Removing C. difficile spores from hands: Enter Sandman

Exit, light 

Enter, night 

Take my hand 

We're off to never-never land
-Metallica "Enter Sandman"

It is well known that hand washing, particularly with soap and water, is critical for preventing the transmission of C. difficile in hospitals. Evidence suggests that the mechanical friction of hand washing is the mechanism behind spore removal. However, is there a way to improve the friction when practicing hand hygiene? To answer this question, investigators at UCSF reported results of a study that compared C. difficile spore removal after washing with 5 different methods including: (1) negative handwashing control: 30 seconds of rubbing with 5 mL of water and 30 seconds of tap water rinsing; (2) 30 seconds of rubbing with 5 mL of 0.3% triclosan soap and 30 seconds of rinsing; (3) 30 seconds of rubbing with a paste consisting of 15 mL of sand mixed with 15 mL of tap water and 30 seconds of rinsing; (4) 15 seconds of rubbing with 5 mL of a 50% baking soda–50% vegetable oil mix and 15 seconds of rubbing with 5 mL of liquid dish detergent followed by 30 seconds of rinsing; and (5) 60 seconds of rinsing.

Lo and behold, washing with sand and water was superior to both the water rub/rinse (0.36-log reduction in spores) and tricolosan soap (0.50-log reduction) - see Table 2, below.

The authors claim that the sand/water method was well tolerated after a single use, although it's hard to imagine that repeated use would be well tolerated. Still, this study raises many interesting questions. For example, what if we used Lava soap containing pumice, or Brillo pads or what if we placed our hands in a rock polishing machine after seeing patients? All kidding aside, you could imagine high-density soaps that have increased friction without the nasty abrasion. In the meantime, I'm going to keep rubbing my hands on my corduroys. 

Reference: D. Isaacson et al. AJIC, May 2015.

SSI Prevention Bundle in Cardiac, Hip, and Knee Surgery - A Home Run

...and I'm being modest...

As I mentioned yesterday, it's really hard to write a post when you've already written the accompanying editorial. Today, I have a taller task - posting on a study led by two close colleagues (and favorite people), Marin Schweizer and Loreen Herwaldt. (COI alert) Fortunately, JAMA Associate Editor, Preeti Malani, has done the heavy lifting with her excellent editorial.

In today's JAMA, Schweizer and colleagues reported the results of an AHRQ-funded trial examining the benefits of an SSI prevention bundle in orthopedic and cardiac surgery. The bundle was outlined in a meta-analysis they published in BMJ two years ago and included preoperative nasal screening for MRSA/MSSA, mupirocin BID and daily CHG baths for 5 days if screen positive and vancomycin added to perioperative prophylaxis if MRSA positive. The quasi-experimental intervention study took place in 20 US hospitals across 9 states with 39 months of pre-intervention SSI rates and 21 months of rates collected during the intervention period.

Overall, the results are impressive (i.e. not modest). First, there was a 42% reduction in SSIs after the intervention was implemented (see Figure, below), despite modest bundle adherence (39% full adherence, 44% partial adherence).

The key finding for me relates to the number of months where there were ZERO SSIs across all 20 hospitals. Looking at the Figure above, you can see that "the number of months without any complex S aureus SSIs increased from 2 of 39 months (5.1%) to 8 of 22 months (36.4%; P = .006 by Fisher exact test)." Seven times as many zero-months in all 20 hospitals. That's not a modest finding. ;)

Key points from the editorial:

"inclusion of patients undergoing emergency or urgent operations, a population recognized as at high risk for SSI, improves the generalizability of the findings."

"the primary study outcome was limited to complex S aureus SSIs, eliminating much of the subjectivity of infection surveillance. Even though surveillance practices varied among participating hospitals, complicated S aureus SSIs are not clinically subtle and can be identified easily by any surveillance system."

and given the modest adherence to the bundle, "Moving forward, efforts to promote and maintain adherence to prevention protocols will remain important"

"The study’s setting is among its limitations. All 20 study sites were from a single health care system with a well-established quality improvement infrastructure - certain factors in this health care system may differ from other clinical settings, including a below-average baseline infection rate. It remains unclear what challenges and barriers may present as this bundle is implemented at other institutions. Further studies in different settings will offer additional guidance."

and my favorite quote:"Although getting to zero is unlikely to be achievable, efforts that move closer to this elusive goal hold tremendous value for clinicians, hospitals, payers, and, most importantly, patients."

My final thoughts:
This is a wonderful study that took many years of planning, hard work and tremendous collaborators, including HCA and Ed Septimus. Congrats to all involved. Not every study is a grand slam, but we'll take a home run for infection prevention.

C. difficile and Hospital Process Measures: What Works?

One of the more difficult things to cover is a study that you've already written about in an accompanying editorial. It's quite hard to come up with anything "new" to write that you haven't already written. Such is the case with a very nice study examining hospital process measures and C. difficile infections just published in BMJ Quality and Safety by Nick Daneman and colleagues from Sunnybrook Health Sciences Centre in Toronto.

Using results of a mandatory CDI prevention practices survey they compared facility-level processes measures and patient level (via ICD-10 codes) CDI rates in 159 Ontario hospitals. Specifically, they looked at implementation of six hospital-level measures: (1) isolation at diarrhea onset, (2) audit of antibiotic use, (3) audit of environmental cleaning, (4) vancomycin as first line therapy and (5) on-site diagnostic testing and (6) reporting of rates to senior leadership. Somewhat surprisingly, none of the process measures were associated with lower risk of CDI.

In the editorial, Nasia Safdar and I wrote:

"First, the authors identified low self-reported implementation of most CDI prevention practices, with only 27% of facilities reporting isolation of all patients at onset of diarrhoea, and 16% reporting auditing of antibiotic stewardship practices. Low adherence rates for these two practices in particular are concerning because prompt institution of contact precautions is necessary to reduce nosocomial transmission of C. difficile. And antimicrobial stewardship is at least as important as infection prevention practices, if not more so, for reducing CDI."

"This study also highlights the importance of implementation science research to tackle the vexing yet pervasive problem of low and variable adherence to evidence-based interventions for reducing HAI, including CDI. The scope of this study did not extend to exploring barriers to implementation or an in-depth assessment of the self-reported practices that may help inform implementation strategies to increase uptake of proven practices."

and of course my favorite part:

"Last, increasing the evidence base for preventing CDI by undertaking pragmatic randomised controlled trials of novel interventions incorporating efficacy and effectiveness is essential to successfully bridge the quality chasm that currently exists in CDI prevention."

Reference: Daneman N. et al. BMJ Qual Saf. 2015 Apr 24 (open access)

Hospital epidemiologists and the IRB: Two views

Viewpoint 1:
Silvia Munoz-Price

During the past few years, my hospital has experienced high rates of Clostridium difficile infections especially in one inpatient unit. This situation is of major concern to Hospital Administration, the Quality Department, the Infection Control Department, as well as medical and nursing leadership. As the Hospital Epidemiologist, my main duty is to better understand the pathophysiology of the infection control problems so that interventions can be tailored to our specific needs. My initial questions in this particular situation focused on where the acquisition of C. difficile strains were occurring. Are patients acquiring C. difficile at home, in the outpatient clinic, or in the inpatient units? If they were already colonized upon admission to the inpatient unit, then that would certainly explain why infection control bundles had been ineffective in controlling this problem for the past year. Or is it that the hospital environment is acting as a reservoir for C. difficile due to inappropriate disinfection? In order to answer these questions, we started a quality Improvement project, testing the unit with DAZO, culturing the environment, and performing active surveillance cultures of consecutive patients on admission and weekly thereafter. These stool surveillance cultures aimed to detect asymptomatic carriers presenting from the community.

After a couple of months of pursuing these initiatives, I am now getting questioned in regards to my lack of IRB approval. Pondering this issue, to me it is clear that as a hospital epidemiologist I am mandated to investigate the answers to the above questions. Should I get IRB approval ahead of time before each of these projects? I think the answer should be no. If we are not testing any invasive procedure or drugs, but rather we are trying to understand how to prevent infections in our patients, we should not be required to get an IRB approval ahead of time. I do think the IRB should be involved once we determine that the data collected merits publication. THAT is the time when hospital epidemiologists should get the IRB involved. Otherwise, we handicap ourselves on the investigations that we do as part of our duties. Another situation that should warrant IRB approval from the start is multicenter studies of infection control interventions, given that their intent from the start is to publish the findings.

It is true that our job duties fall in the gray zone between quality and research, and some of us tend to publish a great deal of what is done as part of our paid job. However, we should always be guided by this initial question: Is the primary goal of the project to help my patients and my hospital or is the primary goal to publish the results? If it is the former, I say do not ask for permission to do your job. If it is the latter, then by all means, IRB approval is necessary.

Viewpoint 2:

Mike Edmond

I agree with Silvia that this is a problematic issue for hospital epidemiologists, and also agree that the interventions she describes should not require submission to the IRB. My view is that you need IRB approval if your intent is to answer a research question, and that you don’t need IRB approval if the intent is to do quality improvement, particularly if you are implementing interventions that have already been shown to be effective in published studies. I don’t think the intent to publish results has anything to do with the decision to submit for IRB review. For example, if I roll out chlorhexidine bathing to the entire hospital and find that our infection rates fall (or increase, or even if nothing happens at all), I don’t think I need IRB approval regardless of whether I choose to publish the results. On the other hand, if I want to do a trial of chlorhexidine bathing and randomize hospital units to test the hypothesis that chlorhexidine reduces infection rates, that would require IRB approval.

If you would like the US Department of Health and Human Services official opinion on what constitutes research and requires IRB review, I have attached their algorithms below. Once you go through those algorithms, it will all be crystal clear!

 

"Question everything you're told"

It's graduation time on many campuses. In fact, we missed many folks at SHEA's spring meeting last weekend because they were attending a family member's or student's graduation.

Twenty-five years ago, when I graduated from the University of Michigan, I was lucky enough to have a good seat for Lawrence Kasdan's (Raiders of the Lost Ark, Empire Strikes Back, The Big Chill, Star Wars: The Force Awakens) speech, which I've posted above. Many things he said on that day, I still carry with me. For example, I suspect that folks that "question everything they're told" are more likely to choose a career in infectious diseases.

A few highlights (full text here):

"Here’s what I can tell you: the hardest thing in the world is to let yourself know what you know. Why? Because life is noisy. Everything we’re told, everything about the way we’re raised and educated and bombarded by our culture makes noise. And that noise makes it very hard to hear the ticking of our own hearts"

"Did you know that eating a double sausage pizza at midnight, on the night before a final, may not be the smartest thing to do....nutrition wise?"

Safety and efficacy of nontoxigenic C. difficile spores in preventing recurrent CDI

Lead Author: Dr. Dale Gerding

We have written and spoken often on the efficacy of fecal transplants in treating recurrent C. difficile infections. Wouldn't it be great if there was a way to prevent recurrent CDI in the first place? What if "good" C. difficile strains that lack toxin production genes could be used to out compete bad strains and prevent recurrent CDI?

There is a new study just published in JAMA that evaluates the safety and efficacy of a nontoxigenic C. difficile strain M3 (VP20621; NTCD-M3) in preventing recurrent CDI in those patients initially treated with metronidazole and/or oral vancomycin. In the four-arms of the phase 2, double-blind placebo-controlled trial they compared patients given oral liquid formulation of NTCD-M3, 10^4 spores/day for 7 days (n = 43), 10^7 spores/day for 7 days (n = 44), or 10^7 spores/day for 14 days (n = 42), or placebo for 14 days (n = 44).

Recurrent CDI occurred in 13/43 (30%) of placebo patients and only 14/125 (11%) of patients treated with NTCD-M3 patients (odds ratio [OR], 0.28; 95% CI, 0.11-0.69; P = .006). Fecal colonization with the NTCD-M3 strain was reported in 69% of treated patients and was associated with lower recurrence: 2/86 (2%) recurrence if colonized vs. 12/39 (31%) recurrence in treated but uncolonized patients (OR, 0.01; 95% CI, 0.00-0.05). Side effects such as abdominal pain, diarrhea and serious side effects were actually higher in the placebo groups. If this smaller study's findings are confirmed in larger trials, we may just have a new treatment for the prevention of recurrent CDI. Very cool.

Check out the video interview with lead author Dr. Dale Gerding, another related video and the JAMA Associate Editor's podcast covering this article and other important studies.

The new healthcare epidemiologist

The April issue of Infection Control and Hospital Epidemiology has a white paper on skills and competencies for the healthcare epidemiologist. True to form, the paper reflects the rather timid approach that SHEA never seems able to shake. As a disclaimer, I should state that I sit on the Board of Trustees of SHEA, and I’m not saying anything in this post that I haven’t shared previously.

While the paper mentions that the healthcare epidemiologist should have an understanding of quality improvement and safety, and is a valuable partner to the Chief Quality Officer (CQO), what it should state is that the healthcare epidemiologist is uniquely qualified to be the CQO. Infection prevention was the first QI program ever to emerge and remains better developed than QI and patient safety. Many healthcare epidemiologists have advanced degrees in public health or epidemiology, and the skill set is directly transferable to QI and safety. Increasingly hospitals are developing CQO positions, but very few of these positions are held by healthcare epidemiologists. In some cases, CQOs may not have a true appreciation for the value of the healthcare epidemiologist, and some of us fear that healthcare epidemiologists as we know them may ultimately be replaced by less trained individuals. Interestingly, Dick Wenzel published a book on quality improvement in 1992, but unfortunately, SHEA chose to remain confined to infectious adverse outcomes rather than expanding into the quality realm.

So my recommendations are these:

1. SHEA should move aggressively and quickly into the quality and safety space.
2. To broaden the skillset of the healthcare epidemiologist, SHEA needs to sponsor education on leadership, implementation science, human factors engineering, Six Sigma, Lean, and other quality improvement and patient safety topics.
3. As much as I hate to talk about certification given the absolute mess the American Board of Internal Medicine has made of our certification processes, I continue to believe that healthcare epidemiology will never be seen as a valid entity until there is certification. Once certification occurs, then it becomes possible to build the requirement for a healthcare epidemiologist into payer’s conditions of participation, hospital accreditation, and hospital quality rankings. We need to make the healthcare epidemiologist indispensable. 
4. SHEA’s journal, Infection Control and Hospital Epidemiology, should specifically solicit papers focused on noninfectious adverse outcomes, quality improvement and patient safety. 

In a nutshell, SHEA should define the role of the healthcare epidemiologist more broadly, which in the long run will help its members more easily achieve leadership positions in hospitals and have a seat at the table when important decisions are made.

Graphic: Stratabridge