Just when you thought you could predict my blog topics, I am going to foil you and not do a post on the rice study in BMJ. I feel like after the last two days with the "meat kills" and "PSA screening saves lives but does not reduce mortality" posts you are not only fed up, but also competent enough to do your own debunking. Let me know if you need any help with that, by the way.
No, in honor of Friday, I will do a fluff post about a show that my family and I are hooked on. Yes, we are addicted to the BBC series "Merlin." Guess what it's about. The new twist is that it is set when both Merlin and Arthur are young men, and it is Merlin's job to keep Prince Arthur from succumbing to his enemies or to his own folly, so that he can lead Camelot forever and ever amen. It has everything you would expect: castles, bloody sword-fight scenes, dragons. Its heroes and villains are an epidemiologist's dream, since they are all evil or all good with nothing in between. It has magic, though that mostly stays in the closet, as Arthur's misguided father King Uther is quite magic-phobic.
Well, last night we witnessed a first in the Episode 3 of Season 3 -- a mischievous goblin got inadvertently released from his lead-lined wooden box and invaded the body of the court physician and Merlin's mentor and friend Gaius. As we all know, of course, goblins are hungry for gold (almost literally -- you'll have to watch the episode). Normally a caring and reasonable man, the pillar of his community, the elderly physician became a raucous and self-centered party animal in search of gold coins at all costs, so-to-speak. In one scene while making a house call to a sick peasant he indicated that the man would die without the potion that Gaius was holding in his hands. Yet he would not part with the potion unless the sick man and his wife produced a gold coin as payment. "But we are so poor," the family explained, " and you have never charged us before." Well, the new and improved market-driven Gaius could not be swayed, and the family ended up giving up their meager wealth to "cure" the husband, who incidentally was merely suffering from a broken rib.
In the next scene, in his continued search for gold coins, Gaius-come-goblin is accosted by Guinevere (in this version she is merely a servant to Lady Morgana -- long story), who is suffering from some ill-defined but clearly innocuous symptom. He takes this opportunity to sell her a potion without which he claims she will succumb to the deadly infection that is gripping Camelot. And despite her obvious skepticism, she is so driven by the fear of the "what if," that she hands over her coin for the tonic and peace of mind.
If all of this seems familiar, but you just can't put your finger on how, I'll give you a hint: our US healthcare "system." It's like there is a goblin in it, who in his relentless pursuit of gold is bankrupting the nation and disease-mongering to increase profit. Of course this allegory has no nuance, and why should it: this is after all a TV series about a magical medieval kingdom whose name itself has come to mean "utopia." Yet it is jarring to realize just how close to our reality this story is.
I am sure you are all anxious to find out how the episode ended. Did the peasant survive? Was Gaius able to regain his body? Did the goblin get back into his box? For answers to all these questions you can go to Netflix. As for our healthcare system, isn't it time we chased the goblins out?
Showing posts with label health economics. Show all posts
Showing posts with label health economics. Show all posts
Friday, March 16, 2012
Friday, February 3, 2012
Teach one thing, or the rule of thirds
When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there -- they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, "I'm gonna teach you one thing today." And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore "I'm gonna teach you one thing today" promise. Well, today is one of those days: I'm gonna teach you one thing.
And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the "Zilberberg rule of thirds." The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the "sweet spot" for intervention. So it is a fool's errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.
Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.
In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:
1. Is the disease in question prevalent?
2. Is the economic impact of the disease known and substantial?
3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?
If the answer to any of the questions above is "no," you really need to think carefully about the value proposition.
Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding "no." So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.
And that is your one thing for today.
And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the "Zilberberg rule of thirds." The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the "sweet spot" for intervention. So it is a fool's errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.
Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.
In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:
1. Is the disease in question prevalent?
2. Is the economic impact of the disease known and substantial?
3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?
If the answer to any of the questions above is "no," you really need to think carefully about the value proposition.
Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding "no." So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.
And that is your one thing for today.
Thursday, December 22, 2011
3 ways to sink a new drug
I don't just rant about methods and evidence -- in my work life I also rant about health economics and outcomes! This is why I was so interested in this post by the health economist Ulf Staginnus called
"New Models for Market Access." I want to give a hat tip to Healtheconomics.com for pointing me here.
The thesis of the article is that we need to refocus our discussion from market access to true innovation in the biopharma sector. There are some priceless quotes here, like this one, for example:
He has this to say about health economics and outcomes and such:
The second problem is that articulating the value proposition of a nascent technology is usually an afterthought. In fact it is self-evident that drug pricing must be fed using the information on the burden of disease, and the impact the new technology can make in mitigating such burden. Unfortunately, time and time again I see companies backing into a price simply in reaction to what their Boards perceive the returns should be. And frequently this is based on the overly optimistic market projections flowing from, you guessed it, market "research."
So, the direct result of all this short-sightedness and business as usual is that even innovative useful products are driven into oblivion because there is no realistic look at what the technology is worth or where best to use it. And fixing the problem after the drug or device is on the market is a much bigger challenge for several reasons. First, the acquisition costs of new technologies are bound to be higher than of those already in use. This puts them at a disadvantage in that they get niched into populations that have much greater burdens of illness and therefore less of a chance of doing well. In other words, they are used as a last ditch therapy, which very rarely ends well. Ironically, these are usually not the populations who were studied in the pre-approval studies, and thus the use turns out to be off-label. But here is the real problem: When these technologies are in the "kitchen sink" category, they will almost always end up looking worse in terms of the outcomes than their older counterparts. And to the untrained eye, or an eye who does not have the time to discern the truth, particularly in the setting of perceived high expenses on the new product, this rings the death toll for the drug. But the reality, of course, is that the abysmal outcomes are the result of confounding by indication, where the drug was inappropriately given to those patients who were very unlikely to benefit from in the first place. But you see how this early lack of attention to the articulation of appropriate populations and health economic data can snowball into failure of a promising therapy.
So, if you want your drug to fail, do the opposite of what I recommend below. In other words DO NOT
1. Develop your market understanding
Do it not from the opinions of a handful of "experts" -- experts will rarely tell you the truth. Instead, do epidemiology studies to understand your population and its subpopulations so as to get the most reasonable idea of the disease.
2. Start thinking about the value proposition early
At the end of a successful Phase 2 program is a good time to do this. The surprise to most companies is how little HEOR studies cost in comparison with their clinical trials program. Yet, as you can see from above, this drop in the ocean can make or break a product.
3. Focus on transparent pricing methods
When pricing the technology, be very very sure that you have all of the ducks in a row, meaning:
a. do understand your market
b. do understand the burden and costs of the disease
c. do understand how your product impacts these costs
d. do price the product to reflect this balance
It is truly embarrassing to have to admit that your price reflects nothing more than the greed of your investors. Trust me, you will not score points with your customers.
Staginnus makes one other important point which I generally agree with:
"New Models for Market Access." I want to give a hat tip to Healtheconomics.com for pointing me here.
The thesis of the article is that we need to refocus our discussion from market access to true innovation in the biopharma sector. There are some priceless quotes here, like this one, for example:
Don't you love it? It is hard to disagree. He also calls for more of a focus on the long-term returns than the short-term (duh!), as well as more internal honesty, or having the courage to stand up to the pathologic internal enthusiasm about a late-stage product that will obviously go nowhere. And all of this is on target.It is amusing, at least to me, to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches, etc. all over the place, basically suggesting how the industry just needs to throw a few more people with fancy titles here and there, coupled with slight organizational changes, onto the problem and involve stakeholders and—guess what?!—actually talk to patients and perhaps even payers and all of a sudden, like Alice in Wonderland, everything will be good, after all.The uncomfortable truth is, it won't be. All this “noise” is only good for one thing, paying the bills of the consultants, which is fine, too, as I have been one myself so I can understand. But it will not address the problem the research-based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry's survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.
He has this to say about health economics and outcomes and such:
Of course, you need experience in areas such as HE, outcomes research, pricing, economics, policy, advocacy, etc. and all needs to work in sync and early on and with the payer in mind and, yes, most people have understood that by now. So the problem is essentially not in the capabilities, although some are more advanced than others, but rather in the company cultures.And this, I think, is where I have to disagree with him. In my experience there are glaring deficits in the approach to HEOR within biopharma, though of course there are exceptions to the rule. It starts with the fact that disease burden, and especially its costs, are initially assessed through less than, shall we say, rigorous methods. I have seen this critical information get pieced together through market "research", where 5-10 "thought leaders" are asked for their opinions, and the quantification is based on this tiny non-representative sample of nothing more than guesses. This is a shame because the data usually exist which can give a much more bona fide estimate of the extent of the problem.
The second problem is that articulating the value proposition of a nascent technology is usually an afterthought. In fact it is self-evident that drug pricing must be fed using the information on the burden of disease, and the impact the new technology can make in mitigating such burden. Unfortunately, time and time again I see companies backing into a price simply in reaction to what their Boards perceive the returns should be. And frequently this is based on the overly optimistic market projections flowing from, you guessed it, market "research."
So, the direct result of all this short-sightedness and business as usual is that even innovative useful products are driven into oblivion because there is no realistic look at what the technology is worth or where best to use it. And fixing the problem after the drug or device is on the market is a much bigger challenge for several reasons. First, the acquisition costs of new technologies are bound to be higher than of those already in use. This puts them at a disadvantage in that they get niched into populations that have much greater burdens of illness and therefore less of a chance of doing well. In other words, they are used as a last ditch therapy, which very rarely ends well. Ironically, these are usually not the populations who were studied in the pre-approval studies, and thus the use turns out to be off-label. But here is the real problem: When these technologies are in the "kitchen sink" category, they will almost always end up looking worse in terms of the outcomes than their older counterparts. And to the untrained eye, or an eye who does not have the time to discern the truth, particularly in the setting of perceived high expenses on the new product, this rings the death toll for the drug. But the reality, of course, is that the abysmal outcomes are the result of confounding by indication, where the drug was inappropriately given to those patients who were very unlikely to benefit from in the first place. But you see how this early lack of attention to the articulation of appropriate populations and health economic data can snowball into failure of a promising therapy.
So, if you want your drug to fail, do the opposite of what I recommend below. In other words DO NOT
1. Develop your market understanding
Do it not from the opinions of a handful of "experts" -- experts will rarely tell you the truth. Instead, do epidemiology studies to understand your population and its subpopulations so as to get the most reasonable idea of the disease.
2. Start thinking about the value proposition early
At the end of a successful Phase 2 program is a good time to do this. The surprise to most companies is how little HEOR studies cost in comparison with their clinical trials program. Yet, as you can see from above, this drop in the ocean can make or break a product.
3. Focus on transparent pricing methods
When pricing the technology, be very very sure that you have all of the ducks in a row, meaning:
a. do understand your market
b. do understand the burden and costs of the disease
c. do understand how your product impacts these costs
d. do price the product to reflect this balance
It is truly embarrassing to have to admit that your price reflects nothing more than the greed of your investors. Trust me, you will not score points with your customers.
Staginnus makes one other important point which I generally agree with:
And let's face it, if you need a major workshop and intensive external “coaching” to help define the value of your product … well, there actually is little to none. If it was really good, it would have been obvious from the start. So maybe we ought to stop beating around the bush and move on if there is nothing to be done anymore.There is a nuance here, however, as in most things. Given what I have said above, products are more likely to gut than sell themselves. So, while I agree that you do not need a throng of consultants in suits and hair gel to pollute your offices, you do need to understand how to articulate this value, even when it appears obvious.
Tuesday, May 10, 2011
When do diagnostic tests improve mortality?
I thought this post, originally published last May, was worth revisiting apropos this paper that came out in this week's Archives of Internal Medicine. Below I discuss some of the data in the paper, as they were presented in an abstract at a meeting last year, as the context for understanding various mortality statistics.
The question the title of this post poses is well worth asking, particularly as we argue about the merits of mammography screening. The USPSTF has really stirred up the hornet's nest with this one, and the politicians cannot help but get on their populist pulpit, ignoring the facts completely. Oh well, what else is new?
But the question remains: do screening or diagnostic tests that are more sensitive save lives? A great talk on pulmonary embolism detection and outcomes by a recent graduate from the Dartmouth group at the American Thoracic Society last week prompted me to clarify this. We all hear that mortality from many diseases has decreased over the last few decades. But is this true? In order to answer this question, one has to ask what is meant by mortality. Even people well versed in epidemiology and biostatistics occasionally blur the lines between mortality and case fatality, and to our question the distinction is critical. Case fatality is defined as the proportion of patients with the disease that dies, while mortality is a population-based measure, a proportion of all of the population at risk for the disease that dies. The difference lies in our old friend the denominator, which will always keep us honest.
Let's go through a simple example to illustrate this concept. Let's pretend that the total number of cases of disease D diagnosed using stone-age test T 30 years ago was 100 in a population of 10,000 people. Of these cases, 90 died, giving us the case fatality of 90% and mortality of 9 per 1,000 population. Now, we have a new test for D, a super-Doppler-MRI-PET-cyberscan called über-T, a much more sensitive test than the old "gold standard" test T. And now we detect 1,000 cases of D in the population of 10,000 people. Of the 1,000 cases detected by über-T, 90 have died. The case fatality now has decreased dramatically from 90% to 9%, and we can pat ourselves on the back for a job well done, right? Not so fast, the population mortality from disease D has remained a steady 9 per 1,000 population!
So, what does this mean? Does it mean that über-T, which costs 2 orders of magnitude more than its predecessor, is worthless? Well, decide for yourselves. What it means to me is that the additional cases detected by über-T, though finding earlier stage disease, thus increasing the denominator for the case-fatality calculation, has had no impact on the numerator and therefore has not in fact improved the only mortality that matters: population mortality related to the disease.
So, next time a politician tells you how well we are doing with technological innovation in disease management, ask this simple question: Has all the money and innovation really altered the important outcomes, or is this all smoke in mirrors, a mirage created by our irrational belief that technology is our salvation? This may be an uncomfortable epiphany for some. But think about the 900 excess cases of the pseudo-disease diagnosed in our example above -- how many people could have been saved becoming a chronically ill person, how many complications of follow-up procedures could have been avoided, and yes, how much money could have been spent on something other than healthcare? And asking these questions may help us to identify technological advances that actually improve our lives, as opposed to those that merely create attractive business opportunities and stimulate the economy.
Thursday, March 3, 2011
Quality or value? A measure for the 21st century
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?
Let us now look at my favorite sticky wicket, ventilator-associated pneumonia, or VAP. Now, the IHI bundle aimed at eliminating VAP consists of 5 points of intervention: 1). semi-recumbent positioning, 2). daily screen for readiness to get off mechanical ventilation, 3). daily sedation vacation, 4). prophylaxis against GI bleeding, and 5). prevention of clots. As I have mentioned before elsewhere, adherence of 95% to all these measures is deemed compliance and may be ultimately used as a quality measure by payers to determine levels of reimbursement. And while each of these interventions is basically "motherhood and apple pie", applying them blindly and in toto to 95% of intubated patients may be a strategy for disaster. But what is even clearer is that, in order to implement this and all of the other quality improvement strategies, systems need to be put in place that will safeguard against failing to implement these quality measures. The time and resource expenditures needed to institute and maintain these systems, which have not been described in great enough detail as far as I am concerned, have never been quantified. So, what we are left with is a bunch of interventions that, while looking OK individually in clinical trials (until you really start looking at them critically), are likely providing small, if any, gains in quality at the margins, whose investment-return equation has not even been disclosed, let alone balanced. And because budgets are necessarily limited, as are clinicians' time and cognitive capacities, we need to select a sensible menu of interventions from this practically unlimited feast.
This is the quality conundrum, a clear case of chasing our tails to achieve perfection at the expense of good enough. And while no one in their right mind will argue with the language of improved quality in healthcare, I do think that Muir Gray and his camp are on to something that has been a long time coming. At this time of shrinking budgets, competing priorities and tightening resources, does it not make sense to look at value as a package deal, rather than merely at quality in isolation from its context? Instead of being bombarded by ever-increasing volume of quality measures coming from many directions, would it not be more sensible to prioritize these interventions based on the value that they bring rather than merely on their projected outcomes benefits, so frequently estimated based on data that have very little applicability to the real world? Let's start asking the question: how much quality and at what price? Without paying attention to this critical balance, we will not only bankrupt the system, but also worsen outcomes paradoxically, as we continue to overwhelm clinicians with infinite minutia that may or may not be generating helpful outcomes.
So, in my book, Muir Gray: score; Berwick: keep trying.
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?
Let us now look at my favorite sticky wicket, ventilator-associated pneumonia, or VAP. Now, the IHI bundle aimed at eliminating VAP consists of 5 points of intervention: 1). semi-recumbent positioning, 2). daily screen for readiness to get off mechanical ventilation, 3). daily sedation vacation, 4). prophylaxis against GI bleeding, and 5). prevention of clots. As I have mentioned before elsewhere, adherence of 95% to all these measures is deemed compliance and may be ultimately used as a quality measure by payers to determine levels of reimbursement. And while each of these interventions is basically "motherhood and apple pie", applying them blindly and in toto to 95% of intubated patients may be a strategy for disaster. But what is even clearer is that, in order to implement this and all of the other quality improvement strategies, systems need to be put in place that will safeguard against failing to implement these quality measures. The time and resource expenditures needed to institute and maintain these systems, which have not been described in great enough detail as far as I am concerned, have never been quantified. So, what we are left with is a bunch of interventions that, while looking OK individually in clinical trials (until you really start looking at them critically), are likely providing small, if any, gains in quality at the margins, whose investment-return equation has not even been disclosed, let alone balanced. And because budgets are necessarily limited, as are clinicians' time and cognitive capacities, we need to select a sensible menu of interventions from this practically unlimited feast.
This is the quality conundrum, a clear case of chasing our tails to achieve perfection at the expense of good enough. And while no one in their right mind will argue with the language of improved quality in healthcare, I do think that Muir Gray and his camp are on to something that has been a long time coming. At this time of shrinking budgets, competing priorities and tightening resources, does it not make sense to look at value as a package deal, rather than merely at quality in isolation from its context? Instead of being bombarded by ever-increasing volume of quality measures coming from many directions, would it not be more sensible to prioritize these interventions based on the value that they bring rather than merely on their projected outcomes benefits, so frequently estimated based on data that have very little applicability to the real world? Let's start asking the question: how much quality and at what price? Without paying attention to this critical balance, we will not only bankrupt the system, but also worsen outcomes paradoxically, as we continue to overwhelm clinicians with infinite minutia that may or may not be generating helpful outcomes.
So, in my book, Muir Gray: score; Berwick: keep trying.
Thursday, February 24, 2011
New treatments: What benefits at what costs
Yesterday brought quite a bit of press coverage to a small biotechnology company in Cambridge called Vertex. All this attention was spurned by their gene therapy trial results in cystic fibrosis. The treatment, aimed at a genetic mutation present in about 4% of all CF sufferers, was able to improve the volume that a patient can force out of his lungs in 1 second by over 10%, from about 65% to 75%. Matthew Herper of Forbes on his blog, while being duly impressed by the results, also cautioned that the annual price tag for this medicine is likely to reach $250,000 per patient. So, what does all of this mean in the context of our ongoing national discussion about the value of therapies? Well, let's break things down a bit.
First, let's talk about CF. This is a genetic disorder that essentially makes mucus very sticky. Among its many effects, in its most familiar manifestation this mucus plugs up the airways making it difficult to breathe and predisposing the person to frequent and serious lung infections. When I was a resident back in the early '90s, I remember a devastating case of a young man in his late teens with CF whom we all knew so well from his frequent admissions for exacerbations. Though he was pretty high on the lung transplant list, he ended up succumbing to a devastating pneumonia in our ICU, leaving behind a devoted sister who had been fortunate enough to benefit from a transplant several years earlier. This was a typical course in those days: a brief life punctuated by frequent exacerbations, hospitalizations, antibiotics, gastrointestinal complications, and early death in the second or at best third decade of life with very little hope of procreation. Over the last 20 years things have changed dramatically in the treatment of CF: fewer exacerbations, much lengthened life expectancy and a good chance of having children. Yet we cannot attribute most of these changes to dramatic new breakthrough therapies. To be sure, while there have been tweaks to how we give antibiotics and how pancreatic enzymes are administered to replace the digestive enzymes that the pancreas in CF is unable to produce, most of the progress can be attributed to the increased attention to detail and the advent of almost ruthless care coordination at specialty centers. As a Fellow in the '90s I participated in a clinic where CF patients were transitioning from care by pediatric Pulmonologists to that by adult doctors. The CF specialist running this clinic did not only know all of his patients and their family members by names, but was available 24/7 to them and to his staff for consultation. This is the kind of dedication and vigilance necessary to improve the outcomes in CF.
Now, let's talk about the lesion addressed in the Vertex trial. The type of chronic lung disease caused by CF is called "obstructive." Simply put, it makes exhaling the air in the lungs difficult to do. On lung testing one manifestation of obstruction is the amount of air one is able to force out of his lungs in the first second of the effort, and this is called the FEV1, or forced expiratory volume in 1 second. Another important measure of the degree of obstruction is the amount of air that this volume expired in 1 second represents as a proportion of all of the air in the lungs that can be expired, known as the FVC or forced vital capacity. We say that if the FEV1/FVC ratio is under 75%, then obstruction is present. The size of FEV1 helps us understand how bad the obstruction is.
With this as a background, the primary outcome in many obstructive lung disease trials is the improvement in the FEV1. In the specific trial discussed, the average starting FEV1 in the intervention group was about 65%, which falls in the mild-to-moderate category of obstruction. What this means in terms of symptoms can vary widely. The 10% absolute improvement seen in the intervention group resulted in the average FEV1 of about 75% after treatment, definitely representing fairly mild obstruction (generally FEV1 over 80% is considered to be in the normal range). And this truly is impressive. However, equally interesting is the information that is not in the press coverage, largely based on press releases and sound bites from company executives, since the peer reviewed study is not available at this point. We are not told, but led to assume that, the control group started out on average with a similar deficit in lung function. We are informed that the treatment patients were 55% less likely than placebo patients to have an exacerbation of their disease, yet we do not know what the absolute numbers are; that is we are not told what proportion in each group had an exacerbation, how frequently or how severely. So, this 55%, in the absence of context, while an attention grabber, is not a substantive number. Herper does tell us that there was a remarkable difference in the weight gain (a desirable outcome in the CF population), on average 6.8 lb in the treatment vs. 0.9 lb in the placebo group. This is truly impressive, though it would be even more so if I knew that the trial was double blind, a piece of information I did not notice in any of the reports. Some of the reports have also alluded to symptomatic improvement in shortness of breath, though nowhere did I see this quantified.
The most important piece of data, however, is conspicuously absent from all the stories. What is the proportion of patients who responded to therapy? Why is this important? Well, we know that far from everyone responds to every treatment that they ostensibly qualify for; this is referred to as the heterogeneous treatment effect, or HTE. It is very likely that the 10% improvement in the FEV1 represents at once an inflated estimate referent to those non- or under-responders and a muted one for those patients with a terrific response. The question of a minimal clinically significant change in the FEV1 has haunted the lung trials community for a long time now. Yet, without setting some threshold for a minimum FEV1 improvement that correlates with a meaningful improvement in symptoms, one cannot quantify how well the drug works and hence articulate its value. This is crucial when trying to justify the ostensibly exorbitant price tag anticipated for this drug. How many patients will we need to treat in order to have one of them respond meaningfully with an improvement not just in a laboratory number, but also in their lives? If this targeted drug produces a desirable response even in 50% of all patients with the specific mutation it targets, then it means that we need to spend $500,000 annually to obtain a meaningful improvement in symptoms in one CF patient. But what if it only works this way in 20%? Then we will need to treat 5 patients with this drug to obtain 1 meaningful response at the price of $1.25 million annually. This becomes a bit more daunting, particularly given that the costs will have to be covered through some kind of public or pooled funds and given that this is one of many therapies in the pipeline likely to come with a similar conundrum.
I am not implying that improving a single life is not worth $1.25 million annually. In fact, it may well be a bargain. My point is that these are the serious discussions we need to have as a society, so that when the time comes to make these choices, the discussion will not be subverted by a few loud voices sensationalizing "death panel" slogans. Manufacturers need to know that they should disclose full data, not just selective tidbits that highlight benefits only, but also those difficult pieces of information that shed light on their costs. On our part, we need to understand the gargantuan effort and resources these companies expend to tame these elusive wild therapies that hold so much more promise in the abstract than they end up embodying.
We tread a fine line here. Information and how we assimilate it are the next frontier for cogent decision making. We need to get educated about this now because this train is leaving the station regardless of how we feel about it.
First, let's talk about CF. This is a genetic disorder that essentially makes mucus very sticky. Among its many effects, in its most familiar manifestation this mucus plugs up the airways making it difficult to breathe and predisposing the person to frequent and serious lung infections. When I was a resident back in the early '90s, I remember a devastating case of a young man in his late teens with CF whom we all knew so well from his frequent admissions for exacerbations. Though he was pretty high on the lung transplant list, he ended up succumbing to a devastating pneumonia in our ICU, leaving behind a devoted sister who had been fortunate enough to benefit from a transplant several years earlier. This was a typical course in those days: a brief life punctuated by frequent exacerbations, hospitalizations, antibiotics, gastrointestinal complications, and early death in the second or at best third decade of life with very little hope of procreation. Over the last 20 years things have changed dramatically in the treatment of CF: fewer exacerbations, much lengthened life expectancy and a good chance of having children. Yet we cannot attribute most of these changes to dramatic new breakthrough therapies. To be sure, while there have been tweaks to how we give antibiotics and how pancreatic enzymes are administered to replace the digestive enzymes that the pancreas in CF is unable to produce, most of the progress can be attributed to the increased attention to detail and the advent of almost ruthless care coordination at specialty centers. As a Fellow in the '90s I participated in a clinic where CF patients were transitioning from care by pediatric Pulmonologists to that by adult doctors. The CF specialist running this clinic did not only know all of his patients and their family members by names, but was available 24/7 to them and to his staff for consultation. This is the kind of dedication and vigilance necessary to improve the outcomes in CF.
Now, let's talk about the lesion addressed in the Vertex trial. The type of chronic lung disease caused by CF is called "obstructive." Simply put, it makes exhaling the air in the lungs difficult to do. On lung testing one manifestation of obstruction is the amount of air one is able to force out of his lungs in the first second of the effort, and this is called the FEV1, or forced expiratory volume in 1 second. Another important measure of the degree of obstruction is the amount of air that this volume expired in 1 second represents as a proportion of all of the air in the lungs that can be expired, known as the FVC or forced vital capacity. We say that if the FEV1/FVC ratio is under 75%, then obstruction is present. The size of FEV1 helps us understand how bad the obstruction is.
With this as a background, the primary outcome in many obstructive lung disease trials is the improvement in the FEV1. In the specific trial discussed, the average starting FEV1 in the intervention group was about 65%, which falls in the mild-to-moderate category of obstruction. What this means in terms of symptoms can vary widely. The 10% absolute improvement seen in the intervention group resulted in the average FEV1 of about 75% after treatment, definitely representing fairly mild obstruction (generally FEV1 over 80% is considered to be in the normal range). And this truly is impressive. However, equally interesting is the information that is not in the press coverage, largely based on press releases and sound bites from company executives, since the peer reviewed study is not available at this point. We are not told, but led to assume that, the control group started out on average with a similar deficit in lung function. We are informed that the treatment patients were 55% less likely than placebo patients to have an exacerbation of their disease, yet we do not know what the absolute numbers are; that is we are not told what proportion in each group had an exacerbation, how frequently or how severely. So, this 55%, in the absence of context, while an attention grabber, is not a substantive number. Herper does tell us that there was a remarkable difference in the weight gain (a desirable outcome in the CF population), on average 6.8 lb in the treatment vs. 0.9 lb in the placebo group. This is truly impressive, though it would be even more so if I knew that the trial was double blind, a piece of information I did not notice in any of the reports. Some of the reports have also alluded to symptomatic improvement in shortness of breath, though nowhere did I see this quantified.
The most important piece of data, however, is conspicuously absent from all the stories. What is the proportion of patients who responded to therapy? Why is this important? Well, we know that far from everyone responds to every treatment that they ostensibly qualify for; this is referred to as the heterogeneous treatment effect, or HTE. It is very likely that the 10% improvement in the FEV1 represents at once an inflated estimate referent to those non- or under-responders and a muted one for those patients with a terrific response. The question of a minimal clinically significant change in the FEV1 has haunted the lung trials community for a long time now. Yet, without setting some threshold for a minimum FEV1 improvement that correlates with a meaningful improvement in symptoms, one cannot quantify how well the drug works and hence articulate its value. This is crucial when trying to justify the ostensibly exorbitant price tag anticipated for this drug. How many patients will we need to treat in order to have one of them respond meaningfully with an improvement not just in a laboratory number, but also in their lives? If this targeted drug produces a desirable response even in 50% of all patients with the specific mutation it targets, then it means that we need to spend $500,000 annually to obtain a meaningful improvement in symptoms in one CF patient. But what if it only works this way in 20%? Then we will need to treat 5 patients with this drug to obtain 1 meaningful response at the price of $1.25 million annually. This becomes a bit more daunting, particularly given that the costs will have to be covered through some kind of public or pooled funds and given that this is one of many therapies in the pipeline likely to come with a similar conundrum.
I am not implying that improving a single life is not worth $1.25 million annually. In fact, it may well be a bargain. My point is that these are the serious discussions we need to have as a society, so that when the time comes to make these choices, the discussion will not be subverted by a few loud voices sensationalizing "death panel" slogans. Manufacturers need to know that they should disclose full data, not just selective tidbits that highlight benefits only, but also those difficult pieces of information that shed light on their costs. On our part, we need to understand the gargantuan effort and resources these companies expend to tame these elusive wild therapies that hold so much more promise in the abstract than they end up embodying.
We tread a fine line here. Information and how we assimilate it are the next frontier for cogent decision making. We need to get educated about this now because this train is leaving the station regardless of how we feel about it.
Thursday, January 27, 2011
The price of marginal thinking in healthcare policy
I find it fascinating how our brains have this propensity to latch on to what is at the margins at the expense of seeing the bulk of what sits in the center. This peripheral only vision is in part responsible for our obscene healthcare expenditures and underwhelming results.
I have blogged ad nauseam about the drivers of early mortality in the US. In one post I reproduced a pie chart from the Rand Corporation, wherein they show explicitly that a mere 10% of all premature deaths in the US can be attributed to being unable to access medical care. The other 90% is split nearly evenly between behavioral, social-environmental and genetic factors, of which 60%, the non-genetic drivers, can be modified. Yet instead of investing the bulk of our resources in this big bucket of behavioral-environmental-social modification, we put 97% of all healthcare dollars towards medical interventions. This investment can at best produce marginal improvements in premature deaths, since the biggest causes of the effect in question are being all but ignored.
A couple of other striking examples of this marginal magical thinking have surfaced in a few recent stories covered with gusto in the press. One of the bigger ones is the obesity epidemic (oh, yes, you bet it was intended), and its causes. This New York Times piece with its magnetic headline "Central Heating May Be Making Us Fat" entertains the possibility that because of the more liberal use of heat in our homes we are no longer engaging our brown fat, which is a furnace for burning calories. And this is all well and good and fascinating, in a rounding out sort of a way. And it is just as interesting to hear that lack of sleep may be contributing to our expanding waistlines. But it is also baffling that we are still expending these enormous amounts of energy (OK, this one was not intended) on finding the silver bullet, when the target is not a supernatural being, but a super-sized expectation. Is it really that mysterious that we are fatter now than we were 20 years ago, when our current portion sizes are 70% bigger and we spend our days worshipping at the temple of the screen, in all its manifestations? While I am all for learning as much as we can, what we need right now is immediate action to abrogate this escalating epidemic, and I think we can all agree that the way to do it is not through lowering house temperatures. Plenty of behavioral research is available to inform our strategies to get people to eat less and move more. Let's start translating it into practice rather than latch on to one marginal magical idea after another.
And finally, I have to touch upon lung cancer, of course. The current fodder for this was provided by the Washington Post with this story about the growing advocacy among lung cancer patients for early detection. You may recall that recently I did several posts on the heels of the large NCI-sponsored study National Lung Screening Trial (NLST) whose purpose was to understand whether early detection of lung cancer in heavy smokers may improve lung cancer survival. I do not wish to go into all of the specifics of this study and my interpretation of the results -- you can find my thoughts on this study in particular and on screening in general here. What I do want to reiterate is that 85% of all lung cancer is caused by a single exposure: smoking. And guess what? The same behavioral strategies that can help people stop overeating can be deployed towards smoking cessation. Yet, instead of spending 85% of all expenditures on smoking cessation efforts, we prefer to allocate it to early detection. My point is that we need both, but the balance has to be informed by pragmatism, not the marginal magical thinking.
And so it goes that the Pareto principle is bleeding into our healthcare policy decisions -- this is the steep price of the marginal magical thinking. What will it take to get the blinders off and face up to the idea that some intervention points are just more impactful than others? Marginal panaceas will improve our lives, but only at the margins. And without being addressed, the big elephants in the room are likely to stampede us.
I have blogged ad nauseam about the drivers of early mortality in the US. In one post I reproduced a pie chart from the Rand Corporation, wherein they show explicitly that a mere 10% of all premature deaths in the US can be attributed to being unable to access medical care. The other 90% is split nearly evenly between behavioral, social-environmental and genetic factors, of which 60%, the non-genetic drivers, can be modified. Yet instead of investing the bulk of our resources in this big bucket of behavioral-environmental-social modification, we put 97% of all healthcare dollars towards medical interventions. This investment can at best produce marginal improvements in premature deaths, since the biggest causes of the effect in question are being all but ignored.
A couple of other striking examples of this marginal magical thinking have surfaced in a few recent stories covered with gusto in the press. One of the bigger ones is the obesity epidemic (oh, yes, you bet it was intended), and its causes. This New York Times piece with its magnetic headline "Central Heating May Be Making Us Fat" entertains the possibility that because of the more liberal use of heat in our homes we are no longer engaging our brown fat, which is a furnace for burning calories. And this is all well and good and fascinating, in a rounding out sort of a way. And it is just as interesting to hear that lack of sleep may be contributing to our expanding waistlines. But it is also baffling that we are still expending these enormous amounts of energy (OK, this one was not intended) on finding the silver bullet, when the target is not a supernatural being, but a super-sized expectation. Is it really that mysterious that we are fatter now than we were 20 years ago, when our current portion sizes are 70% bigger and we spend our days worshipping at the temple of the screen, in all its manifestations? While I am all for learning as much as we can, what we need right now is immediate action to abrogate this escalating epidemic, and I think we can all agree that the way to do it is not through lowering house temperatures. Plenty of behavioral research is available to inform our strategies to get people to eat less and move more. Let's start translating it into practice rather than latch on to one marginal magical idea after another.
And finally, I have to touch upon lung cancer, of course. The current fodder for this was provided by the Washington Post with this story about the growing advocacy among lung cancer patients for early detection. You may recall that recently I did several posts on the heels of the large NCI-sponsored study National Lung Screening Trial (NLST) whose purpose was to understand whether early detection of lung cancer in heavy smokers may improve lung cancer survival. I do not wish to go into all of the specifics of this study and my interpretation of the results -- you can find my thoughts on this study in particular and on screening in general here. What I do want to reiterate is that 85% of all lung cancer is caused by a single exposure: smoking. And guess what? The same behavioral strategies that can help people stop overeating can be deployed towards smoking cessation. Yet, instead of spending 85% of all expenditures on smoking cessation efforts, we prefer to allocate it to early detection. My point is that we need both, but the balance has to be informed by pragmatism, not the marginal magical thinking.
And so it goes that the Pareto principle is bleeding into our healthcare policy decisions -- this is the steep price of the marginal magical thinking. What will it take to get the blinders off and face up to the idea that some intervention points are just more impactful than others? Marginal panaceas will improve our lives, but only at the margins. And without being addressed, the big elephants in the room are likely to stampede us.
Thursday, January 6, 2011
National Healthcare Expenditures, 2009 (In pictures)
Well, it's that time of the year again: CMS has given us the accounting of our National Healthcare Expenditures (NHE) in a paper published in Health Affairs. I am sure you have already heard that the spending only went up by 4% this year over last, an all-time low.
At the same time, we have achieved the highest ever NHE as a proportion of the GDP (17.6%) and as expenditures per capita ($8,086). But the GDP proportion is a somewhat deceptive number on the one hand, as the GDP has suffered a substantial drop from its 2008 value of $14.4 trillion to $14.1 trillion in 2009. On the other hand, this implies that healthcare is eating into the rest of our expenditures on life. At the same time the per capita expenditures have continued their relentless rise.
Let us look at the components of the NHE individually and see what they can tell us.
As usual, the bulk of the expenditures went to personal health care (85%). Public health got a measly 3% of the total NHE, and this continues to be one of our gravest misappropriations. You may recall that about a year ago I did a post where I cited some startling statistics about some broad categories of causes of premature death in the US. Access to medical care accounted for a measly 10% of those, and the rest were attributable to behavior, genetics, environment and social factors. So, while, by inference, fixing medicine may impact 10% of these premature deaths, in reality 97% of the entire NHE goes to medicine rather than to potentially more impactful public health interventions. And the real travesty is that, despite these astronomical expenditures, we are still losing 1,000 lives per day to our broken healthcare system.
Looking a bit more closely at the "personal health" category, we see that, just as in years past, hospital costs and professional services comprise the bulk of this spending.
The "professional services" category, 81% of which is physician and other clinical services, is a bit murky. Yet, without too many leaps of faith we can say that if this expenditure buys us better preventive care, it may be a cost-effective area. At the same time we know that we can make this area a lot more efficient by streamlining and realigning incentives to promote better health rather than more care. Hospital expenditures, on the other hand, are a juggernaut that without a doubt requires containing. It is very likely that exchanging our inflated personal healthcare budgets for well placed public health funding along with reimbursement reform and improved end-of-life decisions, could substantially alter this category of spending.
One final data point that interested me was the breakdown of what are considered investments in the healthcare system. This broadly includes government-funded research and allocations for structures and equipment. Now, I am not sure what "structures and equipment" means, so, if any of my readers know, please, enlighten me. I do know what "research" means, however, and am rather disappointed about this breakdown. What I do not understand is, given that structures and equipment should have some kind of a half-life and not be replaced annually, how it is that this budget also grows consistently year-over-year at a steady rate? Would love to get more details on this.
To be sure, the total research expenditure of $45 billion is nothing to sneeze at. The big question is, however, are we spending it on the right research. I am not at all sure that the answer is yes, given that we still struggle with the same issues at the bedside that we have been struggling with for over a decade. But more on this later.
At the same time, we have achieved the highest ever NHE as a proportion of the GDP (17.6%) and as expenditures per capita ($8,086). But the GDP proportion is a somewhat deceptive number on the one hand, as the GDP has suffered a substantial drop from its 2008 value of $14.4 trillion to $14.1 trillion in 2009. On the other hand, this implies that healthcare is eating into the rest of our expenditures on life. At the same time the per capita expenditures have continued their relentless rise.
Let us look at the components of the NHE individually and see what they can tell us.
As usual, the bulk of the expenditures went to personal health care (85%). Public health got a measly 3% of the total NHE, and this continues to be one of our gravest misappropriations. You may recall that about a year ago I did a post where I cited some startling statistics about some broad categories of causes of premature death in the US. Access to medical care accounted for a measly 10% of those, and the rest were attributable to behavior, genetics, environment and social factors. So, while, by inference, fixing medicine may impact 10% of these premature deaths, in reality 97% of the entire NHE goes to medicine rather than to potentially more impactful public health interventions. And the real travesty is that, despite these astronomical expenditures, we are still losing 1,000 lives per day to our broken healthcare system.
Looking a bit more closely at the "personal health" category, we see that, just as in years past, hospital costs and professional services comprise the bulk of this spending.
To be sure, the total research expenditure of $45 billion is nothing to sneeze at. The big question is, however, are we spending it on the right research. I am not at all sure that the answer is yes, given that we still struggle with the same issues at the bedside that we have been struggling with for over a decade. But more on this later.
Monday, December 6, 2010
"Invisibility, inertia and income" and patient safety
Hat tip to @KentBottles for a link to this story
I spend a lot of time thinking about the quality and safety of our healthcare system, as well as our efforts to improve it. I have written a lot about it here in this blog and in some of my peer-reviewed publications. You, my reader, have surely sensed my frustration with the fact that we have been unable to put any kind of a dent in the killing that goes on within our hospitals and other healthcare encounter locations. So, it is always with much interest and appreciation that I learn that I am not alone, and that others have had it with the criminal lack of the sense of urgency to stop this medical holocaust. For this reason, I was really happy to read Michael Millenson's post on the Health Affairs Blog titled "Why We Still Kill Patients: Invisibility, Inertia and Income". I was very curious to see how he structured his argument to boil it down to these three I's, since I think that sexy slogans and memorable triplets are the way to go. So, here is how his arguments went.
First, establish the problem. And indeed, we have been killing around 100,000 people annually since the late 1970s (and probably since before then, as you actually have to look in order to find), which amounts to the total 20-year toll of 2.5 million unnecessary deaths due to healthcare in the US. This is truly appalling. And this is just up through the 1999 IoM report! Here is what I was thinking: And if we take into account not just the killing fields of the hospital, but all of life's interfaces with healthcare, we arrive at an even more frightening 400,000 deaths annually, as known back in 2000. Multiply this by 10, and now we really are talking about a killing machine of holocaust proportions! And I completely agree with Millenson that the fact that we continue to say "more research needed" and other pablum like that is utterly and completely irresponsible. However, is this really an invisible problem? The author makes a good argument for how we minimize these numbers by failing to add them up:
On the to the next "I", inertia. I agree with Millenson generally, and we actually know this, that physicians do not practice evidence-based medicine, and, even when it does, evidence takes decades to penetrate practice. And there is every reason to be upset that the medical profession has not rushed to adopt evidence-based prevention measures that Millenson talks about. But there is a greater subtlety here than meets the eye. True, the Kestone project is frequently held as an example of a simple evidence-based bundled intervention resulting in in a huge reduction in central line-associated blood stream infections. Indeed, this is a great success and everyone should be practicing the checklist instituted in the project by Peter Pronovost's group. What is less obvious and even less talked about is that the same approach of evidence-based bundled approach to prevention of ventilator-associated pneumonia (VAP) has also been piloted by the Keystone group, yet none of us has seen any data from that. All I have is rumors at this point, but they are not good. Why is this? Well, I have discussed this before here and here: VAP is a very tricky diagnosis in a very tricky population. This is not to say that we need not work as hard as we can to prevent it. It is just to clarify that we are not sure of the best ways to accomplish this. Is this in and of itself shameful? Well, yes, if you think that medicine is a precise science. But if you have been reading my blog long enough, you know this is not the case.
Millenson further sites his reading of the Joint Commission Journal, which has been documenting the progress within one large Catholic healthcare system, Ascension, in its efforts to reduce infections, falls and other common iatrogenic harms. By the system's account, they are now able to save over 2,000 lives annually with these measures. This is impressive. But is it trustworthy? Unfortunately, without reading the primary studies I cannot comment on the latter. However, I did publish a review of studies from this very journal on VAP prevention efforts, and here is what I found:
And finally, income. I do agree that it is annoying that economic arguments are even necessary to promote a culture of prevention and safety. What I disagree with is that these economic fallacies of the C-suite impact in any way the implementation of the needed prevention systems. Most of the evidence-based preventions are pretty low tech. And although they do require teams and commitment and systems to implement broadly, small demonstrations at the level of individual clinicians are possible. Also, I shudder at the thought that a group of dedicated clinicians could not persuade a group of equally dedicated administrators to do the right thing, even at the risk of losing some revenue.
Bottom line? While I like Millenson's sexy little "three I's of safety", I think the solutions, as is always the case when you start looking under the hood, are more complicated and nuanced. In a recent post I cited 5 potential solutions to our quality problem, and I will repeat them here:
I spend a lot of time thinking about the quality and safety of our healthcare system, as well as our efforts to improve it. I have written a lot about it here in this blog and in some of my peer-reviewed publications. You, my reader, have surely sensed my frustration with the fact that we have been unable to put any kind of a dent in the killing that goes on within our hospitals and other healthcare encounter locations. So, it is always with much interest and appreciation that I learn that I am not alone, and that others have had it with the criminal lack of the sense of urgency to stop this medical holocaust. For this reason, I was really happy to read Michael Millenson's post on the Health Affairs Blog titled "Why We Still Kill Patients: Invisibility, Inertia and Income". I was very curious to see how he structured his argument to boil it down to these three I's, since I think that sexy slogans and memorable triplets are the way to go. So, here is how his arguments went.
First, establish the problem. And indeed, we have been killing around 100,000 people annually since the late 1970s (and probably since before then, as you actually have to look in order to find), which amounts to the total 20-year toll of 2.5 million unnecessary deaths due to healthcare in the US. This is truly appalling. And this is just up through the 1999 IoM report! Here is what I was thinking: And if we take into account not just the killing fields of the hospital, but all of life's interfaces with healthcare, we arrive at an even more frightening 400,000 deaths annually, as known back in 2000. Multiply this by 10, and now we really are talking about a killing machine of holocaust proportions! And I completely agree with Millenson that the fact that we continue to say "more research needed" and other pablum like that is utterly and completely irresponsible. However, is this really an invisible problem? The author makes a good argument for how we minimize these numbers by failing to add them up:
I laid out those numbers in a March, 2003 Health Affairs article that challenged the profession to break a silence of deed — failing to take corrective actions — and a silence of word — failing to discuss openly the consequences of that failure. This pervasive silence, I wrote:
continually distorts the public policy debate [and] gives individuals and institutions that must undergo difficult changes a license to postpone them. Most seriously of all, it allows tens of thousands of preventable patient deaths and injuries to continue to accumulate while the industry only gradually starts to fix a problem that is both long-standing and urgent.
Nearly eight years later, medical professionals now talk freely about the existence of error and loudly about the need for combating it, but silence about the extent of professional inaction and its causes remains the norm. You can see it in this latest study, which decries the continuing “patient-safety epidemic” while failing to do next what any public health professional would instinctually do: tally up the toll. Instead, we get dry language about the IOM’s goal of a 50 percent error reduction over five years not being met.
Let’s fill in the blanks: If this unchecked “epidemic” were influenza and not iatrogenesis, then from 1999 to date it would have killed the equivalent of every man, woman and child in the cities of Raleigh (this study took place in North Carolina) and Washington, D.C. Does a disaster of that magnitude really suggest that “further study” and a “refocusing of resources” are what’s needed?I guess this makes sense -- adding up the numbers is pretty startling, yet we are reluctant to do so. At the same time I hesitate to call this "invisible", since as you saw in a paragraph above, I just multiplied by 10! Yet I am willing to concede the first "I" to Millenson, since I do see the power in these startling numbers.
On the to the next "I", inertia. I agree with Millenson generally, and we actually know this, that physicians do not practice evidence-based medicine, and, even when it does, evidence takes decades to penetrate practice. And there is every reason to be upset that the medical profession has not rushed to adopt evidence-based prevention measures that Millenson talks about. But there is a greater subtlety here than meets the eye. True, the Kestone project is frequently held as an example of a simple evidence-based bundled intervention resulting in in a huge reduction in central line-associated blood stream infections. Indeed, this is a great success and everyone should be practicing the checklist instituted in the project by Peter Pronovost's group. What is less obvious and even less talked about is that the same approach of evidence-based bundled approach to prevention of ventilator-associated pneumonia (VAP) has also been piloted by the Keystone group, yet none of us has seen any data from that. All I have is rumors at this point, but they are not good. Why is this? Well, I have discussed this before here and here: VAP is a very tricky diagnosis in a very tricky population. This is not to say that we need not work as hard as we can to prevent it. It is just to clarify that we are not sure of the best ways to accomplish this. Is this in and of itself shameful? Well, yes, if you think that medicine is a precise science. But if you have been reading my blog long enough, you know this is not the case.
Millenson further sites his reading of the Joint Commission Journal, which has been documenting the progress within one large Catholic healthcare system, Ascension, in its efforts to reduce infections, falls and other common iatrogenic harms. By the system's account, they are now able to save over 2,000 lives annually with these measures. This is impressive. But is it trustworthy? Unfortunately, without reading the primary studies I cannot comment on the latter. However, I did publish a review of studies from this very journal on VAP prevention efforts, and here is what I found:
A systematic approach to understanding this research revealed multiple shortcomings. First, since all of the papers reported positive results and none reported negative ones, there is a potential for publication bias. For example, a recent story in a non-peer-reviewed trade publication questioned the effectiveness of bundle implementation in a trauma ICU, where the VAP rate actually increased directionally from 10 cases per 1,000 MV days in the period before to 11.9 cases per 1,000 MV days in the period after implementation of the bundle (24). This was in contradistinction to the medical ICU in the same institution, which achieved a reduction from 7.8 to 2.0 cases per 1,000 MV days with the same intervention (24). Since the results did not appear in a peer-reviewed form, it is difficult to judge the quality or significance of these data; however, the report does highlight the need for further investigation, particularly focusing on groups at heightened risk for VAP, such as trauma and neurological critically ill (25).
So, not to toot my own horn here, and not expecting you to read the long-winded Discussion, suffice it to say that we found many methodologic errors in this body of research from the Joint Commission's own journal to invalidate potentially nearly all of the reported findings. My point is again to reiterate that unless you read each study with a critical eye and then put it into the larger context, do not believe someone else's cursory reference to the staggering improvements. I guess pertinent to our discussion, inertia, while present, is a more nuanced issue than we are led to believe.Second, each of the four reported studies suffers from a great potential for selection bias, which was likely present in the way VAP was diagnosed. Since all of the studies were naturalistic and none was blinded, and since all of the participants were aware of the overarching purpose of the intervention, the diagnostic accuracy of VAP may have been different before as compared to after the intervention. This concern is heightened by the fact that only one study reports employing the same team approach to VAP identification in the two periods compared (23). In other studies, although all used the CDC-NNIS VAP definition, there was either no reporting of or heterogeneity in the personnel and methods of applying these definitions. Given the likely pressure to show measurable improvement to the management, it is possible that VAP classification suffered from a bias.Third, although interventional in nature, naturalistic quality improvement studies can suffer from confounding much in the same way that observational epidemiologic studies do. Since none of the studies addressed issues related to case mix, seasonal variations, secular trends in VAP, and since in each of the studies adjunct measures were employed to prevent VAP, there is a strong possibility that some or all of these factors, if examined, would alter the strength of the association between the bundle intervention and VAP development. Additional components that may have played a role in the success of any intervention are the size and academic affiliation of the hospital. In a study of interventions aimed at reducing the risk of CRBSI, Pronovost et al. found that smaller institutions had a greater magnitude of success with the intervention than their larger counterparts (26). Similarly, in a study looking at an educational program to reduce the risk of VAP, investigators found that community hospital staff were less likely to complete the educational module than the staff at an academic institution; in turn, the rate of VAP was correlated with the completion of the educational program (27). Finally, although two of the studies included in this review represent data from over 20 ICUs each (20, 22), the generalizability of the findings in each remains in question. For example, the study by Unahalekhaka and colleagues was performed in the institutions in Thailand, where patient mix and the systems of care for the critically ill may differ dramatically from those in the US and other countries in the developed world (22). On the other hand, while the study by Resar and coworkers represents a cross section of institutions within the US and Canada, no descriptions are given of the particular ICUs with respect to the structure and size of their institutions, patient mix or ICU care model (e.g., open vs. closed; intensivists present vs. intensivists absent, etc.) (20). This aggregate presentation of the results gives one little room to judge what settings may benefit most and least from the described interventions. The third study includes data from only two small ICUs in two community institutions in the US (21), while the remaining study represents a single ICU in a community hospital where ICU patients are not cared for by an intensivist (23). Since it is acknowledged that a dedicated intensivist model leads to improved ICU outcomes (28, 29), the latter study has limited usefulness to institutions that have a more rigorous ICU care model.
And finally, income. I do agree that it is annoying that economic arguments are even necessary to promote a culture of prevention and safety. What I disagree with is that these economic fallacies of the C-suite impact in any way the implementation of the needed prevention systems. Most of the evidence-based preventions are pretty low tech. And although they do require teams and commitment and systems to implement broadly, small demonstrations at the level of individual clinicians are possible. Also, I shudder at the thought that a group of dedicated clinicians could not persuade a group of equally dedicated administrators to do the right thing, even at the risk of losing some revenue.
Bottom line? While I like Millenson's sexy little "three I's of safety", I think the solutions, as is always the case when you start looking under the hood, are more complicated and nuanced. In a recent post I cited 5 potential solutions to our quality problem, and I will repeat them here:
1. Empower clinicians to provide only care that is likely to produce a benefit that outweighs risks, be they physical or emotional.No, they are not simple, they are not sexy, and most importantly they may be painful. Yet, what is the alternative? We must stop this massive bleeder before the American public starts thinking that the cure is worse than the disease.
2. Reward the signal and not the noise. I wrote about this here andhere.
3. Reward clinicians with more time rather than money. Although I am not aware of any data to back up this hypothesis, my intuition is that slowing down the appointment may result not only in reduction of harm by cutting out unnecessary interventions, but also in overall lowering of healthcare expenditures. It is also sure to improve the crumbling therapeutic relationship.
4. We need to re-engineer our research enterprise for the most important stakeholder in healthcare: the clinician-patient dyad. We need to make the data that are currently manufactured and consumed for large scale policy decisions more friendly at the individual level. And as a corollary, we need to re-think how we help information diffuse into practice and adopt some of the methods of the social sciences.
5. Let's get back to the tried and true methods of public health, where an ounce of prevention continues to be worth a pound of cure. Yes, let's strive for reducing cancer mortality, but let us invest appropriately in stuffing that tobacco horse back into its barn -- getting people to stop smoking will reduce lung cancer mortality by 85% rather than 0.3%, and at a much lower cost with no complications or false positives. Same goes for our national nutrition and physical activity struggles. Our social policies must support these well-recognized and efficient population interventions.
Thursday, December 2, 2010
Healthcare quality: 5 ways to stop the insanity
It was Einstein, I think, who defined insanity as doing the same thing over and over again and expecting a different result. You could say that perhaps we are living this definition in the healthcare system today.
I talk a lot on this blog about quality and harms associated with healthcare. My take all along has been that we are continuing to miss the mark. I have known this because I follow and contribute to the emerging literature indicating that we continue to cause healthcare-associated infections and other complications at an alarming rate, even after the massive issue of avoidable hospital deaths was uncovered and popularized by the landmark Institute of Medicine 1999 report "To Err Is Human". And sure enough, over a decade after defining the problem, we now have not one but two studies coming our in tandem to indicate that we have not advanced an inch. At virtually the same time we are also learning that screening heavy smokers with CT scans can reduce lung cancer mortality by a whopping 20% (which in reality turns out to be only 0.3%, alas), with an accompanying risk of a false positive of 25%, as well as the fact that nearly 1/3 of all end-stage cancer patients die in our already overcrowded ICUs. Amid all of this bustle, there are breathless reports of eliminating nosocomial infections through simple checklists and hand washing, yet why are we not seeing any improvement in what really matters -- whether a patient who is meant to leave the hospital alive does in fact do so?
Well, to me this is what defines madness in our healthcare system. The news of the studies coming out of the Office of the Inspector General of the Department of Health and Human Services and from Harvard were not really new, as I have already indicated. More than any other specialty, the ICU community is well aware of the ongoing issues that arise from an onslaught of ever escalating numbers of patients with increasingly complex burdens of illnesses, a spiraling cognitive load of checklists and "evidence-based" quality indicators, and crushing documentation burdens in the face of overwhelming personnel short-falls and diminishing bedside time. Yet the Dartmouth researchers continue to show what they have been showing for decades: we are generously extending limited resources (both of interventions and human cognitive capital) to all who care to partake, without any limitation in the name of appropriateness or humanity. Death panels indeed! And, as the NLST underscores, we continue to look for salvation at the margins, where it is not only financially costly, but, because of the risk of adverse outcomes following invasive work-ups in patients with false positive CT findings, is likely to create an additional cadre of the chronically ill out of people who might not otherwise need to risk exposure to our already overwhelmed healthcare system.
At the same time, because patient turnover is what drives the bottom line, clinicians are compelled by the business of medicine to care for more and more patients. This discourages the time consumption of a thoughtful clinical encounter in favor of quick reactions usually involving multiple expensive tests, many of which may be avoidable with more time and attention to the specific patient at hand. Alas, clinicians who are willing to spend this kind of time do so at the peril to themselves, their families, and their sanity, putting themselves at a high risk for burnout, as their work days bleed into any semblance of personal time they might have hoped for. Because these are the very clinicians highly sought after by many in their communities, they end up giving up sleep in order to serve, and, well you know the story of how sleep deprivation affects judgment adversely, blah blah blah... And then they up and quit medicine.
Is this enough to diagnose insanity yet? Well, if not, then let's go to "evidence" in the relentless juggernaut of evidence-based practice guidelines and policies and reimbursement and quality metrics and and and... We have talked ad nauseam about evidence -- incomplete, invalid in some respects, non-individualizable. Yet, in the buzzing beehive of today's healthcare, it is this very evidence that must replace physician's thoughtfulness about any specific patient. Given its unavailability and inadequacy, coupled with the rush of a typical encounter, is it any wonder we are failing to fix our little quality quagmire? In fact are we not likely to make it even worse by continuing in this vein and rewarding behaviors that ostensibly impact the outcomes but in fact may represent nothing but noise?
So, here are my five potential solutions to the problem. They are not easy fixes, and they will not fit easily in a fortune inside a cookie or on a bumper sticker. All of them require broad educational efforts and social and scientific changes. Yet, we need to consider them seriously if we want to get back to first doing no harm:
1. Empower clinicians to provide only care that is likely to produce a benefit that outweighs risks, be they physical or emotional.
2. Reward the signal and not the noise. I wrote about this here and here.
3. Reward clinicians with more time rather than money. Although I am not aware of any data to back up this hypothesis, my intuition is that slowing down the appointment may result not only in reduction of harm by cutting out unnecessary interventions, but also in overall lowering of healthcare expenditures. It is also sure to improve the crumbling therapeutic relationship.
4. We need to re-engineer our research enterprise for the most important stakeholder in healthcare: the clinician-patient dyad. We need to make the data that are currently manufactured and consumed for large scale policy decisions more friendly at the individual level. And as a corollary, we need to re-think how we help information diffuse into practice and adopt some of the methods of the social sciences.
5. Let's get back to the tried and true methods of public health, where an ounce of prevention continues to be worth a pound of cure. Yes, let's strive for reducing cancer mortality, but let us invest appropriately in stuffing that tobacco horse back into its barn -- getting people to stop smoking will reduce lung cancer mortality by 85% rather than 0.3%, and at a much lower cost with no complications or false positives. Same goes for our national nutrition and physical activity struggles. Our social policies must support these well-recognized and efficient population interventions.
This may be the watershed moment to stop the treadmill of insanity that the business of medicine has created and continues to fuel. We must do better. And to do better, we must change course.
I talk a lot on this blog about quality and harms associated with healthcare. My take all along has been that we are continuing to miss the mark. I have known this because I follow and contribute to the emerging literature indicating that we continue to cause healthcare-associated infections and other complications at an alarming rate, even after the massive issue of avoidable hospital deaths was uncovered and popularized by the landmark Institute of Medicine 1999 report "To Err Is Human". And sure enough, over a decade after defining the problem, we now have not one but two studies coming our in tandem to indicate that we have not advanced an inch. At virtually the same time we are also learning that screening heavy smokers with CT scans can reduce lung cancer mortality by a whopping 20% (which in reality turns out to be only 0.3%, alas), with an accompanying risk of a false positive of 25%, as well as the fact that nearly 1/3 of all end-stage cancer patients die in our already overcrowded ICUs. Amid all of this bustle, there are breathless reports of eliminating nosocomial infections through simple checklists and hand washing, yet why are we not seeing any improvement in what really matters -- whether a patient who is meant to leave the hospital alive does in fact do so?
Well, to me this is what defines madness in our healthcare system. The news of the studies coming out of the Office of the Inspector General of the Department of Health and Human Services and from Harvard were not really new, as I have already indicated. More than any other specialty, the ICU community is well aware of the ongoing issues that arise from an onslaught of ever escalating numbers of patients with increasingly complex burdens of illnesses, a spiraling cognitive load of checklists and "evidence-based" quality indicators, and crushing documentation burdens in the face of overwhelming personnel short-falls and diminishing bedside time. Yet the Dartmouth researchers continue to show what they have been showing for decades: we are generously extending limited resources (both of interventions and human cognitive capital) to all who care to partake, without any limitation in the name of appropriateness or humanity. Death panels indeed! And, as the NLST underscores, we continue to look for salvation at the margins, where it is not only financially costly, but, because of the risk of adverse outcomes following invasive work-ups in patients with false positive CT findings, is likely to create an additional cadre of the chronically ill out of people who might not otherwise need to risk exposure to our already overwhelmed healthcare system.
At the same time, because patient turnover is what drives the bottom line, clinicians are compelled by the business of medicine to care for more and more patients. This discourages the time consumption of a thoughtful clinical encounter in favor of quick reactions usually involving multiple expensive tests, many of which may be avoidable with more time and attention to the specific patient at hand. Alas, clinicians who are willing to spend this kind of time do so at the peril to themselves, their families, and their sanity, putting themselves at a high risk for burnout, as their work days bleed into any semblance of personal time they might have hoped for. Because these are the very clinicians highly sought after by many in their communities, they end up giving up sleep in order to serve, and, well you know the story of how sleep deprivation affects judgment adversely, blah blah blah... And then they up and quit medicine.
Is this enough to diagnose insanity yet? Well, if not, then let's go to "evidence" in the relentless juggernaut of evidence-based practice guidelines and policies and reimbursement and quality metrics and and and... We have talked ad nauseam about evidence -- incomplete, invalid in some respects, non-individualizable. Yet, in the buzzing beehive of today's healthcare, it is this very evidence that must replace physician's thoughtfulness about any specific patient. Given its unavailability and inadequacy, coupled with the rush of a typical encounter, is it any wonder we are failing to fix our little quality quagmire? In fact are we not likely to make it even worse by continuing in this vein and rewarding behaviors that ostensibly impact the outcomes but in fact may represent nothing but noise?
So, here are my five potential solutions to the problem. They are not easy fixes, and they will not fit easily in a fortune inside a cookie or on a bumper sticker. All of them require broad educational efforts and social and scientific changes. Yet, we need to consider them seriously if we want to get back to first doing no harm:
1. Empower clinicians to provide only care that is likely to produce a benefit that outweighs risks, be they physical or emotional.
2. Reward the signal and not the noise. I wrote about this here and here.
3. Reward clinicians with more time rather than money. Although I am not aware of any data to back up this hypothesis, my intuition is that slowing down the appointment may result not only in reduction of harm by cutting out unnecessary interventions, but also in overall lowering of healthcare expenditures. It is also sure to improve the crumbling therapeutic relationship.
4. We need to re-engineer our research enterprise for the most important stakeholder in healthcare: the clinician-patient dyad. We need to make the data that are currently manufactured and consumed for large scale policy decisions more friendly at the individual level. And as a corollary, we need to re-think how we help information diffuse into practice and adopt some of the methods of the social sciences.
5. Let's get back to the tried and true methods of public health, where an ounce of prevention continues to be worth a pound of cure. Yes, let's strive for reducing cancer mortality, but let us invest appropriately in stuffing that tobacco horse back into its barn -- getting people to stop smoking will reduce lung cancer mortality by 85% rather than 0.3%, and at a much lower cost with no complications or false positives. Same goes for our national nutrition and physical activity struggles. Our social policies must support these well-recognized and efficient population interventions.
This may be the watershed moment to stop the treadmill of insanity that the business of medicine has created and continues to fuel. We must do better. And to do better, we must change course.
Tuesday, November 23, 2010
When the fuel gauge is on empty: Gadgetry at the end of life
Today's post was going to be about false positives in screening trials, but this article in the NYT derailed me. So I will talk about false positives in a future post.
The NYT article talks in general about telemonitoring of elderly and chronically ill patients as it might impact both their health and the need for more acute and intensive encounter with the healthcare system. One specific case discussed is the Mayo randomized trial of home telemonitoring, complete with physiologic measurements and adaptive leading questions based on the derived data. If I understand correctly, the data are automatically conveyed to a nurse who can then contact the patient if something seems out of the ordinary. This sounds great, except for a few minor considerations.
One of these considerations, the fact that several recent studies have failed to show any differences in clinical outcomes of patients undergoing monitoring versus usual care, is well explored in the article. And of course, the newer and better studies use newer and better technologies that do not rely on patients to call in their results, and this is why we can expect better results from the Mayo study. Maybe. Or this could be a case of rescue and auxiliary hypothesis biases, no? I guess we will see.
But there is another elephant that stands in the corner without being discussed. This elephant is of course costs. Now, if I were designing the trial, I would also try to demonstrate that these monitoring devices and protocols will save healthcare dollars by reducing hospitalization rates and the need for other acute and costly interventions. Of course, in this case you have to ask "Compared to what?" Well, of course, this is compared to our usual care. And here is where I run into a problem, and in my mind this is the place where we should be intervening.
At the risk of sounding inhumane, I wish to point out several things. The patient discussed at the very beginning of the NYT story is 94 years old and has a chronic lung disease. Later on in the story, we learn that the average age of patients enrolled in the Mayo trial is 80; and we presume that they all have at least one chronic disease that requires monitoring. What am I driving at? No, it is not death panels, but it is a sensible approach to care at the end of life. Has anyone asked the 94 year old Ms. Hofstad with chronic lung disease whether she would prefer to see the healthcare dollars spent on prolonging her life or would she prefer that these dollars were used to provide Ms. Hofstad's daughter with prenatal care and her grandkids with vaccines? For this is the true trade-off: do we continue to invent ways to keep ourselves from facing our own mortality, or do we spend the limited yet wildly escalating healthcare dollars on sensible interventions that assure health for the next generation?
If any of this sounds unethical, I would submit that it is our current blinders-on discussion that is unethical. My guess is that the elderly who were manipulated by the "death panel" rhetoric are not aware of the very real choices having to be made between going on as we are, spending shocking amounts of money for infinitesimal gains at the close of life, being subjected to heroic interventions despite their futility, and allocating this money in favor of public health interventions that will ensure a huge incremental gain in our children's and grandchildren's future. These are personal questions, but when they are wrapped in political rhetoric, they lose their personal meaning. I can tell you unequivocally that, if it came to a choice for assuring ongoing life for me versus a healthy future for my children, even today, while I am still healthy and reasonably young, I would choose the latter. Is it conceivable that Ms. Hofstad and her peers would choose otherwise? I do not thinks so. So, we need to reposition our discussion of ethics of decisions at the end of life. The choices I gave as examples are real and need to be addressed explicitly, and we all need to be aware of these trade-offs in explicit terms.
I am not interested in terminating any life that is not ready to end. However, as I always say, the number one risk for death is being born -- we have not fooled nature or evolution yet to evade this outcome. Nor, in my opinion, should we try. We should all do our best to live a healthy and full life and learn to be comfortable with the idea of our own mortality. It is our evolutionary imperative to insure the durability of our species. Electronic monitoring at the end of life, although sexy and market-friendly, is not the way to set up the future generations for health and success. And it is certainly not a way to address our fear of death, the perennial third rail of our culture. It would be more ethical and responsible to start learning more about how to do this effectively than to continue developing new gadgets to keep the vessel moving even when the gauge is on empty.
I acknowledge that this is only one person's view, and the subject is complex and emotionally jarring. I am sure there are a lot of dissenting opinions on this subject, as there should be. We need a debate, where we name all of the factors and arrive at at a global solution that comports with our personal, societal and global interests. Let us start here and now.
The NYT article talks in general about telemonitoring of elderly and chronically ill patients as it might impact both their health and the need for more acute and intensive encounter with the healthcare system. One specific case discussed is the Mayo randomized trial of home telemonitoring, complete with physiologic measurements and adaptive leading questions based on the derived data. If I understand correctly, the data are automatically conveyed to a nurse who can then contact the patient if something seems out of the ordinary. This sounds great, except for a few minor considerations.
One of these considerations, the fact that several recent studies have failed to show any differences in clinical outcomes of patients undergoing monitoring versus usual care, is well explored in the article. And of course, the newer and better studies use newer and better technologies that do not rely on patients to call in their results, and this is why we can expect better results from the Mayo study. Maybe. Or this could be a case of rescue and auxiliary hypothesis biases, no? I guess we will see.
But there is another elephant that stands in the corner without being discussed. This elephant is of course costs. Now, if I were designing the trial, I would also try to demonstrate that these monitoring devices and protocols will save healthcare dollars by reducing hospitalization rates and the need for other acute and costly interventions. Of course, in this case you have to ask "Compared to what?" Well, of course, this is compared to our usual care. And here is where I run into a problem, and in my mind this is the place where we should be intervening.
At the risk of sounding inhumane, I wish to point out several things. The patient discussed at the very beginning of the NYT story is 94 years old and has a chronic lung disease. Later on in the story, we learn that the average age of patients enrolled in the Mayo trial is 80; and we presume that they all have at least one chronic disease that requires monitoring. What am I driving at? No, it is not death panels, but it is a sensible approach to care at the end of life. Has anyone asked the 94 year old Ms. Hofstad with chronic lung disease whether she would prefer to see the healthcare dollars spent on prolonging her life or would she prefer that these dollars were used to provide Ms. Hofstad's daughter with prenatal care and her grandkids with vaccines? For this is the true trade-off: do we continue to invent ways to keep ourselves from facing our own mortality, or do we spend the limited yet wildly escalating healthcare dollars on sensible interventions that assure health for the next generation?
If any of this sounds unethical, I would submit that it is our current blinders-on discussion that is unethical. My guess is that the elderly who were manipulated by the "death panel" rhetoric are not aware of the very real choices having to be made between going on as we are, spending shocking amounts of money for infinitesimal gains at the close of life, being subjected to heroic interventions despite their futility, and allocating this money in favor of public health interventions that will ensure a huge incremental gain in our children's and grandchildren's future. These are personal questions, but when they are wrapped in political rhetoric, they lose their personal meaning. I can tell you unequivocally that, if it came to a choice for assuring ongoing life for me versus a healthy future for my children, even today, while I am still healthy and reasonably young, I would choose the latter. Is it conceivable that Ms. Hofstad and her peers would choose otherwise? I do not thinks so. So, we need to reposition our discussion of ethics of decisions at the end of life. The choices I gave as examples are real and need to be addressed explicitly, and we all need to be aware of these trade-offs in explicit terms.
I am not interested in terminating any life that is not ready to end. However, as I always say, the number one risk for death is being born -- we have not fooled nature or evolution yet to evade this outcome. Nor, in my opinion, should we try. We should all do our best to live a healthy and full life and learn to be comfortable with the idea of our own mortality. It is our evolutionary imperative to insure the durability of our species. Electronic monitoring at the end of life, although sexy and market-friendly, is not the way to set up the future generations for health and success. And it is certainly not a way to address our fear of death, the perennial third rail of our culture. It would be more ethical and responsible to start learning more about how to do this effectively than to continue developing new gadgets to keep the vessel moving even when the gauge is on empty.
I acknowledge that this is only one person's view, and the subject is complex and emotionally jarring. I am sure there are a lot of dissenting opinions on this subject, as there should be. We need a debate, where we name all of the factors and arrive at at a global solution that comports with our personal, societal and global interests. Let us start here and now.
Saturday, November 20, 2010
Slow medicine
I don't know if you remember, but back in March our Earth started to spin faster. The devastating earthquake in Chile shifted our axis to create shorter days. Not that much shorter -- we are talking about a 1.26-microsecond reduction. Not particularly noticeable. But I have to wonder if our ever-increasing pace of life is not merely emblematic of these periodic but frequent cataclysmic accelerations of the planet.
What a cliche it is to say that we live in a speeding up 24/7 world, where, if you do no keep up, you drop off. We have fast cars, fast communications, fast food, and yes, fast medicine. This fast medicine concept ties together many of the ideas I have discussed here over the last few days and weeks.
It is most peculiar to me that, even in the Communist country of my birth, early on I learned the expression "time is money" from my father. It certainly did not resonate there; in fact, it did not begin to make sense until I was an adult in the US and beginning to understand what makes our economy tick. And indeed, time in our society can be counted off in dollars. Over the past 60 years, the American dream of a suburban house, 2 cars and 2.5 kids, a 40-hour-a-week job, and time on the weekends with the family, has mutated into an endless work day, constant accessibility and distant and loose connections. This is not all bad necessarily, but the promise of more efficient workplace resulting from the proliferation of technology has been forgotten. Instead, this technology, shiny and sexy and laden with the symbology of status, tethers us to perpetual productivity. And the expectation of these productivity increases accompanied by reduced production costs is what drives our economic growth. But at what personal and societal costs?
Aside from the rampant breakdown of communities, many other emerging phenomena are a part of the package. Take the obesity epidemic, for example. We can certainly continue the debate about the factors contributing to it, we can continue our search for the irrefutable smoking gun, but let's be honest: how can our fast food culture not be a major contributor? Of course it is. Along with the sedentary lifestyle and the culturally sanctioned pursuit of fast satisfaction, the biology is indisputable: cheap and accessible highly caloric food and drinks consumed in excess without the balance of physical expenditures -- bingo, the math adds up to this perfect storm. Evidence (and common sense, I might add) suggests that slow food cooked at home may be an antidote to the overdose of the toxic "nutrition" foisted onto the nation, especially the young people. But, in the words of my niece, "we don't have time for Minute rice!" We need to continue running on this treadmill that our lives have become, so as not to miss the opportunity for the carrot at the end of it. Or are we just hallucinating the carrot?
And all of this rushing about has naturally penetrated medicine. Since it is just another market,where productivity drives someone's bottom line, the treadmill will surely continue to speed up. Yet, here, I talked extensively about why the incredible shrinking appointment is such a bad idea: most real issues come at the end of the 15 minutes, when the patient's or the doctor's hand is beginning to turn the door handle. And fortuitously or not, this motif has been carried by other bloggers like Dr. Synonymous here, a dedicated family physician in Columbus, OH, trying to balance good medicine with staying in business. He poignantly describes his every-day struggles to fit his patients' seven to eleven problems into a four-problem widget that he is encouraged to produce. It is doctors like Dr. Synonymous that could rein in our catastrophic healthcare spending just by being given time and space to focus on the patient without the pressures of ever-increasing production. And then Kevin Pho, better known as KevinMD, healthcare blogger royalty, on his blog eloquently connects the dots between the widgetry of the medical appointments and some of our most pressing public health challenges. Here is what he says:
What is the answer? Even when I was in practice, I was a good diagnostician, but when it came to treatment, it did not have that much interest to me. So here, just as in practice, I find myself more interested in defining the problem and letting others help me find the solution. This is my long-winded way of admitting that I do not have the perfect answer. However, patient empowerment is one of those answers, where at the personal level the patients need to understand how to manage this "microwave" medical encounter to the best of their needs. At the policy level, patients and doctors need to pool forces and start naming the problem before the "but" subverts the discussion. And it may just be that the best solution is to restore medicine's social contract and to wrestle medicine out of the clutches of market forces back into the therapeutic arena.
Medicine will never return to its prior rhythm, but we must strive to get it to a better place, where both patients and clinicians have the time to address the obvious. The fast model of medicine, much like fast food, is creating a nation of illness and discontent. Just as in the food movement, let's start creating an infrastructure where our healthcare professionals can practice slow medicine, having the time to address our individual issues thoroughly and completely and in a manner that promotes health rather than perpetuate disease.
What a cliche it is to say that we live in a speeding up 24/7 world, where, if you do no keep up, you drop off. We have fast cars, fast communications, fast food, and yes, fast medicine. This fast medicine concept ties together many of the ideas I have discussed here over the last few days and weeks.
It is most peculiar to me that, even in the Communist country of my birth, early on I learned the expression "time is money" from my father. It certainly did not resonate there; in fact, it did not begin to make sense until I was an adult in the US and beginning to understand what makes our economy tick. And indeed, time in our society can be counted off in dollars. Over the past 60 years, the American dream of a suburban house, 2 cars and 2.5 kids, a 40-hour-a-week job, and time on the weekends with the family, has mutated into an endless work day, constant accessibility and distant and loose connections. This is not all bad necessarily, but the promise of more efficient workplace resulting from the proliferation of technology has been forgotten. Instead, this technology, shiny and sexy and laden with the symbology of status, tethers us to perpetual productivity. And the expectation of these productivity increases accompanied by reduced production costs is what drives our economic growth. But at what personal and societal costs?
Aside from the rampant breakdown of communities, many other emerging phenomena are a part of the package. Take the obesity epidemic, for example. We can certainly continue the debate about the factors contributing to it, we can continue our search for the irrefutable smoking gun, but let's be honest: how can our fast food culture not be a major contributor? Of course it is. Along with the sedentary lifestyle and the culturally sanctioned pursuit of fast satisfaction, the biology is indisputable: cheap and accessible highly caloric food and drinks consumed in excess without the balance of physical expenditures -- bingo, the math adds up to this perfect storm. Evidence (and common sense, I might add) suggests that slow food cooked at home may be an antidote to the overdose of the toxic "nutrition" foisted onto the nation, especially the young people. But, in the words of my niece, "we don't have time for Minute rice!" We need to continue running on this treadmill that our lives have become, so as not to miss the opportunity for the carrot at the end of it. Or are we just hallucinating the carrot?
And all of this rushing about has naturally penetrated medicine. Since it is just another market,where productivity drives someone's bottom line, the treadmill will surely continue to speed up. Yet, here, I talked extensively about why the incredible shrinking appointment is such a bad idea: most real issues come at the end of the 15 minutes, when the patient's or the doctor's hand is beginning to turn the door handle. And fortuitously or not, this motif has been carried by other bloggers like Dr. Synonymous here, a dedicated family physician in Columbus, OH, trying to balance good medicine with staying in business. He poignantly describes his every-day struggles to fit his patients' seven to eleven problems into a four-problem widget that he is encouraged to produce. It is doctors like Dr. Synonymous that could rein in our catastrophic healthcare spending just by being given time and space to focus on the patient without the pressures of ever-increasing production. And then Kevin Pho, better known as KevinMD, healthcare blogger royalty, on his blog eloquently connects the dots between the widgetry of the medical appointments and some of our most pressing public health challenges. Here is what he says:
These are not assertions that require big studies or demonstration projects -- this is the knowledge we gain from living: relationships are everything, and relationships take time to build. And time is what continues to erode in the office encounter.
That’s a valid point. When it comes to their own children, it’s unlikely that trumpeting public health fears is going to significantly sway parents’ opinion, especially if they come in believing that vaccines are associated with autism.A parallel situation is with antibiotic overuse. Again, public health arguments mostly fall upon deaf ears in the exam room, as there are many patients who believe that upper respiratory symptoms require an antibiotic.What’s the answer? More time to spend with patients, for one. And second, Dr. Parikh alludes to the fact that most doctors don’t receive adequate training when it comes to vaccines: “If there is one thing Sears gets right, it is the fact that doctors need more education about vaccine science from the get-go.” [emphasis mine]
What is the answer? Even when I was in practice, I was a good diagnostician, but when it came to treatment, it did not have that much interest to me. So here, just as in practice, I find myself more interested in defining the problem and letting others help me find the solution. This is my long-winded way of admitting that I do not have the perfect answer. However, patient empowerment is one of those answers, where at the personal level the patients need to understand how to manage this "microwave" medical encounter to the best of their needs. At the policy level, patients and doctors need to pool forces and start naming the problem before the "but" subverts the discussion. And it may just be that the best solution is to restore medicine's social contract and to wrestle medicine out of the clutches of market forces back into the therapeutic arena.
Medicine will never return to its prior rhythm, but we must strive to get it to a better place, where both patients and clinicians have the time to address the obvious. The fast model of medicine, much like fast food, is creating a nation of illness and discontent. Just as in the food movement, let's start creating an infrastructure where our healthcare professionals can practice slow medicine, having the time to address our individual issues thoroughly and completely and in a manner that promotes health rather than perpetuate disease.
Monday, November 8, 2010
Death panels and mammography: Only the beginning
A story in today's Washington Post presents the following quote:
Well, let's do the accounting. The WaPo article cites the incidence for prostate CA at 192,000 annually in the US. Let us say that 1/3 of them qualify for Provenge, or 64,000. Treating all of them with Provenge will incur a $5.9 billion aggregate bill. Now, the company did allegedly spend approximately $1 billion on development of the drug. But what does that matter to all of us, free market believers? It is not the company expenditures that should drive the price we are willing to pay, but the value of the medication.
Now, value is a tricky thing. Value is extremely sensitive to perspective. If I am the patient with advanced prostate CA, the price tag may appear reasonable to me. However, if I am an administrator charged with equitable distribution of a limited resource, particularly in the setting of very few workers maintaining the cash flow for each senior in the Medicare program, I am acutely sensitive to the inflated cost-benefit ratio for this drug. So, how do we resolve this tension without resorting to name calling and shouting and accusations of death panels? Should we encourage our citizens to start thinking not only of their individual risks, but also of the real risks to their communities posed by such indiscriminate use of a therapy that is only marginally useful to them personally?
Another way for companies themselves to trouble shoot these situations is to gain a better understanding of what a patient who is likely to have a good response looks like. In fact, we should demand such risk (well, in this case benefit) stratification, so that a clinician can make rational choices with the patient and avoid false hopes or equally false nihilism. Granted, the pool of eligible patients may shrink, but what a way to insure appropriate and responsible use of a resource.
I realize that my suggestions may fall on deaf ears. And although, whenever I give talks on this stuff, the medical people representing the Industry nod wildly, marketers who tend to run pharma are not thrilled. Instead of understanding that limiting use of their technologies to appropriate patients is a sound long-term strategy to preserve the value of their assets, they prefer to put the drug into any person remotely resembling those that qualify, in their race to maximize short-term profit. And this is why lobbyists and famous men with loud reputations are hired as surrogates to promote the message of indignation. And the public, sold on the entitlement idea, simply applauds like a well-trained seal and parrots the absurd logic.
So, under these assumptions, it of course becomes "chilling" for the biggest healthcare payer in the land, the payer that is responsible for paying nearly 1/2 of all the healthcare costs, to be critical of the value proposition of a new therapy. Perish the thought that CMS should be making these decisions for our limited tax dollars. Perish the thought that we should engage in a discussion about these issues based on something other than politics.
Given the erroneous idea that the Republicans' House victories say anything about us other than our wildly absurd expectations, I predict that death panels and mammography "debate" were only the beginning. Expect even more politics, rancor and pandering in the current political climate, and expect that the culture of "me, me, me" will be reaching fevered pitch. It is too bad that this conversation will continue to obfuscate the real issues and much needed solutions to a real crisis of not only our healthcare, but indeed our citizenship.
"It is extremely chilling if, after spending a huge sum of money, time and effort to get a drug through FDA approval, you'll then have to go through it all again to see if CMS will pay for it," said Allen S. Lichter, head of the American Society of Clinical Oncology. "Firing a shot across the bow like this is not the way to have an intelligent and meaningful discussion about how we start to address the complex issue of drug costs."The specific reference is to Medicare's re-evaluation whether or not the new prostate cancer vaccine, Provenge, should be reimbursed at the rates set by the company. The story elucidates that in the trials the vaccine increased median survival with advanced prostate CA by an average of 4 months at a cost of $93,000. Now, compared to Tarceva for advanced pancreatic CA, this is a bargain! But can we afford such a bargain? Furthermore, can we afford such highly placed leaders as Allen Lichter to be so deluded about the value of a therapy that he does not want the Centers for Medicare and Medicaid Services even to have an open discussion about this cost-benefit balance? Really?
Well, let's do the accounting. The WaPo article cites the incidence for prostate CA at 192,000 annually in the US. Let us say that 1/3 of them qualify for Provenge, or 64,000. Treating all of them with Provenge will incur a $5.9 billion aggregate bill. Now, the company did allegedly spend approximately $1 billion on development of the drug. But what does that matter to all of us, free market believers? It is not the company expenditures that should drive the price we are willing to pay, but the value of the medication.
Now, value is a tricky thing. Value is extremely sensitive to perspective. If I am the patient with advanced prostate CA, the price tag may appear reasonable to me. However, if I am an administrator charged with equitable distribution of a limited resource, particularly in the setting of very few workers maintaining the cash flow for each senior in the Medicare program, I am acutely sensitive to the inflated cost-benefit ratio for this drug. So, how do we resolve this tension without resorting to name calling and shouting and accusations of death panels? Should we encourage our citizens to start thinking not only of their individual risks, but also of the real risks to their communities posed by such indiscriminate use of a therapy that is only marginally useful to them personally?
Another way for companies themselves to trouble shoot these situations is to gain a better understanding of what a patient who is likely to have a good response looks like. In fact, we should demand such risk (well, in this case benefit) stratification, so that a clinician can make rational choices with the patient and avoid false hopes or equally false nihilism. Granted, the pool of eligible patients may shrink, but what a way to insure appropriate and responsible use of a resource.
I realize that my suggestions may fall on deaf ears. And although, whenever I give talks on this stuff, the medical people representing the Industry nod wildly, marketers who tend to run pharma are not thrilled. Instead of understanding that limiting use of their technologies to appropriate patients is a sound long-term strategy to preserve the value of their assets, they prefer to put the drug into any person remotely resembling those that qualify, in their race to maximize short-term profit. And this is why lobbyists and famous men with loud reputations are hired as surrogates to promote the message of indignation. And the public, sold on the entitlement idea, simply applauds like a well-trained seal and parrots the absurd logic.
So, under these assumptions, it of course becomes "chilling" for the biggest healthcare payer in the land, the payer that is responsible for paying nearly 1/2 of all the healthcare costs, to be critical of the value proposition of a new therapy. Perish the thought that CMS should be making these decisions for our limited tax dollars. Perish the thought that we should engage in a discussion about these issues based on something other than politics.
Given the erroneous idea that the Republicans' House victories say anything about us other than our wildly absurd expectations, I predict that death panels and mammography "debate" were only the beginning. Expect even more politics, rancor and pandering in the current political climate, and expect that the culture of "me, me, me" will be reaching fevered pitch. It is too bad that this conversation will continue to obfuscate the real issues and much needed solutions to a real crisis of not only our healthcare, but indeed our citizenship.
Friday, October 22, 2010
Comparative effectiveness 101
I have to say I do not understand the opposition to including costs into the comparative effectiveness research (CER) equation. Perhaps I simplify too much, but here is how I think about it.
Comparing two therapies is like using a microscope to focus at different levels of depth. Starting from the lowest magnification, we can ask "do they both work?" Of course in order to make this question answerable with data, we need to define what we mean by "work". Once we have defined that, the question becomes whether or not both comparators produce an effect in the same (desired) direction. If they do not, then the comparison can stop here, as the one with the positive direction of effect wins out. If they do both produce a desired effect, then we focus on the magnitude of that effect. There are several ways to do this, including comparison of 1). the effect size and variability of each to one another, 2). the proportion of patients who achieve a certain threshold of response (aka response rates), and 3). the adverse events frequency and severity. If these parameters are identical between the two, then the decision clearly hinges on the cost. Why is this so hard to accept? We would not want to pay more money for an identical car, so why would we pay more for a drug?
Of course, life is never quite this simple. Most of the time we will find small differences that are amplified by marketing messages as the reason to prefer a particular therapy. And this is all fine and good, and it is OK if a patient prefers one to the other because of some of these subtle differences. The question here becomes "how much are we willing to pay for a unit of this difference?" And unless the patient herself is willing to write the check, this is the pivotal issue facing our society today in the realm of the healthcare debate. So far our politicians have refused to do the real math, and are pandering to the opinion that we can pay for whatever we want in healthcare. This stance resonates with the public, terrified of the fictional death panels, and, more importantly, with the business of medicine, as this approach provides ample fuel for this engine of economic growth. But does it really improve our health, the primary goal of healthcare? I think not, just look at the state of our health and compare it to the rest of the world. And secondly, what is it doing to our national budget?
I will concede that I have simplified a complex issue. But not that much, believe it or not. With a modicum of math literacy people can easily wrap their brains around these concepts and make their own decisions, rather than being manipulated by disingenuous obfuscations of politicians concerned more with stuffing their coffers with corporate money than looking out for the well-being of the nation.
Comparing two therapies is like using a microscope to focus at different levels of depth. Starting from the lowest magnification, we can ask "do they both work?" Of course in order to make this question answerable with data, we need to define what we mean by "work". Once we have defined that, the question becomes whether or not both comparators produce an effect in the same (desired) direction. If they do not, then the comparison can stop here, as the one with the positive direction of effect wins out. If they do both produce a desired effect, then we focus on the magnitude of that effect. There are several ways to do this, including comparison of 1). the effect size and variability of each to one another, 2). the proportion of patients who achieve a certain threshold of response (aka response rates), and 3). the adverse events frequency and severity. If these parameters are identical between the two, then the decision clearly hinges on the cost. Why is this so hard to accept? We would not want to pay more money for an identical car, so why would we pay more for a drug?
Of course, life is never quite this simple. Most of the time we will find small differences that are amplified by marketing messages as the reason to prefer a particular therapy. And this is all fine and good, and it is OK if a patient prefers one to the other because of some of these subtle differences. The question here becomes "how much are we willing to pay for a unit of this difference?" And unless the patient herself is willing to write the check, this is the pivotal issue facing our society today in the realm of the healthcare debate. So far our politicians have refused to do the real math, and are pandering to the opinion that we can pay for whatever we want in healthcare. This stance resonates with the public, terrified of the fictional death panels, and, more importantly, with the business of medicine, as this approach provides ample fuel for this engine of economic growth. But does it really improve our health, the primary goal of healthcare? I think not, just look at the state of our health and compare it to the rest of the world. And secondly, what is it doing to our national budget?
I will concede that I have simplified a complex issue. But not that much, believe it or not. With a modicum of math literacy people can easily wrap their brains around these concepts and make their own decisions, rather than being manipulated by disingenuous obfuscations of politicians concerned more with stuffing their coffers with corporate money than looking out for the well-being of the nation.
Monday, October 4, 2010
Will healthcare be a byproduct of our math illiteracy?
OK, so when I was in practice I pretty much worked every day, including weekends, even when not on call, and can attest to the burn-out potential of this life-style. My "day off" meant that I only spent eight hours in the hospital, instead of the customary twelve to fourteen. My infant son cried when I picked him up because he did not know who I was, there was little time for such mundane pleasures as doing laundry or going grocery shopping, and bedtime reading consisted of two-to-three lines of printed text swimming on a page until the book collapsed on my chest to the accompaniment of my snoring. But let's assume that I am just a wimp, and that most of my peers can take such schedule in stride.
A propos this, I came upon this column by Peter Orszag in the Sunday Times regarding the need to increase hospital efficiencies by keeping hospitals operating 100% 24/7, including the weekends. He cites not only the financial upsides of this arrangement -- basically taking advantage of spreading many of a center's fixed costs over more days of operation -- but also the potential for improving patient safety and quality of care. What I am curious about is what it means for clinicians. Doing the mental math, when the pie size increases without a commensurate rise in the pie consumers, each pie eater has to then eat a bigger piece of the pie. This is certainly a welcome quandary when it comes to my mother's-in-law apple pie, but for the healthcare system it is a horse of an entirely different color. The growth of the healthcare delivery pie must mean an increase in physician and staff work hours, correct? By about 40%, right? Unless of course we can increase the ranks by the equivalent 40% to share the burden.
So up until now I am pretty clear on the math. Here is where confusion begins to creep in. Being a healthcare researcher, I am keenly aware of the projections of shortages for many medical specialties. But most contradictory for the Orszag plan is the monumental shorfall of hospital nursing staff, estimated to reach over 1 million by year 2020! And similar sitution holds for pharmacists, respiratory therapists, etc., just look at some of the annual reports from the American Hospital Association. Given these dire prediction, how do we implement the Orzsag plan? Do we just ask the present personnel to give up all of their free time entirely? What do we think will happen then? Especially as they watch their professions get increasingly more commoditized and their incomes shrink?
And if these conflicting ideas are not enough, there is this headline in today's amednews: "2010 could end up as worst year for hospital layoffs". OK, I will pause for a moment to let it sink in. The story goes on
A propos this, I came upon this column by Peter Orszag in the Sunday Times regarding the need to increase hospital efficiencies by keeping hospitals operating 100% 24/7, including the weekends. He cites not only the financial upsides of this arrangement -- basically taking advantage of spreading many of a center's fixed costs over more days of operation -- but also the potential for improving patient safety and quality of care. What I am curious about is what it means for clinicians. Doing the mental math, when the pie size increases without a commensurate rise in the pie consumers, each pie eater has to then eat a bigger piece of the pie. This is certainly a welcome quandary when it comes to my mother's-in-law apple pie, but for the healthcare system it is a horse of an entirely different color. The growth of the healthcare delivery pie must mean an increase in physician and staff work hours, correct? By about 40%, right? Unless of course we can increase the ranks by the equivalent 40% to share the burden.
So up until now I am pretty clear on the math. Here is where confusion begins to creep in. Being a healthcare researcher, I am keenly aware of the projections of shortages for many medical specialties. But most contradictory for the Orszag plan is the monumental shorfall of hospital nursing staff, estimated to reach over 1 million by year 2020! And similar sitution holds for pharmacists, respiratory therapists, etc., just look at some of the annual reports from the American Hospital Association. Given these dire prediction, how do we implement the Orzsag plan? Do we just ask the present personnel to give up all of their free time entirely? What do we think will happen then? Especially as they watch their professions get increasingly more commoditized and their incomes shrink?
And if these conflicting ideas are not enough, there is this headline in today's amednews: "2010 could end up as worst year for hospital layoffs". OK, I will pause for a moment to let it sink in. The story goes on
OK, so what am I not seeing? Orzsag is a smart economist, but if even he cannot do this math, how can our embattled public with poor math literacy and even less understanding of the intricacies of our Byzantine healthcare bureaucracy get it?As of August, 8,233 employees had been affected by mass layoffs at hospitals. Continuing at this rate, 12,349 hospital employees would be cut in mass layoffs by the end of 2010. That would be the second-highest loss recorded by the BLS since 2000, second only to 13,282 in 2005 -- with 8,687 of those jobs lost because of hospitals shut down because of damage from Hurricane Katrina.In 2009, 11,757 hospital employees lost their jobs through mass layoffs, according to the BLS.
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