Context is everything when it comes to scientific enquiry. The right questions, the right approach and an answer that appears balanced, logical and reasonable are keys to credibility.
Despite this truism,we know well that context is a moving target. And in order to be right on topic - we believe it's important to listen to the voices of many in the Vascular Access Community.
So, new to the website this year - we are adding "Guest Blogs" from invited hosts. These blogs will be authored by pioneers whose voices, work, achievements and opinions matter to all of us in the field. But no free passes here - we will ask them tough questions about context, relevance and the challenges ahead for the field, perhaps some that are uncomfortable or controversial as well.
We've got a star studded cast lined up for the first few posts and plan to bring you these refreshing perspectives every so often in 2016. In keeping with ImprovePICCs goal to remain bias-free, please note that this isn't a megaphone for industry or those with substantial conflicts of interest. All bloggers are required to submit the ICMJE conflict of interest form and these will be reported with their post. The decision to post something is reserved by us and will be based on myriad factors, including suitability and perceived conflict of interest.
This isn't just a club for the elite, though. We do want to hear from those of you in the front lines who have something important and relevant to tell the vascular access community. If you're up to it - draft us a brief outline of a blog you want to write and send us a note using the Contact Us page. We would love to hear from you! Remember the rules regarding Conflicts of Interest and the fact that the decision to post is reserved by us based on content, scope, interest, etc.
And even if you're not interested in writing a blog, tell us what you think by commenting on this or the other guest blog posts. We will be watching these with interest!
Dr. Sanjay Saint is the George Dock Professor of Medicine at the University of Michigan. He is my Primary Research Mentor and has influenced me profoundly when it comes to how best to prevent healthcare-associated infections. I invited him to talk about his recent work on mandating influenza vaccination for healthcare workers here on the ImprovePICC blog site. This is a topic that clearly affects all vascular access nurses, physicians and providers that work in hospitals or inpatient care facilities. He was kind enough to agree.
VC: Tell me about the controversy related to your recent research paper on influenza vaccination.
SS: There has been quite a bit of controversy related to mandating influenza vaccination for healthcare workers. Much of the discussion has appeared on the important blog “Controversies in Hospital Infection Prevention” hosted by infectious disease specialists Drs. Eli Perencevich, Mike Edmond, and Dan Diekema of the University of Iowa. I respond on the blog itself to these issues and am happy to do so here for the vascular access and nursing community.
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 a 22 December 2015 blog post, Dr. Perencevich 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.
VC: Can you tell me a bit about the most compelling studies supporting mandatory vaccinations?
SS: 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. Here are the verbatim 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.
VC: But how may influenza vaccination reduce all-cause mortality?
SS: I am not sure. But previous studies have found influenza vaccination reduces cardiovascular events and venous thromboembolism. How vaccination may affect these outcomes is also not known - but it isn't irrational to also include all-cause mortality as an outcome given the myriad benefits of influenza vaccination in the literature.
VC: What about the other studies you mention?
SS: 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. Here's the abstract:
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). 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.
VC: So where does the controversy stand now?
SS: Dr. Perencevich 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.
VC: Have professional societies weighed in on a mandatory influenza policy?
SS: While the opinion of professional societies may not always be 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.
VC: Is it ethical to mandate flu vaccine for healthcare workers?
SS: For guidance, I turn to Arthur L. Caplan, PhD, one of the country’s foremost medical ethicists and whose opinion about white coats on work you and I are doing was recently highlighted on “Controversies in Hospital Infection Prevention”. 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.”
This year has been an incredibly productive year for us at ImprovePICC.
We've celebrated many successes, including the funding of a large AHRQ grant that will allow us to continue to develop devices that sense the presence, rationale and nature of catheters; the addition of bright, new research and project management staff; and unparalleled productivity in terms of peer-reviewed papers, lectures and seminars.
We've also increased our international presence, punctuated by a deepening partnership with the AVATAR group that led to a substantial Australian NHRMC Grant examining PICC securement and dressing (the PISCES Trial). And with the publication of the first evidence-based "guideline" for when to use a range of IV devices, MAGIC, well...its not hyperbole to say it's been an amazing year.
So as I look ahead to 2016, I cannot help but worry given the strong benchmark we've set! Can we possibly continue to keep up the pace that we have so aptly held this year? What projects will we take on and how will we get these funded so as to ensure success? Will our new staff and faculty soar? Is our success perhaps our greatest enemy?
I know that these thoughts plague many of us in the knowledge and discovery arena, but I am reassured by several facts. First, our mission, vision and values remain strong and our focus on improving the use of PICCs in hospitalized medical patients has never been as laser-like as it is now . Second, we know that important questions regarding the use of vascular devices remain to be answered - a thought that is always good for job security (and grant funding in these tight times). Third, I sense we will begin to make the shift from "observing" practice to "implementing" change given all of the efforts we and others have done that continually show room for improving practice. This last thought is perhaps the most exciting for us at ImprovePICC, because we will now begin to influence the care of patients with PICCs in a real and tangible way through our quality improvement partners across Michigan.
So, we close 2015 in a strong way. We already have ten (yes, 10) research and innovation abstracts submitted to a scientific meeting from our partnership with HMS. We have several papers in press and a few that remain under review. We continue to write grants that focus on translating our research into practice. These important contributions will undoubtedly allow us to keep up our cadence.
I have a feeling 2016 will be a good year. Thank you for being part of our journey. Onwards...
Our first post is a big one -- and sets the bar high because it begins with a conversation regarding our landmark product: The Michigan Appropriateness Guide to Intravenous Catheters (MAGIC). Here's excerpts of our thoughts regarding this project.
Q: What motivated this project?
A: Vascular access is literally the most common procedure performed in hospitalized patients. It is invasive, costly, can lead to finite harm -- and yet the research behind it has not been well organized. When you begin to look at practice, you realize people are acting in very different ways with respect to who gets an IV, who gets a central line, who gets a PICC. This variation brought our attention to the topic.
Q: How do you think current use compares to what was deemed appropriate by the panel?
A: A big problem is defining what current use is. We now have 47 hospitals across Michigan working collaboratively to collect data regarding use of PICCs and outcomes. This experience - now one year old - shows large gaps between what is deemed appropriate and current practice. A classic example: one of the recommendations deemed appropriate by the panel was [to] not place PICCs for durations of less than 5 days, unless you need to give an irritant or a vesicant. Yet in data encompassing over 5,000 PICCs, about 25% are removed within 5 days. It's over 1,000 devices when you do the math. It's astonishing.
Q: Were you surprised by any of the conclusions the panel came to?
A: The surprise wasn't so much the conclusions, as much as the process. It was incredible how extremely collaborative it was. I was also surprised by the intense debate that transpired in specific areas—especially on when and which device to use. The evidence in this area is fragmented and much of it has been generated by nurses, interventional radiology and others. As you can imagine, with the cultural shifts between nursing and physicians, there's lots of disagreement about what device, when and why.
Q: What were the biggest areas of disagreement among the participants?
A: One of the disagreements we had early on was the use of PICCs for short-term periods in patients who had veins that were difficult to access or needed frequent blood draws. The evidence here isn't clear. Ultimately the panel agreed devices other than PICCs may be safer and could achieve these goals. But the process of discussion and deliberation was intense.
Q: How do you get these recommendations into practice?
A: We want to start testing MAGIC in our real-world laboratory, the Hospital Medicine Safety Consortium, which now consists of 47 hospitals in Michigan. We want to figure out what works, what doesn't and why. What we ideally would like to do is create a toolkit, "Here are the top 5 recommendations from this panel of ways to improve your practice around venous access and PICCs," and actually make it simple. Hospitalists can choose 1, 2, 3, maybe all 5 of these recommendations and then track the impact of these changes.
Q: Do you see appropriateness of PICCs eventually being a quality measure?
A: Yes - not just PICCs but venous access in general. What we would like to do, especially for our collaborative, is give hospitals a dashboard. We have started doing this for benchmarking purposes … feeding back things like the number of PICCs that were placed for less than 5 days, how many PICCs developed CLABSI [central line-associated bloodstream infection], how many developed VTE [venous thromboembolism].
Q: Do you think these recommendations will change much based on future research?
A: I sincerely hope so. This is an important first step, but it's just that, a first step. There are going to be newer devices that come out that we haven't even thought about or included. There will be new evidence regarding harm and benefit, and if and when evidence suggesting one device may be better than another, then we should look back on MAGIC and modify recommendations. MAGIC is a great way of organizing what we know, but I sincerely hope it's a living document. Only then will it serve to best take care of our patients.
Blogs written and edited by Vineet Chopra unless otherwise stated in the header. Guest blogs are identified accordingly.