The skullcap feud (Part 2)

Several months ago I posted on the feud between the surgical community and the Association of periOperative Registered Nurses (AORN). This turned out to be a wildly popular post that generated a great deal of discussion on our blog and other websites. You'll recall that AORN outlawed the surgeon's skullcap in its latest guideline on surgical attire. This caused an uproar among surgeons who noted that there was no substantial evidence on which to make this rule.

In a new paper in Neurosurgery, a surgical group at University of Buffalo took matters into their own hands and decided to generate some evidence after their own hospital banned the skullcap and mandated that all OR personnel don bouffant caps. They compared surgical site infection rates for Class I (clean) procedures 13-months before and after the skullcaps were outlawed. During the study period, approximately 16,000 surgical procedures were performed. There was no difference in SSI rates between the two time periods.

So, my hat's off (no pun intended) to the authors. The score now is Surgeons 1, AORN 0. And I suspect that more studies are on the way.

The Playing Field is Still Warped . . .

Over the past decade, public reporting of facility-specific HAI performance has had a dramatic impact on infection prevention programs.  The increased awareness of HAI prevention by an increasing diversity of stakeholders (administrators, payors, patients, etc.) has arguably led to increased emphasis on HAI prevention and, in many cases, more resources to infection prevention programs.  These changes were very apparent at my institution where we increased our IP staff from 3 infection preventionists, 2 hospital epidemiologists and one administrative assistant to 9 IPs, 2 data analysts, 1 chart abstractor, 1 program coordinator, and partial support for 4 HEs (not including the antibiotic stewardship program support).  HAI performance is front and center among our annual quality goals, tied to department chair incentives, and the days since the last HAI are posted publically on our inpatient units for all to see.  Most importantly, our frontline healthcare workers understand and routinely discuss what were once surveillance acronyms like "CLABSI" and "CAUTI."  We've seen remarkable reductions in HAIs (and, more importantly, the associated patient harm) during this time (e.g. CLABSI in our ICUs have reduced 80% in the past 8 years). 

Our story is not unique.  Many hospitals have noted marked reductions in HAI rates.  One could argue that many, if not all, of the "low" and even "middle" hanging fruits have been tackled, and we are starting to reach the area where uncontrollable differences in patient risk factors/case mix may lead to different HAI performance across facilities.  With HAI performance tied to increasing financial consequences, however, the need to better insure a level and fair playing field across facilities is growing.  In this context, the recent report from the HHS Office of Inspector General on the CMS HAI reporting is very interesting.  The report focused on the validation of reported HAI data.  They found that while sufficient data were validated (as per regulatory requirements) and 99% of reviewed hospitals passed validation (only 6 failed), concerns were raised regarding how hospitals were selected for validation:

"However, CMS’s approach to selecting hospitals for validation for payment year 2016 made it less likely to identify gaming of quality reporting (i.e., hospitals’ manipulating data to improve their scores). CMS did not include any hospitals in its targeted sample on the basis of their having aberrant data patterns. Targeting hospitals with aberrant patterns for further review could help identify inaccurate reporting and protect the integrity of programs that make quality-based payment adjustments."

Gaming strategies that may be employed include overculturing (to designate an infection as POA), underculturing (if no blood cultures are collected . . . voila! No CLABSIs!), and adjudication/clinician veto ("I know that met the definition for SSI, but it was just a seroma . . . that I treated with antibiotics . . . uh, prophylactically . . . yeah, that's it!).  We have no clue how widespread these practices may be, but the OIG report notes that the current validation strategy should be enhanced to better capture gaming.  With the growing financial consequences placed on HAI prevention, it is paramount that everyone plays fair to better level the playing field.  Now, if we could also get more patient risk factors into the SIR models . . .

Hand hygiene: facilitators and barriers

Although there are many papers on hand hygiene, this new one in American Journal of Infection Control caught my eye. In this study 3,260 hand hygiene opportunities among 64 ICU nurses in 4 hospitals were overtly observed. When HH noncompliance was observed, the reason was documented. Nearly 20% of missed opportunities were accounted for by 4 activities: carrying something, even as small as a syringe or 4x4 (9%), donning gloves or PPE (6%), pushing or pulling a work station (2%), and using a mobile device (1%).

The investigator observed that nurses who were super compliant (90-100% compliant) found ways to deal with the barriers. For example, if they were carrying something, they shifted the object to one hand and reached for gel with the other. They were positive deviants.

The high performers were asked to explain why their compliance was high and four themes emerged: (1) they had internalized standard precautions; (2) they had experienced a previous exposure and were determined to not allow it to occur again; (3) bonuses and pay raises were linked to compliance; and (4) pregnancy and concern for their unborn child.

A better understanding of the barriers and facilitators may allow us to move the needle a bit on one of the most perplexing problems in infection prevention.

Working while sick

A few days ago, I learned about visual abstracts, a great way to encapsulate the essence of a paper. You can read more about visual abstracts here. Here's my first attempt using a recent paper in the American Journal of Infection Control.

This paper tells us that hospitals can't just mandate influenza vaccine for their workers and think that they have done their job. Preventing the transmission of respiratory illnesses requires a more comprehensive approach that makes a real attempt at keeping sick healthcare workers at home. Of note, the rate of vaccination in the survey participants was 45%, and vaccine effectiveness that season was only 19%.

Bottom line: Influenza like illness (ILI) has many causes, influenza vaccine is modestly to moderately effective against three of those, and healthcare workers continue to place patients at risk by coming to work when sick with ILI.

When will the p-value finally die?

Over the past 7 years!, I've written about my concerns regarding the misuse of p-values, which I've dubbed "death by p-value." First and foremost, no one really understands what a p-value means and perhaps more importantly, a singular focus on a p-value threshold detracts from important concepts such as effect measures (e.g. hazard ratios) or the continuous nature of confidence intervals.

Recently, I've seen an increasing number of calls to hasten the death of the p-value from folks such as Ken Rothman (you might have read one of his books?) and Miguel Hernan. Professor Hernan has a request on twitter saying "statistical significance must go" where he is asking for examples of outrageous misuses of p-values. He's also suggested that "if your journal still uses 'statistical significance' in 2017, retire your statistical consultant."

Below, I've posted a letter to the editor by Professor Rothman and colleagues that he recently circulated. It has a nice brief example of how p-values are frequently misused. The key sentence, I believe, is this one: "given the expected bias toward a null result that comes from non-adherence coupled with an intent-to-treat analysis, the interpretation of the authors and editorialists is perplexing." I'll ask, are there situations such as studies of contact precautions or hand hygiene interventions where they would be analyzed using an intent-to-treat analysis and non-adherence levels might be high?

I'll leave you with this video on p-values from Carl Bergstrom at University of Washington. He and Jevin West have a course and planned book titled "Calling Bullshit: in the age of big data," which has been well received. And to connect this to MDRO, Carl is the author of a 2004 PNAS paper "Ecological theory suggests that antimicrobial cycling will not reduce antimicrobial resistance in hospitals", which is a nice example of how math models can improve our understanding of antimicrobial stewardship interventions. It's still worth reading.

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.

The Updated CDC SSI Prevention Guidelines are (Finally) Released: A Marathon in its Own Right

(First, thanks to Dan, Eli, and Mike for inviting me to join the blogging crew.  I hope I can meet their outstanding level of performance, and I promise not to write only about healthcare worker influenza vaccination [but I am sure it may come up now and then!])

Last weekend I ran my first half marathon, the St. Jude Nashville Rock ‘n Roll Half Marathon.  As I ran the race, I went through several stages: excitement combined with anxiety before the start, the adrenaline rush during the first few miles, the sense of accomplishment at mile 6, the shear exhaustion of mile 11, the exhilaration of finally finishing, and then the realization of “what’s next?”

With the much anticipated release of the CDC’s HICPAC Guideline for the Prevention of Surgical Site Infection (which updates the 1999 guideline), I realized the guideline authors may have had the same thoughts during its development that I had during my race.  (Disclaimer: Dan, Hilary, and I served on HICPAC during the development of this guideline).  This guideline is long overdue, particularly with the increased focus on reducing SSIs combined with the advances in SSI prevention over the past decade. The writing group consisted of experts in infection prevention, surgical sciences, infectious diseases, and public health, and they should be lauded for their extremely tireless and dedicated work (which we saw first hand at HICPAC).  Just as with my race, the process was likely exciting, rewarding, exhausting, and, I suspect, at times frustrating.

There are important things to recognize when reviewing these new guidelines, outlined in the commentary by Dr. Lipsett.  First, we must understand the evidence inclusion criteria for each section. For the Core Practices section, only randomized controlled trials and systematic reviews were included.  For the Prosthetic Joint Arthroplasty section, due to a lack of such high level studies in the literature for many of the key questions, other types of studies were allowed.  This resulted in limitations to the scope of the recommended practices and many “no recommendation/unresolved issue” decisions on key questions such as the timing and redosing of antibiotic prophylaxis.  Other key questions never made it that far, reflecting a paucity of science on these topics.  In addition, detailed guidance on implementation is not present in the guideline or supplementary materials.  Hidden in the Supplementary Material, the guideline does note those key practices recommended in the 1999 Guideline that were not included in the update but still apply to the surgical patient today (see pages 41-42).

Despite these limitations, there are some significant advances recommended (Category 1A), including expansion of several key interventions to a broader surgical population:

1) Glucose control (<200 mg/dL) for diabetic and nondiabetic patients

2) Maintenance of normothermia

3) Provision of increased FiO₂ in intubated surgical patients with normal pulmonary function

Traditionally, these interventions have been used in specific surgical procedures, such as colorectal and cardiac surgery.  With the new guidelines, many healthcare facilities will need to broaden these interventions to a wider surgical population.  Importantly, the guideline minimizes the commonly heard refrain of the need for studies in a specific surgical procedure before implementation of an intervention.  The pathophysiology of a SSI is probably the same for most surgical patients, supporting the expansion of these important interventions to a wider population.  In addition, the guidelines now recommend stopping antimicrobial prophylaxis once the incision is closed in clean and clean-contaminated procedures (vs. the tradition of continuing for 24hrs, 48hrs, or until all drains have been removed), an important recommendation in the era of antibiotic stewardship.

Much like running a half marathon, we are now at the finish line and asking the question “[w]hat’s next?”  While the new guidelines advance SSI prevention, there is a clear need for implementation guidance related to the recommended practices (such as from SHEA, APIC and others), research funding to support high-level studies that examine key questions for which there was not an adequate evidence base, and expert direction on those strategies that will never be studied by randomized control trials.  Guideline’s finally out.  Let’s get running!!

Update from ECCMID: Infectious disease and medical overuse

This is a guest post by Dan Morgan, MD MS. He's an Associate Professor of Epidemiology and Medicine at the University of Maryland, Baltimore.


At the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting last week in Vienna, Austria, a session was dedicated to Medical Overuse and Infectious Disease. To me, it was great to hear smart people thinking about my job, infectious diseases, in the context/language of my hobby, medical overuse.  Medical overuse has been defined as the provision of care in which harms outweigh benefits or the benefits are so small that informed patients would not want care. Although it was the last session of the meeting, it was surprisingly well attended. A few high points follow:

Céire Costelloe from the UK presented work showing 80% of antibiotics are given as outpatients and promote risk of resistance greatest in the first week but antibiotics have a persistent effect six months after use. Targeting overuse of antibiotics in outpatient settings is likely key to address antibiotic resistance.

Alexander Friedrich from the Netherlands, presented a balanced view of how tests can drive overuse—such as blood cultures or rapid malaria testing, but also that testing may have a role in reducing overuse in the use of procalcitonin to stop antibiotics. If clinicians default to antibiotics, then testing may help them step back. However, if clinicians aren’t prone to empiric treatment, testing may increase treatment.

Stephan Harbarth from Switzerland then gave a great overview of how implanted devices like urinary, central-venous catheters and endotracheal tubes are risks for HAIs, MDRO colonization and are often overused. His message was that reducing use of devices is the primary way of reducing infections. (Although note, CDC and other agencies use rates per catheter day, which discourages removal of low risk catheters, so we may need a better metric—like “days of utilization”)

Finally I spoke, closing the session and the conference. My talk focused on what do we know about Overuse more generally and what can we do to prevent Overuse? To me, the basis of Overuse is a skewed view of testing and treatment. I reviewed the evidence of physician over-enthusiasm for benefits of testing and treatment and tendency to underestimate harms of both. I presented a general model for how to address overuse, the Choosing Wisely campaign and how CW could be used by those encouraging stewardship. On the theme of stewardship, there have been interesting studies showing the benefits of diagnostic stewardship, identifying what seems to be a growing trend to modify testing to improve antibiotic use.

There was, of course, much more from ECCMID that is publicly available. Take advantage of their site that has recordings of talks!