Since the late 1960s, a growing body of evidence has suggested the chances that patients truly understand what they are consenting to in informed consent documents are not only unlikely but “remote.”1 A review of 70 studies conducted in a variety of clinical settings demonstrated that, although consent and refusals were legally and institutionally valid, they failed to result in “genuinely autonomous decision making.”
Factors associated with such outcomes included low socioeconomic status, poor education, old age, lengthy hospital stay, stress, language barriers, and misinterpretation of probabilistic data. Accompanying disclosure practices were also found inadequate, though perfectly legal.
Research by the National Quality Forum (NQF) revealed that, despite having signed a consent form, 18% to 45% of patients are unable to recall even the major risks associated with their surgeries. Many cannot answer basic questions about the services or procedures they agreed to receive, while 44% do not know the exact nature of their operation, and most (60% to 69%) do not understand or read the information contained in generic hospital consent forms.2 Treating patients such as these can lead to compromised care and safety and increased medical malpractice risk.
Many bioethicists endorse the position that “striving for fully informed consent is generally unfeasible and perhaps even undesirable.”– Others argue that the concept of fully informed consent should at least serve as an ideal. For that to be achieved, patients would need to understand fully their conditions and treatment. At a minimum, then, and as law, patients have the right to be given information that will optimize their autonomy.3-6 That information includes:
- The nature of the procedure or treatment being offered, including whether it is diagnostic or therapeutic;
- The risks and potential complications of a procedure or medical treatment;
- The benefits of the procedure; and
- Treatment alternatives, along with their risks and benefits.7
The ideal is far from reality. Frequently cited factors interfering with full comprehension, in addition to those already mentioned, include personal or cultural beliefs and low health literacy rates.1,2 Providers’ inability to communicate clearly in a rushed environment is also a factor, as is a tendency for providers who see the act of acquiring informed consent as a legal formality to delegate to a junior colleague.
But “the patient’s consent happens during the process of dialogue with the surgeon,” wrote Bernat and Peterson in the January 2006 Archives of Surgery:8 “The signature on a surgical consent form is merely the culmination and formalization of this preceding consent discussion and agreement.”
A signed consent form represents evidence of the patient’s consent—not of his or her understanding. That signed form may not be sufficient to protect providers in cases of liability. According to Jury Verdict Research, informed consent issues are among the top 10 most common reasons patients file malpractice claims.2
The low health literacy of almost half of adults in the United States limits their ability to understand the basic health information and services that are needed to make appropriate health decisions. In fact, articles in two of the July 2006 issues of the New England Journal of Medicine, as well as the entire August 2006 issue of the Journal of General Internal Medicine, are devoted to the subject of health literacy.9-11
Given that surgeons and other specialists are often responsible for securing informed consent, what are the areas of informed consent to which hospitalists should be attuned?