Pushing the Needle on Influenza Vaccination

Despite continued debates about the use of influenza vaccination mandates in healthcare settings (see prior discussions just on this blog here, here, here, here, and here), facilities continue to move toward implementing some form of ‘mandatory’ program to ensure sustained high levels of influenza vaccination coverage among their staff.  A new article published in JAMA Network Open documents this increase with an update to a multi-year survey project asking about facility infection prevention practices.  I use the word ‘mandatory’ in quotes above on purpose because, as I detailed in an accompanying editorial, the definition of a mandate, when it comes to vaccination policy, is not standardized.

“…Most importantly, it does not appear that mandate was defined. Among respondents who reported having a vaccination mandate, only 74% reported having penalties for noncompliance and 13% allowed declination without a specified reason. Of those reporting no mandate, 21% reported penalties for noncompliance with hospital policy on influenza vaccination and 41% reported requirements for wearing masks if unvaccinated. An article in a bioethics journal⁵ offers the following criteria for using the term mandate in this setting: limiting acceptable reasons for refusal, penalizing nonparticipation, and enforcing these expectations. By these criteria, it is not clear how many programs described in this survey should appropriately be referred to as mandatory—the number may be higher or lower than that reported, although an increase over time seems likely.”

The authors of the survey article also note that the VA is moving to a mandatory vaccine or mask policy this year, which will again increase the number of facilities using some type of mandate.  Hopefully, the VHA will take advantage of their more comprehensive healthcare delivery system to evaluate the impact of the program on both inpatient AND outpatient influenza among their patients, something that has been a persistent gap in prior reports.

ALSO, did you appreciate how easy it was to click the link and access the whole article?  Note that the article and the accompanying editorial are in JAMA Network Open, a new, fully open access journal “in which all content is made freely available to all readers immediately on publication. ….[they] will publish online only, every Friday.” Read more here.

How much more stupid can it get?

Forbes.com recently reported on a psychologist at an academic medical center in New York who was fired because she didn't receive the influenza vaccine this year. Followers of this blog know how I feel about mandatory flu vaccine policies, which are not grounded in high-level evidence. But this case is worse. Much worse. The psychologist is unpaid, occasionally gives lectures, but doesn't see patients. The hospital epidemiologist defended the termination decision on the basis that the psychologist may expose other healthcare workers in the medical library. Wow! All of us come into contact with unvaccinated humans on a daily basis, and many of those contacts are likely more intense than those that occur in a library. What's next? Firing healthcare workers who have unvaccinated family members at home? Where does this end? This is what happens when you enact a misguided policy. One stupid decision just leads to the next more stupid decision. Fortunately for the poor psychologist, a more enlightened medical school offered her library privileges.

When a dead horse is your only horse...

I’d like to thank Tom Talbot and Hilary Babcock, two of the authors of SHEA’s position paper on mandatory influenza vaccination of healthcare workers, for their response to my recent post on why I think this policy is misguided. Hilary and Tom are excellent hospital epidemiologists that I respect. Nonetheless, on this issue, I remain unconvinced by their arguments.

They point out that that I mischaracterized SHEA’s position being based on four nursing home cluster randomized trials, when in fact the position paper has 63 references. There are, indeed, 63 references, the majority of which do not address the impact of vaccinating healthcare workers on patients. In fact, most of the references lay out the biologic plausibility that vaccinating healthcare workers should have an impact on patients, as well as other issues, such as the impact of mandatory programs on vaccine rates. The biologic plausibility arugment is very nicely laid out in their blog post, and I agree with it completely. So, I’ll be more precise: SHEA’s best evidence for their policy is contained in the four cRCTs.

Tom and Hilary go on to cite newer studies that they believe support SHEA’s position, one of which is a cluster randomized trial from the Netherlands. I was not familiar with this paper so I reviewed it. In this trial, 6 hospitals were randomized—3 had an intervention to increase vaccination rates in HCWs and 3 did not. Significantly higher vaccination rates were demonstrated in the intervention hospitals. The patient outcomes were divided into adult and pediatric patients and the outcomes reported for patients were influenza and/or pneumonia and pneumonia. Influenza was not an outcome. Thus, the influenza rates cannot be determined. If the two outcomes are mutually exclusive, then the influenza rate is actually higher in the intervention hospitals (though not likely significantly so). For children, there was no difference between the intervention and control hospitals. And interestingly, the intervention hospitals had significantly higher HCW absenteeism rates, a metric Hilary and Tom argue as important for demonstrating the effect of employee vaccination. Thus, I don’t think this paper in any way supports mandatory vaccination.

Despite the studies published in the seven years since the SHEA position paper was published, there remains an irrefutable fact: there is no high level evidence demonstrating that vaccinating healthcare workers reduces influenza in hospitalized patients. I agree with Hilary and Tom that the four nursing home studies are a dead horse. Unfortunately, however, that dead horse is their only horse.

Everyone has opinions about infection prevention interventions biased by their own experiences and perceptions, and I’m glad that Tom and Hilary pointed out one of mine—bare below the elbows. As I write this post while on service, I’m, you guessed it, bare below the elbows! There’s clearly biologic plausibility that clothing can transmit pathogens to patients, but there is no evidence that following a bare below the elbows approach to patient care lowers infection rates, and in every talk I give on this topic I make that very clear. I would never argue that HCWs wearing white coats should be fired; otherwise, Tom and Hilary would have to be fired (based on their photos). And unfortunately, they missed the entire point of my post. I’m not arguing against vaccination of HCWs. My point is that you can’t mandate an intervention (and in this case threaten a person’s livelihood) when the intervention is not supported by high level evidence. In other words, you can’t mandate on opinion, but that’s exactly what SHEA did. Expectations for compliance with an intervention must be correlated with the strength of the evidence. 

SHEA made a huge mistake when they published this position. And seven years later, there’s still no published evidence that can bail it out. It was wrong seven years ago, and it’s still wrong. Healthcare workers in the US deserve better, especially from a professional society that prides itself on using science to guide practice.

Reporting bias: Missing the point of HCP influenza vaccine mandates

We invited our good friends Hilary Babcock and Tom Talbot, distinguished epidemiologists and co-authors on the SHEA statement regarding mandatory influenza vaccination of healthcare personnel (HCP), to respond to our previous posts on this topic.  Thanks, Tom and Hilary!

Disclaimer: This commentary solely represents the opinions of the authors and does not represent an official statement from SHEA

Nothing seems to ignite the fires of the Controversies blog like a few key infection prevention topics: CAUTI as an HAI metric, bare below the elbows, and the topic of a recent blog post, mandatory HCP influenza vaccination and the SHEA 2010 Position Paper. As authors on the 2005 and 2010 SHEA papers, we provide a different perspective on the issue.

A key misconception of opponents of mandatory influenza vaccination programs is the claim that the 4 cluster RCTs referenced in the recent post are the only evidence underpinning the position of SHEA (and the numerous other professional societies also endorsing such policies). The 2005 SHEA paper has 100 references while the 2010 paper has 63, a majority of which are peer-reviewed publications in the medical literature. The 4 RCTs noted are far from the only “papers on which SHEA based its recommendation,” as Dr. Edmond states and the De Serres paper implies.

These studies are not perfect by a long shot and the challenges of accurately studying the impact of HCP vaccination on patient outcomes have been nicely highlighted in analyses of these trials, of which there are several – the De Serres paper highlighted in the blog, a CDC analysis that came to different conclusions (and surprisingly was never featured as a blog post), and three separate Cochrane analyses (are there not enough topics out there for them to review??). We also encourage readers to closely review the detailed editorial that accompanied the De Serres paper for an excellent response to the many assumptions in their analysis. If only other infection prevention proposals were scrutinized as heavily as these 4 studies (cough, cough, we’re looking at you bare below the elbows . . . ). Of note, the limitations of these 4 trials were noted in the 2010 SHEA paper, which also cites the first Cochrane analysis in that discussion (despite claims to the counter).

What is missed in the arguments against mandatory programs (including the recent blog post) is the biologic rationale and additional supporting evidence for this strategy as part of a comprehensive infection prevention program. We refer readers to the 2005 and 2010 papers for more detail but summarize briefly here:

1. HCP (like our patients) can become infected with influenza.
2. Persons infected with influenza may not present with classical ILI symptoms. This is often missed in criticisms of vaccine effectiveness. Babcock et al demonstrated how poorly the ILI definition captures hospitalized adults with laboratory-confirmed influenza. Thus studies that look just at vaccine impact on ILI will likely miss true influenza outcomes, while also capturing infections due to other viruses not covered by influenza vaccination. Since clinical testing is usually prompted by stereotypical ILI symptoms, lab-confirmed influenza outcomes are also likely under captured. In addition, since hospital length of stay is shorter and most facilities do not have post-discharge surveillance for influenza, the impact in acute care facilities is more challenging to assess than in long term care settings. 
3. Persons infected with influenza can shed virus even with minimal or no symptoms. While not to the same degree as a coughing, febrile person, the role of asymptomatic infection has been noted in numerous studies of households and experimental challenges. A 6-year study from Hong Kong of a cohort of 824 households with an identified 224 cases of secondary influenza infection examined the relationship between symptoms and viral shedding (as detected on nasal and throat swabs). Shedding was detected before onset of respiratory symptoms in influenza A-infected persons but peaked on the first 2 days of clinical illness, while influenza B shedding peaked up to 2 days prior to symptom onset. So relying on HCP to stay home when ill (which they don’t anyway, see below) will not protect patients. 
4. HCP work while ill. Sadly, this is a huge issue, as nicely noted in several posts on this blog. Studies consistently note ~75% of HCP with febrile ILI admit to working while ill, a startling yet unsurprising fact that does not capture those with atypical, mild, or even asymptomatic infection. We completely agree that this is a major infection prevention issue. The SHEA 2010 paper notes the importance of “restriction of ill HCP from working in the facility” as part of a “comprehensive infection control program” to prevent healthcare-associated influenza (and other respiratory infections). We definitely support a stronger stance on the infection risk of HCP working while ill and the various disincentives for staying at home (e.g. leave policies where sick days and vacations days are in one lump “bucket”). Perhaps we need a new chapter of the Compendium focused on the prevention of healthcare-associated respiratory infections?
5. HCP have contact with patients at higher risk for complications from influenza than the general public. The privilege of that close relationship carries an obligation to do all we can to protect those patients. 
6. Many patients won’t be adequately protected by receiving the vaccine themselves. Proponents of mandatory vaccination frequently note the moderate effectiveness of the vaccine, and we completely agree on the need for a better vaccine. The suboptimal effectiveness only emphasizes the need to optimize immunity among those who are more likely to respond in order to prevent transmission of influenza in healthcare settings (to protect the “herd”). Most HCP are healthy and therefore more likely to have a robust immune response to vaccine than already ill patients, many of whom are elderly and/or immunosuppressed. 
7. Most agree that HCP should be vaccinated against influenza, though they may disagree with a ‘mandate.’ Extensive literature now demonstrates that a mandate is the most effective way to increase HCP vaccination rates. If it is an outcome (HCP influenza vaccination) that we all support, should we not encourage its use through the most effective method for high vaccination rates? 

Fortunately, as more institutions have employed a mandatory program, new evidence that further supports the need for HCP immunization that was not available when we wrote the 2010 paper has emerged:

• Researchers at the Denver Health Medical Center reported a decrease in employee absences during the influenza season following implementation of their mandatory program when compared to prior seasons of similar influenza activity. 
• In an analysis of the province-wide vaccination with masking policy in British Columbia, researchers noted a significantly reduced rate of HCP absenteeism due to all-cause illness in vaccinated vs. unvaccinated HCP during the first season of the policy. 

Even more important than the impact on HCP illness is the impact on patient outcomes:

• MD Anderson Cancer Center implemented a mandatory vaccine with masking policy and examined the impact of increasing HCP influenza immunization over the course of 8 years. The proportion of influenza infections that were healthcare-associated among patients significantly decreased and was significantly associated with increased HCP vaccination rates. 
• A cluster randomized trial in the Netherlands of HCP at six medical centers, where the intervention arms offered vaccination to HCP vs. no vaccination at control facilities, noted a significantly lower rate of healthcare-associated influenza among internal medicine patients at the facilities with the higher rates of HCP influenza vaccination (3.9% vs. 9.7% of patients). 
• In a study encompassing 7 influenza seasons and over 62,000 hospitalized patients, a significant association was noted between increasing influenza vaccine coverage among HCP and decreasing healthcare-associated ILI among patients at an Italian acute care hospital.
• Finally, a nested case-control study in France noted a significant association between lower rates of laboratory-confirmed healthcare-associated influenza among patients and higher vaccination rates among HCP.

We don’t have time to go into the ethical arguments for HCP vaccination or the need to broaden these programs to include all recommended immunizations for HCP, but we close with a noteworthy pronouncement made by the Board of the National Patient Safety Foundation’s Lucian Leape Institute: there are two “must do’s” for HCP to ensure patient safety, hand washing and HCP influenza vaccination. 

Time to stop re-analyzing those 4 poor cluster RCTs – that horse has been beaten to death.

It's time to finally fix this

In 2010, the Society for Healthcare Epidemiology (SHEA) published a position paper that stated that annual influenza vaccination of healthcare workers should be a condition of employment on the basis of four studies performed in nursing homes. In other words, SHEA advised hospitals to fire HCWs who refused to get a flu shot. Other professional societies jumped on this insane bandwagon, and CMS made vaccine compliance rates publicly reportable and a metric in their hospital Star Rating program.

From the beginning, I have argued on this blog that SHEA's position was misguided for a number of reasons that I won't rehash in this post (see here, here, and here). Moreover, the Cochrane group evaluated the same four papers on which SHEA based its recommendation and determined there was no conclusive evidence that vaccinating HCWs was effective in reducing influenza in patients. But SHEA didn't back down. Another systematic review by another group came to the same conclusion. But SHEA didn't back down. CDC significantly downgraded the effectiveness of influenza vaccination to worse than placebo in some years. But SHEA didn't back down. And there's even a lack of evidence that influenza vaccine of healthcare workers reduces influenza in healthcare workers.

Now comes a 21-page paper (free full text here) in PLoS One by a group of Canadian epidemiologists that decimates those four nursing home studies. And all I can say is: SHEA better back down.

According to these investigators, all four studies violate the principle of dilution by reporting greater percentage reductions with less specific outcomes (i.e., the studies report percentage reductions in all-cause mortality > influenza-like illness (ILI) > laboratory-confirmed influenza). The principle of dilution requires that vaccine efficacy must be lower when non-targeted events (non-flu illnesses) are included in the study outcome than when only the target (confirmed influenza) contributes. The authors give the simple analogy of using an item-specific coupon at the grocery store--the percentage reduction in price on that item will always be much greater than the percentage reduction on your entire purchase that includes multiple other items. It's an irrefutable law of mathematics.

They also note several sources of bias. Depending on the study, there were differences in mortality between the control and intervention groups accrued before influenza arrived in the community, and there were issues with the definition of ILI. Estimates of numbers need to vaccinate were so flawed (off by as much as 4,000-fold) that if extrapolated to all healthcare workers in the US, more deaths would be averted than occurred in the 1918 influenza pandemic.

Here's the bottom line per the authors: Each of the four cluster RCTs used to champion compulsory HCW influenza vaccination policies reports benefits that are mathematically impossible under any reasonable hypothesis of indirect vaccine effect. It's hard to imagine a stronger conclusion.

If you don't read the entire paper, please read the discussion. Here's the concluding paragraph:

Through this detailed critique and quantification of the evidence we conclude that policies of enforced influenza vaccination of HCWs to reduce patient risk lack a sound empirical basis. In that context, an intuitive sense that there may be some evidence in support of some patient benefit is insufficient scientific basis to ethically override individual HCW rights. While HCWs have an ethical and professional duty not to place their patients at increased risk, so also have advocates for compulsory vaccination a duty to ensure that the evidence they cite is valid and reliable, particularly in the absence of good scientific estimates of patient impact. The diversion of resources from more evidence-based efforts and other important but less tangible costs related to loss of trust and credibility also need to be considered, including the implications for other immunization programs and workplace policies. Although current data are inadequate to support enforced HCW influenza vaccination, they do not refute approaches to support voluntary vaccination or other more broadly protective practices such as staying home or masking when acutely ill.

And if that's not enough, there's a commentary in the same journal, responding to the Canadian study written by the lead author of one of the nursing home studies. He defends his study, but importantly he states that the findings should not be extrapolated beyond the nursing home setting.

As I see it, unless SHEA cites alternative facts, it has three choices: change its position to recommending (not mandating) annual influenza vaccine for healthcare workers, articulate a damn good reason to support its current policy despite the evidence (hard to imagine what that would be), or simply retire the guideline (as it has quietly done for the 2003 highly controversial MRSA/VRE search and destroy recommendation). Given the assault on science that we are likely to see over the next four years in the US, SHEA must lead by ensuring that all of its recommendations are solidly based in evidence and that expectations for compliance with interventions correlate with the strength of the evidence. Just as we must defend vaccines from false claims of adverse effects, we must also truthfully acknowledge their limitations and shape our policy on science not opinion.

The almighty influenza vaccine

A recent study in Clinical Infectious Disease that analyzed the effectiveness of the influenza vaccine for the 2014-15 season was sent to me by a colleague. Wow. Overall effectiveness (for influenza A and B combined) was a whopping 19%, but for influenza A was 6%. Honestly, placebo is more effective than that. For the 2015-16 season, overall effectiveness was 47%, and 55% for influenza A.

CDC used to cite that the flu vaccine was 70-90% effective, but more recently they have revised that significantly. I was quite surprised when I looked at the CDC website today and I made the graph below from their data.

In 12 consecutive flu seasons, effectiveness hit 60% just once. If you average those 12 seasons, the effectiveness was 41%. We are sorely in need of a better vaccine. The CDC analysis begs many questions: Should hospitals make this weakly effective vaccine a condition of employment? Should SHEA take another look at its guideline? Does anyone still believe that we should fire healthcare workers that are not vaccinated with a vaccine that provides such poor protection? How many hospitals fire employees who come to work sick with influenza? Would you rather be hospitalized at a hospital with a mandatory flu vaccine policy or a hospital that makes a serious attempt to minimize presenteeism?

You better not cough!

I have to thank Eli for rekindling my interest in the mandatory influenza vaccination controversy. I had resigned myself to it being water under the bridge and had not thought much about it until the last week. What I didn't realize is that another Cochrane review was published last year on influenza vaccination of healthy adults. This is very useful to our discussion since most healthcare workers fall into the category of healthy adults. A free full-text version of the review can be found here. This review examined 69 clinical trials involving 70,000 participants, 27 cohort studies with 8 million subjects, and 20 case control studies with 25,000 participants. The bottom line is that the parenteral vaccine was 60% efficacious in preventing influenza, which didn't seem surprising to me. However, the absolute difference in influenza infections between the vaccinated and unvaccinated groups was only 1.3%. That knocked my socks off! All of the energy and resources consumed and ill will created in trying to increase vaccination rates in healthcare workers, including firing people, for a vaccine that reduces infection by 1% is about as stupid as it gets. Merry Christmas!

Photo: NBC News

Mandatory Influenza Vaccination for Healthcare Workers: Agreeing to Agree

This is a guest post from Sanjay Saint, MD, MPH, the George Dock Professor of Internal Medicine at the University of Michigan, the Director of the VA/University of Michigan Patient Safety Enhancement Program and the Chief of Medicine at the Ann Arbor VA Medical Center.

----

I begin by thanking my friend and colleague, Dr. Eli Perencevich, for allowing me use of “Controversies in Hospital Infection Prevention” for my first blog post. 

Our recent editorial in The Wall Street Journal on mandatory flu vaccination for healthcare workers elicited strong opinions, especially on social media. The impetus for our editorial was a recent paper published in Infection Control and Hospital Epidemiology in which we found through a national survey of lead infection preventionists that 42.7% of nonfederal hospitals had a policy mandating flu vaccinations for healthcare workers while only 1.3% of VA hospitals did.

In his 22 December 2015 blog post, Eli clarified his position by writing that he is “in favor of mandating influenza vaccination of healthcare workers (for now)”. I am in agreement. While the data supporting mandatory healthcare worker flu vaccination is perhaps not as robust as researchers would like – when is it? – in my opinion, it is compelling enough to move forward unless new data emerge that reveal the mandate to be unnecessary or ineffective.

What are the most compelling studies supporting mandatory vaccinations?

The first is a systematic review from Faruque Ahmed, PhD -- a senior scientist in the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) – and four other CDC researchers.  I paste below the Results and Conclusions from their abstract:

Results. We identified 4 cluster randomized trials and 4 observational studies conducted in long-term care or hospital settings. Pooled risk ratios across trials for all-cause mortality and influenza-like illness were 0.71 (95% confidence interval [CI], .59–.85) and 0.58 (95% CI, .46–.73), respectively; pooled estimates for all-cause hospitalization and laboratory-confirmed influenza were not statistically significant. The cohort and case-control studies indicated significant protective associations for influenza-like illness and laboratory-confirmed influenza. No studies reported harms to patients. Using GRADE, the quality of the evidence for the effect of HCP vaccination on mortality and influenza cases in patients was moderate and low, respectively. The evidence quality for the effect of HCP vaccination on patient hospitalization was low. The overall evidence quality was moderate.

Conclusions. The quality of evidence is higher for mortality than for other outcomes. HCP influenza vaccination can enhance patient safety.

How could influenza vaccination affect all-cause mortality? I am not sure but previous studies have found influenza vaccination reduces cardiovascular events and venous thromboembolism.  How vaccination may affect these outcomes is not known - but it isn't irrational to also include all-cause mortality as an outcome given the myriad benefits of influenza vaccination.

The second study (not included in the aforementioned systematic review, but mentioned in the postscript), is a cluster randomized trial of hospitalized patients in the Netherlands published in June 2013. I paste the abstract below:

Nosocomial influenza is a large burden in hospitals. Despite recommendations from the World Health Organization to vaccinate healthcare workers against influenza, vaccine uptake remains low in most European countries. We performed a pragmatic cluster randomised controlled trial in order to assess the effects of implementing a multi-faceted influenza immunisation programme on vaccine coverage in hospital healthcare workers (HCWs) and on in-patient morbidity. We included hospital HCWs of three intervention and three control University Medical Centers (UMCs), and 3,367 patients. An implementation programme was offered to the intervention UMCs to assess the effects on both vaccine uptake among hospital staff and patient morbidity. In 2009/10, the coverage of seasonal, the first and second dose of pandemic influenza vaccine as well as seasonal vaccine in 2010/11 was higher in intervention UMCs than control UMCs; all p<0 .05="" span=""> At the internal medicine departments of the intervention group with higher vaccine coverage compared to the control group, nosocomial influenza and/or pneumonia was recorded in 3.9% and 9.7% of patients of intervention and control UMCs, respectively (p=0.015). Though potential bias could not be completely ruled out, an increase in vaccine coverage was associated with decreased patient in-hospital morbidity from influenza and/or pneumonia.

A third study (from another group in the Netherlands) used decision-analytic modeling to estimate the effects of healthcare worker influenza vaccination in the hospital setting.  The abstract is below:

Nowadays health care worker (HCW) vaccination is widely recommended. Although the benefits of this strategy have been demonstrated in long-term care settings, no studies have been performed in regular hospital departments. We adapt a previously developed model of influenza transmission in a long-term care nursing home department to study the effects of HCW vaccination in hospital wards. We study both the effectiveness and efficiency in reducing the hazard rates of influenza virus infection for patients. Most scenarios under study show a similar or higher impact of hospital HCW vaccination than has been predicted for the long-term care nursing home department. Therefore, it seems justified to extend the recommendations for HCW vaccination, based on results in the long-term care setting, to short-term care settings as well.

Eli recently wrote: “There is no data supporting the benefits of healthcare worker vaccination in acute care hospital settings…We are basing acute-care hospital policy on one observational study.” I would thus modify this by stating we are basing acute-care hospital policy on a cluster randomized trial done in a hospital setting, an observational study performed in a hospital setting, a decision analytic model explicitly focusing on an acute-care setting, and 4 randomized studies from long-term care settings as part of a well-done systematic review.

While the opinion of professional societies is not always correct, I am impressed by the strong support in the scientific community for mandatory influenza vaccination for healthcare workers.  The list of societies that support mandatory influenza vaccination for healthcare personnel includes: American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Hospital Association, American Public Health Association, Association for Professionals in Infection Control and Epidemiology, Infectious Diseases Society of America, National Patient Safety Foundation, and Society for Healthcare Epidemiology for America.

Finally, is mandating flu vaccination for healthcare workers ethical? For guidance I turn to Arthur L. Caplan, PhD, one of the country’s foremost medical ethicists and whose opinion about white coats was highlighted on this blog. Writing in 2013, Professor Caplan states:

“The moral case for limiting health care workers' choice concerning influenza vaccination rests on 4 principles: the professional duty to put patients' interests first, the obligation to do no harm, the requirement to protect those who cannot protect themselves, and the obligation to set a good example for the public. It is hard to see how the invocation of personal liberty claimed by some health care workers who oppose mandates could overcome this powerful “four-legged” moral case in support of an influenza vaccination mandate…Mandating vaccination is consistent with professional ethics; benefits many, some of whom must rely on health care workers to protect them; and sets an example that permits honest engagement with the public in educating them to do the right thing about all recommended vaccines.”

Festivus Grievances: Are Mandatory Influenza Vaccination Policies and Banning White Coat Ceremonies Ethically Equivalent?

"Welcome, new comers. The tradition of Festivus begins with the airing of grievances. I got a lot of problems with you people! And now you're gonna hear about it!"  - Frank Costanza

BB8 is for BBE

(Warning: Mild Star Wars spoiler at the end, although I surveyed folks here and no one complained)

Outside my recent posts on influenza vaccine mandates, I have very few infection control grievances to air this year. To start, 2015 saw the return of original science to the annual SHEA spring meeting, a tradition that will continue in the May 2016 meeting chaired by Silvia Munoz-Price and Tom Talbot. And the year ended with NIH planning to spend $461 million in FY 2016 on antimicrobial resistance research, an increase of $100 million over FY 2015. On a personal note, University of Iowa was selected as one of CDC's new Prevention Epicenters. Our team is honored and excited to join the other 5 new centers for the kick-off meeting this January. Thus, things are truly looking up in our fight against antimicrobial resistant bacteria. If we can convince congress, NIH and CDC to continue to gradually increase research funding over the next decade, we should have many things to celebrate in 2025. That is, if we can fix the ID fellowship match and the reimbursement issues that have plagued us the past 10+ years.

...but back to influenza vaccine mandates. Several folks have wondered how we bloggers could support banning white coats and at the same time question influenza vaccine mandates, especially since both interventions have similar levels of evidence (i.e. biological plausibility, math models, observational data, limited RCT data). This is an interesting question. Just to clarify, Mike is against compulsory influenza vaccine policies and I grudgingly support them and neither of us wants to ban white coats - we favor voluntary policies that make it OK not to wear a white coat - which is exactly what Mike instituted at VCU and plans here at Iowa, starting in 2016.

Yet ignoring our policy stances, the assertion that bare below elbow policies are somehow equivalent to vaccine mandates from an ethical standpoint is incorrect. Let's consider the current situation in the US with white coat ceremonies and the pressure that medical students, housestaff and faculty are under to wear white coats. If white coats are harmful (and many would agree that it is equally likely that white coats harm patients as influenza vaccines protects patients), then the current situation would be the ethical equivalent of forcing healthcare workers to not get vaccine.

That is, white coat ceremonies force healthcare workers to cause harm to their patients, which is not morally or ethically the same as requesting healthcare workers to help protect themselves and their patients by receiving an influenza shot. In a Star Wars context, forcing FN-2187 to murder villagers on Jakku (wearing white coats) is not ethically equivalent to requesting that Finn defend the people of Takodana from a First Order attack (influenza vaccine). 

Forcing healthcare workers to wear white coats that they deem to be harmful is wrong. We need to eliminate white coat ceremonies and stop coercing healthcare workers into wearing white coats.

Clarification: I'm in favor of mandating influenza vaccination of healthcare workers (for now)

There's been some misunderstanding of the motivation behind my recent posts offering suggestions for improving the implementation of compulsory influenza vaccination policies and acknowledging the limitations of the existing data supporting vaccine mandates. Most of the snark was on twitter where folks challenged my commitment to infection prevention and my interpretation of the data. If I can dish it, I better be able to take it. With that being said, however, I still feel a need to clarify my support for mandatory influenza vaccination policies in both acute care and long-term care settings. But...

1) I will only support such policies for 4-5 years. If those that push these policies can't come up with better clinical trial data during that time, I'm going to call BS. There is simply no excuse for stretching the existing data to drive change now and not validating your claims. Recommend the mandate, but then do the proper studies.

2) CDC and others must fund studies evaluating the benefits of mandatory vaccine policies in acute care settings. There is never going to be a better time than now, when hospitals are implementing mandatory vaccination programs, to fund the necessary cluster-randomized and quasi-experimental studies. Wouldn't it be great if we could find 50 or more hospitals planning to implement an influenza vaccine mandate and then fund a mixed-methods, stepped-wedge cluster randomized trial as those hospitals implemented the policy over the next 3-4 years? I think it can happen and SHEA, IDSA, PIDS and APIC need to demand such a study.

3) As Sara Cosgrove and I wrote in the 2007 SHEA Business-Case Guideline: "Most hospital epidemiologists or infection control specialists want to increase the resources available for infection control activities, but it is important to avoid overestimating benefits or underestimating staff and time costs. Overestimation in an initial analysis may improve the situation in the short term, but it will hinder efforts and necessary trust in the long term after actual resource audits are performed." There's simply no excuse for hand waiving and over promising the benefits of healthcare worker influenza vaccination. It erodes trust and prevents the necessary validation studies from being funded. Please take the long view and don't be afraid to challenge dogma.

Happy holidays!

Influenza Vaccine Mandate Math

Last week, I described five steps individual hospitals, systems and society should take when implementing compulsory influenza vaccination of healthcare workers. One component of many influenza vaccine policies is mandatory surgical masks for healthcare workers who refuse or otherwise cannot receive the vaccine. Does masking unvaccinated healthcare workers even make sense? Or rather, who is more likely to spread influenza in hospitals - an unmasked, vaccinated healthcare worker or an unvaccinated, masked healthcare worker? Let's look at the numbers.

Let's assume influenza vaccine is 50% effective. In 2014-15, overall effectiveness was 19% while in 2012-13 and 2013-14 it was 49% and 51%, respectively. I'll give the vaccine a mulligan last year since during the prior decade, vaccines were far more effective. Let's further assume with vaccine mandates, 90% of healthcare workers receive the vaccine and 10% do not.

If 90% receive a vaccine that is 50% effective, we will have 45% of healthcare workers in our hospital protected and 45% unprotected. The tricky thing is that we won't know who is protected or unprotected. And what if the 45% vaccinated but non-immune healthcare workers assume they are immune and work while sick? You can imagine them saying - "I'm sick, but it's not influenza because I was vaccinated, so I'll do my ICU shift." Any mandatory vaccination policy should consider that scenario or it's possible that the mandate could make hospitals less safe. But what of the 10% required to wear masks? I suspect they'd be more likely to stay home if sick, but even if they don't they'll be wearing a mask!

Finally, if I had a choice between being cared for by a vaccinated, unmasked healthcare worker or a masked, unvaccinated healthcare worker, I'd chose the mask. That is, until we implement influenza prevention bundles that focus on presenteeism.

Note: Mike wrote a fantastic quantitative post (in 2010!!) comparing a vaccine mandate to a presenteeism reduction policy. His conclusion: "Reducing presenteeism by 1 percentage point (from 70% to 69%) would have the same impact as increasing vaccination from 70% to 98%." It's too bad not many read the blog back in 2010...

Pronovost weighs in on the white coat

Peter Pronovost, arguably the nation's leading expert in patient safety, gave us his thoughts on the white coat debate yesterday on The Armstrong Institute's blog Voices for Safer Care. His conclusion: there's enough evidence to ditch the white coat.

Here is the core of his argument (in his words):

We could voluntarily ditch the white coats without needing a clinical trial to tell us it’s OK. We know that white coats can carry pathogens, and it is logical to think that germs could be transmitted from physician to patient. Given that confirming this theory could be prohibitively expensive, we can look at the implications of acting and not acting. While the risks of maintaining the white coat tradition are clear — potentially more infections and preventable deaths — the risks of removing this potent symbol of professionalism would be less significant, though certainly real for some clinicians. How would patients react? Studies disagree on whether they prefer the white coats — some may find them reassuring, but others may see them as elitist. 

Some experts may argue that we should instead focus on proven infection control practices, such as hand hygiene. Yet it's hard to see how voluntarily giving up your white coat would distract from that. It may even raise awareness in general about the importance of hand hygiene once clinicians consider the pervasiveness of germs on their attire, stethoscopes and keyboards. The risks of doing nothing seem much greater than of making the change.

As we have said for several years, mandates should be reserved for interventions with the highest level of evidence to support them. Neither banning the white coat nor mandating flu vaccine for healthcare workers are backed by evidence at that level. But there's enough evidence to suggest that hanging up your white coat and getting a flu shot are probably the right things to do. And to get a flu shot you have to take your white coat off anyway. So do both and leave the coat behind!

Mandatory Influenza Vaccination of Healthcare Workers: The end or just the beginning?

"Just don't let the human factor fail to be a factor at all" - Andrew Bird, Tables and Chairs

We are all in favor of protecting patients from preventable harm. No question. With that aim, the intervention du jour (in the US) is mandatory influenza vaccination of healthcare workers. SHEA, IDSA and PIDS support such a policy, yet a recent Cochrane review stated "there is no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza or its complications (lower respiratory tract infection, hospitalization or death due to lower respiratory tract infection) in individuals aged 60 or over in LTCIs and thus no evidence to mandate compulsory vaccination of healthcare workers."

Yet given the inevitability of mandatory influenza vaccine policies in the US, what can we do to protect our patients from healthcare-acquired influenza and other viral illnesses since mandates would be expected to have minimal or even negative effects on nosocomial influenza transmission? To explain this further, compulsory vaccination policies are technical interventions which are relatively simple to implement. But we have seen over and over that ignoring the human equation or socio-adaptive factors behind infection prevention initiatives leads to failure. As Sanjay Saint and Sarah Krein have written eloquently in their recent book: "Our research has shown that the principle reason is the failure of the hospitals to win their staff's active support of the infection prevention initiatives. In their focus on the technical aspects of an initiative, these hospitals have give short shrift to the human aspects." (You can read my Doody review of their book at Barnes & Noble here)

What are the additional components that we need to consider when implementing an influenza vaccine mandate? Some suggestions:

1) First, acknowledge that we know the vaccine is imperfect through the develop of communication strategies that highlight the proven benefits of the influenza vaccine to the individual health care worker. Since the data supporting direct benefits to patients is more theoretical at this point, highlighting the protective effects for the individual receiving the vaccine - including reduced risks of cardiovascular outcomes could improve acceptance of the mandate.

2) Next, mandate additional components in our influenza prevention bundle, especially those highlighted in the Cochrane review which included "hand-washing, masks, early detection of influenza with nasal swabs, antivirals, quarantine, restricting visitors and asking healthcare workers with an influenza-like illness not to attend work."

3) Offer additional sick leave to healthcare workers required to receive the vaccine. Policies that include bans on presenteeism (working while sick), should be accompanied by additional paid sick leave. In this specific instance, influenza vaccine is associated with fever (especially high-dose vaccines that are associated with benefits in older adults). Providing additional sick leave shows our understanding of vaccine side-effects, demonstrates support for staying home sick and most importantly, respects the individual health care worker.

4) Include in the mandate bundle a plan to de-implement the vaccine mandate if future studies demonstrate that they're ineffective. Doing this will gain more trust with our healthcare workers, which may, counterintuitively, improve the effectiveness of the mandate.

5) Finally, fund large studies evaluating the efficacy, effectiveness and implementation (i.e. barriers) of influenza vaccine mandates in our health care systems. Funding research acknowledges that the data around vaccine mandates isn't perfect, but we are doing the best we can to protect patients now, while simultaneously validating the safety and efficacy of this policy to protect future generations of patients AND our healthcare workers.

There are many things we need to consider as we implement mandatory influenza vaccine policies. The mandate is just the beginning. We have a long road ahead before we can state convincingly that our hospitals are safe from hospital-acquired influenza.

"And how 

How I wish 

I, I had talked to them 

And I wish they fit into the plan"

-Andrew Bird, Tables and Chairs

Evidence, schmevidence! Occupational medicine edition

The LA Times reports today that another porn star has become infected with HIV. This brings the total of infections to three in the past year. Although porn workers are required to be HIV tested every 14 days, condoms are not mandated. The lack of mandate is unfortunate given that we have great evidence for the effectiveness of condoms in reducing HIV transmission.

Now let’s switch gears and talk about healthcare workers. Increasingly, hospitals are mandating influenza vaccination. A new paper in the latest issue of the American Journal of Preventive Medicine by investigators at Johns Hopkins describes a systematic review of the literature on mandatory influenza vaccination for healthcare workers. One key finding was that mandating influenza vaccination increased compliance (imagine that!). But (and it’s a very big but) there was either no demonstrated statistically significant reduction in sick leave after mandating vaccination or no evaluation was performed in the studies reviewed. Moreover, none of the studies evaluated the impact on patients. At the end of the day, we still have no evidence that vaccinating healthcare workers reduces influenza in hospitalized patients. That doesn’t mean vaccination is not a good idea. I would argue that bare below the elbows is a good idea, but I’m quick to acknowledge that we don’t have data that it reduces infections, and therefore I don't support a mandate.

So here we have two industries struggling with evidence: one won’t mandate a proven prophylactic strategy, and the other seems quite comfortable mandating a prophylactic strategy that isn't proven. The root cause in both cases appears to be the same—an attempt to please the customer. It’s a whole lot easier for hospitals to mandate flu vaccine and publicly pat themselves on the back and tout how they are serious about patient safety than to develop and enforce policies and practices that keep healthcare workers home when they are sick.

Photo: Francine Orr, Los Angeles Times

Here come the maskers

Recently, the New York State Health Department mandated that all healthcare workers either be vaccinated against influenza or wear a mask. This week’s JAMA has a commentary by the ethicist Art Caplan and New York’s Commissioner of Health, Dr. Nirav Shah. In the JAMA piece they argue the ethical imperative underlying the mask ruling. You can read about the ruling here and the JAMA commentary here (free full text). Unvaccinated HCWs will be required to wear the mask during periods of widespread influenza activity. It’s important to note that over the past 6 years, the period of widespread activity in New York varied from 11 to 22 weeks. That’s a long time to wear a mask, which is required in any area where patients are typically present. The document notes that this includes the cafeteria, though the unvaccinated worker is allowed to be mask-free when eating.

For many reasons, I dislike mandatory influenza vaccination. But I despise the mask regulation. I have to question the rationale. It seems to me to be less about ethics and more about being coercive and punitive. It’s wasteful. There have been periods of time when masks were in short supply with the shortage being made worse by the maskers. Most importantly, wearing a mask for prolonged periods of time is impractical—it’s uncomfortable and distracting. If we are going to argue for masking on an ethical basis, since influenza vaccination is only 60% effective at best, wouldn’t it be consistent to argue that all healthcare workers, vaccinated and unvaccinated, should wear a mask? It's also laughable that the ethicist doesn't mention that it's unethical to come to work while sick with influenza, which studies tell us is quite common. Presenteeism remains the elephant in the middle of the room, and reducing it is likely far more important than mandating influenza vaccine or masks to prevent transmission of infectious diseases in the healthcare setting.

Photo: REUTERS/Yuri Maltsev

Infection control rule #1: if you're sick, stay home.

A new study from the University of Pittsburgh Graduate School of Public Health uses epidemic modelling to determine the impact of reducing presenteeism on workplace transmission of influenza during a pandemic, such as the one we experienced with H1N1 in 2009.

The investigators compared the status quo (72% of employees with paid sick days stay home with flu, while 52% of those without sick days do not) to three other scenarios: (1) all employees have access to paid sick days, (2) all also have access to 1 flu day, or (3) all also have access to 2 flu days. The concept here is that employees are specifically paid to stay home when ill with influenza.

The findings:

• Universal paid sick days resulted in a 6% reduction in workplace transmission (applied to Allegheny County, PA [population 1.2 million] that is equivalent to nearly 4,000 fewer infections).
• Adding 1 flu day resulted in a 25% decrease in workplace transmission (15,000 infections averted)
• Adding 2 flu days resulted in a 39% decrease in workplace transmission (26,000 infections averted)

Bottom line:  Efforts to reduce presenteeism (a horizontal infection prevention strategy) can have significant impact. 

Implication:  If we're really serious about reducing infections transmitted to patients in hospitals from staff, we must start thinking about how to reduce presenteeism. And that's a lot harder than firing healthcare workers who refuse to take their flu shot. 

Photo:  Man by Virgil Cantini, 1965, bronze and steel sculpture on Parran Hall at the University of Pittsburgh Graduate School of Public Health.

The lunacy continues

It appears that an increasing number of hospitals are requiring healthcare workers that are not vaccinated against influenza to wear masks (see a recent example here). I have yet to see any evidence to support such a policy, and I'm not even sure of the purported intent (is it to prevent infection of the unvaccinated HCW, or is it to prevent the infected HCW from transmitting to patients?).

Whatever the intent, it seems completely impractical. Wearing a mask for 8-12 hours is uncomfortable and an unnecessary distraction. I suspect it also impacts morale. So none of this makes sense to me, but neither does mandatory influenza vaccination.

Last week, the Massachusetts Nurses Association characterized the mask policy as an act of bullying. That's a strong word, but after thinking this over, I admit that I have to agree. I don't think the mask requirement has been promulgated to reduce transmission of influenza; rather, I suspect it's to punish those who don't comply with vaccination. So here we have a mandate that doesn't make sense, aimed at those who don't comply with another mandate that doesn't make sense. And the lunacy continues....

Photo:  3M

Shocking: Another review of the evidence finds flu vaccine has no miracle powers

The Science section of the New York Times this week had an article on a new report regarding influenza vaccination. This report (free full text here) from the University of Minnesota is the kingdaddy of all analyses on influenza vaccination--a 3-year project funded by the Alfred P. Sloan Foundation that reviewed 12,000 papers back to 1936 and involved interviewing 88 influenza experts. The report is 123 pages without appendices and includes over 500 references. 

Here's my summary of the chapter on vaccine performance of the two major vaccines (trivalent inactivated influenza vaccine [TIV] and live attenuated influenza vaccine [LAIV]):

Population	TIV	LAIV
Children	Inconsistent evidence of protection	High level of protection (83%)
Healthy adults	Moderate protection (59%)	Lack of evidence of protection
Elderly	Paucity of evidence for protection	Inconsistent evidence of protection

What about use of the vaccine in healthcare workers? This can be found on pages 57-58 of the report and I have pasted below the important discussion of the HICPAC recommendation regarding offering influenza vaccine to healthcare workers):

The 2006 statement on influenza vaccination of healthcare personnel (HCP) from the Healthcare Infection Control Practices Advisory Committee (HICPAC) and ACIP illustrates potential concerns with using a grading scale.[63] This recommendation used the HICPAC grading scale, which is similar to the GRADE criteria in that it provides a structure for ranking the evidence. All recommendations were approved by the HICPAC and the ACIP. This document has been used widely as evidence to support HCP vaccination policies, including mandating vaccination. It offers six recommendations, and one was deemed to have the highest possible evidence, category IA. Category IA recommendations are “strongly supported by well-designed experimental, clinical, or epidemiological studies.”[63] The recommendation in the HICPAC document that received a category IA rating states:  “Offer influenza vaccine annually to all eligible HCP to protect staff, patients, and family members and to decrease HCP absenteeism. Use of either available vaccine (inactivated and live, attenuated influenza vaccine [LAIV]) is recommended for eligible persons. During periods when inactivated vaccine is in short supply, use of LAIV is especially encouraged when feasible for eligible HCP.”[63]

This recommendation is supported in part by this key summary statement in the HICPAC document: “Vaccination of HCP reduces transmission of influenza in healthcare settings, staff illness and absenteeism, and influenza-related morbidity and mortality among persons at increased risk for severe influenza illness.[64-67]” In the first study cited, the authors did
not find a statistically significant reduction in patient mortality associated with HCP vaccination, after adjusting for covariates.[64] In the second study, the authors concluded that “we do not have any direct evidence that the reductions in rates of patient mortality and influenza-like illness that were associated with HCW vaccination were due to prevention of influenza.”[65] In the third study, vaccination did not reduce the episodes of self-reported respiratory infection or the number of days ill with a respiratory infection, but it did reduce the time employees were 58 unable to work because of a respiratory infection.[66] In the fourth study, the authors reported reductions in absenteeism and illness among HCP that were not statistically significant.[67] The authors did, however, report serologically confirmed vaccine effectiveness of 88% for H3N2 and 89% for influenza B across three influenza seasons.[67] Since only two of the four studies cited provide some support for the HICPAC statement and the others no support, it is unclear how the quality of evidence in these studies received a category IA evidence grade. Another review conducted in the same time frame by the Cochrane Collaboration noted that the two RCTs cited in this recommendation were at “moderate risk of bias.”[68] They concluded that “both elderly people in institutions and the healthcare workers who care for them could be vaccinated for their own protection, but an incremental benefit of vaccinating healthcare workers for elderly people has yet to be proven in well-controlled clinical trials.”[68]

So this report questions the evidence base for even recommending influenza vaccination to healthcare workers. Yet, SHEA's position is so over-reaching that it calls for mandating vaccination and firing noncompliant healthcare workers. This is now the fourth independent analysis that does not support the SHEA position statement (read about the others here, here and here).

I continue to be fascinated by the post-modern disdain for evidence. A marvelous example from this week is the shock and utter disbelief suffered by Mitt Romney and his staff on learning that Barack Obama won the presidential election, despite nearly every poll indicating that Romney would lose. I guess I naively thought that somehow epidemiologists were immune to such bias but SHEA's flu vaccine position suggests otherwise.

One of the recommendations in the Minnesota report is that "scientifically sound estimates of influenza vaccines’ efficacy and effectiveness must become the cornerstone of policy recommendations." Amen. And it's time for SHEA to retract its policy!