Where did all the pediatric HAIs go?

In keeping with the pediatric theme this week, there is a nice study just published in Pediatrics outlining the general trends in Pediatric HAIs between 2007 and 2012. Stephen Patrick and colleagues from Vanderbilt and Boston Children's Hospital used CDC NHSN data from 173 NICUs and 64 PICUs to track CLABSI, VAP and CAUTI rates.

The good news is that CLABSIs declined from 4.9 to 1.5 per 1000 central-line days in the NICU and from 4.7 to 1.0 per 1000 CL-days in the PICU. There were also significant reductions seen in VAP in both NICUs and PICUs. CAUTIs were not adequately reported in NICUs; however, in PICUs the authors found that CAUTI rates did not change significantly over the 6-year study period. I've included the NICU and PICU figures below. Importantly,  CLABSI rates were twice as high and VAP rates were over three times as high in very low birth weight ( < 1500g) infants.

Apart from highlighting recent successes in reducing HAI, I think the main messages (as I've already stated elsewhere) are that HAI are still very common in VLBW infants and that rates remain above zero in all pediatric populations. Thus, despite cultural changes, implementation of insertion bundles and technological innovations, such as antimicrobial-coated catheters, we still need additional evidence-based methods to prevent HAI in children. While we might take this occasion to rest on our laurels and celebrate past successes, we should instead increase funding for development of HAI prevention interventions, particularly in VLBW populations.

And while policymakers might think we can mandate further HAI reductions through such things pay-for-performance, it is clear from these data that those tools have already done their job yet there's much more hard work to do. Notice the almost flat rates in both figures over the past 3-4 years. We need more than quality-improvement goals. Without scientifically proven methods to further reduce HAI, I suspect rates will remain stagnant. That would be unfortunate.

Annual cost of HAIs in the US = $10 billion

A new paper in JAMA Internal Medicine aims to give us an update on the impact of healthcare associated infections in the US. Given all the focus on HAIs, particularly with the rollout of value based purchasing, this is an important study. The investigators performed a systematic review, which included papers that were published this year, to determine attributable cost estimates, used NHSN data for incidence estimates, then performed Monte Carlo simulation. Total cost of the 5 major infections (CLABSI, CAUTI, VAP, SSI and C. difficile) was estimated to be $9.8 billion per year. The table below shows the breakdown by infection type.

Eli may want to comment on the methodology of the study and the validity of the results, but I suspect these numbers will be cited frequently.

Does pay for performance in HAI pay off?

The data is piling up suggesting that the CMS policy for nonpayment for HAIs have had little impact on reducing preventable HAIs in acute-care settings. The straw that might break the camel's back is a study in this week's NEJM by Grace Lee and colleagues.  Using a quasi-experimental design and time-series analysis, this AHRQ-funded study looked to see if there was a change in HAI rates after (vs before) the October 2008 nonpayment policy went into effect. 398 NHSN hospital provided data. The results are pretty conclusive: there were no changes in CLABSI, CAUTI or VAP after the implementation of the policy.  In the figures below you can see that things are getting better, just not due to nonpayment.

Of course this is not surprising. Peter McNair published a very nice study in Health Affairs (2009) that estimated that the total financial impact across the entire US would be about $1.1 million annually for six avoidable conditions. When you divide that amount by the number of US hospitals you get...about nothing per hospital. I think CMS might need a bigger stick.

Source: Lee GM et al. NEJM 2012; 367: 1428-37

Did the CMS no-payment rule impact hospital HAI prevention practice?

Beginning in October 2008 CMS stopped reimbursing hospitals for excess costs attributable to CLABSI or CAUTI.  While numerous studies and surveys have linked high compliance with HAI prevention bundles for CLABSI and VAP to reduced infection rates, few studies have looked at whether CMS no payment rules improved HAI prevention process measures.

To answer that question, Sarah Krein at the VA Ann Arbor Healthcare System completed surveys of VA and non-VA hospital HAI prevention practices in 2005 and again in 2009.  Their hypothesis was that if adoption of HAI bundles differed between non-VA and VA facilities, some of this difference could be do to the CMS no payment rules since VA facilities aren't directly affected by CMS rules.

The results are pretty interesting and don't really support any impact from the CMS no payment rules.  For CLABSI, both VA and non-VA hospitals reported significant increases in bundle component use with VA having higher use in both 2005 and 2009 (see graph below).

Similar results were reported for VAP and CAUTI.  The authors conclude by saying that "the CMS payment rule is likely not the primary driver of the increased use of infection prevention practices among US hospitals over the past several years."

Source: Krein et al. JGIM July 2012

Bundle fumble?

This week's JAMA has an excellent review (free full text here) on the prevention of ventilator-associated pneumonia (VAP). Specifically, the authors offer a critical assessment of the widely utilized IHI VAP bundle. They offer two important conclusions:

• "The ability of the bundle to prevent VAP has not been definitively established with high quality studies."
• "No large randomized study has demonstrated that reducing VAP using any strategy, including the IHI bundle, is associated with improvements in clinical outcomes."

Here's another example where an intervention has been touted as gospel, pushed hard and implemented broadly without the evidence necessary for a hardline approach.

Photo: OregonLive

Can you tell a hospital is safe by its "broken windows"?

This past weekend there were many discussions of James Q. Wilson's "broken windows" theory. Dr. Wilson, unfortunately, passed away this past week. The theory and research suggest that perception of a safe neighborhood prevents crime. If people feel they're in a safe place, they are less likely to commit a crime. If, however, they feel the neighborhood is unsafe or crime-ridden, they're more likely to commit crime. Thus, under this theory, police forces should arrest and prosecute even the smallest crimes, such as graffiti, and cities should quickly repair broken windows.

I lived in Rudy Giuliani's New York City during the implementation of this strategy, but I'm not here to defend his law enforcement policies one way or another, since I'm not an expert. Crime did fall, but it might have been for other reasons.  What I'm more interested in is if there could be an analogous theory in hospitals?  Is there a safe hospital theory?  It made me wonder if clinicians in safer or cleaner hospitals are more apt to practice hand hygiene or have higher compliance with CLABSI checklists.

I'm not aware of much data in this regard.  Two of the better analyses were done by Pat Stone's group at Columbia (I was a co-author). Looking at data from 415 ICUs in 250 hospitals they found that there was no convincing evidence of a cross-over effect between CLABSI and VAP; that is compliance with the CALBSI Bundle elements was never associated with a decrease in VAP rates.  In a separate paper, they found that compliance with the VAP bundle did not lower CLABSI rates. So for at least two device infections, there appears to be no such thing as a safe hospital. Lankford et al. in EID (2003) hypothesized that hand hygiene would increase after construction of a shiny new hospital. It actually decreased from 53% to 23%.  Hopefully Mike and Dan can add to this list of studies.

There has been a lot more research on what makes a quality hospital outside of infection prevention.  Twenty years ago, there was an important study in Medical Care that looked at disease-specific mortality in acute myocardial infarction, congestive heart failure, pneumonia, stroke, obstructive lung disease, or gastrointestinal hemorrhage in 30 hospitals. They found little correlation between disease-specific mortality rates within each hospital. So, MI mortality was not correlated with CHF mortality, even if they were likely to be treated by the same physicians and nurses. If mortality isn't a quality indicator, one wonders if other quality indicators have any relevance.

And what is a post without a non-scientific anecdote? Several years ago, when I was the hospital epidemiologist at a large hospital in Baltimore, we had high rates of MDR-Acinetobacter infections. This led our group to conduct a pilot study looking at the impact of universal gown and gloves in ICU-settings. At the time a new Chief Medical Officer, who happened to be a pulmonary-critical care specialist, started attending in our ICUs. He was struck at the level of gown/glove compliance that he saw and declared that he had never seen such a safe hospital. This actually meant something, since he had just moved from Barnes Jewish Hospital in St. Louis; home to one of my heroes, Vicki Fraser.  Were we really safer than BJH? I don't know, but the sight of all of those gowns and gloves did make it appear that we were really trying our best to be safe. Soon after, our CLABSI rates fell drastically, after a lot of effort sure, but the culture was changing. Maybe there is something in this theory that applies to hospitals after all? Too bad there appears to be no such thing as a "safe" hospital.

Zero: the enemy of objectivity

I had a busy travel week, first at the Remington course and then a HICPAC meeting. It was interesting to begin the week giving a lecture on VAP prevention, and then to end the week discussing changes to the VAP definition that increase objectivity, and even make it amenable to a purely electronic reporting algorithm. Since this proposed new measure is already being reviewed by the National Quality Forum, I thought I would share the general outline with the course attendees. A couple of them came up to me afterwards, nervous about a more objective definition. You see, by virtue of the fact that the new definition is based mostly on objective measures of sustained respiratory decline in a stable/improving ventilated patient, it isn’t meant to define VAP, but rather “ventilator associated complication”, or “VAC”. There are subcategories of VAC for events associated with an inflammatory response and/or signs of infection (call them “iVAC”), but the main measure destined for public reporting is meant to be VAC.

The problem? For those centers that have successfully pushed their VAP rate to “zero”, by whatever means necessary, the new VAC definition is threatening. Not only will a new definition unmask the gaming that occurs with subjective definitions, but the number of VACs will greatly exceed the VAPs at most centers. Take a look at the table below (double-click it to expand it), from a recent PLoS One paper that compared VAC and VAP at three hospitals in the Prevention Epicenters program. There were more than twice as many VACs as VAPs. Also of interest, VAC was associated with in-hospital mortality. VAP, not so much….not at all, in fact.




Although VAC may be the first in line, the concept is the same for other definitional changes—achieving greater objectivity in surveillance definitions requires that our unhealthy focus on zero (or “elimination”) must itself be eliminated.

For more VAP-happy goodness, check out this thought piece by Mike Klompas, the master of all things VAP.

WHAP VAP in 8 easy steps

We’ve covered this before…..how difficult it is to define VAP, how easy it is to reduce rates without improving outcomes, etc. Well, now Michael Klompas has published a handy guide entitled, “Eight initiatives that misleadingly lower VAP rates”. You’ll need a subscription to AJIC to read it, but it is a compelling document. I’m disappointed that he couldn’t come up with just 2 more, to make it a “top 10” list. How about adding: “lie”, and “make 'infinity' the new denominator”. That was easy!

Guideline fail?

What if adherence to a guideline was associated with worse outcomes? How much independent validation of guideline recommendations should occur? Is it realistic to expect guidelines to be subjected to “real-world” testing prior to adoption?

If these questions intrigue you, you’ll be interested in a Pfizer-pfunded four-center performance improvement initiative that included education around the ATS-IDSA pneumonia guidelines and a prospective assessment of outcomes. As the authors report in Lancet Infectious Diseases this week, patients who received “guideline compliant” empiric therapy were more likely to be dead at 28 days than were those who received “guideline non-compliant” therapy.

Before you submit your resignations to IDSA and ATS, you should know that there were plenty of problems with this observational study—most of them are well-summarized in an accompanying editorial. The failure of the authors to consider appropriate de-escalation of therapy in their determination of guideline compliance is an especially big problem, given that antibiotic overuse has been linked to increased mortality in the ICU.

Despite the limitations, I think this study raises important questions about guideline-driven approaches to complex infections. It is interesting, for example, that guideline non-compliant empiric therapy was equally or even more likely to cover the eventually-isolated pathogen than was compliant therapy (85% vs. 81% of the time, respectively).

And there will be prizes!

The U.S. Department of Health and Human Services just sent me an e-mail announcing two new national awards to recognize success in “reducing and eliminating central-line associated bloodstream infection and ventilator-associated pneumonia.” The awards are co-sponsored by the Critical Care Societies Collaborative.

The announcement states that the awards are intended to motivate. There should already be several potent motivators at work here (e.g. saving lives, reducing lengths of hospital stay and costs, CMS public disclosure requirements, etc.). But if the prospect of getting a plaque and a free trip to Chicago is what your organization needs to get over the hump, then by all means get to work. I’m also in favor of anything that raises the profile of HAI prevention, so it is good to see on that level.

Speaking of raising profiles, there was a very similar award presented at the Fifth Decennial, to recognize excellent team performance in infection prevention. It would have been nice to see SHEA, APIC and IDSA co-sponsoring this, too.

Award announcement here

Two new NPSGs from the Joint Commission target VAP and CAUTI

University of Iowa, Class of 2013

The Joint Commission has just released new National Patient Safety Goals for 2012-13 for full implementation by January 1, 2013.  They cover VAP and CAUTI in hospitals and LTCF and are open for public comment until 1/27/2011.  The strategies were published in the October 2008 SHEA Compendium in ICHE. 

Two comments: (1) I thought the world was going to end in December 12, 2012, so probably not much to worry about, apart from the world ending and (2) VAP may be going away in NHSN to be replaced by process measures, so I wonder how VAP outcomes will be tracked, as required, when no one can decide on a definition? I'm sure you have comments and they want to hear from you.

Note: It looks like even if the Mayans were wrong about 2012, we may still not make it through 2013.

Example for VAP, NPSG.07.06.01 in Hospitals requires 7 steps:
1) A plan
2) Hand hygiene before/after caring for ventilated patients
3) Semirecumbent position of patient
4) Regular antiseptic oral care
5) Daily weaning assessment
6) Daily sedation interruption
7) Measure VAP process measures and outcomes

Hospital Program draft versions of NPSG.07.06.01 (VAP) and NPSG.07.07.01 (CAUTI) (PDF)
LTC Program versions (PDF)
JC page that provides links for submitting comments.

h/t Marc Wright

Happy Weekend: VALORI or Volaré?

Remember those 1979 Plymouth Volaré ads?  Remember how the Volaré was the car that brought bankruptcy Chrysler's way?  Me neither.  Well, when I see the the acronym VALORI (Ventilator Associated Lower Respiratory Infection) like in Dan's recent VALORI post, I start singing Volare in my head.  Now, perhaps, the same thing will happen to you. For that, I'm truly sorry. To apologize, I bring you Dean Martin, the pride of Steubenville, Ohio.

My new VAP definition is unstoppable!

As we have blogged on numerous occasions, existing ventilator-associated pneumonia (VAP) definitions (for both clinical and surveillance purposes) are craptastic. In Mike’s recent post about this problem, he calls for CDC to collaborate with IPs and hospital epidemiologists to help develop better definitions. Well, the CDC is doing just that. They have been working with critical care and ID physicians, as well as with some of the CDC Epicenters, to develop and assess a new definition for “VALORI” (Ventilator Associated Lower Respiratory Infection). A simple algorithmic summary of the approach is below, courtesy of Dr. Shelley Magill, who gave an excellent talk at a recent CDC/HHS meeting I attended in DC:

The major objection voiced to the draft VALORI definition is that by removing some aspects that introduce subjectivity, the definition becomes more of a severity of illness measure than a description of what we know clinically to be VAP. The definition also retains some elements that are subjective (or hinge on clinician behavior, such as use of antibiotics), so it isn’t clear if it will have better performance characteristics than the current NHSN definitions.

In my view, we should not use VAP as a quality measure, period. VAP rates should not be compared across hospitals, publicly disclosed, or used in any pay-for-performance schemes. For as soon as they are, hospitals will quickly learn to reduce their rates without doing anything that actually improves patient outcomes (e.g. by narrowly interpreting clinical signs or CXR findings, by seeking consensus among multiple IPs for each case, or by incorporating clinician’s opinions regarding the diagnosis).

In the meantime, we can probably agree on some practices that could be selected for public reporting and benchmarking (i.e. process measures). The practices chosen should be those that are demonstrated to improve meaningful patient outcomes in controlled clinical trials. A great example is this 4-center study of spontaneous awakening + spontaneous breathing trials. The investigators, recognizing the futility of defining VAP, instead demonstrated reductions in ICU days, vent days, hospital days, and mortality in the intervention group.

Tracheotomy, VAP, p-values and death

There is a new RCT just published in JAMA by a large group in Italy looking at the benefits of early (day 6-8) vs late (day 13-15) tracheotomy completed in 12 ICUs. The primary endpoint was VAP. There is also a very nice accompanying editorial. There are several interesting findings. First, patients randomized to early tracheotomy were less likely to develop VAP by day 28, 14% vs 21%, but the p-value was 0.07. Since the p value was greater than 0.05, the authors were forced to say that there was no benefit from early tracheotomy.

Interestingly they also found significantly greater vent-free days, ICU-free days, successful weaning and ICU discharges in the early tracheotomy group. There was even a trend towards higher survival in the early vs late group, HR=0.80, 95% CI 0.56-1.15. The authors and editorial do a nice job of pointing out that 31% of early and 43% of the late group didn't even receive a tracheotomy due to impending extubation or death. The editorial even makes the point that selecting an early tracheotomy is really a strategy of more trachs. The study did not assess patient comfort, which may be associated with early tracheotomy.

What is always troubling to me is that scientists, editorialists, journals and clinicians are stuck in this p-value trap. Here we have a study, a very good randomized trial, which shows likely clinically significant reductions in VAP and potentially lower mortality, but since the study was underpowered we are forced to say "no difference." I wonder if you calculated how many patients are intubated each year in the US (or Italy) and reduced VAP rates by 33%, how many VAPs would be prevented and how many deaths would be prevented? I know this study should be repeated, but will it? You have a negative JAMA study, what's the incentive? I describe this phenomenon as "Death by p-value."

VAP: Do you know it when you see it? (Again!)

There's a new paper on the utility (or lack thereof) of CDC's definition of ventilator-associated pneumonia. In this study 4 persons reviewed 50 cases of ventilated patients with respiratory deterioration >48 hours after intubation. Two reviewers were experienced infection preventionists who applied the CDC definition. A third IP used a modification of the CDC definition that was more quantitative, and the fourth reviewer was a physician board-certified in infectious diseases and critical care who used clinical judgment to define VAP. Using the standard definition, one IP assigned the VAP diagnosis to 11 patients and the other, 20 patients. The IP using the modified definition assigned 15 cases as VAP. The physician diagnosed VAP in 7 patients. The IPs agreed on 62% of cases (kappa=0.40). All 4 reviewers agreed on the VAP diagnosis in only 4 cases. This is not the first study to show how complex assigning the diagnosis of VAP can be.

Given that public reporting has raised the stakes to high levels, the CDC can no longer ignore this issue. Consumers cannot make choices on where to receive care if inter-hospital comparisons of infection rates are not valid. There needs to be a convening of IPs and hospital epidemiologists who use the definitions on a daily basis to thoroughly assess each of the HAI case definitions and begin to work on the development of new ones that will be fair to hospitals and helpful to consumers. Otherwise, it's garbage in, garbage out, and the entire concept of public reporting is undermined.

Defining our way to zero?

Here is a quote from an Emerging Infections Network post today, regarding how we define central-line associated bloodstream infections (CLABSI):

Is it really worthwhile to adjudicate blood stream infections in patients with central lines as "primary" or "secondary"? The adjudication according to the "definition" is still subjective. For example, a Klebsiella bacteremia in a pt with a PICC and PEG was ascribed to "gastroenteritis" since the pt had some coincident diarrhea and stool fecal leukocyte+ (hence bacteremia was considered secondary). A candidemia was attributed to pneumonia since the pt was immunocompromised (on steroids for BOOP), had a fluctuating CXR and had Candida in his sputum (hence the candidemia was considered secondary). I was told that these attributions were completely reasonable since they were compatible with the definitions and that the institution regularly passes muster when audited. It is distasteful to argue but anyone looking closely would see a discrepancy between the clinical diagnosis and the adjudicated diagnosis. Since the public is taking these numbers seriously, there is a problem.

This EIN post goes to the heart of a very important issue in healthcare associated infection reporting—the subjective interpretation of National Healthcare Safety Network (NHSN) definitions. Of course we already know that ventilator associated pneumonia (VAP) rates are a load of crap (I’ll leave it to Klompas and Platt to explain why). It is less well recognized how much fiddling is going on with the CLABSI definition. The post above is a great example of what is happening across the country in hospitals that are under increasing pressure to “get to zero”, and as public reporting of infection rates becomes the norm rather than the exception. Hence those hospitals that apply the NHSN CLABSI definition very strictly are punished with higher CLABSI rates. Meanwhile, hospitals celebrating “zero” rates may in fact be no more “safe” than before they began fudging their definitions.

How to fix this? Either via an expensive and cumbersome validation system for public reporting (any ideas for CDC and state public health departments on how to do this?), or via more specific definitions from NHSN.

Decontamination: not so selective?

Remember the NEJM study from the Netherlands that compared selective digestive decontamination (SDD) vs. selective oropharyngeal decontamination (SOD) vs. placebo for infection prevention in ICU patients? The upshot, using 28 day mortality as an endpoint, was that both SDD and SOD were beneficial, but there was no evidence that one was better than another.

These investigators have now published a report on changes in antimicrobial resistance after the prophylactic use of antibiotics in this study (tobramycin, polymyxin E and amphotericin for oropharyngeal (SOD) or nasogastric (SDD) administration, and 4 days of IV cefotaxime (SDD)).

Surveillance of rectal and respiratory tract samples from patients in the 13 participating ICUs demonstrated that resistance to ceftazidime, tobramycin, and ciprofloxacin increased in GI tract flora after the SDD intervention and increased in respiratory flora after both SDD and SOD interventions.

I have to read the fine print more closely, but this confirms my view that we should stick with chlorhexidine oral care to suppress oropharyngeal flora, rather than SDD or SOD approaches that use therapeutic antibiotics.

VAP: Do you know it when you see it?

Ask any infection control nurse, infectious diseases physician, or intensivist and they will tell you of the difficulty in trying to define and diagnose ventilator-associated pneumonia (VAP). This is because there are a number of other conditions that can mimic VAP. A new study in the Journal of Critical Care compares three VAP definitions to autopsy findings in 253 patients to determine the utility of the definitions. The CDC definition was not used, but is similar to one of the definitions applied in the study. None of the definitions performed well. The most sensitive definition (65%) had a specificity of 36%. On the other hand, one definition had a nearly perfect specificity (99%), but its sensitivity was dismal at 5%. The results of this study coupled with conventional wisdom should be taken as a warning that public reporting of VAP rates may mislead consumers, and other metrics for reporting should take precedence.