Quote of the day

Photo: Iowa Medical Society

There's an article in today's Baltimore Sun on influenza vaccination of healthcare workers. What a piece of work! Here's a quote from the chief medical officer of a large health system in the Maryland/DC area:

 "If you look at data on how many people die in this country from influenza, it overwhelms all other hospital-acquired infections in numbers, and you couple that with the voluntary vaccination programs that weren't successful in getting 98 to 100 percent of employees, and this becomes an argument for a mandatory policy."

Really?

Let's examine the data. According to CDC, it is estimated that there are about 100,000 deaths due to hospital-acquired infections in the US. Also, according to CDC, on average, 25,000 persons in the US die from influenza each year. And it's important to consider that the vast majority of influenza cases are not acquired in the hospital. So what in the world is the CMO talking about? Most intelligent people who read this article would conclude that influenza kills more inpatients than all other hospital-acquired infections, yet that is absurd. Inside and outside the hospital, flu kills one-fourth the number of patients who die from non-flu HAIs.

I won't rehash my arguments about mandatory influenza vaccination; you can read them here. But even if you're a believer in the get-vaccinated-or-get fired school of thought, I think you have to admit that the impact of such programs pales in comparison to those aimed at reducing CLABSIs, for example. So articles like this one in the Baltimore Sun simply misinform the public and divert attention from bigger, more important problems.

Are we closer to a universal flu vaccine?

Eli has blogged before about the potential for a more universal flu vaccine, using conserved epitopes. Last week the same group that previously described a monoclonal antibody targeting a conserved epitope on group 1 influenza A viruses, reported on a second monoclonal antibody that has broad neutralizing activity against group 2 viruses. Both of the antibodies described by this group bind to conserved regions at the base of a hemagglutinin stalk and interfere with fusion of the virus with host cells.

Joint Commission and Influenza Vaccination: IC.02.04.01

This seal in no way suggests that the
Joint Commission approves of this blog

The Joint Commission has just released proposed requirements addressing influenza vaccination of staff and licensed independent practitioners. Revisions to current requirements are proposed for Hospital, Critical Access Hospital, and Long Term Care accreditation programs with new requirements proposed for Ambulatory Care, Behavioral Health Care, Home Care, Laboratory, Medicare Based Long Term Care, and Office-Based Surgery accreditation programs.  Comments will be gathered until May 17, 2011.

You can review the proposed standards and leave comments on the JC site here.

For the Hospital Accreditation Program IC.02.04.01, elements 1-3 remain the same, elements 4 and 5 have been revised and elements 6-9 have been added. The new text is bolded below and the revised elements are:

1. The hospital establishes an annual influenza vaccination program that is offered to licensed independent practitioners and staff

2. The hospital educates licensed independent practitioners and staff about, at a minimum, the influenza vaccine; non-vaccine control and prevention measures; and the diagnosis, transmission, and impact of influenza. (See also HR.01.04.01, EP 4)

3. The hospital provides influenza vaccination at sites accessible to licensed independent practitioners and staff.

4. The hospital annually evaluates vaccination rates and the reasons given for declining the influenza vaccination.

4. The hospital includes in its infection control plan the goal of improving influenza vaccination rates. (For more information, refer to Standard IC.01.04.01)

5. The hospital takes steps to increase influenza vaccination rates.

5. The hospital sets incremental influenza vaccination goals, consistent with achieving the 90% rate established in the national influenza initiatives for 2020.

6. The hospital develops a written description of the methodology used to determine influenza vaccination rates. All hospital staff and licensed independent practitioners are to be included in the methodology for determining the influenza vaccination rates. (See also IC.02.04.01, EP 1)

7. The hospital evaluates the reasons given by staff and licensed independent practitioners for declining the influenza vaccination at least annually.

8. The hospital improves its vaccination rates according to its established goals and at least annually. (For more information, refer to Standards PI.02.01.01 and PI.03.01.01)

9. The hospital provides influenza vaccination rate data to key stakeholders including leaders, licensed independent practitioners, nursing staff, and other staff at least annually.

Flu vaccine breakthrough

Influenza virus, A/Hong Kong/1/68

Yesterday, when commenting on Bill Gates' vaccine efforts, I wrote that a key breakthrough might be "an influenza vaccine that targets a conserved region of the virus, which would eliminate the need for costly annual vaccinations."  As if on cue...

The Guardian reports of an influenza vaccine breakthrough out of Oxford University. The new vaccine, developed by Dr Sarah Gilbert's team, targets proteins inside the flu virus that are common across all strains. The two proteins, Nucleoprotein and matrix protein 1, are more than 90% conserved across all influenza A strains and less liable to change over time.

In their initial human trial of 11 healthy vaccinated people and 11 non-vaccinated people, they exposed them to what I think is A/Wisconsin/67/2005 (H3N2). Fewer vaccinated people got the flu and vaccinated people had more T-cells and more activated T-cells. We will have to wait a bit for more details, since they have just submitted the paper for publication. Interesting that the Guardian is reporting this before a a medical journal. Given how dysfunctional the peer-review process is these days (STAR-ICU trial anyone?), I don't blame them for communicating the results in this time-efficient manner.

You can read about the initial vaccine creation and phase 1 safety trial of the Modified Vaccinia virus Ankara vector encoding nucleoprotein and matrix protein 1 in the January 1st CID.

Guardian article by Alok Jha

Berthoud et al Clin Infect Dis, January 1, 2011

Take me home, country roads, to the place….

…where hospitals can decide for themselves how to vaccinate their workers against the flu. Sorry, those lyrics don’t really work. Still, West Virginia has decided against a statewide mandate for healthcare worker influenza vaccination.

I’m not sure this is big news, as I am not aware of how many states have decided to step into this issue—I had assumed that most would leave it up to each hospital. Maybe someone can enlighten.

I am blogging about this for two reasons. First, and most importantly, because West Virginia is Mike Edmond’s home state (or at least he went to college and med school in West Virginia). Here is a photo of Mike as a child, before he decided to pursue a career in medicine and was more interested in the banjo. Second, I wanted to report that our hospital is now at a 93% influenza vaccination rate without a mandate. If you recall, last year our shiny new mandate went down in flames after SEIU filed an injunction. So I’m especially proud of the fact that our healthcare workers are stepping up to be vaccinated without being forced to do so by threat of termination.

Another reason why mandating flu shots is stupid

I wanted to share with readers a simple, back of the envelope calculation that points out the folly of trying to control respiratory illness in healthcare workers by mandating influenza vaccine.

Here are the assumptions for the calculation:

• Our hypothetical hospital has 5,000 healthcare workers
• It’s a nonpandemic influenza season, in which 7% of the population (including healthcare workers) gets an influenza-like illness (ILI), of which 7% is due to influenza (these estimates are from the control arms of 95 influenza vaccine trials involving 1 million subjects over the course of four decades). Now of course the 7% of the 7% (those with influenza) can be reduced by influenza vaccination.
• The hospital has a baseline influenza vaccination rate of 70% without mandating the vaccine
• We’ll generously assume that influenza vaccine is 90% efficacious at preventing influenza (though it has no impact on non-influenza ILI)
• Presenteeism is 70% (i.e., 70% of healthcare workers come to work when they are sick)

Now let’s take 2 different approaches to reduce the risk of transmission of ILI to patients. In the first approach, we’ll mandate influenza vaccine and achieve a vaccination rate of 98% (we'll assume that 2% of HCWs have a contraindication). In the second approach we won’t mandate vaccination and we’ll maintain the vaccination rate at the baseline of 70%, but we undertake an educational campaign to reduce presenteeism.

So, the question is this: what reduction in presenteeism would have the same impact as achieving 98% influenza vaccination in terms of the number of HCWs at work with ILI? The answer is an astonishing 1% absolute difference. Reducing presenteeism by 1 percentage point (from 70% to 69%) would have the same impact as increasing vaccination from 70% to 98%. So in our 5,000 employee workforce if we could get 4 HCWs with ILI to stay home it would have the equivalent effect of mandating influenza vaccine. 

Now one could argue with the assumptions and we could re-run the numbers using different percentages for any of the variables. But the primary and irrefutable message is this: pathogen-specific interventions (i.e., vertical approaches) for controlling transmission of infection in the hospital are inefficient when compared to multipotent, horizontal approaches. And remember that a sizable fraction of the patients are vaccinated against influenza (we don't have vaccines for the rest of the ILIs), which actually increases the differential impact of the strategies in favor of reducing presenteeism.

Unfortunately, the horizontal approach to controlling ILI won’t make any companies any money, and in our sound bite culture, the path of least resistance (which SHEA and others have fallen prey to), is to simply call for mandating flu vaccine.

Let me once again emphasize I am not anti-vaccine. I get a flu shot every year. But I think the costs of forcing resistant healthcare workers to get vaccinated in terms of unintended consequences outweigh the benefit. So I can live with 70% compliance and find other ways to protect our patients.

P.S. my calculations are below:

	Baseline	Alternative strategies
	70% vaccinated, 70% presenteeism	98% vaccinated, 70% presenteeism	70% vaccinated, 69% presenteeism
Total HCWs	5,000	5,000	5,000
Vaccinated HCWs	3,500	4,900	3,500
Unvaccinated HCWs	1,500	100	1,500
HCWs with non-flu ILI (6.5%)	325	325	325
Unvaccinated HCWs with flu (0.5%)	7.5	0.5	7.5
Vaccinated workers with flu (0.5% x 10%)	1.75	2.45	1.75
Total HCWs with ILI	334	328	334
HCWs at work with ILI	234	230	230

American Academy of Pediatrics Recommends Mandatory Influenza Immunization of all Health Care Workers

We have already posted several times in the last week regarding the SHEA Position Paper.  The AAP Policy Statement comes to a similar conclusion.  They appear to come from the position that compliance with vaccine is low, low is bad and mandatory programs can increase compliance. No good information in the document regarding financial COI, but they do include a statement that they were internally disclosed and resolved through a Board-approved process.  Not being a member of AAP, I'm not sure what that means.  Perhaps someone can enlighten us.

Interestingly, the AAP paper has 24 references vs SHEA's 63.

AAP Policy Statement

Previous SHEA Position Paper posts: here, here and here.

Conflicts of interest are not always financial. Role up your sleeves...and get your flu vaccine?

I joined this blog in December 2009.  There were several reasons for this including what I saw was a great need for conversation among hospital epidemiologists and infection preventionists around complex and important issues such as N95 masks in 2009 novel H1N1, ADI for MRSA and mandatory influenza vaccination of HCW.  That's why I was so excited to see that SHEA was finally releasing a position paper endorsing "a policy in which annual influenza vaccination is a condition of both initial and continued HCP employment and/or professional privileges."  I was so excited in fact, that I haven't read the document.  To be fair to myself, I've been pretty busy and I've seen several talks and debates on the issue. However, I was excited because it would awaken the debate again within the medical community and, more importantly, this blog.

Dan, Mike and I have all commented on the conflict of interest issue. It is true that several authors of the SHEA position paper have financial ties to vaccine manufacturers.  I agree, as I probably said 1000 times during high school debates, that 'perception is key' and that ideally we could produce documents such as this SHEA paper free of financial conflicts.  However, given that this document has been produced, what can and should we do with it?  How will we interpret it in the light of other organizations (e.g. AAP) coming to the same conclusion? Additionally, to be fair to the document and process, this isn't purely a SHEA position paper, but rather it was "approved by the Board of the Society of Healthcare Epidemiology of America and endorsed by the Infectious Diseases Society of America."

You could argue that we should post or even eliminate all of the potential "financial" conflicts of all of the board members of these societies and I would, at first pass, agree with you.  So now, in the future, we might have all board members and all guideline writers be free of all financial conflicts of interest. That may be theoretically possible for one subject, but all subjects? I doubt it.  I also don't think that "financial" conflicts of interest are the most important or result in the most bias.  I think it's not even close; but more on that in a minute.

Now if you think I've gone off my rocker (again), well, I was lead author on a SHEA guideline back in 2007 titled "Raising standards while watching the bottom line : Making a business case for infection control," and that guideline was conceived of, supported, edited, modified and approved by many members of the SHEA board.  In my opinion, a majority of those on the SHEA board must have pushed for this new flu vax position paper knowing what the outcome would be.  In fact, didn't SHEA produce a 2005 position paper containing a different recommendation? So why go through the effort to produce another document so soon, if they didn't know it would produce a different or this exact recommendation? Importantly, the SHEA position paper adheres to all current guidelines and lists financial conflicts of the authors. Nothing is perfect, but I don't think we should discount the recommendations for that reason.

On to another subject.  In April and June of this year I wrote posts discussing what I see is the most important bias in science and in life. That bias is confirmation bias.  My first post on the subject discussed how all of us that have pre-specified opinions, especially ones that are well known to others, root for results of new trials to support our pre-existing beliefs. It's just natural. This tendency for people to favor information that confirms preconceptions regardless of whether the information is true can influence our search for information, how we interpret information and even our memory.  Now, I'm not sure a definitive study has been done, but I suspect that if you have stated a strong public opinion for or against a certain "thing" it would take a lot of money to get you to change your mind and I haven't even mentioned status quo bias. Cognitive biases....if only the solution was so simple as listing or eliminating financial relationships!

While I'm on the subject of definitive studies, I will first state that I have great respect for the Cochrane reviewers and the SHEA position paper authors (and of course my co-bloggers).  However, no amount of genius can overcome the lack of studies/data/funding that exists for the evaluation of infection prevention interventions. So, again, even though I've not read the SHEA paper or the Cochrane reviews, I can definitively say that they are both wrong. Why? No one has completed the necessary cluster-randomized trial in 50-100 hospitals during different influenza seasons with different vaccine-virus matches in different countries with different acuity levels of the hospitalized patient populations etc, etc, etc.  No one will.

To me, the key issue around mandatory vaccine for HCW is not whether the vaccine works, as Mike discussed on Saturday. Rather, it is how much better HCW compliance would be under a mandate. I think most can agree that mandates greatly increase vaccine compliance, but if the data suggests that the vaccine doesn't work, then the question shouldn't be whether or not to mandate the vaccine. The question should really be whether we even offer it to HCW at all, or less seriously, even bother tracking compliance.  I think Mike's post or rather the Cochrane reviews have far more serious implications that stretch way beyond HCW mandates. To me though, there is enough data to support the efficacy and safety of influenza vaccine both in direct protection and also herd immunity. Thus, I think the key issue is compliance; but again, I haven't read it (yet).

So, what would I have done if asked to determine the benefits of mandatory influenza vaccine in HCW?  I might have completed a different type of research synthesis, altogether. I could have taken data like Mark Loeb's 2010 JAMA paper showing the benefits of herd immunity imparted on the unvaccinated by vaccinating children in small rural communities in Canada. Then, I'd have built a decision-analytic type model accounting for the non-linearity of influenza transmission in hospitals, adjusted for various levels of HCW vaccination compliance, completed numerous sensitivity analyses and then reported in which hospitals, in which countries and in which influenza seasons (H3 vs H1) we would expect influenza mandates to be most effective. Too bad that's not gonna happen.  Oh, and people wouldn't believe the model anyway.  It's just math for goodness sake and nobody trusts equations. No, most of us would much rather put our faith in conflicted human beings.  Go figure.

No links today; gotta spend time reading SHEA's new position paper

More on SHEA's Flu Vaccine Mandate for Healthcare Workers

Last week, Dan blogged about SHEA’s new position paper, which calls for annual influenza vaccination as a condition of initial and continued employment for healthcare workers (HCWs). Simply put, SHEA is recommending that HCWs without a contraindication to influenza vaccine be fired if they refuse to be vaccinated. That’s a strong stance coming from an organization that typically avoids strong stances. I’ve blogged before about why I think that mandating influenza vaccination is a bad idea, but in this posting I want to focus on the evidence behind the recommendation.

Of note, there are 3 Cochrane reviews on influenza vaccination published this year that are worth reading. If you’re not familiar with Cochrane Reviews, you can read more about them here. These reviews are generally thought of as the highest quality, most rigorous reviews of the medical literature, and the reviews are developed free of any commercial funding.

The first Cochrane review, Influenza Vaccination for Healthcare Workers Who Work with the Elderly, is most applicable to the SHEA position statement. SHEA’s position on the utility of vaccinating HCWs to prevent influenza transmission to patients is based on 4 studies in long-term care facilities (LTCFs). And of note, those 4 studies are part of the Cochrane review, which comes to the following conclusion: “We conclude there is no evidence that vaccinating HCWs prevents influenza in elderly residents in LTCFs.”

Another recent Cochrane review evaluated the utility of influenza vaccination of healthy adults, which presumably represents the majority of HCWs. The authors concluded: “Influenza vaccines have a modest effect in reducing influenza symptoms and working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission.”

The last Cochrane review is least applicable to our current discussion, but interesting nonetheless. In reviewing the effect of influenza vaccine for the elderly, the authors conclude “The available evidence is of poor quality and provides no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for people aged 65 years or older.”

So given the lack of rigorous evidence supporting the utility of vaccinating HCWs to prevent transmission to patients, I find it astonishing that the Society for Healthcare Epidemiology would adopt such a position. I certainly would have no problem with a position statement that strongly encourages vaccination, but to recommend that HCWs be fired for noncompliance with vaccination is over the top and undermines SHEA’s credibility. The level of compliance with any intervention to improve the quality or safety of patient care must be correlated to the strength of the evidence, and in this case, the evidence for a mandate is lacking.

As I was looking at the Cochrane reviews, I wondered aloud how the SHEA guideline writers could have come to their conclusion. My good friend and colleague, Gonzalo Bearman, quickly responded, “they were blinded by dogma.” Amen, Gonzalo!

SHEA endorses mandatory flu vaccine for healthcare workers

Here is the position paper, and here is SHEA’s press release. We have blogged on this issue often, so you can read some of these posts here, here, here, here, here, here and here. More can be had by linking to related topics in our “labels” section to the right.

One of my posts makes reference to the conflict of interest issue. I know it is complicated. But in an ideal world, “official” position papers such as this would be written by those who have no financial ties to vaccine makers. This is not meant to sound snarky or holier-than-thou (I have my own industry ties, related to research funding). I also know that this means many future position papers and guidelines will be written by professionals who have a lower profile, since almost all opinion leaders have some conflicts in their area(s) of expertise.

I will make no further comment, though perhaps others who read this blog regularly (including one or more of the authors of the position paper) wish to comment!

CDC's recommendations for flu vaccine

CDC has just released its annual recommendations for influenza vaccination for the upcoming flu season. You can view the document here. There are very few new recommendations. The biggest change is that vaccination is now recommended for all persons 6 months of age and older. The publication notes the availability of high dose vaccine for persons 65 years and over but offers no recommendations regarding its use.

Opting-in vs. opting out

In this week's JAMA, there's a research letter evaluating two strategies for achieving healthcare worker compliance with influenza vaccination. HCWs (n=480) were randomized to an "opt-in" group or an "opt-out" group. In the opt-in strategy the HCWs received an email with a link to a website where they could schedule their vaccinations. In the opt-out strategy, the HCWs  were sent an email with a scheduled appointment for vaccination. Compliance with vaccination was 33% in the opt-in group versus 45% in the opt-out group (P=.008). The authors conclude that automatic scheduling of vaccination may be an effective method for increasing compliance with influenza vaccination. While that may be true, what is striking to me is the abysmal compliance rates in both groups. We are aware of hospitals that are achieving >90% compliance without mandating vaccination, but by actively promoting vaccination and providing incentives. At my hospital, we recently decided that for the upcoming season we would not mandate vaccination, but more aggressively promote vaccination, make vaccination even more convenient, and aggressively promote the message that ill healthcare workers should stay at home. Like handwashing, keeping ill HCWs at home is a multipotent intervention that will not only reduce the potential for spread of influenza but for other respiratory pathogens as well.

Healthcare worker vaccination programs: what works?

There is a new study out in ICHE by Tom Talbot and colleagues that looked at which factors of an influenza vaccination program were associated with a higher proportion of healthcare workers being vaccinated for seasonal influenza. The survey was completed during June 2008 and looked at programs in place during the 2007-2008 influenza season at 50 hospitals within the 78-hospital University HeathSystem Consortium (UHC) Benchmarking Program. The proportion vaccinated was the same whether or not hospitals required a signed declination from refusers. Factors association with higher compliance were weekend provision of vaccine, train-the trainer programs, report of vaccination rates to administrators or to the board of trustees, a letter sent to employees emphasizing the importance of vaccination, and any form of visible leadership support. Sadly, the median compliance was 55% and ranged from 26% to 81%. Perhaps I should have titled my post, "what didn't work" because it's hard to say anything really worked with compliance this low.