Big changes in the world of VAP?

As you may or may not be aware, the four main professional societies in the US that include large critical care constituencies, AACN, Chest, SCCM and ATS, have created something called a Critical Care Societies Collaborative (CCSC). Its purpose is essentially to give the critical care community a voice in shaping public policy. And, as you can imagine, one of the current-day issues they are tackling is performance measures.

Now, on this web site we have spent a lot of virtual ink talking about quality metrics, particularly where ventilator-associated pneumonia, or VAP, is concerned. Well, I am happy to report that finally, a strong voice in Critical Care medicine is in agreement with what we have been saying: the VAP bundle needs to go! In fact, here is the sum of the recommendations made to the National Quality Forum in a letter dated February 9, 2012, from the CCSC leaders about VAP (emphasis mine):

The Task Force felt that the VAP “care bundle” minimizes the importance of each individual component measure and neglects the fact that many elements of the existing VAP bundle are known to have important effects outside of VAP reduction, including improved patient survival. The task force also notes that one of the components of the VAP care bundle, stress ulcer prophylaxis, may actually increase the risk of VAP.51Therefore, the Task Force would like to make the following recommendations regarding measure gaps related to VAP:(1) Dissolve the VAP care bundle and instead develop a new group of quality measures related to general evidence‐based practices for patients requiring mechanical ventilation (described above.) These potential measure gaps would include care processes known to reduce morbidity and mortality in patients who are ventilated.
(2) Develop measures using the VAP‐specific measure gaps supported by recent guidelines.52,53 These may include measures for the following evidenced‐based practices:
• Orotracheal rather than nasotracheal intubation to prevent VAP54;
• Subglottic secretion drainage to prevent VAP55;
• Elevating the head of bed to 45 degrees to prevent VAP56;
• Oral antiseptic administration to prevent VAP57;
• When empiric antibiotics are used to treat VAP, initial treatment based on qualitative endotracheal aspirates rather than quantitative bronchoscopic aspirates58; and
• No more than an 8‐day course of antibiotics as treatment for uncomplicated VAP.59
All of these VAP prevention strategies are supported by randomized‐controlled trials. However, not all have favorable cost‐benefit profiles, and all have significant barriers, which may make widespread adoption unfeasible. Although we list them all here, we note that all may not be good quality measures.

So, here it is -- the recommendation. But will it be followed? When I was at SCCM, I heard a presentation that talked about some new metrics being developed by the CCSC in collaboration with the CDC, which will likely replace VAP as the focus of mechanical ventilation complications. I am in the process of learning more about these developments even as we speak, and will update my readers on what I learn. Suffice it to say, change is coming to the world of VAP. And it's about time. 

Intervention in ICU reduces hospital mortality, but by how much?

Addendum #2, 12:09 PM EST, 2/2/11:
So, here is the whole story. Stephanie Desmon, the author of the JH press release, e-mailed me back and pointed me to Peter Pronovost as the source for the 10% reduction information. I e-mailed Peter, and he got back to me, confirming that 

"The 10 percent is the rounded differences in differences in odds ratios"

Moral of the story: The devil is in the details.


And speaking of details, I must admit to an error of my own. If you look at the figure reproduced below, I called out the wrong points. For adjusted data, you need to look at the open circles (for the intervention group) and squares (for the control group). In fact, the adjusted mortality went from about 20% at baseline to 16% in the 13-22 months interval for the Keystone cohort, while for the control group it went from a little over 20% to a little under 18%. This makes the absolute reduction a tad more impressive, though there is still less than a 2% absolute difference between the reduction seen in the intervention vs. the control group, leaving all of my other points still in need of addressing. 


Addendum #1, 11:00 AM EST, 2/2/11:
I just found what I think is the origin of the 10% mortality reduction rumor in this press release from Johns Hopkins. I just e-mailed Stephanie Desmon, the author of the release, to see where the 10% came from. Will update again should I hear from either Maggie Fox or Stephanie Desmon.  

Remember the Keystone project? A number of years ago when we started to pay close attention to healthcare-associated infections (HAI), and hospitals started to take introspective looks at their records, it turned out the the ICUs in the state of Michigan for one reason or another had very high rates of HAIs. As this information percolated through our collective consciousness, the stars aligned in such a away as to release funding from the AHRQ in Washington, DC, for a group of ICU investigators at the Johns Hopkins University School of Medicine in Baltimore, MD, headed by Peter Pronovost, to design and implement a study employing IHI-style (Boston, MA) bundled interventions to prevent catheter-associated blood stream infections (CABSI) and ventilator-associated pneumonia (VAP) across the consortium of ICUs in MI. Whew! This poly-geographic collaboration resulted in a landmark paper in 2006 in the New England Journal of Medicine, wherein the authors showed that the bundled interventions directed by a checklist aimed at CABSI were indeed associated with a satisfying reduction of CABSI. Since 2006 the ICU community has been eagerly awaiting the results of the VAP intervention from Keystone, but none has come out. When there is a void of information, rumors fill this void, and plenty of rumors have circulated about the alleged failure of the VAP trial.

I do not want to belabor here what I have written before with regard to VAP and its prevention, and what makes the latter so difficult, and how little evidence there really is that the IHI bundle actually does anything. You can find at least some of my thoughts on that here. But why am I bringing up the Keystone project again anyway? Well, it is because Pronovost's group has just published a new paper in BMJ, and this time their aim was even more ambitious: to show the impact of this state-wide QI intervention on hospital mortality and length of stay. This is a really reasonable question, mind you, since, we could argue that, if the intervention reduces HAI, it should also do something to those important downstream events that are driven by the particular HAI, namely mortality and LOS. But here are a couple of issues that I found of great interest.

First, as we have discussed before, whether or not VAP itself causes death in the ICU population (that is patients die from VAP), or whether VAP tends to attack those who are sicker and therefore more likely to die anyway (patients die with VAP) remains unclear in our literature. There is some evidence that late VAP may be associated with an attributable increase in mortality, but not early, and these data need to be confirmed. Why is this important? Because if VAP does not impart an increase in mortality, then trying to decrease mortality by reducing VAP is just swinging at windmills.

So, let's talk about the study and what it showed as reported in the BMJ paper. You will be pleased that I will not here go through the traditional list of potential threats to validity, but take the data at face value (well, almost). The authors took an interesting approach of comparing the performance of all eligible ICUs regardless of whether they actually chose to take part in the project. Of all the admissions examined in the intervention group, 88% came from Keystone participants. This is a really sound way to define the intervention cohort, and it actually biases the data away from showing an effect. So, kudos to the investigators. The comparator cohort came from ICUs in the hospitals surrounding Michigan, those that were not eligible for Keystone participation. One point about these institutions also requires clarification: I did not see in the paper whether the authors actually looked at the control hospitals' QI initiatives. Why is this important? Well, if many of the comparator hospitals had successful QI initiatives, then one could expect to see even less difference between the Keystone intervention and the control group. So, again, good on them that they biased the data against themselves.

This is the line of thinking that brings me to my second point. Reuters' Maggie Fox covered this paper in an article a couple of days ago, an article whose byline lede (thanks for the correction, @ivanoransky) floored me:

(Reuters) - A U.S. program to help make sure hospital staff maintain strict hygiene standards lowered death rates in intensive care units by 10 percent, U.S. researchers reported on Monday.

Mind you, I read the article before delving into the peer-reviewed paper, so my surprise came out of just knowing how supremely difficult it is to reduce ICU mortality by 10% with any intervention. In the ICU we celebrate when we see even a 2% absolute mortality reduction. So, it became obvious to me that something got lost in translation here. And indeed, it did. Here is how I read the data.

There are multiple places to look for the mortality data. One is found in this figure:

Now, look at the top panel and focus on the solid circles -- these depict the adjusted mortality in the Keystone intervention group. What do you see? I see mortality going from about 14% at the baseline to about 13.5% at implementation phase to about 13% at 13-22 months post implementation. I do not see a 10% reduction, but at best about a 1% mortality advantage. What is also of interest is that the adjusted mortality in the control group (solid squares) also went down, albeit not by as much. But almost at every point of measurement it was lower already than in the intervention group.

Then there is this table, where the adjusted odds ratios of death are given for the two groups at various time points:

And this is where things get interesting. If you look at the last line of the table, the adjusted odds ratios indeed look impressive, and, furthermore, the AOR for the intervention group is lower than that for the control group. And this is pleasing to any investigator. But what does it mean? Well it means that the odds of death in the intervention group went down roughly by 24% (give-or-take the 95% confidence interval) and by 16% in the control group,each compared to itself at baseline. This is impressive, no?

Well, yes, it is. But not as impressive as it sounds. A relative reduction of 24% with the baseline mortality of 14% means an absolute reduction in mortality of 14% x 24% = 3.4%. But, you notice that we did not actually observe even this magnitude of mortality reduction in the graph. What gives? There is an excellent explanation for this. It is a little known fact to the the reader (and only slightly more so to the average researcher and peer reviewer) that the odds ratio, while a fairly solid way to express risk when the absolute risk is small (say, under 10%), tends to overestimate the effect when the risk is higher than 10%. I know we have not yet covered the ins and the outs of odds ratios, relative risks and the like in the "reviewing literature" series, but let me explain briefly. The difference between odds and risk is in the denominator. While the denominator for the latter is the entire cohort at risk for the event (here all patients at risk for dying in the hospital), that for the former is that part of the cohort that did not experience the event. See the difference? By definition, the denominator for the odds ratio is smaller than for the relative risk calculation, thus yielding a more impressive, yet inaccurate, reduction in mortality. 

Bottom line? Interesting results. Not clear if the actual intervention is what produced the 1% mortality reduction -- could have been secular trends, regression to the mean or Hawthorne effect, to name just a few alternatives. But regardless, preventing death is good. The question is were these improvements in mortality sustained after hospital discharge, or were these patients merely kept alive so that they could die elsewhere? Also, what is the value balance here in terms of resources expended on the intervention versus the results that may not even be due to the particular intervention in question?

All of this is to say that I am really not sure what the data are showing. What I am sure of is that I did not find any evidence of a 10% reduction in mortality reported by Reuters (I did e-mail Maggie Fox and at this time still awaiting a reply; will update if and when I get it). In this time of aggressive efforts to bend the healthcare expenditures curve we need to pay attention to what we invest in and the return on this investment, even if the intervention is all "motherhood and apple pie."                  

VAP: A case of mistaken identity?

This week in my class we are talking about systematic reviews and meta-analyses. As in the past, I assigned this excellent example published a couple of years ago by Canadian friends:

BMJ. 2007 Apr 28;334(7599):889. Epub 2007 Mar 26.

Oral decontamination for prevention of pneumonia in mechanically ventilated adults: systematic review and meta-analysis.

Chan EY, Ruest A, Meade MO, Cook DJ.

Department of Nursing Services, Tan Tock Seng Hospital, Singapore. ee_yuee_chan@ttsh.com.sg

Comment in:

• BMJ. 2007 Apr 28;334(7599):861-2.

Abstract

OBJECTIVE: To evaluate the effect of oral decontamination on the incidence of ventilator associated pneumonia and mortality in mechanically ventilated adults.

DESIGN: Systematic review and meta-analysis.

DATA SOURCES: Medline, Embase, CINAHL, the Cochrane Library, trials registers, reference lists, conference proceedings, and investigators in the specialty.

REVIEW METHODS: Two independent reviewers screened studies for inclusion, assessed trial quality, and extracted data. Eligible trials were randomised controlled trials enrolling mechanically ventilated adults that compared the effects of daily oral application of antibiotics or antiseptics with no prophylaxis.

RESULTS: 11 trials totalling 3242 patients met the inclusion criteria. Among four trials with 1098 patients, oral application of antibiotics did not significantly reduce the incidence of ventilator associated pneumonia (relative risk 0.69, 95% confidence interval 0.41 to 1.18). In seven trials with 2144 patients, however, oral application of antiseptics significantly reduced the incidence of ventilator associated pneumonia (0.56, 0.39 to 0.81). When the results of the 11 trials were pooled, rates of ventilator associated pneumonia were lower among patients receiving either method of oral decontamination (0.61, 0.45 to 0.82). Mortality was not influenced by prophylaxis with either antibiotics (0.94, 0.73 to 1.21) or antiseptics (0.96, 0.69 to 1.33) nor was duration of mechanical ventilation or stay in the intensive care unit.

CONCLUSIONS: Oral decontamination of mechanically ventilated adults using antiseptics is associated with a lower risk of ventilator associated pneumonia. Neither antiseptic nor antibiotic oral decontamination reduced mortality or duration of mechanical ventilation or stay in the intensive care unit.

The meta-analysis looks at effectiveness of oral care in preventing VAP. Of interest was the overall finding that VAP could indeed be prevented, but preventing it altered neither mortality nor such hospital utilization parameters as duration of mechanical ventilation (MV) or ICU length of stay (LOS).

The study has precipitated a vigorous discussion in class. I will excerpt below some of my responses to the students' questions (all right, so I feel a little tacky quoting myself, but perish the thought I should be accused of plagiarizing anyone, even myself).

One of the students brought up CMS never events (you know, those hospital-acquired conditions that CMS will no longer pay for because they should never happen), and presented me with an opportunity to talk about the subtleties of VAP diagnosis within that context:  

I could not agree more that prevention is critical. The question of whether we can prevent VAP 100% of the time is a little more complicated, however. For one, we are not even sure how to diagnose VAP. Applying the CDC's surveillance definition results in rates of VAP that are quite different from invasive diagnostic testing data. Applying the same definitions to different populations results in rates that are vastly different. Furthermore, diagnostics are driven by somewhat arbitrary thresholds for bacterial counts that may not have the greatest sensitivity or specificity. So, when you are dealing firstly with the wild west of the patient and disease interaction, then add the muddy diagnostic issues to the stew, and season everything with variable processes of care, the issue to me, at least, becomes a little less straight forward. 

Then, when I asked them what is the use of preventing VAP when it does not impact such important outcomes as mortality or LOS, I got some great answers, appropriately ranging from "you are full of s**t" to "OK, my intuition tells me VAP is good to prevent, but here we have no reason for it". Some even referred to these outcome as patient-oriented, so this was a great teachable moment. So, I responded, reiterating:

I am personally a great believer in prevention, but a). it has to be sensible prevention and not just a convenient conglomeration of poorly tested modalities, and b). not everything can be prevented. There are a couple of points to make here.

CMS has not curtailed payment for VAP for the reasons that I outlined above -- what exactly constitutes VAP, what are the best preventive strategies, and exactly how good are they. CMS, on the other hand, HAS stopped paying for completely preventable errors (yes, there are such things), such as leaving instruments inside patients during surgery or administering the wrong unit of blood. These are process errors for which zero tolerance is reasonable. 

Now, on to VAP. From the Chan MA we are under the impression that there is no reason to prevent VAP, since there is no difference in patient-oriented outcomes. First, let me challenge your notion that LOS and MV duration are patient-oriented outcomes. I would argue that the patient cares less about this than about comfort, quality of life, post-critical illness functional status and the development of PTSD after the ICU stay, to name a few. These are rarely measured in RCTs. So, even if the LOS and mortality are not altered by VAP prevention, there may be other perfectly valid reasons to prevent it. Not to mention curbing the use of antibiotics to curtail the spread of resistance. 

One final point to make. Each of the studies was not powered for mortality difference. Having said that, combining the data into a very respectable total number of >3,000 patients analyzable for mortality, this should have been enough to at least show an important trend, if there was one. And in fact the VAP literature is fraught with controversy on whether VAP imparts attributable mortality or not. The LOS issue is even more complex, however. Because LOS is an infinitely variable outcome, an RCT powered to capture this difference would have to be enormously large (a measly 2000 patients would not do). However, the epidemiologic and outcomes literature abounds with data on attributable LOS and $$ due to VAP.

So, here is a valuable MA that shows that there are sound strategies to prevent at least some cases of VAP, but by implication does not justify the effort for its prevention. Here is a situation, where policy requires expert analysis. 

Bottom line, MAs are useful and dangerous at the same time. Their results, if not examined carefully and in context can worsen rather than improve care. And the MA that I assigned is actually of great quality!

I posted this to underline how tricky applying evidence can be. Particularly in an area where there is so much diagnostic confusion. This of course does not mean that we should not strive to understand things better. On the contrary, this calls for more integration of knowledge in a multidisciplinary fashion.

Fools rush in where wise people fear to tread...  

 

  

Why medicine is not like a parachute

At the recent meeting of the American College of Chest Physicians I went to a session on hospital rapid response teams. This was a talk given by a senior and respected member of the Pulmonary and Critical Care academic community, well published and known. Now, if you are wondering what the heck is a rapid response team, I will tell you: it is a team composed variously of an ICU physician (or a hospitalist, depending on local patterns), a nurse or two, a pharmacist and sometimes other ancillary personnel. The role of this team is to be at the beck and call of the ward nursing staff to evaluate urgently any floor patient whose clinical condition may appear to be deteriorating. The ultimate goal, of course, is to avert a catasprophic emergency called a code, where the patient deteriorates to the point of needing emergent resuscitation.

While such a team makes a lot of sense, no study has convincingly shown that it does what it is meant to do -- either prevent codes or save lives. The presenter, a man quite invested in the sensibility of such teams, was making the point that perhaps we just have not focused on the correct outcomes to measure for this intervention. Ultimately, he said, we should continue to support such teams because of our gestalt that they work. After all, he went on, nobody has tested the effectiveness of the parachute in a randomized controlled trial.

When I heard this, I realized that I had been hearing this comparison a lot lately, of medical interventions to parachutes. And since his statement seemed somehow wrong to me, I started to think about why such an analogy is completely fallacious. And here is the startlingly obvious answer: the number needed to treat (NNT) for a parachute is 1! What this means is that one only needs to "treat" one person with a parachute (or strap it on before jumping out of a plane) to save one life. Now, is there really anything that we do in medicine whose margin of effectiveness comes even close? Last week we argued about a screening test with the NNT of 2,000. And we also talked about a therapy with a NNT of 16 which is not being utilized because of high costs.

So, let's not be intellectually lazy and let's not resort to comparing anything we do in medicine to a parachute. The parachute is made to mitigate the laws of physics, which are inherently more predictable, stable and generalizable than the laws of biology. Instituting a rapid response team may feel good to us, but, in addition to lending no measurable improvements to patient care, it may have the "unintended consequences" of abandoning patients who really need our attention at that moment to better their outcomes.

A similar argument can be made about many interventions whose mere face validity we take as God's own word. We and others have cautioned against such gullibility, particularly in a world that runs with half-truths and misinformation under the banner of quality measures. None of us has the cause to be so self-congratulatory as to compare our wares to the parachute. Now more than ever, experts need to think and present critically, soberly and objectively, lest we continue the trend of parochialism in our out-of-control disease care system.    

The cost-effectiveness of patient empowerment

I think by now there is not a person in the US who cannot quote at least approximately how much we spend annually on healthcare. Fewer people appreciate that nearly 1/3 of this $2.2 trillion bill is eaten by hospitalizations, amounting to about $680 billion. Although the data in the diagram below represent a single year, the overall distribution of expenses is remarkably constant over time.

Of this staggering amount of money, no less staggering is the ICU expenditure, quantified at nearly $60 billion in 2000.

The role of the ICU is to support a patient through his/her critical illness. The reason ICUs exist is that these patients require more intense human and technological interventions, and this geographic segregation allows for more efficiently concentrated care. The philosophy behind putting a patients in the ICU is that of a therapeutic trial. In other words, no one knows for sure a priori whether the ICU intervention will make any difference in the individual patient's outcome. What we have to go by is evidence from studies of similar patients that tells us what on average the expected outcome may be.

Until about a decade ago we never had the luxury of inquiring about what an ICU survivor might be doing a year later: we were fixated only on getting the patient through the acute illness. In fact, about 10 years ago, when I had the chance to ask a very well known and respected academic intensivist whether he cared about what happened to the patient once the ICU doors closed behind him, he, like so many of his peers, gave a resounding "no". Well, we have learned a lot over the last two decades about how to improve ICU outcomes -- more patients are surviving to leave the ICU. So now we have started to be concerned about their longer-term outcomes. After all, surviving an ordeal today just to die or, even worse, wish you were dead, tomorrow is not the kind of a victory anyone would want to claim. Unfortunately, what we are learning is that their long-term outcomes are not particularly encouraging. More than half of those patients who survive a prolonged critical illness die within the subsequent year. Even more discouraging is that fewer than 10% are actually at home living independently. So, when starting a therapeutic trial of an ICU, both the clinician and the family of the patient need to have a clear end in mind, so as to minimize pain and suffering for both, the patient and the family. And a byproduct of this conscious minimization of suffering through inappropriate care is potential avoidance of economic ruin.

What triggered this rumination for me is the paper published in this week's New England Journal of Medicine looking at the clinical course and outcomes of nursing home residents with advanced dementia.
In this prospective study following 323 patients, more than one-half were dead by 18 months. This is not in and of itself surprising. What should, however, shock an uninitiated reader is that 4 out of 10 of these unfortunate patients undergo at least one burdensome intervention, including a hospitalization or an ED visit, in the last 3 months of life. Although as a former clinician I have no trouble believing this number, as a member of the human species I am absolutely appalled! Is there really ever a point to such torment knowing that any potential postponement of death is at best temporary and at worst painful for the patient?

Another interesting point in this study is that what reduced the likelihood of this infliction of pain was a clear understanding by the patients' loved ones of their dismal prognosis. So, although some of the less informed yet loud and disingenuous voices tout them as government-sponsored death panels, the reality is that end-of-life discussions are not intended to limit necessary care. Rather, their intent is to create an honest and transparent dialogue between the clinicians and the patient and his/her family, thus empowering them to make the right choices according to their values. Perhaps the fear-mongers in their torrent of feverish activity have been too busy to notice that the age of paternalistic medicine is over. In the 21st century patient empowerment is the mantra. End of life discussions are just that, empowering.

If I were a politician driving a message, I would stop here. I would not connect this message of empowerment to dollars. But I am an outcomes researcher, so I must. There are examples in corporate America who say that if you do the right thing for the customer, the money will follow. To me this is simply an extension of the golden rule. Call it karma, call it what you will, but doing what is right is often contagious and causes a domino effect. And yes, in the case of spending the necessary time with the patient and the family to discuss the best course of action, the desired byproduct may be to help curb the waste of Medicare dollars on useless interventions, thus ensuring not only the best for the patient, but also the program's sustainability.

Our PLoS H1N1 predictions: right so far (UPDATED)

In August we published a knol in PLoS Currents: Influenza, where, based on the data to date, we modeled hospitalization, respiratory failure and death rates from H1N1. Because "preditions are hard, especially about the future", we could not be sure that we got the numbers right, especially since they were quite staggering.

Well, yesterday, the CDC and ANZIC published the US experience with the first 272 hospitalized patients and the winter flu season Australian-New Zealand ICU experience with H1N1. Here is a table that compares our predictions to what the CDC they found:

	Zilberberg knol (base case)	CDC NEJM study	ANZIC study
ICU admission		25%
ARF (relative to ICU)			65%
Acute Respiratory Failure rate [ARF] (relative to hospitalization)	12%	25% x 63% = 16%
Mortality rate (relative to ARF)	58%	Not reported	17%/65% =26%*
Mortality rate (relative to ICU)			17%
Mortality rate (relative to hospitalization)	12% x 58% = 7%	7%

*Based on assumption that all deaths occurred in ICU patients
Clearly, we got it right at least partly right -- totally consistent with the CDC numbers, and slightly higher on mortality than ANZIC. Also of interest in the CDC study is the data on antibiotics use:

Of 260 patients for whom data were available regarding antibiotic therapy, 206 (79%) received antibiotics. Of 198 patients for whom the date of initiation of antibiotics was available, such therapy was started before admission in 30 patients (15%), on admission in 117 patients (59%), within 48 hours after admission in 44 patients (22%), and more than 48 hours after admission in 7 patients (4%). Patients received a median of two antibiotics (range, one to seven); 70% of the patients received more than one antibiotic. Commonly used antibiotics included ceftriaxone (in 94 patients), azithromycin (in 84 patients), vancomycin (in 56 patients), and levofloxacin (in 47 patients). Seventy-threepercent of patients who had radiographic findings that were consistent with pneumonia were treated with antiviral drugs, and 97% were treated with antibiotics.

It is not surprising that there was such a high rate if antibiotics use, as these patients represent a group with very high severity of illness, where you throw everything at them up front and ask questions later. The rate is also similar to what was reported in the Spanish study, though those patients might have been even sicker since they were all in the ICU.

What concerns me more, however, is the 15% rate of use of outpatient antibiotics in the setting of this viral illness. I am not pointing any fingers here, as it is a decision that has to be made individually in the office by the doctor and patient. But, as I have done in the past, I do want to caution about what indiscriminate use of antibiotics could do to the incidence of C. diff and other resistant infections. We need to be very judicious in our use of these therapies as the onslaught of the H1N1 pandemic continues.

Compilation: H1N1 and ICU prioritization plans resources

Here are some approaches that have been suggested for how to prioritize limited ICU resources in a case of a mass casualty/pandemic situation. Some of the key points are:
1. Need to codify these protocols prior to the actual event, so as to maximize efficiency and minimize chaos
2. It is desirable to get community buy-in
3. Broad adoption is also needed to avoid litigation downstream

Here are some resources:
1. The Canadian protocol
2. American College of Chest Physicians disaster preparedness presentation
3. Recent joint MA DPH and HSPH statement on altered standards during a pandemic
4. Critical care during epidemics
5. Allocation of vents in a public health disaster (from NYC DPH)
6. SCCM podcast from Dr. Randy Wax
7. Chest Journal supplement: Definitive care for the critically ill during a disaster
8. Canadian Pandemic Resources for Critical Care
9. NYS DOH draft document on ventilator allocation (hat tip to Scott Hensley)

And here are a few posts on this blog that have discussed some of the issues:
1. Imagination and H1N1 preparedness
2. A narrowing window of opportunity
3. H1N1: Why we are unprepared
4. H1N1 predictions demystified
5. Notes from a pandemic

This is by no means an exhaustive list, but just some stuff I could come up with off the top of my head. Please, feel free to suggest other relevant resources in your comments.

Power: a true test of character

As I mentioned in a previous post, the Department of Health and Human Services has contracted with the American Association for Respiratory Care to do a count of ventilators available in the US hospitals. This step is necessary in order to understand the capacity for accommodating the potential 300,000 victims of H1N1-induced acute respiratory failure. The AARC web site gives this interesting disclaimer:

"The U.S. Department of Health and Human Services further secures the privacy of your institution’s data through participation in the Protected Critical Infrastructure Information (PCII) program administered by the U.S. Department of Homeland Security. Resulting from the Critical Infrastructure Information Act (CII) of 2002, the PCII program protects voluntarily submitted critical infrastructure information from public release through Freedom of Information Act (FOIA), state and local disclosure laws, and use in civil litigation. Additionally, PCII can not be used for regulatory purposes. Institutions and facilities sending important data into the Federal government can be assured of the highest commitment to confidentiality and security of their data."

Why might the AARC feel the need to include it in order to conduct a legitimately needed survey? Clearly, they must feel that the responders would be reluctant to disclose publicly their vent numbers. Should the number of available ventilators really represent classified information under the current circumstances? How much more difficult does such secrecy make the already Sisyphean task of preparing our nation for what may be coming? It is like preparing for a war without knowing the number of rifles available to the army. And if it is this difficult to get a vent count, how impossible is it then to come up with an integrated triage plan? If the CEOs do not want known the number of shovels they can contribute to this sandbox, I hardly think they are running to volunteer the information on more advanced equipment (bulldozers, e.g.) or personnel to any foreman. Yet this is a very complicated sand castle construction, with many turrets, moats and portcullises, which without central oversight could do a lot of damage if not put together properly.

Having exhausted the sandbox metaphor, I will move on to several other, equally over-used ones. It is obvious that there are all-out preparations underway at the state, county and municipality levels. Further, hospitals are working hard as well to make sure they can provide best care possible to the greatest number of people. And the DHHS is working tirelessly to keep abreast of all the current developments to have mitigation measures in place. Unfortunately, all of the parties are brilliant musicians playing at the same time without a conductor. Federal regulators are constrained by state laws, regional agencies are confined to their own regions, and single institutions are ultimately driven by what is in their best interest; and besides, they are also beholden to the anti-trust laws!

Thus, suggestions (they are called "recommendations") are made, but there is currently no mandate that they be followed. It is like a surgeon suggesting that anesthesia be given to the patient before the first cut -- it may or may not happen. The President's advisers recommended in their report that he appoint an H1N1 Czar to oversee our preparedness efforts. But what is a Czar without the power to demand accountability, but a deposed monarch?

To me this fragmentation of effort falls in line with the mounting public paranoia that the government is using H1N1 as an excuse for a wholesale take over of the healthcare system, described nicely in a recent musing by Dr. Rob Lamberts, one of the top medical bloggers. In reality this is about turf battles and assertion of powers more than it is about any real threats to them. I know I keep referring to the NEJM piece that I reviewed a few days ago comparing Israel's state of medical preparedness to ours. I do not have to tell you that Israel has one of the most effective crisis mitigation systems in the world. Their healthcare system has to be ready for a mass casualty situation at a moment's notice. One of the central differences between them and us is competition between hospitals (they don't have it, we do). In the current instance, this competitiveness may be getting in the way of even the most rudimentary efforts at readiness. Hospitals already stand naked before a firing squad, having to report errors and other quality measures. What's the big deal about quantifying preparedness?

Abraham Lincoln once said "Nearly all men can stand adversity, but if you want to test a man's character, give him power." Let's look at this as an opportunity to show off our character, and share the power for the greater good.

Notes from a pandemic

Informative report in Eurosurveillance yesterday from New Zealand summarizing their H1N1 experience to date. A few encouraging signs are that a). the pandemic seems to be slowing down, b). proportion of people needing hospitalization is low, on the order of 0.3%, of whom ~12% require an ICU, and c). the case fatality rate is about 0.005%. All this in the face of an estimated attack rate of 11%. Very encouraging!

So, given what I said yesterday in my post, perhaps we can revise down our estimates for the US. If we were to do that on the back of a napkin, we would see a much less concerning picture of around 33 million infections, ~100,000 hospitalizations, ~12,000 ICU admissions and a little over 1,500 fatalities. Whew! Much better than what either our group or the White House advisers predicted. But is this the right time to recalculate? Maybe not.

Here is why. First, the Southern hemisphere is still in the middle of its flu season, and flu epidemics are known to come in multiple waves, separated by intervals from months to years. So, while the slow-down is encouraging, the fat lady has not yet sung. Second, the New Zealand report notes that the native Maori and Pacific peoples, two socio-economically disadvantaged ethnic groups with marked health disparities, exhibited triple to quintuple the attack and case fatality rates seen in their European counterparts. Given that 47 million people in the US are without routine access to the healthcare system, and racial and ethnic healthcare inequalities are rampant, we remain at high risk for seeing a lot of severe cases. Finally, and most importantly, New Zealand has a comprehensive nation-wide plan for mitigating a pandemic (and it is a much smaller nation than ours). Some of the phases include extensive pre-pandemic planning, improved surveillance, border control aimed at containment, and quarantining active cases if necessary. Our plan, which is actually many different plans, is still evolving and is unlikely to be this comprehensive, uniform or enforceable.

So, while I am encouraged by what is being reported, I am not willing to hang my hat on it yet, and neither should the US Department of Health and Human Services. It is true that we may get lucky this time. But this should serve as our national wake-up call, since in our global village it is only a matter of time until we are faced with a devastating health emergency. Do we really want to rely on luck next time?

H1N1 predictions demystified

The President's Council of Advisors on Science and Technology report on the US preparations for the 2009 H1N1 influenza estimate of 90,000 fatalities is getting a lot of heat from an unlikely source: the Centers for Disease Control and Prevention. According to a New York Times story, there is disagreement with this prediction. Anne Schuchat, the director of the National Center for Immunization and Respiratory Diseases is quoted as saying "We don't necessarily see this as a likely scenario". A CDC press officer apparently confirmed that no one at the CDC "expects anything like 90,000 deaths".

If you look at the report itself, even the authors hedge on this point: they prefer to present is as a "planning scenario", rather than a prediction. OK, I'll buy this but what is a prediction but a planning scenario? True, it could be fewer. But if we sit around and simply argue about the number, it could be a lot worse.

Let me tell you a little bit about why and how we create these predictions (or planning scenarios, your choice). The why is pretty self-evident: we want to be prepared. Preparation entails having an idea, vague though it may be, of what's to come. Why do you care about tomorrow's weather forecast? So that you can plan what to wear, how long to allocate to your commute, or whether or not to cancel that trip to Florida during the hurricane season. Similarly, policy makers need to have some idea of how to allocate resources in the future. So, we make predictions, create forecasts or planning scenarios.

The irony is that all this future planning is built on past events as we know them in the present. (So you can see how a rapidly-evolving pandemic can throw a monkey-wrench into any estimates.) What makes us think that there are likely to be 30,000-90,000 fatalities associated with H1N1 in the US this flu season? Its past behavior, of course -- we look at what has happened to date, both in the US, and, in this case, in the Southern hemisphere, where the flu season is in full swing, and we apply those numbers to our population. The result is a mathematical formula which, when populated with these carefully evaluated assumptions, spits out the desired estimate. Now, it is also possible to include some other assumptions into the model, such as what happens at different levels of vaccine availability, efficacy and penetration. However, since all of these factors are to date unknown, putting them into the model would create a tremendous amount of uncertainty, and the model would be useless.

But even without introducing conjecture around potential modifiers, these estimates are prone to a large degree of uncertainty. This is why whenever you hear a report of a single number as the estimate derived from a prediction model, ask for more: there is usually a confidence interval calculated around that number based on varying the assumptions across some justifiable range. Generally, the tighter the confidence interval, the more useful the prediction. For example, in our recent study we estimated that on average we can expect ~300,000 cases of acute respiratory failure associated with H1N1 in the US, with the confidence interval ranging from ~225,000 to ~450,000. Now, this is a wide range, and it betrays our uncertainty about assumptions that went into the model.

One final note. The estimates provided by the White House advisors and the ones derived by us do not necessarily account for the effect of an all-out effort at prevention. So, if we sit by and wait for the virus to hit, and if it does not get more or less virulent than its current incarnation, we will have the predicted number of fatalities. That is a lot of "ifs", some of which are certainly within our control -- aggressive education, prevention, containment, to name a few.

So, with all of the pitfalls of planning scenarios, they are necessary for us to appreciate the potential magnitude of the problem and to plan for it rationally. Sweeping them under the rug and throwing their creators under the bus is just playing politics with an uncertain situation: these numbers evolve, and we need to acknowledge that. After all, as that populist philosopher Yogi Berra once pointed out: "Predictions are very hard, especially about the future".

H1N1: Why we are unprepared

We just published a paper in PLoS Currents: Influenza estimating what our ICUs can expect this flu season in the US due to the H1N1 pandemic. The picture is not pretty: about 300,000 extra patients needing assisted breathing from ventilators, and some of them requiring advanced modes of ventilation available only in specialized centers! Herein lies the paradox of this flu: by and large it does not cause a particularly severe disease, save in a small proportion of its victims. However, its contagion potential is high, and large numbers of the US population are likely to be affected (about 46 million by our estimates), accompanied by a large number of critically ill, thus potentially overwhelming the ICUs.

Here is how it fits into the overall picture of critical care in the US. ICU beds are perennially occupied, personnel numbers are shrinking and the volume of the sickest of the sick is growing at a clip 6 times that of all hospitalizations. Not to mention that 1/3 of all hospitals are financially in the red, and ~1/2 of all EDs are on diversion at some point (and, by the way, in the majority of these situations the reason for diversion is lack of ICU bed availability). Given that there are about 1 million patients on ventilators in the US annually, we are talking about a 33% surge likely compressed into a few months of the flu season! So what do you think is going to happen?

My friends on the ground tell me that we are not ready. Jeremy Kahn, MD, MS, Assistant Professor of Medicine and Epidemiology at the University of Pennsylvania School of Medicine and Senior Scholar in the Leonard Davis Institute of Health Economics, who happens to be one of the foremost experts on ICU capacity and regionalization in the US, told me that "we are woefully under prepared" for this pandemic. He is very concerned that critical care bed and ventilator supply will be outstripped by demand. But what concerns him even more is that "most municipalities do not have resource allocation or disaster preparedness plans in place". What this means is that we do not have plans in place to use the available resources optimally.

There are other ways in which we are unprepared. One is manifesting itself in our current national discourse on healthcare reform. The level of immaturity and selfishness in this "debate" makes me worry that we are not prepared as a population to make the tough decisions that have to be made during a disaster, which is what this pandemic is promising to be. Canadian Critical Care investigators came up with a protocol for their ICU resource allocation in case of a mass casualty event. This is an explicit scheme spelling out how prioritization is to take place. (Oh, yes, there will be prioritization). In a Society of Critical Care Medicine's podcast Dr. Randy S. Wax, a co-author of the Canadian protocol to triage ICU care during a pandemic, talks about this scheme. He uses the phrase "distributive justice". What this boils down to is that in the face of a public health disaster a bedside doc is responsible to the society at large even more so than to an individual patient. It is critical to have an explicit and transparent prioritization protocol, developed and put into place with full participation of community members. This is necessary as much for clarity and community buy-in as it is for protection from liability. The Canadian scheme has been available for 3 years -- have we heeded the call? Clearly not. And what is the Society of Critical Care Medicine doing? Well, to be fair, they have offered some disaster management courses. Now, at the 11th hour, they are advertising a web cast on September 17 at a cost of $65.00 for individual non-members!

So, where does all this leave us? As I said before, with our pants down! Is this sad state of affairs another reminder why we need a healthcare system devoid of the profit motive? A few days ago I reviewed a paper in the New England Journal of Medicine comparing Israeli preparedness scheme to ours. Some of the pivotal differences between our two systems are the centralized nature of planing and enforcement functions (they have it, we don't), competition between centers (they don't have it, we do), and the profit motive (they don't have it, we do).

Since it is too late for this pandemic to benefit from a philosophical and infrastructural overhaul, we need to have a realistic national plan. We have to do as much as we can to put plans into place that optimize the use of currently available resources. At the same time, prevention is clearly going to be the cornerstone of this effort. I believe that we need to be exceedingly aggressive with preventive efforts, including school and business closures, travel restrictions and the like. In fact, this may be a great opportunity to test to its fullest our communications web. It is possible that if we handle this potential catastrophe with some measure of common sense, we may gain useful insights not only into who we are as a community, but how our vast technological resources can make us into a more compassionate and efficient work force.

Unintended consequences

Thomas Szasz said: "Formerly, when religion was strong and science weak, men mistook magic for medicine; now when science is strong and religion weak, men mistake medicine for magic". I used this quote as a jumping off point in an editorial that I wrote, coming out in Critical Care Medicine journal shortly. The editorial accompanied a study from North Carolina illustrating communication gaps between healthcare teams and families during the care of a critically ill member. You see, when a person is ill and old and frail, an acute illness can easily tip the balance for that person into a critical situation. Even something as simple as a urinary tract infection can be catastrophic and bring one to the brink, where death is inevitable without the use of "everything". Let's be very clear: when "everything" is instituted in this situation, it is the last ditch attempt to stabilize the individual so that he/she and the family can have some closure and time to make decisions before the next time comes; and it will because death is still an inevitable outcome.

Back to the study and my editorial. We have known for a long time that persons who require a prolonged course of ICU care do not do well in the long run: most of them will be dead within one year, and the survivors have persistent problems with cognition, self-care, anxiety, depression. Furthermore, the burden on the family care givers is substantial. In fact, in the North Carolina study, only 9% of the patients were alive and functioning independently one year after their critical illness. Because this knowledge is not particularly new, you would expect that the doctors talk to the patients' families about what to expect, right? Well, it turns out that this happens in less than one-third of all cases as the families are faced with making choices for their ill loved ones! And even in the rare instances when the communication does take place, families often make decisions that in retrospect seem misguided.

Of course, because nothing is completely straight-forward in medicine, there are many reasons, which I discuss in my editorial, that may account for the misaligned communications and poor decisions. For example, patients' families may be too distressed to hear the truth. Additionally, and this has happened to me, physicians may be reluctant to be completely honest about the dismal prognosis of their patient, particularly when they sense the families' distress. Also, and this is particularly shocking, the treating physician may simply be unaware of the data that I just mentioned indicating a dismal prognosis in the long term.

And these are all the reasons it is so important for the elderly and the ill and the frail to have these discussions with their families and physicians before they are tipped into critical illness; it is just a sensible and humane thing to do. This has nothing to do with the hysteria over rationing or cutting costs; it just has to do with avoiding useless and painful prolongation of real people's agony. In this vein, the fact that the Senate has removed the end-of-life discussion provision from their version of the healthcare reform bill is distressing, and has all the appearance of making an issue of critical importance into a political football. But, I have to ask myself, do we really need to legislate these discussions? Can we not simply rely on the good sense of our healthcare providers to hold them without being compelled to do so statutorily? Well, firstly, the legislation, as I understand it, is not aimed at compelling anyone to do anything of this sort. It merely provides a framework and a reimbursement mechanism for such planning. Secondly, doctors are a "mavericky" bunch, and do not like to be told what to do or be a part of the herd, and scientific evidence takes decades to diffuse into practice. And, as Dr. Gawande pointed out to us, some doctors are driven by their bottom line more so than by what is best for their patient. In the current system doing more, not doing better, buffets the bottom line. We deserve better as patients and as citizens!

As in everything about this so-called "healthcare debate", we are choosing to focus on quantity over quality. The rhetoric of "death panels" is being replaced by a less inflammatory and more culturally acceptable language of "unintended consequences". Unintended by whom? This whole bedlam is an unintended consequence of a very timely and humane idea. So, again, no good deed goes unpunished, and we continue to be told lies in the interest of political advantage. And instead of bringing in reason, the press are panting over this "debate", since it lathers the masses. Where are the voices of people who have lived "everything", who have delivered "everything", and who have learned the hard way what the term "unintended consequences" really means?

A narrowing window of opportunity

Catching up on last week’s journals, two seemingly unrelated pieces caught my eye: one in JAMA and the other in the New England Journal of Medicine. The one in JAMA talked about how the Israeli health system deals with mass casualty-related surge capacity, and the one in the NEJM focused on how growth of corporate medicine can benefit healthcare in the US. Juxtaposing these two papers made for an interesting exercise in gap analysis.

In their JAMA Commentary, Peleg and Kellermann point to evidence from studies by the Government Accountability Office, the Institute of Medicine and the House Committee on Oversight and Government Reform, that the US hospitals lack infrastructure and resources in case of a mass casualty event. The authors then offer a formalized schema used by the Israeli health authorities to address their contingencies for disasters. Their planning, testing and enforcement functions are centralized: a government body is not only held accountable for developing and testing the systems, but also is imbued with authority to demand compliance from the participating institutions. In the US, on the other hand, the responsibility for disaster planning is divided between the CDC, Homeland Security and the department of Health and Human Services, and none of these bodies monitors preparedness and surge capacity on the ground, leaving the hospitals themselves to take them on individually and voluntarily.

Turning now to the NEJM Perspectives piece by David Cutler, a grim, albeit not unfamiliar, picture of the US hospitals emerges: ¼ of all US hospitals operate in the red, with another 11% making a less than 2% annual profit margin. In the current financial situation Medicare and Medicaid increases don’t have a snowball’s chance in hell, and private third-party payers are steadily negotiating lower reimbursements. Of direct relevance to disaster planning, emergency departments are seeing 30% more visits than they did two decades ago, and among urban centers, those most likely to be affected by a mass casualty event, two-thirds operate at or over capacity. How does one prepare in this context?

Back to Israel. Three points are critical in the Israeli preparedness plan. First, they have a concrete blueprint for de-clogging the EDs, the central point for efficient and effective management of the sick. Do we? Second, Peleg and Kellermann also remind us that centralized coordination, so well designed and executed in Israel, is possible there partly because of universal access to healthcare: hospitals do not have the incentive to see insured clients over engaging in potentially less lucrative mass casualty care. Not so here. Finally, communication and collaboration between healthcare institutions are key to the success of preparedness efforts. In the US competition precludes such collaboration.

Let’s add the threat of H1N1 to this mix. Now, I am not a catastrophist, and I do not want to be perceived as Chicken Little of the 2009 flu season. I recognize that so far this flu seems by and large to cause less severe disease than its seasonal counterpart. What I am also appreciating is that this flu is highly contagious, so, despite a relatively low frequency of complications, their volume may be vast. These predictions are based on what we know so far, and, while they may not come true, we need to be moving as if they were certainty. If we do not, and they come true, we will be caught with our pants down and suffer more than just a red face. Yet no one is at the wheel coordinating a response to this likely event. If the EDs are operating at or over capacity and have no contingency plans, how do we expect them to provide adequate care this fall? If hospitals are having to let go of essential personnel due to financial difficulties, how can we expect them to care for 30-60% more patients coming through their doors with the flu? Although the Federal Government has allocated funding for institutional preparedness, no one has overseen its implementation and the math is not adding up.

The situation poses an obvious conflict between our collective need to be prepared and our societal fear of centralization, exacerbated by the healthcare system’s financial ruin. Further, our culture of individualism is driving absurdly self-centered discussions without any regard to the reality or application of wisdom to the upcoming potential disaster: not everyone will get everything. In fact, even if we had the will to implement a preparedness schema akin to Israel’s getting all of our ducks in a row, rationing during a pandemic would be mandatory. What will things be like when tough choices have to be made under the pressure of a chaotic situation, choices that we as a society are ignoring now, when there is time to approach them rationally? Why are we engaging in hysterical lies about government-sanctioned euthanasia instead of discussing this challenging and rapidly approaching reality?

Today in New Hampshire Obama appealed to our civility and common sense as a nation in our discourse on healthcare reform. We need to heed this message, turn away from demagoguery and focus on developing a roadmap for realistic scenarios of 5 patients competing for one ICU bed, of our EDs clogged with a relentless influx of casualties from H1N1, and of having to make end-of-life choices for our critically ill grandma because asking her about her preferences when she was well would have amounted to a Nazi execution.

Both, the JAMA and the NEJM papers offer solutions to the US problem of healthcare capacity and preparedness. These solutions require time and a culture shift. But time is short, and culture change before the fall is unlikely. Yet this is a teachable moment in which we need leadership. Mainstream media should lead this conversation without attention to their ratings and in more than sound bites. Treat us, the citizens, like intelligent adults, and we will rise to the challenge; treat us like spoiled children, and we will miss this narrowing window of opportunity.