By Kelly M. Pyrek
A new research consortium through which to address persistent knowledge gaps could be precisely what the healthcare epidemiology and infection prevention community has been waiting for in light of urgent scientific and clinical questions requiring more definitive answers. A report from the Research Committee of the Society of Healthcare Epidemiology of America (SHEA) reveals the results of a recent survey of SHEA members on their perceptions of gaps in the healthcare epidemiology knowledge base and members priorities for SHEA research goals. The survey also assessed whether members would be willing to participate in consortium to address identified gaps in knowledge, and evaluated the need for training for the next generation of investigators in the field of healthcare epidemiology. (The survey return rate was 46 percent, with 593 out of 1,289 members responding.)
The newly formed SHEA Research Collaborative is expected to help address critical issues that SHEA members identified in the survey, such as setting the scientific agenda for healthcare epidemiology; developing collaborative infrastructure to conduct research; and developing funding mechanisms for research.
More than 88 percent of respondents said they believed that developing a robust infrastructure for training in research should be a primary role for the SHEA Research Committee, and that almost 92 percent of respondents characterized as important or somewhat important the concept of creating a collaborative infrastructure among SHEA members and partners to conduct research in healthcare epidemiology. SHEA members responding to the survey suggested a number of professional organizations as potential partners for the research consortium, including the Infectious Diseases Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the Centers for Disease Control and Prevention, the Institute for Healthcare Improvement (IHI) and the National Institutes of Health (NIH).
This SHEA member dialogue was continuing around the time of the Fifth Decennial International Conference on Healthcare-Acquired Infections held in March, during which a plenary session addressed the need for an adequately resourced, rigorous research agenda for the coming decade. Panelist David Henderson, MD, deputy director for clinical care and associate director for hospital epidemiology and quality improvement of the National Institutes of Health Clinical Center, noted that there is a problem with the science base that supports infection prevention and control. He explained that it is inadequate to provide definitive support for the HAI-reduction recommendations that are made. "Implementation science has reduced risk but it is not the complete answer," Henderson said at the Decennial meeting. "The existing guidelines have a one-size-fits-all approach that wont work in diverse healthcare settings." For example, Henderson pointed to the concept of bundles; while they appear to be effective, Henderson said some aspects of the interventions are better known than others and this knowledge gap is of concern.
"We need a stronger science base," emphasizes Henderson, who is also chair of the SHEA Research Committee. "It is much easier if you have ultimate scientific confidence in the principles you are implementing. We talk a lot about bundles of practices we know with varying degrees of certainty that aspects of bundles work and in some settings its entirely possible that some aspects of the bundle might actually be detrimental. Thats why we need the kind of studies that can help sort out those risk factors. If a practitioner calls me and says, Heres the nature of whats happening at my hospital and the patient population we have, it would be nice to be able to say with certainty, This is an approach you might take that will be successful. But we just dont have a science base that operates at that level currently."
At the heart of translational research is translating an idea from research into practice, going from the concept to the proof of the principle and then moving principle into practice in the real-world setting of healthcare. Henderson pointed to the current knowledge gaps, which included pathogenesis and the mechanisms of acquisition; epidemiology (including the role of the environment, optimal sites for culturing, settings in which screening is beneficial); the efficacy of prevention interventions such as hand hygiene, isolation, bundles, decolonization); study design; and technology (such as rapid diagnostics).
Reflecting on his comments at Decennial, Henderson says the concept of implementation science continues to be important in the fight against healthcare-acquired infections (HAIs) and adds, "Hopefully it will help us do the things we already know how to do well." Henderson explains further, "If one looks at the checkered history of hospital epidemiology all the way back to Semmelweis, there are many practices that are recommended but we dont accomplish them. If studies can help us implement the principles we know to be effective, then that will move us down the path toward increasing patient safety. But thats just part of the story. If implementation science depends on knowing what we actually think we know -- and there are many instances where I suspect thats not true or at least not true in specific settings there are factors that may influence a patients outcome that vary from one facility to another. So there is urgency for research in healthcare epidemiology across the spectrum, to try to help us understand epidemiology and pathogenesis; as we move from early translational science and work out principles in more detail, then implementation science will be even more powerful over time."
There is certainly no lack of critical issues requiring additional research, as enumerated in the SHEA member survey; respondents ranked the following issues as most important:
1. Multidrug-resistant Gram-negative organisms
2. Antimicrobial stewardship
3. Methicillin-resistant Staphylococcus aureus
4. Effective hand hygiene
5. Clostridium difficile infection
6. Intravascular catheterassociated infection
7. Surgical site infections
8. Preventing transmission of highly contagious infectious diseases
9. Implantable device-associated infection
10. Ventilator-associated pneumonia
11. Catheter-associated urinary tract infection
12. Vancomycin-resistant enterococcal infection
13. Improving healthcare worker safety
14. Preventing noninfectious healthcare-associated medical complications
"I believe the SHEA membership gave us a laundry list of issues that was quite accurate," Henderson says. "I think that the new research consortium is likely to address those issues based on scientific opportunity, that is, when one of our members or someone from the outside has a great idea about how to answer those questions, we have the vehicle to do it. Like a bullet train, you can bring your question and get on board and hopefully develop an answer with a high degree of accuracy in a short period of time because of the power of 350 or 450 hospitals working together."
Henderson continues, "These are the issues that healthcare epidemiologists and infection control professionals around the country work with on a daily basis. Many aspects of hospital epidemiology are sort of common sense-based and things our mothers might have told us to do, such as wash our hands. The problem is there is no adequate science behind these practices to say anything beyond the common sense perspective that these actions are associated with risk. What we really need is an allied group of hospitals that can take on these questions and come to a resolution on issues so we can tell healthcare professionals at the bedside that they need to mask and gown and heres why definitively."
Unresolved issues have lingered, and as the SHEA Research Committee notes, "The fact that many of these important questions have been identified for years but remain unanswered underscores the complexity of the topics." Research also has been stymied by significant barriers, including those identified by SHEA members:
1. Inadequate funding for specific projects
2. Lack of protected time for research
3. Inability to obtain grant, contract, and/or outside funding
4. Inadequate number of personnel
5. Human subjects protection approval process
6. Research is not a part of institutional mission
7. Inadequate clinical research training
8. Inadequate biostatistical support
9. Inadequate mentoring during training
10. Uninterested in clinical research
11. Regulations and regulatory oversight
12. Inadequately trained personnel
"Adequate funding addresses so many of these barriers," Henderson acknowledges, "so if we had more physicians who were funded to conduct research in the science of healthcare epidemiology, some of the other issues would disappear, such as lack of protected time, inability to retain a grant, and inadequate number of personnel. Admittedly, its a tough time for everyone with regard to funding. Its challenging all across academic medicine, and in my opinion, we represent a relatively underfunded area of science that we need to focus on over the next 15 years to begin to get a hold of the problem of healthcare-acquired infections."
The lack of controlled, randomized, multi-center studies has vexed the community for some time, with experts bemoaning the plethora of weak or ambiguous data instead. And when the rare study comes along that challenges practitioners current thinking, it can be a slow crawl toward getting the data published and implemented into practice. Such is the case with the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR-ICU) trial conducted by Charles Huskins, MD, and colleagues, which its author says "was designed to rigorously address an important and practical clinical question: Does an intensive infection control strategy reduce the endemic incidence of MRSA and VRE colonization or infection in adult ICUs more than a standard infection control strategy does?" By "intensive," Huskins refers to using surveillance cultures on admission and weekly, as well as aggressive contact precautions and hand hygiene; by "standard," Huskins indicates hand hygiene, standard precautions and unit-defined isolation precautions. As Huskins (2007) notes, "Only limited data in the peer-reviewed literature directly address this question, and no data are available from a randomized, controlled trial. We believe many people are keenly interested in the answer to this question."
"The STAR-ICU study was basically a test balloon, so to speak, to try to do the kind of studies we want to do, and that we need to do," Henderson says. "I think it has faced some challenges because these are very complicated studies to conduct. We want intellectual criticism and so you want people to say, Well, heres a real problem with this study and we need to somehow address this," but we need 200 Charlie Huskins working on this problem. With a larger patient population and a larger group of institutions we are more likely to have more horsepower to be able to answer questions such as the one posed by the STAR-ICU study. That was a great first attempt."
The bottom line is that not only could the consortium address the unresolved issues, it could serve as a vehicle for more effective communication and collaboration across disciplines and get practitioners out of their isolating silos of thought, research and practice.
"I think its essential to collaborate across the spectrum," Henderson says. "Many APIC members are tuned into the implementation aspects of what we do, some of the infectious disease physicians are closer to the bench, and the bulk of healthcare epidemiologists live someplace in between. So there is ample work for all of us to do and we will get it done best if we collaborate."
SHEA Research Committee. Charting the course for the future of science in healthcare epidemiology: Results of a survey of the membership of the Society of Healthcare Epidemiology of America. Infect Control Hosp Epidem. 2010; 31(7):669-675.
Huskins WC, et al. Design and methodology of the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR-ICU) trial. Infect Control Hosp Epidem. 2007;28(2).