Wednesday, March 30, 2016

Protecting human subjects in medical research

There was a tragedy in France recently that did not involve offensive cartoons, radicalized jihadists or terrorists masquerading as refugees. Innocent French citizens were taken down by a profession whose mission is to heal and comfort. A medical clinical trial careened off the rails and crashed. Ninety volunteers were in a study testing the safety of a psychiatric medication. One is dead and others have suffered irreversible brain damage. While a horrible outcome is not tantamount to guilt, this is a deeply disturbing event that must be investigated.

Were these volunteer study patients properly informed? Are medical study patients here in the U.S. truly making a free choice?

From time to time, friends, patients and relatives ask my advice if they should participate in a medical experiment. While I am a doctor, I usually say no. And, once I explain to them the realities of medical research, they usually say no also.

While my colleagues may chastise me for not encouraging my patients to join clinical trials, my primary obligation is to advocate for the patient before me, not for society. If physicians contemplate changing this ethical construct to consider the greater good when we advise patients, then we need to engage the public in a serious conversation on this issue.

When an individual joins a research project, the medical study is not designed to benefit the individual patient. This point is sorely misunderstood by patients and their families who understandably will pursue any opportunity to help an ailing relative. I get this. I wonder, however, how many of them would sign up if they knew that they would be unlikely to personally benefit.

There are 3 powerful conspiring forces that may exert undue influence on prospective study patients:
• Medical research needs a steady diet of new study recruits. In other words, the beast must be fed.
• Medical investigators often have biases favoring their research and truly believe that the new drug or treatment has a real chance of helping study patients. Phrasing such as “preliminary results are quite promising” may be well intentioned, but may be beyond the facts.
• Patients, particularly those who are not responding to conventional treatment, are vulnerable.

Here's the truth. Medical research projects and clinical trials are designed to generate new knowledge that will be used to help patients down the road, not those in the study. Of course, I cannot assert that a study patient won't realize a favorable result, but this serendipitous outcome is not the study's planned yield.

Beware of the packaging. If your mom or dad has Alzheimer's disease, of course, you would be susceptible to the following pitch.

Is someone you love struggling against Alzheimer's disease? Our Neurological Institute has been fighting hard against Alzheimer's disease and is now testing a new drug to help conserve memory. Call for confidential information. Doesn't this wording suggest direct benefit toward volunteers? Are study participants, in fact, facing risks without benefit?

I strongly support medical research which is our source of future cures and treatments. The medicines and treatments that we use today are the result of years of research done years ago. We need to generously fund our respected research institutions. But, we must ensure that the research community adheres to the highest ethical standards, and that any breaches are exposed and remedied. There's a reason that the term informed consent contains the word informed. Uninformed or misinformed consent can't be tolerated.

We will find out soon enough if the French study subjects were given all the information they were entitled to, and if investigators and others behaved properly. Even if no lapses are discovered, it will underscore that experimental treatment has unknown risks, which may be devastating. In other words, investigators may be unaware of the full extent of a study's risks. Hence, patients aren't fully aware either.

If you want to join a medical study to serve humanity and not yourself, then you are free to make this informed choice, and I applaud your decision. Helping others is a praiseworthy act. So is telling the truth.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
Tuesday, March 29, 2016

Fatness, affluence, adaptation, and hope

Colleagues and I recently submitted a grant application to a large foundation, seeking funds to support a cause that I founded, the True Health Initiative. The funds, should we be fortunate enough to secure them, will accelerate the development of a global communication campaign to convey the evidence and consensus-based fundamentals of healthy living, and notably, healthy eating. In particular, the grant would support a rigorous evaluation so that we could demonstrate the replacement of widespread confusion and doubts about consensus related to healthful, sustainable eating at baseline, with clarity and understanding by virtue of our efforts.

The True Health Initiative is global, and the research project is intended to be as well. Our application calls for targeted interventions, aimed at raising awareness, in five or more countries around the world. Those countries were chosen to represent both places where the so-called “Western” diet is long established, such as the U.S., England, and Australia; and places where that diet is fast replacing local traditions in the wake of cultural transition, such as China, India, and much of the Middle East.

While working on this grant, and thinking about its geographic scope, something odd to the point of paradoxical kept pestering me. In the U.S. and much of the long-industrialized world, one of the principal risk factors for obesity, and attendant metabolic mayhem, is poverty. In the U.S., the fattest and sickest among us tend to be the poorest, while affluence is a robust, if imperfect, defense against obesity and related chronic diseases.

In contrast, in the fast-developing countries, including but not limited to the massive populations in India and China, the situation is just the reverse. Affluence, at the population level, is propagating the tidal wave of obesity and chronic disease by which these nations are being engulfed. Within those populations, the most affluent are first in line to acquire the very morbidities that extract the greatest toll of years from lives and life from years, and which we have been striving for decades to overcome.

How can it be that affluence, at the same time but in different places, is both apparent impediment, and invitation, to obesity, diabetes, and so on?

I believe the 1 word answer is ”adaptation,” and there is a glimmer of genuine hope in it.

For many years, I have occasionally incorporated into my talks what can only be called an epic, if whimsical and rather Seussian, original poem entitled: Polar Bears in the Sahara. Delivery of the poem is routinely accompanied by a sequence of slides, including the eponymous image, which has become my figurative trademark over the years. I suspect I am known in some quarters as “that polar bear guy,” and it suits me fine.

These days, alas, that image could pertain to climate change, and a grim fate to which these extraordinary animals may be subject, more or less. My reference, though, going back some 25 years, is not about that. My reference is to adaptation.

I note that polar bears, marvels of survival though they may be, are adapted to a particular habitat, and the very traits, tendencies, and attributes that foster their survival in it would conspire against them in another. Soak up and retain heat where it's very scarce, it helps keep you alive; do the same beneath the burning Sahara sun, where the survivalists dissipate heat rather than concentrating it, and it is sure to cook your goose.

We humans, so goes my argument, are the same. Throughout almost all of human history, calories were relatively scarce and hard to get, and physical activity unavoidable. The latter was called survival, no gym membership required, and everybody just did it every day. We have devised a modern world in which physical activity is scarce and hard to get, and calories unavoidable. We have not adaptations to such a world; no native defenses against caloric excess or the lure of the couch, having contended only with their opposites throughout all the ages.

No defenses, I go on to say, save one: great, big Homo sapiens brains. We are, arguably, smarter than the average bear- and have the potential, at least, to think ourselves out of this mess of our own devising.

Which brings us full circle, back to that grant, ourselves, the future, and fundamental truths about healthy, sustainable living.

The Western diet, alternatively known, here at least, as the “typical American diet,” or “standard American diet” (referred to, aptly, as SAD) is a public health disaster. Despite all the noisy debate over whether its ills are a product of sugar, saturated fat, or something else, the simple reality is that it is a diet of dubious foods and drink in misguided combinations and excess. Its liabilities include both saturated fat and sugar, and are by no means limited to them.

But it is tasty to a species long adapted to crave sugar, salt, and fat. So when we can first get our hands on it, we do, and greedily. That's just what is going on now in China, India, South Africa, Qatar and elsewhere, with rather calamitous consequences.

Here, though, at the epicenter of this mayhem, we have had some time to habituate. Those with the most resources, inevitably the affluent, are starting to mount a defense. The wealthy and well educated are seeking, and finding, alternatives to a diet of hyper-processed grains, added sugar, soda, meat, butter, and cheese. The resource-rich are finding their way first, past the obstacles in our culture, to a diet of wholesome foods, mostly plants, in sensible combinations, and water when thirsty.

A stanza near the beginning of my poem, referring to the age-old struggle to get enough to eat, goes like this:
“... now, come to have when once had not
it's clear we've overshot-
in fact, by quite a lot.
So the challenge that emerges
as our culture clearly verges
on the brink of several scourges-
heart disease, obesity, stroke, diabetes
perils immune to our pleas and entreaties
is related to excess;
can we manage to suppress
the menace mingled with success?”

The answer, it seems, is a qualified yes. Given some time to get used to the temptations of bagels and burgers, Pop Tarts and pepperoni, the advantages of affluence help overcome them. Where the wealthy are starting to navigate past the perils of the modern, glow-in-the-dark diet, we are witnessing evolution, albeit cultural rather than genetic evolution. We are seeing it over an accelerated timescale play out around us, and it has important implications for the health of the world- people and planet alike.

There are 2 key lessons here, and 1 urgent call to action.

The first lesson is that the popular meme advocating for more “meat, butter, and cheese” is utter nonsense. It is belied not just by research, including randomized trials, but by perhaps the largest natural experiment of all time. As populations around the world with traditional diets of simple, minimally processed, mostly plant foods adopt a Western diet with greater emphasis on both highly processed foods, and animal foods, their health goes to hell in the proverbial hand basket. As the privileged members of Western populations find their way back to diets of simple, wholesome foods, mostly plant, in sensible and often time-honored combinations, they wind up with far better health than everyone around them.

The second lesson is that we can, apparently, adapt to, and overcome, the temptations of the modern diet. We can, in fact, out-think this mess of our own devising.

The urgent call to action is, of course, the obvious. We cannot stand idly by while huge populations around the world follow in the footsteps we know lead to folly. We cannot abide a divide in our culture where the health of the relatively disadvantaged is scavenged to fill the coffers of corporate profit.

We are seeing some early indications that, yes, we can, with time to adapt, and resources at our disposal, rise to meet the menace mingled with our success. If the affluent are gradually acquiring defenses against the assaults of the modern diet on health, those defenses must be generalized. Practices that help add years to lives and life to years cannot be the exclusive purview of the privileged. Those of us in public health are duty bound to identify these very practices, and do our utmost to propagate them. Our grant application, and the True Health Initiative, are devoted to just this proposition, so here's to their success.

Resources help us acquire the things we want. There is an urgent need to alert the global, human family that we need to be very careful about what we wish for, or we may get it. There is a need, in our culture, to share the advantages of affluence, and in cultures elsewhere to shift aspirations from running on a diet of donuts, to time-honored sustenance in the service of longevity, vitality, and a better life.

We are a uniquely adaptable species. It has led us into trouble that imperils ourselves, and our planet alike. There are early indications of hope that it could lead us out as well.

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.
Friday, March 25, 2016

One doctor's approach to the quantified self

“What gets measured, gets managed.”
—Peter Drucker

Despite being considered one of the techie people in the physician/rheumatology community and a self-proclaimed Apple fanboy, it might be surprising to know that I don't own (or want) an Apple Watch.

Part of my reasoning comes from the importance of avoiding interruptions.

But the main reason I don't own any type of smartwatch is that I don't see anything useful that they allow me to track.

When I look for things to track, I look for key performance indicators (KPIs): things that I consider modifiable activities, that when tracked or measured, correlate with improvement in specific goals.

With this in mind, I'll start with a few of the more common activities that I don't track (and why):
Steps per day. Although the recommendation to walk 10,000 steps per day is an arbitrary number, I do find that it is an excellent suggested baseline level of activity for most people. However, since I'm a fairly active person that exercises most days of the week (and even uses a standing desk at work and at home), I don't find that this has any correlation with my fitness level.
Bodyweight. I'm fortunate enough that my bodyweight has varied little throughout my life. I credit this mostly to exercise (primarily strength training since my teenage years), along with generally watching my diet. Certainly, if my bodyweight would increase (especially in the form of adipose tissue), this would quickly become one of my KPIs.
Calories. In recent years, increased importance on the type of foods that we eat has been recognized. While the total energy that we consume certainly matters, the effects of different types of food also clearly play an important role. In other words, you would expect your body to react differently to 2,000 calories of pure sugar versus 2,000 calories of grass-fed steak.

Activities that I track (and how):

Heart Rate Variability (HRV). HRV is a measure of how much beat-by-beat variation occurs in your heart rate, which is governed by the balance of sympathetic and parasympathetic nerve activity. More simplistically speaking, HRV can give a sense of how much stress the body feels at a given time. (PDF of a review here). In a fully rested/low stress state, you should have a high HRV, and under conditions of high stress, you would expect your HRV to decrease. Increasingly, high level athletes are using measure of HRV to titrate their level of training for the day.

I use an app called HRV4Training (App Store) to track my HRV most mornings, which uses the iPhone camera and flash to measure your heart rate via plethysmography with surprisingly good accuracy (especially if used in a dark room). After this, your HRV can be viewed in the form of rMSSD (the unit by which HRV is calculated, called the Root Mean Square of the Successive Differences).

In my case, whenever my HRV rMSSD is above 80, I'm fairly well rested (which means I'll probably do deadlifts that day).

I've found that my HRV seems to most strongly increase with the amount of perceived rest that I get, with frequent moderate-high level exercise, and with meditation. My HRV seems to decrease the most when I'm sleep deprived, when I'm sick (or feeling like I might be getting sick), or after overly intense exercise (especially too many deadlifts).

Exercise. I track exercise using a website called beyond the whiteboard, which is popular in the CrossFit community, and fits very well with the style of workout that I often perform. The site allows you to analyze your overall fitness level in comparison to other athletes who use the site, and also helps you identify strengths and weaknesses in your overall fitness.

Sleep. I have a Sleep Number bed that has built in sleep tracking, although I don't find that it always correlates with my perceived level of rest. Sometimes, this is because I'll fall asleep in my son's room while putting him to bed, so the data is wrong (such as on Sunday of the picture below).

Meditation. Over time, I've come to find a great deal of benefit from meditation (and I'll give Dr. Ronan Kavanagh credit for initially turning my onto the idea of it.) I currently try to meditate 10–20 minutes each morning using the Headspace app (Web | App Store), and have felt increased ability to focus and generally calmer.

Other: Mobility & Diet. I use an app called Way of Life (App Store) to get a big picture view of a few things I'm tracking, such as meditation and exercise, and other things I'm trying to watch, such as doing some mobility work (especially hips, ankles, and shoulders) most days. The app essentially allows you to check yes or no for each day, and encourages you to go on a streak of 3+ days.

Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington. This post originally appeared on his blog, World's Best Site.
Thursday, March 24, 2016

The ethics of performance measurement

For years I have argued that performance measurement has significant potential for unintended consequences. But today, I read an article that crystallized my concerns in an important new light. The article is written about the ethics of studying work hours,”Leaping without Looking — Duty Hours, Autonomy, and the Risks of Research and Practice“. As I read the article, the implications of the ethical arguments stimulated my thoughts about performance measurement. While I hope you will read the entire article, these lines have particular relevance here: “Bioethicist and legal scholar Michelle Meyer has described our “tendency to view a field experiment designed to study the effects of an existing or proposed practice as more morally suspicious than an immediate, universal implementation of an untested practice.” She argues that people in power often rely on intuition in creating and implementing wide-reaching policies.”

Most physicians would argue that people in power (CMS and insurance companies) have relied on intuition in creating and implementing performance measures. Please reread the above paragraph and consider seriously the problem here. Performance measures have had serious untoward consequences. Patients have suffered because of overly aggressive diabetes control, overly aggressive hypertension control and the 4-hour pneumonia rule. In the Britain's National Health Service pay-for-performance program, care improved only slightly for targeted care but deteriorated for unmeasured parameters.

With respect to performance measurement, I have long argued that we need prospective randomized controlled trials prior to adopting any performance measure. Advocates will argue that we cannot afford the time or money needed to perform such studies. But if we accept a non-zero probability of adverse patient outcomes due to a performance measure, how can we ethically adopt such a measure?

Imposing a performance measure can have a similar impact as a new pharmaceutical agent. If we really believe the dictum primum non nocere then we have a moral obligation to object to the potential that a policy could induce negative patient outcomes.

We should not consider this concept as radical or only hypothetical, as we have clear examples of measurement impacting patient care, outcomes and even access to care. We could argue that performance measurement raises important concerns about professionalism, if indeed concern about our report cards changes how we provide patient centered care.

These ideas are important. I thank Dr. Rosenbaum for writing a brilliant piece that made me think. If only we could get “people in power” to think.

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.
Wednesday, March 23, 2016

Is concierge medicine ethical, or elitist?

Massachusetts General Hospital (MGH), perhaps the most prestigious hospital in the United States, has just announced that it is joining the concierge medical universe. Concierge medicine offers patients Rolls Royce care for an extra fee. This model has gained popularity across the country and is attracting both patients and physicians. Patients receive white glove treatment on demand and physicians have more time with each patient as they no longer are pressured to increase patient volume to pay bills. I'm sure that some of these physicians have increased their incomes, but others may be paid the same, but enjoy seeing 6 patients per day instead of 20.

I was struck by $6,000 annual feel that MGH was charging concierge patients, the highest I had ever seen before. The typical fee I had seen was in the $1,500 per year range. Six grand per year will get Bay Staters personalized care whenever they want. They will never wait for an appointment. I imagine that the waiting rooms will be Zen gardens, with music, art and aromas that create an aura of wellness.

Keep in mind that the concierge medicine fees are in addition to medical insurance payments.

A criticism of concierge medicine is that it is an elitist, 2-tiered system of medicine for Americans. This is ridiculous. We already have a multiple-tiered medical system in place. Does anyone doubt that wealthy individuals receive a different level of medical care and quality? Concierge medicine is simply another avenue for them to do so. Incidentally, this option is not just for the wealthy. I know working people here in Cleveland who have paid a $1,500 yearly fee because they are frustrated with the medical status quo and are willing to pay more for a higher quality product. Another working family may decide instead to pay $1,500 for a family vacation. We all have different priorities.

While I believe that every American is entitled to receive quality medical care, I don't believe that someone should be prevented from paying more for a higher quality of service. The same argument applies to college education, automobiles, vacations, homes, and legal advice. Preventing folks from paying more to get more harms them, but helps no one else.

Full disclosure: I am neither a practitioner nor a patient of concierge medicine. Wonder what a concierge gastro practice would look like. Gold-plated colonoscopes? Organic hemorrhoid creams? Sushi laxatives?

I have also eschewed concierge blogging. No elitism on this site. I give it all away for free.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
Tuesday, March 22, 2016

People and arms, rights, and reason

Scientists at the National Center for Health Statistics at the CDC just published a research letter in JAMA, reporting on a comparison of life expectancy at birth in the U.S. to peer countries, mostly in Western Europe. The U.S. lags behind many, and these researchers analyzed causes of death to explain why. Their data suggest that 3 factors are responsible for denying Americans the full measure of life enjoyed by our European counterparts: car crashes, drug abuse and poisonings, and firearms. Guns made the largest contribution of the 3.

If we were prone to value epidemiology over ideology, that might be a basis for action. As is, any meaningful response is very much in doubt.

Personally, I don't believe that the gun troubles in this country owe all that much to ideology. The ideologues who think they are doing us all a favor defending us and our liberty by hoarding weapons on their ranch in Idaho against the advent of our government running tyrannically amok are not the real concern. At the population level, they are a rounding error. There are other errors related to their thinking, from my perspective, but propriety dissuades me from noting them here.

The main argument is not between dueling sets of idealists, or ideologues. The main argument has little to do with ideology, or idealism. Rather, and inevitably, it has much to do with money. The NRA may cater to idealists, but it is run by devout capitalists.

Looking at NRA-related exchanges over a span of years, I am induced to think of other mighty, self-perpetuating institutions, like the hierarchy attached to any given religion. There are foot soldiers with genuine zeal, but those wielding the real power are much harder to gauge. Some may be true believers, but we have ample to cause to think that many may not.

Guns and bullets represent money, lots of money. Frankly, I think that's what our societal impasse is all about.

Those who want to assault my gun control advocacy as an expression of gullible trust in our government can't assign my distrust of the gun industry's motives to cynicism. There's no such thing as a gullible cynic. It's oxymoronic, give or take the oxy. Gullibility means trusting those you should not; cynicism means doubting everyone.

Sadly, I think I am more cynic than rube. Life has taught me to be less trusting than I would like to be. An excess of trust, in the government or anything, does not tend to be my problem.

I don't trust the gun industry. I think they are using the Second Amendment as a smoke screen, behind which lots of money is changing hands.

But let's pretend that's not the case. Let's pretend this is really a battle of ideals, or ideologies. I think we are getting it wrong even so.

The Second Amendment refers to people, and arms. It does not specify who is meant by the former, or what is meant by the latter.

In other words, no matter how we sanctify the sage counsel of our Founders, we are obligated to interpret it. There is no alternative.

Clearly, we don't take the Second Amendment to mean that the people have a right to nuclear launch codes, or even lesser, private caches of nuclear weapons. Clearly, we don't take the Second Amendment to mean that the people should be allowed to stockpile smallpox in their basements. We have arms the Founders likely never dreamed of, but either way, we are obligated to interpret “arms.”

We are no less obligated to interpret “people.” Surely, although they are people, the right does not extend to inmates in our prisons. Surely it does not extend to any given kindergartner on a playground, or their younger sibling in a crib. Surely, it does not extend to psychiatric in-patients.

But the Second Amendment specifies no such exceptions. These are all people, clearly, and thus part of “the people.” And so, arguably, the right in question extends to them all. Yet, we seem to have decided otherwise. Are we defying the Founders?

That we have decided anything at all, about people or arms, is telling. It tells us that we can't call this all the wisdom of the Founders, and punt. We are interpreting the applications of the Founders to our 21st century reality.

And so it is that the gun debate in America is well advised by an adage from our English progenitors: in for a penny, in for a pound. If the responsibility to interpret the words of the Founders resides with us, even a little, then what we do is not just a product of the Founders' brilliance. It is also a product of our own muddling efforts to interpret, and apply.

The interpretation with which we advocates of gun control are throttled, or shot perhaps, is that the Founders said just what they meant, and there is no counter argument. We should shut up, accordingly.

But that is, in a word, rubbish. They just said “people,” and “arms.” Our interpretations of both are on flagrant display. That we need to interpret is not theoretical; it's a done deal.

All that leaves for us to debate, and determine, is: interpret, based on what? If not all conceivable arms for all people all the time, then what restrictions?

I won't attempt to answer the question here. For one thing, there is no need. The validity of the question is the intended provocation. For another, I have painted a sufficiently bold bullseye on myself already, with predictable effects. But most importantly, I don't know the answer, and no one person does. It should best be based on data, such as the recent assessment in JAMA, and adjudicated by good people spanning the ideological spectrum who are actually willing to work hard, and listen to one another.

What that new analysis suggests is that our current interpretation of which arms for what people is costing us dearly, in the treasure of young people's lives. That seems an invitation to bridge the partisan divide and debate our way to a better interpretation. Instead, the Second Amendment is itself brandished like a loaded gun, and the very idea of interpretation is shot down. But as noted, that part is neither optional nor debatable. We are already interpreting. All that remains is to do so rationally, or irrationally.

Yes, we, the people, have the right to bear arms. But what that means in the real world is that it isn't just rights that reside with us. It is responsibility, too. It is the application of reason.

We may thank our Founders for the wisdom to impart to us Americans certain inalienable rights. We must acknowledge, however, that the renunciation of reason, the denunciation of sense, and the abdication of responsibility for our misapplications of their wisdom are certainly not among them.

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.
Monday, March 21, 2016

Reducing harm in health care

When we talk about harm in the world of health care, we're usually referring to patients and the facilities in which we provide care. These are the typical things we hope to avoid, not only because they are bad outcomes, but because they now carry the specter of financial penalties when they occur:
• medication errors
• wrong side surgeries
• hospital mishaps, like falls
• missing a diagnosis
• hospital-acquired infections and those induced by medical hardware

But Gary Cohen of the advocacy coalition Health Care Without Harm takes a much broader view of the harms that health enterprises can cause. Founded in 1996, HCWH is now a multi-national coalition of health care enterprises, governmental and non-governmental agencies, and other advocacy groups.

Cohen and HCWH have had some amazing successes. In less than two decades, HCWH has been able to reduce the number of medical waste incinerators in the U.S from more than 5,000 to fewer than 100. Why should we care? It turns out that burning medical waste pours tons of the harmful chemical dioxin into the environment.

Another example: The formerly ubiquitous mercury thermometer. They used to break all the time. Fun to play with the drops of mercury, but highly toxic. Neurotoxic, in fact. And when mercury gets in our water supply, the fatty fish we eat (salmon, swordfish, tuna, mackerel, even shark) slowly poison us, which is why pregnant women and children are advised to avoid eating fresh fish in more than minute quantities.

HCWH was able to make the case that there are technological alternatives to mercury thermometers that work just as well and are much, much safer. And they've been successful. When's the last time you saw or used a mercury thermometer?

For this tireless advocacy, which also includes making hospital food supplies safer and hospital buildings themselves green and super safe (think natural disasters), Cohen was awarded a MacArthur Foundation Fellowship (think “genius grant”) last Fall.

You can hear an interview with Cohen here — give a listen and broaden your perspective on reducing harm in health care.

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.
Friday, March 18, 2016

It's all about the communication

Despite all the challenges that we, and every other nation, faces with their health care systems, it's worth remembering that in the broader picture we really have progressed in leaps and bounds over the last several decades. How easy is it to forget that only 100 years ago the average life expectancy was in the 20s to 40s in most parts of the world (just as it was for nearly all of human history). The simplest of infections could easily kill you, there were no vaccines, and the most natural act of childbirth was a highly dangerous and precarious process for any mother to go through.

Today, we take for granted that all of our health care interactions will be safe and successful, and that's also a testament to how high we've set our standards. In the modern and technologically advanced system that we work in, with cutting edge medications and treatments, the other side of the coin is that it's also easily forgotten that health care is still very much about human beings and real people.

If there's one common thread that links everyone who has ever needed medical attention, from those first cavemen to our current generation, it's just that. Hippocrates, the father of medicine, said over 2 millennia ago; “It is more important to know what sort of person has a disease than to know what sort of disease a person has”. It was true then, and it's just as true today.

Another one of my favorite quotes from Hippocrates is that physicians should; “Cure sometimes, treat often, comfort always”. This is something that no physician should ever forget as they go about their daily routine and what can seem like “busy work.” Every interaction is sacred, and the trust placed in us and our decisions is humbling. Communication, empathy and compassion with patients and their families is paramount, and the most important part of what we do. Racking your brains out, ordering a battery of tests, and coming to a potential diagnosis means little if that information isn't properly communicated.

As a physician who has worked in several different hospitals up and down the East Coast, and also internationally—from major academic institutions to more rural outposts—this has been universal no matter what the patient's background, demographic, educational level or social class. We as physicians need to maintain the highest standards when it comes to communicating clearly the diagnosis, treatment options, and prognosis to our patients.

By the same token, as we look to improve quality and outcomes in health care, and administrators bang their heads together to try to figure out how to do this, communication is actually at the core of many of the problems we face. Not just with patients, but between healthcare professionals too. The fragmentation in our system is undoubtedly made ten times worse by inadequate communication amongst physicians, nurses, case managers and all manner of other professionals at the frontlines of medicine. In hospitals, this applies particularly to medically complicated patients who are seeing several different specialists during their stay, aren't given crystal clear instructions on discharge, and don't get the quick follow-up they need. The downstream effects of this are what cause excessive testing, readmissions and even unrealistic expectations. Needless to say, the effect on healthcare costs is enormous.

Years ago, Bill Cliniton's campaign strategist James Carville coined the phrase; “It's the economy, stupid”, to simplify the reality of what drives election results. To apply the same quote to healthcare, so that we don't lose the forest for the trees as we search for overly complicated solutions to often not so complicated questions. Instead of looking towards expensive answers involving things such as more administrators, costly information technology, new “Apps”, and mountains of bureaucracy, just remember that with health care: It's about communication, Stupid.

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.
Thursday, March 17, 2016

Improving patient experience, within reason

My friend, Dr. Gurpreet Dhaliwal, had a most interesting opinion piece in the Wall Street Journal, “If Only Health Care Would Focus On This 1 Thing.” In this post he suggests that we should not worry about multiple aims (the triple aim or the quadruple aim), but rather focus health care design and delivery from a patient perspective. He writes: “In health care, our keystone habit should be taking the patient's perspective. If we could develop the habit of always seeing health care from the perspective of the patient, we would have 1 guiding principle—not 4—for the tough decisions and trade-offs that need to be made as we reform health care. How long should patients have to wait to make an appointment? It is worth investing in e-mail communication systems with patients? If the response is governed by balancing patient experience, quality measurements, costs considerations and worker satisfaction, the answer gets complicated. If instead we habitually ask, ‘What do I want when I'm a patient?’ the answer is clear.”

In general I agree with his major point, however, it does need a major caveat. We see too many patients who make unreasonable demands: overtesting demands or inappropriate medication demands. As professionals we have a responsibility of primum non nocere (first, do no harm). Opiate over prescribing is a great example. How many patients demand opiates, when their use has great danger?

I have written recently that we must strongly consider the patient's perspective on value in health care. However, we must temper our patient centeredness. When one patient's concerns impact our ability to help other patients, then we must make the choices.

So bravo to Dr. Dhaliwal, with these cautions.

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.
Wednesday, March 16, 2016

Emergency on-call physician policy, a doctor dissents

I am known by my patients and friends for my calm, imperturbable manner. Yes, I am equipped with the full range of human emotions, but few folks have ever seen me raise my voice or demonstrate bulging next veins. I am not suggesting this is a virtue or a character flaw, but is just the way I am wired.

Sure, I get irritated and frustrated with the absurdities of life, as we all do. For those who cannot relate here, may I suggest calling any airline carrier to discuss changing your ticket reservation. If that fails, then have a go at reaching out for tech support when your home internet goes ‘poof’!

Last week, I did become irritated when I was notified 1 evening about a patient's abnormal blood test result. I was on-call for our gastroenterology group, so I would be the designated physician to notify with concerning test results. Why, then, was I miffed?

Our community hospital uses a “new and improved” system for notifying physicians after hours of significantly abnormal test results. The hospital loves it. I hate it. Here's how it works.

First, I receive a text message notifying me that a patient has a CRITICAL TEST RESULT. I am then directed to call a 10-digit phone number, when I will be greeted by a robotic menu system. After enduring this labyrinth, I will be directed to insert a long series of numbers, a code which will lead to either a non-human voice announcing an abnormal lab value, or to a radiologist's dictation of a CAT scan report or some other X-ray study. The hospital is happy as once I complete the process, their system indicates that the physician has heard the message and now bears full responsibility. They are in the clear. Here's some of my objections.
• The initial text message often arrives when I am driving. Attempting this process while driving would be suicidal.
• The messages announcing the abnormalities are not given with any patient contact information or medical details. While the hospital is happy, I then have the fun and excitement of trying to find the patient's phone number, not easy to do at 9 p.m. When I can't reach the individual, it guarantees a night of insomnia for me.
• Try listening to any radiologist's dictation. I've done this many times and often cannot ascertain which language is being spoken.

I called the lab director and begged to be removed from this automated system. I argued that, while it satisfied the hospital's documentation police, it was not serving patients or doctors well. If a test result is CRITICAL, then I want to be called by a living and breathing human being. The 2 of us will have what is called a conversation, providing me with sufficient knowledge so that I will be reasonably equipped when I reach out for the patient. I may want, for example, to hear results of prior tests, so that I will understand the current results in context. Get the point here?

The lab director couldn't promise to release me from electronic bondage. Throughout the medical profession, I witness the duel between documentation and doctoring. Guess who's winning.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
Tuesday, March 15, 2016

On beyond Zika

Like everyone else who has heard the news about it, I find the rapid spread of the Zika virus extremely alarming. The newly recognized capacity of this virus, which historically has caused mild, self-limited infections in adults, to induce microcephaly, a terrible birth defect, is nothing less than devastating. To date, Brazil has borne the brunt of this development, with thousands of newborns affected. But the virus has now been identified in at least 20 countries in the Americas. As I write this, the World Health Organization is scrambling to catch up with the global proliferation of this emerging infectious disease, and poised to declare a public health emergency.

As inevitably occurs when a new health threat emerges, this one is generating lots of media attention, with coverage in both the scientific literature and popular press. Predictably, much of that attention is specific to the Zika virus itself, with relatively less addressing the general circumstances that foster our vulnerability to such crises. Both topics matter.

This particular virus was originally identified in Uganda some 70 years ago, first in monkeys, then in people. That likely makes it a zoonosis at the start, a disease transmitted to our species from another. The vector shuttling between the two was the Aedes mosquito, the bite of which transmits the virus. The first human who got Zika, in other words, was likely stung by a mosquito that had drawn blood from an infected monkey not long prior. For the past half century, Zika has generally been limited to Uganda and Tanzania, with isolated outbreaks seen occasionally in other parts of the world.

That there is no specific treatment for Zika, named after the forest in Uganda where it was first identified, and no vaccine, is because until now the virus has not inspired much global concern, partly because it was not all that serious, and partly no doubt because it was “over there.”

Exactly why this infection, in the same family with the viruses that cause yellow fever and dengue fever, is suddenly implicated in an epidemic of birth defects is a work in progress. One likely explanation, for which there is evidence, is an evolutionary change in the virus itself. That may be compounded by exposure of new human populations, with perhaps different genetic vulnerabilities; transmission at a new scale; or other factors yet to be determined. We are currently on the steep part of the learning curve, racing to catch up with current events.

That's a familiar race. We ran it for Ebola, too; and SARS, and MERS. Whatever the next outbreak is, we will likely need to run it again. We keep getting left behind.

For now, practical advice about Zika is limited, and mostly of the “easier said than done” variety. Countries mired in the outbreak are advising against pregnancy. We are all encouraged to avoid mosquito bites. Travel advisories are being issued.

As we confront Zika, but mostly fail to think beyond it, I am tempted to compare this predicament to its analogy in the space I work in all the time, nutrition. For decades, we have shifted from 1nutrient fixation to the next. Fat, carbohydrate, sugar, gluten, and generally been left behind by the big picture. The result has been a flurry of misguided, mono-nutrient activity, and no meaningful improvement in our prevailing vulnerability to the marketing of junk food. We just keep encouraging the invention of new varieties of junk food, and reaping what we sow. At present, we have sown a bumper crop of gluten-free junk.

The situation with emerging infections is much the same. We react to each as if the particular bug is the entire problem, while paying far less attention to fundamentals of public health practice and preparedness that account for vulnerability not just to the last outbreak and the current one, but the next. That same tendency—the neglect of public health until we have cause to think about panic, outrage, or both—is on display in Flint, Michigan as well.

The implications of the Zika crisis are not confined to this particular pathogen, for there will be a next, and a next. I am reasonably confident that an acute concentration of resources and ingenuity on Zika will result in a vaccine. Welcome though that will be, perhaps even by some prone to misguided railing against vaccination, it will do nothing to resolve our basic vulnerability.

As the climate changes, and we are past the point of debating the fact of it, the distribution of pathogens is changing too. We have seen this many times already, and are thus forewarned: we will be seeing it again. Whether or not we are forearmed depends on how we react, and allocate resources.

There is, thankfully, ever more attention to how the more than 7 billion of us Homo sapiens are roughing up the planet's remaining pristine places. There is less, however, to the ramifications of it. For one thing, more people in more places inevitably means more encounters with bugs formerly unencountered. For another, the disruptions of ecosystems often circle back to bite us.

Another issue, relevant to almost every major peril our species now faces, is the very fact that there are more than 7 billion of us, and rising fast. There aren't just humans in ever more places, there are ever more humans in ever greater concentrations everywhere. Whatever else we may be, we are just one, vast Petri dish to our pathogens. Plagues are a product of dense populations and unprecedented population densities will predictably mean new plagues.

And then finally, there is our proclivity to disperse into our competing factions: nations, religions, political parties, and so on. The distinctions between “us” and “them” may matter enormously to us, and them, but to the Zika virus, we are all the same, accommodating species. From the bug's eye view, there is no “over there.” In a world of increasing global travel, the bug is right.

In our fantasies, we acknowledge that. The usual scenario is a science fiction adventure in which humanity is attacked by a scourge from without by an extraterrestrial menace, and that common threat provides common cause, and unifies us. We overcome our differences to defend our home, and our shared humanity.

From what we know about the universe, the probability of extraterrestrial visitation, hostile or otherwise, seems vanishingly remote- for reasons entirely unrelated to the probability of life on other planets. If interested in the mind-boggling barriers to such inter-stellar concourse, I recommend Lawrence Krauss' book, A Universe from Nothing, as a good place to start.

But the threats to us all, threats blind to the borders of nations, and deaf to the distinctions of ideology, are already here. They have no need to traverse the distance between stars.

The faults we must overcome for our own security lie not with exotic perils from distant stars, but with dangers evolving right here at home. The faults lie most particularly with ourselves. Ironically, Zika is named after a forest, and one of our great liabilities is the recurrent failure to see the forest through the trees. We react to each new pathogen, while doing little to anticipate the next.

We often fail as well to perceive and prioritize our common humanity. We rally to the defense of it when fighting the threats of science fiction fantasy, but miss the opportunity to do so in the face of real, clear, present, and inevitably recurrent danger.

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.

Test responsibly

I got a heads up the other day that our organization had been dissed by a CNN reporter who was frustrated by her inability to get tested for Zika. You can read her original piece and the follow-up here. Short version is that she was upset that it was difficult for her to get tested after returning from a vacation to Costa Rica where she encountered “a good amount of mosquitoes” and later developed a mild febrile illness.

I won't defend that she was made to feel like she was getting the run around, and it seems like at the very least we could have done a better job of communicating with her. But what she seems to dismiss, even though it goes to the core of her encounters with all of the medical providers she contacted, is whether she should have been tested at all.

Sorry, but “I have insurance and was willing to pay” and “I just wanted to know for sure” fall well short of appropriate indications for any medical test. Responsible testing involves engaging a patient in a discussion about the clinical circumstances, the reliability of testing, and the likelihood of the results having an impact on management. Isn't that why medical testing requires a physician's order?

I am not saying that patient preference has no role in testing. I have had plenty of conversations with patients over the years, for example, about the utility of measuring lipid subfractions or performing coronary artery calcium scoring to refine individual cardiovascular risk assessments. No 2 of those conversations were ever the same, because they were influenced by lots of patient-specific circumstances: their tolerance for uncertainty, their sense of self as “well” or “sick,” and their willingness to undertake an intervention such as lifestyle modifications or medications, to name just a few. But I grounded every 1 of those conversations with the questions like “What are we going to do with the information” and “How would doing this test change how you feel or act”? Ordering tests because patients are “insured and curious” is irresponsible.

Those considerations seem to have been completely absent in the case at hand. Ms. Kosik concluded her article by saying that it is a “bitter irony” that she never got tested for Zika, and may have instead exposed herself to other pathogens waiting in ERs to get tested. To me, the irony is that she didn't recognize that she was complaining about not getting a test she had no reason to get.

What do you think?
Monday, March 14, 2016

The science of medicine applied to the Zika virus

Last week I told you of my admiration for Dr. Mona Hanna-Attisha, the Michigan pediatrician and epidemiologist whose strong research and advocacy was able to finally bring a shining light to the problem of lead in the water supply of Flint.

Continuing with a theme, I now bring you the story of Dr. Adriana Melo of Campina Grande, Brazil.

Dr. Melo is an OB-GYN who subspecializes in Maternal-Fetal Medicine (MFM), the branch of obstetrics that deals with high-risk pregnancies.

She lives and works in northeast Brazil, which is less populous and more economically challenged than the southern, more well-known parts of the country (including Rio de Janeiro and Sao Paulo).

Dr. Melo noted an uptick in the number of fetuses with small heads on ultrasound, which is the main tool used by MFM doctors to diagnose babies in utero.

How much of an uptick? A rough look at the statistics shows 100 times the normal rate of babies born with microcephaly, the medical name for the condition.

Dr. Melo had a suspicion that the mothers giving birth to these babies all had a common trait: They'd all told her that they'd had the characteristic rash associated with the mosquito-borne Zika virus.

When she tested the mothers for evidence of the Zika virus in their blood, the tests were negative. Not deterred, she convinced public health authorities to test the amniotic fluid of mothers carrying microcephalic fetuses. And indeed a strong correlation was found between exposure to Zika and microcephaly.

It's this story of a doctor in a somewhat out-of-the-way place using her clinical insight to prove a correlation which I find inspiring.

Dr. Melo could have been content to merely diagnose and treat these poor mothers and babies, perhaps simply reporting up her findings on the increase in microcephaly. Instead, she decided to push against the inertia of daily medical practice because what she was seeing really bothered her, and as a mother of young children herself, she felt the urge to get to the bottom of the new trend.

If you follow health news, you no doubt have heard a lot about the Zika virus in the last few weeks, including warnings from both the CDC and the World Health Organization. As is often the case with warnings from these organizations, a certain amount of panic ensues, such as women in Latin America feeling that they're being told not to get pregnant, for example.

I want to make it very clear that though there is a stong association between the rise in cases of Zika in the tropics of the Western Hemisphere and a concurrent rise in babies born with microcephaly, we must remember: Correlation does not equal causation. The public health agencies issuing travel and birth control warnings, while sounding dire, are making best guesses for us all to minimize our chances of harm. But drowned out in the response is the fact that we don't yet know for certain that Zika is the cause of microcephaly. That work is ongoing.

For example, many experts think something else may be the cause—perhaps the use of dangerous pesticides in Brazil (that are banned elsewhere). That also sounds plausible since pesticides are used to “control the mosquito vector.” It's entirely possible that microcephaly is occurring because of a chemical effect.

For now, we must wait and hope that science can show us the true cause of the uptick in microcephaly.

I also think it's important to remind ourselves of two things about Zika virus: We've known about it since the 1940s, when it was discovered in Africa, so though if feels new, it's really not. Secondly, at least for non-pregnant people, it only appears to cause mild flu-like symptoms and be a self-limited illness (not more than a few days at most).

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.
Friday, March 11, 2016

Medicine: Where have the stories gone?

I was at a dinner meeting for our hospital last week, and before everyone went in to sit at their tables and hear the evenings' speeches, there was some time for the usual networking over wine in the reception room. I got chatting to an established local primary care physician, a respected member of the hospital staff who has been in practice for over 30 years. He's quite a presence and a great clinician, someone who still finds himself coming into the hospital to work on various administrative duties. I expect every hospital in the country has characters like him wandering around.

We got chatting about all the changes that have occurred in medicine over the last few decades since he first graduated, and the conversation quickly turned to his dislike of the current information technology systems (the IT crowd unfortunately tend to live in a bubble of the “wonderful world of connectivity, big data, and cloud solutions”—but this conversation could have happened anywhere in America). During our discussion—as we commiserated about how physicians and nurses are glued to their computer screens nowadays, clicking boxes, and typing away furiously on their keyboards—he said something that really struck a chord. He said, “You know what, Suneel? The stories have really gone from medicine”.

What did he mean by this? He elaborated and we continued talking. In a nutshell what he meant was that in the past, every patient was a story. A unique person. A human being. This patient was well known to their personal physician, whom they usually had a good and strong relationship with. Even when documenting information in a hospital, when a physician saw a patient (regardless of whether that physician already knew the patient), there would be a story that would appear on the computer or in the chart in the form of a transcribed letter. This was either a “history and physical” report or a “discharge summary.” It would take the form of a narrative, in proper English with logical paragraphs and sentence construction, and tell you all about what was wrong with the patient, their individual history, and the diagnosis and treatment plan.

Unfortunately, what has occurred over the last few years has been quite the opposite. If you look at these narratives as they appear in the world of healthcare IT, they have developed into reams of computer gabble. A patient's story is now a series of tick boxes, random meaningless data, and ill-thought-out information flow—difficult to read and decipher. Glance at a print out of this, and they are no better than a typical handout you would get from a car dealership after your car has been serviced. Far inferior to the good old-fashioned transcribed letters that would tell you what happened to a patient in a more proper format. Worse still, many office-based interactions with physicians are now reduced to screen staring and mouse clicking, as the patient's story gets told in a row of tick boxes.

While nobody wants to go back to the days of paper charts, we must do better than this. Doctors are intelligent people, and the computer output that results from our most important interactions needs to return to a well-designed and more logical narrative.

The physician that I had this conversation with likely only has a few years left till retirement. I'm glad many of his generation are still here to give us their perspective of the changes we've seen occur in the practice of medicine. As for his patients, many of whom I've taken care of, they are still very much in awe of a doctor who knows how it's done. A doctor who listens to them, talks to them face-to-face, and keeps his clinical reasoning skills. And one who ultimately understands that health care is all about real people who are all their own stories.

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.
Thursday, March 10, 2016

Since when is medicine about productivity?

45 years ago I entered medical school to join the medical profession. My father, a psychologist, always expressed great admiration for the medical profession. He strived to convince psychologists that they should hold their profession to the same standards as medicine.

If he were still alive, I can only imagine his commentary about the following common topics: productivity, relative value units, performance scorecards and our inane documentation rules. Productivity has several definitions. Economists define it as :

the rate at which goods and services having exchangecvalue are brought forth or produced.

When did our profession adopt this definition? If I spend 1 hour talking with a patient, examining that patient, reading old records, going to the literature to answer some questions, going to radiology to review the films, calling a consultant and then explaining everything to the patient, I represent lousy productivity. But I have demonstrated great professionalism. We entered medicine to help people. The patient's welfare is the main goal.

Where is the patient in the productivity definition? How much time should we spend with each patient? I would argue that we should spend the proper amount of time with the patient to address the patient's problems. Some visits are rather simple, but some visits are very complex. We have short visits and long visits. Sometimes we need to do significant work away from the patient.

The adoption of the term productivity has, in my opinion, a destructive influence on our professionalism. Similarly, RVUs give the same undesirable message.

Our payment schemes are driving these terms. When I hear them, I hear fingernails scratching on the blackboard. How do these terms impact physicians? Obviously, I would argue that they redefine our profession in negative way.

We all need to reconsider how to define our professionalism. We need focus on how to best deliver excellent patient caring. We need to focus on how we can best serve our patients. Sometimes that takes longer than the formula dictates we should spend.

So please do not describe productivity equations, or bonuses based on RVUs. Please do not explain coding, upcoding and downcoding. Please tell me stories about how you help the patient achieve their health needs.

As Voltaire first said, “The people's representatives will reach their destination, invested with the highest confidence and unlimited power. They will show great character. They must consider that great responsibility follows inseparably from great power. To their energy, to their courage, and above all to their prudence, they shall owe their success and their glory.”

We have great power, and thus we have great responsibility. We must continue to explain that responsibility to all those who threaten our professionalism. Our patients deserve our commitment.

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.
Wednesday, March 9, 2016

Are high-deductible health plans working?

May I whine for a few sentences please? My staff and I have a high-deductible medical insurance plan. As the costs of coverage increased each year, we had to find a product that we could afford for our small private practice. As any small business owner knows, margins are tight, revenue is declining, and expenses inexorably rise. And physicians, unlike other retailers, cannot raise our fees. Would you want to invest in a company with this business model? If so, then contact me directly.

High-deductibles health plans are painful for consumers. The first several thousand dollars are borne by the individual. While we have a Health Savings Account (HSA), which confers a tax advantage, it is still painful to fork over wads of one's wages to cover medical expenses. Isn't that what medical insurance is supposed to do?

Would we expect fire insurance to cover only part of our house if it burned down?

But, I recognize that high-deductible health plans are an effective means to combat over-diagnosis and over-treatment, 2 of the deepest systemic failings in the medical profession. Indeed, highlighting these 2 practices has been a leitmotif of this blog. I have repeated in multiple posts my belief that patients need to have skin in the game if cost-effective medicine is to be achieved.

Just this past week I have seen how this works.

A close acquaintance has been suffering from arm pain and consulted an orthopedist. A steroid injection was administered and the situation fortunately improved. The individual contacted the physician's office for additional advice and an MRI of the arm was advised. The patient replied that she would research area radiology facilities for pricing as this service would be out-of-pocket as she had a high deductible plan. Later, on reflection, the individual decided to hold off on the MRI, particularly as she was improving.

There's a lot we can learn in this vignette.
• It's easy for physicians to order tests that cost them nothing.
• It's easy for patients to accept tests that cost them nothing.

I'm sure that if my acquaintance had full coverage with no deductible, that she would have dutifully accepted the advice for an MRI. Why not? The doctor wants the test and it's free. However, if this patient has to shell out a thousand bucks to view the internal workings of an ailing arm that's making progress, there may be some push back. My personal belief is that this MRI was not only expensive, but was not medically necessary, a terrible combination that is responsible for so much rot in our health care system.

Of course, I realize the dangers of high-deductible plans. Indeed, many previously uninsured folks who have been “rescued” by Obamacare are now facing this predicament. Many of them forfeit medical care that they and their families need because they can't afford it. For so many families, a $5,000 deductible is like not having medical insurance at all. This has to be fixed, and it won't be easy.

Let me share an arcane law of economics. It's easier to spend someone else's money. Consider this example. When you are in a fancy restaurant, and someone else is paying, do you order differently?

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.
Tuesday, March 8, 2016

The fantasy of randomized trials, and how we know what we know

I suppose I might be more expert in randomized controlled trials if I had ever had the actual opportunity to fetch a pail of water without 1 when my foot caught on fire, as I've said I would do. I can't say I'm sorry that hasn't happened.

I feel qualified to opine on the topic just the same. I have designed, conducted, and published dozens of such trials. I have written two textbooks about them, too, 1 addressing details of methodology, the other addressing both that, and its application to clinical decisions. I know a thing or 2 about randomized trials.

So here's the punch line: I know a thing or 2 without a need for randomized trials, too.

There is a fantasy taking over the world of nutrition, especially acute in the aftermath of the contentious Dietary Guidelines release, that nobody really knows anything. The arguments are made at times by seemingly expert people, although we often find they are either not the experts they pretend to be, or are badly conflicted. Or, sometimes,xboth.

One of the shibboleths with which this camp routinely differentiates itself is the contention that all reliable knowledgein science, at leastresults from randomized, controlled trials (RCTs). Implied, if not stated, is that RCTs are not just necessary and better, but presumably, infallible. The argument continues that such trials are glaringly absent in nutrition, and then finishes with the flourish: We therefore know nothing about nutrition. I can only guess how much Big Food loves this sequence.

It is, however, nonsense, from start to finish. We know plenty about the basic care and feeding of Homo sapiens, in part from excellent RCTs, but by no means limited to them.

For starters, RCTs do only a very specific job, although admittedly, they can do it uniquely well. They are designed to answer questions when there is considerable uncertainty about the best or right thing to do. In the absence of such uncertainty, RCTs quickly bog down in ethical problems. We have, for instance, no RCTs of treating gunshot wounds to the chest or abdomen, versus watching them bleed to see what happens. We have no RCTs of actual vs. sham emergency surgery in this circumstance, or comparisons of trauma surgery to Gregorian chants.

Similar reasoning extends well beyond the bounds of the emergency department. We have no RCTs of spraying water on a house fire vs. watching it burn to see which saves more of a family's possessions. We have no RCTs of spraying water vs. spraying gasoline.

These silly examples aren't as silly as they seem. They point out two serious flaws in the RCT fantasy: (1) for ethical reasons, you simply cannot always run a RCT, and (2), when you do run 1, the answer is only ever as good as the question.

Randomization, technically, is a methodologic defense against something called confounding, which is the influence of an overlooked variable. For instance, if one compares coffee drinkers to non-drinkers and finds more emphysema in the former group, it suggests that coffee might cause emphysema. If, however, coffee drinkers smoke far more often than non-drinkers, it would account for the finding without indicting coffee. Coffee is an innocent bystander. There are innumerable variations on this theme; randomization is a robust, albeit imperfect, defense against them.

Blinding, as in “double blind,” is a defense against bias. The idea is that if no one knows who is in which group, no one can contrive the results—intentionally, or otherwise—to correspond with expectations or hopes. However, it's rather difficult to blind people randomly assigned to, say, beef vs. broccoli. They tend to notice the difference. The technique is very useful, but not universally applicable. It is most important when the outcomes are least definitive, and most subjective. If, for instance, the outcome is survival rate, you can imagine the difficulty, not to mention legal problems, in contriving it.

Finally, controls, or as they are generally known, placebos, serve to distinguish specific from non-specific effects. If, for instance, you compare a pain pill to nothing, and pain gets better with the pill, it might be due to specific effects of the pill. However, it might be due, in part, to people getting “something” expecting to get better, and people getting “nothing” expecting no such luck. These expectations map to a complex physiologic response that can, itself, relieve pain and exert other effects. Placebos and control groups guard against mistaking the effects of expectation for the effects of a given treatment.

So, RCTs have decided strengths. But they have rather profound limitations, too. They tend to require rather large treatment effects in relatively short periods of time. If we are looking for effects over a lifetime, in a study of, say, longevity, and feel we need a RCT, then our RCT will need to last 100 years. Those aren't done very often.

The strict stipulation of inclusion and exclusion of RCTs makes them quite robust in one way, but very contrived in another. The result is that: what happens in a RCT may stay with the RCT. In other words, people who agree to participate and play by the trial rules may look too little like the rest of the world to tell us much of anything applicable to it. And as noted, ethics alone preclude RCTs in many circumstances.

Lastly, RCTs can get it wrong, badly wrong. This can happen because the trial is flawed in some way, or the question is misguided; or it can happen because the results are sound, but misinterpreted by scientists, the media, or a bit of both. I won't repeat the tale here, but colleagues and I discovered that what we thought we knew about hormone replacement at menopause based on observational trials was a bit wrong in one direction, while what we thought we learned from subsequent RCTs was at least as wrong in a different direction.

Just about everything currently passing for wisdom about RCTs and nutrition is wrong. The claim that we have no RCTs is wrong; we have many, and some quite dazzling. The claim that other forms of evidence are inevitably lesser is wrong; sometimes other data sources are all there is. Blue Zone populations have not been randomly assigned to live as they do, but how absurd to ignore their shining example for that reason. Results at the level of whole populations over a span of generations trump just about anything we could hope for in even the most lavish of RCTs. The idea that RCTs are themselves infallible is every bit as silly as the questions they are sometimes designed to answer.

And finally, and most importantly: You don't need me or anyone else to tell you that you know some things pretty darn well in the utter absence of evidence from randomized trials. Just ask yourself what you would do about it if your foot ever caught on fire.

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.
Monday, March 7, 2016

I have a new hero

I have a new hero. Her name is Mona Hanna-Attisha, MD, MPH. Dr. Hanna-Attisha is a pediatrician in Flint, Michigan. She grew up in a suburb of Detroit. She graduated from the University of Michigan before attending medical school at Michigan State University. During her clinical years (the 3rd and 4th years of medical school), she spent many months at Hurley Medical Center in Flint, which serves as a clinical training site for MSU medical students (far from the flagship campus—something I can relate to).

As you may know from recent news, Flint has had some problems—especially due to an overabundance of lead in its drinking water.

For cost-saving reasons, the city of Flint switched the source of its drinking water from the Detroit system to the Flint River in April 2014. Almost immediately residents of the town began noticing the water looked, smelled, and tasted different. It took nearly a year and half for both state and federal officials to acknowledge that there was too much lead in the Flint water—repeatedly questioning the evidence that it was so.

That's where our new hero comes in.

Dr. Hanna-Attisha directs a pediatric residency training program at Hurley. There are 190 pediatric residency training programs in the United States, training in total about 2,600 pediatricians every year.

I can relate to this part of her job—my most recent role was directing an Internal Medicine residency. Though the medical issues are different (kids vs. adults), residency program directors have three essential jobs: recruiting medical school graduates, charting the learning curriculum, and making sure the program stays accredited.

Program Directors become role models for trainees. We try to inspire and motivate residents, offering career and life advice during what is a demanding three year training curriculum.

On top of clearly being good at this role for her residents (7 per class for a total of 20 or so residents), Dr. Hanna-Attisha uses her MPH training to do science—in this particular case epidemiology.

She combed through records at her medical center and discovered that lead levels measured in children's blood in Flint (as part of routine pediatric care) had on average nearly doubled since the time of the water source switch. Though her claims were at first disputed by state officials, Dr. Hanna-Attisha kept at it, talking to parents, hospital leadership, and advocating with state and federal officials.

In the end, the simple elegance of her team's science got the message across. The story has now received national attention, including the declaration of a federally-recognized ‘State of Emergency’ in Flint over its water supply.

I was researching Dr. Hanna-Attisha, and came across this TED-like talk she gave at a Michigan State College of Medicine event in 2014. It predates the Flint water story, but it shows her to be a dedicated public servant—not only committed to her trainees and her patients, but beyond that to questioning the very core of what makes people unhealthy: the social determinants of health.

Take a look and let me know what you think.

What do you want to be when you grow up? from MSU MD on Vimeo.

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.