REDUCE MRSA by getting horizontal

The results of this large cluster-randomized trial of different MRSA prevention strategies are now out in the New England Journal of Medicine, and are being widely (and mostly accurately) reported in all the major media outlets. Those who have followed this blog for any length of time know that we are not surprised at the results. Here’s just a sample of what we’ve written on the topics of active surveillance and the difference between horizontal and vertical infection control strategies.

I can keep this post short, because Mike Edmond and Dick Wenzel have already done my work for me in their excellent accompanying editorial (no subscription required!). I’d mostly like to congratulate and thank Susan Huang (pictured) and her excellent group of collaborators from HCA and CDC for making this very important contribution to the infection prevention literature, a contribution that should have a major impact on prevention practices.

But is it really “case-closed” on universal MRSA active surveillance, as the title of Mike and Dick’s editorial suggests? Every study that has questioned the effectiveness of MRSA screening has been followed by a barrage of letters-to-the-editor questioning the findings, and I suspect that this study will be no different. Later this week I will predict the contents of these future letters with uncanny accuracy. Stay tuned….

15th ESCMID-SHEA Training Course in Hospital Epidemiology - Brussels

Last year I joined the faculty of the annual ESCMID-SHEA training course in hospital epidemiology. It was one of the most rewarding and educational experiences I've had during my 15 years in hospital epidemiology. The course is held annually in a location that allows close interaction and fellowship between the students and faculty. For this year, we've updated the content with a new course concept. The course has three contemporaneous modules:

Module A: Healthcare-associated Infection Prevention and Management Core Module (Limit 50 participants)

Module B: Applied Infection Control Module (Limit 35 participants)

Module C: Healthcare-associated Infection Advanced Epidemiology Module (Limit 25 participants)

Date: 22-25 September 2013

Please see the brochure and website for further details on registration and the individual modules.

Course Faculty:
Marc J. M. Bonten, MD, PhD Utrecht, The Netherlands
Ben Cooper, BSc, Msc, PhD Oxford, UK
Markus Dettenkofer, MD Freiburg, Germany
Bart Gordts, MD, MBA Antwerp, Belgium
Loreen Herwaldt, MD Iowa, USA
Arno Hoes, MD, PhD Utrecht, The Netherlands
Jan Kluytmans, MD, PhD Amsterdam and Breda, The Netherlands
Leonard Mermel, DO, ScM, AM (Hon), FSHEA, FIDSA, FACP Rhode Island, USA
Eli N. Perencevich, MD, MS Iowa, USA
Evelina Tacconelli, MD, PhD Tübingen, Germany
Christina Vandenbroucke-Grauls, MD, PhD Amsterdan, The Netherlands
Andreas Voss, MD, PhD Nijmegen, The Netherlands
Andreas F. Widmer, MD, MS Basel, Switzerland

Broad Street chump

We now revere John Snow, the father of modern epidemiology, for his brilliant work in tracing (and eliminating) the source of a cholera epidemic. Back in the day, though, Lancet founding editor Thomas Wakley was, to put it mildly, not a big fan. Here is John Snow’s obituary, published in Lancet on June 26, 1858:

“This well-known physician died at noon, on the 16th instant, at his house in Sackville Street, from an attack of apoplexy. His researches on chloroform and other anaesthetics were appreciated by the profession.”

Well, last month Lancet decided to right this wrong by publishing a “corrected” obituary. Read the interesting backstory for an explanation of why Snow had so many critics at that time. Note his private life, which mirrors that of many present-day epidemiologists:

“He took no wine nor strong drink; he lived on anchorite's fare, clothed plainly, kept no company, and found every amusement in his science books, his experiments and simple exercise”

h/t to the Iowa Dept of Public Health for including the Lancet link in their weekly update

FDA shoots self in the foot

Last week I blogged about the FDA's ruling to classify human stool as an investigational new drug, making it more difficult for patients with recurrent C. difficile infection to undergo fecal transplantation, an incredibly effective therapy.

I was scheduled to perform a fecal transplant on a patient this morning, but notified her a few weeks ago that we could not proceed because of the new ruling. She asked to keep the appointment with me anyway. She presented to clinic this morning and informed me that she had performed the transplant at home a few days ago. And she was happy to report that she was feeling much better!

As it turns out, I have at least 3 more patients in the process of preparing for self-administered fecal transplant at home. The instructions for doing so are readily available on the internet. I suspect this do-it-yourself movement will now become widespread. It's ironic that the attempt by the FDA to regulate this procedure in the interest of safety appears to be driving a completely unregulated and more risky response.

Someone should have reminded the FDA that unlike the usual investigational new drug, which is impossible to obtain outside of a highly regulated and structured mechanism, human stool is readily available, easy to procure, and impossible to regulate. These patients are highly motivated, know the data on effectiveness, and won't be told no!

Photo:  Vendor Alley

The end of antibiotic stewardship, 2013 edition

Back in the 1990's when I was a wide-eyed ID fellow, I'd wonder out loud to my co-fellows Sara Cosgrove and Dan Levy why it was that we needed an oncologist's approval to prescribe chemotherapy but any clinician could prescribe antibiotics. My reasoning was that if you make a mistake with chemotherapy in a cancer patient, you only harm that one patient, but when untrained clinicians prescribe antibiotics all willy-nilly they harm the whole planet. Well, it's 2013 and I'm still wide-eyed and have the sinking feeling that antibiotic prescriptions are about to go way beyond willy-nilly. And I'm a bit scared.

The reason for my worry is this paper by Hanne Albert and colleagues in the European Spine Journal. In the study, patients with 6-months of low back pain and Modic 1 changes on MRI were randomized to 100 days of antibiotics (amoxicillin + clavulanic acid). The reasoning behind antibiotics for back pain is a study that found P acnes and C propinquum in surgical specimens from lumbar herniated disks. Anyway, the study reported improved primary and secondary outcomes with treatment and no change with placebo.

So why am I worried?  Just look at the headlines from my google search above. I would normally link to these articles, but I don't want to send traffic to posts that aren't appropriately skeptical of this single trial and the public health implications of giving everyone with back pain 100 days of antibiotics. One UK surgeon was even reported to have said this finding is worthy of the Nobel Prize. Yikes.

For an appropriately skeptical and balanced discussion of this study and the surrounding hype, please read this Observation in BMJ by GP Margaret McCartney. After I read the study and Dr. McCartney's excellent commentary, I forwarded them onto Sara Cosgrove. It was therapeutic for me to share my concerns with an old friend. But now I'm back to panicking.

The kibosh

Over the past several days I have spent a lot of time talking to patients, trying to explain why I've had to cancel their upcoming fecal transplant. The FDA has ruled that stool is an investigational new drug (IND), which now imposes a huge bureaucratic hurdle to getting a much needed therapy for patients with recurrent or intractable C. difficile infection. Today's Omaha World-Herald covers the new ruling and features our fellow blogger Dan Diekema. 

Even before the FDA did this, there were already hurdles for patients who are really suffering a great deal. First, there are few physicians who are providing this therapy. I have had patients drive over 8 hours to come for a treatment that is quite primitive but amazingly effective. For the doctor it's time consuming and the reimbursement is very poor. Nonetheless, I have felt morally compelled to provide this therapy and as a result I have many thankful patients. Then there is the issue of insurance companies not covering the cost of donor testing, which costs $1500-2000. Now there's the additional burden of the FDA red tape and the numerous documents required by institutional review boards.

So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can't say but will either approve or not approve my protocol. Now wouldn't it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I'm-thinking-and-wait-30-days game?

Ok, enough Debbie Downer. Now something positive: here's an article about a pathology resident at Emory University, Dr. Hunter Johnson, who goes beyond the call of duty and serves as a stool donor. In the article he talks about how important it is to perform on command. I learned that lesson the hard way. When I first starting performing fecal transplants, I explained to patients the important exclusions for donor selection, such as no recent foreign travel and no recent antibiotics. But I never thought to tell patients that choosing a donor who has problems with constipation is probably not a wise choice until the day the patient arrived for a transplant with his donor but with no stool specimen in hand. Constipation is now on my list of exclusion criteria for donors!

Photo of Dr. Hunter Johnson by Eric S. Lesser, NBC News.com

Hat tip: Kathy Kreutzer 

Hand Hygiene Causes Obesity

Subtitle: "Or how you can associate almost anything with a weak study design."

One of my favorite epidemiological study designs is the temporal association "ecological" study that attempts to infer causation by showing one exposure increasing and one outcome increasing and then implying that the exposure is causing the outcome. You know, "Hey, they are both going up so one thing causes another." Vaccine use and autism rates anyone?  So, just for fun I've produced the graph above and as you can see, through the efforts of CDC, WHO, VA and many individually hard-working IPs, hospital epidemiologists and clinicians hand hygiene compliance has increased. And as you can also see obesity is also increasing, ergo hand hygiene causes obesity!  Just try to disprove it!

Now, why am I wasting time with such an exercise? Because there is a paper in this June's ICHE that uses a similar study design and comes to an equally incorrect and perhaps dangerous conclusion.  The study used 2008-2011 data from Ontario to compare yearly hand hygiene compliance rates to quarterly MRSA rates and monthly CDI rates. The study found that despite increases in hand hygiene compliance there was little change in MRSA and CDI rates over this period. The author then concluded: "This study supports the emerging evidence that once a threshold level of hand hygiene compliance is achieved, there is very little if any benefit to attempting to achieve higher rates of hand hygiene compliance among healthcare providers."

Well, except that you can't conclude that from such a study design. For one, the author didn't have exposure and outcome from the same time periods. Why would we think average hand hygiene compliance over an entire year would correlate with monthly CDI rates and quarterly MRSA rates?  And how can we not consider other factors at play like the emergence of NAP1 or CA-MRSA during this period? Maybe there's even a Simpson's Paradox here, but that's a topic for another day. Oh, and keep washing your hands. I doubt we've reached a "threshold" of compliance!

Addendum: Probably the biggest flaw in this study is the accuracy of the reported hand hygiene compliance rates. No doubt the rates are lower than reported.

Who is Maurice Hilleman?

This will be the correct response if Alex Trebek ever says: “American vaccinologist credited with saving more lives than any other scientist in the 20th century”. It amazes me that Hilleman is not a household name, and that he didn’t win a Nobel prize. Even after paying close attention during medical school, internal medicine residency, and two fellowships (in infectious diseases and clinical microbiology), I had very little understanding of his immense contributions to infection prevention until I begin reviewing the mumps vaccine literature during the Iowa mumps outbreak in 2006.


So please, take a few minutes to read this excellent NY Times piece about Hilleman.