Wednesday, April 30, 2014

Mammograms are not as awesome as we said they were

A few weeks ago I wrote a blog that addressed a newly released study of the effectiveness of mammograms. This article, in BMJ, looked at women who were followed over a 25-year period as part of a Canadian study, found that there was no evidence that mammograms reduced deaths from breast cancer. Most women who will die of breast cancer do so regardless of whether that cancer was diagnosed by a mammogram, and the few who are saved because their cancers were diagnosed earlier than they would have been if only clinical exam were used may have been canceled out by the far more significant number of women who were harmed by overdiagnosis, that is being diagnosed with a breast cancer that would never have troubled them had they not had mammogram screening.

I was concerned that this didn’t set off a huge discussion among doctors and all of the rest of us about whether we should really continue to do regular screening mammograms. Our lives, health and billions of dollars rest partially on the answer to this question. The fact that it is so important is probably why the conversation has been so slow to start. Not doing the tremendous number of screening mammograms we now do would be very destabilizing since hospitals and surgeons and radiologists depend heavily on this revenue stream.

Women’s health centers at hospitals are primarily about mammograms and breast cancer diagnosis and treatment. These employ nurses and administrative assistants and social workers and counselors. There are ongoing and yearly campaigns designed to get women to get mammograms. A major change in policy has the potential to free up a great deal of financial and human resources, but at the same time jobs will be lost and budgets broken. If we accept that mammograms have led to substantial overdiagnosis, this will have a huge emotional impact on women who have been diagnosed with breast cancer as a result of mammogram screening.

So it is not surprising that the response to this Canadian study was measured.

Two articles were published in the Journal of the American Medical Association, 1 addressing mammograms in general and the other mammograms in women over the age of 74. These articles have been published less than 2 months after the BMJ article and are already getting lots of press and lots of discussion. The article about the overall risks and benefits of mammography is a review of multiple studies, including the BMJ article, and is really interesting to read. It delicately steps around some strong evidence that mammograms have no particular value in saving women’s lives and comes up with numbers that nevertheless make preventative mammogram screening look unattractive. The conclusions are that mammograms do reduce breast cancer deaths, but on the order of 1-50 per 10,000 women screened for 10 years, depending on age. A total of around 300 will be diagnosed with breast cancer and up to a third of these cancers will be overdiagnosed, resulting in women presumably being treated with radiation, surgery and chemotherapy for tumors that would not have caused harm. Six thousand of the 10,000 screened with mammography, fully 60%, will be called back during this 10 years for abnormal mammograms that will need further workup, including more imaging and biopsies. Still, the conclusion is that mammograms reduce breast cancer mortality, but only a little bit.

But what about the Canadian study published in February? This looked at women aged 40-59 who were screened with either clinical examination (examination of the breast by a trained health care provider) or mammograms plus clinical examination over the 5 year study period and then followed for 25 years. The only difference in the groups at 25 years is that the mammogram group had more breast cancer. There was no mortality difference. Did the Canadian women in the BMJ study play catch-up and get mammograms after the study was done and so reap all of the mortality benefit? If so, they appear to have also avoided a certain amount of overdiagnosis by taking their 5-year holiday. There are many ways to study the efficacy of mammogram screening, and none of the many studies that have been analyzed and meta-analyzed was really able to do a gold standard approach. Because of the fact that we have embraced mammogram screening as our standard of care, we have not done the definitive study. Ideally we would compare a group of women who were denied access to mammograms for 25 years and only received clinical breast exams or breast self-examination to a group who had mammograms at varying frequencies, say every 1-4 years, along with their clinical breast exams. No such experiment has been done so we rely on evidence gleaned from huge populations over many years but with less than ideal designs.

The other article in today’s JAMA tackles the question of mammogram screening in patients older than 74. No actual studies have been done on this population and many countries stop recommending mammography for patients aged 70-75 years of age. In the U.S., a significant proportion of women getting mammograms are over 74. Today’s article concludes, based on extrapolating the data we have based on younger patients’ data, that there would be a mortality benefit of mammogram screening if the women in question were expected to live 10 or more years. That is such a can of worms. I have very warm and respectful relationships with many older women who are my patients and I find it very difficult to admit to myself, much less them, that I expect they will die before 10 years elapse. That also assumes that I have any reasonable idea. The most important predictor of being alive tomorrow is being alive today, which is the message I like patients to take with them.

In a delightful juxtaposition, Dr. Mary Tinetti, an academic geriatrician, wrote an article about how extrapolating benefits of interventions from younger to older patients is often inaccurate. She doesn’t address the mammogram issue, but her article is well placed. We really don’t know what good or harm mammogram screening will do for our patients beyond the ages we have studied. It does appear, however, that overdiagnosis increases with age (see the BMJ article), so more women in their final decades will be diagnosed with breast cancers that would never have caused them harm if we continue to subject them to screening mammograms. I have watched my elderly patients suffer through radiation and chemotherapy and it is a lousy way to enjoy retirement.

So this kerfuffle about whether to do mammograms or not is a really big deal, and there is much damage control going on. It is interesting to look at this from the sidelines, and I am sure there is much that I am not perceiving. Many well-meaning people are highly invested in the prevention of breast cancer and much good work is being done. Mammography is definitely not going away. It is a reasonable way to detect breast cancer, and detecting breast cancer comes before treating it, and we have improved tremendously in our ability to effectively treat and cure it. Mammogram screening for patients at high risk yields a whole different set of numbers than what I have quoted. There may also be ways to augment mammogram screening with other testing to make sure that the breast cancers we treat actually need to be treated. It is past time, though, that we question the wisdom of pushing for regular mammograms in unselected women over the age of 50.

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.

The grass is green

She looked at me, eyes pleading, telling me without needing to say a word: I am not lying to you. I am not crazy. I am not making this up.

I sighed. ”We’ve done the work-up and know this is not your heart. I don’t think there are a lot more tests that can be run.” I studied her expression, trying to discern what she wanted to hear from me.

I’ve come to understand that there are two questions my patients are looking for me to answer:
1. Is there anything serious?
2. Can you make me feel better?

Doctors don’t seem to know this list, instead either focusing on a third question What is wrong with me?, or failing to answer one of these two questions. I’ve heard countless tales of frustration over hours spent at the doctor’s office only to hear the final judgment of “nothing is wrong.” These doctors have answered question #1 without addressing #2, leaving the patient to feel like they aren’t believed by the doctor. In the best case, this is a well-minded doctor who simply doesn’t consider the patents’ perspective; in the worst case, the doctor questions the validity of the patient’s story.

Not knowing which question was weighing on my patient, I asked directly: “So, are you still concerned that this is a dangerous condition? I know it’s hard to have chest pain whenever you exercise and not be a little worried, but I think the risk of this being serious is pretty low.”

“It just hurts,” she told me flatly. ”I exercise through the pain, but it gets pretty bad at times.”

There. She clearly wanted question #2 answered. Yet I had already been trying different things to get rid of this pain, none of which were working. Part of me wanted to shrug and explain that I’d done all that I could do, sending her home only with the reassurance that she wasn’t going to die from it, it was just going to hurt and there was nothing I could do.

Attempting to remain disciplined in my approach, I thought through the list of possible causes: What lives in that zip code?
The heart does, but we’d pretty much ruled that out as the cause.
The lungs are there, but when does a person simply experience pain in the upper chest because of the lungs, especially without shortness of breath? I don’t think it’s that.
The esophagus takes a trip through that area, but again, what’s the chance of exertional esophageal pain? Not impossible, but quite unlikely. Besides, she’s already on Prilosec.
People with anxiety sometimes complain of chest pain, but it’s usually during emotional stress, not physical exercise.
That leaves only the chest wall as the best explanation, but I’d already gone after that with both systemic and topical medications with little improvement.

A small voice spoke out in the back of my consciousness: It makes no sense! She must not be telling the truth! Clearly I’ve done all I can do, and so there must not be an answer. There is nothing wrong with her really!

I hear that small voice whenever I am at a loss. The voice comes out of frustration at not being able to help patients, but mainly out of my own insecurity. I don’t want to fail. I want to be a superhero, swooping in with my cape to solve my patients’ problems and to make them all happy. I don’t want people to be disappointed in me. You don’t go into medicine without at least a small need for people to admire you. For me, that need is a 800-Lb gorilla. I want people to be proud, not disappointed. I want to look smart, not dumb.

Another part of this voice comes from the small group of people who want to use the doctor as a vending machine. They know if they say certain things and push the right buttons, the doc will give them what they want, whether it’s an antibiotic, a pain medication, or an order for a test. They hit me at a second insecurity: the fear of not being in control. It should come as no shock that most doctors have this insecurity. We hate being used or manipulated (do you hear that, payors?). I’ve concluded that, in my population at least, few of my patients are this way (and those who are, eventually leave disappointed).

Fortunately, I’ve learned to ignore that voice of my own insecurities.

Unfortunately, many docs out there haven’t been so successful, and some will actually openly question whether the patient is actually experiencing the symptoms they report. The skepticism with which patients are met as they tell their stories is most acute in the “quick fix” settings, like the ER or urgent care center, but it happens everywhere. Patients are on the defensive as they tell about their symptoms, trying to justify their visit to the doctor, and to “get the doctor to believe” what they are saying. It’s as if the patient is considered duplicitous until proven honest.

Here’s the problem I faced as I met with this patient: if I accepted her story as true, I had to accept my inability to help; but if I didn’t accept her story, I label her as a liar, someone who wastes my time, a cheat, or an incredibly mentally disturbed person. For what reason would she make this stuff up? I couldn’t come up with any. She was telling me her experience: that for her the pain goes like this, the medications I did helped like that. To her, the grass looks green. If I doubt her reality, I am essentially telling her that pain isn’t what she said, the medication didn’t have that action, and that the grass actually is blue, not green. I am telling her that her reality is not real.

Who am I to invalidate another person’s reality? I can question conclusions she draws, but not the reality itself. Our realities are all we’ve got, and we have to trust our own senses.

“I’m kind of stumped here,” I confessed to her, going through my list of possible causes. Together we discussed the possible options of diagnostic testing and treatment. While we talked, she continued showing a glimmer of fear in her eyes. It wasn’t that she thought she’d die from this, and I don’t even believe it was a fear that I couldn’t help her; it was a fear I would tell her the grass was not green. Maybe her reality isn’t real. Maybe she is crazy.

Doctor and patient. Insecurity meets insecurity. Weak helping weak.


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.

Improving ambulatory care

I recently attended the IHI conference entitled “Improving Patient Care in the Office Practice and the Community“ in Washington, D.C. It attracted about 1,000 people from around the country to share their stories about how to make care better, and I want to share two of them with you.

If you have ever imagined what primary care could look like if you “blew it up” and started over instead of nibbling around the edges of process improvement, then you would enjoy learning more about the Southcentral Foundation. Their president, Katherine Gottlieb, and their medical director, Steve Tierny, gave a detailed account of their journey from a dysfunctional, bureaucratic provider-driven health system providing mediocre care to native Alaskans to a national Baldrige Award winner built around the concept of community wellness.

Don Berwick is quoted on their website as saying that “I think it’s the leading example of health care redesign in the nation, maybe the world,” and I can see why. They have truly put “customers” (not “patients,” which would imply that all of the people they serve are in need of medical care instead of wellness promotion) at the center of what they do, and have wrapped data-driven team-based services around them in what they call the “Nuka” system of care. Really impressive.

Laura Adams of the Rhode Island Quality Institute gave a keynote address in which she told a cautionary anecdote about ill-conceived efforts of providers to become more “patient centered.” She had been involved in the design of a “breast center” at a hospital in a small community, which had included all the things that the providers believed (without asking) that women wanted—pastel colors, soft lighting, soothing music, massage therapy and the like. After it opened, she interviewed patients to see how much they liked it and was horrified when one asked her “what were you thinking when you named this the ‘Breast Center?’” The woman went on to say that she didn’t want her friends and neighbors to know that she had something wrong with her breasts, any more than a man would feel comfortable walking into a building with a big sign that said “testicle center” or “penis pavilion” over the door. Ooops!

Turns out we really don’t know what people want or patients need unless we ask!

Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.
Tuesday, April 29, 2014

When less is more

When I meet a new patient, I’m frequently astounded by the health care he has received. I’ve met patients with absolutely no cardiac symptoms who have been receiving EKGs every 6 months for years. I’ve had patients brag to me about their annual executive physicals in which myriad tests including treadmill stress tests and chest X-rays were routinely performed. Patients get head-to-toe CT scans under the mistaken hope that they might save their lives by finding something. I’ve seen patients with no family history of colon cancers have colonoscopies every 2 years, because they really want to make sure that they don’t get colon cancer. Some patients do the best they can to be tested for everything.

In the absence of appropriate indications, all these tests are not only without value, they can be harmful. Even in perfectly healthy patients they can yield abnormal results simply through error. (These results are called false positives.) These results then have to be pursued with more invasive tests that can have complications and risks. This isn’t just a theoretical risk. I’ve seen patients harmed by tests that should never have been done.

Doctors are quick (and correct) to roll their eyes when patients take various unproven alternative medicines. When they take Echinacea for their colds, pop their multivitamins, and take black cohosh for menopausal symptoms. Patients should know that what they’re doing is unproven. But it occurs to me that doctors are much less critical when unproven or ineffective interventions are pushed by our colleagues. An unindicated stress test is every bit as unlikely to help a patient as a multivitamin, but potentially riskier. After all, a false positive result from a stress test may lead to an unnecessary angiogram, a risk that the multivitamin doesn’t carry.

The incentives that perpetuate the first type of ineffective medicine—the herbs, supplements, and vitamins—are obvious. Suppliers want to sell their product. They label and advertise their product with messages that fall just below the threshold for fraud, and patients interpret these messages to mean far more than they do. Eager to find something effective for what is frequently an untreatable problem (like a cold) patients understandably flock to these ineffective remedies.

But ironically, ineffective tests and remedies prescribed by physicians have even more perverse incentives. At least the patient has to pay for her own Echinacea and her own vitamins. The pointless EKG and stress test are covered by insurance! In a system in which tests are covered and the prices are fixed by the insurance company, the incentive is to deliver as many tests as possible. The doctor doesn’t lose anything if some of those tests lead to needless anxiety and further invasive testing. The patient doesn’t think to ask questions about the proven risks and benefits because he’s not getting the bill. The incentives do not reward achieving health, or preventing disease, or maximizing patient satisfaction. They reward delivering services. And we’re surprised that the result is the delivery of lots of services with no value.

Escaping the insurance system makes it easier to see the problem more objectively. I get paid by patients to listen to them and give them advice. I don’t get paid more if I order a test, and I also don’t get paid less. And I’m not paid by anyone but the patient. So I can actually take the time to educate the patient about the risks and benefits and figure out if she really wants the test. The net result is that patients pay me more so I can make sure they get more education and less healthcare.

I’ve written before about how our current healthcare market broke and how I believe it could be fixed. I think insurance coverage of routine care is a major flaw in the current system. We are currently expending enormous resources trying to insure everyone. If, as I believe, insurance is the problem and not the solution, the results will be even worse than the broken system we started with.

Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000. Holding privileges at Cedars-Sinai Medical Center, he is also an assistant clinical professor at UCLA's Department of Medicine. This post originally appeared at his blog.

QD: News Every Day--State medical boards adopt telemedicine guidelines

State medical boards adopted policy guidelines for safe practice of telemedicine, a need that is shown by the trouble one physician is undergoing after prescribing antibiotics by phone.

Representatives of the Federation of State Medical Boards (FSMB) approved updated guidelines to help ensure the safety and quality of telemedicine technology. The Model Policy on the Appropriate Use of Telemedicine Technologies in the Practice of Medicine provides advisory guidance that state boards can use to ensure that patients are protected from harm.

Among its key provisions, the model policy states that the same standards of care that have historically protected patients during in-person medical encounters must apply to medical care delivered electronically. Care providers using telemedicine must establish a credible “patient-physician relationship,” ensuring that patients are properly evaluated and treated and that providers adhere to well-established principles guiding privacy and security of personal health information, informed consent, safe prescribing and other key areas of medical practice.

“Telemedicine offers wonderful tools to help expand treatment options for patients, particularly in helping provide care in remote areas, lowering costs and helping support preventive care efforts,” said FSMB President and CEO Humayun J. Chaudhry, DO, MACP, in a press release. “But as telemedicine has grown, so too, has the need for clear, common-sense guidelines that help health care providers transition to this exciting new environment in a safe way.”

Dr. Chaudhry noted that the new guidelines are designed to provide flexibility in the use of technology by physicians, ranging from telephone and e-mail interactions to videoconferencing, as long as they adhere to widely recognized standards of patient care.

The policy adopted by the FSMB’s House of Delegates, which represents all of the nation’s 70 state and territorial state medical licensing boards, is advisory, meaning state boards are free to adopt it as is, modify it, or retain their own current policies regarding telemedicine.

But one physician is already facing possible loss of board certification and other consequences in the 9 states in which she is licensed after Idaho’s medical licensing board sanctioned her for prescribing a common antibiotic over the phone. Two physicians in the state’s legislature are working on a bill that would standardize telemedicine rules for all practice of medicine.
Monday, April 28, 2014

Weight loss resistance and choices

Weight is not a behavior, and weight is not a choice. Nobody wakes up and decides what to weigh today. In an age when healthy and unhealthy behaviors are increasingly subject to incentives and disincentives, respectively, this is all too easily forgotten.

Of course, weight is largely the byproduct of behaviors and choices, namely what and how much we eat, and what and how much we do: calories in and calories out. But the simple math of energy balance and the simple premise that our choices are in charge of it are complicated by two considerations.

First is that the choices we make are in turn dependent on the choices we have, and in the case of energy balance, all of modern culture conspires against good choices. In particular, foods designed to be all but addictive and maximize the calories it takes to feel full, designed with the aid of such powerful technologies as functional MRI scanning no less, are a potent sabotage of personal responsibility and good choices.

Second, 2 people may make the very same choices and wind up at very different weights. As a clinician with some 25 years of direct patient care experience, I can say categorically that 2 people can eat the same amount and exercise the same amount, yet 1 gets fat and 1 stays thin. This, of course, is not at all fair. But we have all, I trust, been around that block a time or two. We know life isn’t necessarily fair. Or at best, it’s fairly unfair over time, as bad things happen all too often to thin people, too.

Let’s quickly acknowledge that differential weight outcomes despite comparable diet and activity levels do nothing to repudiate the laws of thermodynamics. The relationship between matter and energy characterized initially by Newton is a basic tenet of physics, and all but unassailable. Certainly, it is stationed well above the pay grade of New-Age iconoclasts who debate the relevance of calories to no valuable end. Yes, calories do count. They are a measure of energy, and anyone wanting to contest the relationship between energy and matter has to go toe to toe with Sir Isaac. He’s never lost yet.

There is no need to revisit laws of physics to explain the paradox of differential weight outcomes. We need only visit the local car dealership. We are well accustomed to the list of attributes highlighted when cars are on sale, and among these is fuel efficiency. Obviously, it varies. That does not alter the properties of the fuel. It does not challenge the reliable meaning of a gallon or liter. It merely indicates that not all engines are created equal.

That is exactly true of the human engine, our metabolism, as well. We vary markedly in fuel efficiency due to various factors. Some are as obvious as our heritage. There are whole populations, such as the Pima Indians of the American Southwest (and originally, Mexico) whose ancestors adapted to survive in a very frugal desert environment, who are remarkably fuel efficient. Such groups, notably including many Native Americans and Pacific Islanders such as the Samoans, gain weight with stunning ease when exposed to modern living, and shed pounds very laboriously.

Underlying such ethnic variation is, of course, genetic variation, so variable response to particular doses of calories in and calories out is partly explained by genes. It is partly explained by body composition as well, which is in turn partly explained by still other genes, as well as experiential factors. A higher mass of muscle increases the calories needed to maintain weight. A lower mass of muscle and higher fat content has the opposite effect.

And then still other factors, some known and some doubtless yet unknown, influence weight outcomes in ways we are just beginning to appreciate. One that is well established is hormonal responses, in particular that of insulin. People who need higher levels of insulin to maintain normal blood sugar are preferentially disposed to deposit calories into body fat and gain weight. Weight gain then tends to worsen insulin resistance, and this very readily becomes a degenerating and very frustrating, spiral.

A more recent and increasingly salient consideration is the status of our microbiome, the bacteria that colonize our bodies, and especially our gastrointestinal tract. We have long known that bacteria outnumber our cells roughly 10 to one, and figure importantly in digestion. We are learning all the time how important they are to other body functions as well, from immune responses to hormonal balance.

One of the new frontiers in medicine is the recognition that significant alterations of the gastrointestinal flora can produce significant alterations in weight. In some cases, it can apparently result in extreme weight-loss resistance.

I have had patients in this category, people who eat very frugally, exercise strenuously and just can’t seem to take off weight. Of course, sometimes people seemingly in this category are telling themselves and their doctor, perhaps inadvertently, little white lies, exaggerating how few calories they consume, or how much they exercise. But among my weight-loss resistant patients are some who have undergone full metabolic testing, verifying the truth of their claims. Some people are almost shockingly fuel efficient, vulnerable to weight gain and resistant to weight loss.

This frustrating problem prompted me to create an online exchange for those affected, so a community could come together and benefit from the ‘hive mind.’ I invite any in this camp to visit the site, and I invite experts in this area to contact me via email to explore the possibility of sharing that expertise. My thanks in advance to those who do so.

There are cases, few and far between thus far, where extreme weight-loss resistance has been linked to disruption of gastrointestinal flora, due to antibiotics or some other trauma. And, in some cases, the still extreme option of fecal transplant, introducing a full suite of normal intestinal bacteria, has proven therapeutic. Lesser instances of the same basic problem may respond well to probiotics, prebiotics or a combination.

In some cases drugs, such as the diabetes drug metformin, may prove useful: metformin enhances insulin sensitivity, and has a potential role in treating insulin resistance in addition to diabetes. In some cases, nutrient supplements may be appropriate. Cinnamon can help stabilize blood sugar and insulin levels. Green coffee bean extract appears thus far to be a safe and effective means to boost metabolism slightly. Garcinia cambogia may help attenuate appetite, among other effects. A product called PGX made from dietary fiber can blunt the glycemic effect of food.

The right response to weight-loss resistance will vary. In some cases, it will be learning to love the skin you’re in, not everyone who wants to lose weight really needs to do so. If you carry extra pounds but are fit and vital and healthy, perhaps you can and should learn to accept rather than fight your “natural” weight, shape and size. Your life may be better if you do.

For those who can’t or won’t accept their weight, or whose health is compromised by it, the options for addressing weight-loss resistance should be explored with a health care professional who knows what they are doing. The approach should be individualized, and given the limits to our current knowledge, will likely involve some trial and error. But it can result in success, so keep the faith.

Weight-loss resistance is real. I’ve seen it, up close and intimately.

Weight, per se, is not a choice. Addressing the variable challenge of weight management with insight, understanding and compassion certainly is. It’s a choice we should all be making.

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.

QD: News Every Day--Government-funded vaccinations prevented illness in millions, saved billions

A government program implemented in 1994 likely prevented an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 deaths in children born between then and 2013, and likely saved $295 billion in direct costs and $1.38 trillion in total societal costs, a model showed.

The Vaccines for Children (VFC) program began in 1994 to ensure that eligible children do not contract preventable diseases because of inability to pay. It was a response to a measles resurgence that resulted in approximately 55,000 cases reported from 1989 to 1991.

The resurgence was caused largely by widespread failure to vaccinate uninsured children, and was linked to an ongoing reservoir of the virus among high-density, low-income, inner-city populations. Although most children had a health care provider, providers missed opportunities to give measles vaccine when children were in their offices, sometimes referring low-income children to another clinic where vaccines were available at no cost

Researchers at the CDC used information on immunization coverage from the National Immunization Survey and a previously published cost-benefit model to create the estimates. Coverage for many childhood vaccine series was near or above 90% for much of the period.

Results appeared in Morbidity and Mortality Weekly Report

“Because of sustained high coverage, many vaccine-preventable diseases are now uncommon in the United States,” the authors wrote. As an example, “Measles was declared no longer endemic in the United States in 2000, in contrast to model estimates that 71 million cases would have occurred in children born in the VFC era without immunization.”
Friday, April 25, 2014

Staphylococcus aureus: here, there and everywhere

To spend any time on our infectious diseases consult service is to be knee-deep in invasive, difficult-to-treat Staphylococcus aureus disease. Most S. aureus (including MRSA) disease is caused by a strain previously colonizing the host, and given that up to a third of the human population carries S. aureus it is easy to understand why the disease is so common. Exposure to health care is a major risk factor for invasive S. aureus disease, simply because so many health care interventions (surgery, device use, antibiotic exposure) provide opportunities for the organism to invade.

Nonetheless, the conventional wisdom still holds that a large proportion of health care-associated S. aureus disease results from patient-to-patient transmission events—the corollary being that prevention of S. aureus disease should focus primarily on preventing transmission (including active detection and isolation).

However, a careful assessment may demonstrate that interventions solely designed to interrupt transmission are responsible for only a small portion of disease reduction in observational studies (for an example, see my previous post on the VA MRSA directive). This is important, as it should focus our attention on preventing disease among those at risk for colonization (everyone), via such horizontal measures as device-associated infection prevention bundles, chlorhexidine bathing, and suppression/eradication of the carrier state during high-risk intervals.

A study by UK investigators published in Clinical Infectious Diseases provides further evidence that patient-to-patient S. aureus transmission is a relatively uncommon event, even as an explanation for S. aureus ”acquisition” events in the ICU. Using whole genome sequencing, the investigators found that only 7 of 37 ICU patients who “newly acquired” S. aureus were colonized with strains that were closely related to other patients who had an overlapping ICU stay.

There are several limitations to the work, most of which are outlined by the authors in their discussion and by the excellent accompanying editorial by David and Daum. The limitation most concerning to me is the assumption that a single nares + perineum culture plated directly to solid agar media (chromogenic agar and Columbia CNA) is a sensitive method for detection of S. aureus carriers. It isn’t. Failure to perform a throat culture or to use broth enrichment probably reduced sensitivity by 30-50% (explaining their overall carriage rate of only 16.7%, when most published studies demonstrate S. aureus colonization rates of closer to 30%).

We recently performed a study wherein we cultured 500 pregnant women at 5 body sites. The table below is taken from our presentation at the Decennial meeting in 2010 in Atlanta.

The bottom line? Using only nares and perineal cultures directly plated to solid agar media would have missed more than half of our S. aureus carriers. Achieving 90% sensitivity (using a positive culture at any of the 5 body sites as the gold standard) required sampling both the nares and the throat and using overnight broth enrichment.

So what about all those “acquirers” carrying isolates that didn’t match other ICU patients? In addition to implicating other potential reservoirs (personnel, visitors, etc.), I’d wager that some were prior carriers who were newly detected due to sampling issues, increase in CFU associated with healthcare exposure, etc. Intermittent detection of S. aureus carriage is well described, and would be magnified using the microbiological techniques in this study.

Finally, while I agree with the authors that whole genomic sequencing is the new gold standard for assessing genetic relatedness, the use of spa typing as the “conventional method” comparator is too easy. As we found in our recently published study, roughly half of all MRSA isolated from epidemiologically unrelated clinical infections in 43 U.S. hospitals were from a single spa type! (How’s that for discriminatory power?) If you’re going to write off the conventional methods, at least use a method with better discrimination, such as pulsed-field gel electrophoresis!

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--Our guard may be down about measles eradication

Two recent measles outbreaks should remind clinicians of the dangers of measles, a disease officially eradicated in the U.S. in 2000, but one that could still reoccur due to lack of vaccinations and the potential of secondary transmission at health care facilities, a commentary stated.

The success of the measles vaccine has led many clinicians have never seen measles and may not be able to recognize its features. Yet, the median annual number of cases has been rising steadily, with an average of 155 cases per year since 2010. Its eradication means that many clinicians might not recognize it, or might mistake its presentation for something else, the author noted.

The commentary appeared at Annals of Internal Medicine.

The recent outbreaks in New York City and Orange County, California, resulted from people traveling from overseas, and then spreading measles through communities with large numbers of unvaccinated people, the author noted. Most postelimination measles cases have been due to outbreaks, mostly in unvaccinated people.

Clinicians should have a high level of suspicion for measles in those with febrile rash illness who have recently traveled or have had contact with travelers and are able to recognize its clinical features: a prodrome of fever up to 40.6° C, cough, coryza, and conjunctivitis.

The rash is red, blotchy, morbilliform one that appears 2 to 4 days after symptom onset, beginning on the face and then spreading downward and becoming confluent. Pathognomonic Koplik spots appear 1 to 2 days before the rash and last 2 to 3 days; they are small, slightly raised, bluish-white spots on an erythematous base and have been reported in 60% to 70% of patients with measles. Confounding its dermatological presentation, measles rash may be confused with other viral exanthems such as fifth disease, roseola, Kawasaki disease, or scarlet fever.

“As measles incidence increases, clinicians have a vital role to play,” the author wrote. “We need to talk to our patients about measles vaccination and remind them what is at stake if imported measles cases continue to land in communities of unvaccinated persons, especially for those who are too young or ineligible to be vaccinated. Meanwhile, we must ensure that our facilities do not become centers for secondary measles transmission—prompt recognition of suspected cases and rapid implementation of control measures are critical to prevent further spread.”
Thursday, April 24, 2014

Do hospitalists improve or detract from quality of care?

Editor’s Note: This column originally appeared in 2 parts at MD Whistleblower.]

Part 1

Hospitalists are now firmly planted in the medical landscape. These doctors have no office practices and earn their living exclusively by managing hospitalized patients. These guys and gals are either hospital employees or are private groups who are under contract by hospitals. The market and the profession were hungry for this new specialty, which has exploded across the country. The advantages to patients and to practicing physicians are enormous. Are there drawbacks?

When these hospital physicians first appeared on the hospital scene, there was buzz that patients would push back against these stranger-docs wanting their own office doctors to attend to them instead. This never materialized. Patients no longer had the expectation that their own doc would be available to them 7 days a week. Indeed, medical physician groups and institutions had on-call rosters such that it was likely that the doctor available was not the patient’s actual physician. So, the heavy lifting had already been done.

Once patients and their families recognized the high quality of care that hospitalists provide, whatever doubts that may have existed evaporated.

Here’s the upside.
• Hospitalists provide superior hospital care because of their training and experience. It is probably true that a physician who treats 75 heart attack patients each year is more skilled at doing so than is a family doctor who does this quarterly. In general, higher volume translates to higher quality.
• Hospitalists are there around the clock. They are available to check on patients throughout the day and night. Can anyone argue that this is not superior to the prior system of the attending physician seeing the patient once daily? Go ahead. Make your case.
• Hospitalists allow primary care physicians to stay clear of the hospital so they can focus on their out-patient practices, where their skills are better matched. Additionally, it is very inefficient for a primary care physician to come each day to the hospital to see a patient or 2. For these reasons, the vast majority of primary care physicians refer their hospitalized patients to hospitalists for care and treatment.
• Internists enjoy a higher quality of life as they no longer have to stagger in at 3 a.m. to admit one of their patients.

Part 2

There is the Achilles’s heel of the hospitalist system. While the advantages are clear and substantial, there are serious vulnerabilities which have not yet been adequately remedied.
• Hospitalists cannot appreciate the medical nuances, personality, family dynamics, life events and prior experiences that may be well known by the out-patient physician.
• There are serious communication lapses, all of which cannot be bridged. The out-patient doc may know that the patient’s chest pain is his typical anxiety and that it is not necessary to repeat the cardiac evaluation that was done 2 years ago. The hospitalist may take a different tack here.
• Despite their best efforts, hospitalists know that they will not be seeing the patients after discharge. As they are not permanently vested, they may not address certain patient concerns, punting these to the outpatient arena. While this may be medically acceptable, it may be frustrating for some patients.
• The hand off back to the out-patient doc after hospital discharge can be a minefield. Patients may be on new medications. They may have had a variety of laboratory and radiology tests. Some of these results might be ‘pending’ at the time of discharge. How does the out-patient physician reliably receive these results and understand their context? Did medical specialists on the case leave recommendations that the primary physician now has to track and implement? When the primary care doctor resumes care of a patient who had a complex hospitalization, is he now responsible to search out and address every loose end contained within the voluminous hospital record? Could a single laboratory abnormality buried in the record that was totally unrelated to the medical illness become a medico-legal issue years later? Do we really think that the hospitalists discharge summary to the primary care physician is airtight?

A primary care physician recently complained to me that the local hospitalists never call him when his patient is admitted when he might provide useful information about his patient that only he knew. This is a legitimate gripe.

No system is perfect.

So, which side of the issue has the better argument?

This post by Michael Kirsch, MD, FACP, appeared as part 1 and part 2at 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--Most doctors, med students couldn't answer this question

One in 4 physicians and medical students correctly answered a single question testing their ability to correctly interpret the false positive rate of a diagnostic test result, a research letter found.

The researchers replicated a 1978 study by asking a convenience sample of physicians, house officers, and students the same question: “If a test to detect a disease whose prevalence is 1/1,000 has a false positive rate of 5%, what is the chance that a person found to have a positive result actually has the disease, assuming you know nothing about the person’s symptoms or signs?”

The convenience sample at a Boston-area hospital assessed answers of 24 attending physicians, 26 house officers, 10 medical students, and 1 retired physician, across a range of clinical specialties. Results appeared online April 21 at JAMA Internal Medicine.

Only 14 doctors and students provided the correct answer of 2%. The most common answer was 95% (27 respondents). Among the range of answers, from 0.005% to 96%, the median was 66%, which authors noted is 33 times larger than the true answer.

Responses in the replication study were not significantly different from the 11 of 60 correct responses (18%) in the original study. Also, in both studies the most common answer was 95%. Respondents often knew to compute positive predictive value but accounted for prevalence incorrectly.

The researchers noted that understanding positive predictive value “is particularly important when screening for unlikely conditions, where even nominally sensitive and specific tests can be diagnostically uninformative.”

The authors suggested incorporating aids into ordering software, and even using point-of-care tools like smartphones. They also suggested revising premedical education standards to incorporate training in statistics instead of calculus, which is seldom used in clinical practice.

In an accompanying editor’s note, Joseph S. Ross, MD, MPH, ACP Member, noted that disease prevalence matters for testing, as does test sensitivity and specificity.

“The persistent inability of physicians to reliably manage this cognitive exercise implies that our educational programs need to do a better job at teaching numeracy skills,” he wrote. “Because imprecise diagnostic decision making is leading to excessive testing, patient harm, and excessively costly care, we must raise the bar and master these cognitive skills.”
Wednesday, April 23, 2014

Principles of critical care medicine for non-intensive care specialists

I just got back from Boston where I visited friends and went to a really good and useful Harvard Medical school continuing medical education course. Harvard is one of the few institutions that I have found to have consistently good classes for practicing physicians, with a few exceptions.

This Spring I wanted to get myself to Boston and so I went to the online list of Harvard CME courses, which is more exciting than a candy store. In the time block that I had available they offered 2 delicious options. One was a week long course on everything anyone ever wanted to know about internal medicine, which would have earned me over 60 hours of credit while crushing my soul with 10-hour days of densely packed information mainly intended to help practicing physicians pass their board exams. The other was the course that I chose, which delivered almost 20 hours over 2.5 days, leaving me time to walk along the waterfront and eat a little lobster and even frolic with my friends.

The course, the 2nd Annual Principles of Critical Care Medicine for Non-Intensive Care Specialists was designed with the knowledge that much of the intensive care delivered in the U.S. is by physicians who don’t do intensive care medicine as their main thing, and haven’t received fellowship training in it. Many of us have become pretty good at it, but we sure can benefit from hearing what highly intelligent and rigorously educated intensivists have to say.

Three intensive care and pulmonary medicine specialists from Harvard’s Beth Israel-Deaconess, Drs. J. Woodrow Weiss, Jeremy Richards and Peter Clardy, along with guest speakers, shared information that was geared to what I really needed to learn. They gave us evidence-based recommendations, but more importantly they told us how things worked in their hospital’s intensive care unit, what they had done to improve patient care and outcomes and what that actually looked like. They focused on some of the most deadly diseases, sepsis and acute respiratory distress syndrome, and about some relatively dismal long-term outcome information for the patients who are saved from their dread diseases in intensive care units, often to be faced with long term physical and mental disability. They taught us to manage ventilators more skillfully and to actually engage our brains by remembering how human physiology is reflected in some of the data which is presented to us so copiously in critically ill patients. They taught us how we might prevent delirium in patients who frequently become confused and have a very hard time coming out of it. We were gently encouraged to give blood products only to patients who could really benefit from them, which is still a bit of a moving target.

In skills workshops that were wound into the lecture and small group problem solving sessions we had a chance to use ultrasound to practice procedures and image the hearts of a few live volunteers. We were taught the standard bedside echocardiographic views and used “phantoms” to practice placing central venous catheters and sampling fluid in the abdomen and chest. Having attended many specific ultrasound training workshops I was a little disappointed in the cursory nature of these workshops, but the course was short and there truly was not enough time to cover everything that people should learn. The fact that bedside ultrasound was a part of the course means that the organizers not only feel that it is part of what should be done in intensive care units, but also that it is at the core of what anyone who practices intensive care medicine should be able to do, even (or maybe especially) at small community hospitals. This is a good message.

The course was small enough that it was possible to talk to all of the speakers and ask individual questions. The folks who attended were an interesting mix. We were primarily physicians who managed patients in hospitals where there were no intensivists, but we were also emergency physicians and advanced nurse practitioners and physician’s assistants. It is unusual to run into many of these people at conferences because they are often too busy to attend, and we are a small minority of physicians in the U.S.

There was a feeling in the course of trying to make sure every recommendation was based on some kind of reputable research. Since only a minority of interesting questions have been addressed adequately by reputable researchers, this approach was impractical, and as the course wore on we more often treated to experience, deduction, good sense and critical questioning. There was a nice mix of research results and practical recommendations.

The course was held in the World Trade Center on the water in South Boston, where not too long ago only warehouses and fishing boats lived. It is near a beautiful museum of contemporary art, is served by $3 ferries to all sorts of destinations on the Boston Harbor, and has easy walking access to excellent restaurants. There is a very long foot path called the Harbor Walk, which makes it easy to get exercise at the edge of the water. The Seaport Hotel where conference attendees stayed was large, well appointed, expensive but not ridiculously so. The World Trade Center was also hosting the Boston Flower and Garden Show, so parking would have been terrible, but renting a car was superfluous so it didn’t matter. The show was really interesting, if you like that sort of thing, and it was possible to walk in from the conference without paying the $20 entrance fee, which was probably not intentional, but did not appear to be forbidden.

What I learned is readily usable. I look forward to treating my next intensive care patients to what is presently the cutting edge at one of America’s best hospitals and sharing some really great ideas with my doctor colleagues.

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.

The medical monopoly you've never heard of

Have you had a prescription filled electronically?

The difference is no longer being handed a written prescription and having to take it to a pharmacy to be filled. E-prescribing enables the doctor to electronically send the prescription right from her computer. Fast. Clean. One stop shopping. If she picks a medication that’s a) not covered by your insurance or b) risky for a medication interaction, then the computer alerts her and she can make a different choice.

This is all possible because of Surescripts, a consortium consisting of national pharmacy chains, independent pharmacies, and the big “pharmacy benefit managers” (groups like Express Scripts or Caremark). Last year, the Surescripts network surpassed the 50% mark: half of all prescriptions are now generated electronically. It’s a big number: Surescripts reports handling 6 billion electronic transactions a year.

Imagine Coke and Pepsi uniting with artisanal/local cola makers to create a single distribution and delivery system nationwide, in which they’d share proportionally in the costs and the utilization. Seems inconceivable. Yet it’s exactly what’s happened in the retail drug industry.

Read more about it here, on NPR’s Shots blog.

One exception to e-prescribing I didn’t cover in the piece: Most states still require written prescriptions for narcotic (opioid) pain medications (think Vicodin, Lortab, Percocet, etc.) This is to add hurdles to the process for a variety of reasons. Fodder for future posts.

This post by John H. Schumann, MD, FACP, originally appeared at GlassHospital. Dr. Schumann is a general internist. His blog, GlassHospital, seeks to bring transparency to medical practice and to improve the patient experience.

The bending cost curve

I attended a really interesting conference last week on “Innovation in Health Care” that was cosponsored by The Advisory Board and the Aspen Institute. It was a 1-day affair in Washington, attended by about 1,000 people from around the country who were treated to talks by a star studded cast that included Health and Human Services Secretary Kathleen Sebelius, Peter Orszag, Jeffrey Brenner, former U.S. Senators Tom Daschle and Bill Frist, and a guy with more titles than I can count, Patrick Conway.

A few things stuck with me.

First, the overall message, from across the political spectrum and from different corners of the health delivery landscape is that fee-for-service is—and ought to be—dying as the predominant mechanism of health care financing. In fact, the day often seemed like a requiem for fee-for-service; it was mostly discussed in the past tense, with the new world of value based purchasing and accountable care in its many forms the focus.

Patrick Conway (wearing his CMS Chief Medical Officer hat) reviewed some amazing data regarding declining readmissions and improving quality metrics among Medicare beneficiaries. Perhaps most striking was the slide he showed illustrating that the growth of Medicare spending has dramatically slowed over the last several years, and is now lower than the growth in overall GDP.

This has been pointed out before but this is a very big deal.

Peter Orszag explained why. First, he reviewed many of the things that are not responsible for the downward growth curve. It is not a reflection of the great recession; it is not a result of lower prices; it is not a consequence of baby boomers swelling the ranks of Medicare beneficiaries at the low end of utilization. No, the explanation is lower utilization across the board of medical services, and specifically a decline in the rate of hospitalization among Medicare recipients.

Orszag went on to speculate why this is happening, which is where this really got interesting.

He believes that providers are changing practice in anticipation of new models of payment. He cited as an example the work that many hospitals have done to lower their readmission rates even when their current and short-term economic interests are better served by filling the beds. The implication of this interpretation of the data is clear. Whatever gains have been made in “bending the cost curve” are fragile, and can only be baked in if payment models continue to evolve away from fee-for-service. If CMS does not continue to ratchet up the impact of value based purchasing or expand novel payment models, or if commercial payers do not accelerate their transition to risk-based contracting, the curve will likely bend right back up.

Oh, and one more thing, in case you don’t think it is important which way the curve bends. Orszag also pointed out that if current trends continue, all of the long-term fiscal challenges facing the United States, which seem to be driving so much of the invective in Washington, just go away. Completely. Imagine that.

Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.

QD: News Every Day--False-positive mammograms may not increase long-term anxiety

False-positive mammograms were associated with increased short-term anxiety but not long-term anxiety, and such results increased women’s intention to undergo future breast cancer screening, a study found.

Researchers conducted a telephone follow-up survey among 1,000 women as part of a quality-of-life sub-study. Randomly selected women with positive and negative mammograms requiring follow-up testing or referral without a cancer diagnosis were assessed for their willingness to undergo future mammographic screening. They were also presented with a hypothetical scenario in which they could travel and stay overnight to undergo a new type of mammography that would identify as many cancers with half the number of false-positive results.

Results appeared online April 21 at JAMA Internal Medicine.

Women’s plans to undergo mammography within the next 2 years did not differ by screening outcome. But, 25.7% of women who had a false-positive mammogram characterized themselves as “more likely” to undergo future breast cancer screening compared with 14.2% of those who had a negative mammogram. However, there were no differences in women’s attitudes toward the anticipated anxiety they would feel if they were to have a positive mammogram in the future.

Women’s experience of a false-positive mammogram did not influence their willingness to travel to avoid a false-positive mammogram in the future, with the vast majority of women in both groups being willing to travel up to 4 hours to avoid such a result. A small minority in each group were willing to travel and stay overnight to avoid a false-positive mammogram (10.5% in the negative and 9.9% in the false-positive group). When women were asked to choose between a new type of mammography that would avoid breast compression and one that would avoid false-positive mammograms, most (81.6%) chose the latter.

The authors wrote: “The fact that women’s anticipated anxiety about future false-positive mammograms was a correlate of willingness to travel and stay overnight to avoid such a result, but the actual experience of a false-positive mammogram was not, further highlights opportunities to educate women about screening outcomes.”

In an editorial, Kurt Kroenke, MD, MACP, wrote, “These adverse consequences would be less concerning if false-positive mammograms were an uncommon event. However, the cumulative probability of a woman receiving at least 1 false-positive mammogram within 10 years is 61.3% with annual and 41.6% with biennial screening. The cumulative probability of biopsy recommendations based on a false-positive mammogram is 7% with annual and 4.8% with biennial screening. This increase in likelihood of a false-positive mammogram over the screening life span of a woman amplifies the adverse consequences at a population level.”
Tuesday, April 22, 2014

Do regulations predispose to diagnostic errors?

Last week I presented my diagnostic talk, “Learning to Think Like a Clinician” at the Virginia ACP meeting. Afterwards several physicians wanted to discuss the reasons for diagnostic challenges. They convinced me that many regulations from CMS and other insurers have influenced policies that increase anchoring and diagnostic inertia.

When the emergency department physicians admit to the hospital, they have to give an admission diagnosis. At least in the United States, I believe they cannot admit for abnormal chest X-ray, or fever, but rather they must postulate a diagnosis. That diagnosis then drives case managers and protocols. Patients often receive their first treatments before the admitting physician has even met the patient.

The emergency physicians get criticized if they do not proceed in a timely fashion. The hospital worries that they have a diagnosis that supports admission rather than observation status. If they designate the wrong status, they face a financial problem.

But patients do not always arrive with diagnoses. Some diagnoses take time. Patients would benefit if the diagnosis was purposely made unknown disease with manifestations rather than pick a diagnosis for billing and quality purposes.

Too often, the physicians stated, a diagnosis induces a therapeutic freight train. And then if the patient is not discharged promptly (according to the expectations of the admission diagnosis) the admitting physician gets criticized.

Something is wrong with the system. (Actually much is wrong because we do not really have a system, rather we have rules.) We need ways to more acceptably label a patient as a diagnostic puzzle. We need the “system” to allow us to not know the diagnosis and realize that pursuing the diagnosis is job #1.

We must develop systems to avoid diagnostic anchoring and inertia. Our patients deserve our full diagnostic attention. Unfortunately, we see too many diagnostic misadventures.

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 Regional Associate Dean for the Huntsville Regional Medical Campus of UASOM. He still makes inpatient rounds over 100 days each year. This post originally appeared at his blog, db's Medical Rants.
Monday, April 21, 2014

Needed: a research agenda and program for clinical informatics

I recently had the opportunity to hear a talk by Philip Bourne, PhD, the new Associate Director for Data Science at the National Institutes of Health (NIH). I have always been impressed with Dr. Bourne's work in bioinformatics, and I welcome the NIH paying attention to data science throughout it new Big Data to Knowledge (BD2K) Program.

Dr. Bourne gave an excellent talk, laying out a vision for how data science will improve health. He also reiterated his view of "Big Data," published recently in Journal of the American Medical Informatics Association (JAMIA), which focused less on the quantity of data and more on clinical, research, and other health-related organizations making maximal use of all of their data assets1. This is in distinction, as noted by another commentary, about a certain vagueness when definitions of Big Data focus on the word "big"2. Dr. Bourne's utilitarian view makes more sense to me, since there are many "small" data issues around clinical data, such as quality, completeness, and provenance, that must be solved before we can trust and apply the output of Big Data systems3.

Nonetheless, what I believe was under-appreciated in Dr. Bourne's talk, which is common among those coming from the bioinformatics world where data is more regular and complete, was the scientific issues underlying the challenges of clinical data. Yes, we are (finally!) entering an era when patient data is increasingly captured in electronic form. But just because clinical data is plentiful does not mean it is good data, and there is no evidence, as is sometimes asserted, that more plentiful quantities of data will overcome some of its quality problems. I certainly agree that clinical trials as we now perform them are small, expensive, and may not have generalizability. But that does not prove that multiple orders of magnitude larger quantities of observational data will be better.

I certainly have enthusiasm for using data in our clinical systems. I believe there will be tremendous opportunities for leveraging the value of data, especially when it is of high quality. We will, for example, be able to validate the results of experimental studies on a much larger scale. We will also be able to find many uses for predictive analytics, such as identifying patients where we can intervene to ward off poor outcomes or find ways to deliver healthcare services more efficiently. There is no end to the possible value of Big Data in healthcare and biomedicine.

But the fruits of more data will not be realized just by accumulating more of it in digital systems. One of the big challenges was eloquently stated by another attendee of the talk, Dr. Justin Starren of Northwestern University, who noted that while data science deals with important problems, it takes place outside of the workflows addressed by clinical informatics. On the front end, data science says very little about data entry, workflow, usability of EHRs, and other factors that have, according to a recent survey by Medical Economics magazine, made EHRs the bane of many clinicians4. On the back end, there are challenges too, such as whether the output of data analytical algorithms can be applied in ways that measurably benefit clinical outcomes5.

These are important as growing criticism emerges from clinicians regarding currently used EHRs. We also know that while a good deal of research shows benefits of IT6, other research raises concerns about its safety7. Clearly we have a ways to go before we solve the end-to-end goal of electronic record-keeping leading to improved health or healthcare delivery.

To this end, we need a research agenda for clinical informatics. The problem is that we do not have a well-funded federal agency devoted to research in this area. The National Library of Medicine (NLM) is an obvious home for such research, especially as many of us have careers that have been propelled by NLM funding. However, many people don't immediately think of a "library" for this kind of work. In addition, the NLM's research budget is small; for example, only 13 research grants were awarded last year. Another government agency that funds this kind of work might be the Agency for Healthcare Research & Quality (AHRQ), which has a rich health information technology (HIT) portfolio. However, as important as AHRQ studies are, they mostly focus on applications of HIT and do not get down to the core scientific issues addressed above. Some of the other institutes of the NIH fund informatics research, but is usually applied in disease-specific ways (e.g., the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. There are other government agencies that funded some general types of informatics research, such as the National Science Foundation (NSF), although NSF eschews disease-specific research.

I recognize we are in an era of tight federal research funding, with few dollars for investing in new programs. I am hopeful that the investments being made in data science will take a broad focus and include investigation into better ways to produce high-quality clinical data as well as optimally use it to improve health, clinical outcomes, and health care delivery. In the long run, however, our health care system really needs a research agenda and program for clinical informatics.

References1. Bourne PE, What Big Data means to me. Journal of the American Medical Informatics Association, 2014. 21: 194-195.
2. Ward JS and Barker A, Undefined by data: a survey of big data definitions. Databases (cs.DB), 2014.
3. Hersh WR, Weiner MG, Embi PJ, Logan JR, Payne PR, Bernstam EV, et al., Caveats for the use of operational electronic health record data in comparative effectiveness research. Medical Care, 2013. 51(Suppl 3): S30-S37.
4. Verdon DR, Physician outcry on EHR functionality, cost will shake the health information technology sector, Medical Economics. February 10, 2014.
5. Amarasingham R, Patel PC, Toto K, Nelson LL, Swanson TS, Moore BJ, et al., Allocating scarce resources in real-time to reduce heart failure readmissions: a prospective, controlled study. BMJ Quality & Safety, 2013. 22: 998-1005.
6. Jones SS, Rudin RS, Perry T, and Shekelle PG, Health information technology: an updated systematic review with a focus on meaningful use. Annals of Internal Medicine, 2014. 160: 48-54.
7. Anonymous, Health IT and Patient Safety: Building Safer Systems for Better Care. 2012, Washington, DC: National Academies Press.

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.

Hospital medicine doctors: In the driving seat to improve patient satisfaction

Improving patient satisfaction and enhancing the hospital experience is all the buzz today in health care. Every hospital executive across the country is talking about it, and coming to terms with how their organization’s reimbursements will be directly tied to their performance in this area. A decade ago, none of us had ever heard of HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, the core metric by which healthcare facilities are now being evaluated. And while improving patient satisfaction scores is a complex issue that requires a multifaceted approach from all levels of the organization, one thing is certain: as the most visible frontline clinicians during any medical patient’s hospitalization, hospital medicine doctors are key to driving this improvement. They are the face of the hospitalization, act as the main point of contact for the patient, and are the doctors who will be most involved in their care. The old model of the hospitalist being present “to just round” on patients in place of their regular primary care provider is long outdated. It’s therefore crucial to recognize their role in improving the hospital experience. Here are some everyday ways hospitalists can do this:
• Making clear to the patient from the beginning the role of the hospitalist, their relationship with the patient’s primary care provider, and how they will be in charge of the patient’s complete care as part of a collaborative care team. This helps to reassure an often anxious elderly patient and their family;
• Regularly using aids such as explanatory introductory cards, pamphlets and business cards. Leave them on the table in the room so that family members can also see them and know the doctor who’s in charge of the care;
• Making a clear plan for the patient every day. Utilize whiteboards in the patient’s room and keep them updated;
• Developing more optimal patient rounds, including multidisciplinary rounding models to ensure that all members of the healthcare team are on the same page;
• Setting aside dedicated time for extended patient and family meetings each day, usually in the afternoons;
• Making clear that you are regularly communicating with the specialists who are also involved in the patient’s care; and
• Developing and maintaining good communication skills, always displaying empathy and compassion.

Statistics show that two of the most frequently cited patient complaints are a lack of time with their doctors and healthcare staff exhibiting poor communication skills. On a practical level, in order to maximize time with patients, hospitalists obviously need a manageable daily patient census.

Formal communication skills training is often well received by physicians, especially if feedback is given in a friendly and collegial atmosphere. It’s traditionally been an area that the healthcare profession hasn’t gotten into, and older physicians in particular are much less likely to have ever received any formal training or skills advice. Worried about pushback if you bring up the concept? Most physicians actually enjoy thinking about the topic, and are very keen to improve their skills.

Ultimately, it’s all about making the patient feel comfortable, at ease, and listened to. Some proven communication techniques that physicians should utilize include making eye contact, sitting down, and asking open-ended questions. These are very basic, but often forgotten about during a typical hectic day. They can all be taught, improved upon, and coached.

Specialists also need to step up to the mark. They need to be encouraged to maximally collaborate with the hospital doctor and to make the patient feel like all their care is being coordinated. The other touches that go into improving a hospital stay, such as regular nursing checks, being clear on wait times, and following up post-discharge with a personal (non-automated!) message from a nurse or administrator, should all be added to the mix.

Let’s remember that this isn’t simply about saying that you’ve “improved patient satisfaction” and raising survey scores for the sake of reimbursements. Patient satisfaction is really about understanding what the patient is experiencing and the emotional roller coaster that goes with being sick. HCAHPS scores, while by no means the perfect survey, may be the jolt the medical profession needs to strive for what it should have been doing all along: providing patients with a high level of customer service at a low point in their lives.

Hospital medicine doctors are best placed to engage the patient from the beginning, and by focusing on them to lead the way, organizations can soar to new heights.

Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care. This post originally appeared at his blog.
Friday, April 18, 2014

Tranexamic acid--why you may be less likely to bleed to death in Britain than the U.S.

The other day at an interdisciplinary rounds meeting at the hospital, one of our nurses who is also an emergency medical technician mentioned that in Britain injured patients receive tranexamic acid before arriving at the hospital because it reduces death from bleeding. “What’s that?” I said. I kind of barely remembered hearing this medication’s name associated with the treatment of a rare disease, but not treatment of trauma. So I was guessing that this was some drug that was invented long ago which had been found to be quite effective in other countries, but has not been really optimally used in the U.S. because it is generic and therefore unlikely to make drug companies money.


Here’s the story, as far as I can determine.

Tranexamic acid is a relatively simple cyclic molecule that blocks the fibrinolytic process, that is, the natural breakdown of blood clots in the body. In the setting of any injury, especially severe ones, fibrinolysis is intensified, leading to a condition of excess bleeding in trauma victims. This is hardly ideal, and tranexamic acid can help reverse this. It also appears to have an effect on reducing inflammation, which may be even more significant.

There have been a couple of major studies in the last 3 years showing significantly better outcomes in patients who have traumatic injury and who are treated with tranexamic acid intravenously soon after injury. The most recent study, published in the Archives of Surgery, looked at 896 patients injured in the military from registries in the UK and the U.S. and identified the subset treated with tranexamic acid. Although this group was generally more severely injured, the mortality rate was significantly lower, 6.5% lower, than the group that had not received the drug. In very seriously injured patients, those who received massive transfusion of blood products, the difference in survival was nearly 14%.

It is not often that we see an effect this powerful, especially in a group like this who are healthy and will likely have long and productive lives after being saved. An earlier study, published in 2011 in the Lancet titled CRASH-2, showed similar results in civilian trauma victims, with a double-blind, prospective design. The Cochrane Collaboration, a group of researchers who review randomized controlled trials, concluded that tranexamic acid was safe and effective in reducing mortality in trauma patients without increasing adverse events.

So maybe it’s actually very expensive, then. I called our hospital pharmacy to ask about that. Apparently a gram of it costs about $44. The usual protocol for trauma is 1 gram intravenously right away and then another gram over the next 8 hours. So $88 times 100 equals $8,800 to save 6.5 lives (using the data from the military study), or $1,353 per life saved. That’s pretty cheap. And since it probably reduces the severity of illness in the rest of the patients treated, it may end up reducing overall treatment costs.

Presently the only FDA (Food and Drug Administration) approved indication for this drug in the U.S. is an oral formulation to be used for women with heavy periods and intravenously for prevention of dental bleeding in hemophiliacs. It is also used off-label to reduce transfusion requirements in total joint surgeries (that’s why we have it in our pharmacy), also in some places for prostate surgery, general surgery, gastrointestinal hemorrhage, bleeding around pregnancy and delivery and bleeding within the eye. It reduces the frequency of attacks of swelling in a condition called hereditary angioedema, which is rare, and was why I had even heard of it in the past. It has been available over the counter for years in Europe, marketed for heavy menstrual bleeding. The injectable formulation is also on the World Health Organization’s list of 350 essential medicines which are considered safe and effective and necessary worldwide.

So what are its side effects? It may increase the risk of blood clots in the legs and lungs, but studies have shown this to be far less of an issue than one might guess, and it looks like the lives saved far outweigh this risk. The CRASH-2 study showed that there might be a slight risk of increasing mortality if it was given to trauma patients more than 3 hours after their injury.

Why is it not FDA approved for reduction of bleeding in trauma and other similar situations for which there is ample evidence of safety and efficacy? The FDA approves drugs and devices when approval is requested, and usually the drug or device manufacturers who stand to make money from an FDA approved indication are the ones to make the request. I suspect there has been no request for approval for these other indications. Just because it is not FDA approved to reduce bleeding in trauma and surgery doesn’t mean it can’t be used, but physicians have a certain hesitance to use unfamiliar drugs off-label.

So the story of tranexamic acid is another excellent example of how simpler, cheaper and sometimes more effective treatments are not being widely used in the U.S., even though our patients may receive exorbitantly expensive medications and treatments of dubious or minimal benefit. This is because we allow powerful pharmaceutical companies to inform our practice. Sometimes this actually works, when companies produce groundbreaking innovations and encourage us to adopt them. It is unlikely, though, to help us find creative uses for inexpensive drugs that have been around a long time. This dynamic may mean that 6 or so people of the 100 who are probably just now being involved in accidents with bleeding will die when they would not have if use of this drug part of our routine practice.

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.

What the new dietary fat study results really mean

No, it is not suddenly good to eat more saturated fat, and the new study grabbing headlines showed no such thing.

The new study, a meta-analysis (meaning a pooling of previously published studies, not new research) in the Annals of Internal Medicine, shows the following 2 things in particular. You cannot get a good answer to a bad question, and there is more than 1 way to eat badly.

We’ll come back to those shortly, but first here’s an overview of the study objectives, methods and findings. The investigators, an international team, started out questionably by asserting that dietary guidelines emphasize “changes in fatty acid composition to promote cardiovascular health.” There is some truth to that, but there are some fundamental problems with the assertion as well. Dietary guidelines make recommendations about any given nutrient in the context of the overall diet. So, for instance, advice to eat less saturated fat also comes along with advice about eating less sugar. It is not in the form of “eat less saturated fat and do whatever else you want.” More importantly, good dietary guidance is increasingly about foods rather than isolated nutrients, although that is admittedly still a work in progress.

So, having framed the issue questionably, the researchers set off in the appropriately questionable direction to address it. They looked at variation in the intake of specific fatty acid categories (e.g., saturated, monounsaturated, polyunsaturated, trans), sub-categories (e.g., omega-3 and omega-6 polyunsaturates), and specific fatty acids within those sub-categories and corresponding variation in coronary heart disease.

The methods, as noted, were meta-analytic, the pooling of data from multiple prior studies to reach a summary conclusion. Some experts in meta-analysis have raised concerns about the methodologic details, with at least one expert at Harvard suggesting there may be a major mistake. But that debate can be left to play out. We will give the analytic methods the benefit of the doubt, and assume they correctly answer the questions asked.

Those questions were: What are the differences in rates of coronary heart disease (defined rather vaguely in the paper) in observational studies when the top third of intake is compared to the bottom third of intake for some particular class of fatty acid?; and what are the differences in coronary disease rates in intervention trials between groups when one group is given some kind of fatty acid supplement?

For the observational studies, representing more than 500,000 people, the investigators found more coronary heart disease in the highest intake of trans fat compared to the lowest; and less heart disease in the highest intake of omega-3 fat compared to the lowest. There was a hint of benefit for higher monounsaturated fat intake. And then the part spawning the predictably exaggerated headlines: there was no appreciable difference in coronary heart disease rates seen comparing the top to bottom third of saturated fat intake, although there was in fact a suggestion of more heart disease with more saturated fat consumption. There was no difference when comparing the top to bottom third of omega-6 fat intake either.

For the most part, the intervention studies, which included more than 100,000 people, administered some omega-3 supplement. A smaller batch of studies administered some other kind of polyunsaturated fat. You may recall we had already heard the news that omega-3 supplements, all other things being equal, did not appreciably reduce rates of coronary disease, so it should come as no surprise that this study found the same. In fact, while not statistically significant, there was a trend toward benefit seen with all of the polyunsaturated fat supplements, including omega-6 fat. For long-chain omega-3 fat, or so-called “fish oil,” the apparent benefit was very close to statistically significant.

Now, consider for a moment some of the leading arguments about diet and health swirling around us. Are they all about dietary fat? Not remotely. Much of our collective attention over recent years has been focused on sugar, starches, carbohydrates in general, meat in general, processed meats and grains.

I searched the new paper for the word “sugar,” and could find no mention of it. None.

People eating less saturated fat don’t simply stop eating a nutrient and leave a big hole in their diets. They eat less of A, and make up for it by eating more of B. The most obvious of questions, yet one to which this study was totally inattentive, is: what is B?

We know those trends at the level of the general population. When we started cutting back on saturated fat, we started eating more refined starch and added sugar. We also know that excess intake of sugar, starch, and calories is associated with obesity, diabetes, and coronary disease. So if eating less saturated fat means eating more sugar, it would at best be a lateral move in terms of health, and probably worse than that. The study simply ignored this consideration.

Does this show, as the titillating headlines suggest, that saturated fat is unrelated to coronary disease? No, however we might wish it to be so. It merely shows there is more than one way to eat badly, and from my perspective, our culture seems committed to exploring them all.

Basically, this study showed that if you vary your intake of saturated fat or omega-6 fat without altering the overall quality of your diet, you are not likely to alter your health much either. That’s not much of a revelation, and unlikely to make any headlines expressed as such. But the headlines we are getting, while much more exciting, are entirely misleading. There was no suggestion at all here of any health benefits of saturated fat, and some hint of harmful effects despite the important study limitations. There were suggestions of favorable effects of the usual suspects, omega-3 fat and monounsaturated fat.

But moving on from such one-nutrient-at-a-time preoccupations, there is a bigger fish to fry here than just fish oil, or olive oil or lard. Dietary guidance must be about the whole diet, and should be directed at foods rather than nutrients. If we get the foods right, the nutrients take care of themselves.

This study does nothing to refute what we already knew about diet and health, and frankly, that was quite a lot. We know what dietary patterns are associated with the longest, and most vital lives among peoples in the Blue Zones. We know what dietary patterns are associated with dramatic reductions in the lifetime risk of all chronic diseases. We know what dietary patterns are associated with reductions in the rate of heart attack in intervention studies.

Are such diets low in saturated fat? Yes, but as a byproduct of the foods that are eaten. A diet that is made up mostly of vegetables, fruits, beans, lentils, nuts, seeds, and whole grains, with or without fish, seafood, lean meats, eggs and dairy simply has less room for saturated fat, let alone trans fat. Such a diet is natively high in omega-3 and monounsaturated fat, and balanced in terms of polyunsaturates. Just as important, such a diet is relatively low in refined starch and added sugar, and natively rich in fiber, vitamins, minerals and antioxidants. Attend to the forest, in other words, and the trees thrive. Bark up any given tree, and you may fail to notice that the forest has burned to the ground.

Our one-nutrient-at-a-time approach to diet and health has been a decades long public health boondoggle. Our penchant to talk about nutrients rather than food is antiquated and substantially misguided. There is saturated fat in salmon and salami. There is carbohydrate in lentils and lollipops. Lumping foods together across such a spectrum is the garbage in that invites studies that will inevitably spit garbage out. Looking at variation in saturated fat while ignoring sugar is an exercise in futility.

Our inclination to play Ping-Pong with scientific findings comes at a cost in human potential. Our proclivity for hyperbolic headlines is a public health menace.

This new study shows we can vary our intake of any given fatty acid and not alter the quality of our diet or health. Well, duh. There is more than one way to eat badly.

And there are no good answers to misguided questions.

My advice is as it ever was. Chew carefully on headlines before choosing to swallow the hyperbole, and eat a diet of wholesome foods reliably associated with good health across a vast and stunningly consistent literature. Do that, and let the fatty acids and other nutrients sort it out for themselves.

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.