More realism about informed consent

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• Acknowledgment
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In “Some realism about informed consent,” Carl Schneider challenges the tenability of applying standard legal and bioethical notions of informed consent to clinical practice. Schneider’s argument is twofold. First, he asserts that clinicians rarely elicit complete informed decision-making from patients. Second, he proposes that “even if doctors devoted themselves lavishly to educating patients, many patients would spurn the gift of autonomy courts and ethicists want for them.” This work will address Schneider’s challenges and introduce a third challenge that uncovers how clinicians, executing proper informed consent, can still usurp their patients’ choices. In response to these challenges, I will offer a brief account of how informed consent can reasonably be applied to clinical practice. Although Schneider also discusses informed consent in the research context, I will restrict my comments to informed consent in clinical medicine.

Schneider begins his argument regarding the impracticality of applying standard conceptions of informed consent by way of the quantification by Braddock et al¹ of how poorly physicians elicit informed choices from patients. Indeed, despite a likely Hawthorne effect¹ and modest criteria for completeness of informed decision-making,¹ only 9% of clinical encounters met criteria. Schneider suggests that “when a reform has long been widely advocated and still falls short, we should ask why the reform is unachieved and whether hopes for it are realistic.” Informed consent as a robust process of fully informing patients and facilitating the synthesis of patient beliefs and values is not yet a clinical reality. Why clinicians are not embracing this process is multifactorial, but the reasons likely include such factors as prioritization of physical outcomes over abstract principles, the belief that the proposed intervention will result in greater patient satisfaction, a tradition of paternalism, and role models who have not incorporated informed consent into daily practice. But for the simplest explanation, we need only follow the money.

Clinicians work within a system of reimbursement that punishes those who spend time talking with patients and rewards those who perform procedures. Financial disincentives to adequately informing patients in the acquisition of consent function in at least 2 ways. First, to physicians, spending time discussing benefits and burdens results in their seeing fewer patients, getting home later, or taking of shortcuts to clinical care. In this way, the practice of informed consent constitutes additional uncompensated—or, at best, poorly compensated—services physicians are being asked to provide.

The second financial disincentive to physicians promoting informed patient decision-making is most easily appreciated in the surgical specialties. In a “patient as decision-maker” model, not only must surgeons spend time explaining the frightening risks of surgery, but they must then spend more time putting these risks into perspective and reassuring patients. This can result in patients’ delaying or even forgoing surgery altogether. Additionally, patients in the process of becoming informed may return for another office appointment to review the risks and reconsider the surgery. Although another office visit may be financially worthwhile for a physician in a nonsurgical specialty, a major financial function of a surgery clinic is to set up highly compensated surgical procedures. The data presented by Braddock et al hardly represent physicians’ profound philosophical objections to informed consent. A conscientious surgeon earning $20,000 less than last year on account of his or her completely informing patients—that is some realism about informed consent.

The widespread reluctance of clinicians to adopt the practice of informed consent is real, but we must remember that the results published by Braddock et al do not speak to the tenability of eliciting informed consent. The factors working against informed consent outlined above perhaps ought to mitigate our current expectations of clinicians. But neither these data nor the aforementioned factors constitute an argument against the long-term feasibility of achieving informed patient decision-making. Rather, as Schneider rightly proposes, they suggest a need to identify and examine barriers to proper consent.

Schneider complements his first, clinician-based argument with a second, patient-based argument that, given the opportunity to make their own medical decisions, “many patients would spurn the gift of autonomy.” He cites the work of Ende et al² demonstrating that although patients have a high affinity for clinical information, they have a low affinity for clinical decision-making. Schneider goes on to explain patients’ reluctance to make clinical decisions by asserting, “It’s not just that people’s values are often undeveloped. It’s that people have trouble predicting even relatively simple preferences… .” I agree that patients may not have a full array of well-developed values, or even hold consistent ones, but they certainly know when their values have been offended. How many patients with low desire for decision-making would respond favorably to their doctor’s making a decision they do not like?

I interpret Ende et al’s findings regarding patients’ weak overall desire for clinical decision-making yet strong overall desire for information to mean that patients very much want to be empowered by information, even if they do not want to exercise that power. My experience is that many patients do not participate actively in clinical decision-making until they feel the need. Ende et al’s respondents are, I believe, expressing their trust and respect for clinicians’ expertise while expressing their reluctance to turn over complete control of their health care. How would the cohort described by Ende et al score on a scale in which 100 is “I want final say over what happens to my body” and 0 is “I want no say”? Informed-consent requirements enjoy considerable public popularity on the basis that patients overwhelmingly want the power and security that such requirements engender. A real function of informed consent, I propose, is the safeguarding of patients from the power differential that traditionally gave doctors the final say.³ This aspect of informed consent serves a valuable purpose and must be preserved.

Although Schneider’s second argument is somewhat convincing of a conclusion that applying a robust conception of informed consent to all patient interactions is unrealistic, it does not support his claim that patients reject medicine’s promotion of their autonomy. Even Ende et al’s study title, “Measuring patient’s desire for autonomy…”, is a misnomer, for choosing a mode of decision-making is itself a choice. Electing to trust your physician’s recommendation is often a legitimate expression of autonomy. Nevertheless, Schneider makes the invaluable point that the courts and the bioethics community ought to reflect the reality that many patients wish to exercise their autonomy by way of a less robust form of consent—for instance, by simply trusting the doctor. Schneider’s claim that many patients are incapable of engaging in a more robust form of consent raises many questions. Unfortunately, a full treatment of this claim is beyond the practical scope of this work.

In The Practice of Autonomy, Schneider⁴ presents a third, potentially fatal challenge to the meaningful application of informed consent. The following overzealous appeal to patient autonomy depicts how clinicians may misuse the patient-as-decision-maker model. A physician recalling his days as a patient wrote, “My doctor asked me who I wished to be referred to: an orthopedic surgeon, a neurologist, a rheumatologist, etc. I did not know. All I wanted was to be told what was wrong and what should be done about it.”⁴ Which decisions ought to involve patients and which ought to remain exclusively with clinicians may be debated. Nevertheless, the manipulation of patient autonomy described above is misguided. Exploiting the zeitgeist, medical residents increasingly disguise a lack of medical knowledge by offering patients choices. Ordering computed tomography or magnetic resonance imaging, prescribing amoxicillin or azithromycin, palpating for hepatomegaly or asking further questions—are these patient decisions?

Clearly, dozens of decisions go into every clinical encounter. Braddock et al somehow identified an average of 3 per clinic visit.¹ It would be impossible to discuss the benefits and burdens of every decision made in the context of a clinic appointment, much less throughout a hospitalization. Which decisions are made available to patients is itself an important clinical decision. Ultimately clinicians must exercise judgment with regard to which decisions are likely to hinge on values and desires. The problem is that not only will such a judgment be forever underdetermined, but also that the clinician’s ability to withhold particular options and even whole decisions appears to undermine the power and security that informed consent hoped to guarantee patients. Ironically, a popular saying among clinicians explaining risks to patients is “There are no guarantees in life.” In this case, perhaps the best we can expect of clinicians is that they exercise sound judgment and adhere closely to community standards regarding which decisions typically involve patient input.

I accept Schneider’s challenge of “an honest, realistic, and modest reconsideration of the implementation of informed consent.” I agree that our laws, policies, and professional opinions ought to reflect what can realistically be expected of informed consent in clinical practice. A reasonable theory, and practice, of informed consent must account for patients’ choosing to forgo active participation. Moreover, informed consent in the clinical context must accommodate the many ways in which patients choose to make medical decisions. For some patients, informed consent is the robust process of patient-driven decision-making that maximally incorporates patient beliefs and values. For others, it is an expression of blind faith in their physician’s recommendations. And for most, informed consent is a combination of the two. Empirical data describing the proportion of patients wishing to make decisions to varying degrees supports the commonsense notion that patients are a heterogeneous bunch. As such, there will always be some distribution between 0% and 100% of patients wishing to exert some degree of control over 0% to 100% of clinical decisions. I take seriously the notion that clinicians ought to afford even a minority of patients wishing to take charge of their medical decisions the power to do so.

Whether the current legal or bioethical literature support it, many patients and physicians are already employing flexible forms of shared decision-making that work. The “physician as tour guide” model likens physicians to the American Automobile Association, designing routes from point A to point B based on where patients are and where they want to go. Patient-centered models have physicians maintaining an open invitation for patient participation in clinical decision-making to whatever degree, within reasonable limits, the patient desires at that time. But no model of informed consent is a panacea: Clinicians will fall short of completely informing patients; patients will make suboptimal medical decisions, even with full information; and clinicians will exercise their own judgment, occasionally failing to adhere to community standards, when deciding which choices to offer patients. Nevertheless, informed consent as a process that encourages meaningful conversations between patients and their physicians is perhaps what we ought to have envisioned from the start.

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I thank the following people for their honest and timely feedback: Dr Jeffrey Kahn, Dr Lilah Suzan Ekim, Dr Richard Satin, Dr Chris MacDonald, Dr Greg Gepner, Dr Nancy Baker, Dr Mark Fefergrad, Alicia Hall, and Rebekah Tempest

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References 

1. Braddock CH , Edwards KA , Hasenberg NM , Laidley TL , Levinson W . Informed decision making in outpatient practice (time to get back to basics) . JAMA . 1999;282:2313–2320
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2. Ende J , Kazis L , Ash A , Moskowitz MA . Measuring patients’ desire for autonomy (decision making and information-seeking preferences among medical patients) . J Gen Intern Med . 1989;4:23–30
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3. Katz J . The silent world of doctor and patient . New York: Free Press; 1984;
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4. Schneider CE . The practice of autonomy (patients, doctors, and medical decisions) . Oxford, UK: Oxford University Press; 1998;
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