Friday, August 30, 2013

Data scientists must also be research methodology scientists

I had the chance last week to attend a conference in Singapore, Big Data and Analytics in Health Care. It was an interesting blend of academics, operational health information technology professionals, and data scientists from companies in the emerging analytics market. I was also in Singapore for the end in-person session of the 10x10 ("ten by ten") introductory informatics course we offer there.

The talks were all interesting, but I was struck by the difference in the content and tone of the academic and clinical operations speakers compared to those from analytics companies and who called themselves "data scientists." Whereas the academic and clinical operational types were cautious in their methods and results, the data scientists implied their techniques would revolutionize healthcare and threw around terms like "big data" and "analytics" at every turn.

One of the latter types showed a "model" of the pathways leading to good (conservative) and bad (surgery) outcomes in back pain, with the intermediate nodes representing actions along the path, such as medication use, physical therapy, and chiropractic care. It was not clear to me how this model could be used to improve care, and I am not sure the speaker really understood that correlations do not prove causality. A second such speaker showed some interesting correlations between words and phrases that occur in clinical narratives of patients with diabetes and aspects of their care. I understand machine learning and how it might be used to "learn" things about patients with diabetes, but I did not see any evidence that this work would lead to any kind of improved patient outcomes.

Another concern I have about proponents of clinical data analytics is their presumption that their algorithms can somehow take all of the growing amount of operational electronic health record (EHR) data and automatically turn it into medical knowledge, as if they could turn a crank with data going in and knowledge emerging. I do have great enthusiasm for some of what can be done with this data, but I also have concerns about the quality and completeness of this data as well as the causality issues that arise without controlling observations in experimental ways.

I had the opportunity to speak at the conference as well, and gave a talk pulling together my cautious enthusiasm for using operational clinical data for research and other analytical purposes. This was the first public talk I have given on this topic since publication of a paper with 10 other colleagues on caveats for the use of operational electronic health record data in comparative effectiveness research in the journal Medical Care [1]. The paper was commissioned by AcademyHealth and is part of a special supplement of the journal devoted to electronic data methods.

Our paper notes that while there are many opportunities for using clinical data for research and analytics, we also must remember the limitations of such data. In particular, EHR and other clinical data may be:
--Inaccurate - data entry is not always a top priority for clinicians, and they may take shortcuts, such as copy-and-paste--Incomplete - patients do not get all of their care in one setting--Transformed in ways that undermine meaning - coding for billing is the best known example of this--Unrecoverable for research - data may be in clinical narratives or other less accessible places--Of unknown provenance - we need to know where data comes from and how likely it is to be accurate--Of inappropriate granularity - data too coarse for research purposes--Incompatible with research protocols - patients are not always diagnosed and treated consistently with best practices

Despite these caveats, I am optimistic that there will be uses for this data, especially if we can generate it in a standards-based way and otherwise improve its quality. Hopefully clinicians, researchers, patients, public health authorities, quality improvement leaders, and other who might benefit from the data will have incentive to improve it by more meticulous entry as well as use of standards-based, such as those proscribed by Stage 2 of the meaningful use program [2]. For many clinicians especially these days, the EHR can be a data sink hole into which they enter data, spending a great deal of time but getting little in return.

The bottom line is that while data scientists may be able to generate interesting and important results with their methods, they must also understand basic principles of research science, such as inferential statistics, clinical significance, and cause and effect. In addition, they must demonstrate their methods lead to improvements in health and/or healthcare, and are not just generating interesting associations. In other words, they must show evidence that their methods add value, just as medical care and informatics are required to do.

1. Hersh, WR, Weiner, MG, et al. (2013). Caveats for the use of operational electronic health record data in comparative effectiveness research. Medical Care. 51(Suppl 3): S30-S37,
2. Metzger, J and Rhoads, J (2012). Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use. Falls Church, VA, Computer Sciences Corp.

QD: News Every Day--Little evidence supports opioids for low-back pain

There is very low to moderate quality evidence for short-term use of opioids to treat chronic lower back pain compared to placebo, according to an updated review of the literature.

To determine the efficacy of opioids in adults with chronic lower back pain, researchers reviewed 15 randomized controlled trials (5,540 participants) all at least four weeks in duration that assessed opioids as monotherapy or in combination with other therapies. The trials all compared non-injectable opioids to placebo or other treatments, and were excluded if they only compared different opioids.

Most people included in the trials were aged 40 to 50 years and all reported at least moderate low-back pain. Most of the trials were supported by the pharmaceutical industry.

Results appeared online Aug. 27 at The Cochrane Library.

The review concluded that tramadol (five trials; 1,378 participants) was better than placebo for pain (standardized mean difference [SMD], -0.55; 95% confidence interval [CI], -0.66 to -0.44; low quality evidence) and function (SMD -0.18, 95% CI -0.29 to -0.07; moderate quality evidence). One other trial with 1,583 participants demonstrated that tramadol compared to celecoxib showed little difference for pain relief (RR, 0.82; 95% CI, 0.76 to 0.90; very low quality evidence).

Transdermal buprenorphine (two trials, 653 participants) may make little difference for pain (SMD, -2.47; 95% CI, -2.69 to -2.25; very low quality evidence). There was no difference compared to placebo for function (SMD, -0.14; 95% CI -0.53 to 0.25; very low quality evidence).

Strong opioids such as morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol (six trials; 1,887 participants), were better than placebo for pain (SMD, -0.43; 95% CI -0.52 to -0.33; moderate quality evidence) and function (SMD, -0.26; 95% CI -0.37 to -0.15; moderate quality evidence).

Two trials with 272 participants found no difference between opioids and antidepressants for either pain (SMD, 0.21; 95% CI -0.03 to 0.45; very low quality evidence) or function (SMD, -0.11; 95% -0.63 to 0.42; very low quality evidence).

Researchers noted that people who received opioids reported more pain relief and had less difficulty with daily activities in the short-term, but there is little data based on objective measures of physical functioning. There is no information supporting safety and efficacy beyond four months. The review did not show that opioids are more effective than other analgesics, such as anti-inflammatories or antidepressants, for low-back pain.

They wrote, “The initiation of a trial of opioids for long-term management should be done with extreme caution, especially after a comprehensive assessment of potential risks. There are no placebo-RCTs supporting the effectiveness and safety of long-term opioid therapy for treatment of chronic lower back pain.”
Thursday, August 29, 2013

Electronic medical records save money! (Never mind)

Electronic medical records (EMR) were supposed to rewire the medical grid. It would increase efficiency, reduce redundancy, improve quality and reduce costs. On these measures I offer a grade of 0 for 4. Ask any practicing doctor how EMR has impacted on his practice and be prepared for some remarks that differ from the government's Kool-Aid talking points. EMR, thus far, hasn't been ball bearings for the system. More often, it gums up the works.

The government spent billions of dollars with cash payments to induce hospitals and doctors like me to jump on board the EMR express. The Rand Corporation helped to fuel this euphoria in 2005 when it predicted exaggerated benefits of EMR. By the way, this study was financed in part by EMR companies whom, I politely suggest, had a vested interest in the study's conclusion. Rand denies that they were unduly influenced by their backers, and I don't claim that they caved on their principles. Nevertheless, the propriety of taking money from folks whose survival may depend upon the study's outcome is ethically problematic. But, Rand was wrong and has publicly admitted it now. The Rand folks are now back flipping across the countryside with new and improved pronouncements stating that EMR has added to medical costs and hasn't delivered on its other rosy promises.

This wasn't an epiphany. Many folks in 2005 didn't swallow the Rand bait. The Whistleblower was blowing hard but apparently the frequency was above what human ears can perceive. EMR is a money pit that has made many companies rich. EMR systems are expensive, clumsy to use and do not communicate easily with other EMR systems. Patients have the notion that the hundreds or more EMR systems out there can easily communicate with each other. They can't. I have a few posts on EMRs, and they're not pretty.

The point here transcends the EMR mirage. How many other promises of Obamacare will crumble in the years ahead? Again, this won't be a revelation. Many of us were shouting about this on day 1. No one could hear us above the din of health care reform. Will these reformers, like Rand, admit that they were wrong as the evidence piles up? Wouldn't that be the fair and balanced thing to do?

We're in the Era of Medical Ridiculousness. Call it EMR.

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.

We should require meaningful notes

I had a nice conversation with a dermatologist at party last night. He started complaining about the notes he receives from other physicians. He used terms like "piles and piles of junk."

Talk to any experienced physician and they will tell you that once upon a time our teachers taught us to write notes appropriate to the situation, not appropriate to the billing system.

Several years ago I ranted about the necessity for coding experts. What does that have to do with good medical care?

In 1973 we were taught to write SOAP notes. SOAP notes served me and my patients well throughout my internship, residency, and early years in outpatient practice. What happened? With the introduction of resource-based relative-value units, bureaucrats had the opportunity to make rules about what constituted a level 1, 2, 3, 4 or 5 note. Thomas Sowell stated succinctly, "You will never understand bureaucracies until you understand that for bureaucrats procedure is everything and outcomes are nothing." The bureaucrats came up with a plan for documentation that shows a total lack of understanding of medicine.

Electronic medical records have made this worse. Now we have institutionalized bad notes. And bad notes harm patient care.

Physicians now spend too much sorting through the haystack of notes that document unnecessary 12-point review of systems, and repeated complete physical exams when they are totally unnecessary. We see note after note repeating all the laboratory data.

The problem here is that the physician note writer is not involved in figuring out what data are important. Our current notes are mindless. They do not reflect our thought processes.

When we were taught about SOAP notes, they went like this:
1) Write a separate SOAP note for each problem, either a diagnosis or a complaint.
2) For each problem include first the subjective data related to that problem.
3) Then include the objective data, physical exam, relevant lab data and imaging.
4) Then include your analysis. This section reflects your current thought process.
5) Finally, include the current plan: lab tests, medications, surgical consult, etc.

We need to know what our colleagues are thinking. We need to review our students and residents thought processes. Notes written like this require thinking, thinking about what are the relevant data and how one evaluates the data.

I believe that such notes help us think more clearly about our patients. They clearly make it easier for other physicians to review our notes and thought processes.

We must demand that we return to meaningful notes. We must let everyone know our outrage over cut and paste notes, data overload notes, and non-thinking notes. Our patients deserve understandable notes. Unfortunately, today we have horrible notes, and we are not teaching our students and residents to think, partly because of the notes they must write for billing purposes only.

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

QD: News Every Day--Statins may benefit people over 65

Statins significantly reduce the incidence of myocardial infarction and stroke, but do not significantly prolong short-term survival rates in subjects ages 65 and older who are at high cardiovascular risk without established disease, a meta-analysis found.

Researchers reviewed eight randomized, controlled trials enrolling nearly 25,000 people, nearly 13,000 randomized to statins and more than 12,000 to placebo, and reported their results in the Journal of the American College of Cardiology.

Myocardial infarction occurred in 2.7% of subjects taking statins compared to 3.9% of those in placebo during a mean follow-up of 3.5 years (relative risk [RR], 0.606; 95% confidence interval [CI], 0.434 to 0.847; comparison, P=0.003; heterogeneity, P=0.028. The annual myocardial infarction rate was 1.1% in patients taking placebo and the number needed to treat was 24 patients treated for 1 year to prevent 1 event.

Stroke was reported in 2.1% of subjects randomized to statins compared to 2.8% in placebo during follow-up. Statins significantly reduced the risk of stroke (RR, 0.762; 95% CI, 0.626 to 0.926; comparison P=0.006; heterogeneity P=0.130). The annual rate of stroke was 0.8% in patients randomized to placebo and the number needed to treat was 42 patients for 1 year to prevent 1 event.

Statins did not significantly reduce the risk of all-cause death compared to placebo (RR, 0.941; 95% CI, 0.856 to 1.035; comparison, P=0.210; heterogeneity, P=0.570) or cardiovascular death (RR, 0.907; 95% CI, 0.686 to 1.199; comparison P=0.493; heterogeneity, P=0.831).

There was no difference in the rates of cancer (RR<0.989; 95% CI, 0.851 to 1.151; P=0.890).

Because the on-treatment mean LDL cholesterol remained above the recommended target of 100 mg/dL, higher benefit could be achieved if the current recommend targets are reached. However, researchers noted, identifying high-risk elderly patients without established cardiovascular disease “remains challenging” since calculation of absolute cardiovascular risk over 10 years does not apply to subjects older than 80.

An editorial noted, “The consequences of MI and stroke are much more serious for older than younger patients, both for death and long-term disability. The incidences of CV events also increase with increasing age. For these reasons, the elderly without evidence of atherosclerosis and their caregivers face a high stakes decision on statin treatment, with no clear direction from current guidelines.”

However, it continued, “Older people differ more among themselves than younger ones do, and the decision to treat or not treat an older individual with a statin often requires clinical discernment. The clear results of this meta-analysis will hopefully lead to more older individuals receiving treatment that will reduce their CV risk.”
Wednesday, August 28, 2013

Crazy ideas

A patient calls or e-mails me with a problem. I talk with them over the course of a few days, using whatever form of communication works best. Eventually, they need to come to the office to be seen, either for something needing to be done in-person (examination, procedure, or lab test), or because of the advantages of face-to-face communication. At the visit, I not only deal with one problem, but there are other issues needing to be addressed. Finally, after the visit, follow-up on the problem continues until it is either resolved, or at least is not causing much trouble.

So how do I document that?

In the past I would’ve had a clear structure for the “office visit” and separate “encounters” for the documentation of the communication done outside of the office. The latter would be done largely with narrative of the conversation, and some direct quotes from the patient. The former, the “office visit” would include:

• A re-telling of the story of the “chief complaint” and what’s been happening that caused this encounter to be necessary.

• A sifting through other symptoms and past-problems to see if there is any information hidden there that may be useful.

• A documentation of past problems (already in the record) to support the thought process documented later in the visit.

• An overview of the physical exam, again to support the decisions made as a result of the visit.

• A discussion of my thoughts on what I think is going on.

• A telling of my plan on how to deal with this.

• A list of any advice given, tests ordered, medications changed, prescriptions written, and follow-up as the details of that plan.

• A signature at the end, attesting to the validity of what is contained in the note.

But here’s the problem: it’s not real. I don’t make all of my decisions based on the visit, and the patient’s story is not limited to what they tell me. Details may be left out because they are forgotten, questions aren’t asked, or things just haven’t happened yet. This signed and sealed unit of care, represented as a full story, actually represents only fragments of the story, of many stories actually, and only as a moment on the continuum of the patient’s care.

But there it stands, the office visit, the center of the patient’s medical record. It is what my past life defines as “health care.” But for me now, it is an anachronism: an old-fashioned idea that has nothing to do with my present reality. My care is no longer episodic, so why should my records be? I no longer need “visits” as units of commerce, and no longer need “problems” as the goods for which I am paid. This took me quite a while to figure out, and has me making some radical (crazy?) changes to how I think about care.

1. Stop artificially defining units of care from my perspective.

The “office visit” is a unit defined from the physician’s perspective. This may actually undermine a clear thought process, though, fooling me into believing I’ve finished something that isn’t complete. Instead of breaking care into a temporal unit, why not define it another way:

1. The narrative – what is going on with the person. The patient narrative goes over their lifetime, some of which happens in my office. Narrative would best be a combination of patient input and my observations as a third-party. My job is not necessarily to do the narration, but to guide it by asking questions and to prioritize that which I think is most salient. Each “problem” may have its own narrative, but those lines often blur, as the chronic disease causes depression, and both the chronic disease and depression lead to fatigue and increased pain. How do you divide those? Do you need to?

2. The investigation – both through my questions, examination, and through tests I order, I work to solve puzzles. The patient wants me to make sense of confusing parts of their narrative, so I step in and investigate. Tests are ordered for a reason, and exams are generally problem-driven. One of the most important “tests” to do is to wait and see what happens. Sometimes stories only become clear as they unfold, and it is my job to know when it’s best to do nothing other than wait and observe.

3. Interventions – medications, lifestyle changes, education, and procedures are what most people think of when they define “health care.” Yet these are entirely driven by the narrative and investigation. They add to the narrative and often become part of the investigation, but they never stand alone. Well, they shouldn’t stand alone, despite the fact that they are what doctors are largely paid for in this country.

4. Destinations – what are our goals? What is the goal of the patient in the bigger sense, and what are our goals for individual narratives? The destination is the entire purpose of the doctor-patient interaction. The patient doesn’t like their destination and I am called on to help them go somewhere else, or they just want to be sure they are not inadvertently going to a bad locale.

Can I do a record based on these categories? If I do, would it end up as a crazy jumbled mess?

2. Find strings to tie the pieces together.

Each part of the record of care is tied together in different ways, with different things that they share with the other pieces of information or narrative.

1. Diseases – these were referred to as “problems” in my past life, a euphemism if there ever was one, but part of each record is usually devoted toward the prevention, treatment, or management of disease. Narrative, investigation, intervention, and destination could address these aspects of disease.

2. Symptoms – these also (perhaps more appropriately) were listed as “problems” in my past life. They are how health directly impacts the patient. Symptoms may or may be related to a one or many diseases, or may be mysterious.

3. Risks – These are sometimes determined by choices of the patient (smoking, drinking) or not (family history). The reason we at all care about smoking or family history is the risk they confer.

4. Events – Big events, such as heart attacks or motor vehicle accidents can result from or cause disease, but they are tied together in a temporal way. In the same way, an office visit is a temporal way to tie together interactions with a patient on a given day. (I didn’t say it’s entirely bad to consider visits as units; it’s just bad to only define them that way).

5. Situation/Environment – What’s going on in the other areas? Is the person getting a divorce? Is it allergy season? Is there a flu epidemic?

6. Population factors – some narratives, investigations, interventions, and destinations can transcend a single patient. My ability to see the population as a whole will help me to give better individual care.

Where does this lead?

What does a record in such a world look like? I can’t say I’ve come to a clear idea, but there are some things I’ve started doing:

1. Treating narrative as a separate entity – Whether communication happens via secure message, on the phone, or via email, narrative is narrative. It is the fuel that propels good communication (my listening to it) and by which proper care is given. Lumping narrative with the other areas tends to artificially categorize it. The result is a separate documentation of narrative from exam, intervention, etc. in the record.

2. Tying narrative and the other areas together using things they have in common. I have started using diseases, symptoms, risk factors, and events as tags, tagging narrative, consults, lab results, medications, and anything else with these fathers (so I can see all conversations, examinations, lab tests, consults, hospitalizations, etc. related to a person’s diabetes, for example, or seeing all other parts related to a specific medication).

3. Allowing free-flowing use of tags to give me different views of the same parts of the record. In general, the more perspectives one has when looking at something, the more accurate the picture. This means tagging needs to be simple (perhaps automatic) and robust. It also means that I need to be able to quickly get those views when I (or the patient) need them.

4. Working with the patient to come up with a destination – an overall plan of what they expect to get out of my care.

5. Going over the progress toward those destinations on a regular basis.

6. Making all of this fully available to my patients. This assures the accuracy of the information and keeps it focused where it should be: on the person for whom this whole system is built.

Sounds crazy? Sometimes I wonder. But then I look at what my past life as a doctor involved, and what “care” was defined as, and I begin to grin. That was crazy. This is simply being myself, which, for once, doesn’t seem so crazy.

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.

Medical tourism--some ideas, and maybe what not to do

There are many ways to visit exotic destinations, including cruises, tours, adventure travel, business-related meetings and just plain going there. I always thought it would be most interesting to visit a place and practice medicine, since it would give me the opportunity to meet interesting people, do interesting things and maybe actually help. I first went overseas as a doctor about 23 years ago after finishing my medical residency. I traveled north from Bangkok to Chiang Mai where I found my way to the McKean leprosy hospital. There I spent a week rounding with the American physician who was the medical director, surgeon and primary doctor for all of the leprosy patients. There were also visiting dentists from Germany and other people who helped in various ways, including carrying on a religious mission for the Episcopal Church. It was one of the most memorable weeks of my life and flavored my ideas about medicine for the decades I have practiced since then.

I have looked for ways to visit developing countries in a medical capacity and learned about what seemed to me to be a disturbing development: medical tourism. For a significant chunk of change, a physician can visit some out of the way destination, be assured of room and board and expect to work as a doctor. I have nothing against paying for travel or donating money to worthy overseas medical causes, but it seemed to me that, if it cost thousands of dollars to go far away and do good, perhaps I ought to just donate that money and stay home. Also it seemed that if it was so very expensive to go ply my trade, perhaps my expertise wasn't actually very valuable in those places.

Haiti in 2010 offered me the opportunity to be a doctor in a faraway place without actually resorting to a medical tourism agency. I traveled with friends to evaluate the needs of a few small communities on the island of La Gonave off the coast of Port Au Prince. My friends' projects included women's rights, gardening and the economics of arts and crafts. I brought a suitcase full of remedies which seemed like they might be useful, saw patients, visited dysfunctional health centers and observed the work of a group of flying doctors who come in for 2 weeks every year to treat patients who lined up for hours to be seen. It turned out that what I could do medically in 2 weeks was close to nothing, since people needing acute care couldn't get to me or had died or gotten well all on their own. Many people did need help, but it was more of an ongoing need, and not something I could provide in the time I was there. There were some advanced cancers, HIV, non-healing wounds and severe hypertension. Undoubtedly there were tropical diseases which I couldn't recognize and there was chronic pain, mainly headaches and belly aches.

When I made the trip a year later I brought close to no remedies and saw only a few patients in a clinic setting. I concentrated on talking to people about their existing health care and its obstacles, encouraging sanitation projects and handing out condoms. I sat in meetings with women and men in which I tried to address their concerns by blowing up condom balloons and telling stories with the help of a skilled creole translator, which made them laugh and perhaps dispelled some rather physiologically implausible myths. In other meetings we talked about what they had and didn't have and what they wanted and what seemed possible and sustainable. Although I can't confidently say I did no harm, we did engage in mutually satisfactory dialogue.

The problem with going to places to help is that it can set up a relationship of dependence, especially if the help that is provided is something that is necessary and not otherwise available in that place. And that kind of help is also exactly what we would want to provide. Our natural impulse is to share our tremendous wealth with people we see as being helpless and destitute. The projects that are most successful in this capacity, I think, are projects that can be completed in a limited amount of time such as cleft palate repairs or cataract extractions, or ones that develop staffing and infrastructure in the country they serve that is at least partly self-sustaining.

Paul Farmer has done this in Haiti, dealing with many aspects of chronic diseases in hospital/health care center settings, as has Jill Seaman in her work treating the deadly tropical disease Visceral Leishmaniasis in South Sudan. Provision of medical care in disaster settings is also a good idea, since its scope is usually time limited, supporting an overwhelmed medical system at a vulnerable time. Providing a higher level of care briefly in a setting where it is needed long term is not particularly useful and can upset the progress in healthcare that may have been developing organically.

Recently I visited Tanzania with some medical students who taught ultrasound to Tanzanian students and medical professionals (see the separate post here), kind of an introduction to bedside ultrasound class. I felt like the techniques were really powerful and the students made sure to coordinate with a school there and a radiologist who would probably continue with the teaching. Ultrasound machines are not so very expensive in the developing world, especially as newer, smaller machines are replacing older, still adequate ones. Increasing the baseline competence of people who will be delivering care has the potential to reduce suffering and improve patients' lives in a country with a staggering deficiency of doctors. The motivation for the project was beautiful in itself, medical students bringing the cool thing they had just learned to a place where it could really make a difference.

Another issue with medical projects overseas concerns scarce resources. When I was in Haiti I noticed that there were lots of small, short haired, gentle dogs who barked at intruders and ate garbage. Most of them were thin, and about half of them eventually had puppies. The puppies were incredibly cute and were treated with complete indifference by most people, even as they appeared to cling so very tenuously to life. Undoubtedly most of the puppies died. We were the only people to feed the puppies food scraps because there wasn't enough food for all of the people, or even the mother dog. If all of those puppies survived, a person would not have been able to put a foot down without stepping on a dog.

The human infant mortality rate in Haiti is high and lifespan is short, which results in a pretty stable population in the very resource limited island I visited. If medical care is really successful and the very young and the old live longer there will not be enough food or anything else to support everybody. In some places healthier people produce more food and shelter which offsets this problem, but we need to be very careful about how we focus our philanthropy. If babies are to survive in families that can care for them, there must also be adequate birth control and improved gardening and other industry.

Should we doctors just stay home? No. Emphatically. Unless we want to. But those of us who are motivated to go forth and help people should pay attention to the complexity of the systems we are driven to change. We should open our hearts to the possibility that it is we who are benefited most by our adventures as we meet, care for and in turn are cared for by people whose backgrounds and social contexts are very different from our own.

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.

'Miracle' powers of the flu vaccine

This blog hasn't always been kind to the humble influenza vaccine. So in fairness to our trusty old vaccine friend, I'd like to highlight a recent study published in Lancet ID by Jeffrey Kwong and colleagues in Toronto. They utilized 19 years of data (1993-2011) from the universal health care system databases in Ontario Canada to assess the risk of Guillane-Barré Syndrome (GBS) after influenza vaccination and after influenza infection. They accomplished this using a self-controlled, risk-interval design. This design compares the risk of GBS in a predefined risk interval after exposure to the vaccine or infection and compares it to the risk in the control period outside the selected exposure period.

In this case, the exposure period was the first 6 weeks post exposure and the control period was weeks 9-42. Importantly, the patients were conditioned on having GBS in either the risk or control period and each patient served as their own control, which eliminates selection bias. Outcome of GBS was determined using ICD-9 or ICD-10 primary billing codes, which have reported positive predictive values in the 60% range. This is a limitation of the study.

They identified 2,831 patients with GBS. Within the 42 week period, 330 cases were preceded by influenza vaccination and 109 cases were preceded by influenza infection. The risk of GBS was 1.5 times higher in the initial 6 weeks post vaccination compared to weeks 9-42. The risk peaked in the third week post vaccination with twice the risk. The risk was higher in patients ages 18-64 compared to older adults. Importantly, even this increased risk adds up to one GBS admission per 1 million vaccinated. I also don't think we can rule of influenza infection causing this post vaccine risk since people are more likely to receive vaccine when influenza virus is circulating in the community.

In the 6 weeks post influenza-coded healthcare encounter, the risk of GBS was 15 times higher than baseline and peaked at 61 times higher in the first week post infection. Pending a formal competing risk analysis, patients should continue to be informed of a small increased absolute risk of GBS associated with the vaccine, but also a large risk associated with the infection. Of course, there other benefits associated with influenza vaccination, which should also be discussed with patients. To be clear, influenza vaccine IS a miracle when it's compared to influenza infection.

Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands). This post originally appeared at the blog Controversies in Hospital Infection Prevention.

QD: News Every Day--Possible pathway found for increased melanoma risk among red-heads

Researchers may have found a genetic reason why people with red hair have a 10-to 100-fold higher frequency of melanoma.

Red hair and light skin is caused by a mutation in the melanocortin-1 (MC1R) gene receptor, and a mouse model suggests that the same mutation promotes an important cancer-causing pathway.

Previous work by some of the same researchers showed that MC1R plays a key role in protecting melanocytes from UV-induced DNA damage. A new study found that the mutation MC1R-RHC promotes the PI3K/Akt signaling pathway when a red-haired individual is exposed to ultraviolet radiation. PI3K/Akt is a cancer-causing pathway involved with other cancer of the breast, ovaries and lungs.

The findings appeared in Molecular Cell.

Cell cultures and mouse models showed that in normal circumstances, MC1R binds to the tumor suppressor gene PTEN. A lack of PTEN results in elevated signaling in the cancer-causing P13K/Akt pathway. MC1R-RHC mutations found in people with red hair lacked this protective mechanism, so UV-B exposure resulted in an increased destruction of PTEN in the mutated pigment cells.

Researchers also found that elevated PI3K/Akt activity in MC1R-RHC pigment cells was boosting cell proliferation and was synchronizing with another well-known cancer mutation in the BRAF gene that is found in nearly 70% of human melanomas.

Researchers said in a press release that drug inhibitors that target the PI3K/Akt signaling pathway could be used in combination with a drug that targets the BRAF oncogenic protein, to treat melanoma patients who have both BRAF and MCIR variants.
Tuesday, August 27, 2013

Dietary supplements: magic or medicine?

When I ask a patient what medications they take there are two classes of drugs they often forget to mention: birth control pills and dietary supplements. This is one of the most important take-home points in Dr. Paul Offit’s Do You Believe In Magic: The Sense And Nonsense Of Alternative Medicine: medicine is medicine.

The title gives a good idea of where Dr. Offit falls on this question, and he rarely states an opinion without a historical and scientific reference. That doesn’t mean the book isn’t readable; in fact, it’s a good read for partisans and non-partisans alike, giving a history of the regulation of both standard pharmaceuticals and supplements such as vitamins. (At my request, Dr. Offit sent me a free copy of the book, which I did not imply that I would review).

I’ll leave the details to Dr. Offit, whose convincing prose explains what most doctors know: there is no such thing as a “side effect.” Any substance that can affect human health can have multiple effects, some good, some neutral and some bad. We call the bad one’s “side effects” but biologically they are no different from the desired effects.

The source of the chemical is also irrelevant. A bottle of cholesterol medicine made by a large pharmaceutical company is no more or less a drug than an herbal tea. What counts is the dose and its biological effects. The labels “alternative” and “supplement” hide important facts: these are simply words for drugs and procedures, often manufactured by large corporations, that have not been proved safe and effective. This doesn’t render all supplements dangerous, but knowledge is important. The guy behind the counter at GNC dispensing vitamins and health advice is doing the same thing as a pharmacist but without a license or a supply of medicines rigorously tested for safety and efficacy.

Not that traditional pharmaceutical manufacturers are angels: They can bury negative data, run biased studies, engage in sketchy marketing. But it’s more than is required of the same companies when they sell vitamins and supplements, many of which have been shown to be harmful or potentially so.

Vitamins and supplements are drugs. That they aren’t subject to the same regulation as “real” drugs should bring comfort to no one.

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

Does AHEAD set us back?

One of the more prominent items of medical news recently was the final analysis of the Look AHEAD trial, allegedly indicating that a lifestyle intervention and associated weight loss did not reduce heart disease risk in adults with diabetes. There is little we seem to love more than scientific findings that refute the current consensus and imply perpetual confusion, so media uptake of this story was predictably robust. Most of the coverage accentuated the negative, with headlines such as: "Disappointing Results for Weight Loss and Diabetes."

If the Look AHEAD trial truly has debunked the health benefits of weight control in diabetes, then it has potentially set us back rather severely. Fortunately, this ostensibly disappointing news is not, in fact, disappointing, or news.

The trial is not news because these same results were reported, and received widespread media attention, last fall. This matters, because double dipping gives the impression that this is the second trial in the past year to reach this same conclusion. A repetitive drumbeat is much more compelling than a single note, so this repetitive coverage makes the story seem bigger. For reasons not entirely clear to me, the story was reported widely in October 2012, when the study was stopped early, and again now when the data analysis was brought fully to the point of all "I"s dotted, and "T"s crossed. But this is the same study, and these are the same data. We are hearing the story twice, but it is just one story. So this isn't really today's news. It is yesterday's news.

Nor are the results truly disappointing, for a number of reasons. First and perhaps foremost among them is the fact that if you compare two groups that don't differ much in their treatments, you can't expect them to differ much in their outcomes.

Look AHEAD compared an intensive lifestyle intervention to fairly conventional diabetes education in a cohort of over 5,000 obese adults with type 2 diabetes. The data now making news relate to the 10-year follow-up, which proves to be important.

Initially, study participants in the intensive lifestyle group lost an average of roughly 8.5% of their body weight. But at 10 years, that had fallen to an average of 6%, indicating these folks had been gaining back some weight over recent years. In contrast, the control group lost only 1% of their body weight on average at the start, but by year 10 that was up to 3.5%, indicating these folks were gradually losing more weight. Several salient considerations jump out at us.

For the long-term outcomes making news now, the study was comparing a 6% weight loss to a 3.5% weight loss. That represents the effects of a weight loss difference of 2.5% of body weight. If two individuals started the study at 200 pounds each, this equates to looking for a difference in cardiac event rates because one now weighs 188 pounds, and the other now weighs 193 pounds. No one could reasonably expect to see much difference in outcomes with so small a difference in exposures, and frankly, that's just what the study showed: not much difference. In absolute terms, cardiac events did occur a bit less often in the intensive intervention group. The difference was just too small to qualify as statistically meaningful.

Second, given that the intensive treatment group was gaining back the weight they lost early while the control group was losing more weight slowly, the person weighing 193 pounds is now apt to be gradually losing weight, whereas the person weighing 188 pounds is now apt to be gradually gaining. There are physiologic effects of active weight loss and gain that influence cardiovascular risk independent of absolute weight, so this would further narrow the already tiny outcome gap for which we might have hoped. With almost no "exposure" difference, we simply could not reasonably expect much difference in outcome.

Third, as noted, the intervention group did have fewer cardiac events, just not enough fewer to matter in statistical terms. But what that means is: Even that very modest weight loss difference may have conferred a small benefit. It looks that way, we just can't be sure.

Fourth, the study endpoint was a composite of cardiac death, heart attack, stroke, or hospital admission for angina. Risk factors for these overlap substantially, but are not identical. A hybridized outcome measure like this will tend to bias the results of any study toward insignificance.

Fifth, and finally, the authors note that the rate of cardiac events was lower than expected in the entire study cohort. So much so, in fact, that they had to expand the definition of the study outcome so they would have enough events to measure. I trust we all know the adage: If it ain't broke, don't fix it. Closely related is this: If it has already been unbroken, fixing it more may not matter much (or be discernible). If the participants in this study were already being conscious about their health and experiencing a lower than expected rate of cardiac events, it would have been hard to show additional benefit on top of that. This, too, would bias results toward insignificance.

With those five declarations, the defense might rest. But, in fact, there is much more to this tale, as was beautifully expressed by Nanci Hellmich, writing for USA Today. Bucking the "Look AHEAD sets us back" trend that predominated, Ms. Hellmich entitled her article "Diabetes Study Finds New Weight Loss Benefits." That is exactly right, assuming one takes "new" with a grain of salt, for these very benefits were reported last fall as well.

Look AHEAD resulted in reduced rates of kidney disease, eye disease, and depression in the intervention group. There was also improved overall quality of life, fewer hospitalizations, enhanced mobility, and reduced medication use. And all of these benefits were seen despite the modest between-group differences noted above.

There is another point I emphasized when this story broke in the fall, worth reiterating now. The intensive intervention of Look AHEAD was based on the methods of the Diabetes Prevention Program. That study showed this lifestyle intervention, producing an average weight loss of 7%, could prevent the onset of diabetes in nearly 60% of high-risk individuals. Look AHEAD does nothing to invalidate those findings. It just may be that a lifestyle intervention works better when applied earlier. Once diabetes is established, perhaps the returns diminish somewhat, although Look AHEAD indicates there clearly are still returns.

A number of important messages issue from Look AHEAD. One is that very small intervention differences are apt to produce very small outcome differences. Another is that medicine of great value early may be of less value when administered late. Medication that can prevent asthma flairs is useless in treating an acute one. Ditto for migraine. This phenomenon is more common than not. If weight loss is medicine, the timing of its application may matter enormously. Yet even so, there was clear, and almost surprising, evidence of intervention benefit in Look AHEAD.

Yet another message is the importance of how, and even how often, medical news is reported. If headlines say "weight loss is of no benefit in diabetes," that is apt to be all readers take away. If the very same data could be reported as showing that "novel benefits are attached to weight loss in diabetics," then perhaps a bit too much of what we think we know comes down to how things get spun.

We may also be doing a disservice to the power of lifestyle interventions by focusing excessively on weight. While weight loss was a study goal, the real medicine was lifestyle. In the aggregate, the evidence is overwhelming that the same basic lifestyle prescription does prevent heart disease, and diabetes, along with every other major chronic disease.

Look AHEAD tells us that lifestyle medicine, though more powerful overall than all other medicine we've got, is not miraculous. It works as other medicine does, with effects depending on dose, and timing, and disease severity. Some lifestyle as medicine is always better than none, but for specific effects in specific populations, it is clearly possible to administer too little, too late, or both. This in turn simply indicates that lifestyle is real medicine, not a magical mix of unicorn horn and snake oil.

The power of lifestyle to prevent both diabetes and cardiovascular disease outright is irrefutably established. If we truly "get" AHEAD, however, understanding its details in context and look beyond the prevailing headlines, then it in turn should help us get ahead, not set us back. Even a little lifestyle medicine late still confers meaningful benefit.

But I dare hope we might look ahead to earlier, more consistent use of the largely latent power of prevention. Were we to do so, dramatically fewer of us would ever get diabetes. And this truth we hold to be self-evident, whether looked at ahead, behind, or sideways: the diabetes you never get will never increase your risk of heart disease.

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--Calcium, vitamin D does not reduce joint symptoms in postmenopausal women

Calcium and vitamin D supplementation did not reduce the severity of joint symptoms in postmenopausal women, a study found.

Researchers applied data from more than 1,900 patients in the Women’s Health Initiative (WHI) who had been randomized to receive daily supplementation from a combined oral pill with 1,000 mg of calcium carbonate and 400 IU of vitamin D3 or placebo and had undergone serial joint symptom assessment. The women (oversampled for minorities) also completed a questionnaire about joint pain and joint swelling before entry and two years after randomization.

Results appear in the Journal of the Academy of Nutrition and Dietetics.

At baseline, joint pain reported by 73% and swelling reported by 34%, rates that were comparable between the daily supplement use and placebo groups. Two years later, no statistically significant differences were seen for joint pain frequency between the treatment and placebo groups (74.6% compared with 75.1%; P=0.79) or joint swelling frequency (34.6% compared with 32.4%; P=0.29) or in severity scores for either outcome.

There was no influence found for age, body mass index, physical activity, non-protocol calcium and vitamin D supplement use, race/ethnicity, and hormone therapy. No significant interaction was evident with non-protocol vitamin D supplement use at entry. However, participants using nonprotocol calcium supplements at entry reported less joint pain compared with those in the placebo group (interaction P=0.02).

The authors wrote, “The statistically significant, positive interaction that was seen between baseline nonprotocol calcium use and joint pain benefit from protocol CaD was an unexpected finding. This result could reflect the play of chance or self-selection bias, especially because calcium has not historically been linked to joint symptoms. Alternatively, one could speculate that a calcium threshold level is required for vitamin D to favorably influence joint symptoms. In any case, the calcium result seen in a subgroup analyses clearly requires further study.”
Monday, August 26, 2013

Prostate cancer--a fish tale

Have you heard that fish oil supplements cause prostate cancer? The news items come from an article published online July 11, 2013 by Brasky et al. in the Journal of the National Cancer Institute, "Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial."

This study looked at 834 men diagnosed with prostate cancer, and compared them with 1,393 men, matched for age and race, that did not have prostate cancer. They then looked at the amount of omega-3 in their blood and compared the groups.

They found that those with the highest omega-3 levels had the highest risk of prostate cancer, 44% higher overall. This study followed up on one published earlier by the same group that suggested increased risk from fish consumption. The levels of omega-3 in the highest group were fairly modest, equivalent to eating an oily fish, such as salmon, twice a week.

Before jumping to the conclusion that men should not take fish oil or consume much fish, there are a number of things to consider. First of all, association does not imply causation. What does that mean? Just because two things occur together, it does not mean that one caused the other. If you look outside on a rainy day, you will see many people carrying umbrellas. But you would be wrong to conclude that carrying umbrellas caused it to rain.

It could be that it wasn't the omega-3 in fish, or fish oil supplements, that caused prostate cancer, but rather something else in the products, such as mercury or other toxins in the fish. If you ate fish raised in places low in pollution, or consumed ultra-filtered fish oil, then perhaps it would not be a problem. This study does not answer that question.

Even if eating fish or taking supplements increases the risk of prostate cancer, studies have shown it decreases the risk of cardiovascular (heart) disease, which is far more common.

This study was not the preferred double-blind, placebo controlled study, and the conclusion may just be wrong. After all, other studies have shown that fish consumption decreases prostate cancer. For example, one in the Lancet showed decreased risk of prostate cancer in those who ate moderate or high amounts of fish. Also, consider that Japanese men consume much more fish then American men, yet have far less prostate cancer.

So until I see more convincing evidence, I'll continue to take my fish oil capsules, and enjoy eating salmon.

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

QD: News Every Day--9 out of 10 doctors accept Medicare, a rate that remains steady

Office-based doctors have steadily continued to accept Medicare patients in recent years, at a rate of about nine out of 10, the Department of Health and Human Services reported.

According to federal survey data, the percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% in 2012.

The National Center for Health Statistics analyzed seven years of federal survey data from the National Ambulatory Medical Care Survey to draw its conclusions, which it reported online.

About 650,000 physicians participated in Medicare in 2011 and nearly 1 million clinicians did. A possible increase in the number of providers opting out was offset by an increase in the share of other physicians who accept new Medicare patients, the agency reported.

Compared to the number of physicians who accept new patients with private insurance, the percentage of physicians accepting new Medicare patients for most of 2005 through 2012. And, the percentage accepting new Medicare patients may have increased slightly in 2011-12 while the percentage accepting new privately insured patients may have decreased slightly.

More than three-quarters of Medicare beneficiaries reported no delays in getting care, the report continued. The Medicare Payment Advisory Commission (MedPAC), an independent Congressional agency that advises Congress, conducted an annual survey of 4,000 Medicare beneficiaries and 4,000 privately insured individuals age 50-64. In 2012, 77% of Medicare beneficiaries reported they never experienced an unwanted delay in getting an appointment for routine care, compared with 76% in 2008. These rates were comparable to people with private insurance. The large majority of beneficiaries had no problems getting an appointment with a new physician, the report stated, and Medicare beneficiaries were less likely than the privately insured to report forgoing needed medical care (8% vs. 11%) in 2012.

Even more studies you should ignore

Back when I was a medical student (in the Cretaceous Period) we were taught that someone once did a study comparing folic acid levels in the blood of cancer patients compared to the blood of healthy patients. The cancer patients had, on average, significantly lower folic acid levels. And the ones with the largest, fastest growing tumors tended to have the lowest folic acid levels. "Aha," they thought. "Something about folic acid deficiency predisposes them to cancer. We should give folic acid to cancer patients." Bad idea. A randomized trial showed that cancer patients given folic acid died sooner than those given placebo.

What happened? Low folic acid levels are a consequence, not a cause, of cancer. Folic acid is needed to synthesize DNA, and DNA synthesis is necessary for one cell to divide into two cells. So folic acid gets used up by rapidly dividing cells, like cancer cells. Giving cancer patient folic acid just gives their tumor a helping hand. (This roundabout insight led to medications that block folic acid metabolism which are used as chemotherapy to this day.)

The main lesson here is that correlation tells us almost nothing about causation. That means if A and B occur together, we say that they are correlated, but we have to be very careful not to assume that one causes the other. A might cause B, or B might cause A, or they may both be caused by some other factor that we're not paying attention to. This is the cognitive error that the farmer makes when he notices that the daily number of deaths of his livestock correlates with sales of ice cream in the town's ice cream parlor. He figures that some waste from the ice cream is contaminating his feed or water. He lobbies the legislature to ban ice cream sales around his farm. He doesn't realize that the rise in ice cream sales and his livestock deaths are both caused by very hot days.

This week a study was published that encourages just such a mistake. It should be universally ignored, but a handful of patients have already emailed me about it, and it's receiving a fair amount of confused media attention.

Before we look at the study, we need to learn a little about omega-3 polyunsaturated fatty acids. Omega-3 fatty acids are the predominant molecules in fish oil. They have been proven to lower triglycerides. They have gained popularity in the last few years, though the most recent trials (reviewed last year by The Medical Letter) have failed to show that they prevent stroke or heart attacks. There is certainly no convincing reason for the general population to be taking fish oil.

This week's study, published in the Journal of the National Cancer Institute, compared blood levels of omega-3 fatty acids in patients with prostate cancer to those levels in healthy adults. Prostate cancer patients had higher levels of omega-3 fatty acids. Note that the study had nothing to do with fish oil supplements or diet. None of the study subjects were asked about supplements or how frequently they ate fish. The only comparison was blood levels of omega-3 fatty acids of people with prostate cancer to healthy people.

This should remind you of the ancient folic acid study.

The study authors conclude that this should make us worry about the risks of increasing omega-3 fatty acids in our diet, and some of the media coverage warns that fish oil supplements may increase the risk of prostate cancer, but the study proves no such thing. Other possibilities are that prostate cancer patients produce elevated levels of omega-3 fatty acids, or that some unknown metabolic defect both increases prostate cancer risk and elevates omega-3 fatty acid blood levels.

The only way to know for sure is to randomize lots of people to fish oil capsules or to placebo, follow them, and count the resultant prostate cancer. That study hasn't been done, but that study would deserve our attention.

So am I saying that fish oil is safe and everyone should resume taking it? No. It has no proven benefits (except possibly for elevated triglycerides). That the connection to prostate cancer is unproven isn't a reason to take it.

Who knows? Maybe after a randomized trial is done and the biological connection is meticulously worked out this might lead to a new prostate cancer test or treatment. Then medical students not yet born will learn about it as an example of the importance of not confusing correlation with causation.

Learn more:
Hold The Salmon: Omega-3 Fatty Acids Linked to Higher Risk of Cancer (Time)
Too Much Fish Oil Might Boost Prostate Cancer Risk, Study Says (US News)
Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial (Journal of the National Cancer Institute article, abstract available without subscription)
Fish Oil Supplements (The Medical Letter, by subscription only)

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.
Friday, August 23, 2013

'See you in a Coupla Years ...'

A couple of years ago I blogged about my friend's Grandma. She was 93 and had been to see her eye doctor. Things checked out well during her eye exam, so he told her to "follow up with me in two years."

The point of the post (beside the unbridled optimism) was that there's no science on when patients should follow up with doctors. We have rules of thumb, like "annual physicals" that the culture, for better or worse, buys into.

Patients that have chronic conditions like diabetes are often urged to see health pros on a quarterly basis, to check labs (seeing if their average blood sugars have been near normal or not) and get their blood pressure checked. That's four visits per year.

How often do you see your doctor/NP/PA?

If you feel well, and you're a minimalist, your answer might be "as little as possible." (Call that the Hartzband viewpoint.)

If health concerns make you anxious, or you need the peace of mind of knowing that a health professional has evaluated your concern, then you may come more often. (Call it the Groopman approach.)

So, at heart are you a Hartzbander or a Groopmanian?

Dentists, it seems, have locked in the idea of two visits per year for preventive/maintenance oral care.

One tradition that dictates much of the health care economy is that folks with chronic conditions are told specifically when to come back, or asked to make an appointment at some set interval. Though done with good intentions (so that patients aren't "lost to follow up," and conditions can be monitored), there's no denying that mandatory follow ups make a good core business for medical practices. It keeps 'em coming ...

So my friend's Grandma, now 95, returns for her two-year follow-up. Eyes are still good. Doctor wants to schedule a follow up in another two years. "Ninety-seven year olds don't have two year calendars," she quips.

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.

We're number one again. But what does that mean?

Let's share the glad tidings: Johns Hopkins is again ranked as the number-one hospital in all the land. I've written about this before, sharing my misgivings about ranking hospitals. What is the methodology? How sensitive is the ranking to random error, bias, and qualities of hospitals that have nothing whatsoever to do with their quality, like reputation? What are we supposed to do with that information, who really uses it, and do they get better care as a result?

There are enough misgiving here to fill several chapters of a book, and in fact one chapter of mine is devoted to them. But the problem with measuring extends far past the ranking of hospitals. Doctors are being ranked this way, too, with the idea that public reporting of such information will help people make better choices about their health.

At the same time, many are trying to urge our health care system towards greater patient-centeredness. Various research teams are developing measures to quantify how well a given visit with a physician enables shared decision making on the part of the patient-doctor pair.

So, when presented with an array of various numbers, the rank of the hospital; the quality of the doctor; and the patient-centeredness of the practice, which one should the patient choose? Do we ask patients, as a whole, which ranking they find more important? Is each person to mix up a batch of numbers to find whatever aggregate satisfies their preference?

These are big questions. As I outline in my book, there is evidence that precious few patients or doctors actually use these rankings. Perhaps if we include patient-centeredness in the mix, and automatically generate a weighted average (or some other statistical combination of measures) that corresponds to patients' preferences, people will feel like they are getting the best doctor they can find. That would be something to truly celebrate.

Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins School of Medicine. His research interests include doctor-patient communication, bioethics, systematic reviews, and the role of the primary care provider in cancer care. He is also the author of "Talking to Your Doctor." This post originally appeared at his blog.

QD: News Every Day--Does the phrase 'palliative care' need a makeover?

Would rebranding palliative care improve patient cancer patients’ acceptance of it?

Patients and providers might both assume that palliative care—defined in a patient-centered model as relief from the symptoms, pain, and stress of a serious illness regardless of the diagnosis—means hospice care and that it can’t be combined with active treatment, wrote the authors.

To assess whether the term and/or description of palliative care services affected patient views, researchers conducted a telephone survey of 169 patients with advanced cancer. Patients were randomized into one of four groups that differed by name (supportive care vs. palliative care) and description (patient-centered vs. traditional) and were asked to rank on a 0-10 Likert scale their understanding, impressions, perceived need, and intended use of services.

Results appeared online at Supportive Care in Cancer.

When compared to palliative care, the term supportive care was associated with better understanding (7.7 vs. 6.8; P=0.021), more favorable impressions (8.4 vs. 7.3; P=0.002), and higher future perceived need (8.6 vs. 7.7; P=0.017). There was no difference in outcomes between traditional and patient-centered descriptions. When compared to the term “palliative care,” the term “supportive care” was associated with more favorable impressions (P=0.003) and higher future perceived need (P=0.022).

The authors wrote, “In our study, over half of the patients did not know what palliative care meant. This finding builds on prior research demonstrating a lack of familiarity with the term among oncology nurses and the general public, as well as among patients with cancer. Palliative care also lacks a standard definition in the supportive and palliative oncology literature.”

Further compounding the problem is that palliative care often occurs at the end of life, oncologists may define it as end-of-life care, and hospice care has been around longer. Researchers noted that the subspecialty board certification is called “Hospice and Palliative Medicine.”

Still, the authors concluded, oncologists could take advantage of patients’ lack of knowledge by introducing it in a more positive way, or by using a different term such as supportive care.
Thursday, August 22, 2013

The cost of colonoscopy: a new payment model

There is a steady push to change the way that physicians are paid. No compensation model is ideal. The fee-for-service model has become Public Enemy #1 as it is felt to be responsible for overtreatment generating excessive costs and utilization. Salaried physicians may be freed from the fee-for-service conflict of interest, but it has other drawbacks including a diminished incentive to provide exemplary service to patients and to referring physicians.

Since physicians did not initiate compensation and health care reform decades ago when we should have, we are now being squeezed hard by external forces that will overcorrect on the system's deficiencies. It's always better to fix your own house. There should be a lesson here for other professions who are in need of some reform and repair. Teachers, in my view, were dragged into the education reform arena, and will suffer because of it. Attorneys have been smug and cavalier about the legal profession's obscene excesses and I believe that they will rue their inaction.

What do patients think about how their doctors should be paid?

I've done over 20,000 colonoscopies. As I have written in this blog, I'm not even sure how much I charge for the procedure. It's not simply because I have little interest in the business of medicine. It's also because colonoscopies are like air travel. No two passengers pay the same price.

Which system would you favor for pricing a colonoscopy?
(1) Flat fee for the procedure for every insurance carrier.
(2) Hourly rate. If a colonoscopy is tough and takes twice as long, the physician should get double the dough.
(3) Graduated rate depending upon experience. Should a 20-year gastro veteran be paid the same as a green newbie?
(4) Airline model. We now know that various airline seats have been designated as premium seats because they afford an extra centimeter of leg room or the oxygen mask actually works. Similarly, certain colonoscopy time slots could be subject to a surcharge, such as the first appointment of the day when the physician is energized and not yet running behind. The 5 p.m. slot, in contrast, would be discounted as the physician is fatigued and is trying to make a 6 p.m. dinner reservation.
(5) Name your own price model as is done with air travel, car rentals and hotel rooms. Patients offer an on-line price in advance and the GI practice decides to accept this or wait for a higher bidder. This adds a fun element to the colonoscopy adventure.
(6) Patients decide after the procedure to pay the doctor what they feel the training, knowledge, experience and judgment are worth. Some patients, I fear, may valuate the colonoscopy only by the 10 minutes duration. This is not quite fair. Once in Cape Cod, I saw a beautiful sand sculpture of a mermaid. I asked the artist how long it took him to create the art. His response was '30 years and 7 hours'. Get the point?
(7) Barter system as functioned well historically. One colonoscopy = 6 Box seats at sporting event = set of luggage = last year's iPhone model = 1 hour plumbing service = 5 car gas fillups
(8) No charge at all. You can't put a price on your health, and we shouldn't try.

While I've never regarded myself as business savvy, perhaps I'm onto something here. What do readers think? Is it time to take off the rubber gloves and wear suits and ties or should I keep my day job?

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.

Lower ABIM pass rates are not just a work hour problem

You have to love the blogosphere. The latest big issue concerns lower ABIM pass rates. Here are a series of blog posts worth considering.

Dumber Doctors?

"One concern that has a ring of truth to it is that young doctors have become great 'looker-uppers,' and have lost the sense of what it's like to actually read and study medicine. While doctors enter the profession with a commitment to lifelong learning, some of us fear that the young folk only go far enough to commit to lifelong googling."

"Another key point: in today's era of restricted work hours, something has to give. Too often, when residents must complete the same amount of work in a limited amount of time, what's sacrificed is the didactic portion of the education: the stuff we do by running through case after case, discussing subtleties and action plans. When time is limited, the work's simply gotta get done."

Not Dumber, But Different

"I think that a big problem underlying the current examinations systems in most specialties and jurisdictions is that they ask questions that often have not changed with the times. Most importantly, they value the lower levels of learning (e.g. Bloom's Taxonomy level = 'Remember' and perhaps 'Apply') rather than critical reasoning and problem solving."

The Real Problem with Board Exams-and How to Solve It

"This week there's been a debate brewing about why so many young doctors are failing their board exams. On one side John Schumann writes that young clinicians may not have the time or study habits to engage in lifelong learning, so they default to "lifelong googling." On the other, David Shaywitz blames the tests themselves as being outmoded rites of passage administered by guild-like medical societies. He poses the question: Are young doctors failing their boards, or are we failing them?"

Of course I have read these blog posts and tried to make sense of the discussion. I have the advantage of starting as a ward attending in January 1980. I have worked with residents and students for 33 years and counting.

We have two big problems. We have changed work hours without changing how we admit and follow patients. We have not decreased the number of patients, just the time in the hospital. In order to meet the hours, we have less productive rotations like "night float". We have less time for didactic sessions. We have interns and residents taking days off during the week, thus impairing any sense of continuity in an educational offering.

At the same time, the pressure on attending physicians for patient care has risen and many attending physicians do not spend enough time teaching.

With that as a background let me propose solutions.

1. Attending physicians should teach, and residents should focus on learning the basics. Sure we can look some things up on the internet. But we can only look things up that we are aware are holes in our knowledge base. But we all must know the basics. We must have a developed strategy for approaching common complaints. We must know how to care for the common admitting problems.

2. Attending physicians should focus on teaching residents and students how the think. On my rounds we often search the internet for information. But the Internet cannot teach us how to approach problems. We cannot depend on searching for all the information. Often when we search the internet, we are looking for something that we know partly and need more information.

3. We should consider a different attitude towards testing. I love the idea of defining the necessary information that we expect graduating residents to know. We focus too much on the rare, the trivia, and the unusual. We need that experience, and a strategy for evaluating the unusual, but we must know the usual in depth so that we can recognize when the patient is not usual.

I personally do not consider Millenials and Gen X different from us baby boomers. We lived in different times, but we too disliked the tests. We wanted to learn the basics and learn how to think. Our residents are wonderful and want to be the same type of physicians that we have become.

We in medical education must think differently about rounds, about what we teach, and how we teach it. We should not blame the current generation. We should try to remember the 70s and 80s; we were not that different. The current generation is wonderful; they just have different constraints. We have handicapped them, and we have to work with them to develop solutions.

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

QD: News Every Day--Large-scale program nearly doubled hypertension control

A large-scale hypertension program that included evidence-based guidelines and performance metrics was associated with a near-doubling of hypertension control between 2001 and 2009 among, a study found.

Marc G. Jaffe, MD, ACP Member, of the Kaiser Permanente South San Francisco Medical Center, South San Francisco, Calif., and colleagues examined outcomes from the program, which included a comprehensive hypertension registry, development and sharing of performance metrics, evidence-based guidelines, medical assistant visits for blood pressure measurement, and single-pill combination drug.

Results from this group were compared to insured patients in California between 2006-2009 who were included in the Healthcare Effectiveness Data and Information Set (HEDIS) maintained by the National Committee for Quality Assurance (NCQA) quality measure reporting process. A secondary comparison group included the reported national average NCQA HEDIS commercial rates of hypertension control between 2001-2009 from health plans that participated in the NCQA HEDIS quality measure reporting process.

Results appeared in the Aug. 21 issue of JAMA.

Between 2001 and 2009, the Kaiser hypertension registry increased from nearly 350,000 people to more than 650,000. Hypertension control increased after implementation of the hypertension program from 43.6% in 2001 to 80.4% in 2009. The national mean NCQA HEDIS control rate increased from 55.4% to 64.1% between 2001 and 2009.

Following the study period, the hypertension control rate within Kaiser continued to improve, from 83.7% in 2010 to 87.1% in 2011.

The authors also found that the rate of single-pill prescriptions within Kaiser increased from 13 to more than 23,000 prescriptions per month from 2001 to 2009. During this period, the percentage of ACE inhibitor prescriptions dispensed as a single pill in combination with a thiazide diuretic increased from less than 1 percent to 27.2%.

An accompanying editorial noted that, “The transition to value-based models in all sectors of U.S. health care and the looming growth of accountable care organizations and shared savings models provides a framework wherein health care organizations have the flexibility to implement care models optimized to deliver the best outcomes at the lowest cost, without being constrained to face-to-face physician encounters to drive reimbursement. In this context, studies such as the one by Jaffe et al on the science of health system-level quality improvement are particularly powerful and hopefully will prompt hypertension guidelines and perhaps other guidelines to include recommendations about system-level approaches to managing risk factors.”
Wednesday, August 21, 2013

Real meaningful use

It has been nearly 6 months since I started my new practice, since I took the jump (or, more accurately, was pushed off the ledge) into a brave new world. It seems very distant, like I should get Shirley MacLaine or Gwyneth Paltrow to help me channel my old sad self. It is tempting.

I have a vague recollection, a memory shrouded in mist, where I pondered what seemed like a radical question: What would a health record look like if my only concern was patient care? This was a radical question because in my previous life I was an electronic health record aficionado. I was good at EMR, which meant that I was really good at finding work-arounds:

• How can I work around the requirements for bloated documents and produce records that are actually useful? The goal of records in that previous life was to justify billing, not for patient care.

• How can I work around the financial necessity to keep my schedule unreasonably full and keep my visits unreasonably short and still give good care?

• How can I work around the fact that I am paid better when people are sick and still try to keep them healthy?

• How can I work around the increased amount of my time devoted to qualifying for “meaningful use” and still give care that is meaningful?

Computers were all about automating the drudgery, organizing the chaos, and carving out a sliver of time so I could spend the extra minutes needed to give the care I wanted to give. I was using them to give good care despite the real nature of the medical record: a vehicle for billing.

But that was my past life. Now I no longer have to worry about a Medicare audit (and the looming threat of an accusation of “fraud” for simply not obeying the impossible documentation rules). I no longer have to keep my office full and my patients sick enough to pay the bills. I am actually rewarded for handing problems early, for communicating well, and for keeping patients healthy and happy, as it keeps them paying the monthly subscription fee.

Ironically, in asking the question, what would a health record look like if my only concern was patient care, I was really asking the question: what does “meaningful use” of the record really look like? Now this question is no longer a hypothetical; it is real. My rejection of EMR systems that catered to my previous needs and my quest to build one that fits my current needs have given me the chance to work very hard at answering that question. The success of my practice, and the success of other practices like mine, will depend on our ability to answer that question. I am now in a system that actually values communication, prevention, and organization, so I no longer need computers for work-arounds; I need computers to help me reach those goals.

As I’ve spent an enormous amount of time and energy (a.k.a. obsession) on my own system, I have come up with unexpected opportunities:

1. Abandon the artificial centrality of the office visit.

The care I gave in my former life was held hostage to the office visit. This is not only (as I have mentioned before) the unit of commerce, but the unit of documentation. Even in my new practice, where I am no longer loathe to give time and information outside of the office visit, I still am drawn to this unit of documentation. Why? Isn’t in-office care merely one of many communication options? Isn’t it part of a continuum of communication happening over time? Why should I separate the phone call earlier in the day from the visit that phone call prompted? Why should I wait until they are in the office before getting a history?

An example came a few weeks ago when a patient injured her finger. She has close contact with a dentist, who offered to get an X-ray of the hand. I got a secure message with a jpg attachment of that X-ray, revealing a fractured bone at the end of the finger. I messaged her back, telling her what to do about it, including my nurse on the message, asking if we had purchased splints when we started the practice. We hadn’t, and so Jamie ordered them, notifying the patient when they arrived. The patient spent a total of 5 minutes in my office, but the care extended over several days.

This scenario has repeated itself in other forms, including: diaper rashes that don’t heal (more pictures), intermittent abdominal pain, new-onset diabetes treatment, and post-lumbar puncture headaches. Attending to these problems as they happen (instead of requiring office visits) is far better for both patients and me. My availability to help patients in this circumstance lets me handle problems while keeping my office empty, while my empty office enables me to have the time to answer these questions (without the previous angst over lost revenue).

So how do I document this? The records of my former life didn’t consider such questions, but my new freedom brings this issue front and center.

2. Embrace Simplicity and Organization.

When dealing with such problems, the focus is not only on communication, but informed communication. Since I am not forced to gather all of the facts at an office visit (a truly impossible task for both doctors and patients), I need to have a better way of keeping track of things. I have to have a record that immediately tells me what I need to know about the person with whom I am interacting. The best decisions are made with the clearest picture of the situation, and I need a record that gives me that picture as efficiently as possible.

This is a far cry from my former life, where I was forced to include massive amounts of E/M vomit in every note to justify billing. The facts were hidden in the medical record, not revealed by it. What was the penalty for not having all the information I needed or for the bad decisions that were the result? Patients stayed sick, came back to the office, and I got paid more.

So, I have been forced to find new ways of organizing information. When I look at a person’s medical condition or a specific symptom, I want to have access to:

1. All medications related to it.

2. All encounters where it was addressed.

3. All associated testing, procedures, surgeries, and hospitalizations.

4. The opinions and contributions of other doctors on the issue.

5. A clear idea of its impact on the patient.

I want this information with as little work as possible so my communication can be as efficient and effective as possible. It’s been a tough task, but I think I’ve found a way to do this without demanding extra work.

3. Give that record to the patient.

I am not the only one who needs good information; the patient is an equal participant in these conversations, and the one with the most to gain from good decisions. The only solution I can see is to put this information where it belongs: in the hands of the patient.

If I had embraced this idea fully in my previous life, I would have been faced with a problem: the medical records sucked. The useful information that happened to be present in the record was buried in piles of coding compliance refuse, obscured by reams of superfluous data. Our records were better than most, and yet sharing them would reveal to our patients how little time was spent keeping them organized and accurate. We simply had more important things to do: things that paid the bills.

Creating a truly meaningful and useful record has not simply been something I’ve done for myself; my ultimate goal is to not only give them to the patient, but to invite them to help me in the never-ending task of keeping them organized and updated. My job will be to curate that information, as I better understand which parts of the information should be emphasized, and which should be available when needed.

I’ve got more points to make, but will let that go to another post. The point I want to make clear is this: The radical change in my payment model has forced an equally radical change in the systems that support that model. I can’t put new wine in old wineskins. The medical record of my past life was built to help with the problems inherent in that sad existence, and they served to amplify the sadness of that existence. Now living in a much happier, patient-centered world, I can build something that will increase that goodness and happiness.

Sorry Shirley and Gwyneth. I think I will stay where I am.

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.