Getting to Yes

In an insightful new book, medical anthropologist Sharon Kaufman persuasively delineates the forces that lead older patients to “yes.” Despite all the rhetoric about shared decision-making, about patients making choices based on their personal values and preferences, an interlinked series of powerful forces conspire to shape that “decision.” It’s not surprising, according to this compelling account, that invasive technology is used so extensively in older patients, with the threshold for what is considered old constantly rising.

The first step, in Professor Kaufman’s account, is that the scientific establishment, fueled by NIH and increasingly by private industry (medical device makers and pharmaceutical companies), develops ever more sophisticated, potentially life-extending technology. If the FDA finds the technology to be “safe and effective,” then Medicare, the insurer for virtually every person over age 65, will by and large pay for it. Once payment is assured, the technology quickly moves from being “acceptable” to being the “standard of care.” After all, surely whatever is on offer must surely be advisable. And if it might prolong life, and it’s free (or almost free), why not? Finally, the families who will often be the ones to administer or monitor the technology if patients avail themselves of it, and who will take mom or dad to the hospital when something goes wrong, find themselves in a position of feeling morally required to support the technology’s use. Sometimes that even means donating a kidney or resigning one’s job.

Kaufman concludes that there’s no simple fix to a health care system that relentlessly provides more and more to older and older people, regardless of cost and despite its burdens. Simple “decision aids,” with their focus on rational choice and clear depiction of risks and benefits, cannot possibly counteract the “ethical field,” the social, cultural, and market-driven environment in which patients along with their families and their doctors operate. But I think there is a ray of hope. And it may be a brighter ray than what Kaufman proposes, which is that if only we understood the complicated underpinnings of today’s reality, an understanding that she goes far to advance, we would be in a better position to change that system. 

I suspect that her linear model of the forces propelling us towards ever more technology in medicine—the scientific enterprise, the FDA, Medicare, societal norms, and patient/family morality—is actually more complex. It’s very likely a series of feedback loops, with each factor influencing and being influenced by all the others. Yes, scientific discoveries and technological inventions, when their efficacy is demonstrated in clinical trials, lead to Medicare reimbursement. But the awareness on the part of the device manufacturers and the drug companies of the circumstances under which Medicare will pay for their products also shapes what avenues of inquiry they pursue. Yes, patients’ understanding that Medicare will pay for a device or a procedure shapes their view of the standard of care. But patients’ expectations also influence Medicare’s coverage decisions.

If the health care system is even more complex than “Ordinary Medicine” suggests, doesn’t that make reform even more hopeless? Not necessarily. Precisely because the current system is sustained by multiple feedback loops, it may be possible to effect change by applying pressure on a single lever that operates in multiple loops. That lever is the Medicare program. We may not be able to reform capitalism or to change the tendency for patients to assume that whatever is paid for by health insurance constitutes necessary care. But we just might, someday, be able to modify Medicare.

The Deciders

Shared decision-making has become something of a sacred cow in medicine, even though few physicians actually practice it. There is certainly evidence that patient participation in discussions about their health care and patient engagement in self-care lead to better outcomes, as well as to greater patient satisfaction. Promoting patient autonomy requires that patients play a role in shaping their fate. So some kind of patient involvement is decidedly a good thing. But shared decision-making, I argue in an article just published in the Journal of Medical Ethics, needs to be re-engineered for it to work in practice.

To be sure, not everyone means exactly the same thing by shared decision-making. But most of the definitions look like this one, offered by a leading proponent and expounder of the model: shared decision-making is an approach in which the patient receives information about available treatment options (including their risks and benefits), the clinician and the patient consider each one in light of the patient’s situation, goals, and preferences, and the two parties jointly select the best option.

The focus of all this deliberation is the selection of a treatment. Which treatment to provide is what the doctor needs to know. And the reason for involving patients in the decision-making is that, unlike in selecting which antibiotic to use in the treatment of pneumonia, which is strictly a technical decision, deciding whether to use chemotherapy or radiation for the treatment of cancer, or whether to use fourth line chemotherapy or hospice for treatment of cancer when it progresses to a very advanced stage, depends on the patient’s values. But what I suggest in my essay is that respecting patient autonomy requires eliciting those values. Once the doctor understands the patient’s goals, once he or she knows what is most important to the patient, that information constitutes data that goes into the decision about treatment along with other data involving outcomes, side effects, and probabilities. To ask the patient to draw conclusions about which treatment is best, rather than to have the doctor make a recommendation based on a whole raft of information that includes the patient’s input about goals and values, makes no more sense than providing a patient with data about antibiotics and then expecting a patient to select which antibiotic he should take for his pneumonia.

I argue that despite several decades of work seeking to overcome the barriers to shared decision-making—barriers such as cognitive biases, innumeracy, and health illiteracy—and despite evidence that sophisticated decision aids can help patients, most doctors and patients don’t like the conventional approach to shared decision-making and don’t use it. Even medical ethicists who believe strongly in honoring patient autonomy and who have traditionally advocated shared decision-making balk when they themselves or their family members develop cancer and the physician tries to implement shared decision-making. 

The approach I advocate doesn't go back to the older paternalistic model in which physicians decree and patients obey; rather, it reformulates the way shared decision-making takes place by suggesting that what needs to be shared is the process of determining the patient’s goals of care, not the process of deciding how to translate those goals, along with other highly technical information, into a treatment decision.

Kissing Consent

Last week was a tough week for humankind. My heart goes out to the hundreds of refugees and would-be immigrants who drowned trying to flee oppression, war, and poverty, and to the thousands of Nepalese who died or lost everything just because they were in the wrong place at the wrong time. But I also ache for the 78-year-old Iowan man accused of rape—and mercifully exonerated—after being intimate, in some form or another, with his demented wife.

It’s always dangerous to discuss a case based exclusively on information from the media or arguments based in court. So I won’t presume to know what actually happened in the nursing home between Mr. and Mrs. Rayhons in her nursing home bed. But I do worry about the well-being of all those who have dementia. And I think that seeking to deprive people with dementia of one of the few pleasures they may still be able to experience in life is tragic.

The pundits have been pontificating that the Rayhon case is all about informed consent. But is it? Since when is informed consent required for anything other than a medical procedure or a research study? The case seems to me to be more about the quality of life of individuals with diminished cognitive capacity and the medicalization of society than about consent.

Informed consent is a tremendously important concept in medical treatment and medical research. One hundred years ago, future Supreme Court Justice Benjamin Cardozo ushered in the modern era of informed consent when he stated forcefully that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body”—and that performing surgery without consent was assault and battery.

The need for informed consent, and the devastating consequences of performing medical experiments without it, were brought home after World War Two, when Nazi experimentation on hapless prisoners was revealed. The Nuremberg Code, promulgated in 1947 in response to the horrors inflicted in the name of science, established voluntary consent as essential to the ethical conduct of research. A mere twenty years later, the anesthesiologist Henry Beecher divulged to the American medical community that research without informed consent was occurring with alarming frequency. As a result, a regulatory framework was put in place to assure ethical conduct by physician investigators, at least among those applying for NIH funding of their work. Voluntariness is the bedrock of informed consent. But what does all this have to do with intimacy between two members of a married couple?

Not much. Sexual intercourse is not a medical procedure. Deciding whether or not to engage in intimacy is not like deciding whether to participate in medical research. It is something that is normal and expected within the context of the marital relationship. Nor do we expect people with Alzheimer’s disease to sign an informed consent form before they have dinner, acknowledging that they are aware of the risks and benefits of the meal they are about to eat. We don’t ask people with Alzheimer’s disease to formally agree to wear a coat when it’s cold out. What business do doctors, nurses, and nursing home administrators—let alone courts and juries—have interfering in the private relationship between two adults? To be sure, not all sexual relationships are voluntary, even within a marriage. People who have dementia are vulnerable and need protection against abuse. But to apply the standard of informed consent to everyday life, a standard meant for people undergoing cardiac catheterization or surgery, or for taking experimental medications of no proven benefit, is profoundly misguided.

We need to broaden our view of how best to approach people with dementia to go beyond a narrow focus on safety. Of course  physicians and nurses and social workers want those in our care to be safe. But many vulnerable older people do not consider safety their paramount concern. They would rather take the risk of falling than be confined to bed. (It’s worth noting that while conventional restraints do not necessarily prevent falls and are in fact associated with injury, surely it would be possible to tie people down using four-point restraints in such a way that they could not possibly get up and fall.) They would rather live on their own, even though they might become ill and have no one with them, rather than forgo their independence. The interest of many, quite likely most, frail or demented older people, is in maximizing their quality of life. And that means interaction with other human beings.

We know that people with dementia experience emotions long after they have lost much cognitive function. We know they respond to a smile or a hug even if they cannot tell you the full name and birth date of the person who is hugging them. Surely to deprive people with dementia of the possibility of intimacy if they are fortunate enough to be in a relationship with a loving spouse, is cruel and unusual punishment. There are other, better ways to protect the vulnerable.