Home News Briefs FDA approves dabigatran antidote

FDA approves dabigatran antidote

Plus, the best question to detect delirium

November 2015

Published in the November 2015 issue of Today’s Hospitalist

FDA approves agent to reverse dabigatran

THE FDA LAST MONTH granted fast-track approval to a drug that clinicians have been anticipating for several years: an agent that can reverse dabigatran, the oral anticoagulant that’s a direct thrombin inhibitor. Idarucizumab, which will be marketed as Praxbind and administered intravenously, is the first reversal agent to be approved for any of the new direct oral anticoagulants.

According to an FDA press release, idarucizumab was tested in three trials that, combined, included fewer than 300 healthy volunteers who were given dabigatran for the studies. Idarucizumab immediately reduced their levels of dabigatran for at least 24 hours, with headache being the most common side effect.

The drug was also tested in nearly 125 patients on dabigatran who had uncontrolled bleeding or who needed emergency surgery. Researchers in this ongoing trial found that idarucizumab completely reversed anticoagulation for 89% of patients within four hours. Side effects included hypokalemia, constipation, confusion, pneumonia and fever.

Drug company Boehringer Ingelheim, which produces dabigatran, also developed idarucizumab. The FDA didn’t mention how much the reversal agent is expected to cost.

Best practices in treating S. aureus

UNIVERSITY OF MIAMI RESEARCHERS analyzing 16 months of their own center’s data have identified processes of care that they say can improve S. aureus outcomes.

Among patients with S. aureus, the research found that 32.4% had clinical failure, defined as a composite endpoint of in-hospital mortality or persistent bacteremia. The practices that reduced patients’ clinical-failure risk included early ID consult (a mean of four days), timely follow-up of blood cultures within less than four days, and beta-lactam treatment among patients with identified MSSA.

The authors recommended using those processes of care as qual
ity and patient safety indicators for patients with S. aureus. They found, however, that an ID consult was called for only 40.2% of S. aureus patients and that only 65% of patients treated with vancomycin received an appropriate dose. Study results were published online in September by the Journal of Hospital Medicine.

Anticoagulation and A fib

A NEW OBSERVATIONAL STUDY finds that oral anticoagulation in A fib patients with one additional stroke risk factor reduces patients’ risk of ischemic stroke, embolism or death. However, anticoagulating A fib patients with no additional risk factors confers no benefit.

Results were published online by Chest. European researchers looked at nearly 9,000 patients with A fib and found that 24% had either zero
or one additional risk factor. More than half (53%) of those patients were prescribed oral anticoagulation.

Within several years, 7% of patients had a major adverse event, but anticoagulation was not associated with better outcomes among low-risk patients (defined as a CHA2DS2-VASc score of 0 for men and 1 for women).

Researchers did find an association between oral anticoagulants and a better prognosis for men with a CHA2DS2-VASc score of 1 or women scoring 2. Guidelines from the American College of Cardiology/American Heart Association currently don’t recommend antithrombotics for patients with a CHA2DS2-VASc of 1.

ICU admission and pneumonia patients

IN A FINDING that surprised researchers, a new study indicates that ICU admission for borderline pneumonia patients improves survival without adding significantly to costs. That conclusion was the opposite of the authors’ working hypothesis.

Writing in the Sept. 22/29 issue of the Journal of the American Medical Association, researchers looked at data for more than 1.3 million Medicare pneumonia patients admitted to 3,000 U.S. hospitals over a period of two years. Among those patients, 29.5% were admitted to the ICU, while the rest were cared for on a general ward.

Among pneumonia patients whose admission to the ICU was considered discretionary, patients had significantly lower 30-day mortality than matched patients treated on the wards: 14.8% vs. 20.5%. At the same time, the two patient groups had no significant differences in terms of Medicare payments or total hospital costs.

The authors defined “borderline” as “patients whose need for intensive care is uncertain” and “those for whom ICU admission depends on the hospital to which they present.”

Think twice before ordering 
CTs for suspected PEs

NEW GUIDELINES on evaluating suspected pulmonary embolism urge physicians to avoid plasma D-dimer testing and CT imaging, and instead use clinical prediction rules to estimate the probability of PE in patients.

The guidelines, which were published by the American College of Physicians in the Sept. 29 issue of Annals of Internal Medicine, say that there is little evidence that CT imaging improves outcomes. The guidelines recommend against using imaging as the initial test in patients with a low or intermediate pretest PE probability.

The guidelines recommend instead using the Wells or Geneva rules to estimate pretest probability, and the Pulmonary Embolism Rule-Out Criteria (PERC) to identify low-risk patients who should not receive further testing. Doctors should, however, get a high-sensitivity D-dimer initially in patients with intermediate risk or patients with low risk who don’t meet all PERC criteria.

Also recommended: using age-adjusted D-dimer thresholds, not a generic one, in patients over age 50 to help decide if imaging is warranted.

Are one in 20 diagnoses wrong, 
or one in 10?

HOW PERVASIVE are missed or delayed diagnoses? The Institute of Medicine, which released a report on just that topic in September, didn’t give an exact estimate.

However, the report pointed out that studies indicate that 5% of outpatients every year suffer a missed or delayed diagnosis, while autopsies suggest that diagnostic errors are a factor in one out of every 10 patient deaths. In addition, chart reviews find that such errors make up 17% of adverse events in the hospital.

Often, the report noted, diagnostic errors aren’t the result of poor medical judgment, but a problem of poor coordination of care and poor communication. Other problems, the authors wrote, are that the current delivery system “is not well designed to support the diagnostic process” and that doctors receive limited feedback about the accuracy of their diagnoses.

The report, which can be downloaded for free, is the third in a series of IOM reports that began with “To Err is Human” in 2000.

What single question 
can identify delirium?

IF YOU’RE LOOKING for the single best way to screen patients for delirium, you might start by asking them to recite the months of the year in backwards order.

That’s according to a study published online in September by the Journal of Hospital Medicine that tried to identify the best single and paired mental status test items to predict the presence of delirium. Asking patients to recite the months of the year backwards yielded better results than any other single question, with a sensitivity of 83% and a specificity of 69%.

Researchers also found that the most effective pair of questions to detect delirium was asking patients to recite the months of the year backwards and to identify the day of the week.

The study concluded that those questions work well even in patients with dementia. If validated, the authors wrote, “these items will serve as an initial innovative screening step for delirium identification in hospitalized older adults.”

Safety-net hospitals
 should screen boomers for hep C

BECAUSE LOWER-INCOME PATIENTS are disproportionally affected by HCV, screening baby boomers in the hospital for hep C “may be a high priority for safety net hospitals.” That’s the conclusion of a group of Texas researchers who screened a cohort of hospitalized patients who’d never been tested before over a period of 21 months, then followed patients for more than nine months. Study were posted online by Hepatology.

Among those screened, 6.7% tested positive for anti-HCV antibodies, while among those patients, 61% were viremic. That group made up 3.8% of the total cohort, a rate that authors pointed out was nearly twice as high as that found in the general community.

One-third of that group had noninvasive testing that revealed advanced fibrosis or cirrhosis. Those diagnoses were more prevalent among Hispanic patients, those who were older or obese, those with alcohol abuse or dependence, or patients lacking insurance.

Between 3 and 4 million patients in the U.S. are infected with HCV, the study pointed out. Three-quarters of them are baby boomers, and one-half aren’t aware that they’re infected.

How well can you predict discharges?

HOW ACCURATELY hospitalists can predict when patients will be discharged depends a lot on the time of day. In a new study, Duke University researchers asked inpatient physicians if their patients would be discharged the next day, that same day or neither. The study was published online in October by the Journal of Hospital Medicine.

The research logged physicians’ discharge predictions in the morning (between 7 a.m.-9 a.m.), at midday (12 noon-2 p.m.) and in the late afternoon (5 p.m.-7 p.m.). For next-day discharges, the sensitivity and positive predictive value of physician predictions were lowest in the morning (27% and 33%, respectively) but much improved by late afternoon (67% and 69%).

Predictions about same-day discharges were also more accurate at midday (88% sensitivity and 79% positive predictive value) than in the morning.

The data suggest, the authors wrote, that for next-day discharges, late afternoons may be the best time for physicians to meet with multidisciplinary discharge teams.

Can your EHR cure 
the weekend effect?

IF YOUR HOSPITAL is looking for a way to solve the “weekend effect,” it might want to start by looking at EHR technology. That’s one conclusion of a study in the Annals of Surgery, which examined the effects of “and solutions for “the dip in quality that is believed to occur in hospitals over the weekends.

The authors looked at more than 126,000 emergent or urgent surgeries conducted at more than 150 hospitals in Florida between 2007 and 2011. Using length of stay as the metric to gauge weekend effect, researchers found that while most hospitals they studied slowed down over the weekend, a subset was able to mitigate weekend problems by using five strategies.

The biggest single factor in reducing the weekend effect was the full adoption of electronic medical records, which study authors hypothesized may improve the coordination of care. Other strategies included increasing nurse-to-bed ratios, establishing a pain management program
or a home health program, and providing inpatient physical rehabilitation.

Making that medical uniform 
work for you

TO GAUGE the effect of wearing a uniform, an Esquire journalist donned four of them, spending time on the streets of Chicago dressed as first a priest, then a security guard, a mechanic and a doctor.

No one reacted to him when he was dressed as a mechanic or a security guard. When he was wearing the priest uniform, people wanted to be blessed or to take selfies with him. But when dressed in scrubs and a white coat and hurrying while staring at his phone screen, the author found that people went out of their way to help him, with bartenders pouring him free beer and taxi drivers waving him through intersections.

“The world wants to help a doctor,” the author wrote. “The uniform conveys a responsibility that people are willing to share.”

What makes CME effective?

MORE MAY BE MORE when it comes to live CME presentations. That’s according to a new study, which is the first to gauge the association between teaching effectiveness scores and characteristics of CME presentations in hospital medicine.

Researchers surveyed both audience members and presenters at
a 2014 Mayo Clinic hospital medicine conference. They identified the following factors as boosting the “stickiness” of CME material: using audience response systems vs. no audience response, having a larger number of slides (more than or equal to 50 slides vs. fewer), and having presentations last more than 30 minutes vs. less than 30 minutes.

The authors noted that they weren’t sure why longer presentations were associated with greater learning effectiveness, a finding that previous CME research has not demonstrated. Teaching effectiveness was not increased, however, with the use of clinical cases, summary slides or defined goals.

Results appeared in the September issue of the Journal of Hospital Medicine.