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Tag: Marya Zilberberg

Not Everything that Counts Can Be Counted

Have you ever wished that instead of choosing a single answer on a multiple choice exam you could write an essay instead to show how you are thinking about the question? It happened to me many times, particularly on my medical board exams, where the object seemed more to guess what the question writers were thinking than to get at the depth of my knowledge. And even though each question typically had a menu of 5 possible answers, the message was binary: right vs.wrong. There was never room for anything between these two extremes. Yet this middle ground is where most of our lives take place.

This “yes/no” is a digital philosophy, where strings of 0s and 1s act as switches for the information that runs our world. These answers are easily quantifiable because they are easily counted. But what are we quantifying? What are we counting? Has the proliferation of easily quantifiable standardized testing led us to more and deeper knowledge? I think we all know the answer to that question. Yet are heading in the same direction with electronic medical data? Let me explain what I mean.

There was an interesting discussion yesterday on a listserv I am a part of about structured vs. unstructured (narrative) clinical data. I don’t often jump into these discussions (believe it or not), but this time I had to make my views heard, because I believe they are similar to the views of many clinicians.

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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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FOO For Thought

Health Foo image via Paul Levy @Running A HospitalI cite this favorite quote from Max Planck in my book (and every chance I get):

A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.

I think this applies to all walks of life, not just science. Yet sometimes an argument so compelling comes along that, though reluctantly at first, one by one the old guard drop at its feet. This is what happened to me this weekend at the Health Foo Camp in Cambridge, MA.

First, what is Health Foo? Well that was my first question when I received an invitation to attend this strangely named meeting. A Foo Camp is something put together by O’Reilly, the pioneering digital media group. Started 12 years ago, these meetings are thematic gatherings of “Friends of O’Reilly,” hence “Foo,” intended to bring together a diversity of thought about a specific field. The camp that I attended was the second such gathering in the healthcare space, supported in part by the Robert Wood Johnson Foundation, and held at Microsoft’s New England Research and Development Center in Cambridge. How can I ever thank O’Reilly, RWJF and Microsoft for this mind-shifting event?

As I mentioned in my previous post, the attendee roster was so full of luminaries that I frankly wasn’t sure that the invitation had not ended up in my Inbox by mistake. But mistake or not, what a privilege to attend! I spent the weekend getting to know the faces and the substance behind such familiar names as Regina Holliday, Paul Levy, Alan Greene, Ted Eytan, Susannah Fox, Gilles Frydman and others. And what still has my mind spinning is my conversations with people I don’t normally interact with — computational scientists, game designers, food advocates and international public health movers and shakers.

The most risky aspect of this meeting was the very essence of its success: we were to free-range. No agenda was set; space, food and company were provided. The resulting sessions ran the gamut from the usual nerd porn of probability to such far-reaching topics as memory and the role of faith, poetry and the arts in medicine (my personal favorite, where I got to play in the sandbox of participatory painting led by Regina. Take that, left brain!)

I have to say I spent a part of the weekend in a bit of a fog. What is gamification of medicine? What does “deep modularity” mean? But the full impact of such diversity of knowledge did not hit me until I was heading West on the Turnpike away from the meeting in the direction of home. It felt like a deep air pocket, and for a moment I couldn’t catch my breath.Continue reading…

Why Patient Lab Data Should Be Liberated

I am admittedly not an expert on health IT, but I am a firm believer in the empowerment of patients to be the driver of her/his health decision making. So this whole discussion about lab data being available directly to the patient is of great interest to me. But it does seem like yet another instance of the two sides coming together not to listen to each other but to be heard by the other side. And as well know, this works so well for any relationship!

Each side’s view is represented roughly thusly:

Patients These are my data and I have the right to access them as soon as they are available.
Doctors We are worried that the sheer volume, complexity and irrelevance of (much) of the data will make it confusing and unnecessarily alarm the patient

Both arguments are valid, of course. But it is important to ask what lurks below the visible portion of each iceberg.

Let’s take the patient view. Why do I want immediate access to my data? Well, obviously, because it is mine, it represents the results of testing on my body, and the record should belong to me. I should be able to access it freely whenever I damned well please. I am also more than a little exasperated with having to wait sometimes days to hear from my doctor’s office about a result that has been available for a while, but was buried under the reams of paperwork on the MD’s desk or his/her assigning a low priority to my data. And I am most exasperated when my lab results get lost or otherwise never make it to me at all. Perhaps if I have direct and unfettered access, this will make thing more efficient for me as an individual.

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Quality Improvement Under the Microscope

So much media and journal space has been devoted to financial conflicts of interest, particularly within and related to pharma and device manufacturers, that to write any more about it may be redundant. On this site we have also intermittently addressed COI from other perspectives, such as financial interest of the members of the American College of Radiology in maintaining mammography screening status quo, thinly veiled in its own version of the pernicious “death panel” language. We have also spoken a bit about the non-financial COI. And even though we are so very much aware of COI’s potential to lurk around every corner, there are still some surprises.

Take the sacred cow of “quality improvement” in healthcare. Even the name, much like the “pro life” moniker, suggests that it is untouchable in its purity and nobility of purpose. So necessary is it because of the epic magnitude of morbidity and mortality attributed to healthcare itself, that the billions of dollars spent on it seem unquestionably justified. Indeed, much like our public education system, the QI movement garners higher and higher allocations simply due to the sheer face validity of the assumption that more of it is better.

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Remember: Social Media is Social

A few days ago, several news outlets reported on Newt Gingrich’s unfortunate turn of phrase about our President. In a speech in Georgia he referred to Obama as “the most successful food stamp president in modern American history.” Promptly, David Gregory of NBC News called Newt on the potential racist connotations of this remark, thus precipitating a maelstrom of “liberal media” accusations from the usual suspects (here and here). And so it goes, possibly a careless figure of speech, possibly racially charged code, but everyone is now yelling and screaming about whether or not it was OK to say and subsequently to accuse.

There is a much bigger issue at stake than just the utterance of these words. While they offend me and make me think that they were spoken deliberately to elicit racial tensions, the point is that, in an obtuse sort of a way, they can be defended as non-racial in nature. Unfortunately, the speaker’s intention is not the issue any longer, so much as the fact that these words can easily be construed as racially inciting by large swathes of the population. And this is an important point: once squeezed out, much like the toothpaste from its tube, these words cannot be forced back. They will exist in perpetuity and continue to elicit visceral reactions.

Such is the nature of public discourse. Which brings me to the discussion on Bryan Vartabedian’s site about the etiquette of healthcare professionals on Twitter. The example of the particular Twitter stream from a healthcare professional who tweets anonymously under a nom de plume, precipitated a spirited discussion (see over 100 comments) about the propriety and professionalism of her messages in this public forum. While many saw her behavior as at the very least undesirable, some MDs and, more concerning, medical students, did not see a thing wrong with her eructations. Furthermore, she responded via Twitter that she was quite surprised by this tongue lashing and did not know what was so offensive in her messages.

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How Many Diseases Does It Take?

It is not a secret that I dislike tobacco companies. Intensely. I do not see the point of allowing them to sell a product whose value is all in the negative. I am appalled that we are looking for expensive ways to diminish lung cancer mortality before considering a complete ban on this disease promotion apparatus. Yet this story in the LA Times got my goat. Briefly, a woman who has smoked for years and has had smoking-related obstructive lung disease since 1989 decided to sue tobacco companies after developing lung cancer in 2003. The suit has been making the rounds in various levels of courts, since the defendants asserted that she had exceeded the 2-year statute of limitations following the onset of her smoking-caused disease, referring to the 1989 COPD diagnosis. However, the California State Supreme Court has ruled that she can still sue the manufacturers, since she filed her suit within two years of the lung cancer diagnosis. So, why am I bothered?

Well, here is the thing: once you develop lung disease, followed by periodontal disease, as this woman did, had she really remained unaware that cigarettes are bad? That they cause problems? Is it really possible to live in our world and NOT be aware that tobacco kills? And if she was aware and continued to smoke, whose responsibility is it that she developed lung cancer, hers or the manufacturer’s? Well, you say, but the tobacco companies are unethical and lied about making cigarettes more addictive by adding undisclosed ingredients. So, how are we, the consumers, to know? Well, this is pretty simple: We have free will, don’t we? And if you have the free will, you have to exercise some will power, no? Is this not what the human condition is all about? Continue reading…

Invalidated Results Watch

My friend Ivan Oransky runs a highly successful blog called Retraction Watch; if you have not yet discovered it, you should! In it he and his colleague Adam Marcus document (with shocking regularity) retractions of scientific papers. While most of the studies are from the bench setting, some are in the clinical arena. One of the questions they have raised is what should happen with citations of these retracted studies by other researchers? How do we deal with this proliferation of oftentimes fraudulent and occasionally simply mistaken data?

A more subtle but no less difficult conundrum arises when papers cited are recognized to be of poor quality, yet they are used to develop defense for one’s theses. The latest case in point comes from the paper I discussed at length yesterday, describing the success of the Keystone VAP prevention initiative. And even though I am very critical of the data, I do not mean to single out these particular researchers. In fact, because I am intimately familiar with the literature in this area, I can judge what is being cited. I have seen similar transgressions from other authors, and I am sure that they are ubiquitous. But let me be specific.

In the Methods section on page 306, the investigators lay out the rationale for their approach (bundles) by stating that the “ventilator care bundle has been an effective strategy to reduce VAP…” As supporting evidence they cite references #16-19. Well, it just so happens that these are the references that yours truly had included in her systematic review of the VAP bundle studies, and the conclusions of that review are largely summarized here. I hope that you will forgive me for citing myself again:Continue reading…

Another Swing at the Windmill of VAP

Sorry, folks, but I have been so swamped with work that I have been unable to produce anything cogent here. I see today as a gift day, as my plans to travel to SHEA were foiled by mother nature’s sense of humor. So, here I am trying to catch up on some reading and writing before the next big thing. To be sure, I have not been wasting time, but have completed some rather interesting analyses and ruminations, which, if I am lucky, I will be able to share with you in a few weeks.

Anyhow, I am finally taking a very close look at the much touted Keystone VAP prevention study. I have written quite a bit about VAP prevention here, and my diatribes about the value proposition of “evidence” in this area are well known and tiresome to my reader by now. Yet, I must dissect the most recent installment in this fallacy-laden field, where random chance occurrences and willful reclassifications are deemed causal of dramatic performance improvements.

So, the paper. Here is the link to the abstract, and if you subscribe to the journal, you can read the whole study. But fear not, I will describe it to you in detail.

In its design it was quite similar to the central line-associated blood stream infection prevention study published in the New England Journal in 2006, and similarly the sample frame included Keystone ICUs in Michigan. Now, recall that the reason this demonstration project happened in Michigan is because of their astronomical healthcare-associated infection (HAI) rates. Just to digress briefly, I am sure you have all heard of MRSA; but have you heard of VRSA? VRSA stands for vancomycin-resistant Staphylococcus aureus, MRSA’s even more troubling cousin, vancomycin being a drug that MRSA is susceptible to. Now, thankfully, VRSA has not yet emerged as an endemic phenomenon, but of the handful of cases of this virtually untreatable scourge that has been reported, Michigan has had plurality of them. So, you get the picture: Michigan is an outlier (and not in the desirable direction) when it comes to HAIs.Continue reading…

Quality or value? A Measure for the 21st Century

One of the founders of the evidence-based medicine movement, Muir Gray

Fascinating, how in the same week two giants of evidence-based medicine have given such divergent views on the future of quality improvement. Here (free subscription required), Donald Berwick, the CMS administrator and founder and former head of the Institute for Healthcare Improvement, emphasizes the need for quality as the strategy for success in our healthcare system. But here, one of the fathers of EBM, Muir Gray, states that quality is so 20th century, and we need instead to shine the light on value. So, who is right?

Well, let’s define the terms. The Merriam-Webster dictionary defines quality as “the degree of excellence.” The same source tells us that value is “a fair return or equivalent in goods, services or money for something exchanged.” To me “value” is a holistic measure of cost for quality, painting a fuller picture of the investment vis-a-vis the returns on this investment. What do I mean by that?

Simply put, the idea behind value is to establish what is a reasonable amount to pay for a unit of quality. Let’s take my used 1999 VW Passat as an example. If my mechanic tells me that it needs to have some hoses replaced, and it will cost me under $100, and the car will run perfectly, I will consider that to be a good value. However, if my transmission has fallen out in the middle of Brookline Ave. in Boston (really happened to me once, many years ago and with a different car), and it will cost me $5,000 to fix, I may say that the value proposition is just not there, particularly given that the car itself is worth much less than $5,000. Given that my budget is not unlimited, I have to make trade-off decisions about where to put my money, so I may instead spend the money on another used Passat that has good prospects.

But in medicine, we routinely avoid thinking about value. There seems to be an overall impression that if it out there on the market, and especially if it is new, it is good and I am worth all of it. This impression is further enabled by the fact that CMS has no statutory power to make decisions based on value of interventions — they are legislatively mandated to turn a blind eye to the costs. Does this make sense? How toothless is our comparative effectiveness effort likely to be if it has to ignore half of the story?Continue reading…