Wednesday, September 28, 2011

Long term azithromycin to prevent COPD exacerbations?

In this NEJM study the effect was modest (9 months to first exacerbation as opposed to 6 months) and at the price of hearing impairment developing in a few patients at 1 year. The impact on antimicrobial resistance, though a concern, is unknown.

Via Hospital Medicine Quick Hits.

Friday, September 23, 2011

FDA warning on Zofran and QT prolongation

This is surprising. It is unusual nowadays to see QT problems surface long after a drug has been on the market, since drugs are routinely tested in vitro for K+ channel blocking effects early in development.

The Arizona CERT, which is the definitive repository of information on QT prolonging and torsades inducing drugs, puts Zofran in an intermediate risk category:

Drugs with a Possible Risk of Torsades de Pointes
Drugs that prolong the QT interval and/or in some reports have been associated with torsades de pointes but at this time lack substantial evidence for causing torsades de pointes.

Zofran use is ubiquitous on the wards. I'm aware of no reports of it causing torsades. On the other hand, how many patients with unexplained arrests on the wards are getting Zofran?

The FDA is making some significant labeling revisions:

The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.

That represents a lot of patients being monitored!

HT to Hospital Medicine Quick Hits.

Thursday, September 22, 2011

Global ST elevation: pericarditis or massive STEMI?

Global ST segment elevation (seemingly not confined to a vascular territory) is a differential clue favoring pericarditis over STEMI. The rule, however, is not absolute, because very proximal occlusion of a wrap around LAD variant would threaten the anterior, inferior and lateral walls, leading to widespread ST segment elevation.

Accompanying a tracing showing pericarditis at Dr. Smith's ECG blog is a discussion of other electrocardiographic features in the differential. PR segment depression is a well known clue to pericarditis. Less well known is a QTc of at least 372 ms in nearly all cases of anterior STEMI and reciprocal ST segment depression in nearly all cases of inferior STEMI, features not characteristically present in pericarditis.

Monday, September 19, 2011

The Million Hearts initiative

This, a promotional piece about a new government initiative, and one of dubious value at that, does not belong in a scientific journal IMHO.

The Million Hearts initiative takes some low hanging fruit concerning cardiovascular hygiene (good diet, smoking avoidance, BP control), turns it into a set of performance measures and throws government money at it. There's not a shred of evidence that this sort of sound-good, feel-good approach will work. Moreover, our experience with these sorts of performance measures over the past decade suggests that in all likelihood it will not work.

Dr. Wes weighs in:

Now I do not hold a Masters in public health or public policy, but I do know a thing or two about evidenced-based medicine and cardiology. So it seems only appropriate that a cardiologist should comment on the proclamations made by an infectious disease specialist and pediatrician who promise to "save a million hearts," especially when we consider the billions of taxpayer dollars that have been or will be allocated to their programs.

Even more from Dr. John M.

Theocracy hysteria

This post is worth the read if only for the concluding sentence:

Theocracy is forever descending on the United States, but somehow it always lands in the Middle East.

A Cochrane review on P4P

Here were the findings:

Six of the seven studies showed positive but modest effects on quality of care for some primary outcome measures, but not all. One study found no effect on quality of care. Poor study design led to substantial risk of bias in most studies. In particular, none of the studies addressed issues of selection bias as a result of the ability of primary care physicians to select into or out of the incentive scheme or health plan.

At best, then, these results are “modest” and mixed. When looked at alongside significant design flaws, particularly the failure to take into account selection bias, there is no convincing evidence, conclude the review authors, that P4P consistently improves quality of care.

The studies cited in the review looked mainly at performance. What's missing from the discussion in the review is any attempt to distinguish between performance and real quality. If we have learned anything at all from our experience with core measures and public report cards it's that performance does not equal quality. If the evidence that P4P improves performance is scant it's somewhere between slim and none for quality.

More from Medscape and DB's Med Rants.

Friday, September 09, 2011

Massive patient privacy breach at Stanford

CT negative for SAH. Is LP the next step?

That's been the traditional teaching. But that teaching is based on low level data, much of it from the era of early generation CT scanners. This new study in BMJ sought to determine the sensitivity of present day CT scanners as a function of time. The findings:

Of the 3132 patients enrolled (mean age 45.1, 2571 (82.1%) with worst headache ever), 240 had subarachnoid haemorrhage (7.7%). The sensitivity of computed tomography overall for subarachnoid haemorrhage was 92.9% (95% confidence interval 89.0% to 95.5%), the specificity was 100% (99.9% to 100%), the negative predictive value was 99.4% (99.1% to 99.6%), and the positive predictive value was 100% (98.3% to 100%). For the 953 patients scanned within six hours of headache onset, all 121 patients with subarachnoid haemorrhage were identified by computed tomography, yielding a sensitivity of 100% (97.0% to 100.0%), specificity of 100% (99.5% to 100%), negative predictive value of 100% (99.5% to 100%), and positive predictive value of 100% (96.9% to 100%).

The results of this study suggest that if CT using a late generation scanner is done within 6 hours, LP is not necessary to rule out SAH.

Decline in catheter associated UTIs noted long before Medicare's blame game

---according to this study. The study period was 1990 through 2007. Medicare's blame game, the no pay for adverse events program, was announced in 2007 but didn't start until 2008.

Thursday, September 08, 2011

How should hospitalists collaborate with consultants and what's the risk?

The relationship between the attending physician and the consultant has never been perfectly clear. It varies with different people's expectations and certainly from hospital to hospital. The concept of comanagement has, in many settings, taken it from unclear to nebulous.

Dr. Brad Flansbaum, blogging at The Hospitalist Leader, pointed me to this article illustrative of how the collaboration can go wrong. The article is so poorly written, as Dr. Flansbaum points out, that it's difficult to know what really happened, but perhaps there are some lessons.

Important questions are raised. When is it appropriate to order a consult? To what extent should the rules for comanagememt be hammered out in advance and what are the key issues?

For my twelve year hospitalist career I've worked in only one program although I've seen different styles. Some hospitalists consult liberally, others sparingly. Either style can go to the extreme, to a fault. I've heard of hospitalists who consult for every deranged organ system, others who hunker down and feel they can handle anything. Some consults are for a legitimate clinical question. Others are for a procedure. Many are CYA---sometimes with good reason. After all, if there is a bad outcome, the specialty talent was available and you didn't utilize it, then what?

Chronic meds disappear from the list at discharge

---as documented in this recent paper. Important meds, like antiplatelet agents and statins. And it was even worse if the patient was in the ICU.

The study period was 1997 to 2009. Although systems initiatives (computer generated med lists, collaboration with the hospital pharmacy) to help improve discharge medication instructions were well in place by 1997 med rec as we now know it was not introduced until 2005. These processes all required someone to pick and choose from an array of medications followed by computer generation of a list for the patient. Good intentions, the systematization of the process, added steps to the old method of ordering “patient to continue meds per previous home routine with the following changes:...” Those added steps complicated the loop and created opportunities for error.

Wednesday, September 07, 2011

Righthaven meltdown?

As the blogosphere breathes just a little easier. For now.

Doctors need help to make decisions---but what kind of help?

Brad Flansbaum addressed this topic recently, blogging at The Hospitalist Leader. The post, interestingly, had little to do with the blog's overall focus on leading hospitalist groups. One implication of the post seemed to be a pitch for a greater role of policy and expert panels weighing in on patient care decisions. Was he talking about government leaders, guideline authors or something else? He didn't say. If I knew of any particular political leanings on Dr. Flansbaum's part perhaps I could make a guess, but I don't.

Somehow the post rubs me the wrong way. It's difficult to criticize because though it asks provocative questions, talks around many things and implies many things it doesn't make a declarative statement about much of anything.

But at the risk of erecting the straw man (with apologies in advance if I do) I'll try to parse it out. First, the background for the post is a new study in the Journal of General Internal Medicine (JGIM) which compared the way a sample of doctors and a sample of patients looked at numbers from a hypothetical clinical trial:

Respondents were asked to interpret the results of a hypothetical clinical trial comparing an old and a new drug. They were randomly assigned to the following framing formats: absolute survival (new drug: 96% versus old drug: 94%), absolute mortality (4% versus 6%), relative mortality reduction (reduction by a third) or all three (fully informed condition). The new drug was reported to cause more side-effects...

The proportions of doctors who rated the new drug as more effective varied by risk presentation format (abolute survival 51.8%, absolute mortality 68.3%, relative mortality reduction 93.8%, and fully informed condition 69.8%, p less than 0.001). In patients these proportions were similar (abolute survival 51.7%, absolute mortality 66.8%, relative mortality reduction 89.3%, and fully informed condition 71.2%, p less than 0.001). In both doctors (p = 0.72) and patients (p = 0.23) the fully informed condition was similar to the absolute risk format, but it differed significantly from the other conditions (all p less than 0.01). None of the differences between doctors and patients were significant (all p greater than 0.1).

There's a lot we could unpack here but what are the essential findings of the study? First, we all, doctors and patients alike, are subject to framing bias. No surprise there. Then there was the fact that docs and patients responded similarly when presented only the relative risk reduction. No surprise there, either. In fact it says very little because the information presented to the respondents provided no test of critical analytic skill. With only the relative risk reduction presented the respondent has no way to assess the effect of framing. The astute response to such a scenario would be “it depends” (on the baseline risk, raw numbers, etc) but I'm sure the survey questions didn't offer that option. What might raise some eyebrows is that when absolute risk reduction and comprehensive information were presented patients and doctors still responded similarly.

The authors of the paper were appropriately guarded in their conclusion:

Framing bias affects doctors and patients similarly. Describing clinical trial results as absolute risks is the least biased format, for both doctors and patients. Presenting several risk formats (on both absolute and relative scales) should be encouraged.

This paper addressed framing bias. It did not address whether doctors are better in the real world at critically appraising the medical literature than patients. It did not purport to do so. The hypothetical scenarios presented were too simple to be a meaningful test of critical appraisal. To conclude that doctors are no better at interpreting medical literature than the lay public is not only ridiculous on its face (a little Bayesian thinking might be in order here) but goes far beyond anything demonstrated by the study. Yet Dr. Flansbaum dances around that very idea.

So, again trying hard to avoid the straw man, here are my reactions to a couple of the other questions raised in Dr. Flansbaum's post:

Are auto mechanics more worthy of their fiduciary duty than doctors?

The opening sentences of Dr. Flansbaum's post read:

I assume, incorrectly perhaps, that mechanics have a basic knowledge of their craft such that routine auto repairs require little effort. The tasks do not supersede the expected competency of the repairperson, and the customer can expect a car that operates at the time of pick up. A small percentage of jobs may stretch that assumption, but that is okay by me.

But the snark in the next two paragraphs hint that he doesn't feel quite the same about doctors.

Do doctors need policy setting expert panels in order to practice EBM?

From Dr. Flansbaum's post:

I also observe that politicians object to “meddling” when EBM-based policies from expert committees passively (or actively) affect the doctor-patient relationship, especially as it relates to decision-making and the counsel we provide. Just watch the nightly news—sound bites abound. This relationship is sacrosanct after all, and our advice is authoritative and 98.7% correct. Who would question a physician after all?

Well, first, I know of no pundits or politicians who assert that we should never question doctors, or that doctors are authoritative or 97% correct. Now if Dr. Flansbaum is pitching for more policy-based control of physicians' practices it's strange that he would invoke EBM. EBM, much like “patient safety” and “antibiotic stewardship,” is one of those catchy terms all too easily used to bolster a specious argument.

The true notion of EBM does not apply here at all. In fact, according to David Sackett's original definition, EBM can only be applied with individual clinical expertise at the level of the individual patient. So there can be no such thing as “EBM based policies from expert committees.” I've heard many arguments in favor of more central control of doctors' practices. Though I disagree with that position I respect many of the arguments. Just don't invoke EBM. However much there may be to like about central control of medical practice, it isn't EBM.

So back to the title of the post. What kind of help do we really need? As I've said before the focus needs to be on improving access to educational resources so doctors can more quickly and easily apply the best external evidence to individual patient care.

Oh, BTW---were the editors of JGIM in too big a hurry to get this paper out or were the spell checkers at the Journal on the blink that day?

Tuesday, September 06, 2011

Obamacare's popularity continues its decline

Health Care BS posts this and writes:

The Obama administration has made real history with ObamaCare. They have created the only nanny-state entitlement in history that gets less popular as time goes on.

Accountable care organizations: managed care on steroids

Accountable care organizations (ACOs) are being touted by policy elitists as the way to integrate health care services, improve quality and reduce costs. To many in the trenches of health care who have experienced the law of unintended consequences this view is naïve. We know that more intrusion from government means more conflicts and more pressure to game the system. According to this Pajamas Media piece by Paul Hsieh ACOs will merely bring new and more perverse cost incentives leading to cherry picking of patients along with new and creative ways to abuse the system:

Less scrupulous providers will thus be tempted to manipulate the assignment rules to avoid these burdensome “ACO lepers.” Consulting firms are already advising prospective ACOs on the pros and cons of various patient assignment systems. Because the financial stakes are so high, some will inevitably seek to exploit these rules to their advantage, even if it’s at their patients’ expense...

Under ObamaCare, the winners will be those lobbyists, consultants, and less-scrupulous hospitals and doctors willing to “game” the system to their advantage. The losers will be those doctors unwilling to play those games — and their patients.

Monday, September 05, 2011

Woo promoting article in The Atlantic

This is an article about the growth of quackademic medicine in our teaching institutions and it's celebratory more than critical. It profiles the integrative medicine clinic of Dr. Brian Berman. That's right, this Dr. Berman. I blogged about him four years ago and it seems his clinic at the University of Maryland is still going strong. Stronger, apparently.

The article, like integrative medicine itself, is a mixture of quackery and general distortion with a little science and pseudo skepticism thrown in. A central premise is that no matter how nutty the idea, you can't call it quackery if it carries the imprimatur of a respected academic institution:

Concerns of outright malpractice or naked hucksterism seem grossly misplaced when applied to a clinic like Berman’s.

Below are a few more of the distortions contained in the article:

The false dichotomy between the conventional medicine approach and “healing.”

The claim that conventional medicine ignores prevention.

The notion that the principles of conventional medical science are obsolete because they originated in the era when acute infectious diseases were the leading killers.

The idea that medical science has failed to make significant advances in the care of chronic diseases. (Tom Sullivan debunks that popular canard here).

By and large the purported benefits of integrative medicine, as illustrated by the numerous testimonials in the article, are the result of the placebo effect and the generous time and personal attention lavished on the patients who attend. So, some might ask, what's the problem? Aren't those reasons enough to justify integrative medicine?

Not when those benefits are attributed to a quacky intervention. It's just unethical. As Steve Novella, interviewed for the piece, said:

Novella is a highly respected Yale neurologist, and the editor of Science-Based Medicine, an influential blog that has tirelessly gone after alternative medicine. I met with him in his home outside New Haven, Connecticut, where he argued that claims about the practitioner-patient relationship are only intended to draw attention away from the fact that randomized trials have by and large failed to show that alternative treatments work better than placebos. And while he concedes that sham treatments can give patients a more positive attitude, which can confer real health benefits, he is adamant that providing sham treatments at all—essentially fooling patients into believing they’re being helped—is highly unethical. “Alternative practitioners have a big advantage,” says Novella. “They can lie to patients. I can’t.”

Aside from the ethical considerations cited by Novella the argument raises another false dichotomy: that spending lots of time with patients and approaching them as whole persons is somehow uniquely inherent to integrative medicine and foreign to conventional medicine. For many counter-examples to that argument just read DB's many posts on the true nature of mainstream internal medicine or my post here where I cite the example of the late Thomas Brittingham as the exemplar.

No, it's not the pure notion of the whole person or spending time with patients that's unique to integrative medicine. So what is integrative medicine's uniqueness? I would submit that, in part, it's the fact that it makes quacky claims that are so appealing and sensational to the uncritical public that patients are willing to pay handsomely for it out of pocket. That eliminates some of the time pressure that exists under the reimbursement system for conventional medicine.

The article additionally points out the alarming degree to which quackademics are infiltrating the renowned Mayo Clinic, to a greater degree than even I was aware. Even the dean of the medical school is on board.

Some of the Mayo doctors quoted in the article are in favor of integrative medicine but their arguments are mainly sophistry. Though superficially appealing the defects and half-truths in their statements become apparent once a little critical thought is applied.

Friday, September 02, 2011

What's up with all the drug shortages?

As hospitalists we brace ourselves for the shortage of the month. It's usually an older drug, often a generic, and one you'd least expect.

A pharmacist blogging over at Science Based Medicine offers an interesting analysis. The supply chain is complex and, it seems, the problem is multifactorial, but with a common theme: under increasing regulatory and economic pressure industry players are consolidating and restructuring. So now we need a new field. If pharmacokinetics and pharmacodynamics address what happens once a drug is inside the patient, what about getting the drug to the patient? Pharmacologistics?

More on the differential diagnosis of wide complex tachycardia

A commenter on my last post on this topic pointed me to a search that uncovered two interesting and helpful papers I was not aware of.

This review traces the history of methods distinguishing between VT and aberrancy on the surface electrocardiogram. The tried and true method, which assesses for AV dissociation (including that evidenced by fusion and non aberrant capture) or VA conduction with block, is accurate and conceptually sound. However, it is difficult to use with faster ventricular rates, at which atrial impulses are often not well seen. The use of morphologic analysis has gradually improved. Unreliability of early criteria drove the emphasis on analysis of AV relationships. Simple criteria based on QRS width or axis have fallen out of favor. Various early criteria were based on the resemblance of the QRS complex to either bundle branch block. These were popular because they were intuitive, but suffered from low sensitivity and specificity. Several improved methods were developed leading up to the popular Brugada criteria which established morphologic analysis as a more reliable method. More recently criteria involving only lead aVR have been validated.

The aVR method, as explained in this paper, is comparable in accuracy to the Brugada method and appealing in its simplicity.

Gout management in patients with CKD

An update from CCJM.

Thursday, September 01, 2011

Effect of a MRSA bundle for hospitalized patients

From a NEJM report:

The bundle consisted of universal nasal surveillance for MRSA, contact precautions for patients colonized or infected with MRSA, hand hygiene, and a change in the institutional culture whereby infection control would become the responsibility of everyone who had contact with patients. Each month, personnel at each facility entered into a central database aggregate data on adherence to surveillance practice, the prevalence of MRSA colonization or infection, and health care–associated transmissions of and infections with MRSA...

During this period, the percentage of patients who were screened at admission increased from 82% to 96%, and the percentage who were screened at transfer or discharge increased from 72% to 93%. The mean (±SD) prevalence of MRSA colonization or infection at the time of hospital admission was 13.6±3.7%. The rates of health care–associated MRSA infections in ICUs had not changed in the 2 years before October 2007 (P=0.50 for trend) but declined with implementation of the bundle, from 1.64 infections per 1000 patient-days in October 2007 to 0.62 per 1000 patient-days in June 2010, a decrease of 62% (P less than 0.001 for trend). During this same period, the rates of health care–associated MRSA infections in non-ICUs fell from 0.47 per 1000 patient-days to 0.26 per 1000 patient-days, a decrease of 45% (P less than 0.001 for trend).

Platelet disorders in pregnancy

Free full text review.

Warfarin nephropathy: a newly described entity

Think of it in any patient on warfarin (INR can be high, low or therapeutic) with AKI (usually AKI on CKD).  A  post at Nephron Power has the key points and primary sources.

Management of uremic bleeding disorder

A free full text evidence based review was published in Nature Clinical Practice Nephrology.

Commentary here from Renal Fellow Network.

Hospitalized patients die with hyponatremia more than from it

---according to this study.

Death was far more often due to associated conditions than to neurologic damage attributable to the hyponatremia. There was also a U shaped curve, with mortality increasing as sodium levels decreased, but the trend reversed at sodium levels below 120. This apparently means that underlying medical conditions are generally associated with levels of 120-134. Levels lower than that are more likely to be caused by external factors (medications, etc) rather than severe underlying medical illnesses.