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Tag: NEJM

Z-Packing

It was during my residency that the first indication of heart toxicity of antibiotics affected me personally.  The threat was related to the use of the first of the non-drowsy antihistamines – Seldane – in combination with macrolide antibiotics, such as Erythromycin causing a potentially fatal heart arrhythmia.  I remember the expressions fear from other residents, as we had used this combination of medications often.  Were we killing people when we treated their bronchitis?  We had no idea, but we were consoled by the fact that the people who had gotten our arrhythmia-provoking combo were largely anonymous to us (ER patients).

Fast forward to 2012 and the study (published in the holy writings of the New England Journal of Medicine) that Zithromax is associated with more dead people than no Zithromax.  Here’s the headline-provoking conclusion:

During 5 days of therapy, patients taking azithromycin, as compared with those who took no antibiotics, had an increased risk of cardiovascular death (hazard ratio, 2.88; 95% confidence interval [CI], 1.79 to 4.63; P<0.001) and death from any cause (hazard ratio, 1.85; 95% CI, 1.25 to 2.75; P=0.002).  Patients who took amoxicillin had no increase in the risk of death during this period. Relative to amoxicillin, azithromycin was associated with an increased risk of cardiovascular death (hazard ratio, 2.49; 95% CI, 1.38 to 4.50; P=0.002) and death from any cause (hazard ratio, 2.02; 95% CI, 1.24 to 3.30; P=0.005), with an estimated 47 additional cardiovascular deaths per 1 million courses; patients in the highest decile of risk for cardiovascular disease had an estimated 245 additional cardiovascular deaths per 1 million courses. (Emphasis Mine).

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Nurse Staffing, Patient Mortality, And a Lady Named Louise

How many nurses does it take to care for a hospitalized patient? No, that’s not a bad version of a light bulb joke; it’s a serious question, with thousands of lives and billions of dollars resting on the answer. Several studies (such as here and here) published over the last decade have shown that having more nurses per patient is associated with fewer complications and lower mortality. It makes sense.

Yet these studies have been criticized on several grounds. First, they examined staffing levels for hospitals as a whole, not at the level of individual units. Secondly, they compared well-staffed hospitals against poorly staffed ones, raising the possibility that staffing levels were a mere marker for other aspects of quality such as leadership commitment or funding. Finally, they based their findings on average patient load, failing to take into account patient turnover.

Last week’s NEJM contains the best study to date on this crucial issue. It examined nearly 200,000 admissions to 43 units in a “high quality hospital.” While the authors don’t name the hospital, they do tell us that the institution is a US News top rated medical center, has achieved nursing “Magnet” status, and, during the study period, had a mortality rate nearly 40 percent below that predicted for its case-mix. In other words, it was no laggard.

As one could guess from its pedigree and outcomes, the hospital’s approach to nurse staffing was not stingy. Of 176,000 nursing shifts during the study period, only 16 percent were significantly below the established target (the targets are presumably based on patient volume and acuity, but are not well described in the paper). The authors found that patients who experienced a single understaffed shift had a 2 percent higher mortality rate than ones who didn’t. Each additional understaffed shift carried a similar, and additive, risk. This means that the one-in-three patients who experienced three such shifts during their hospital stay had a 6 percent higher mortality than the few patients who didn’t experience any. If the FDA discovered that a new medication was associated with a 2 percent excess mortality rate, you can bet that the agency would withdraw it from the market faster than you could say “Sidney Wolfe.”

The effects of high patient turnover were even more striking. Exposure to a shift with unusually high turnover (7 percent of all shifts met this definition) was associated with a 4 percent increased odds of death. Apparently, patient turnover – admissions, discharges, and transfers – is to hospital units and nurses as takeoffs and landings are to airplanes and flight crews: a single 5-hour flight (one takeoff/landing) is far less stressful, and much safer, than five hour-long flights (5 takeoffs/landings).Continue reading…

NIH and Drug Innovation

For most of the past decade, Democrats and Republicans in Congress have competed over who could pour more money into the National Institutes of Health, the largest funder of biomedical research in the world.

But the party is over. The budget cuts proposed by a leading House Republican this week included cancellation of the $1 billion that the Obama administration wanted to add to the $31 billion NIH budget.

It was part of a broad assault on science funding that was announced by appropriations chairman Hal Rogers, R-Ky., who also called for large cuts at the National Science Foundation, the White House Office of Science, the National Oceanic and Atmospheric Administration and the National Aeronautics and Space Administration.

The purpose, according to Rogers, is “to rein in spending to help our economy grow and our businesses create jobs.”

If creating jobs is his goal, Rogers might want to take a look at a new study that appeared yesterday in the New England Journal of Medicine, which found that publicly-funded research is a far more important contributor to the creation of new drugs and vaccines than previously thought. The classical view of innovation is that government funds basic science, while industry comes up with the new and innovative products based on that science.Continue reading…

The Decade-Long Journey To NEJM Case 34-2010

The most popular article in last week’s New England Journal of Medicine did not tout the discovery of a novel gene, nor describe a cardiology clinical trial with a clever acronym as its title. Rather, it was the report of a case in which a surgeon at the Massachusetts General Hospital performed the wrong operation on a 65-year-old woman.

This was a breakthrough for the Journal – the first time in its storied 86-year history that the Case Records of the MGH published such a report. But it was not the first opportunity the NEJM had to publish such a piece… that occurred a decade earlier. The story of the path from then to now reflects the evolution of the patient safety movement. It’s a story I know well since it involved one of the lowest points in my professional life.

Before I share the back story, a word on last week’s article. David Ring, a prominent Harvard hand specialist, performed a carpal tunnel release on a patient who actually needed a trigger finger release – an entirely different operation. Showing great courage, Ring described his own error, with safety expert Gregg Meyer providing the color commentary.

As always, the pathophysiology of this misfire was a combination of active (i.e., somebody did something wrong) and latent (the system was a setup for failure) errors that jibed entirely with Jim Reason’s famous “Swiss cheese model” of “organizational accidents.”

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