Tuesday, August 4, 2009

MRSA active surveillance: More sources of bias

A few days ago, Dan blogged about some sources of bias in the MSRA active surveillance debate--publication bias, citation bias, and editorial bias. To that I would add another form of bias, which I'll term "guideline committee bias." In 2003, the SHEA Guideline for Preventing Nosocomial Transmission of Multidrug Resistant Strains of Staphylococcus aureus and Enterococcus was published. This guideline has been used repeatedly by those outside the infection control community to argue that all hospitals should perform active surveillance for MRSA, a position actively espoused by Drs. Farr and Jarvis, two authors of the guideline. The guideline lists 7 authors, each of whom is a reputable healthcare epidemiologist. However, what is not apparent to many readers is that of the 7 guideline authors, 3 were relatively senior and 4 were relatively junior. All 4 of the relatively junior authors were former trainees of 2 of the senior authors. So it leads me to wonder whether there were 7 independent minds sitting at the table when the guideline was developed. Moreover, one must speculate as to whether the outcome of the process was predetermined and the individuals chosen to make that outcome happen. All trainees are heavily influenced by their mentors--the entire process of mentoring centers around the handing down of a thought process for approaching problems. In my own case, though my professional decision making is now independent of my mentor, I would venture to guess that we agree almost always on our approaches to problems in infection control. The proverbial apple doesn't fall far from the tree.

There's one last form of bias that is worth mentioning and was noted by Wachter et al in an editorial in the Annals of Internal Medicine last year. They criticize a CMS policy that required that the first dose of antibiotics for pneumonia patients be given within 4 hours of arrival to the emergency department. This policy, which was not well thought out, had unintended consequences that ultimately required that the rule be revised. They write:
In addition to financial conflicts of interest, caution should be exercised when individuals are both key investigators and policymakers, particularly when the stakes are high. In the case of TFAD [time to first antibiotic dose], several key researchers had positions with CMS and IDSA and helped drive the conversion of their own studies into performance standards. None of us can be entirely impartial when judging the merits of our own research.

Over five years have elapsed since the SHEA guideline was published. It's time for a new guideline, and SHEA should ensure that the process is open, fair, and includes experts with varying viewpoints on how to control multidrug resistant pathogens.

10 comments:

  1. Was Copernicus “Biased” By Seeing Scientific Data

    Edmond argues that the authors of the 2003 SHEA Guideline for control of MRSA and VRE were “biased.” He also says that 4 authors were “relatively junior,” but 4 were senior investigators (3 of these had served as SHEA President), and one of the “relative juniors,” a CDC investigator on the 2001 U.S. anthrax outbreak, had finished his period of working with his mentor as a fellow 11 years earlier at the time the guideline was published. Another “relative junior” had finished working with her mentor as a fellow 4 years earlier and had worked as Hospital Epidemiologist at a major university teaching hospital during those 4 years.

    Authors of the 2003 SHEA Guideline were selected without the old style bias of ageism [which Edmond implies that he may still favor] but rather because of demonstrated expertise [which usually implies a requirement for success] controlling nosocomial, antibiotic-resistant pathogens like MRSA and/or VRE.

    By contrast, most of the people selected to serve on HICPAC who authored the HICPAC/CDC Guideline for controlling MDROs published on the CDC website on October 18, 2009were chosen politically to represent various constituencies and had no track record of demonstrated expertise controlling nosocomial, antibiotic-resistant pathogens like MRSA and/or VRE. Moreover, it is likely that most HICPAC members had never even seen such pathogens convincingly controlled at hospitals where they worked. Likewise, the 2008 SHEA Compendium MRSA recommendations were authored by many (including many “relative juniors”) with little or no expertise documented by publications demonstrating control of MDROs in general or MRSA in particular. Among senior Compendium authors there seemed to be a preponderance of opponents of routine active detection and isolation (ADI) for MRSA. Did author selection for the Compendium thus reflect bias? The MRSA Compendium Guideline was discussed during a conference call of the Council of Past SHEA Presidents, and Dr. John Boyce asked why the current SHEA Board [who were represented on the call] would exclude him from working on such a guideline after the many MRSA studies he had conducted and published throughout his career. No cogent answer was provided during the call.

    Was Copernicus “biased” against the hypothesis that the Earth was the center of the universe and being orbited by the sun as preached dogmatically for eons or was he merely influenced by seeing scientific data? Was Dr. P. C. A. Louis “biased” against the hypothesis that bloodletting was beneficial to pneumonia patients as preached dogmatically since the time of Hippocrates or was he merely influenced by seeing his epidemiologic data? Was recent Nobel laureate Dr. Barry Marshall “biased” against the hypothesis that peptic ulcer disease couldn’t be caused by infection as preached dogmatically for many years, or was he merely influenced by seeing his data about Helicobacter pylori?

    Edmond doesn’t bother to mention that over 160 epidemiologic studies have reported success controlling MRSA and/or VRE using ADI [as advocated by the 2003 SHEA Guideline] and that relatively few studies [each with serious methodological problems] have reported failure. Are epidemiologists “biased” once they have seen data repeatedly showing that an intervention works [when the vast majority of U.S. healthcare facilities have shown poor control for decades]? Scientists are supposed to be able to change their views to accept what the bulk of the pertinent data show to be true—otherwise their views are due to prejudice based on dogma.

    Once you’ve seen photographs of the Earth taken from the moon, it is hard not be “biased” against the medieval hypothesis that the Earth is flat.

    Sincerely yours,

    Barry Farr, MD, MSc
    William R. Jarvis, MD

    ReplyDelete
  2. Over 160 studies demonstrate that ADI works to control MRSA, the military has been doing it for years with success, and in our small state of NH one of our hospitals that instituted it cut their MRSA rate by 50% which was recognized with an award from the IHI.

    The reason this hospital implemented it was because their new medical director came from the VA system and basically convinced top management at HCA that they needed to mandate it. Are other hospitals in NH doing it? No. Do you know why? The answer I hear from legislators and healthcare decision makers in our state is: "We don't have national guidelines for it." They same the same thing about tracking VAP, which has a mortality rate of 46%.

    What we need in healthcare are more experts in quality control from fields outside of medicine.
    We have too many minds focused solely on a research model for implementing guidelines instead of common sense and proven measures that work. Provonost proved that when he came up with a simple checklist.

    In the meantime, states are dragging their feet with mandating things like infection reporting, ADI for MRSA & VRE, or even tracking MRSA or C.Diff because they claim that: "we need national guidelines before we can do that."

    In them meantime, national guidelines are often too slow to come and anemic at really addressing patient safety and reducing patient harm or death from these infections.

    If only researchers, public policy, public health, and healthcare administrators would set the agenda for these guidelines by first asking "how can we best reach an optimal reduction in patient harm and death from HAI's?" will they arrive at guidelines that provide real solutions.

    ReplyDelete
  3. You cite a hospital that lowered their MRSA rate by 50% using ADI, which is an outcome that we should applaud. However, at my hospital we have lowered MRSA rates by 84% WITHOUT ADI. So the point is that while ADI may lower MRSA rates, there may be cheaper, more patient friendly, safer and more effective ways to approach this problem.

    ReplyDelete
  4. Mike,

    You present an example of the very conondrum that we find ourselves in; every hospital is practicing in it's own vacuum, 'trying' different approaches that they 'think' might work. In the meantime, patients are being harmed and dying, their families infected with MRSA when they carry it home, etc, etc.

    I hear from families every day who tell me that hospital staff never even disclosed that it was a MRSA infection, never told them it could be carried home to their families, and never told them that they might have life-long consequences.

    What we need is an oversight agency that sets standards (like OSHA)that would go in and do an independent investigation every time a patient is harmed or dies of a diagnosis that was different form their admission diagnosis. Most hospitals aren't even keeping track of MRSA and hospital associations across the country are fighting legislation that would require tracking so how can we expect to address a problem that we're not even tracking the frequency of?

    Tracking, screening, & isolation are basic public health and infection control guidelines no matter what communicable disease is being discussed.

    Sadly when it comes to MRSA and other HAI's (C. Diff, VAP, etc.) the politics of running hospitals and protecting their reputaions is getting in the way of reducing harm and saving patients lives.

    Just look at the national attention and public health $$ that's being invested in H1N1. Yet evidence is showing that a good proportion of the deaths associated with H1N1 is due to co-infections with bacterial infections like MRSA.

    The more I learn the more I've come to realize that the very healthcare system that we depend on to get us well again is in reality a leading cause of death in America.

    It's like 'Freakanonics'...we have the very best healthcare in the world if you're faced with a serious diagnosis. But you're more at risk of dying in a hospital as a patient from unsafe care than you are of dying in a motor vehicle accident.

    ReplyDelete
  5. Dr. Edmonds' said:

    "So the point is that while ADI may lower MRSA rates, there may be cheaper, more patient friendly, safer and more effective ways to approach this problem."

    As someone who has been a well-known opponent to MRSA and VRE control, I find it suspicious that Dr. Edmonds is now taking credit for a success for which he cites no information or data to support.

    In his eagerness to disparage the 2003 SHEA guideline, Dr. Edmonds refers to authors of that guideline, in polite terms, as mere dupes of their self-interested mentors.

    Furthermore, Dr. Edmonds casual comment that maybe we can find cheaper and less burdensome ways of controlling hospital-spread MRSA and VRE, rather than using an overwhelmingly proven effective approach (i.e. ADI), he demonstrates a callous disregard for the lives of patients in real time and betrays his lack of concern over the egregious spread of these pathogens in healthcare.

    It is the "leadership" of people with the thinking of Dr. Edmonds that is responsible for enabling this four-decade long epidemic to spiral out-of-control.

    As far as Drs Farr and Jarvis are concerned; they are the type of scientists and physicians that my father once respected and looked up to. Had there been more healers like Drs Farr, Jarvis, and Muto, my father's life would not have been taken by hospital-spread MRSA and VRE.

    Shame on you Dr. Edmonds!

    ReplyDelete
  6. First, I thank you for reading our blog and sending your thoughts. Second, I am very sorry for the loss of your dad. I just got home from a long day of caring for inpatients with many types of infections. I take my responsibilities as a doctor and epidemiologist very seriously so I found some of your comments about me personally to be unfair. I am so concerned about the transmission of infection that I no longer wear a lab coat, long sleeves, or even my wedding ring when I see patients. When I am not seeing patients, the rest of my time at work is devoted to figuring out ways to reduce infections.

    How to control multidrug resistant infections in the hospital is one of the greatest debates in infection control. Drs. Farr and Jarvis favor a vertical approach—pick the pathogen you want to eliminate, find the patients who have it, and isolate those patients. I favor a horizontal approach—universally and at a very high level of consistency apply simple practices like handwashing, bathing of patients with chlorhexidine, meticulous placement of intravenous lines, etc.

    My zest for the horizontal approach is that it not only prevents transmission of VRE and MRSA but numerous other pathogens found in hospitals. I just finished analyzing my hospital’s data for 2009 and comparing it back over the years since we began our horizontal program. We have progressively reduced infections due to all organisms. In fact, for the last 6 consecutive months, there has not been a single hospital-acquired, device-related MRSA infection in any of the 8 ICUs in our large, urban teaching hospital. Our MRSA infection rate in 2009 was 94% lower than it was in 2003. MRSA now accounts for <4% of our hospital acquired infections. Our hospital-wide hand hygiene rate has increased from 45% several years ago to 91% in 2009 (45,000 observations performed in 2009). So I have demonstrated that my approach works in my hospital. I have never argued that the Farr/Jarvis approach doesn’t or can’t work. However, I strongly disagree with their assertion that their way is the only way.

    Here’s my challenge to you: pick the hospital epidemiologist that you think has the best approach and ask them how many MRSA infections they’ve had across their ICUs over the past 6 months. I’ll make you two wagers: (1) they won’t answer your question, and (2) if they did, their results would be no better than mine.

    I encourage you to keep following our blog!

    ReplyDelete
  7. Thank you for responding Dr. Edmond.

    I apologize for my visceral response, however, the subject matter involves life and death on a grand scale and the clear failure of healthcare leadership to address it effectively for decades deserves far more than casual conversation.

    The approach advocated by the 2003 SHEA guideline does not in anyway substitute controlling MRSA and VRE for other pathogens. In fact, numerous studies have shown reduction in other bugs, such as C. diff, when an aggressive infection control program such as the 2003 SHEA guideline is deployed and complied with.

    On the contrary, numerous studies have also shown hand hygiene campaigns to have no appreciable effect on lowering MRSA and VRE rates (Huang et al, and Rupp et all to name just two).

    It is without controversy that MRSA and VRE have been the two most egregiously out-of-control pathogens in healthcare for a very long time. Therefore focusing special attention of them not only makes sense, it is a moral imperative since they are injuring and killing enormous numbers of people.

    Assuming arguendo that your statements about your hospital's success are accurate, the question is still left begging of why you would opt for a strategy that is backed by little science instead of one that is supported by overwhelming science? And, who is to say that the approach that you espouse can be replicated across a wide variety of settings the way that the 2003 SHEA guideline approach has been proven effective and sustainable in a full spectrum of venues?

    As far as your challenge; I'm certain that there is no shortage of epidemiologists in Northern Europe, Western Australia, or the entire US Veterans Administration hospital system that could point to rates lower than what you state you have achieved and for much longer periods of time. In the case of Northern Europe, the time frame would be measured in decades. How many lives were saved over that time as compared to what has taken place in our hospitals?

    Dr. Edmond. My passion for the approach advocated by the SHEA guideline springs from the love of my father who after having sacrificed more for this country than 50 of us put together was tortured to death by the failures of our healthcare system. And he was infected with at least 6 different pathogens, not just MRSA and VRE.

    Every day, there are more and more Michael Bennetts being created by this systemic negligence.

    Again, I apologize for my visceral response. But I hope that you can understand why I and so many others feel so strongly about this and are so disappointed in those whom we would prefer to trust and respect and whom we know would be taking a far more aggressive position if it were doctors and nurses that were being injured and killed.

    ReplyDelete
  8. If you email me at medmond@vcu.edu, I would be happy to set up a time to discuss further. We share the same goal (reducing HAIs) and I suspect there is much more common ground between us than you may think.
    best--
    mike

    ReplyDelete
  9. I'm glad that you've gotten your rates down to zero...but if you really care about saving lives, why are you being so dismissive of known methods of prevention for long term suffering and preventable death from MRSA and other healthcare-associated infections? ADI has worked with large volumes of people--and that's what we need it to do here in the U.S.

    If you really want to help, use your knowledge, expertise and talent to convince the CDC that we need a national mandate to implement the basic standards of communicable disease prevention in our hospitals; detection/isolation/decolonization/tracking & reporting.

    Between MRSA, VRE, and C.Diff, we have a leading cause of death from communicable disease being spread in our hospitals/nursing homes with no nationally accepted/implemented guideline to prevent it with urgency.

    Each hospital is working in its own vacuum 'trying' different approaches and because we don't have access to meaningful outcome data, we don't even know which ones are working or not.

    Is there a cure for politics, bureaucracies, and egos in the most expensive healthcare system in the world?

    ReplyDelete
  10. In medicine we have to always be looking for better, more effective ways of treatment and prevention. Wouldn't it be sad if we mandated an approach, when there's actually a potentially more effective method being discovered? ADI is not a holy grail. We need to keep looking and testing in all that we do, otherwise we'll be locked in a time warp forever. If someone told me 5 years ago that hand hygiene at my hospital could exceed 90%, I would have laughed at them. Ten years ago, nearly no one believed that central line associated bloodstream infections could be reduced to the levels that were first shown by Pronovost. Progress entails a constant search and an open mind.

    ReplyDelete