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February 1, 2013 Volume 77, Number 2
Informed Consent and Shared Decision-Making Colleen E. O’Leary, M.D. Committee on Professional Liability

Karen B. Domino, M.D., M.P.H., Chair Committee on Professional Liability



A 28-year-old ASA Physical Status 1 female soccer coach underwent knee arthroscopy for anterior cruciate ligament repair under uncomplicated general anesthesia. A femoral nerve block was performed for postoperative pain relief using ultrasound guidance. The patient developed a femoral neuropathy, requiring surgical lysis of adhesions, with persistent weakness. After a year, she filed a malpractice claim alleging inadequate informed consent for the nerve block. The anesthesiologist had discussed the block but did not document the informed consent discussion or the risk of nerve damage or persistent weakness. A settlement of $65,000 was made on behalf of the anesthesiologist.

Informed Consent
Obtaining informed consent is an ethical obligation of the practice of medicine and a legal requirement per statute and case law in all 50 states. Patients have the right to make decisions regarding their well-being without coercion from others. Informed consent requires a thoughtful dialog between physician and patient wherein sufficient information is offered so that the patient can make an educated decision. Unfortunately, physicians often do not share the information patients need to make an informed decision.

What constitutes “sufficient information”? Twenty-five states and the District of Columbia use the “reasonable person” standard (i.e., what a reasonable patient would consider pertinent in making an informed decision), and 23 states use the “professional practice” (i.e., what another physician in the community would disclose under similar circumstances). The laws in the remaining two states are vague.1

The required elements of informed consent are shown in Table 1. The informed consent discussion should focus on the indications for the proposed treatment, a description of the procedure in terms a layperson can understand and an explanation of available alternatives. A frank disclosure of material risks of the recommended and alternative treatments is important. Material risks are those that a reasonable person would want to be made aware of before deciding to undergo or reject the recommended therapy. Material risks include those that occur frequently but have little long-term consequence, as well as those that are rare but may result in serious, long-term morbidity or mortality. For example, in the consent discussion for a femoral nerve block, frequently occurring risks include block failure, infection and local pain/discomfort. Rare material risks include nerve damage/paralysis, seizures and coma/death. Unfortunately, many anesthesiologists fail to mention rare risks in the informed consent discussion.2 Not only are material risks required to be disclosed, failure to disclose may increase liability.3

Role of Informed Consent in Medical Malpractice Claims
Differences between physicians and patients in expectations of outcome of procedures often result in litigation. Inadequate informed consent is an important underlying factor that can lead to perceptions of medical malpractice. Although lack of informed consent is rarely the sole reason for a lawsuit, it becomes an issue when associated with a poor outcome, as in the above case. In the closed claims database, inadequate informed consent was an issue in 10 percent of claims against anesthesiologists. The lack of informed consent contributed to the settlement of the claim in which care was otherwise appropriate (as in this case). In addition, up to two-thirds of low-severity claims involved inadequate informed consent, resulting in high defense and indemnity costs. These findings demonstrate a substantial opportunity to reduce low-severity claims by improving the informed consent discussion.

Documentation
Informed consent must be documented in the medical record. Methods include a note in the medical record, a separate preprinted anesthesia consent form (required by some hospitals, states and liability insurers), an anesthesia section on the preprinted surgical consent form, or new interactive computer programs or decision aids.

An easy way to document the specific discussion is to document specific risks in the preoperative or anesthetic record. A preprinted anesthesia consent form can be clearly detailed in an efficient documentation process. Patient-specific risks can be added in long hand. Use of the preprinted surgical consent form does not eliminate the need for an anesthesia informed consent discussion by the anesthesiologist. New interactive computer programs may provide the best evidence that a meaningful exchange of information has taken place between the patient and physician.

Shared Decision-Making
Shared decision-making is a new approach to informed consent that empowers and engages patients in treatment decisions. It actively elicits patients’ preferences and understanding of benefits, risks and alternatives in decision-making. The elements of shared decision-making are shown in Figure 1. Shared decision-making can improve physician-patient communication in the informed consent discussion, in addition to providing liability protection to physicians. Communication failure between physicians and patients is an important element associated with medical malpractice.4,5

Summary
Informed consent with appropriate documentation of the discussion and specific risks is an ethical and legal requirement. Failure to disclose material risks and poor documentation of this discussion can have adverse medico-legal consequences. New methods such as shared decision-making or computerized interactive programs may enhance physician-patient communication and patient understanding of risks, benefits and alternatives.



Colleen E. O’Leary, M.D. is Professor and Vice Chair, Department of Anesthesiology, SUNY Upstate Medical University, Syracuse.

Karen B. Domino, M.D., M.P.H. is Professor of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle.


References:
1.  Studdert DM, Mollo MM, Levy MK, et al.: Geographic variation in informed consent law: Two standards for disclosure of treatment risks. J Empir Leg Stud 2007; 4:103-24.
2. Brull R, McCartney C, Chan V, et al.: Disclosure of risks associated with regional anesthesia: a survey of academic regional anesthesiologists. Regl Anesth Pain Med 2007; 32(1):7-11.
3. Domino KB: Informed consent for regional anesthesia: what is necessary? (Editorial) Regl Anesth Pain Med 2007; 32(1):1-2.
4. Hickson GB, Clayton EW, Githens PB, et al.: Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 1992; 267(10):1359-63.
5. Vincent C, Young M, Phillips A: Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994; 343(8913):1609-13.