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Let the Patient Drive the Informed Consent Process: Ignore Legal Requirements

Waisel, David B. MD

doi: 10.1213/ANE.0b013e31821bfc1f
Editorials: Editorials
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From the Department of Anesthesiology, Perioperative and Pain Medicine, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts.

Supported by the Department of Anesthesiology, Perioperative and Pain Medicine, Children's Hospital Boston, Harvard Medical School.

The author declares no conflicts of interest.

Reprints will not be available from the author.

Address correspondence to David B. Waisel, MD, Department of Anesthesiology, Perioperative and Pain Medicine, Children's Hospital Boston, Harvard Medical School, 300 Longwood Ave., Boston, MA 02115. Address e-mail to David.Waisel@childrens.harvard.edu.

Accepted March 21, 2011

In the April 2011 edition of Anesthesia & Analgesia, Tait and colleagues1 report that parents of children receiving elective surgery had inadequate recall of the anesthesia informed consent discussion. Similar to authors of other studies showing inadequate recall, they concluded that the lack of recall reflected in part an inadequate disclosure of information.

I worry about how anesthesiologists will interpret this study. Lack of recall does not indicate incomplete disclosure of information, impaired decision-maker comprehension, or inadequate decision-maker consent. Information can be used in one moment and forgotten in the next. (I point to signing my mortgage agreement as exhibit A.) Unfamiliar events impair retention. Elevated cortisol levels in certain situations relevant to the informed consent process impair working memory and retrieval of memories.2 I suspect the most likely reason for poor recall was that the information was irrelevant to the parents or that the disclosure was too cluttered with pro forma information.

But more concerning are 2 messages inherent in recall studies. First, to declare disclosure content inadequate falsely assumes an unwavering standard of disclosure content (as compared with a standard of disclosure process). Second, readers may erroneously infer that disclosure is the primary, if not sole purpose, of the anesthesia informed consent discussion. These misunderstandings thwart the informed consent process.

Routine anesthesia informed consent is obtained in situations that differ from most other consent situations. Patients and families rarely use the informed consent process to decide whether to have anesthesia; at most, decisions center on choosing available anesthetic options consistent with receiving surgery. Other differences often include no prior relationship with the anesthesiologist, the beginning of therapy within minutes of obtaining consent, and the inability to test a therapy (as in trying medical therapy). These situations are particularly odd because they occur during clinically elective care.

These circumstances challenge whether anesthesiology should accept the standard requirements for informed consent. There is precedent for regarding operating room relationships as different. For example, most of the initial approaches to perioperative do-not-resuscitate orders involved replicating the ward procedure-based orders. But restrictions on mask ventilation, intubation, and cardiopulmonary resuscitation clashed with the nature of intraoperative care. Perioperative do-not-resuscitate orders were then modified to the more successful goal-directed orders, which encourage patients to guide therapy by describing in plain language their reasons for pursuing surgery and their desires for postoperative care.

I would propose the same is true with informed consent for anesthesia. Given that anesthesia consent is rarely used to decide whether to receive anesthesia, the primary purpose of anesthesia consent should be to meet the needs of the decision makers (which I will use to mean patients, parents, and other surrogates). Some decision makers want reassurance. Some want brisk efficiency. Some want to know everything whereas others only want to know their choices.

Individual preferences for the extent of information disclosed vary. A gross summary of the literature suggests that approximately 10% of decision makers prefer not to know information that most would assume is legally recommended, such as rare but significant complications.3,4 Preferences for the decision-making process also vary. Literature broadly suggests that a quarter of patients want patient-based decision making, a quarter of patients want physician-based decision making, and half of patients want shared decision making.58

As an aside, evaluate informed consent studies cautiously. For example, a study by Garden et al.9 compares informed consent forms of minimal, standard, or full information. Sixty-four percent of the subjects who had only seen the minimal form felt it was “just right.” After seeing all 3 forms, however, only 37% felt that the minimal form was “just right.” Some authors concluded that patients prefer more rather than less information. But that does not mean that the minimal form was inadequate. Furthermore, the percentage that thought the standard form provided “too much” information doubled (13% to 26%) and the percentage that thought the full information form provided too much information tripled (20% to 64%). Perhaps the only valid conclusion from the study is that patients' preferences vary.

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AN INFORMED CONSENT PROCESS FOR MEETING THE NEEDS OF THE PATIENT

Anesthesiologists should seek to develop a standardized informed consent process driven by the need of the decision makers and the characteristics of the perioperative procedures.

Decision makers initially should be given only necessary information. Necessary information includes the events that will prepare them for the postoperative period (e.g., postoperative nausea and vomiting, sore throat), the presence of options that will affect the perioperative experience, and other clinically significant information. Rote listing of complications clutters the process, obscures more relevant matters, is ethically unnecessary, and may bore the patient (the average attention span for an adult is 15 to 20 minutes).10 Of course, as the relationship between the anesthesiologists and the decision makers develop during the interview, anesthesiologists may deem other information necessary. For example, particularly nervous parents in need of reassurance may benefit from being informed about the rare risk of death.

“Clinically significant information” means information that decision makers may want to use for decision making. This information frequently includes (1) anesthetic options that offer advantages but have different or greater risks, and (2) concerns of sufficient frequency and harm that anesthesiologists believe should be considered in decision making. Although a precise definition of “clinically significant information” is difficult, I would suggest that anesthesiologists recognize this level of information in specific cases. Clinically significant information is palpable to the anesthesiologists.

After disclosing necessary information, anesthesiologists should ask decision makers if they want more information. Additional information may include a fuller description of the risks and benefits of options that affect the perioperative experience. Options that affect experience occur preoperatively (e.g., premedication), intraoperatively (e.g., regional versus general anesthesia), and postoperatively (e.g., peripheral nerve catheter versus patient-controlled parenteral analgesia).

For example, the parents of a healthy 5 year old having a herniorrhaphy do not need to be initially informed about the rare (hence nonpalpable) risks of injury to vocal cords, postoperative ventilation, severe adverse drug reactions, or brain damage. Knowledge of these risks will not affect decision making and will not prepare parents for postoperative care. The parents may then be asked if they wish to learn about rare but significant risks.

Although part of this model limits the amount of information initially offered, this model promotes highlighting relevant information. For example, if the same child had an upper respiratory infection, anesthesiologists would be obligated to discuss the (palpable) risk of bronchospasm to help the parents decide whether to proceed.

For subtler examples, consider a child who received an angiotensin-converting enzyme inhibitor the morning of elective surgery despite the local policy to withhold angiotensin-converting enzyme inhibitors on the day of surgery. Although the anesthesiologists may think it is acceptable to proceed, they would be obligated to inform the parent about the policy and the reasons why they recommend proceeding. Informing the parent about this dissonance is necessary in large part because the clinical concern is sufficiently relevant to develop a policy. Or consider the decision whether to insert a thoracic or lumbar epidural in a child. These approaches likely have different risks and benefits in terms of insertion, postoperative analgesia, and classes and concentrations of drugs infused. Parents can be included in these decisions to the extent they desire.

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LEGAL ISSUES

The beloved but deadly physician rarely gets sued. Meeting the needs of the decision maker by tailoring the informed consent probably decreases the risk of being sued.1113 Indeed, litigation regarding the anesthesia informed consent process is rare in the absence of clinically negligent events. Informed consent liability is determined by whether a reasonable person would have chosen differently had they known that information. Although having a signed document presents a rebuttable presumption that certain information was given, informed consent liability can result from decision makers feeling rushed or having unanswered questions. As Denner and Pellegrino14 tell prospective clients, “Simply signing a form does not mean you have given informed consent.”

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CONCLUSION

Anesthesiologists have minutes to establish an interactive relationship. Focusing on legal requirements suffocates the primary goal of the anesthesia informed consent process: to satisfy decision-makers' needs. Unfortunately, describing what decision makers want devolves into mockable platitudes.15 But that does not invalidate the description. Decision makers want someone who is kind, gentle, and caring. They want a doctor who works with them to meet their needs. Indeed, I suspect that the specific content of the informed consent process is secondary to most patients. Sincerity, genuineness, and the development of a patient-physician relationship are what count.

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REFERENCES

1. Tait AR, Voepel-Lewis T, Gauger V. Parental recall of anesthesia information: informing the practice of informed consent. Anesth Analg 2011;112:918–23
2. Elzinga BM, Roelofs K. Cortisol-induced impairments of working memory require acute sympathetic activation. Behav Neurosci 2005;119:98–103
3. Kain ZN, Kosarussavadi B, Hernandez-Conte A, Hofstadter MB, Mayes LC. Desire for perioperative information in adult patients: a cross-sectional study. J Clin Anesth 1997;9:467–72
4. Litman RS, Perkins FM, Dawson SC. Parental knowledge and attitudes toward discussing the risk of death from anesthesia. Anesth Analg 1993;77:256–60
5. Mazur DJ, Hickam DH. Patients' preferences for risk disclosure and role in decision making for invasive medical procedures. J Gen Intern Med 1997;12:114–7
6. Arora NK, McHorney CA. Patient preferences for medical decision making: who really wants to participate? Med Care 2000;38:335–41
7. Deber RB, Kraetschmer N, Urowitz S, Sharpe N. Do people want to be autonomous patients? Preferred roles in treatment decision-making in several patient populations. Health Expect 2007;10:248–58
8. Benbassat J, Pilpel D, Tidhar M. Patients' preferences for participation in clinical decision making: a review of published surveys. Behav Med 1998;24:81–8
9. Garden AL, Merry AF, Holland Rl, Petrie KJ. Anaesthesia information: what patients want to know. Anaesth Intensive Care 1996;24:594–8
10. Veatch RM. Implied, presumed and waived consent: the relative moral wrongs of under- and over-informing. Am J Bioeth 2007;7:39–41
11. Marco AP. Informed consent for surgical anesthesia care: has the time come for separate consent? Anesth Analg 2010;110:280–2
12. Caplan R. Informed consent: patterns of liability from the ASA closed claims project. ASA Newslett 2000;64:7–9
13. Cydulka RK, Tamayo-Sarver J, Gage A, Bagnoli D. Association of patient satisfaction with complaints and risk management among emergency physicians. J Emerg Med 2011 . [Epub ahead of print]
14. Denner JA, Pellegrino RD. Surgical Errors and the Problem of Informed Consent. Available at: http://www.dennerlaw.com/Medical-Malpractice/Surgical-Errors-and-Informed-Consent.shtml. Accessed February 16, 2010
15. Bendapudi NM, Berry LL, Frey KA, Parish JT, Rayburn WL. Patients' perspectives on ideal physician behaviors. Mayo Clin Proc 2006;81:338–44
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