On Shared Decision-making and Informed Consent

In the idealized concept of shared decision-making, the physician and patient comprise a collaborative clinical decision-making dyad.¹ The physician contributes medical knowledge, training, experience, and judgment, whereas the patient contributes personal values and health care goals through which to evaluate how each treatment option could fulfill those goals. As partners, the patient and physician collaboratively achieve a mutually agreeable medical decision through an ongoing communication process that creates informed consent.²

Scholars have offered various definitions and metaphors to capture the essence of shared decision-making. One of us described it as the optimal blending of physician expertise and patient choice.³ Others depicted it metaphorically as a moving vehicle in which the patient serves as pilot and the physician as navigator⁴ or as the process of locating the optimum balance between physician power and patient choice.⁵

In this issue of Neurology: Clinical Practice, Lapides⁶ provides a clinically useful and ethically sound systematic approach to guide neurologists to achieve optimal shared decision-making when treating patients with autoimmune neurologic disorders, given the uncertainties of treatment efficacy and safety resulting from inadequate data. Neurologists who follow his approach fulfill a high standard of medical and ethical practice. In our commentary, we explore how shared decision-making has become the contemporary actualization of the older concept of informed consent.⁷

Historically, informed consent was delineated as a legal doctrine before it was analyzed as an ethical duty. Its requirements grew during a century of American legal cases because the locus of medical decision-making evolved from being physician-centered to patient-centered. Informed consent is composed of 3 essential elements that must be satisfied to become ethically valid: (1) the physician must convey adequate information to the patient, (2) the patient's consent must be obtained freely and without coercion by individuals or agencies, and (3) the patient must have the capacity to consent or refuse.²

Informed consent is a bidirectional communication process and not an event. Physicians must distinguish fact from opinion to allow patients to agree with the medical facts while possibly disagreeing with a treatment recommendation. Physicians have a duty to frame treatment decisions objectively without exaggerating risks or benefits which could be coercive.² Adequate information is that which a reasonable person needs to know to make a medical decision⁸ and includes treatment options, their basic risks and benefits, and the physician's recommendation. When the patient lacks decision-making capacity, the physician should establish the same dyad with the patient's lawful surrogate to make medical decisions on the patient's behalf.⁹ Elsewhere, one of us recently described the process of surrogate decision-making in incapacitated neurologic patients.¹⁰

The collaborative partnership of shared decision-making provides sufficient elasticity to flexibly accommodate widely differing levels of patients' desires to actively participate. All experienced clinicians know the tremendous variation among patients in their wish to take part in their medical decisions. At one extreme is the educated and assertive patient who wants to sit in the driver's seat and dictate exactly what tests and treatments to receive. Such patients may have read extensively and reached a high level of sophistication and a strong opinion. Here, the physician's role is reduced to that of a medical advisor and facilitator of the patient's wishes.

At the other end of the spectrum is the often older, sicker, and more dependent patient who trusts the physician to make all medical decisions because of the physician's knowledge, experience, and judgment. Here, the physician sits in the driver's seat. Although the physician may try to elicit the patient's preferences, the patient may simply respond, “I want you to take care of me and do whatever you think is best.” Most patients fall between these 2 extremes and share decisional authority. The art of medicine is in intuiting and satisfying which role each patient needs.⁵

Decision aids enhance shared decision-making, particularly in highly value-laden clinical decisions. High-quality decision aids are targeted, evidence-based, balanced, print, or video informational interventions that inform and assist patients by making their decisions clear, providing accurate information about diagnostic/treatment options and their resulting benefits/harms, and clarifying the match between patients' values and their clinical decisions.¹¹ A recent Cochrane Database of Systematic Reviews concluded that “people shown decision aids felt more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction.”¹¹ High-quality decision aids thus enrich shared decision-making and informed consent in complex clinical decisions.

Remaining challenges to shared decision-making include caring for patients who want an unproved therapy or one that conflicts with the physician's expertise or personal ethics. We agree with Lapides that shared decision-making does not require a physician to offer or order unproved therapies. Some patients elect not to follow a physician's recommendation and choose a disproportionately risky or less effective therapy. This choice should elicit a physician's inquiry about why the patient chose that particular course. If the patient offers adequate reasons, understands the risks and benefits, and if the choice is an accepted therapy for the condition, the physician generally should accede to the patient's choice. However, there are times a physician may find a patient's choice to be ethically unacceptable. One such example is a terminally ill patient who requests physician-assisted death where it is lawful, but whose physician regards it as unethical. Here, shared decision-making requires the physician to explore the reasons for the patient's choice, offer acceptable alternatives such as palliative care, and compassionately explain why the physician will not participate.¹²

Author Contributions

J.L. Bernat and M.P. McQuillen: drafting/revising the manuscript and analysis or interpretation of data.

Study Funding

No targeted funding reported.

Disclosure

The authors report no disclosures relevant to the manuscript. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp.