Infection Prevention Summer Reading

With apologizes to our colleagues in the Southern Hemisphere, many of us are traveling a bit this summer and are looking for good things to read. At the top of my reading list is Ed Yong's new book, "I Contain Multitudes: The Microbes Within Us and a Grander View of Life." The book by the highly regarded UK science journalist (The Atlantic, National Geographic) digs into the relationship between microbes and animals. Unfortunately, the book won't appear until August 9th, so you'll have to be a bit patient and find something else to read.

In the meantime, I've listed five recently published journal articles/studies that will hopefully tide you over until "I Contain Multitudes" appears at your bookstore.

1) A Flawed Revision of the Common Rule (Joffe and Magnus, Annals 19 July 2016). The Common Rule is the regulatory framework that guides human subjects research, think IRB. Last September, 16 federal agencies released a Notice of Proposed Rulemaking outlining proposed changes to the Common Rule. There are several potentially important changes that could negatively impact infection prevention and stewardship studies. First, the Notice seeks to redefine all research on biospecimens, including de-identified specimens, as human subject research requiring "broad consent" before storing the specimens. The discussion didn't mentioned microbiology specimens specifically, but this requirement is concerning. Second, the Notice would only exclude QI research from review if it analyzed proven interventions and limited study endpoints to utilization outcomes (e.g. cost). However, QI projects such as quasi-experimental studies of the impact of CLABSI checklists on BSI rates or mortality WOULD require IRB review and potentially individual informed consent. (Yikes!)  My sense is this could drastically curtail important research in MDRO prevention and most infection control research. Stay tuned.

2) Control of an Outbreak of Middle East Respiratory Syndrome in a Tertiary Hospital in Korea (Park GE et al. Annals, 19 July 2016). From May to July 2015, 186 confirmed cases of MERS-CoV occurred in S. Korea. The authors provide an in-depth description of a 92-person outbreak in a single tertiary-care hospital in Seoul. Interestingly, 82 of the cases occurred after exposure to a single secondary patient cared for in their emergency department. All cases were identified through contact tracing and monitoring of exposed patients and healthcare workers and all in-hospital transmission was secondary to three patients with pneumonia and productive cough. The description of events was very sobering.

3) Colonization With Methicillin-resistant Staphylococcus aureus and Risk for Infection Among Asymptomatic Athletes: A Systematic Review and Meta-analysis (Karanika S et al, CID 15 July 2016). The results of this study suggest that you shouldn't be an athlete (6% MRSA colonization rate), especially a wrestler (22% MRSA colonization rate). Additionally, the authors reported that colonization increases the risk of subsequent skin and soft tissue infection 7 times. If only it were safer to lay around on the beach this summer.

4) Addressing Infection Prevention and Control in the First U.S. Community Hospital to Care for Patients With Ebola Virus Disease: Context for National Recommendations and Future Strategies (Cummings KJ et al. Annals 5 July 2016). Authors from the CDC, Texas Health Presbyterian Hospital in Dallas and other other institutions describe the massive infection prevention response that followed the infection of two MICU nurses who cared for the index patient from Liberia. The responses included protocols for specimen handling, managing medical waste and standardized PPE with education and monitoring. Nothing particularly novel in 2016, but the article certainly highlights the massive efforts and costs associated with the N=1 response that was required because of a chronically underfunded public health and infection prevention infrastructure.

5) A Novel Microbiome Therapeutic Increases Gut Microbial Diversity and Prevents Recurrent Clostridium difficile Infection (Khanna S et al. J Infect Dis 15 July 2016). The authors describe an alternative method to fecal transplants that could potentially avoid donor screening among other barriers. They tested SER-109, which is encapsulated spores captured from healthy human donor stool that was treated with ethanol to eliminate pathogens, for the prevention of recurrent CDI. The cohort of patients had to have had >3 CDI cases in the prior 12 months and a clinical response to antibiotic therapy for their current CDI episode immediately prior to dosing of SER-109. The 15 patients in cohort 1 received high-dose capsules (15 on day 0 and 15 on day 1) and 15 patients in cohort 2 received lower dose capsules on a single day. Overall, 87% achieved the endpoint of no CDI at 8 weeks. If you're interested in reading more, there is an excellent accompanying editorial.

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!