Chapter 3: Informed Consent

Intro

Introduction

Although informed consent is legally required, many physicians are skeptical because patients can never understand medical situations as well as doctors and because they can usually persuade patients to follow their recommendations. In some situations, however, therapeutic options differ dramatically in terms of their side effects and impact on the patient, and no option is clearly superior.

In these situations, there is no best approach, and the patient’s values and preferences will be decisive. This chapter discusses the definition of informed consent, its justification, its requirements, and problems with informed consent. In some complex decisions, physicians should go beyond the minimum legal requirements of informed consent to promote shared decision making with patients.


Case 3.1. Mastectomy or lumpectomy

Ms. B was a 58-year-old woman who was found to have a small breast cancer, stage T1N0M0. Her surgeon recommends mastectomy and informs her of the benefits and risks of the operation, including side effects such as lymphedema of the arm. The surgeon says that a less extensive operation may not remove all the tumor. Ms. B’s daughter searched the Internet for information about breast cancer and learned that her mother’s cancer could also be effectively treated with lumpectomy plus radiation therapy, which would avoid disfiguration and lymphedema.

Ms. B’s surgeon needs to discuss alternatives to the mastectomy he is recommending. Because lumpectomy plus radiation therapy has fewer complications and equivalent long-term outcomes, it needs to be offered. Physicians’ recommendations should be supported by published evidence and evidence-based guidelines. Even if Ms. B’s surgeon believed that mastectomy was the best approach, he still should inform her about the option of lumpectomy plus radiation therapy and tell her that it is recommended in evidence-based guidelines.

He can then explain why he thinks mastectomy is better for her. The surgeon should not expect Ms. B or her daughter to take the lead in asking about alternatives to mastectomy. From the patient’s perspective, the Internet may be an invaluable source of information about cancer treatments. The National Cancer Institute, the American Cancer Society and medical school websites offer reliable information.


Evidence-based practice guidelines recommend breast-conserving surgery for early breast cancer. Survival and disease-free survival are similar for mastectomy and for lumpectomy plus radiation. The percentage of women who receive breast-conserving surgery, however, varies strikingly by geographical region, and many women may not participate in decisions regarding surgery to the extent they wish [1]. Before a mastectomy, the legal duty of informed consent requires surgeons to disclose the nature of the operation, its risks, and the alternatives. Case 3.1 illustrates, however, that a narrow vision of informed consent, while meeting legal standards, may result in suboptimal patient care decisions.

What is Informed Consent?

Discussions about informed consent are often confusing because people use this term in different senses.

Agreement with the Physician’s Recommendations

Patients usually agree with physicians’ recommendations, particularly in acute illness or injury, when the goals of care are clear, one option is superior, the benefits are great, and the risks are small. For example, a patient who suffers a wrist fracture needs a cast. A patient with a severe exacerbation of asthma that has not responded to inhaled bronchodilators needs systemic corticosteroids.

In such situations, informed consent seems tantamount to obtaining the patient’s agreement to the proposed intervention because there are no medically sound alternatives. Physicians often speak of “consenting the patient,” implying that it is a foregone conclusion that the patient will agree, and indeed almost all patients do agree.

Right to Refuse Interventions

Patients have an ethical and legal right to be free of unwanted medical interventions and bodily invasions. Many early court cases associated with consent involved patients who had undergone surgery or invasive procedures and suffered serious adverse effects.

The patients claimed that they would not have agreed to the intervention had they been told about these risks. Legally, competent patients must be informed of the risks of the proposed care and have the right to reject their physicians’ recommendations. This right to refuse also extends to noninvasive care, such as diagnostic tests and medications.

Choice Among Alternatives

More broadly, patients should have the positive right to choose among medically feasible options, in addition to the negative right to refuse unwanted interventions. For instance, Case 3.1 involves a choice between two different types of surgery. This case also illustrates that patients or families may obtain medical information from sources other than the physician and may consider options that the physician has not mentioned.

Shared Decision Making

A still more comprehensive view is shared decision making by the physician and the patient [2]. Both parties play essential roles in clinical decisions. The physician has medical knowledge and judgment. Patients know their values and preferences, for example, what risks and side effects are acceptable. Shared decision making is a back-and-forth process. The physician can also help educate patients, correct misunderstandings, help them deliberate, make recommendations, and to try to persuade them to accept the recommendations [2], [3].

Shared decision making is a continuum [4]. The physician may simply explain the medical options or may also make a recommendation based on the patient’s goals and values. Or the patient and physician may be equal partners and deliberate together. In informed dissent, the patient may reject the physician’s plan or agree tacitly. Finally, the physician may decide about predominately technical issues, keeping in mind that patients or surrogates may have preferences regarding apparently value-neutral aspects of care or want to be involved in them. Patients may have different preferences for decision-making procedures for different decisions or at different times.

Reasons for Informed Consent and Shared Decision Making

Several ethical and pragmatic reasons justify a broader conception of informed consent [5].

Respect Patient Self-Determination

People want to make decisions about their bodies and health care in accordance with their values and goals. One court declared, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body [6].”

Patient choice should be promoted because in most clinical settings, different goals and approaches are possible, outcomes are uncertain, and an intervention might cause both benefit and harm [7]. Individuals place different values on health and the risk of medical interventions. Some patients are wary about the side effects of treatment, while others want to try risky therapies that have a higher probability of achieving desirable outcomes.

Most women choose lumpectomy because it is less disfiguring and has fewer side effects. For some older women, however, conservation of the breast may be unimportant and returning for 6 weeks of radiation therapy may be burdensome. Physicians might not accurately predict patients’ preferences. Doctors and patients often disagree on treatment preferences [8]. For example, patients with newly diagnosed cancer are more likely than physicians, nurses, and the general public to prefer intensive chemotherapy with little chance of cure.

Enhance the Patient’s Well-Being

The goal of medical care is to enhance patient well-being, which can be judged only in terms of the patient’s goals and values. The patient’s values are particularly important if various treatment approaches have very different characteristics or complications and involve trade-offs between short-term and long-term outcomes, if one option carries a small chance of a serious complication, if the patient has strong aversions toward risk or certain outcomes, or if there is uncertainty and disagreement among physicians [9].

The choice between mastectomy and lumpectomy/radiation in Case 3.1 has many of these characteristics. In addition, participation in decisions might have other beneficial consequences for patients, such as increased sense of control, self-efficacy, and adherence to plans for care.

Requirements for Informed Consent

Ethically and legally, informed consent requires discussions of pertinent information, obtaining the patient’s agreement to the plan of care, and freedom from coercion [5].

Information to Discuss with Patients

Physicians need to discuss with patients information that is relevant to the decision at hand (Table 3-1). Most court decisions and legal commentaries use the term disclose, and, when summarizing legal doctrine, this book also uses this term. In general, however, we prefer the term discuss to emphasize that a dialog with the patient is preferable to a monolog by the physician.

Table 3-1.Information to Discuss with Patients

  • The nature of the test or treatment
  • The benefits, risks, and consequences of the intervention
  • The alternatives and their benefits, risks, and consequences

Patients must be told the nature of the intervention, the expected benefits, the risks, and the likely consequences. Risks that are common knowledge, already known to the patient, of trivial impact, or very infrequent do not need to be discussed. For instance, patients do not need to be told the risks of venipuncture. For invasive interventions, courts have ruled that physicians need to discuss rare but serious risks, such as death or stroke.

Patients also need to understand the alternatives to the proposed test or treatment and their risks, benefits, and consequences. In particular, alternatives that are recommended in the medical literature and by evidence-based consensus guidelines need to be offered, even if the physician personally disagrees. The alternative of no intervention needs to be discussed. If a patient declines the recommended intervention, the physician needs to explain the adverse consequences of the refusal. In a case where a woman refused a Pap smear, the court ruled that the physician needed to discuss how the test could diagnose cancer at an early stage and avert death through early treatment [10].

The extent of disclosure will depend on the clinical context. For conditions such as appendicitis or fracture, where there is only one realistic option and it is highly effective, relatively safe, and strongly recommended, a detailed discussion of alternatives offers little benefit to patients [11]. However, the physician still needs to tell the patient the nature of the treatment, the risks, and the consequences, such as the course of convalescence.

Physicians must take the initiative in discussing information rather than wait for patients to ask questions. Patients might be uncomfortable asking questions or not even know what questions to ask. Discussions about the proposed test or treatment and the alternatives should be conducted by the attending physician or by the physician performing the intervention.

It is controversial whether physicians need to inform patients of alternatives for care that they do not believe are medically indicated. Obviously, physicians do not need to mention treatments that have no scientific rationale, would provide no medical benefit, or are known to be ineffective or harmful. However, physicians should inform patients of alternatives that other reasonable physicians would recommend, particularly if there is strong evidence of effectiveness and safety.

Some kinds of information that the law does not require be disclosed may still be ethically desirable to disclose, as the following case illustrates [12].


Case 3.2. Disclosure of prognostic information

Mr. A was a 50-year-old man who, after resection of a carcinoma of the pancreas, was recommended to have adjuvant chemo- and radiation therapy. He had indicated to his oncologist that he wished “to be told the truth about his condition.” The doctor told him that the therapy was unproven, that most patients with pancreatic cancer die of the disease, and that there was a serious risk of recurrence. He died a year later, and his family sued, claiming that had he been told outcomes data, he would have declined chemo- and radiation therapy and put his business affairs in order.

At the time, adjuvant chemo- and radiation therapy were unproven. The California Supreme Court ruled that physicians did not need to give patients statistical data on outcomes. “Statistical morbidity values derived from the experience of population groups are inherently unreliable and offer little assurance regarding the fate of the individual patient.”

Based on Arato v. Avedon, 858 P.2d 598 (Cal. 1993)

Although the courts do not require physicians to offer to present outcomes statistics to patients, there are good ethical reasons to do so. Although it is true to statistics cannot predict what will happen in a particular case, they do provide estimates of the likelihood of outcomes. Physicians can always discuss with patients the features of the individual case that make it likely that their prognosis is better or worse than the numbers in the literature.

Public health experts and evidence-based guidelines are now advocating that patients calculate individualized probabilities of outcomes to help them guide decisions about their care. The Framingham cardiac risk index and the World Health Organization fracture risk tool are available online for patients to use to guide their decisions regarding treatment of cardiac risk factors or treatment for osteoporosis.

This case illustrates how ethical standards for informed consent may be higher than legal requirements.


After resection for pancreatic cancer, the 5-year survival rate is about 20% for patients with clear surgical margins and negative nodes. Quantitative information may be material to patients’ decisions, notwithstanding the court’s ruling. Physicians can explain why an individual patient might be expected to do better or worse than average. Even if not legally required, it is ethically desirable for physicians to provide such information to patients.

Other information may also be ethically desirable to discuss, although not legally required. The hospital’s and surgeon’s experience might be pertinent to a patient’s decision, because increased volume is associated with significantly better outcomes for some operations and surgeons have a “learning curve” for new procedures. For example, the mortality for pancreatic resection is over 12% higher in low-volume hospitals than in high-volume hospitals [13].

Similarly, patients might find it pertinent to know the outcomes of a surgical procedure at a given institution or by a particular surgeon, not outcomes reported in the literature. Some states make such surgeon- and hospital-specific, risk-adjusted outcome data for coronary artery bypass surgery publicly available [14]. For cardiology procedures, it was recommended that patients receive information about clinician and institutional outcomes, with benchmark comparisons, or, at a minimum, information about experience and procedure volumes [15].

Although some courts have ruled that physician-specific experience needs to be disclosed for some operations, other courts have not [16]. The majority of surgical patients regard it as essential to their decision to have surgery knowing the surgeon’s experience with a highly innovative procedures [17]. Another issue that many patients might find pertinent is the role of trainees in their care, particularly with invasive or surgical procedures, as Chapter 36 discusses.