Wednesday, May 27, 2015

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!


Saturday, May 23, 2015

"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?"

Tuesday, May 5, 2015

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.

Sunday, May 3, 2015

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 

Thursday, April 30, 2015

ECCMID 2015 - "Best Of" Infection Control Literature (Part 1)

Every year it seems that one of us at the University of Iowa is roped into giving one of these "Best of Infection Control" talks at an annual conference. This year it seems that almost all of us have been asked and for some inexplicable reason, we all said yes! I was the lucky one to kick off the 2015 season with this talk I gave last week at ECCMID in Copenhagen. I covered S. aureus, MRSA, VRE, VRSA, surgical site infections and hand hygiene. I look forward to Mike's talk at SHEA. Loren Herwaldt's talk at ICPIC and Dan's talk at IDWeek. On Iowa.

Saturday, April 18, 2015

Value: The physician perspective

This week I was asked to give a very brief talk on value from the physician perspective as part of a panel discussion at the University of Iowa Carver College of Medicine's Annual Quality Improvement and Patient Safety Symposium. My remarks are below.

As we have heard today, value is defined as quality per unit cost. And I've been asked to address value from a physician perspective. Importantly, value and population health go hand in hand. Clinically, I work as an infectious disease physician, and when I think about value, it seems apparent to me that for several reasons, ID doctors are more oriented to population health and to value than any other clinical specialty than I can think of.

First, the drugs we use, antibiotics, are the only class of drugs that affect not only the patients we treat but other patients in the population, because we humans share our bugs, and antibiotic usage is correlated with the development of antibiotic resistance. Many of our diseases have public health implications, and we frequently make decisions to control transmission of infection to others in the population. Some of us work as hospital epidemiologists and antibiotic stewards, where we closely look at population health within the healthcare setting.

Clearly, RVU volume-based compensation has had a terrible impact on our field. It’s difficult to evaluate patients with complicated, undiagnosed conditions quickly enough to generate enough RVUs. Many ID doctors have been unable to generate their salaries and have left the field. And the number of young physicians entering ID is at a record low. But we do add value, in ways that I mentioned and in other ways, and I’m hopeful that in a value-based compensation model, a more level playing field will treat us a little better.

In my previous job as the chief of the infectious diseases division at another academic medical center, I inherited a dispirited faculty and a nearly million dollar debt (if you’re not in ID, I need to tell you that a million dollars is a whole lot of consults). I worked hard to increase our clinical volume, and over 5 years, despite reducing the number of faculty members through attrition, our clinical productivity grew four-fold, and our debt was eliminated. This was done by working in partnership with our faculty, outlining common goals and working towards a shared vision. All of us in the ID division were working hard, and had no complaints that we were being paid at the AAMC 25th percentile. And this is where value comes back into the picture. Not value the noun (quality per unit cost), but value the verb—to be made to feel that what you do every day as a physician is important work.

Consultants were brought in to develop a new volume-based compensation plan. It took years to develop the complicated formulas, and it was touted as the best thing since sliced bread. One of the leaders went to departments and announced that in the new comp plan, “the sky’s the limit. Your salary can be whatever you want it to be.” Nearly every ID doctor was projected to have a new salary at the AAMC 75th percentile based on their prior RVU productivity. But the new comp plan gave no credit for other important duties, such as teaching, mentoring, the quality of the clinical work provided, or scholarly publications. The comp plan was enacted, and over the next year, what do you think happened to clinical productivity? It plummeted, because almost every doctor in the ID division made an independent decision that they would rather see fewer patients and make less money. Now this should have come as a surprise to no one. The comp plan was based on the faulty assumption that all physicians are motivated by money. We are all homo economicus!...Except we aren't. ID is the lowest paid specialty in the world of adult medicine—if money were your driver, you probably wouldn't have chosen the job that pays the least. You see, in the new comp plan, the ID doctors no longer felt valued; caring for patients was reduced to nothing more than a series of transactions.

In his book Drive, Daniel Pink tells us that highly educated people, such as physicians, are motivated by 3 things. And interestingly, those 3 things don’t include money. In fact, he believes money is a poor motivator, because in order to maintain it’s effect on motivation, it has to be constantly increased as the effect of any given amount tends to extinguish. What gives us a high level of drive are: 
  • Mastery:  This is the willingness that all of us have demonstrated to spend 1-2 decades trying to understand the incredibly complicated structure, function, and pathology of the human body, and the even more complicated human spirit.
  • Autonomy:  As experts in our respective fields, we tend to have a reasonably good understanding of how to do what we do, and we’d like that to be recognized. At my old place, another group of consultants were retained to convince all of the 700 faculty that each of us should have the exact same clinic schedule. They decided that all new patients would be given a 40 minute slot. Now I worried how I could do an evaluation of fever of unknown origin in 40 minutes, especially when in my clinic the nurses typically needed the first 20 minutes of the visit to do their assessment. But a hand surgeon pointed out that his physical exam typically involves a single finger, and what in the world would he do to fill a 40-minute slot? Autonomy recognizes the expertise we bring to the table.
  • Sense of purpose:  When we leave the hospital at the end of the day, we simply want to feel that we have made a difference.
Mastery, autonomy, and sense of purpose: these are the forces that motivate us, and when they are encouraged to exist and allowed to flourish, we feel valued.

So the moral of my story is this: value is a two-way street. Each of us physicians on the pointed edge of the patient encounter must work hard to maximize quality and minimize cost to bring about truly high value health care. We physicians own value, the noun. And to those of you who have the difficult job of administering healthcare, or herding us cats, you must make us physicians feel valued. Value, the verb, is yours.

Sunday, April 12, 2015

Punished for precision (or, too much information (TMI) from the micro lab!)

We recently had a patient's blood culture turn positive for a Gram-positive, catalase-positive, facultative diphtheroid. In the “pre-MALDI” era, we’d have called this isolate a “diphtheroid”. Taking into account other aspects of the case, the NHSN definition would have categorized this as a contaminant (diphtheroids being on the “common commensal” list maintained by NHSN). By virtue of the wonders of mass spectrometry, we are now able to identify the organism to species-level as Actinomyces neuii, an organism previously categorized as CDC group 1-like coryneform bacteria (also on the “common commensal” list). 

Actinomyces neuii isn’t anywhere on the NHSN organism lists. However, Actinomyces species (as a group) can be found on the “all organisms” list but NOT on the “common commensal” list. The NHSN rules tell us we have to categorize any organism on the “all organisms” list that isn’t also on the “common commensals” list as a pathogen, meaning this positive blood culture now helps define a central-line associated bloodstream infection (CLABSI).

And that’s the story of how a contaminated blood culture became a CLABSI. We’ve had other similar cases since we introduced MALDI-TOF. Before the CLABSI rate became worth millions of dollars to a hospital’s bottom line and reputation, this might have been easy to navigate. Now, though, it’s a much bigger deal. 

These and other issues regarding the impact of microbiological advances on infection prevention will be discussed at SHEA 2015 (ever heard of it?). Register now!