Apologies and Outcomes

What if a study shows that the course of action we know to be right doesn’t “work”? Or that it may even place us at a disadvantage?

When bad things happen to patients in the course of medical treatment, doctors traditionally have avoided apologizing or even expressing sympathy to patients, for fear that such expressions would be used against them in malpractice court as an admission of guilt. So multiple states have passed “apology laws” excluding such expressions from trials, in order to encourage doctors to make apologies. The underlying idea is that the act of apologizing helps to enhance communication between patients and physicians and to assuage some of the anger that leads people to sue their doctor, thereby reducing the likelihood of a malpractice suit.

However, a recent extensive study found that in states where apology laws are on the books, doctors’ risk of malpractice suits actually increased, as did the average payment to settle a claim.

Assuming for the sake of argument that the results of the study are valid, what conclusions are we to draw from them? It seems like a right, normal, ethical, human thing to do to apologize when we have harmed someone. Should doctors avoid apologizing to patients if it will increase their risk of a malpractice suit? More generally, how much do we allow outcomes (a major buzzword in medicine these days) to influence our moral reasoning and acting? Take, for instance, the opposite scenario: What if a wrong action is shown to have a beneficial result? For example, what if a study showed that a stem-cell therapy that relied on destroying embryos would effectively cure diabetes, or Alzheimer’s? Should such a compelling good outcome sway our moral reasoning and acting?

Outcomes need to be taken into account, but they must not be the only or the overriding factor in making ethical decisions. Just as a potentially good outcome does not make it more right to destroy an embryonic human, a potentially bad outcome does not make it less right to apologize to a fellow person when we have done them harm.

Excuse Me, Doctor, What Exactly Do You Profess?

The late Edmund Pellegrino, M.D., revered medical educator, ethicist, and physician, often made the point that a professional professes something. Merriam-Webster  confirms that the etymology of the word, profession, includes the Latin for “public declaration.”

The Hippocratic Oath, probably penned by members of the Pythagorean sect, according to Ludwig Edelstein (see Ancient Medicine: Selected Papers of Ludwig Edelstein. Baltimore: Johns Hopkins University Press, 1987), has for centuries been accepted as the gold standard for the practice of medicine. Nigel M. deS. Cameron (The New Medicine: Life and Death After Hippocrates. Chicago: Bioethics Press, 2001)
 explicates the Hippocratic Oath as containing four parts:

1.   Covenant with Apollo and others

2.   Duties to teacher

                            Regard teacher as equal to parent

                            Treat him as a partner in livelihood

                            Share money with him when needed

                            Consider his children as siblings

                            Teach medicine to own children, children of teacher, and pupils who take the oath

3.  Duties to patients

                            Use treatment to help the sick, never to injure or wrong them

                            Give no poison to anyone though asked to do so, nor suggest such a plan

                            Give no pessary to cause abortion

                            In purity and in holiness to guard the practitioner’s life and art

                            Use no knife on “sufferers from stone,” but allow others trained to do so

                            Enter houses to help the sick, not to participate in wrong doing or harm

                            Keep oneself from fornication with woman or man, slave or free

                            Not to divulge, but guard as holy secrets those things that are heard by the practitioner

4.  Sanction

Oath-taking by medical students has increased in the last 50 years, as reported by Neil Chesanow, in “Is it time to retire the Hippocratic Oath?” Medscape, 25 Jan 2017.  The form of oath taken by medical students has also changed. Many schools have re-written the oath in “updated” language, and a good number of students craft their own.

Do they swear not to have sex with their patients? Do the medical students or newly minted physicians now swear not to give poisons or pessaries? What oaths are taken in those states where physician-assisted suicide has been made legal? It would be good for the public to know. Perhaps it is time for physicians to post on their walls (actual and virtual) exactly what it is they profess to be and to do.

 

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.

 

Conflicts of Interest in unsuspected places

Patient advocacy organizations — groups such as the American Cancer Society, the American Diabetes Association, the Arthritis Foundation — are non-profit organizations that seek to help patients with a specific disease or disorder by providing services to patients, sponsoring research, influencing government and insurance policy, and promoting and promulgating guidelines that are followed by doctors and patients to diagnose and treat disease. They are sometimes viewed as altruistic voices for powerless patients, providing a necessary counterweight to evil (or at least uncaring) government regulators and policymakers who are only interested in saving healthcare dollars at the expense of helpless sick people.

A study from this week’s JAMA Internal Medicine suggests the picture may not always be so clear. The study authors surveyed a random sample of leaders from 7800 or so patient advocacy organizations. 68% of them reported receiving funding from for-profit industry groups including pharmaceutical, medical device, and biotech companies. About 10% reported receiving more than half of their funding from industry sources, and 8% of respondents “perceived pressure to conform their positions to the interests of corporate donors.”

Patient advocacy organizations are “influential health care stakeholders.” They have accomplished many unarguably beneficial advances for patients. But part of their positive influence is due to the perception that they are not entangled in the financial conflicts of interest which have been so well-documented among physicians, physician specialty societies, and clinical guideline authors. And in my experience, this perception has sometimes led patients to insist on following the recommendations of an organization that knows little of their personal circumstances rather than following the recommendations of their personal physician. For the sake of transparency and good patient care, it is important to ensure that these organizations, which maintain that they speak for patients’ interests, are not beholden to the interests of companies whose aim is to benefit financially from those same patients.

 

 

 

 

 

 

(DISCLAIMER – It is sheer coincidence that a blog post about Conflicts of Interest is appearing on the same day as the Presidential inauguration.)

Party politics, people’s lives

As health care financing rises yet again to the top of our national legislative agenda, some fundamental questions ought to be strongly considered. First, and most fundamental: Is some level of healthcare a right, that the government is therefore obligated to protect? Is it better viewed as a common good, like roads and fire protection services, that everybody pays for through taxes and everybody benefits from? Should it be treated as a luxury item, like large-screen TVs and designer clothing, that only those who can afford it get to enjoy?

Other important questions: What are the strengths and weaknesses of the current system of financing health care? Who does it benefit? Who does it harm? What will be the effects on patients, intended and unintended, of changing the current system? Who will benefit, and who will be harmed by those changes? What will be the effects on physicians and health insurance companies? How will any changes affect the patient-physician relationship, for good or for ill?

Is the free market the best way to finance health care? Or is it best publicly financed? Or some mixture of both? Why?

A most important question is, How does the system treat the most disadvantaged, the poorest, the most helpless or down on their luck, and the ones who need it the most? How should it treat them?

What should the ideal health care system for patients look like? Can we start moving towards that ideal? How?

Other fundamental questions will no doubt present themselves to the reader. However, instead of questions like the ones above, it seems that the following questions are being debated instead: Which party and which president designed the system we have now? If it’s not my party, how can we get rid of the current system (and who cares if we have nothing to put in its place, let’s repeal it anyway)? How can we protect our party (whichever one it happens to be) from the political fallout that will occur as changes are made? What does the ideal health care system for my party look like?

I have many patients who have benefited from the most recent changes to the system. I have others who are starting to feel the downside of those changes. For patients, it is not primarily about parties or presidents, but about their health, their lives, and whether they are treated with dignity by the health care system. Health care financing will always be expensive, and therefore contentious. But our contentions should be based primarily on concern for patients. Recent legislative discord on the subject seems to stem not from concerns about what is best for patients, but what is best for political party power.

Another election, another round of health care reform

Now that we Chicagolanders don’t have the World Series to distract us anymore, we have to go back to thinking about the upcoming election. Health care financing is of course one important issue in the presidential race. One side wants to repeal and replace the Affordable Care Act (aka Obamacare), the other wants to keep it and work to fix it. Whoever wins, it’s evident that changes are coming.

Archie Cochrane wrote a book in 1972 called Effectiveness and Efficiency: Random reflections on health services. The book was commissioned to evaluate the National Health Service (NHS) in the UK. An article about this book was published in the journal Medical Humanities last month, and a sentence from the article caught my eye:

Cochrane describes three different kinds of output from the NHS: ‘freedom from worry about the cost of medical treatment and care,’ ‘increased equality [of health care] between social classes and between different parts of the country’ and ‘improved care for those who cannot look after themselves.’

I don’t anticipate that we’ll be setting up a system anything like the NHS anytime soon. But as changes are made to the way health care is financed in this country, these three “outputs” or principles of Archie Cochrane’s would be a good start for sound and moral targets to aim for. There are still many, many people in this country who avoid getting necessary health care or taking their medications because of worry about the cost; there are large inequalities in health care between those of different socio-economic groups; and many of those who can’t look after themselves are discharged from hospitals to live on the street every day. However we decide to finance health care in this country, definitively addressing the plight of these groups is a moral obligation, and seems far more ethically compelling than protecting the interests of large companies or political parties.

The surprisingly small benefit of some very (expensive) Big Ideas

Last week, JAMA published online a Viewpoint provocatively titled, “What Happens When Underperforming Big Ideas in Research Become Entrenched?” The overarching Big Idea to which the article refers is the “narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health.”

The article highlights three technologies that are integral to the Big Idea but that have not lived up to their promise. The first is genetics/genomics; as an example of unfulfilled promise, the authors trenchantly observe, “Sixty years after the discovery of the genetic defect, no targeted therapy has emerged for sickle cell anemia” — one of the simplest genetic diseases, caused by a single gene. The second is stem-cell therapies; the authors point out one analysis of studies of stem cell therapies, in which the supposed effectiveness of the therapy was directly proportional to the number of factual discrepancies in the published study. The third is electronic health records (EHRs), which have cost billions, but have not realized either the improved care and cost savings that were their major selling point.

Despite the lack of evidence of real benefit, these three technologies have received vast amounts of NIH and government monies. The article recommends changes such as the “NIH should fund many more high-risk, unconventional ideas instead of supporting the same familiar highly funded research fronts.” It also calls for accountability for funded studies to show real benefit.

The article’s title asks what happens when underperforming big ideas become entrenched — vast amounts of money and energy are wasted — and suggests solutions. But the article does not address why those Big Ideas have become entrenched in the face of all evidence, and this must be addressed before solutions can work. I do not pretend to have a definitive answer. But I think there is an even Bigger Idea that overlies all of these lesser ideas: the idea that more technology is inherently good, and in higher-tech medicine will be our salvation.

For example, look at those things that have been shown to make “transformative improvements” in mortality, morbidity, and life expectancy: Quitting smoking. Getting off the couch and doing a bit of exercise. Eating your fruits and veggies. Getting immunized.

Now, which sounds more exciting for research funding: stem cells that we confidently assert can cure Parkinson’s even though we can’t quite prove but it’s pretty obvious that they should, or finding ways to get more grocery stores into poor neighborhoods whose most affordable food source has golden arches in front of it?

Testing, testing: Prenatal genetic screening

The June 2016 issue of Obstetrics and Gynecology includes a study of the conversations between patients and “Health Care Providers” about prenatal genetic screening (PGS). The objective of the study was to “assess how obstetric health care providers counsel patients regarding prenatal genetic screening and how these conversations influence patients’ screening decisions.” PGS refers to blood and ultrasound tests performed early in pregnancy to determine whether a fetus is at high risk for various chromosomal anomalies, especially the anomaly that leads to Down syndrome. Several findings of the study are troubling.

First troubling finding: providers’ counseling of patients about PGS lasts an average of 1.5 minutes.

Second troubling finding: False-positive rates of PGS are discussed so rarely that they could not be reliably analyzed in the study. The false-positive rate refers to how often the screening test is wrong when it suggests that an abnormality is present; when a test says the baby has Down syndrome, but the baby in fact does not have Down syndrome, it is a false-positive. The guidelines of the American College of Obstetricians and Gynecologists suggest that false-positive rates ought to be discussed in counseling about PGS.

But counseling about false-positive rates is itself troubling. The false-positive rate of PGS is somewhere around 5%. Most of us hear this and think, “OK, 95% of the time the test is right when it says that the baby has Down Syndrome.” However, to answer the question, “What percentage of the time is a positive test correct?” you can’t look at the false-positive rate; instead, you have to know something called the Positive Predictive Value. And for PGS, the positive predictive value is only 10%. That means that 90% of the time when PGS says “Down syndrome,” the baby does not have Down syndrome. (Numbers are higher for cell-free fetal DNA testing; however, this test is fraught with its own problems, and the study under consideration here did not include this test.)

Third troubling finding: In 51% of the discussions analyzed, health care providers did not clarify the fact that PGS is not diagnostic. PGS is a screening test, not a diagnostic test. The difference is crucial. Since 90% of abnormal PGS tests are wrong, an abnormal test requires a follow-up procedure to actually make a diagnosis. That follow-up test is usually an invasive test involving a needle into the uterus and a small chance of causing a miscarriage. I have known of several women who didn’t understand the screening nature of the test when they had it performed; when the test came back showing high-risk for a genetic abnormality, they then refused the more definitive diagnostic test. The result was either they spent their entire pregnancy in needless anxiety until the child was born without the anomaly, or they aborted the child on the basis of a false test result.

Why is all of this so troubling? Because medical tests are a big deal. Our understanding — or misunderstanding — of the results of medical tests shape how we see and understand ourselves. And PGS medical tests are a bigger deal than most; because if the results of this study are true, parents are frequently getting cursory explanations (1.5 minutes) from “providers” who give inadequate information about PGS tests. They are then using that (mis)information to make life-or-death decisions for the children they carry. If we’re going to practice eugenics, we should at least make sure that we’re doing so in a fully-informed fashion.

Medical errors and more medical errors

Last week the BMJ reported that annually, there are 251,000 hospital deaths due to preventable medical errors in the US. There’s some debate about the calculations that they used to arrive at that number, and about what exactly constitutes a medical error. However, rather than quibble over the fine points, let’s acknowledge that medical errors are an ethical problem that must be addressed. In this post I would like to widen the conversation beyond the hospital walls. Below is a sample of some deaths due to preventable medical errors that weren’t included in the BMJ calculations (most of these ones happen outside of hospitals); nevertheless, they too affect thousands of people annually. I will also attempt to provide a taxonomy of the relevant errors.

Deaths due to the inability of the patient to obtain medical care because they couldn’t afford the care or the insurance — unknown number. The medical error here is a systemic one, the rationing of health care on the basis of who can pay for it.

Deaths of patients due to their being the subjects of human research — unknown number. This is peculiarly prevalent among embryonic patients (as Jon Holmlund wrote about last week). The medical errors include the failure to extend to embryonic research subjects the protections enumerated in the Declaration of Helsinki. There is also a category error: classifying embryonic patients as something other than human beings.

Deaths of embryonic or fetal patients through elective induced abortion — 977,000 (2014 data). The same category error as previous comes into play here: the failure to recognize the humanity of the unborn human.

Deaths of patients from drugs prescribed by their physician for the purpose of suicide — the numbers data is incomplete. The number is relatively low but projected to grow as more jurisdictions legalize physician-assisted suicide. The errors here include a professionalism lapse (forgetting that the professional status of medicine was established, among other things, on the dictum that doctors do not give deadly drugs, even if asked to do so). There is also the error of hubris: the belief that doctors can decide that someone should be allowed to kill themselves.

Preventable medical errors, all.

“The Enormity of the Moral Mission of Medicine”

As I write, Paul Kalanithi’s book When Breath Becomes Air sits atop the New York Times Bestseller List. I highly recommend it. It is beautiful.

This book was written by a dying man. All books are, I suppose, but this author knew with more certainty than most that his time was short. Paul Kalanithi was finishing a grueling neurosurgery residency and on the cusp of a brilliant career when he discovered he had advanced lung cancer. In this book, written during the last months of his short life, he tells his story, a story of his search for meaning. He initially looked for meaning in the study of words, as he collected degrees in English and history and philosophy. But he discovered that meaning is not just read about, but lived, lived in relationships with others. As he thought about relationships, words, minds, and the brains through which words and minds are expressed, he writes that he “couldn’t let go of the question: Where did biology, morality, literature, and philosophy intersect?” The answer wasn’t to be found, for him, in the classroom: “. . . I found myself increasingly often arguing that direct experience of life-and-death questions was essential to generating substantial moral opinions about them. Words began to feel as weightless as the breath that carried them. . . It was only in practicing medicine that I could pursue a serious biological philosophy. Moral speculation was puny compared to moral action.”

And this illustrates one of the great strengths of the book: the profound understanding that medicine is at its heart a moral practice. Kalanithi writes of “The enormity of the moral mission of medicine . . .” He pursued one of the most technical of specialties, neurosurgery, yet he did not let the technical aspects obscure the moral core of medicine, the patient-physician relationship. As he writes, “When there’s no place for the scalpel, words are the surgeon’s only tool.”

As he explores the moral practice of medicine, Kalanithi writes insightfully of informed consent, not as “a juridical exercise in naming all the risks as quickly as possible . . . but an opportunity to forge a covenant with a suffering compatriot.” As a neurosurgeon he writes of the experience of life and death from the bedside. He learns that “the physician’s duty is not to stave off death or return patients to their old lives, but to take into our arms a patient and family whose lives have disintegrated and work until they can stand back up and face, and make sense of, their own existence.”   Then he receives his own terminal diagnosis, and writes eloquently of his experience of life and impending death from the patient’s bed. The ending of the book, along with his wife’s epilogue, is deeply, deeply moving, but not maudlin.

(Quotes from pp. 32, 43, 44, 87, 88, and 166)

 

The End of Meaningful Use: A Meaningful Opportunity

The Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt said Monday that 2016 would likely see the end of the meaningful use program. Meaningful use is a carrot-and-stick government program designed to get medical providers to use electronic health records (EHRs) and to set standards for using them. The carrot: medical providers who show compliance with meaningful use regulations get incentive payments from the government. The stick: those who do not are assessed financial penalties (257,000 received penalties in 2015).

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The latest Mayo Clinic study on physician burnout shows that in 2014, 54.4% of physicians admitted to at least one symptom of burnout. This is up from 45.5% in 2011. In the non-physician population, the number is about 25%.

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Why the burnout? Lots of reasons, but a major one is that many doctors are spending a lot of time doing things that are not just peripheral to what we went into medicine for, but inimical to it.

When I decided to go into medicine almost thirty years ago, I wanted to do work that didn’t involve sitting in front of a computer all day. My father was a computer systems analyst, and while he brought home cool stuff from the office, I wanted to work with people. So I chose medicine. And somewhere along the way, something changed.

Like many doctors, over the years I found myself spending more and more of my patient care time staring into a computer screen. This in and of itself might not have been so bad, except that it was time taken away from the time I used to spend looking at my patients: looking them in the eye, observing the subtleties of their body language, watching how they breathe or fidget or tremor. And increasingly, the time in the computer was spent doing things that satisfied “Meaningful use” standards, but in no meaningful way improved the care I was providing to the person in the room; in fact, it detracted from care by taking the finite resource of the time I spend with patients and wasting it on irrelevancies. Instead of serving patients, doctoring began to feel like serving the machine, responding to its needs in preference to the needs of patients. Unsurprisingly, a lot of doctors feel this way.

Serving machines instead of people: a good recipe for burnout. The CMS may finally be figuring that out.

Meaningful use was based in part on the blind faith that technology is good, so more must be better. That’s why, in Andy Slavitt’s words, it “reward[ed] doctors for the use of technology.” Think about that: a program that rewards doctors not for improving patient care, or fostering better patient-physician relationships, or making contributions to medicine, but for . . . using technology. Might as well pay us for using smart phones.

Current EHRs have been designed (from all appearances, without knowledge of what physicians actually do in the office) to facilitate increased billing  and to meet meaningful use. Getting rid of meaningful use is an opportunity to completely redesign EHRs — using what physicians actually do as a guide — to make them a useful adjunct to the practice of medicine, rather than a burnout-promoting waster of colossal amounts of time; to enhance (or, at the very least, not detract from) the patient-physician relationship; and to put the patient rather than the technology back at the center of what physicians do.

This may require hefty changes, the complete rethinking and redesigning (maybe scrapping) of current EHR systems. This could be disruptive; but sometimes, when you make a mistake, the best thing to do it to go back and erase it and start over. And if change resulted in doctors getting back to being doctors, I think most of us would welcome it. As Slavitt said on Monday, “We have to get the hearts and minds of physicians back. I think we’ve lost them.” Using this opportunity to completely rethink and overhaul EHR systems is a good way to see that happen.