Do We Really Want To Separate Clinical Data Gathering and Data Analysis?

flying cadeuciiAt the core of the controversy ignited by the recent New England Journal of Medicine(NEJM) editorial comparing data scientists to parasites brings is the emergence of data science as a distinct discipline, and the question of how it should relate to traditional academic clinical research (I’ve discussed the editorial here and the implications for incentives here.)

The Core Issue

To put it another way, is the activity of data analysis properly viewed as separate, and separable from the activity of data gathering?

For most academic clinical studies today, the researcher recruits patients, collects the data, analyzes the data, and publishes the results. Raw data are rarely shared and zealously guarded.

As data science has gained momentum and sophistication – and as the reproducibility of published science (particularly observational studies) has been increasingly scrutinized – the question becomes (as many have debated on twitter) whether the researchers collecting the data are necessarily the ones who are best positioned to interpret these data.

Wouldn’t science be best served, many data scientists ask, if the data collectors would deposit their information in an easily-accessible repository. Data scientists could then, in the words of Cloudera co-founder Jeffrey Hammerbacher, party on the data,” extract hidden relationships and deliver new insights.

Many academic clinical researchers worry that without a deep understanding of how data are generated, analysts might misinterpret the data; this is a key argument made by the NEJM editors.

Clinical researchers are also disinclined to part with their data because they often spend years and even decades recruiting and maintaining cohorts of patients who are analyzed and characterized.   After devoting so much time not only building these cohorts, but also in exploring the right ways to study them – including understanding the subtleties and limitations of measurement techniques — these investigators are often loathe to simply give away the data they’ve worked so hard to collect, and to which they feel so viscerally connected.

In theory, an appealing solution would be to recognize and reward data gathering and data analysis as distinct activities, each associated with its own methodologies, hurdles, training and reward system.

But the issue is that the research enterprise is fundamentally about insight generation, not cohort building. Clinical investigators invest their careers in building cohorts and gathering data not because they particularly enjoy these activities, but because they’re keenly interested in getting to the analysis stage at the end. From their perspective, it can seem absurd to spend years collecting the ingredients and baking a cake only to have someone else come along at the end and enjoy it.

In response, data scientists have asked, what about the patients? After all, isn’t research supposed to be conducted to improve the care of patients, not to advance careers?

This stinging criticism has struck many clinical researchers–especially many MD-investigators–as particularly hypocritical; many clinical investigators believe they’ve devoted their lives to caring for and understanding the lives of afflicted patients. To many clinical researchers, data scientists (often but not always PhDs with no access to patients) are simply looking for yet another data set to compute upon; while data scientists may say they want access in the name of patients and the name of science, many clinical investigators are skeptical and believe data scientists are simply trying to advance their own careers.

In brief: data scientists say clinical researchers are hoarding data to advance their careers, clinical researchers say data scientists are seeking access to data to advance their careers and each group believes the other is disingenuously claiming to be motivated by an interest in the quality of science and in the care of patients.

My Take

I suspect both science and medicine would be best served by a close integration of data gathering and data analysis, and by ensuring patients truly own and control access to the use of their data.

First: while collecting and interpreting data may seem like separate activities, in practice, they are–or should be–closely related. Data are collected based on how the researcher plans to analyze them, and how you analyze data may be influenced by what you learn about how they are collected. This doesn’t mean raw data shouldn’t be made available. Rather, the idea is that science is far better served, and will progress faster, if the research model isn’t premised on the idea of throwing raw data over a wall and receiving a completed analysis back over a wall, but rather if the gathering and analysis occur as part of a rich, ongoing and dynamic conversation.

Second: we must account for the role of impassioned, integrative clinical investigators (not necessarily a clinician; consider the example of Mary Claire-King), who through their passion and determination, through their enduring commitment to and unique understanding of their patients, are able to drive the science forward in a way that atomized researchers cannot. Medicine, I would argue, recognized too late the cost of deconstruction, of optimizing process segments (Taylorization) at the expense of an integrated whole, of prioritizing a care system over a caring individual. Rather than Taylorize clinical research, it would seem preferable to bring together data collection and data analysis in a way that doesn’t lose sight of the whole picture: the patient, the science and the value of a researcher committed to and invested in connecting the two.

Finally, of course, there’s something more than a little unseemly about different groups of scientists arguing who has access to patient data. The patient should be at the center of modern research model, and should easily and explicitly control and manage access to his or her own data. A research enterprise centered around self-organizing patient groups might effectively compel both data collectors and data analyzers to commit to a level of engagement and data sharing or risk being excluded from the system.

Bottom line

The editors of the NEJM choose perhaps the worst framing (and most inflammatory language) possible to make what is actually a reasonable point: Data gathering and data analysis are ideally integrated activities, and it will be better for both patients and science if these disciplines work cooperatively rather than independently. More explicit data ownership by patients could go a long way in ensuring constructive collaboration among all stakeholders.

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What Trump’s Plan to Negotiate With Pharma Should Tell Us

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Donald Trump’s proposal to allow the federal Medicare program to negotiate prices with drug companies should be a wake-up call for the pharmaceutical industry.

Trump is leading in the polls for the Republican nomination and is even drawing the support of Tea Party conservatives who, just a year or two ago, never would have supported a candidate endorsing such strong government intervention into a private-sector industry.

Characteristically, Trump didn’t give a lot of detail about his plans. He claimed $300 billion in savings per year (about 10 times more than is realistic). But that doesn’t matter. If the leading GOP presidential candidate—a man who has proved masterful at reading the public mood and playing to it—has signed on to this idea, it proves that change has come.

I know that many veterans of the pharmaceutical industry think they have seen this horror movie before and know how it ends. There have been several past public furors over the price of prescription drugs, and each one gradually faded without major disruption for drugmakers. But this time feels different.


Trump’s proposal is just the latest indicator of the increasing bipartisan support for government action on drug pricing is one reason why things are different this time.

One reason for that is this is the first big drug price controversy since Medicare Part D kicked into effect 10 years ago. That means this issue is not only hammering seniors—the most sympathetic and most-likely-to-vote segment of the population—but it also affects the federal budget.

Republicans in Congress, if you haven’t noticed the past few years, are not eager to run up federal spending. Remember Marco Rubio saying in October that some drug companies are engaging in “pure profiteering” and that high prices could “bankrupt our system”?

Another reason the drug price controversy is different this time is that consumers are more exposed than ever to high drug prices. One out of every four Americans covered by an employer is in a high-deductible health plan, according to Mercer’s latest survey. That up from just 3 percent in 2006. And pretty much everyone buying coverage on the Obamacare exchanges is in a high-deductible health plan.

High deductibles mean all those patients are exposed to the full brunt of high-cost drugs.

So then it’s no wonder that 77 percent of Americans said in an October tracking poll by the Kaiser Family Foundation that the top health priority of the president and Congress should be “making sure that high-cost drugs for chronic conditions … are affordable to those who need them.” Even 73 percent of Republicans agreed with that statement.

Nearly two-thirds of Americans—63 percent—supported “government action to lower prescription drug price.” Such actions also drew support from a majority of Republicans, 56 percent.

If the drug price controversy is different this time, it means the response from pharma needs to be different. At least if the industry wants to avoid draconian limits on its ability to reap rewards from its most innovative research.

One interesting idea floated on this blog recently by Dr. Soeren Mattke, a senior scientist at RAND Corp., was for the industry to voluntarily limit price growth on mature drugs.

“A solution could be for the research-based companies to adopt a voluntary code of conduct that would limit price increases on established products to inflation or to the cost of inputs,” Mattke wrote, adding, “This would be a small step for multi-billion dollar companies, but a giant leap towards becoming a respected partner when decisions about the future of healthcare are being made.”

Here’s another idea: create an industry-wide information service for patients and their doctors that combines the findings of comparative effectiveness studies with price information. Such a service would extend pharma’s medical commitment to deliver the right medicine to the right patient at the right time into the financial realm, delivering the right-cost medicine for each patient’s circumstances.

If drug companies were working hard to make sure heart patients who only need and can only afford a low-cost generic statin get it, or that diabetes patients who only need and can only afford metformin don’t get sold a high-priced diabetes drug, they would have a lot more credibility  charging higher prices for medicines those patients need when their conditions worsen beyond first-line therapies.

Last, pharma companies could ramp up the donations and discounts they give patients—and not just to the poorest customers. Indianapolis-based Rx Help Centers has been having success getting drug companies to give discounts or, via their foundations, donations to moderate-income patients. These patients have commercial insurance—yet still face crippling costs from a high-cost prescription drug.

If drug companies voluntarily removed the sting off their high-cost medicines for both poor and working-class Americans, they’d likely be accomplishing both their missions: promoting health and promoting profits—because they would fix a problem before public outcry makes politicians do it for them.

J.K. Wall is a reporter and editor at the Indianapolis Business Journal, where he has covered health care since 2007.

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Love and Measurement

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Many of us recall the final scene of Mad Men where Machiavellian dealmaker, philanderer, and ad mogul Dan Draper sits in lotus position finding either true inner peace or the next cynical direction from which to profit. This scene came to mind as I read another apparent conversion experience by Robert M. Wachter, MD in his recent opinion piece in the New York Times on how the metric measurement business fails physicians and teachers.

Remarkably, Dr. Wachter, once the Chairman of the  American Board of Internal Medicine (ABIM) that is responsible for “continuously” measuring, re-testing, and re-certifying US physicians, seemed to pivot from his former self by quoting a few of Avedis Donabedian’s words on quality assessment suggesting “the secret of quality is love.” Unfortunately, Dr. Wachter conspicuously failed to acknowledge the full context of Donabedian’s words.

“I think that commercialization of care is a big mistake. Health care is a sacred mission. It is a moral enterprise and a scientific enterprise but not fundamentally a commercial one. We are not selling a product. We don’t have a consumer who understands everything and makes rational choices — and I include myself here. Doctors and nurses are stewards of something precious. Their work is a kind of vocation rather than simply a job; commercial values don’t really capture what they do for patients and for society as a whole.

“Systems awareness and systems design are important for health professionals but are not enough. They are enabling mechanisms only. It is the ethical dimension of individuals that is essential to a system’s success. Ultimately, the secret of quality is love. You have to love your patient, you have to love your profession, you have to love your God. If you have love, you can then work backward to monitor and improve the system. Commercialism should not be a principal force in the system. That people should make money by investing in health care without actually being providers of health care seems somewhat perverse, like a kind of racketeering.” Avedis Donabedian

I suppose if he can transition from a physician executive to a “down to earth” Bob Wachter, MD hitting “high notes” as Elton John at the Mandalay Casino while simultaneously profiting from a company that now under federal investigation for overbilling Medicare, why not?  Such is our current reality of politics, medicine, and corporate cronyism.

It was nearly four short years ago that Dr. Wachter wrote that we needed the ABIM’s Maintenance of Certification program “more than ever.” Perhaps the lucrative Digital Party in medicine was just too big for the ABIM leadership and the members of its Foundation to ignore. At the time, those in Wachter’s World held the view that assuring physician quality meant physicians not only had to be re-certified every ten years but soon had to participate in some form of the ABIM’s measurement program every two years for the sake of  “external stakeholders and a troubled public.”  As a result, physicians were required to perform unproven practice improvement exercises, perform un-monitored research on themselves, and become glorified data entry personnel to continuously “maintain” their “board certification” or risk losing their right to practice. All of these exercises were subsequently revealed to be primarily for the medical industrial complex’s extraordinary monetary gain and undisclosed political activities.  Such “love,” indeed.

The expanded ABIM board certification requirements after 1990 have served as the goose that laid the Golden Egg for condo purchases, chauffeur-driven Mercedes rides, spousal travel fees, undisclosed corporate consulting arrangements, corporate mergers, political influence and the program’s continuing transition to Assessment2020 – much of these occurring while Dr. Wachter served as a Director or Chairman of the ABIM. For the ABIM and its parent organization, the American Board of Medical Specialties (ABMS), success in the digital medical world still appears to mean the doctor-patient relationship has to be owned, bartered, and commoditized to serve their bottom line without really understanding all that this entails to the doctor, their patients, and the credibility of our profession.

If Bob Wachter, MD is a true physician advocate and is now having a genuine conversion experience, he would be speaking out about these abuses of physicians’ trust. In fact, as the “Most Influential Physician Executive and Leader 2015,” he would be leading this charge. Or perhaps I am missing something.

Meanwhile, despite all of the fast-paced changes in health care under way, the same rubber soles continue to speed down linoleum hallways, call lights blink, keyboards pound, family meetings are held with tears shed, young physicians wonder how they’ll pay their educational debt, productivity quotas expand, administrative meetings multiply, patients grow furious about their rising premiums, co-pays and deductibles, physician autonomy and morale withers, and patient access to their doctor shrinks.

Fortunately, rather than standing idly by, practicing doctors are mobilizing. They are realizing that the bloated and costly bureaucratic arm of our profession has lost its way and are working to restore its integrity. Practicing physicians are finding they have a voice and are not powerless against these corporate entities that unjustifiably risk compromising their ability do their job. With these efforts, members of Wachter’s World are beginning to realize they’re at risk of losing their golden goose:

Last week, Andy Slavitt, Medicare’s acting administrator, announced the end of a program that tied Medicare payments to a long list of measures related to the use of electronic health records. “We have to get the hearts and minds of physicians back,” said Mr. Slavitt. “I think we’ve lost them.”

Despite these concerns of a few of our bureaucratic medical policy elite, practicing physicians remain little more than an account to be landed, a work to be optimized. To them, practicing physicians represent an opportunity to invest in new corporate ventures like Health2047, no doubt for the “love” that’s involved. The respectful partnership that practicing physicians would like to have would not include the many corrupt financial practices and undisclosed conflicts of interest of the AMA and the ABMS specialty board credentialing system, their collaborating subspecialty societies, and numerous for-profit physician reporting businesses. They invoke ethics, morals, and “love” at their own risk.

In my career, I’m unaware of a broader breach of the trust of working physicians and of medical ethics by fellow colleagues than by those who secretly created the ABIM Foundation in 1989 and then funneled over $55 million of testing fees collected from working physicians while hiding its existence from physicians and the public until 1999. Yet many in our academic and bureaucratic physician community continue to support this testing agency that appears to have been expanded solely for political, corporate, and personal gain, and are indifferent to them using strongman tactics with physicians. What a perverted form of “love.”

This system must change.

As health care moves forward in these uncertain times, a few of Donabedian’s (other) words on quality assessment, uttered a month before his death, are prescient:

“It is the ethical dimension of individuals that is essential to a system’s success. … Commercialism should not be a principal force in the system. That people should make money by investing in health care without actually being providers of health care seems somewhat perverse, like a kind of racketeering.”

Perverse indeed.

Right now there are residents who have no idea how they’ll ever pay off their educational debt and millions of patients who can’t afford insurance or their drugs. If the House of Medicine can’t look inward at its own bloated, self-serving, bureaucratic ranks of the ACGME that are sucking the life from direct patient care, what does this say about the prognosis for US health care?

As Tina Turner once sang, “What’s love got to do with it?”

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There is Nothing Free about The “Health Care” Market

Nortin Hadler“Universal Health Care”, “Single Payer”, “National Health Insurance”, “Socialized Medicine” are all semiotics symbolizing the subjugation of physician and of patient autonomy to government control for the sake of the common good. This is not sophistry. Max Weber was a Prussian political philosopher who laid the foundation for modern sociology with such books as The Theory of Social and Economic Organization (1920, English translation 1947) in which he proclaimed, “Bureaucratic administration means fundamentally the exercise of control on the basis of knowledge. This is the feature of it which makes it specifically rational.” (p. 339).

However, Weber knew that the goal of a rational bureaucracy was more often elusive than realized, if it is ever realized for long. As Karl Marx observed in a mid-19th C critique of Hegelian political philosophy, “The bureaucracy takes itself to be the ultimate purpose of the state.” That observation is mirrored in a televised speech delivered by Ronald Reagan on October 27, 1964, “No government ever voluntarily reduces itself in size. Government programs, once launched, never disappear. Actually, a government bureau is the nearest thing to eternal life we’ll ever see on this earth!”

The upshot is that society has an inherent love-hate relationship with bureaucracy. As I discuss in Citizen Patient, till the end of the 20th Century American medicine contained and controlled its own bureaucracy and was willing to downplay such short-comings as inequities in the delivery and quality of care. Even the legislating of a Medicare bureaucracy had little impact on the medical hegemony; the legislation delegated clinical indications and fees to medicine’s own bureaucracy and much else that is costly to the marketplace. American medicine remained secure in its autonomy. Meanwhile, elsewhere, in nearly all similarly “advanced” countries, the will to tackle inequities in the distribution and quality of care and in cost-effectiveness had come to predominate by early in the 20th C. These countries sought a solution in the evolution of governmental bureaucracies. Several of these bureaucracies, these national health insurance schemes, remain examples of Weber’s rationality. Several of the national health insurance schemes, such as in the United Kingdom and France, are fraying.

The ACA

Enter Obamacare. The Patient Protection and Affordable Care Act (PPACA) – also known as the Affordable Care Act or ACA, and often referred to as Obamacare – is the landmark health reform legislation passed by the 111th Congress and signed into law by President Barack Obama in March 2010. It is America’s attempt to create one of Weber’s rational bureaucracies to the serve America’s ill. The ACA is meant to salve the afflicted who are disaffected and disavowed and all else who were not well served in the 20th C by America’s institution of medicine and the “health care delivery system” it had commandeered. The ACA is a fatally flawed attempt.

The ACA was born of controversy and limps along in controversy, some as a reflection of false starts and unintended consequence. However, more is a reflection of the philosophical divide that was circumvented with compromises rather than confronted. David Blumenthal likens the political process that resulted in the ACA to Jefferson and Hamilton debating against and for a Federal finance bureaucracy. But I disagree. Both Jefferson and Hamilton had principled platforms and constituencies. The ACA emerged from a cacophony of prejudices and agendas, which were further inflamed by compelling but unverified inferences emanating from the academy. David Blumenthal was of the latter ilk and was brought into the Obama administration as the new National Coordinator for Health Information Technology. He was charged with building a private, secure nationwide health information system and to support its “meaningful use”. With unprecedented speed, America completed one of its largest ever, publicly funded infrastructure investments. THCB is laden with posts describing shortcomings and decrying some consequences, many of which must be close to the mark since CMS has now announced an impending revamping of “meaningful use”, which term has gained the baggage of an Orwellian oxymoron.

The shame of this chapter in the history of American medicine is that unlike the Jefferson-Franklin debates and unlike the debates regarding the moral underpinnings of the bureaucracy, the ACA was born out of debates on form and function but not on substance and ethic. Economists, policy wonks, politicians and all the various stakeholders came together to devise an insurance scheme that would be sufficiently granular to define who is at risk, for what and at what price. Health care insurance was likened to an enormous aggregation of personal articles floaters. All we had to do is capture the number of individuals, itemize their valuables, and calculate a premium that would cover replacement costs. The debate was in defining the premium that underwrote the system, not necessarily the premium that indemnified what was of value to the individual. It’s the same mindset that can price a year of quality living at $50,000 or more.

It is a mindset that turns health into a commodity, disease into a product line and physicians into a sales force. It is a mindset that believes that the free market champion those who are ill and in need of caring. It is a mindset that has been fooled. As Søren Kierkegaard said, “There are two ways to be fooled. One is to believe what isn’t true; the other is to refuse to believe what is true.”

The “Free” Market

Every serious student of political philosophy and economics knows of Adam Smith and probably his book, The Wealth of Nations, which he published in 1776. It is a text that remains oft quoted and still stimulates scholarship. I’d recommend a brilliant essay in the New Yorker by Adam Gopnik for starters. Adam Smith believed that a perfectly competitive market would benefit society at large. Further, whenever purveyors conspire with regulators, freedom is at risk. Smith’s dictum is, “It is not from the benevolence of the butcher, the brewer, or the baker, that we expect our dinner, but from their regard to their own interest. We address ourselves, not to their humanity but to their self-love, and never talk to them of our own necessities but of their advantages.”

Smith knew that a perfectly competitive market, an unblemished exercise in supply and demand, required “an invisible hand.” Smith never defined this notion; many a subsequent scholar has attempted to fill the void. It is generally agreed that Smith was not a deist. Certainly, his close friend David Hume was an irreligious radical epistemologist. So, you can make what you will of Smith’s “invisible hand”, as many have including the Nobelist Joseph Stiglitz who simply dismissed it as non-existent. “Invisible hand” aside, Smith’s notion of this unfettered free market has influenced important scholars for 250 years. Ever since Friedrich Hayek commanded the rapt attention of the Reagan and Thatcher administrations, an unfettered free market has become a shibboleth for right-leaning politicians and policy. Central authority, it is argued, can never have complete enough information to reliably allocate resources. Society is far better off if it relies on the price of goods and services in a free market to determine allocation. Hayek’s formulation of this principle earned him the Nobel Prize in Economics in 1974.

Caveat Emptor

By its very nature, the ACA is a denial of this line of reasoning. It is assigning the control of the provision of health care to a central authority, even to the extent of defining, demanding and enforcing “meaningful use”. What is not under the thumb of the Federal bureaucracy is delegated to the burgeoning bureaucracies of stakeholders including the “health” insurance and hospital/clinic enterprises along with PHrMA and the device industries. This dialectic stands in opposition to Adam Smith and all the political philosophy that has followed his example, including the powerful body politic that dominates legislatures across the country today. Hence, there was no way to marshal the ACA through Congress without compromise. The compromise that won the day for Obamacare and its myriad bureaucracies was to leave the definition of “care” and the pricing of “care” unspecified in the Act. It was assumed that the free market would work its magic.

Neither Smith nor his “invisible hand” could have imagined the “health care market” that awaited the ACA. Supply and demand is not under the control of the consumer; both are the purview of the bureaucrats who populate the front offices of the stakeholders. I do not mean to imply that these front offices are populated just by greedy misanthropes. Rather, these stakeholders have become the bureaucracies Weber feared and Marx foresaw. They are rational in their collective drive toward self-service but they are irrational in terms of their ethical mandate. As Richard Gunderman said in a recent THCB post, “Financial priorities begin to take precedence over why the organization exists in the first place – to care for patients.” Gunderman ascribes this to “…the growing bureaucratization of healthcare, driven in part by consolidation among healthcare organizations.” This tautology misses the mark. The reason these bureaucracies are immoral is that they are not held to a transparent, definitive and articulated standard of decency because society has been sold a bill of goods in the free marketplace.

More Foxes than Hens in the Henhouse

Despite the FDA and the EBM establishment, much that is sold to patients as beneficial remains a pig-in-a-poke, devices in particular. Much that is licensed and marketed as offering efficacy is supported by data that has been tortured or generated in studies that are too methodologically flawed to be interpreted with any confidence.  Furthermore, much that passes methodologic muster offers evidence for trivial if not elusive benefits. All these shortcomings are overshadowed by aggressive marketing designed to bolster the “margins” of purveyors, salutary or not. It follows that pricing in the health care market is far more a reflection of marketing prowess than of the value of the goods to the consumer. Stakeholders in the private sector garner adulation from shareholders for milking this market. This shell game also results in largesse that hides under blankets that only not-for-profit entities can contrive: minions of highly paid administrators housed in shiny facilities and plied with whatever perks they consider appropriate. All of this is immoral.

To my mind, the most immoral aspect of the evolution of this marketplace in the 21st C is in depriving the patient of access to the evidentiary basis for saying, “Thanks, but no thank you.” What kind of free market deprives the consumer of choice? Furthermore, most purchases are for goods without face value. It’s not as if one is asked to choose between automobiles. One is asked to purchase between putative benefits. That requires an informed and empowered patient, which in turn requires a trustworthy dialogue with a physician. To nurture this dialogue requires a marketplace that considers this dialogue a valuable priority. Rather it is rapidly becoming an overlooked demand and an endangered supply by an ever more irrational bureaucracy and a duped citizenry.

Nortin M. Hadler, MD is a graduate of Yale College and Harvard Medical School. He joined the faculty of the University of North Carolina in 1973 and has been a professor of medicine and microbioogy/immunology since 1985. His assaults on medicalization and overtreatment appear in many editorials and commentaries and 5 recent monographs: The Last Well Person (MQUP 2004) and UNC Press’ Worried Sick (2008), Stabbed in the Back(2009), Rethinking Aging (2011) and Citizen Patient (2013).

 

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Guideline-Centered Care

flying cadeuciiDoreen, Ahmed and Henry have recently had their medication changed in response to a new guideline for prescribing Statins, cholesterol-lowering drugs.

None of them came to ask for a change in their medication. In each case the change was recommended by a clinician in response to a new guideline against which our practice will be judged and financially rewarded or penalised.

Here are the NICE guidelines 2015:

The NICE guideline on lipid modification recommends that the decision whether to start statin therapy should be made after an informed discussion between the clinician and the person about the risks and benefits of statin treatment, taking into account additional factors such as potential benefits from lifestyle modifications, informed patient preference, comorbidities, polypharmacy, general frailty and life expectancy.

and

NICE recommends that statin treatment for people with CVD [Cardio–vascular disease] (secondary prevention) should usually start with atorvastatin 80 mg daily.

It is very easy to judge whether or not people with CVD are on Atorvastatin 80mg, but almost impossible to judge whether the decision to start therapy has been made as a result of thoughtful deliberation between the patient and the clinician. Thoughtful deliberation is at the heart of patient-centered care (not doing whatever the patient wants, as is often confusingly assumed).

Increasingly, financial incentives are being used to ‘improve quality’ in healthcare, which usually means that payment depends on the proportion of patients with condition ‘a’, receiving treatment ‘z’.

The assumption is that good quality medicine is about drugs like ‘z’ treating conditions like ‘a’. It says very little about Doreen, Ahmed or Henry.

Doreen is 67 and has CVD, chronic pain, depression, COPD, and recurrent vertigo. She lives alone, is socially anxious and isolated, frequently misses appointments, hates going to hospital, forgets to take her medication less often than she chooses not to take it – which is very often. She smokes about 30 roll-ups a day and has never exercised, and is very thin.

Ahmed is 47, has had two heart attacks, has type 2 diabetes with complications affecting his eyesight and his kidneys, he is overweight and cannot exercise because of chronic gouty arthritis. He has high blood pressure and cares for his wife who has schizophrenia, doesn’t speak any English and is frequently admitted to hospital.

Henry is 91, he has had a series of strokes and moderately severe Dementia – a mix of Alzheimer’s disease and stroke disease. He has metastatic prostate cancer and pain in his back from where the cancer has spread. He cannot speak and needs nursing assistance for all his needs.

Doreen, Ahmed and Henry are not the kinds of patients who are going to object when the doctor they know and trust, or even the expert they have never met before, changes their medication to include Atorvastatin 80mg. Dozens of people like them are my patients. I have no desire to impose an unnecessary burden of treatment upon them. I have every desire to practice with wisdom and compassion, to understand what matters most to them, what they want to get out of their treatment, to know how much is enough and how much is too much, to know which risks are worth taking and which are not. I want to know, in the context of their lives and their complex multiple conditions how much, and in what ways they are likely to benefit from changing their medication to include Atorvastatin 80mg. It is almost impossible to answer these questions without time. Guidelines do not, and cannot possibly take into account the characteristics of every patient. They generalise and we attempt to contextualise. Guidelines are rarely ever put together with or even for, patients. They rarely ever have any shared-decision making support and are not written in a way that is easily accessible to patients. Guidelines recommend that we are patient-centred, but they are not.

I am not sure that shared-decision making tools aren’t heading down a blind alley. They assume that people making decisions are rational and interested in abstractions like statistical tools and flow-charts, when the way my patients usually talk about healthcare is in personal narratives with significant events, characters, aspirations and moral negotiations. Compare Richard Lehman’s description of a shared decision making process or Paul Haidet’s description of a consultation with the NHS shared decision making website.

There is another, perhaps more important issue that this case highlights. GP appointments are a valuable and scarce resource. If the agenda for discussion is to be determined by neither the patient nor the doctor, but by the guideline, then there is less time to discuss other issues that may be of far greater importance and potential benefit. One important question to ask before administering any guideline is, “are there more important issues or interventions to discuss with your patient?”

Thousands of doctors and nurses struggle all day, every day to share difficult decisions with their patients. Making the right decision in the face of the natural complexity of medical practice and our patients’ lives, requires ‘phronesis’ or practical wisdom, informed by guidelines, but not led by them. Thousands more clinicians, caught in a trap with too little time and too much pressure to prescribe will skip the deliberation and simply default to the bit of the guideline that tells them what to prescribe.

When our patients look at the league tables and the accountants look at our books, will they be able to tell us apart?

Tomlinson is a physician in the UK. He blogs at A Better NHS , where this post first appeared.

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Wild Mushroom Soup

No, this is not chicken soup, but it’s still damn good for the soul!! The incredible earthiness and creaminess of this soup makes it very grounding and warming. Goodness knows we could all use some warmth here in Toronto, Canada.

These past couple of weeks have been very busy for the McJordan’s (that’s our new last name.. whatcha think? McCarthy + Jordan? haha) with public speaking events, webinars and just life in general. I’m sure you can relate! I’m finding the lack of sleep with an 18-week old and constantly go-go-go is taking it’s toll on my immune system so as I sit here and write this I’m fighting a cold. Which is why you can see I decided to use this trio of immune boosting ingredients: mushrooms, onions and garlic.

Wild Mushroom Soup

This soup did two amazing things for me! Helped me slow down and boost my immune system, which is exactly what I need right now. I made it last night because I’ve had some dried wild mushrooms from Forbes Wild Foods sitting in my kitchen cabinet just begging me to make use of them.

I love the beauty of these ingredients (real food is soooo gorgeous!!) and being in the kitchen. It is truly my happy place. Even though I was feeling under the weather, making this soup in the warmth of our home with Vienna chattering in the background and hanging out with Walker made for a very joyous evening.

Wild Mushroom Soup

This soup was incredibly creamy without ant added nut milk. Here’s the recipe.

Wild Mushroom Soup
2016-01-28 18:16:06
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Ingredients
  1. 1.5 cups wild dry mushrooms (chanterelles etc)*
  2. 2 tbsp extra virgin olive oil or grapeseed oil
  3. 6 shallots or 1 large white onion, chopped
  4. 3 garlic cloves, chopped
  5. 2 cups crimini mushrooms, chopped
  6. 4 cups stock
  7. 4 tsp dried tarragon
  8. Optional: 2 tbsp organic salted butter
  9. Salt and pepper to taste
Instructions
  1. Place the wild dried mushrooms in a medium bowl with room temperature water to rehydrate. Let sit for 10-20 minutes. Do not discard water!
  2. Meanwhile on stovetop, sautée shallots and garlic in olive oil for a few minutes, then add crimini mushrooms. Set aside to cool slightly then transfer to a blender and combine with stock and blend until smooth.
  3. Drain the wild mushrooms and add this to the blended mixture.
  4. Transfer blended mixture to large soup pot, add rehydrated mushrooms, tarragon, sea salt and pepper. Toss in butter if using for some added richness or extra olive oil. Reheat if needed.
  5. If you wish a creamier texture (although mine was very creamy) just add half a can of full fat coconut milk.
  6. Enjoy!
Notes
  1. I used 42 grams*
  2. Serves 4-6 people
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I also made my sundried tomato pesto and chickpea bread to go with this wonderful soup. It was seriously the perfect winter meal. 

Wild Mushroom Soup

Mushrooms are an incredible immune-boosting food and wild mushrooms just can’t be beat.

They have an extensive list of phytonutrients responsible for directing and instructing immune system cells called white blood cells how to do their job. More often then not we equate ‘immune-boosting’ foods to simply fighting and preventing colds and flus, which they do very well. However, the immune boosting and anti-inflammatory effect of mushrooms also help reduce the risk of heart disease, cancer and arthritis.

Wild Mushroom Soup

Joy McCarthy

Joy McCarthy is the vibrant Holistic Nutritionist behind Joyous Health. Author of JOYOUS HEALTH: Eat & Live Well without Dieting, professional speaker, nutrition expert on Global’s Morning Show, Faculty Member at Institute of Holistic Nutrition and co-creator of Eat Well Feel Well. Read more…

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Employer Sponsored Insurance: Unfair and Unaffordable

flying cadeuciiFor all those Americans faced with higher health insurance premiums or less coverage (that’s most of us), the temptation is to blame the Affordable Care Act. Maybe instead we should be blaming the one thing the ACA didn’t significantly change: employer sponsored insurance—the norm for most working Americans.

Although the ACA imposed some new standards for coverage, ESI employers remain free to dictate most insurance details, the tax-exclusion of ESI benefits is largely unchanged, ESI premiums are still generally independent of income, and small employers can still offer ESI or not.

Unfortunately for millions of workers, it’s a model that’s increasingly neither affordable nor equitable. What seemed a reasonable approach fifty or sixty years ago when healthcare costs were far lower is now one of the most regressive health insurance systems in the industrialized world.

The Kaiser Family Foundation’s most recent employee benefits report demonstrates the problem.

Average ESI premiums are now $6,250 for an individual and $17,500 for a family. Most workers must pay part of the premium, with contributions averaging rather more than $1,000 for individuals and around $5,000 for family coverage. Most employees are also faced when they need care with substantial deductibles, averaging $1,300 for an individual and two or three times that for a family. (These figures are averages; in many cases, especially for smaller firms, the numbers are much higher.)

The out-of-pocket costs for premium contributions and deductibles may be tolerable for a manager earning $200,000 annually but can be a catastrophe for a$55,000 median income worker with a family. A look at the numbers for two typical employees shows just how unfair ESI has become.

The $200,000 manager with a family receives a tax-free benefit worth $22,400 in after-tax dollars, while the $55,000 worker gets only a $20,100 benefit. While both pay a $5,000premium contribution, it’s just2.5 percent of the manager’s salary,but almost four times this percentage of the worker’s pay. An even biggerinequity comes with the deductibles: incurring a typical $4,000 family deductible may be unwelcome for the manager, but it’s a crisis for the worker facing a choice between forgoing urgently needed care and financial disaster.

And it’s getting worse.

Each annual rise in healthcare costs requires employers to decide between increasing their share of premium costs and passing more of the burden onto their workers. Arecent survey of projected 2016 employer benefits illustrates what’s occurring. Faced with average 6 percent premium increases over 2015 levels (assuming no change in coverage), the typical employer is choosing to bear just a third of the increase, while dealing with the other two-thirds by simultaneously raising employee contributions and reducing coverage (usually by increasing deductibles).

Based oncurrent trends,in ten years’ time ESI premiums will average around $10,000for individuals, with employees paying close to $2,000, and some $30,000 for family coverage, with employee contributions near $9,000. Deductibles are expected to rise even more steeply, as employers try to control costs andalso avoid the Affordable Care Act’s delayed “Cadillac tax,” intended to curb overly generous coverage, but now likely to hit many more workers than originally expected.

If recent years’ pattern of close-to-inflation wage increases continues over the next decade, the well-paid manager (at $250,000 a year by 2025) will be able to afford the $9,000 family premium contribution and a potential deductible of $5,000 or more, but the average worker (at a projected $69,000) may find these costs impossible to bear. Two comparisons shows the unfairness.The manager will receive a benefit worth $38,500 and the worker one worth $4,000 less. Meanwhile, the manager will pay 3.6 percent of income as premium contribution and the average worker a big13 percent. (For lower-paid workers, the percentage will be even greater.)

Simple arithmetic shows thatby 2025, the combination of premium contributions and deductibles is likely to result inmany workers having to spend up to a quarter of their income to get any care at all.

The Affordable Care Act may have made healthcare available to more Americans, but in its attempt to minimize disruption for the majority of employees, it perpetuated a system that is increasingly unfair and unaffordable for those same workers and their families. (It’s also a system that healthcare economists have criticized for hurting smaller employers, reducing employment flexibility, damaging the overall economy, and doing far too little to encourage insurer competition.)

A fundamental re-think is needed. If we want employee health insurance to be fair and affordable, we must abandon the ESI system’s one-size-fits-all approach to premiums and deductibles. As in virtually every other industrialized nation, the cost of health insurance should be tied in some way to income.

Better yet, we should eliminate the employer role entirely. Replacing ESI and its unfair tax subsidies with coverage selected by individuals – not employers — would have several advantages. Insurance would no longer be tied to employment or be dependent on employer decisions, the true costs of healthcare would be more apparent, the bias against small businesses would be eliminated, employees would have more choices, insurer competition would be enhanced, and – most important of all – coverage costs could fairly reflect family income.

Roger Collier is the founder of the Campaign for a Rational Healthcare System (http://ift.tt/1Wj2u8E). He was formerly CEO of a national healthcare consulting firm.

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