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. 

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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.    

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Marie Curie, Geiger counters and mass hysteria: more in common than meets the eye

What do Marie Curie, a Geiger counter and mass hysteria have in common? Well, to answer this question we need to go Sir Arthur Eddington, who was a British astrophysicist and philosopher of science at the turn of the 20th century. He came up with what is frequently referred to as the Eddington parable, which has nothing to do with the stars specifically and everything to do with how we make scientific progress. Here it is for your reading enjoyment, as told in this editorial (available by subscriptionby Diamond and Kaul, two highly respected clinician-researchers:

Let us suppose that an ichthyologist is exploring the life of the ocean. He casts a net into the water and brings up a fishy assortment. Surveying his catch, he [concludes that no] sea-creature is less than two inches long. An onlooker may object that the generalization is wrong. "There are plenty of sea-creatures under two inches long, only your net is not adapted to catch them." The ichthyologist dismisses this objection contemptuously: "Anything uncatchable by my net is ipso facto outside the scope of ichthyological knowledge, and is not part of the kingdom of fishes which has been defined as the theme of ichthyological knowledge. In short, what my net can't catch isn't fish”.

Suppose that a more tactful onlooker makes a rather different suggestion: "I realize that you are right in refusing our friend's hypothesis of uncatchable fish, which cannot be verified by any tests you and I would consider valid. By keeping to your own method of study, you have reached a generalization of the highest importance—to fishmongers, who would not be interested in generalizations about uncatchable fish. Since these generalizations are so important, I would like to help you. You arrived at your generalization in the traditional way by examining the fish. May I point out that you could have arrived more easily at the same generalization by examining the net and the method of using it?"

So,you see my point? Tools determine knowledge. Period.

  

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