NEW @ THCB PRESS: Surviving Workplace Wellness. Spring 2014. Al Lewis and Vik Khanna. e-book edition. # INNOVATION: PCORI APP Challenge

prevention

I am known in the disease management and wellness fields as a naysayer, critic, curmudgeon, and/or traitor…and those are only the nouns that are allowed to be blogged across state lines.  This is because I am driven not by wishful thinking but rather by data.  The data usually goes the wrong way, and all I do is write down what happened.  Then the vendors blame me for being negative — sort of like blaming the thermometer because the room is too hot — because they can’t execute a program.

However, the nonprofit Iowa Chronic Care Consortium (ICCC) apparently can execute a program.  They reduced total diabetes events by 6% in the rural counties they targeted.  This success supports a hypothesis that in rural (presumably underserved) areas, disease management fulfills a critical clinical gap:  it provides enough basic support that otherwise would not be provided even to those who actively seek it to reduce near-term complications and exacerbations.

This result will likely produce its own unanticipated consequence: because many people now believe (thanks, ironically, to some of my own past work) that disease management doesn’t produce savings, there will be widespread skepticism about the validity of this study.  Quite the opposite:  this “natural experiment” is as close to pristine as one could hope for in population health, for five reasons:

  1. There was no participation/self-selection bias because outcomes were measured on all Iowa Medicaid members.
  2. The program was offered in some Iowa counties but not others, so there was no eligibility or benefits design bias, Medicaid being a statewide program.
  3. The program encompassed only one chronic condition (diabetes) rather than all five common chronic conditions normally managed together (asthma, CAD, CHF, and COPD being the other four).   Since all five conditions were tracked concurrently, whatever confounders affected the event rate in one of those conditions should have affected all of them.   And event rates in the four other conditions did indeed move together in both the control and study counties.   Just not diabetes.
  4. The data was collected exactly the same manner by the same (unaffiliated) analysts using exactly the same database so there is no inter-rater reliability issue.
  5. Both groups contained hundreds of thousands of person-years and thousands of events.

As one who has reviewed another high-profile “natural experiment,” North Carolina Medicaid, and found that the financial outcomes were the reverse of what the state’s consultants originally claimed (incorrectly, as they later acknowledged by changing their answer), I can also say that natural experiments in population health don’t harbor some as-yet-unidentified confounder that causes the study population to outperform the control population.

Continue reading “Stop the Presses: A Disease Management Program Worked”

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Every now and then the title of a book influences your thinking even before you read the first page.

That was the case for me with Thomas Moore’s “Care of the Soul” and with “Shadow Syndromes” by Ratley and Johnson. The titles of those two books jolted my mind into thinking about the human condition in ways I hadn’t done before and the contents of the books only echoed the thoughts the titles had provoked the instant I saw them.

This time, it wasn’t the title, “Cultivating Chi”, but the subtitle, “A Samurai Physician’s Teachings on the Way of Health“. The book was written by Kaibara Ekiken (1630-1714) in the last year of his life, and is a new translation and review by William Scott Wilson. The original version of the book was called the Yojokun.

The images of a samurai – a self-disciplined warrior, somehow both noble master and devoted servant – juxtaposed with the idea of “physician” were a novel constellation to me. I can’t say I was able to predict exactly what the book contained, but I had an idea, and found the book in many ways inspiring.

The translator, in his foreword, points out the ancient sources of Ekiken’s inspiration during his long life as a physician. Perhaps the most notable of them was “The Yellow Emperor’s Classic on Medicine”, from around 2500 B.C., which Ekiken himself lamented people weren’t reading in the original Chinese in the early 1700′s, but in Japanese translation. One of his favorite quotes was:

“Listen, treating a disease that has already developed, or trying to bring order to disruptions that have already begun, is like digging a well after you’ve become thirsty, or making weapons after the battle is over. Wouldn’t it already be too late?”

Ekiken’s own words, in 1714, really describe Disease Prevention the way we now see it:

“The first principle of the Way of Nurturing Life is avoiding overexposure to things that can damage your body. These can be divided into two categories: inner desires and negative external influences.

Inner desires encompass the desires for food, drink, sex, sleep, and excessive talking as well as the desires of the seven emotions – joy, anger, anxiety, yearning, sorrow, fear and astonishment. (I see in this a reference toarchetypal or somatic medicine.)

The negative external influences comprise the four dispositions of Nature: wind, cold, heat and humidity.

If you restrain the inner desires, they will diminish.

If you are aware of the negative external influences and their effects, you can keep them at bay.

Following both of these rules of thumb, you will avoid damaging your health, be free from disease, and be able to maintain and even increase your natural life span.”

On the topic of Restraint, the Yellow Emperor text states:

In the remote past, those who understood the Way followed the patterns of yin and yang, harmonized these with nurturing practices, put limits on their eating and drinking, and did not recklessly overexert themselves. Thus, body and spirit interacted well, they lived out their naturally given years, and only left this world after a hundred years or more.
Continue reading “The Samurai Physician’s Teachings on the Way of Health”

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It’s fitting that this year’s ACOG meeting was held in New Orleans, because navigating the 2013 ASCCP Pap Smear Management Guidelines presented there feels like trying to make my way through the Mississippi bayou. The guidelines include 18 different algorithms encompassing almost any combination of pap and HPV abnormality we docs are likely to encounter among our patients.  But all tributaries lead to the same place, where we achieve optimal reduction in cervical cancer with minimal harm.

Cervical cancer prevention is a process with benefits and harms. Risk cannot be reduced to zero with currently available strategies, and attempts to achieve zero risk may result in unbalanced harms, including over treatment. …optimal prevention strategies should identify those HPV-related abnormalities likely to progress to invasive cancers while avoiding destructive treatment of abnormalities not destined to become cancerous. Adopted management strategies provide what participants considered an acceptable level of risk of failing to detect high-grade neoplasia or cancer in a given clinical situation.

I’m not even going to try to spell out everything in the guidelines, which come from the American Society of Colposcopy and Cervical Pathology (ASCCP), except to say that they represent further movement away from aggressive screening and treatment of pap smear abnormalities, especially in younger women, in whom treatment carries small but real childbearing risks. The guidelines are increasingly reliant upon HPV testing to determine who and how often to screen, and when to treat.  They also acknowledge the role of testing for HPV 16 and 18 as a way to be sure that those women with adenocarcinoma of the cervix (which is less likely to show up as cancer on a pap smear) are identified and treated.

From the guidelines-
Continue reading “The New HPV Guidelines. Balancing Benefits and Harms of Cervical Cancer Screening”

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There is a certain irony in the nearly immediate juxtaposition of the rare introduction of a new FDA-approved drug for weight loss (Belviq) to the marketplace and the recognition of obesity as a “disease” by the AMA. A line from the movie Jerry Maguire comes to mind: “You complete me!” Drugs need diseases; diseases need drugs.

And that’s part of what has me completely worried. The notion that obesity is a disease will inevitably invite a reliance on pharmacotherapy and surgery to fix what is best addressed through improvements in the use of our feet and forks, and in our Farm Bill.

Why is the medicalization of obesity concerning? Cost is an obvious factor. If obesity is a disease, some 80 percent of adults in the U.S. have it or its precursor: overweight. Legions of kids have it as well. Do we all need pharmacotherapy, and if so, for life? We might be inclined to say no, but wouldn’t we then be leaving a “disease” untreated? Is that even ethical?

On the other hand, if we are thinking lifelong pharmacotherapy for all, is that really the solution to such problems as food deserts? We know that poverty and limited access to high quality food are associated with increased obesity rates. So do we skip right past concerns about access to produce and just make sure everyone has access to a pharmacy? Instead of helping people on SNAP find and afford broccoli, do we just pay for their Belviq and bariatric surgery?

If so, this, presumably, requires that everyone also have access to someone qualified to write a prescription or wield a scalpel in the first place, and insurance coverage to pay for it. We can’t expect people who can’t afford broccoli to buy their own Belviq, clearly.

There is, of course, some potential upside to the recognition of obesity as a disease. Diseases get respect in our society, unlike syndromes, which are all too readily blamed on the quirks of any given patient and other conditions attributed to aspects of character. Historically, obesity has been in that latter character, inviting castigation of willpower and personal responsibility and invocation of gluttony, sloth, or the combination. Respecting obesity as a disease is much better.

And, as a disease, obesity will warrant more consistent attention by health professionals, including doctors. This, in turn, may motivate more doctors to learn how to address this challenge constructively and compassionately.

But overall, I see more liabilities than benefits in designating obesity a disease. For starters, there is the simple fact that obesity, per se, isn’t a disease. Some people are healthy at almost any given BMI. BMI correlates with disease, certainly, but far from perfectly.

Continue reading “Is Obesity a Disease? I Vote No”

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Health-contingent workplace wellness, the two-time darling of federal legislation codified in both the Health Insurance Portability and Affordability Act (HIPAA) and the Affordable Care Act (ACA), is now plagued by doubts about effectiveness and validity that are inexorably grinding away its legitimacy.  This puts employers, particularly large employers who have committed to it so vocally and visibly, in an awkward spot.  In the style of politicians nervously trying to change the terms of debate, wellness advocates are now walking back the assertions that have undergirded their entire construct for more than a decade.  While some business leaders are apparently either unwilling or unable to back away from this self-inflicted wound, staying the present course is neither inevitable nor required.  A course correction might actually prove quite liberating, especially for leaders of smaller and mid-sized businesses who must scratch their heads wondering how they’re supposed to reproduce a big-company style workplace wellness program or even why they should, given the dearth of data on effectiveness.

As a case in point, we offer GE, an iconic American multinational with 305,000 employees, $147BN in revenues, and $16.1BN in earnings worldwide in 2012.  The company offers its employees a much-lauded wellness program, saluted by the National Business Group on Health (NBGH) in a fawning 2009 case study. GE’s wellness program has several things to recommend it:

  • A top line focus on environmental change
  • An emphasis on strong and consistent positive health messaging to employees
  • The “Health By The Numbers” strategy that asks employees to commit to essential behavior changes (don’t smoke, eat more produce, walk more, and maintain a healthy body mass index [BMI]; there is wisdom in these choices, as they are the baseline activities for good health)

Beyond these obviously beneficial wellness program components, the GE wellness program veers off into a compendium of wellness convention, with encouragement for employees to take HRAs and get screenings, in particular, mammography, colonoscopy, cholesterol, and blood pressure.  Some of the affection for diagnostics springs, of course, from GE’s corporate commitment to health care, which includes selling a broad variety of diagnostic devices to medical care providers who must, in turn, induce demand in order to pay for their contribution to GE Healthcare’s $18.2BN revenue stream.

As far as is discernible from publicly available documents, the wellness program targets GE worksites with over 100 employees, and GE claims in the NBGH case report that over 90% of employees worldwide participate.  Beyond these data, however, it is remarkably difficult to understand what results GE gets and at what cost.  The only publicly available insight on expense comes from GE wellness leader Rachel Becker in an essay published online by EHS Journal, in which she reports $100,000 per site as the wellness startup cost.   Extrapolating this figure to GE’s more than 600 global worksites produces a wellness capitalization expense of about $60M, which presumably does not include annual wellness program operating costs.  This might be why GE makes absolutely no mention of the cost or results of its wellness program in either its annual report or its 10K filing, although the NBGH quotes GE as saying the implementation was “inexpensive”.  Even though $60M is equal to only 0.38% of GE’s 2012 earnings, it nonetheless might seem an untidy sum to skeptical shareholders.

Continue reading “GE’s Wellness Program: Bright Shining Light or Dim Bulb?”

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This past week, Google had its annual developers conference, Google I/O. One of the more provocative talks, called “The End of Search as We Know It,” was by Amit Singhal, who is in charge of search for Google.

The vision, as described by Amit, is that instead of typing words into a box on a website or mobile app, we will have conversations with Google, enabling a much more personalized, refined experience. The holy grail, of course, is that Google analytics become both predictive and prescriptive, serving you content that is just right for you and anticipates your needs.

It seems there is a race on now to achieve this vision. One could argue that Amazon, Apple, Facebook, Pandora and others are all in the same mode. Best I can tell, the promise these companies are floating to advertisers is that their ads will be served up to that focused slice of the population that will find their product relevant in the moment.

If you apply this thinking to healthcare, several controversies/topics come to the fore.

Is Google competing with IBM’s Watson? Undoubtedly yes. On the other hand, I’m guessing Google is disenchanted with the consumer health space after the demise of its personal health record (PHR). And IBM seems to be focused on clinician decision support. So early in the game, with respect to healthcare anyway, maybe there is not much competition. The path for clinician decision support is clear and the market obvious, whereas the path and market for consumer health decision support are blurry.

Continue reading “Is the End of Search the Beginning of Personalized Prevention?”

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As we look back over the past year and some of the amazing medical breakthroughs like wearable robotic devices, genomic sequencing and treatments like renal denervation that are improving people’s lives, it bears reflection on what else we could be doing better. Our world has changed more in the past century than in thousands of years of human history. We not only know more about our biology than ever before, but science and technology are unlocking the secrets of the very building blocks of our health. Somehow, in the midst of this incredible innovation, we’ve gotten fat, and not just a little. The result? Alarming rates of obesity and related chronic disease that threaten to crush us physically and financially.

But is it technology’s fault that we’ve become fat? A recent study by the Milken Institute that tied the amount an industrialized country spends on information and communication technologies directly to the obesity rates of its populations thinks so.

Most of us are guilty of a little overindulgence around the holidays but for many, overindulgence is a normal way of life. As economies transition to more sedentary, the physical movement that burned calories and kept us fit simply does not occur. Our lifestyles compound the issue — dual-income homes rely on the convenience of packaged meals, and our leisure activities have shifted to heavy “screen time” with movies, games and social media.

Continue reading “Is Technology Making Us Fat?”

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A woman’s mother dies at age 56. A blood test is done. The woman finds out she has a genetic pre-disposition to cancer. She takes what action she thinks she needs to take. A familiar story repeated over and over again every day. I’ve met many women who have made this choice. While not “normal”, it is a familiar situation. These women’s difficult choices go unheralded. But not Angelina. She has a voice and she’s not afraid to use it.

I am of two minds about Ms. Jolie’s announcement. Unlike double mastectomies for ductal carcinoma in situ (DCIS), which isn’t necessarily a cancer and can be treated with a lumpectomy, BRCA1 gene mutations can’t be treated any other way. Unless I hear differently from my breast surgeon friends, I’d say she probably did the right thing. Her decision to talk about it is probably encouraging to women who have or will have to make that choice. It raises awareness of the gene mutation. It puts breast cancer on the front page of the New York Times. Again.

Here’s my problem: double mastectomy is not a benign procedure. Ms. Jolie seems to have had a remarkably easy time of it. Yes, she says she was right back to her normal life soon after, but since Jolie’s life is not normal that’s hard to generalize. The truth is there is significant pain involved, a long period of waiting while the tissue expanders do their work, then there’s further procedures for the implants, which can develop capsules around them, or rupture, or get infected. If Angelina had chosen breast reconstructive surgery there would be the risk of the flap losing blood flow, multiple drains, overnight stays in recovery rooms or ICUs, and many many surgeries for revision, nipple creation, etc. And the results are not always beautiful. I understand that it is not Ms. Jolie’s role to scare people, but to encourage them. I would just warn against falsely rosy expectations.

I am not trying to discourage double mastectomy. Sometimes it is necessary. I do think that people who have extraordinary access to public attention must pay extraordinary attention to what they say. I wish Angelina all the best for a complete, and beautiful, recovery.

Shirie Leng, MD is a practicing anesthesiologist at Beth Israel Deaconess Medical Center in Boston. She blogs regularly at medicine for real.

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The U.S. Preventive Services Task Force formally published its recommendation for routine HIV testing for all individuals age 15 to 65 in the Annals of Internal Medicine this week. An editorial and patient materials are all available free to anyone with an Internet connection.  Many people who work in HIV hoped that this would finally move HIV into mainstream medicine.

With a U.S. Preventive Services Task Force Recommendation, patients don’t need to ask for the test, it would become a routine blood test like many others, stigma would be reduced, and insurance would likely cover it. The evidence backs it. However,  within 24 hours of the Task Force Recommendation going up online, the American Academy of Family Physicians questioned age 15 as the logical starting point, instead urging that testing begin at age 18. This is just some of the resistance that the medical community is putting forward now.

Several months ago, I spoke with Roger Chou, MD, MPH, associate professor of internal medicine at Oregon Health and Science University, Portland, Oregon, who headed the evidence review for the U.S. Preventive Services Task Force. “About 25% of people who have HIV and are not aware of it,” Chou said. “They have no identifiable risk factors.”

Other reasons why data to back routine HIV testing are in, include that the screening test is highly accurate, we have direct evidence from randomized controlled trials that we can reduce the risk of transmission by 90%, and that you can’t trust what your patient says, , or that patients don’t always think that they are at risk,” said Chou.

Continue reading “USPSTF Backs Routine HIV Testing”

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The most important study in American health policy in decades, the Oregon Health Insurance Experiment, published two-year results Wednesday in the New England Journal of Medicine. If you’re reading up on the topic, get ready for bombastic claims and scorching heat as opposed to illuminating light. The quick read leads to an easy Drudge headline – “MEDICAID DOESN’T MAKE PEOPLE HEALTHIER: OBAMACARE WILL FAIL!” – but a fuller reading of the evidence provides a more optimistic, and honest, take.

In 2008, Oregon had 90,000 individuals who wanted to enroll in its Medicaid program, but the funding to enroll only a fraction. So it decided to use the opportunity to create an unparalleled experiment: the first Randomized Controlled Trial (RCT) – the gold standard research methodology that is able to isolate the causal effect of an intervention – in Medicaid history. It endeavored to show nothing less than the actual, causal effect that Medicaid has on its population, a first in the field.

This study, in other words, is a big, big deal.

Two years of data are in, and the results are mixed. First up, the disappointing: Medicaid coverage.

Continue reading “Evidence That Health Does Not Equal Healthcare? Early Results From the Oregon Experiment Are In”

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