Friday, March 29, 2013

Choose wisely when choosing wisely

The media was a buzz with the latest recommendations from lead medical organizations about overused tests and treatments.

Maggie Fox from NBC news states, "You don't need an MRI for lower back pain. You don't need antibiotics for a sinus infection. And you don't need to be screened for osteoporosis, either, if you're under 65. " The Washington Post's headline reads, "Group releases list of 90 medical 'don'ts.'" The New York Times similarly describes this report as a list of "don'ts."

All this stems from the Choosing Wisely initiative from the non-profit American Board of Internal Medicine Foundation in conjunction with Consumer Reports. The group asked most of the major physician specialty societies to come up with a list of the most common unnecessary things done in medicine. Each group came up with the top 5, to make up a list of 90 commonly overused tests and treatments. A few examples include:
--a feeding tube in patients with advanced dementia. (American Academy of Hospice and Palliative Medicine and American Geriatrics Society)
--a routine annual Pap test if you're 30 or older, or under 21. (American College of Obstetricians and Gynecologists).
--DEXA (dual-energy X-ray absorptiometry) screening for osteoporosis in women under 65 or men under 70, unless there's a suspicion of bone loss.
--a CT scan for a child with a minor head injury. (American Academy of Pediatrics)

This work is important as due to our fee-for-service system that reimburses for ordering tests and treatments whether or not they are effective or worthwhile, has proven to be costly and inefficient. Thus, cutting unnecessary testing or treatment in medicine will both save money and potentially reduce harm. For example, in many ERs across the country, almost all children that come in after a head injury get a CT scan. Not only has this not been proven to be effective, but radiating a child's head can increase the risk for cancer.

However, a word of caution is needed. Based on the headlines, one might think that these tests or treatments should never be done. Two major media outlets call these a list of "don'ts." However, this is not what the experts were saying. These are commonly overused tests and treatments, not useless. There might be very good reasons to get a CT scan after a head injury in a child that outweigh the very small potential increase risk for cancer. It is very important to understand this because it is possible that insurances and/or the government will use these recommendations to determine reimbursement.

While it is correct that physicians and patients should question the routine use of these tests or treatments, patients and doctors shouldn't have to fight with insurance companies to use these tests and treatments when they feel it is necessary.

Finally, if as a patient you question your physician about a test or treatment they recommend (which is the entire purpose of the Choosing Wisely campaign), be prepared to sign something that states you won't sue them should your refusal of their recommendation turn out to be wrong. While the Choosing Wisely campaign starts to address the problems with our fee for service reimbursement system, it fails to address the other major driver of health care costs- malpractice. Many physicians would likely gladly give up these over-used tests and treatments, but will not for fear of being sued.

Matthew Mintz, MD, is a Fellow of the American College of Physicians. He is board certified in internal medicine and has been practicing for more than a decade. He is also an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients. This post originally appeared at Dr. Mintz' Blog. Conflict-of-interest disclosures are available here.

We're doing it wrong--influenza vaccine edition

This prospective cohort study out of University of Michigan demonstrated that influenza vaccine didn't protect against PCR-documented influenza illness, influenza transmission in households, or medically-attended influenza. Given the good match between vaccine and circulating viruses during the 2010-11 season, and given that the population studied was predominantly healthy young adults and children, these results are pretty shocking (even in the context of other underwhelming data on the effectiveness of influenza vaccination). As John Treanor and Peter Szilagyi opine in the excellent accompanying editorial, "the apparent failure of influenza vaccine under optimal conditions seen in this study is indeed troubling."

One of the more intriguing findings of this study is that receipt of flu vaccine the previous year seemed to reduce the effectiveness of the vaccine, a finding that is not new. What struck me most after reading these two papers, though, was this statement in the editorial: "It is frequently stated that evaluation of influenza vaccines in randomized controlled trials is 'unethical,' but given that the effectiveness of the vaccine is unclear, the subjects in such studies are typically at extremely low risk of serious disease, and that effective antiviral therapy is available, perhaps this statement should be reconsidered."

When a vaccine's effectiveness causes experts to consider a return to randomized controlled trials, it's safe to say that the vaccine in question is pretty awful. We desperately need something better.

Daniel J. Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. This post originally appeared at the blog Controversies in Hospital Infection Prevention.

QD: News Every Day--SGIM commission recommends payment reforms

The National Commission on Physician Payment Reform said this week that fee-for-service payment is inefficient and problematic and should eventually be replaced.

The recommendation was one of 12 issued by the commission, which was convened last year by the Society of General Internal Medicine (SGIM) "to recommend forms of payment that would maximize good clinical outcomes, enhance patient and physician satisfaction and autonomy, and provide cost-effective care."

The commission found that although many factors affect the high cost of health care in the U.S., the fee-for-service payment system stood out as the most important. The recommendations included a call for a "transition to an approach based on quality and value," to be accomplished by testing new models of care over five years and then incorporating them gradually into more and more existing practices. Additional recommendations addressed payment for facility-based services, reimbursement for small practices, and Medicare's sustainable growth rate (SGR) adjustment, among other topics.

"Controlling rising expenditures for health care will not occur without changing the way that physicians are paid," the commission concluded. "This will require the aggressive pursuit of new physician-payment models with no delusions that the fee-for-service model will be swiftly or entirely eliminated. As we transition to various forms of blended physician payment, fixing current payment inequities under fee-for-service models will be of the utmost importance."

The commission's report was published March 27 by the New England Journal of Medicine and is available free of charge online.
Thursday, March 28, 2013

Price of health care a mystery to most

You have a $5,000 annual deductible and need a test or treatment. It should be easy to find out upfront what it will cost, right? Good luck with that one!

I've written before about the problems with health care price transparency and hidden costs but there hasn't seemed to be much improvement over the years. A new study published in the Journal of the American Medical Association found that only 16% of hospitals surveyed were able to provide an estimate for the total cost of a hip replacement procedure.

The researchers surveyed 122 hospitals covering all 50 states and asked each hospital to estimate the cost of a hip replacement for a 62 year old, uninsured individual who would pay "out-of-pocket." They found that:
--Only nine of the 20 orthopedic hospitals and 10% of the other hospitals could provide a full cost estimate for hospital and physician fees after a minimum of five phone calls;
--12 of the orthopedic hospitals could provide a complete cost estimate after the researchers contacted the hospital and affiliated physicians separately; and
--54 of the remaining hospitals could provide a complete cost estimate after the hospitals and affiliated physicians were contacted separately.

Many of the people they asked at hospitals seemed perplexed with the question and many times researchers were told they needed to make an office visit just to get an estimate.

Now are you ready for this? The cost estimates varied from $11,000 to more than $125,000.

It is unlikely that they were comparing apples to apples. Some estimates failed to cover physician fees or all costs but still, the question was quite simple and direct. They also found no correlation between high cost and top-ranked hospitals and there is no data that shows certain high cost hip implants were better than cheaper options.

There is no way consumers can be "market driven, cost conscious" if they can't get accurate pricing information. And there is really no justification for the price variance. It can't be explained by quality outcomes or any other measure.

If you live in the U.S., you cannot be an informed consumer of health care.

This post originally appeared at Everything Health. Toni Brayer, MD, FACP, is an ACP Internist editorial board member who blogs at EverythingHealth, designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

For the record

For the record: I am a geek. I love technology. I adopted electronic medical records (EMRs) when all the cool kids were using paper. Instead of loitering in the "in" doctors lounge making eyes at the nurses, I was writing clinical content and making my care more efficient. I was getting "meaningful use" out of my EMR even when nobody paid me to do it.

But now who's laughing? While they are slaving away trying to get their "meaningful use" checks, I've moved on to greener pastures, laughing at their sorry butts! It's just like my mom promised it would be. Thanks mom.

Really, for the record, I am not so much a technology fan as a "systems" guy. I like finding the right tool for the job, building systems that make it easier to do what I want, and technology is perfect for that job. I am not so much a fan of technology, but what technology can do. Technology is not the goal, it is the best tool to reach many of my goals. There are two things that measure the effectiveness of a tool: Is the tool the right one for the job? Is the person using the tool properly?

So, when answering the question I posed at the end of my last post, what constitutes a "good" EMR, I have to use these criteria.

How is technology the right tool for the job? The job I seek to do is not what EMR's are designed for: documenting health care. I want a tool to help me give care. I can afford to focus on giving better care since I am no longer paid to document, which is what the health care system demands of doctors. I spent the past 16 years using a documentation tool for care, which is definitely a mismatch.

What then would a care tool look like? Here are the things I think are most important for good care:

1. Communication over documentation

While data gets all the attention of IT vendors, health executives, and government drones, it is the communication of that data that constitutes good care. One of my first goals in my new practice is to use whatever tools possible to enable that communication. Standard health care only allows communication in the exam room (although many patients would say that doctors are so focused on documentation that they don't listen there either). Between office visits there is virtual silence from the patient, as if their life is not happening during that time.

I've considered making bumper stickers that say: "My doctor answers my e-mail" or "My doctor answers the phone," with my logo and web address underneath. This is effective because of the insinuated truth that most doctors don't do either. The system dictates this, but good care says otherwise. My patients have been delighted when I answer questions, view the spreadsheets they fill out, and interact with them on a daily basis. It's communication, and tech makes it much easier.

Documentation is OK, as long as that documentation centers on the communication of data, not just the data itself.

Yet even I use the term "medical record," which refers to a static collection of data rather than a tool to allow that data to be used well. Any good health IT system must not simply document the communication, but must enable that communication as to happen easily as possible. This means both getting information from my patients and putting it into their hands. This is why another central goal of my practice is to give patients access to their records. Too much of patient care is done blindly, not knowing what care has been done, relying on the patient to re-recite their medical history. With the proliferation of mobile technology, my patients can bring their medical record with them wherever they go. This, in turn, enables better communication with other providers.

2. Organization of data

Walking around with a computerized stack of paper, however, is not all that my patients need; they need the information to be organized. This is another of the strengths of IT. An astute commenter on my last post gave a link to a TED talk on the beauty of data visualization, which shows how organizing and presenting data in the right way can make dry data tell rich stories. I want an EMR that shows me a timeline of the patient tagged with their symptoms, medications, lab results, vital signs, and any other pertinent data I want to see. What is the relationship of exercise to your depression? Did that back pain start after you added that medication?

The point of organization is to see through the extraneous to see the meaningful. It is, in essence, another part of communication. As I listen to a patient's story, I ask questions and bring out important details they may have missed, and ignoring that which I know is not significant. This is what makes a good diagnostician, and the ability to this with the volumes of patient data is what would allow IT to improve care.

3. Collaboration, not ownership

The world of health IT is obsessed with something called "data ownership." This is kind of crazy, as data is information, and information is fluid. How do you "own" information? If I learn a fact, do I "own it?" If I possess a book, does that make me the owner of its ideas? The wonderful world of HIPAA and the threat of identity theft has bolstered the cause of "ownership." Unfortunately, communication of ideas is diametrically opposed to this concept. IT must not be about building walled gardens of data, but about collaborating with that data for the sake of patient care.

I first heard of the term, collaborative health record from Dave Chase (the guy who first told me about my kind of practice), and I really like the concept. The idea is that the ideal patient record is a collaboration between the patient and the caretakers. Patients know things I don't: what meds they've been taking, how they feel, whether they are married, are smoking, or if they had measles as a child. In fact, if you look at a typical note in a patient chart, the majority of the information is originally "owned" by the patient. So why not let them take care of those parts of the record? Why not let them update when they've been to a specialist and had their medication changed? Better yet, why not have the specialist take part in this too, collaborating to make sure the patient got the message correctly?

Why, in fact, do I need to re-create what the patient could do better than me? Why not just look at what they've done instead of transcribing it into "my" record?

This sounds suspiciously like a wiki. What resource on the internet gives useful (albeit sometimes inaccurate) information in a format that elementary school students understand? Wikipedia. Isn't this a better way to organize patient data than a typical EMR?

4. Easy does it

In considering what I need from IT to give patient care, there is one more thing I need – something that is clearly lacking in most EMR systems: ease of use. I should have seen the writing on the wall when my EMR vendor insisted I pay for 4 days of onsite training before I could use their system. I don't want to learn a new language, and my patients want it even less. Just as a medication a patient cannot afford is useless, a technology a patient won't use is also useless. Tech can go either way on this: either making difficult tasks easy or making simple things complicated. This is where Steve Jobs was right: design simplicity.

I don't want my patients to have a separate log-in for each part of their care. I want a single sign-in and a uniform experience. I want an app that they press which pops up options to "refill my meds," "contact my doctor," "update my record," and "look up a result." I don't want them to need to own certain software or download files. It's got to be easy and well-designed.

Putting it together

So in thinking about this wish list, it occurred to me that there is one company that could deliver all of the goods here: Google. Apple and Microsoft have many of the same tools, but they are far more proprietary in their approach. If I share a spreadsheet with a patient, I don't want to have to worry they own Excel. If I want to do a video chat, I don't want to have to consider if they've got a device that can do FaceTime. Google does e-mail, spreadsheets, video chat, groups, web pages, organizes data, and has lots of cat videos to boot. And all of these services are easy to use and free. Most of them are free.

So should Google get back into health IT? Didn't they already try health IT and fail? Ah, but it's not just having the right tool that is important, it's knowing how to use it.

So, Google, if you really are interested in changing the world for the better, you know where to find me. I suppose I'd be willing to talk.

After taking a year-long hiatus from blogging, Rob Lamberts, MD, ACP Member, returned with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind), where this post originally appeared.

QD: News Every Day--Death rates fall 8% for hospitalized patients, even as hospitalizations rise

The number of patients who died in the hospital decreased 8% in 10 years, as did the rate of hospitalizations ending in death, the Centers for Disease Control and Prevention reported.

The 8% decrease is a fall from 776,000 in 2000 to 715,000 in 2010, while the number of total hospitalizations increased 11%.

Among the 715,000 patients who died in the hospital in 2010, one-quarter were ages 85 and over. Patients who died in the hospital had longer average hospital stays than all patients.

The CDC report is derived from National Hospital Discharge Survey (NHDS) data.

Also, death rates fell for all first listed diagnoses except septicemia, which rose 17%. Death rates fell for respiratory failure by 35%, for pneumonitis due to solids and liquids by 22%, for kidney disease by 65%, for cancer by 46%, for stroke by 27%, for pneumonia by 33%, and for heart disease by 16%.

Among other findings:
--Female inpatient hospital deaths decreased from 411,000 in 2000 to 364,000 in 2010. Male inpatient deaths did not change significantly during this time.

--In 2000, 2005, and 2010, about 75% of the inpatients who died in the hospital were aged 65 and over (Figure 2).
--The percentage of hospital deaths for those under age 65 increased 9%, from 24% in 2000 to 27% in 2010, while the proportion of inpatient hospital deaths for those aged 65 and over decreased 3%, from 76% in 2000 to 73% in 2010.
--The average age of patients who died during their hospital stay was 72–73 years throughout the period from 2000 to 2010.
Wednesday, March 27, 2013

Do insurance companies want you dead?

ATTENTION: Your patient's request for the following medication has been denied. A licensed clinical pharmacist has reviewed your prior authorization request. Your prior authorization request has been denied.

Me to favorite nurse: "Can you call this company and find out what's up? Who is this pharmacist denying my patient an effective, inexpensive drug he's been on for years? Can you please get them on the phone?"

A few hours later ...

Nurse: "They said that you cannot call to speak to the pharmacist. He will call back if and when he feels like it."

Me: [redacted]


"Hi, my name is DrPal and I'm calling on behalf of my patient Mr. [...] whose medication is being denied."

Drone on phone: "Do you have his plan number?"

Me: "No, but I have the name and date of birth."

Drone: "Can you give me the social security number?"

Me: "No, we're not allowed to collect and keep that information."

Drone: "Can you give me the name and date of birth?"

Me: "Yes!"

... Beethoven piano concerto on hold. Not bad ...

... Second movement starting ...

Drone: "The medication was denied."

Me: "Yes, we stipulated that. Why?"

Drone: "Have you tried Medicine A?"

Me: "That wouldn't be appropriate due to his other medical problems."

Drone: "What about Medicine B?"

Me: "That isn't used to treat the condition in question. At all. Ever."

Drone: "Sir, I'm trying to help you."

Me: "You could help by giving my patient the medicine he's been on for years. Who is this pharmacist who hasn't seen the patient? What do they know about my patient?"

Drone: "Sir, I'm just a third party."

Me: "Does that mean he can't sue you when he suffers a problem from his lack of medication?"

Drone: "Please hold"

... First movement of concerto begins ...

Peter A. Lipson, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. After graduating from Rush Medical College in Chicago, he completed his internal medicine residency at Northwestern Memorial Hospital. This post first appeared at his blog at Forbes. His blog, which has been around in various forms since 2007, offers "musings on the intersection of science, medicine, and culture." His writing focuses on the difference between science-based medicine and "everything else," but also speaks to the day-to-day practice of medicine, fatherhood, and whatever else migrates from his head to his keyboard.

Do probiotics work? Marketing mania tramples science

My kids know that I enjoy a spirited argument. During the days when the dinner table was our public forum, I tried hard to offer a responsible voice of dissent on the issues before us. I admit now that the view I espoused was not always my own, but one that I felt merited inclusion in the discussion. I still do this with them and to others in my life who are willing to succumb to probing of the mind. I willingly subject my own mind to the same process.

Because I am a gastroenterologist, folks assume that I have special expertise in nutrition. I should, but I don't. Perhaps, medical education has evolved since I was in medical training, but in my day, a soft subject like nutrition was bypassed. I am hopeful that I can remedy this knowledge vacuum in the years ahead.

These days, nutrition is part of the burgeoning tsunami of wellness medicine, a discipline that races beyond known science as it seeps into the marketplace.

Several times a week, I am queried on my view of probiotics, which are bacteria that confer health benefits on the human who ingests them. If you were to survey the public, I suspect that a majority would express that probiotics promote health and are effective in treating or preventing various maladies.

These products are included in the billion dollar enterprise of alternative medicine that is not subjected to any Food and Drug Administration (FDA) oversight. Their claims are very difficult to study and there is no standardization in the industry of what constitutes probiotic treatment. This is a different universe that conventional drugs inhabit. These medicines, prescribed by physicians, are subjected to rigorous oversight by the FDA and must demonstrate safety and efficacy. Alternative product purveyors, free from these constraints, can appeal to our New Age beliefs with promises that are seductive but unproven. They promise better health but don't have to prove anything.

If you were in the business of selling medicine, would you choose to spend gazillions dollars and several years praying your drug gets through the FDA, or promote a probiotic that a public is ready to swallow on faith? If you're stuck on this question, then consider my alternative blog MDWhistleblower for Dummies for remediation.

Do probiotics treat or prevent disease? Are these companies overpromising? Clearly, the marketing claims are a light year or two beyond verifiable and supportive science.

I know that many of us want probiotics to be the panacea for what ails us. I know that wellness and preventive medicine have become a religion for many of us. I suggest that we need some old-fashioned wisdom to restrain New Age converts.

Don't misunderstand me. I'm not dissing Alternative Medicine acolytes. Does their stuff really work or is belief of efficacy sufficient? Why aren't these companies utilizing the scientific method to determine if their potions are just placebos? Kick this issue around your own dinner table and make sure that dissent is on the menu.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

QD: News Every Day--Duty-hour regulations may cut into learning opportunities

While housestaff got more sleep working under duty-hour regulations, they had fewer learning opportunities, a study concluded.

To determine the effects of the 2011 Accreditation Council for Graduate Medical Education duty hour regulations compared with the 2003 regulations, researchers conducted a crossover study design among 4 medical house staff teams (43 interns), who were randomly assigned using a 3-month crossover design to a 2003-compliant model of every fourth night overnight call (control, n=560) with 30-hour duty limits or to one of two 2011-compliant models: overnight call every fifth night (Q5, n=420) or a night float schedule (n=140), both with 16-hour duty limits.

Results appeared online March 25 at JAMA Internal Medicine.

Compared with controls, interns on night float slept longer while on call (mean, 5.1 vs 8.3 hours; P=.003), and interns on Q5 slept longer during the postcall period (mean, 7.5 vs 10.2 hours; P=.05). However, both models increased handoffs, decreased availability for teaching conferences, and reduced intern presence during daytime work hours, the researchers noted.

For example, interns admitted a higher proportion of patients each month on the control model (79%) compared with the Q5 model (61%) or the night float model (64%) (P less than .001 across groups). Each control intern admitted more patients per month (mean, 24.8) compared with each Q5 intern (mean, 16.5) and night float intern (mean, 17.4), and cared for more patients (mean, 31.5) compared with each Q5 intern (mean, 27.0) and night float intern (mean, 27.2).

Both experimental models reduced opportunities to attend a daily noon conference by 25%, researchers noted.

Control interns worked a mean of 39 hours per week between 8 a.m. and 6 p.m., which was 30% more than Q5 interns and 13% more than night float interns.

Handoffs between interns increased from 3 in the control model to as high as 9, a 130% to 200% increase, in the experimental models. Control models involved a minimal number of 3 different interns caring for a patient compared to 5 for the experimental models, a 33% to 67% increase.

Finally, residents and nurses in both experimental models perceived reduced quality of care, so much so with night float that it was terminated early.

Researchers wrote, "This disruption in education can reduce the effectiveness of training programs' current provision of formal and informal curricula. Our models preserved 2-hour morning bedside rounds led by our assistant chief of service, a cornerstone of our educational curriculum. However, interns on our experimental models were on the wards less during standard work hours and had fewer opportunities to work with our faculty, consultants, and other health care professionals who are present more often during these hours."
Tuesday, March 26, 2013

How to perform a fecal transplant--why make this so very difficult?

Fecal transplant, thanks to the recent article out of the Netherlands in the New England Journal of Medicine, has made it to the front page, the big time. In my inbox today was a link to a how-to article from Medscape from a doctor from Eastern Virginia Medical School who apparently does the occasional fecal transplant for recurrent Clostridium difficile colitis.

In this article, the author says that one must do $500 worth of testing on the donor, then make up a particle free stool slurry of stool and non-bacteriostatic saline under a hood (due to the biohazard aspects of making poop soup) filter it and instill the mixture via a colonoscope to the patient who has taken 3 gallons of polyethylene glycol solution and preferably had only clear liquids for 2 days. He says that the procedure should only be done for patients who have had C. difficile for 3 months which has not responded to antibiotic therapy.

There is no evidence to suggest that giving donor feces by colonoscopy is any better than giving it by low volume enema, at home, or by nasogastric tube. Colonoscopy carries significant risks: anesthesia is risky and colonoscopes can cause perforation and bleeding. Colonoscopies are expensive. The recent article in the New England Journal used a naso-duodenal tube, not a colonoscope.

There is reasonable evidence that fecal transplant is effective for treatment of ulcerative colitis, an autoimmune disease of the colon that causes chronic disability, colon cancer and internal bleeding. Acute C. difficile claims many lives, and there is abundant experience of treating it with fecal transplant. Limiting this therapy to chronic cases seems a bit excessively restrictive.

The author of the Medscape article notes that some of the patients in the recent trial of fecal microbiota transplantation developed new diseases, some of them autoimmune, which might have been related to the transplants. It seems unlikely, but I would also wonder whether some of the patients found that more problems than just their C. difficile were resolved. Much is still not known and will only be revealed as more research is done with larger groups of patients.

As far as the $500 of tests that need to be done on the donor, I wonder if perhaps some of these could be eliminated. Clearly the donor should be checked for body fluid transmitted diseases such as HIV and hepatitis, though a family donor of known low risk (a child, for instance) might safely be presumed to be uninfected. Extensive stool testing for bacteria and parasites in a donor with no intestinal difficulties might also be unnecessary, especially if that person's history was well known.

As far as the actual logistics of delivering donor stool to recipient colon, I suspect nothing more than a commercially available enema bag and tubing would be necessary. The soup to be delivered could probably be easily and cleanly mixed up in a Ziploc bag, with no need for a blender. As far as preparation with a clear liquid diet and gallons of polyethylene glycol, I am curious to see evidence that supports this (I don't think there is any, yet). Cleaning out the bad bugs seems like a good approach, but patients get very weak after a standard colonoscopy prep so a prep that includes days of fasting plus more polyethylene glycol might lead to its own problems.

I am starting to think about the nuts and bolts of all of this because, as a hospital physician, I will soon be faced with a patient for whom fecal transplant will be an obvious life-saving intervention, and I will have to figure out how to do it with as little fuss as possible. It will be unethical for me to allow someone to die when antibiotics fail, as they so often do, when evidence shows that a fecal enema would probably be curative.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health care so expensive?, where this post originally appeared.

Unintended consequences of progress--safety, burnout and health care reform

Bob Wachter, MD, FACP, wrote in frustration, "Is the Patient Safety Movement in Danger of Flickering Out?"

All too often legal remedies lead to unintended consequences. In medicine we are all too familiar with well-intentioned laws. We moved to resource-based, relative-value units (RBRVS) to have a more intelligent payment system, but our new system became unwieldy and penalized primary care. We have seen gaming the coding system as a reaction, and the Centers for Medicare and Medicaid Services spends way too much money in physician payments.

Privacy aspects of the Health Insurance Portability and Privacy Act (HIPAA) represent a really good idea, but in practice it hampers the necessary exchange of medical information.

RBRVS abuse led to requirements for documentation that have made most notes unreadable.

Meaningful use of EHR leads to frustration and more time needed per patient.

Now the threat of the Affordable Care Act (ACA) is leading to hospitals focusing more on preparing for the ACA than continuing progress on patient safety.

I would add to Bob's lament that we too often confuse performance measures and safety measures. We can clearly decrease central line infections and complications, and the strategies are clear and doable. We can clearly decrease medication errors through improving processes. We can make wrong site surgery a thing of the past.

Those measures make sense as do the efforts to improve patient safety.

However, too many in government and in insurance companies conflate performance measures with safety measures. Performance measures can lead to worse safety, for example, the 4-hour pneumonia rule, trying to achieve HgbA1c less than 7 through the addition of a third drug, anticoagulation for patients with high risk of bleeding.

Here is the real problem. Patients need physicians who focus completely on them and their problems. We know from the safety movement that multi-tasking leads to errors. When we ask physicians to multi-task and do not pay them for the extra work, then attention often leaves the patient.

I wrote on burnout last September:

What are the common root causes of burnout? Primarily burnout comes from loss of control and overwhelming undesirable activities.

Burnout occurs when the job becomes overwhelming.

These many interventions lead to burnout. Bob recognizes that the unintended consequence of increasing rules and regulations without attached pay is burnout. And burnout decreases attention to safety.

But Bob's focus on safety is the tip of the iceberg. Physician burnout impacts every aspect of patient care. We need common sense, not more laws. We need a payment system that focuses on time spent. We need to calculate the true cost of electronic health records, and any economist will tell you that extra time spent is a true cost.

If we truly care about patient safety, if we truly care about patients, and if we truly care about physicians, then we must radically change our health care system to allow physicians to work with their patients. We should pay physicians and others to improve safety.

We must reconsider the toll that government interference has on physicians as human beings.

None of us wants a burned out physician to provide our care.

This is not just a safety issue.

db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Associate Dean for the Huntsville Regional Medical Campus of UASOM. He also serves as a frequent ward attending at the Birmingham VA Hospital. This post originally appeared at his blog, db's Medical Rants.

QD: News Every Day--Psychological effects of false-positive mammography can linger

Women who have a false-positive mammogram experience psychosocial consequences that range between those experienced by women with a normal mammogram and those with breast cancer for as long as three years.

Researchers created a cohort study among 454 women with abnormal findings in screening mammography over a 1-year period. Women with false and true positives on a screening mammogram were matched to two women with normal results who were screened the same day at the same clinic. Participants answered a questionnaire of 12 psychosocial outcomes at baseline and months 1, 6, 18 and 36.

Results appeared at the Annals of Family Medicine.

Six months after the final diagnosis, women with false-positive findings reported changes in existential values (delta=1.15; P=.015) and inner calmness (delta=0.13; P=.423) as great as those reported by women with a diagnosis of breast cancer. Women with false-positive results consistently reported greater negative psychosocial consequences compared with women who had normal findings in all 12 psychosocial outcomes (delta greater than 0 for 12 of 12 outcomes; P less than .01 for 4 of 12 outcomes) for as long as three years after being cleared of cancer.

Women who had false positives reported statistically greater negative consequences at one month for the outcomes of dejection, anxiety, behavior, sleep, breast examination, sexuality, attractiveness and focus as women who had normal findings, but had significantly less-negative consequences than women with breast cancer. At 6, 18 and 36 months, women with breast cancer had greater negative psychosocial consequences than women with false positives, who in turn experienced greater negative psychosocial consequences than women with normal findings.

There was no statistically significant difference in regards to inner calm and existential values between women with false positives and those with breast cancer as long as 6 months. Researchers wrote, "These findings imply that the degree of change in inner calmness and existential values within the first half-year after final diagnosis were just as great for women with breast cancer as for women receiving false-positive findings, and that changes in existential values within 3 years were still greater for those having false positives compared with those with normal findings."
Monday, March 25, 2013

Better diet? Bigger picture!

A study just published online in the New England Journal of Medicine demonstrates a reduction in both chronic disease and premature death with adoption of a Mediterranean diet. This has some journalists opining that we now have evidence of a benefit we did not have before. Actually, that is untrue. We have long had evidence of the disease-fighting, death-defying potential of a well-practiced Mediterranean diet.

The new study has longtime proponents of the Mediterranean diet crowing as if this now proves it is the best diet going. That, too, is untrue. While an attempt was made in the new study to compare the Mediterranean diet to a healthful low-fat diet, participants in that group didn't really cut bad fats out of their diet. They mostly just kept eating a typical Western diet, which we already knew was bad. That the Mediterranean diet was better than the typical, prevailing diet of industrialized countries is yesterday's news. Those who want today's news to be that the Mediterranean diet has been proven superior to other truly good diets will need to wait until tomorrow, or longer. We had previously lacked any good head-to-head comparisons of "best diet" candidates, and we still do.

My colleagues who advocate for healthful low-fat eating have been quick to note that the comparison group in this trial was not it. But they may also go too far in defense of preconceived notions if they refuse to acknowledge that based on the evidence we have, a good interpretation of the Mediterranean diet is likely to be just as good as veganism for human health, if not necessarily as good for the planet and our fellow species.

What shakes out of all of this is the perennial tendency to find the patterns we are seeking, while missing the forest for the trees. Do we know what single dietary pattern is best for human health? We do not.

Do we know what fundamental theme of eating is best for human health? We certainly do -- as surely as we know that pandas should eat bamboo, and koalas should eat eucalyptus, and for many of the same reasons. Do we know how great the benefit of lifestyle as medicine could be? We do indeed, if only we could get the right medicine to go down. And no, more spoons full of sugar would not be helpful!

We have plenty of relevant science. We also have our common sense, although we tend not to apply it very commonly where diet is concerned. And we have, if we are willing to take in the view, an opportunity to see the (whole) elephant in the room.

Science, sense and elephense

(This poem was originally published in the online supplement to: Katz DL. 2011 Lenna Frances Cooper Memorial Lecture: The road to HEaLth is paved with good InVentions: of science, sense, and elephense. J Acad Nutr Diet. 2012 Feb;112(2):313-321. The audio link to the 2011 Lenna Frances Cooper Memorial Lecture is available here.)

Where the perils that threaten
prevail and surround-
it's not in small parts
that solutions are found.
There can be cause to love reduction
But I see the menace in its seduction.
In saying so,
I intend no provocation
Of this worthy congregation-
I just have this predilection
For review, and redirection.
And my fervor lies in finding means
to answer the right question;
Not in seeking foot of emperor
to practice genuflection!
So while I, too, profess compliance-
(In the company of giants)
With the tried and true of science-
I allow for some defiance:
Skiers race
An avalanche, a flight
That's make or break;
Would it count as
Defiance to say
There's no science
To indict a particular flake?
A river swells to
Cresting; its banks devolve
To mud. There's no science
To say that no science
Can say which sandbag
Stops the flood.
When with steadfast equanimity
We have parsed all plausibility
When to our telomeres we're diced
And from their bits, genomes respliced-
We may agree it is terrific
To be robustly scientific-
But lest we're muddled in denial
we must concede the best-run trial-
Though potentially inspired
Is still in tribulations mired.
For while to build a better sandbag,
we might design a RCT;
That we're wet and need a levee,
is on display for all to see.
We need science for microscopes
We need science for telescopes
But let's acknowledge, my friends
That the view decides the lens!
And while perceiving complications
may be something like reflex
A job may be hard instead of easy,
yet still be simple, not complex.
In this mad view, there's method,
whatever you may think-
For while it's true, I do see elephants-
they're only very rarely pink!
Through the trees to the forest,
we must all strive to perceive
When we do, we can't tarry-
We'll get no reprieve
We'll have miles to go, to get out
of the wood
And turn WHAT we all know,
into HOW to do good!
With utensils in hand
To carve up the beast...
We might pause to consider:
On what parts we feast?
Trees and forest;
View and lens-
Knowledge and power
Science and sense:
What road
We ought to choose
At the fork twixt
Win, or lose-
Could just come down
To views; and seeing
Past parts...
To whole elephense.
My friends, from the start
it was my intention
To make the case for good invention
for where there's a will
There's a way to be paved
So the health of our families
Can be righted, and saved.
And I'm confident
We can all escape our doom-
If we'd just see the elephant
Here in the room!

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.

Health in China

The Chinese are less concerned about safety than American. We worry about health risks, perhaps obsessively at times, but from my perspective it's less of a concern to them. As I wrote, I thoroughly enjoyed a recent trip to China, but now want to discuss some observations on medical issues in China.

They smoke much more, and allow smoking in many more places. No smoking signs are often ignored.

In some of their cities, they breathe in much more pollution. The Chinese government publicly posts measurements of the air quality, but it's often significantly less than the United States Embassy measurements. Here are readings I recorded during our trip.

This score of particulate matter was created by the Environmental Protection Agency and goes up to 500, which was supposed to be the scale maximum. Recently readings in Beijing have been as high as 755. According to China's Ministry of Environmental Protection, less than 6% of vehicles in the country meet the highest environmental standards, and there is particularly a problem with the tiny particles known as PM2.5, thought to be particularly toxic. Most of this is generated by older cars and trucks.

Bicycle and motor scooter riders don't wear helmets. In 3 days of driving around Beijing our guide never wore seat belts, even on the highway. The driver only wore it one time briefly. Eighty percent of car sales are to first time buyers, and many of them have little experience. Pedestrians do not have the right of way. One evening we drove past a man crumpled up on the street, with a man standing next to him talking on the phone, and no ambulance in sight. I can't be certain, but I believe he was hit by a car trying to cross the street. Shortly after leaving our hotel in Shanghai on the way to the airport, our bus was temporarily stopped in traffic after a motorcyclist was hit and was laying on the ground. If we saw two people hit in 8 days, imagine how often it must occur.

They seem to be less germaphobic than most Americans. Their tap water is not potable unless you've lived there long enough to have developed resistance. They eat family style sharing multiple dishes, but do not give serving utensils, so everyone dips their own chopsticks into the common food.

According to an article in the 11/14/12 China Daily newspaper, obesity is becoming more common in Shanghai. It said that roughly 40 percent of adults in Shanghai are obese or overweight. A survey released at the end of 2011 showed the average weight of male residents had increased by 2.9 kg (6.4 pounds), and weight circumference had increase 2.3 cm (0.9 inches) since 2000. Certainly they have much less obesity than we do in the United States, but it's likely to get worse. They are less physically active, with motor bikes more common than bicycles, and their diet is getting more westernized. I saw many McDonalds, Haagen-Dazs, and Starbucks in Beijing and Shanghai.

Another article in the same issue said the number of people in mainland China with diabetes has doubled in the past decade to about 9.7% in those 20-years-old and older, and that only 40% of them have been diagnosed. Because of the increase in chronic illnesses there, pharmaceutical company Eli Lilly & Company plans to expand in China to increase sales of their drugs for diabetes, the heart and cancer.

We went to the China Academy of Chinese Medical Sciences at the Science and Technology Center. While our feet soaked in a tub of tea, someone came and talked about the center. It was started in 1955 under the direction of Mao Tse Tung. It mostly serves the government leaders. He said none of them have heart problems, cancer or high blood pressure. He said only Chou Enlai had liver cancer in 1976 when they were less developed.

Next students massaged our feet while a doctor examined me, then my wife, while a woman translated. He felt the pulse with three-fingers check on each side. He said I had problems with blood pressure and fatty liver and said I should lose 5-6 kg. I've not had problems with the first two, but wouldn't argue with the last. He also asked if I had an eye problem. I actually have had some problems with eye inflammation, but perhaps he looked in my eyes and noticed the effect of a combination of air pollution and jet lag. He recommended two medicines, each 650 yen (about $100) for a month supply and said I needed to take it for only one to two months. He said I would be amazed at the difference. When I hesitated he asked if my patients take their medicine when I prescribe it. I ended up buying a one month supply for myself as I felt a little guilty they had spent all the time on us, and it was place that didn't seem to get many foreigners. I figured if for nothing else, it would make a good blog post. In my n=1, non-blinded, non-placebo controlled study, I found no difference after taking the medications for one month. Well actually I did lose about 3 pounds, but I suspect that was from following my New Year's resolution with more exercise and an even better diet. Considering that I felt the same, despite being a month older, maybe it did do something.

Although I joke about it, I suspect some herbal medicines are effective. After all, some pharmaceutical medications in use today are derived from plants. Before taking such medications long term, one should be concerned about not only effectiveness, but safety, including the risk of contamination with lead and other chemicals.

I was going to try acupuncture, but our guide couldn't find a place she felt comfortable recommending (sterile needles, etc.).

Prior to the trip I obtained a hepatitis A vaccination. That's the one viral hepatitis that can be transmitted by contaminated food, which although it doesn't cause a chronic infection, can definitely put a damper on your vacation.

China seems to be moving in the right direction in some areas related to health and the environment, which I hope they sustain. They don't need to adopt all the practices of Western society, nor would I wish them to do so, but the Chinese people shouldn't needlessly suffer from such things as traffic fatalities, pollution, and smoking, and those things should minimized as much as possible.

Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington. This post originally appeared on his blog, World's Best Site.

QD: News Every Day--Doctors balance patient's respiratory infections vs. drug resistance

Patients who were treated with antibiotics for nonspecific acute respiratory infections were not at increased risk of severe adverse drug events and had a small decreased risk of hospitalization for pneumonia compared to those who were not treated with antibiotics, according to a review of 1.5 million patients.

To assess the risks and benefits of antibiotic use, researchers assessed records of adult patients from June 1986 to August 2006 from a U.K. primary care database. Results appeared in the Annals of Family Medicine.

The cohort included more than 1.5 million visits, of which 65% resulted in a prescription for antibiotics. Antibiotic prescribing among the 326 practices ranged from 3% to 95% of visits. Amoxicillin was most frequently prescribed (51.2%), followed by penicillin (17%) and erythromycin (12.7%).

There were 0.37 fewer events per 100,000 patient visits (95% CI, -5.31 to 2.07) for patients treated vs. not treated with antibiotics. The adjusted risk difference for treated vs. untreated patients per 100,000 visits was 1.07 fewer adverse events (95% confidence interval [CI], -4.52 to 2.38; P=.54) and 8.16 fewer pneumonia hospitalizations (95% CI, -13.24 to -3.08; P=.002). The number needed to treat to prevent 1 hospitalization for pneumonia was 12,255.

Researchers wrote, "Although the number needed to treat to prevent 1 pneumonia hospital admission exceeds generally accepted thresholds for preventing serious infections, antibiotic treatment of ARIs is still common; the precise value of that boundary can depend on the perspective of the decision maker and, even for the most conscientious of us, may differ between what we may deem ideal for society in general and what we decide for the patient sitting in front of us."
Friday, March 22, 2013

Was this year's flu vaccine good enough?

Let me tell you about two patients.

Mr. S is thirty years old. He shuffled into the office in a sweatshirt and pajama bottoms. Black unwashed hair stuck out from a black and silver toque. He looked like he was keeping his head up by sheer force of will, and had no energy left for shaving or other trivialities.

He had a sore throat, a cough, and a fever of 103. He didn't have a flu shot, and tested positive for influenza.

He went home with advice to get some rest and drink plenty of fluids. His wife and children had their flu shots earlier in the year and did not become ill.

Ms. R is eighty. She started to cough and over the course of a couple of days became weak and had trouble breathing. In the emergency department she was found to have influenza and was admitted for IV fluids and oxygen therapy.

A few days later her condition worsened. In the middle of the night she was transferred to the ICU and put on a breathing machine. A chest X-ray showed pneumonia.

Two weeks later she was discharged to a nursing home, and eventually returned to her own apartment. She had a flu shot two months before her illness.

A widely-cited statistic says that this year's flu shot is "62% effective," whatever that may mean. For Ms. R, it was 0% effective. She developed pneumonia as a complication of her flu and was lucky to survive.

What accounts for these different stories? Many people, especially young people, have been spared the flu this season because of the flu shot. But older folks haven't done as well.

A recent Morbidity and Mortality Weekly Report, a publication of the U.S. Centers for Disease Control and Prevention, describes the situation in an update on the efficacy of this year's shot. Influenza A (H3N2) is one of the subtypes in this year's shot, and also a really nasty bug. It tends to cause more severe disease than other influenzas, and has been a big player this season. It turns out the shot has done a good job against this guy, reducing flu-related doctor visits by one-third to one-half. Older folks haven't done so well.

So far this year, the flu shot has failed to show a significant drop in doctor visits for people over sixty-five. This is on par with previous data on flu vaccines. Some studies have shown much less benefit in older adults. But some studies have looked at different end-points, such as death from all causes, or pneumonia or heart attack. Many of these studies have been more encouraging.

The long and short of it is, the flu shot seems to be cutting back significantly on flu cases, which will benefit us all. Since those most vulnerable aren't as well protected by the shot, they will benefit from those around them being vaccinated. If you aren't exposed to the flu, you can't catch it.

The way to protect those who aren't protected by the shot is to vaccinate as much of the population as possible so that we can all benefit from "herd immunity." The flu shot is still a good idea for everyone over 6 months of age.

Peter A. Lipson, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. After graduating from Rush Medical College in Chicago, he completed his internal medicine residency at Northwestern Memorial Hospital. This post first appeared at his blog at Forbes. His blog, which has been around in various forms since 2007, offers "musings on the intersection of science, medicine, and culture." His writing focuses on the difference between science-based medicine and "everything else," but also speaks to the day-to-day practice of medicine, fatherhood, and whatever else migrates from his head to his keyboard.

Data mining systems improve cost and quality of health care, or do they?

Several e-mail lists I am on were abuzz last week about the publication of a paper that was described in a press release from Indiana University to demonstrate that "machine learning, the same computer science discipline that helped create voice recognition systems, self-driving cars and credit card fraud detection systems, can drastically improve both the cost and quality of health care in the United States." The press release referred to a study published by an Indiana faculty member in the journal, Artificial Intelligence in Medicine [1].

While I am a proponent of computer applications that aim to improve the quality and cost of healthcare, I also believe we must be careful about the claims being made for them, especially those derived from results from scientific research.

After reading and analyzing the paper, I am skeptical of the claims made not only by the press release but also by the authors themselves. My concern is less about their research methods, although I have some serious qualms about them I will describe below, but more so with the press release that was issued by their university public relations office. Furthermore, as always seems to happen when technology is hyped, the press release was picked up and echoed across the Internet, followed by the inevitable conflation of its findings. Sure enough, one high-profile blogger wrote, "physicians who used an AI framework to make patient care decisions had patient outcomes that were 50% better than physicians who did not use AI." It is clear from the paper that physicians did not actually use such a framework, which was only applied retrospectively to clinical data.

What exactly did the study show? Basically, the researchers obtained a small data set for one clinical condition in one institution's electronic health record and applied some complex data mining techniques to show that lower cost and better outcomes could be achieved by following the options suggested by the machine learning algorithm instead of what the clinicians actually did. The claim, therefore, is that if the data mining were followed by the clinicians instead of their own decision-making, then better and cheaper care would ensue.

As done in many scientific papers about technology, the paper goes into exquisite detail about the data mining algorithms and the experiments comparing them. But the paper unfortunately provides very little description about the clinical data itself. There is a reference to another paper from a conference that appears to describe the data set [2], but it is still not clear how the data was applied to evaluate the algorithms.

I have a number of methodological problems with the paper. First is the paucity of clinical details about the data. The authors refer to a metric called the "outcomes rating scale" of the "client-directed outcome informed (CDOI) assessment." No details are provided as to exactly what this scale measures or how differences in measurement correlate with improved clinical outcome. Furthermore, the variables of the details of care for the patient that the data mining algorithm supposedly outperforms are not described either. Therefore anyone hoping to understand the clinical value that this approach is claimed to have improved is not able to do so.

A second problem is that there is no discussion about the cost data or what cost perspective (e.g., system, clinician, societal, etc.) is taken. This is a common problem that plagues many studies in healthcare that attempt to measure costs [3]. Given the relatively modest amounts of money spent on the care that is reported in their results, amounting only to a few hundred dollars per patient, it is unlikely that the data includes the full amount of the costs of treatment for each patient, or over an appropriate time period. If my interpretation of the low value of the cost data is correct (which is difficult to discern from reading the paper due, again due to lack of details), the data do not include the cost of clinician time, facilities, or longer-term costs beyond the time frame of the data set.

If that is indeed the case, then it would be particularly problematic for a machine learning system, since such systems make inferences limited only to the data that is provided to the model. Therefore if poor data is provided to the model, its "conclusions" are suspect. (This raises a side issue as to whether there is truly "artificial intelligence" here, since the only intelligence applied by the system is the models developed by their human creators.)

A third concern is that this is a modeling study. As every evaluation methodologist knows, modeling studies are limited in their ability to assign cause and effect. There is certainly a role in informatics science for modeling studies, although we saw recently that such studies have their limits, especially when revisited over the long run. In this study, there may have been reasons for the clinicians following the more expensive path or confounding reasons why such patients had worse outcomes, but they cannot be captured by the approach used in this study.

This is related to the final and most serious problem of the work, which is that the modeling evaluation is a very weak form of evidence to demonstrate the value of an intervention. If the authors truly wanted to show the benefits of the system and approach they developed, they should have performed a randomized controlled trial that compared their intervention with an appropriate control group. This would have led to the type of study that the blogger mentioned above erroneously described this to be. Such a study design would assess some of the more vexing problems we face in informatics, such as whether the advice coming from a computer will change clinician behavior. Or, when such systems are introduced into the "real world," whether the "advice" provided will prospectively lead to better outcomes.

I do believe that the kind of work addressed by this paper is important, especially as we move into the area of personalized medicine. As eloquently described by Stead and colleagues, healthcare will soon be reaching the point where the number of data points required for clinical decisions will exceed the bounds of human cognition [4]. (It probably already has.) Therefore clinicians will require aids to their cognition provided by information systems, perhaps one like that described in the study.

But such aids require, like everything else in medicine, robust evaluative research to demonstrate their value. The methods used in this paper may indeed be the methods to provide this value, but the implementation and evaluation described miss the mark. That miss is further exacerbated by the hype and conflation the ensued after the paper was published.

What can we learn from this paper and its ensuing hype? First, bold claims require bold evidence to back them up. In the case of showing value for an approach in healthcare - be it test, treatment, or informatics application - we must use evaluation methods that provide best evidence for the claim. That is not always a randomized controlled trial, but in this situation, it would be, and the modeling techniques used are really just preliminary data that (might) justify an actual clinical trial. Second, when we perform technology evaluation, we need to describe, and ideally release, all of the clinical data so that others can analyze and even replicate the results. Finally, while we all want to disseminate the results of our research to the widest possible audience, we need to be realistic in explaining what we accomplished and what are its larger implications.

[1] Bennett, C. and K. Hauser (2013). Artificial intelligence framework for simulating clinical decision-making: a Markov decision process approach. Artificial Intelligence in Medicine. Epub ahead of print.
[2] Bennett, C., T. Doub, A. Bragg, J. Luellen, C. VanRegenmorter, J. Lockman and R. Reiserer (2011). Data mining session-based patient reported outcomes (PROs) in a mental health setting: toward data-driven clinical decision support and personalized treatment. 2011 First IEEE International Conference on Healthcare Informatics, Imaging and Systems Biology (HISB 2011), San Jose, CA. 229-236.
[3] Drummond, M. and M. Sculpher (2005). Common methodological flaws in economic evaluations. Medical Care. 43(7 Suppl): 5-14.
[4] Stead, W., J. Searle, H. Fessler, J. Smith and E. Shortliffe (2011). Biomedical informatics: changing what physicians need to know and how they learn. Academic Medicine. 86: 429-434.

This post by William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, appeared on his blog Informatics Professor, where he posts his thoughts on various topics related to biomedical and health informatics.

QD: News Every Day--Knee meniscus surgery, therapy have similar outcomes

Patients with a meniscal tear and knee osteoarthritis had no significant differences in functional improvement at six months whether they underwent physical therapy or surgery, a study found.

Researchers conducted a seven-center, randomized, controlled trial that randomly assigned 351 patients 45 years of age or older with a meniscal tear and mild-to-moderate osteoarthritis to surgery and postoperative physical therapy or to a physical-therapy regimen with the option to cross over.

Results appeared online at the New England Journal of Medicine.

The mean improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5).

At 6 months, 51 patients assigned to physical therapy alone (30%) opted for surgery, and 9 patients assigned to surgery (6%) had not yet undergone it.

Researchers noted that the two groups had similar functional outcomes at 6 months, and the similarity between the groups persisted through 5 years of follow-up.

"Our findings suggest that both arthroscopic partial meniscectomy and referral to physical therapy--with an opportunity to consider arthroscopic partial meniscectomy if substantial improvements are not achieved--are likely to result in considerable improvement in functional status and knee pain over a 6-to-12-month period," researchers wrote. "Given that improvements in functional status and pain at 6 months did not differ significantly between patients assigned to arthroscopic partial meniscectomy and those assigned to physical therapy alone and that 70% of the patients in the physical-therapy group did not undergo surgery, these data provide considerable reassurance regarding an initial nonoperative strategy."

An editorialist wrote, "Currently, millions of people are being exposed to potential risks associated with a treatment that may or may not offer specific benefit, and the costs are substantial. ... These results should change practice."
Thursday, March 21, 2013

New technology, same old reimbursement

One of my tennis friends asked me about new innovative smart phone technology and why it hasn't been embraced in health care. She had just watched a video about Dr. Eric Topol, Chief Academic Officer at Scripps Health in San Diego, and his demonstrations of how a smart phone could monitor blood sugar, take EKGs and cardiac ultrasounds and really deliver health care to the patient at home.

My friend's question; "If this technology is here, why isn't it being used?"

According to Dr. Topol, new apps for the smart phones could eliminate 80% of echocardiograms that are done in facilities, at costs of $300 to $1,500 each. Having patients come into the office when they experience symptoms or for diabetics to get their blood sugar regulated could be eliminated. New technology could be data driven and personalized and save millions of wasted dollars in health care. So why is medicine so far behind the innovation curve?

The answer: No-one pays for it.

Why aren't all physicians using e-mail to communicate with patients and save them an office visit? The politically correct answer is "Remote medicine is not as good as seeing the patient in person and making sure the diagnosis is correct." The real answer is: No-one pays for it.

U.S. health care has complicated payment systems for work done. The payor for health care services is either Medicare/Medicaid (CMS) or hundreds of different (for-profit) insurance companies. CMS sets the payment rules that everyone follows. Medicare and all insurers will only pay for face to face visits. Reimbursement is for doing more and the more you do the more you get.

The doctor that tries to save a patient time and travel by covering a number of problems in one office visit will not be rewarded and, in fact, will be reimbursed less. If you do a skin biopsy on the same day you do a visit for arthritis flare, CMS and insurance companies will not pay for both things. Do them on separate face to face visit days and voila, better reimbursement for your time and skill.

E-mail, remote monitoring, remote echocardiograms, discussing tests via a smart phone are freebies. No patient visit means no reimbursement. The cost of putting in high technology is borne by the physician too.

Most physicians and hospitals and surgery centers and labs and pharmacies are happy with this status quo. There is great fear of change and so we continue to spend more on health care than any nation in the world. We do wasteful mass screenings and one-third of all prescriptions are a waste. People who need care are not getting it and others are getting too much that they don't need.

ObamaCare is trying to make some gradual changes by supporting pilot programs to change the way health care is delivered. But it is slow going and innovative answers are out there. If we could just figure out how to pay for services, while using new cost-saving technology we would all be following Dr. Topol's future dream.

This post originally appeared at Everything Health. Toni Brayer, MD, FACP, is an ACP Internist editorial board member who blogs at EverythingHealth, designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

Death of an evangelist

It feels like part of me is dying. I am losing something that has been a part of me for nearly 20 years.

I bought in to the idea of electronic records in the early '90s and was enthusiastic enough to implement in my practice in 1996. My initial motivation was selfish: I am not an organized person by nature (distractible, in case you forgot), and computers do much of the heavy lifting in organization. I saw electronics as an excellent organization system for documents. Templates could make documentation quicker and I could keep better track of labs and X-rays. I could give better care, and that was a good enough reason to use it.

But the EMR product we bought, as it came out of the box, was sorely lacking. Instead of making it easier to document I had to use templates generated by someone else, someone who obviously was not a physician (engineers, I later discovered). So we made a compromise. Since it was easier to format printed data, we took that data and made a printed template. We would then write in the vitals, dictate our history, circle options on the review of systems and physical exam, and dictate our plan. That written record would then be put into the EMR as a finished note by the transcriptionist. It was a strange way to do things, but it was far more efficient. At the first user group meeting (after 9 months of use), we were using the product better than anyone else.

For us, the bottom line was not computers, it was patient care. Our record system was a tool to let us eliminate inefficiency and focus more on care quality. We were spending less time and doing a better job. Within two years I was elected president of the national user group for our EMR and became an evangelist for the benefits of computerized records. I was proof that doctors could adopt technology and not just survive, but thrive. My peers thought I was eccentric (shocking) and I made few converts.

There is one moment during those first years I will never forget: one of the "aha" moments in my life, a time when things snapped into focus. I was trying to figure out how to milk more efficiency out of our system and was thinking about using the data for more than just documentation. My zeal for process improvement earned me the right to be one of the first to have access to the content customization tool for the EMR and I quickly produced content that was very popular (our vendor wisely gave the tool only if we were willing to share our creations).

While I was thinking about ways to improve efficiency, I thought about all of the data at my disposal. I had years of structured data on thousands of patients: vitals, lab results, medications, problem lists, and other pertinent patient information. Whoa! What if I could put all that data together and really coordinate care? What if I could, instead of using the EMR as a fancy word processing program, I used the data I collected to improve care? It was like moving from two to three dimensions. Nobody was talking about this at all; the focus was entirely on documentation, not data. I remember the room I was in when the thought hit me.

Armed with my new vision of EMR, I called my vendor (I was, after all, the president of the user group) and made a pitch to the engineers and company executives. I was clearly one of the top users of their product, but I felt like I was only using a fraction of the product's potential. Yet I was in private practice and so had no access to the resources to tap that potential.

I proposed that the vendor fund my effort to make the product work on all cylinders, to really show what it could do if its full potential was harnessed. The investment wouldn't be much, since we were still a small practice. In exchange for their support, they could use what I made to show the world what really good care looked like. I expected astonished gasps from the other end of the line, but was met by silence. Eventually one of the executives told me that the product was already being used to its full potential. They did, after all, have an E/M coding advisor.

Frustrated at their blindness to my insight, I set out to prove them wrong, spending countless hours wrestling with the system to make it do what I want: improve the care I was giving without taking extra time. The systems I developed helped us offer better care (double the national average on colonoscopy, pneumococcal vaccine, A1c monitoring), and still be in the top 10% of income for primary care. This accomplishment earned us the Davies Award from HIMSS, and earned me a permanent spot on the EMR speaking circuit. Still, I was never really satisfied with the care I gave, and always looked for ways to do it better.

Unfortunately, the increasing popularity of EMR caused increased focus from the government. PQRI, NCQA, HIPAA, and CCHIT all took focus of our vendor from clinical development, instead focusing on regulatory requirements. When the HITECH act passed I was still (delusionally) optimistic that the focus would eventually turn to patient care. But the last update I saw on the product I bought in 1996 showed the truth: The product was certified for "meaningful use," but it was bad. Really bad. We even nicknamed it "Vista." Previously simple tasks were difficult, and data was harder to use, and was not moving at all toward better patient care.

My inability to accept mediocre care (and my obnoxious obsession with improving it, from my partners' perspective) eventually drove me from the world of meaningful use and E/M coding to my current home: a practice that accepts only monthly payments between $30 and $60 a month in exchange for an undiluted attention to patient care. Without the overhead caused by the ridiculous complexity of our payment system, I can finally realize my dream of showing the world what good care actually looks like.

But here's the hitch: EMR has never left the world of note generation. Yes, it does submit data so the doctor can get the check for (ironically) achieving "meaningful use," but that data is still very hard to actually use to improve care. My attempts at using other EMR products to accomplish my goal have proven to me once and for all that to truly give good care I'd have to abandon EMR as I knew it. I've got to look beyond EMR to something better, more focused on the patient and less on the payment. But it's really been a hard search. I know what I want to do, but the road to that goal is not yet evident.

So what do I think really good electronic records should look like? I'm up to 1,144 words now, so that will have to wait for a future post. Instead, let me take this moment to throw a flower on the grave of the EMR enthusiast. It's been quite a ride. I don't join those who look back to the "good old days" of paper records (It's like longing for the "good old days" before indoor plumbing). No, I still look to use technology to make my care better; it just won't include EMRs in the form they are now. In truth, it's never been about computers; it's about the person sitting across from me: the one who is putting their life in my hands. Perhaps the death of this evangelist can prevent other deaths, the real ones.

After taking a year-long hiatus from blogging, Rob Lamberts, MD, ACP Member, returned with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind), where this post originally appeared.

QD: News Every Day--Putting numbers on how primary care access leads to healthier people

Residents living in healthier counties are 1.4 times more likely to have access to a doctor and dentist than those in the least healthy counties, according to a public health database that tracks every U.S. county.

While premature deaths are at the lowest level in 20 years, people in the unhealthiest counties are dying too early at more than twice the rates of those in the healthiest counties, according to the 2013 County Health Rankings, a project of the Robert Wood Johnson Foundation and the University of Wisconsin Population Health Institute.

The project reviewed 25 factors that influence health, including childhood poverty, smoking, obesity levels, teen birth rates, access to physicians and dentists, rates of high school graduation and college attendance, access to healthy foods, levels of physical inactivity, and percentages of children living in single parent households. Interactive maps and new county-level trend graphs detail changes over time for several measures, including children in poverty, unemployment and quality of care.

Among the new, significant trends reported:
--Child poverty rates have not improved since 2000, with more than one in five children living in poverty;
--Violent crime has decreased by almost 50% over the past two decades;
--The counties where people don't live as long and don't feel as well mentally or physically have the highest rates of smoking, teen births, and physical inactivity, as well as more preventable hospital stays; and
--Teen birth rates are more than twice as high in the least healthy counties than in the healthiest counties.

Risa J. Lavizzo-Mourey, MD, MACP, the Foundation's president and CEO, said, "The County Health Rankings can be put to use right away by leaders in government, business, health care, and every citizen motivated to work together to create a culture of health in their community."
Wednesday, March 20, 2013

Finding theme in team

The more I try to help people in this field of mine, the more I realize that it doesn't take a village. It takes a huge industrialized city, all its wires and arteries humming with constant activity, just to try and make one woman better. In this case, one smiling woman in her 50s, ethnicity I couldn't figure and of dubious relevance, who came to our clinic seeking advice about her asthma that we had treated before. The medicines were already at their maximum doses, and she wasn't feeling much better. I perked up when the resident told me what sort of work she did. "She works at a towel factory." A towel factory? Like something out of Dickens?

There's a lot that's Dickensian today: the grinding poverty; the squashed tenements and desperate immigrants; the jobs that you don't want to think about too hard, like towel making. Mounds of dust, is what it involves (as we found out from talking to the patient), layers of dust everywhere, in a factory where the windows aren't opened ("It gets too cold."), no one wears their masks ("It feels like we're choking."), and, of course, the whole establishment is non-union.

I knew to ask these questions because I wrote a PhD thesis on workplace exacerbation of asthma. My methodological and topical interests have shifted, but my interest in workplace health has not changed. Only now I realize what's required to improve this woman's asthma: not just the team here in our Johns Hopkins residents' clinic, but a second team, charged with a broader responsibility of making it possible for her, first, to wear a mask comfortably on the job, and even more fundamentally to be placed in a job which does not worsen her breathing. The medical team needs to meet up with the public health team. We doctors can only make that happen if we realize the possibilities and limits of our roles.

A different example of teamwork is in the hospital during a code. (I am thinking about this because I need to renew my ACLS certification, which one can do online.) A code is done as a team, and every one on that team should fulfill their assigned role to the letter. Clear communication is vital to a good code. Patient safety experts know this.

But as often as the doctor has to play their role to the letter, they also have to know when to step outside it: to make a decision that has not been considered before. Perhaps the woman doesn't have asthma after all, or the code is something that, given previous discussions, should never have been attempted. There are roles, and then there is our responsibility as individuals: the me in team.

As a researcher and clinician, I want to make my patients better and I believe in the value of empirical study. But as a doctor in relationship with his patients, I know that people never fit totally inside the algorithmic checkboxes we try and put them in. My book talks about that difficulty of squaring the individual circle. Just as we need to make sure we can find ourselves in the team, we need to let our patients be their own people inside the system of care.

Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews. He is also a poet, journalist and translator in Yiddish and English. This post originally appeared at his blog.

What Starbucks can teach doctors

I’m sitting in a Starbucks now pleased that I found one of the few plush purple chairs to sink into. While this is not my regular coffee haunt, I will patronize them at times. I cannot drink their high octane coffee and will order some milder tasting overpriced beverage instead.

I don’t come here for their food and drink. I come in spite of them. I buy a drink and consider this my rent for the time and space.

I am put off that one can’t use traditional English when requesting a specific beverage size here. Is there something wrong with the conventional terms small, medium and large? You won’t hear me utter the highfalutin descriptions tall, grande or vente. If I want a medium hot chocolate, my usual purchase, then those will be my chosen words.

At Dunkin Donuts, where coffee is velvet, the staff sport T-shirts emblazoned with the statement: Friends Won’t Let Friends Drink Starbucks.

This should replace In God We Trust as our national motto.

Yet, this place is packed. The car line at the drive through was a dozen cars long. Folks will wait 20 minutes in line to buy an overpriced beverage that could be used as industrial insecticide.

How do they do it?

I wish my office waiting room could lure crowds like this. Perhaps, I have a chronic case of Frappuccino envy. There’s brilliant marketing and branding going on in the guts of Starbucks. As a gastroenterologist, I’m supposed to know something about guts, yet I admit that I am mystified. They have convinced us that this is the hip place to hang out, and we march to them like lemmings. It reminds me of the cosmetics industry, which has masterfully convinced us to pay too much money for stuff we don’t need.
Medicine is a different beast, but maybe we private practitioners can learn a few things from these marketing mavens.

I need to start revising my medical terminology.

The Old Loser Terminology
You need a colonoscopy.
You have a large ulcer.
Skip hemorrhoid creams.

The New Cool Hip Lingo
May I offer you a Colonoscopuccino?
You got a Vente Gastriato Macchiato.
Go No Whip!

Perhaps, I can partner with these guys. Anyone who manages to get their stuff down their gullet will surely need a gastroenterologist.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.