Čojstvo - Humanity - My hope for 2016

Mike has written often about humanism in the context of the white coat debate. He contrasts humanism with professionalism with humanism focusing on the welfare of humankind and professionalism primarily seeking to strengthen a personal professional identity. With that in mind, I was just listening to The Gist and Mike Pesca was retelling the story (around minute 22 of the podcast) behind his favorite sentence for 2015. While on a tour in Montenegro this past summer, he heard the guide try to explain the ethical ideal of the Montenegrin people - Čojstvo i Junaštvo, which roughly translates to Humanity and Bravery, using this sentence:

"Bravery is very easy - it is when you defend yourself from others but humanity is more difficult - it is when you defend others from yourself" - Nino Markovic (Montenegrin Tour Guide)

So from Mike Pesca's sentence for 2015, I've found my hope for 2016:

Čojstvo - Humanity

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.

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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!

Root causes underlying the emergence of influenza vaccine mandates

Those that follow me on twitter or the blog have probably noticed my recent focus on trying to understand the emergence of compulsory influenza vaccination of healthcare workers. Before moving on from this topic, I wanted to share what I've learned in the process.

(1) There doesn't appear to be any estimate of the burden of nosocomial influenza in the US. We know healthcare-associated influenza does occur, but we don't have estimates for the proportion of influenza cases that occur in hospitals. Even if we did know the incidence, we don't have reliable estimates for what proportion is acquired from healthcare workers vs. visitors or family members. It seems like we'd need those numbers before pushing for a mandate.

(2) There is no data supporting the benefits of healthcare worker vaccination in acute care hospital settings. If we look at the CDC systematic review everyone quotes, there were only 4 randomized trials and all 4 were from long-term care settings. If we generously include the observational studies, 3 were from long-term care and only one was from a hospital setting. We are basing acute-care hospital policy on one observational study.

(3) Again from the CDC systematic review, "HCP vaccination rates ranged from 48% to 70% in the intervention arms and 5% to 32% in the control arms." Thus, there is no evidence that raising vaccination above 48% or 70% is beneficial in long-term care settings. Thus, if we have vaccination rates near 50%, do we need a mandate?

The last two things I learned are that none of the above matters. Science is not what is driving the push for mandates, unless you consider the studies showing mandates raise influenza vaccination rates among healthcare workers. Probably didn't need a study to show that.

(4) Yesterday, I wrote a post trying to bias the respondents of a twitter survey in favor of being cared for by a masked unvaccinated healthcare worker over a vaccinated one. As you can see by the results (below), despite my efforts, the large majority want their healthcare worker to be vaccinated. This is critical - despite the science, we just want people to be vaccinated. A huge driver behind influenza vaccine mandates must be this desire. Additionally, it's likely that masks are viewed negatively by patients. Vaccine mandates make folks feel safe and masks don't - very patient centered.

(5) The finally bit that occurred to me is that the reason vaccine mandates exist is because CMS and other governing bodies require hospitals to collect and report influenza vaccine coverage among their workers. There is also a target of 90% coverage that must be met. Thus, we have a QI target that exists despite minimal scientific evidence that it protects patients but we have to meet the target. And the only way to meet such an arbitrary target is through mandates. QED

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...