Archive for February, 2014

They're transplanting what?

Monday, February 24th, 2014

I read an article in The New York Times that gave me pause for a moment. It was on fecal transplants. Initially that didn't seem to make sense. Then I remembered there had been something on this topic last year in the New England Journal of Medicine, a Dutch study done at an academic center with the title "Duodenal Infusion of Donor Feces for Recurrent Clostridium Difficile."  So I did a Google search and found the Mayo Clinic's website for medical professionals where the subject was titled "Quick, inexpensive and a 90 percent cure rate."

Why in the world would you need this kind of a transplant? Well let's start with the possibility of eliminating  a majority of 14,000 deaths a year in this country alone. The CDC website on the bacterial overgrowth that can cause the issue is a good resource, but let's start with a few basics. Your intestines normally have lots of different kinds of bacteria, up to 1,000 varieties according to some experts. The term "gut flora" is often used to mean our normal sea of bowel bacteria.  But when you take antibiotics, especially for a prolonged time, you run a risk of getting rid of the balance between bacterial species and having some (that are normally harmless) cause major problems.

I may need another roll after this one!

I may need another roll after this one!

One of these kinds of potentially nasty "bugs" is called Clostridium difficile technically, or C. diff as a shortcut name. The WebMD site has an easy-to-understand short tutorial on C. diff When it becomes the predominant gut flora it releases toxins that attack the bowel lining and causes severe diarrhea with up to 15 watery stools a day, fever, weight loss, abdominal pain and blood or pus in the stools. The disease often hits older patients (those over 65, so I'm in that higher risk category) and, in the past, was usually treated with one of three antibiotics given orally. Up to a quarter of those so treated need a second round of antibiotics.

The Dutch study randomly assigned patients to standard treatment with a drug called vancomycin, or the same drug plus four liters of a bowel-cleansing solution, or the drug plus that bowel washout plus infusion of a solution of donor feces through a tube inserted through the patient's nose and into their stomach (typically called an NG tube, shorthand for nasogastric). Less than a third of those in the first two groups had their diarrhea resolve while 81% of those given the fecal infusion (13 of 16) improved after one treatment and only one of the three remaining patients didn't improve after a second infusion.

One Mayo Clinic branch had tried a fecal transplant in 2011 in a patient with severe C. diff colitis (inflammation of the large bowel). In that case the medical staff infused the patient with their brother's stool given via a colonoscope, instead of an NG tube, therefore going up the intestinal tract, not down and getting right to the colon. The patient had been bedridden for weeks prior to the procedure, but was able to go home within one day after it.

Since then the same Mayo branch has done 24 fecal transplants. Every one of the patients had their infection go away within a short period of time; only two had a recurrence of the disease. (both had other illnesses). The senior nurse who played the major role in starting the Mayo program interviewed every patient and said their quality of life improved tremendously. Mayo now uses the procedure only for those who have severe relapsing C. diff infections, but is researching its use in other medical diseases.

Then in 2012, Mark Smith who was a doctoral candidate launched OpenBiome with three colleagues. It's a nonprofit 501 (c)(3) organization they organized after a family member/friend had gone through seven rounds of vancomycin for a C. diff infection that lasted a year and a half. They call the procedure Fecal Microbiota Transplantation (FMT) and, according to the New York Times article, they've supplied more than 135 frozen, ready-to-use Fecal Microbiota Preparations to over a dozen hospitals in the last five months. Much of the work is done in M.I.T.'s laboratories. All the medical facility needs is a doctor with an endoscope.

So have we solved the C. diff overgrowth problem or nearly so? I went back to a July 12, 2010 article in The New York Times titled "How Microbes Defend and Define Us." It described the work of a University of Minnesota gastroenterologist, Dr. Alexander Khoruts, who not only performed a fecal transplant on a woman with an intractable C. diff gut infection, but also looked closely at what bacteria were in her intestines before and after the procedure.

In this case the donor was the patient's husband and the analysis of the gut flora revealed his bacteria had taken over, supplanting the abnormal bacteria that were there before the transplant.

Khoruts continued to use the new procedure, fifteen by 2010 with 13 cures, but according to the NYT article, is now concerned that OpenBiome's model is just an early step. The Food and Drug Administration, in early 2013, classified fecal transplants as biological drugs. As such, any clinician who wished to use them would need to obtain an Investigational New Drug (IND) application, much as a pharmaceutical company would need in developing a new antibiotic.

Since then the FDA has relaxed their ruling, slightly, saying doctors performing FMTs for C. diff wouldn't be prosecuted. Smith and colleagues want FMT to be classified as a tissue, not a drug, allowing more research to be done on the procedure in other diseases and conditions and, at the same time, letting clinicians use FMT, at least for C. diff, without an IND permit or fear of FDA reversing its stance on such therapy.

There are a host of other diseases where FMT has been suggested as possibly effective in treatment. Some seem farfetched to me at first glance, but investigators appear interested in pursuing research on many of those conditions. I bet they would need an IND in such cases, even if FMT is reclassified as a tissue.

We all have bacteria in our colons, but in other places too.

We all have bacteria in our colons, but in other places too.

Khoruts and others think FMT for C. diff is just the tip of the iceberg. The NIH has been carrying out a huge Human Microbiome Project since 2007 with the first five years  of the investigational study being devoted to cataloging the microbiome of our noses, skin, mouths, GI tracts and urogenital systems. That term refers to the aggregate of all the microorganisms, including bacteria and fungi that live on and in our bodies. From 2013 on they have shifted gears, aiming at an integrated dataset of biological properites in microbiome-associated diseases.

Having read a number of papers and looked at a variety of source materials on the concept I'm no longer astounded by the idea. It still sounds strange, but obviously reputable academic centers have pioneered this research with great results.

One question that seems unresolved was highlighted on a patient-website. Is my bowel flora the same as someone's who lives in another part of the world and eats a totally different diet?

But it seems like FMT, in one form or another, is here to stay.

Electronic Health Records & Medical Scribes

Wednesday, February 5th, 2014
Turn over the data entry to someone else, doctor.

Turn over the data entry to someone else, doctor.

Recently, in the online version of The New York Times, I saw an article by Katie Hafner titled "A Busy Doctor's Right hand, Ever Ready to Type." The article described a new movement among medical personnel, one to hire scribes to make entries into an Electronic Health Record (EHR).

The concept made great sense to me, but it's clearly not a new one. Our ophthalmologists have, over the last fourteen years, routinely had an assistant who entered data into some form of a medical record, allowing the physician to concentrate on examining us.

Only five years back the use of an EHR was clearly the exception for other medical personnel with perhaps a tenth of physician office practices and hospitals utilizing them. now that percentage is well over two-thirds.

So what are the problems with universal acceptance of EHRs?

One that I touched on in my previous post on EHRs is interoperability between different health-record systems. My translation of that term is that Dr. A using, for instance, Epic at a UCH site like our local hospital, should be able to access and read my medical record from the Department of Defense or the Veteran's Affairs' systems. At the moment I doubt that's even remotely possible and there will obviously be issues with patient confidentiality. Those should be eventually solvable, although the mechanism for doing so is well beyond my computer skill level.

But, for an individual practitioner, on a day by day patient-care basis , there's an entire other set of issues.

I had mentioned in a recent post our pleasure at watching a Family Practice intern who kept eye contact with her patient (in this case my wife) while she examined her and informed her about test results.

The intern wasn't entering data and there's the rub with an EHR. She presumably had the choice of doing her examination and keeping as much eye contact as possible with her patient while remembering all the accumulated data points versus typing while she asked questions and, if she were a typical doc typist, looking at the keyboard and the screen much of the time.

The opposite end of the spectrum was a nurse who, in order to give Lynnette an ibuprofen tablet, spent twelve minutes (I timed the interaction) between my request for her pain med and it being put in her mouth, mostly on the computer, occasionally glancing up to ask a question (e.g., "On a scale of one to ten, what is your pain level? What is your full name and date of birth?{the fourth time she'd asked that during her shift}).

As the EHR has grown more complex, with more mandated information being necessitated by organizational, certifying and governmental entities, the potential for increased human-machine time has grown hugely, while the doctor-patient segment of a physician's day is squeezed.

The potential for burnout of physicians, especially in emergency medicine, family practice and primary care internal medicine has increased. The link is to a free article that appeared in the Archives of Internal Medicine in 2012 comparing both burnout and satisfaction (with physicians' balancing work and outside life) to others in the United States. Bottom line was of the 7,000+ docs who filed in a survey, over 45% had some symptoms of burnout and were much less satisfied with their ability to find a counterpoise between their work time and the rest of their life than those with comparable professional degrees.

Burnout meant less enthusiasm for work, development of cynicism and less of a sense of accomplishment than those of us who practiced medicine years ago had. There are lots of components as to why this has become more common among "front-line" physicians, but as I've talked to some recently the EHR has been a very significant contributor.

This was a somewhat unexpected development for me, although based on what I had seen with my radiologists attempting to dictate into an earlier version of an EHR in 1988-1991, not one that I  should have been surprised by.

Adding one more to the medical team should be easy.

Adding one more to the medical team should be easy.

There is a growing industry providing medical scribes to physicians and others and, since 2010, certification available through a non-profit, the American College of Medical Scribe Specialists. I was somewhat surprised that patients not only haven't objected to a scribe being present, but often have warmly welcomed them. They may be introduced as "my data entry specialist." Obviously, in teaching hospitals, patients see a team of physicians already. Only the most intimate parts of a physical examination would need to be conducted in a one-on-one basis. Then the scribe could be on the other side of a curtain and the doctor would verbally describe her or his findings.

If I had the choice of my physician looking at me almost all of the time and, in essence, dictating her findings (my own doctor is female) or having to type much of the time, my choice would be simple.

Then there's the possibility of a remote scribe. I had envisioned a future EHR which had set areas to be filled in and a practitioner being able to wear a headset and dictate into the EHR directly. I hadn't realized that some practices already have scribes who may be thousands of miles away from the patient-physician encounter, sometimes in India.

I went back to the New York Times article I mentioned initially and saw a quote from a family medicine physician who said, "Having the scribe has been life-changing." An article in the journal Health Affairs said two-thirds of a primary care doctors time at work was spent on clerical duties that could be done by others. Another doctor  said, "Making physicians into secretaries is not a winning proposition." She had surveyed over 50 primary care practice in the past five years, finding those who used scribes were more satisfied with their work and their choice of careers.

Doctors have been dictating patient records for fifty years, but those transcriptions often made their way to the chart many hours later. Having a scribe could cut that lag time immensely.

With our growing need for primary care physicians and the tendency for medical students to avoid those specialities, aiming toward more financially rewarding and less laborious fields in medicine, the advent of medical scribes may be not only a significant improvement for the lives of those already in front-line medical areas, but an inducement for new prospective physicians to join their ranks.

I'm heartily in favor of the idea.