL) for homozygous familial hypercholesterolemia; when LDL cholesterol is greater than 5 mmol/L (190 mg/dL) for heterozygous familial hypercholesterolemia; and when lipoprotein(a) is higher than 150 mg/dL (99th percentile) for very high cardiovascular risk.

“We recommend that non-fasting blood samples be routinely used for the assessment of plasma lipid profiles,” according to the consensus statement. “Laboratory reports should flag abnormal values on the basis of desirable concentration cut-points. Non-fasting and fasting measurements should be complementary but not mutually exclusive.”

Nordestgaard added, "We hope that non-fasting cholesterol testing will make more patients together with their doctors implement lifestyle changes and, if necessary, statin treatment to reduce the global burden of cardiovascular disease and premature death.”


A Third or More of Practice Staff Didn’t Follow Infection Control Protocols

ALBUQUERQUE, NM – Medical practices might be doing everything they should to put policies in place to prevent the spread of infections, but that doesn’t mean all staff members are following them.

In fact, a study published recently in the American Journal of Infection Control found that personnel at New Mexico outpatient care facilities failed to follow recommendations for hand hygiene 37% of the time, and for safe injection practices 33% of the time.

The cross-sectional study of 15 geographically-dispersed outpatient facilities was conducted by researchers from the University of New Mexico and the New Mexico Health Department. At the 15 outpatient sites, which included a variety of practice types, medical specialties, and number of healthcare providers, medical students assessed infection prevention policies and practices during the summer of 2014.

The articles notes that interviews with outpatient facility staff indicated that 93% of recommended policies were in place across the practices.

"Despite high levels of report of hand hygiene education and observed supply availability, observations of hand hygiene and aseptic injection technique showed lack of similarly high behavior compliance," study authors pointed out. "This project highlights the importance of assessing both the report of recommended infection prevention policies and practices, as well as behavior compliance through observational audits. This is critical because there have been outbreaks and infection transmission to patients reported in outpatient settings due to these types of infection prevention breaches, including transmission of hepatitis B and C."

To assess prevention policies, medical students used an outpatient infection prevention checklist developed by the national Centers for Disease Control and Prevention (CDC) that included 14 topic areas such as administrative policies, education and training, occupational health, environment cleaning, hand hygiene, and injection safety. The students also employed direct observation of injection safety and hand hygiene, with each participant asked to observe 10 injections and 20 hand hygiene opportunities at their assigned outpatient practice.

Results indicate that, of the 163 injection safety observations, only 66% of the preparations complied with all of the recommended infection prevention steps, which included performing hand hygiene, disinfecting the rubber septum, using a new needle and syringe, properly discarding single-dose vials, and dating multi-dose vials upon opening.

During the 330 hand hygiene observations, where protocols weren’t followed more than a third of the time, students reported that hand hygiene supplies were always available. Alcohol-based hand rub was used in 3.9% of the observed incidences and soap and water was used 39.1% of cases.

"These findings highlight the need for ongoing quality improvement initiatives regarding infection prevention policies and practices in outpatient settings," the study authors concluded.



Modest Savings Achieved by Some, Not All, Early ACOs in Medicare Program

BOSTON -- Did being an early adopter pay off with the Medicare Shared Savings Program (MSSP) when it launched in 2012?

A study published recently in the New England Journal of Medicine notes that accountable care organizations joining MSSP four years ago achieved modest savings while maintaining or improving performance on measures of quality of patient care in 2013, the first full year of the program.

The program, which now includes 430 participants, began in mid-2012 and early 2013 with the first two cohorts of provider groups. In the first detailed examination of the healthcare payment reform program, researchers from Harvard Medical School found that those practices lowered spending by 1.4% in 2013 compared to a control group of non-ACO providers in the same areas.

That represented a $238 million reduction in spending, study authors emphasized, adding that the savings provide more evidence of early promising results from Medicare ACO initiatives, of which the MSSP is the largest.

The results were not as straightforward as they might have seen at first glance, however. Unlike many other ACO programs such as the Pioneer model, MSSP participants are not required to reimburse Medicare if spending exceeds the benchmark.

The report notes that, while the ACOs joining in 2012 cut spending by $238 million, those signing up in 2013 achieved no savings in their first full year in the program. Furthermore, because Medicare paid out $244 million in shared-savings bonuses to ACOs in the 2012 group, it realized no net savings because of the lower spending.

Study authors question whether the early success of the first participants will be replicated by the ACOs that joined the MSSP in later years.

"These results suggest that ACOs with no downside risk can achieve savings, but that savings to Medicare and society may be slow to develop," said lead author J. Michael McWilliams, MD, PhD. "But the incentives for ACOs to lower spending are currently very weak, so savings may accelerate if the incentives are strengthened."

In a surprising finding, the researchers also found that independent primary care groups participating in the MSSP achieved significantly greater savings than hospital-integrated groups. "Some have presumed that forming a large hospital system that owns a lot of outpatient practices is a prerequisite for ACO success," McWilliams pointed out. "We do not find this to be the case."

"These early results are encouraging overall," McWilliams said. "But building on the initial success of ACO models in Medicare will require stronger incentives and rigorous evaluations to identify groups of systematically successful ACOs whose organizational models and strategies can be disseminated."


Antibiotic Prescriptions ‘Inappropriate’ for Many Respiratory Complaints

ATLANTA – Even though the National Action Plan for Combating Antibiotic-Resistant Bacteria set a goal of reducing inappropriate outpatient antibiotic use by 50% by 2020, until now it hasn’t been clear what percentage of prescribed outpatient antibiotics aren’t really necessary.

A new study from the national CDC attempts to answer that question, finding that about half of antibiotic prescriptions for respiratory ailments were likely inappropriate. Overall, an estimated 30% of outpatient oral antibiotic prescriptions in the United States were unnecessary in a recent one-year time period, according to the report.

The article, which was published in the Journal of the American Medical Association, reports the high rate of inappropriate outpatient antibiotic prescribing in 2010-2011 and argues for better stewardship of the drugs to combat antibiotic resistance. More than 260 million antibiotic prescriptions were dispensed in the time period reviewed.

For the study, CDC researchers used the 2010-2011 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey to estimate the rates of outpatient oral antibiotic prescribing by age and diagnosis, as well as which ones might have been inappropriate in adults and children.

Results indicate that, of the 184,032 sampled visits, 12.6% resulted in antibiotic prescriptions. Patients with sinusitis received antibiotic prescriptions 56 out of a 1,000 times, followed by suppurative otitis media with 47 and pharyngitis with 43.

Using a tiered system to determine appropriate antibiotic prescribing, the study notes that sinusitis, suppurative otitis media, and pharyngitis fall into the second tier for which antibiotics might be indicated in some, but not all, cases.

Overall, acute respiratory conditions led to 221 antibiotic prescriptions per 1,000 population annually, but researchers estimate that just 111 of those were appropriate for the conditions. Among all conditions and ages during the study period, 353 antibiotic prescriptions per 1,000 population out of the 506 dispensed were determined to be appropriate.

"Half of antibiotic prescriptions for acute respiratory conditions may have been unnecessary, representing 34 million antibiotic prescriptions annually,” the study authors wrote. “Collectively, across all conditions, an estimated 30% of outpatient, oral antibiotic prescriptions may have been inappropriate. Therefore, a 15% reduction in overall antibiotic use would be necessary to meet the White House National Action Plan for Combating Antibiotic-Resistant Bacteria goal of reducing inappropriate antibiotic use in the outpatient setting by 50% by 2020.”

The annual antibiotic prescription rate was highest for children 2 and younger, at 1,287 per 1,000 population, according to the report. Regionally, use of antibiotics was highest in the South, with 553 prescriptions per 1,000, compared to the West, with the lowest rate at 423.

In an accompanying commentary, Pranita D. Tamma, MD, MHS, and Sara E. Cosgrove, MD, MS, of the Johns Hopkins University School of Medicine in Baltimore called the estimates of inappropriate usage “conservative,” but suggest the results “offer an important and useful starting point to understand prescribing practices in the ambulatory care setting. Such estimates are necessary to guide public health and outpatient stewardship efforts.”

"Attempts to improve outpatient antibiotic prescribing likely require two complementary strategies: (1) changing clinician behavior to alleviate concerns related to diagnostic uncertainty, alienating patients, and not conforming to peer practices and (2) educating patients and families about the role of antibiotics in medical care,” Tamma and Cosgrove add.



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