Abstract
Purpose
Patients must receive information in a manner that promotes understanding so they can make informed decisions about anesthesia and other medical interventions. Unfortunately, history is replete with examples of the negative consequences of inadequate disclosure of information and lack of patient understanding. While obtaining consent for anesthesia poses unique challenges, the ability of the anesthesiologist to engage the patient in meaningful discussion is critical as a means to ensure that the patient is truly informed. This narrative review aims to: 1) discuss the process of informed consent as it applies to anesthesia practice; 2) describe the salient issues related to patient capacity, disclosure, understanding, decision-making, and documentation of the informed consent process; and 3) discuss current strategies to improve the presentation and understanding of consent information.
Source
Review of the extant literature, including the authors’ own research.
Principal findings
Despite the ethical imperative of informed consent, many decision-makers have limited understanding of medical information. The reasons for this are multifactorial but often result from incomplete disclosure and presentation of generic information that does not take into account differences in information needs, values, and preferences of individual patients. Several simple strategies are available, however, that can enhance decision-makers’ understanding of both written and verbal information.
Conclusions
Despite the unique challenges of obtaining consent for anesthesia on the day of surgery, attention to the manner in which information for anesthesia care is provided and adoption of simple strategies to enhance understanding can go a long way to ensure that decision-makers are appropriately informed.
Résumé
Objectif
Les patients doivent recevoir de l’information d’une façon qui facilite la compréhension pour qu’ils puissent prendre des décisions éclairées sur l’anesthésie et les autres interventions médicales. Malheureusement, l’histoire déborde d’exemples des conséquences négatives d’une divulgation inadaptée de l’information et de l’absence de compréhension par le patient. Alors que l’obtention du consentement pour l’anesthésie crée des défis particuliers, la capacité de l’anesthésiologiste à amener le patient à participer à une discussion approfondie est un moyen essentiel qui permet de s’assurer que le patient est véritablement informé. Cette synthèse narrative vise à: 1) expliquer le processus de consentement dans le contexte de la pratique de l’anesthésie; 2) décrire les problèmes principaux, liés aux capacités du patient, à la communication, à la compréhension et la prise de décision, ainsi qu’à la documentation de la procédure du consentement éclairé; et 3) expliquer les stratégies actuelles pour améliorer la présentation et la compréhension de l’information sur le consentement.
Source
Synthèse de la littérature existante, y compris les recherches personnelles des auteurs.
Constatations principales
Malgré les impératifs éthiques du consentement éclairé, de nombreux décideurs ont une compréhension limitée de l’information médicale. Les raisons en sont multiples, mais aboutissent souvent à une communication incomplète et à la présentation d’une information générique qui ne prend pas en compte les différences dans les besoins d’informations, les valeurs et les préférences de chaque patient. Toutefois, quelques stratégies simples sont disponibles en vu d’améliorer la compréhension de l’information écrite et orale des décideurs.
Conclusions
En dépit des défis uniques que représente l’obtention du consentement à une anesthésie le jour de la chirurgie, une attention à la façon dont l’information concernant les soins anesthésiques est fournie et l’adoption de stratégies simples pour améliorer la compréhension peuvent faire beaucoup pour garantir que les décideurs sont correctement informés.
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“Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” So wrote Justice Benjamin Cardozo in his 1914 U.S. ruling regarding the case of Mary Schloendorff who had consented to examination under anesthesia of a suspected fibroid tumour, but not to its removal.1 At the heart of this classic case was a lack of informed consent, which set an important precedent for the way in which physicians are now required to disclose salient information to patients. Today, informed consent is the accepted mechanism for providing the patient with pertinent information that will allow them to make an autonomous informed choice.
Unique to anesthesia practice is the fact that the first meeting with the patient is typically on the day of surgery. In addition, unlike many other specialties, routine anesthesia does not involve a decision to treat or not to treat (i.e., anesthesia vs no anesthesia), but it may require involving patients in decisions regarding the type of anesthesia (e.g., general, neuraxial, or regional) and techniques for postoperative pain management. Uniquely, anesthesiologists often also provide anesthesia for procedures in which informed consent was obtained by others. As such, anesthesiologists may be liable if that informed consent is later deemed inadequate.2
While the decisions regarding anesthesia may appear less complex compared with other specialties; nevertheless, common challenges remain. For example, Waisel et al. identified several challenges in obtaining consent which anesthesiology trainees had acknowledged, including assessing the patient’s capacity to understand, time limitations, communication barriers, and the amount of information to disclose.3
Beauchamp and Childress4 have described three basic elements of informed consent that serve as the framework for this review:
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1)
Threshold elements (i.e., competence, capacity, and voluntariness in deciding);
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2)
Information elements (i.e., disclosure, recommendation of a plan, and understanding);
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3)
Consent elements (i.e., decision to consent [or to refuse], authorization). We would also add documentation of consent as an important component of this element.
While the focus of this review is primarily on anesthesia practice, the underlying principles are also relevant to the process of obtaining consent for anesthesia-related research.
Threshold elements (competence, capacity, and voluntariness)
Adult capacity for consent
Anesthesiologists not only must disclose salient information about the services to be provided, but they also must assess the patient’s ability to give consent. Competence and capacity are often used interchangeably; however, competence alone has a basis in law. Competence requires that the patient is able to understand the information offered, retain it, and use it to formulate an informed decision.2
Although there is no set consensus definition of capacity, some think that capacity should reflect the ability of the patient to understand, appreciate, reason, and make a rational unambiguous choice free from coercion.5 Although some jurisdictions allow for the presumption of capacity unless there are reasonable grounds to think otherwise,6 misconceptions can occur. This can result from insufficient time to assess the patient, the notion that a patient must have understood because they gave their consent, the need to expedite cases, and the lack of a valid tool with which to measure capacity.5
Anesthesiologists are often faced with patients of varying levels of decision-making capacity. These include those with permanent or fluctuating decisional impairments (such as dementia or delirium), those who are distracted with anxiety or pain, those who have temporary altered mentation as a result of preoperative self- or doctor-administered medications, and lastly, young children who may not have legal decision-making capacity.7 While it is common for patients to receive preoperative medications, on occasion, these medications may also be deliberately withheld in anticipation of obtaining consent. This practice may be potentially coercive in that patients might feel pressured to consent in order to obtain pain relief.
Although, it is well accepted that pain might diminish decision-making capacity and that pain medications may improve the ability to make decisions, this is likely dependent on the patient and/or the situation.8 One study showed that 68% of obstetric anesthesiologists considered women in active labour to be capable of providing consent for neuraxial anesthesia.9 Furthermore, studies have shown that labouring women are mentally capable of comprehending their anesthesia plan.7,10,11
Emergency settings also present a unique situation in that they may negate the ability to assess capacity and obtain consent. In general, anesthesiologists should provide as much information as the situation dictates, either to the patient or to the surrogate, but typically, informed consent for emergency care is based on the assumption that the patient would want to consent to life-saving care.
Given the wide variety of anesthetic, opioid, and anxiolytic drugs administered by anesthesiologists, residual effects of drugs can impact the retention of information both preoperatively and postoperatively.12-14 However, the data are somewhat equivocal. Lucha et al. found no correlation between valid measures of capacity and narcotic dose and that administration of narcotics did not impair the ability to consent.15 In another study, however, 64% of patients had little or no postoperative recollection of information give preoperatively.16 In yet another study investigating information recall in the immediate postanesthetic period, results showed that recall of new information given in the immediate postanesthetic period was poor, while delaying the information by 40 min resulted in improved recall.17 Regardless of these findings, the concerns that patients might not be able to retain information after anesthesia or that they may have impaired judgment as a result of opioids or sedatives reinforces the importance of assessing capacity and documenting the discussion (i.e., information disclosed, questions asked, and any issues related to understanding or reasoning) at the time of consent.
Child capacity for assent
In North America, unless a child is considered either legally emancipated (e.g., married, in the military, financially independent, etc.) or a “mature” minor, parents, as legal proxy decision-makers for their children, are required to give their permission for their child’s treatment together with the assent of the child. Although there has been some debate regarding the operational definition of assent,18 the Canadian Paediatric Society, Bioethics Committee19 and the American Academy of Pediatrics’ Committee on Bioethics20 have both issued position statements outlining the important concepts related to informed consent in pediatric practice, including parental permission, child assent, and dissent.
One difficulty expressed by physicians in seeking assent is determining when a child is capable of providing it. Although the maturity of the child is considered foremost in assessing the ability to assent, the statutory age at which children can provide their assent for treatment varies considerably within and between countries, ranging from 12-19 yr.21,22 In Canada, Quebec is the only province to have specified an age (14 yr) below which parental consent is required for treatment. The practical implications of such arbitrary cutoffs for assent, however, remain unclear. A survey of pediatric anesthesiologists found that only 12% would respect the wishes of a six-year-old refusing to undergo elective surgery, whereas 87% would do so if the reluctant child were aged 15 yr.23 Thus, the use of age cutoffs as criteria for determining child capacity is potentially discriminatory in that it ignores the individual child’s development and maturity. For example, Tait et al. 24 showed that there is considerable variation in children’s understanding of medical information even within age groups, suggesting that age alone as a criterion for capacity may not be an optimal metric. Indeed, some young children, particularly those who are chronically ill, may have an acute awareness of their condition and treatments, while many older children appear to lack simple decision-making ability.21 Thus, in the absence of any objective measure to assess the capacity to assent, it is important that the anesthesiologist communicates with the parent(s) and the child to determine if the child has a developmentally appropriate awareness of his/her condition and an age-appropriate understanding of the information.
Voluntariness
Although a patient may have the capacity to make a decision, it is important that the decision to consent (or not) is made voluntarily without undue influence or coercion from either the physician or family and friends. Beauchamp and Childress4 note that “a person acts voluntarily if he or she wills the action without being under the control of another person or condition.” In addition, Nelson et al. argue that it is important not only to recognize that an influence might exist but also to appreciate how the patient subjectively perceives that influence and the degree to which it controls their decision.25 In anesthesia practice, undue influence may manifest as persuasion, manipulation, or coercion. For example, while it may be perfectly appropriate for the anesthesiologist to offer an opinion, it is important for this to occur in the context of a balanced disclosure without manipulation of information (i.e., deliberately withholding, exaggerating, or misleading). An example of this might be withholding disclosure of the benefits of general anesthesia based on a desire to gain experience with a regional technique. Ultimately, of course, there can never be any suggestion of coercion, be it real or perceived, in making recommendations to the patient.26
Information elements (disclosure and understanding)
Formalizing disclosure
Although checklists, such as the World Health Organization’s Best Practice Protocols,27 might help guide the disclosure of information to patients, there are national and local-specific standards to which doctors may be held in a court of law. The most commonly applied standard in both statute and case law in Canada, the United States, and elsewhere is the reasonable person standard. This requires that disclosure be commensurate with what a hypothetical reasonable person would want in order to make a decision. 2,4 In Canada, this standard was upheld in the 1980 landmark case of Reibl vs Hughes.28 The legal standard for this approach is the “materiality” or significance of the information towards making a decision. In some cases, however, (as in Reibl vs Hughes) the reasonable person standard may be considered in concert with a subjective standard that examines what the patient “would have done” had they had more information. Regardless of how these standards are applied, it is important to remember that informed consent is a process and not simply a signature to satisfy legal requirements and, as such, should be driven by the patient and not by legal concerns.29
For routine anesthesia, there should be a basic discussion regarding the nature of the patient’s condition, procedures to be performed, risks, and consequences. This might include a description of how anesthesia will be administered (e.g., inhalational or intravenous) together with any potential risks (e.g., chipped tooth, sore throat, nausea and vomiting, etc.) and how postoperative pain will be managed. Nevertheless, for procedures that offer anesthetic options (e.g., epidural vs intravenous analgesia) or pose increased risks due to comorbidities, anesthesiologists may need to present a more detailed, yet balanced, explanation of the risks and benefits of each option so that the patient can make an informed decision based on the risk-benefit tradeoffs. Overall, however, these discussions should always follow the tenet of the reasonable person standard.
Although routine anesthesia is considered safe, serious life-threatening situations may occur unexpectedly, and thus, the question remains as to “how much” risk information to reveal to the patient. While discussions regarding the possibility of postoperative nausea and vomiting or post-extubation sore throat may be routine, current newsworthy topics, such as intraoperative awareness, postoperative cognitive dysfunction in adults, and learning difficulties in children, are less likely to be discussed. There is a fine balance between informing and scaring patients with information that may not be material to the decision at hand. Although studies show that decision-makers desire specific risk information, many anesthesiologists report uncertainty regarding the type and amount of information that patients require.3 Studies have revealed that doctors sometimes convey less information than they think they should, disclose information not considered important, and underestimate the amount of information that patients want.30-32 It is hardly surprising, therefore, that disclosure of anesthesia information may vary considerably amongst providers.33
Studies suggest that patients want information. In one study, 88% of patients desired information on postoperative pain, 77% on the different methods of anesthesia, and 63% on all possible complications of anesthesia.34 For children, Litman et al. reported that 75% of parents requested information on all possible anesthesia risks, including death.35 In another study, 96% of parents desired specific information on “all possible” anesthetic complications.36 Furthermore, one review found that patients’ preference for information increased when they preferred a more active role in decision-making.37
Although these studies suggest that most decision-makers want information about anesthesia, it is unclear how much they actually receive. Lagana et al. observed pediatric anesthesiologists during their consent discussions and noted that nausea and vomiting was discussed in only 36% of cases, sore throat in 35%, and emergence delirium in 19%.38 A quarter of the observed discussions involved only general statements about risk, and 30% of cases involved no discussion of anesthetic risk at all. In a survey of regional anesthesia practices, Brull et al. 39 found that common non-serious risks, e.g., headache and local pain, were frequently discussed, while the more serious but less common complications were infrequently disclosed, e.g., paralysis (43%), cardiac arrest (14%), and death (29%). Interestingly, while 74% of respondents reported that they disclosed these risks to inform the patient, 26% reported doing so primarily for medical-legal reasons. In another study, Bray and Yentis40 found that most patients thought that informed consent was necessary for specific “non-routine” airway procedures (e.g., fibreoptic intubation), while most anesthesiologists did not.
It is noteworthy that despite patients’ apparent desire for information, studies suggest that they are generally satisfied with the information they receive even if they don’t fully understand it.41-44 Interestingly, one study showed that a majority of patients randomized to receive one of three anesthesia information leaflets with “minimal,” “standard,” or “full” information judged the information they received to be “just right” until they were shown the other leaflets. On seeing the alternatives, approximately two-thirds of the patients thought that the information they had initially received was now either “too little” or “too much”.41
The belief that disclosure of information may negatively affect the patient’s psychological well-being has been cited as reason not to disclose the risk of potentially serious events.22 Indeed, because the perception of risk is often subjective or based on emotion, information may create anxiety that is not always rational. This view, however, appears outdated; recent studies suggest that the disclosure of risks associated with anesthesia might actually alleviate anxiety rather than increase it.45 This may occur because the provision of information may increase the patient’s perceived sense of control over their hospital experience.46 Recently, Tait et al. showed that 53% of parents reported that knowing the risks of anesthesia had no effect on their level of anxiety, and 39.4% reported feeling “less anxious”.45 Even patients who report significant levels of anxiety have been shown to desire risk information.47
Although the disclosure of a “laundry list” of risks is unnecessary for routine anesthesia for the healthy patient, disclosure of the likelihood and severity of risks needs to be tailored to the individual based on the patient’s preferences, comorbidities, and procedure. Siegal et al. 48 suggest the concept of “information on demand” as a means to discern the patient’s desire for information prior to disclosure. Green and MacKenzie49 emphasize the importance of information tailoring, stating, “It is ethically unsound to assume that one knows so much about the benefits of a technique that it trumps one’s moral obligation to respect a patient’s right to self-determination. That right can only be respected by a thorough elucidation of alternatives and exploration of the details of each patient’s unique circumstances.” As such, it is not merely sufficient to present the medical facts, but it is also important to consider non-medical facts, including patient preferences, values, and expectations. We live in an age of ever-increasing information availability, and information expectation is high. Patients have often researched their procedure and anesthetic options using internet search engines before their surgery, and thus, they deserve more than a few lines of information of possibly uncertain accuracy from Google® or Wikipedia®.
One important issue regarding disclosure involves the potential inclusion of trainees in medical care. In general, trainees, such as medical students or other paramedical staff, cannot examine or be involved in procedures on patients without the express understanding and consent of the patient. This is particularly important when the consent is obtained by someone other than the anesthesiologist performing the case. To mitigate some of these concerns, it is good practice to inform the patient that a trainee may be involved in their care and to outline the extent of the learner’s likely involvement. If possible, the trainee should be introduced to the patient with an assurance that the anesthesiologist will be in attendance at all times to supervise learner activities.
Understanding
Although many physicians do provide detailed information, it does not guarantee that patients will actually understand it. This becomes particularly important when options are presented requiring tradeoff decisions between competing risks and benefits. Despite our best efforts, however, many patients have difficulty recalling the information presented. In a study of consent practices in Spain, Rosique et al. 16 showed that 21% of patients who signed a required consent form did not read it, and two-thirds were unable to recall the information given to them by the anesthesiologist. The literature is also replete with examples where patients, parents, and research subjects were unable to recall or comprehend the information given to them by medical staff.17,50-54
There are many reasons why patients have difficulty understanding medical information, including insufficient time, anxiety, volume of information, use of medical jargon, poor physician communication, cognitive difficulties, age, low educational achievement, and poor literacy or numeracy skills. Cultural barriers to understanding also exist with respect to both language differences and levels of trust in the medical system. Functional illiteracy is frighteningly common in North America. In the U.S., the National Literacy Survey estimates that approximately 45 million American adults have below basic literacy,55 and in Canada, 42% of adults from the ages of 16-65 years have less than level 3 reading proficiency.56
Although it is unreasonable to expect that patients will have complete understanding of all the information presented to them, their failure to do so is not a good reason to question the importance of informed consent.57 Several studies have examined the effect of different strategies to improve the way in which medical information is presented and understood. A review of the literature58,59 suggests that these strategies fall into three primary categories:
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a)
enhanced consent forms
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b)
enhanced communication
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c)
video/multimedia presentations
Enhanced consent forms
Although anesthesia consent forms (if used) should never replace the physician-patient discussion, an understanding of what is needed to enhance the written word can often help enhance the spoken word. The effect that enhanced consent forms have on understanding has been described.58,60 In general, these strategies have focused on i) improved readability and simplified forms, ii) improved formatting and layout, and iii) the use of graphics. While these enhancements focus primarily on consent forms, they are equally relevant in preparing informational handouts or web-based information for anesthesia and pain management.
Readability/simplified forms
Despite the fact that most guidelines recommend simplifying the reading level of medical material, many consent documents are written above the abilities of most individuals. Text-heavy, poorly formatted consent documents can be very intimidating and are an impediment to comprehension. Forms that are easier to read are better accepted than conventional forms and may decrease anxiety;61 however, they do not always improve understanding.61,62 This suggests that it may not be sufficient to improve readability alone. Nevertheless, it would seem important to lower the reading level of any written information, if possible, to at least the eighth grade level. Readability formulae, such as the Flesch Reading Ease, Flesch-Kincaid,63 and SMOG64 (Simple Measure of Gobbledygook), are available within Microsoft Word® and on the internet, respectively.
Formatting and layout
Improved formatting can aid understanding. Dresden and Levitt showed improved understanding among asthma patients when using a consent form with simpler vocabulary, bullet points, and enlarged font.60 Another study, however, showed no improvement in parents’ understanding of a consent form that employed bolded headings and increased white space.65 Recently Tait et al. showed that modified consent forms with improved readability (reading level) and processability (format) resulted in greater overall understanding and acceptance by parents and children when compared with standard forms.66-68
Risk and benefit graphics
Although risks and benefits are the two most important elements that patients need to understand in order to make healthcare decisions, they are often misinterpreted.69,70 Perception of risk may be influenced by a number of factors, including an understanding of the probability and severity of the risk, a sense of vulnerability (particularly while anesthetized), familiarity with anesthesia, and general acceptability of medical processes.71 Poor numeracy is also an impediment to risk/benefit comprehension. Individuals with low numeracy are less likely to make decisions based on numbers than numerate individuals, choosing instead to rely more on emotion and trust in the doctor.72
Framing risks and strategies for risk communication are important in the perception of risk.73 Many individuals, for example, have difficulty converting numerical values into qualitative terms, such as “rare” or “common”, and vice-versa. Fagerlin et al. recommend several strategies, including presenting risks in absolute (e.g., 20% risk of nausea) rather than relative terms (e.g., 50% reduced risk of nausea) and presenting incremental risk (e.g., additional 5% risk of nausea) to highlight how a treatment might change risk over a preexisting baseline level.74 Furthermore, outcomes are typically perceived more favourably when presented as gains (e.g., surviving) rather than as losses (e.g., dying). Additionally, although the data are somewhat conflicting, risks and benefits may be better understood if presented as natural frequencies (e.g., one in 100,000) rather than as percentages.74
Graphical formats provide greater visual salience than text and require less cognitive effort. Graphical presentations of risks have been shown to aid the processing of quantitative information and to be particularly helpful to individuals with poor literacy and numeracy.75-79 Pictographs, in particular, have been shown to be superior to text and other graphical formats in presenting risk/benefit statistics.76-78,80
Verbal disclosure and communication
Good communication is the cornerstone of the informed consent process, but not all physicians are good communicators.81 High-quality concise verbal communication in plain language is particularly important for anesthesiologists given the narrow window of opportunity afforded for disclosure and the fact that many anesthesiologists do not use written consent forms. The importance of good communication has been verified in a number of studies.66 McGuire et al. reported that the use of a simplified language was helpful in improving recall when talking with older patients.82 Furthermore, good communication that includes encouragement in decision-making promotes active involvement in health, whereas inadequate information and time pressures discourage involvement.37 Thus, despite hospital pressures to expedite surgical turnover, sufficient time should be allotted for meaningful preoperative discussion with the patient. Furthermore, because anesthesiologists frequently obtain informed consent numerous times during the work week, there may be a tendency for the discussion to become mundane. We must never lose sight of the fact that the information is almost always novel and important for the individual patient.
Video or multimedia presentations
Visual perception has long been known to play a key role in learning. Visual perception drives conceptual processing and facilitates rapid absorption of complex materials.83,84 The pictorial superiority effect, the ability by which individuals remember concrete items more easily when presented as pictures rather than as words, has been reflected in the maxim “a picture is worth a thousand words” and is now founded in science.85,86 Technological advances in computer graphics and smart phone applications enable higher-quality interactive visual models that can convey medical information to patients in a coherent way. Several studies have confirmed the effectiveness of video and multimedia presentations in presenting information regarding knee arthroscopy,87 ankle fracture surgery,88 colonoscopy,89 and thyroidectomy.90 Presentation of preoperative videos and web-based material has also been shown to improve parent understanding of anesthesia and decrease their concerns.91 Recently, interactive multimedia computer-based programs have been shown to enhance patients’ understanding of cardiac catheterization,42 the risks and benefits of statins,77 and parents’ and children’s understanding of an asthma trial.92
Assessing understanding
Simply asking the patient if they understand the information provided may be insufficient, since individuals typically overestimate their level of understanding.24,52,93 This may be critical, since a lack of understanding can lead to misinterpretation of risks and an inability to follow the doctor’s orders and can reduce the patient’s ability to make an informed decision. As recommended by the Canadian Medical Protective Association (CMPA),94 one useful technique is to employ a “teach-back” approach wherein patients are asked to paraphrase the important elements of the information provided. Having the patient repeat the information and providing corrected feedback has been shown to result in greater recall of medical information.95,96
Consent elements (decision-making, authorization, documentation)
Decision-making
Despite a desire for information, many patients have difficulty with comprehension and consequently struggle with decision-making. Part of the problem is an inability of some physicians to engage the patient in the decision-making process and inadequate disclosure of material information. Patients may also have difficulty in the assessment of uncertain risks and outcomes. In the presence of uncertainty, individuals can be overwhelmed by having to weigh different risks and benefits and may resort instead to emotion, intuition, and rules of thumb (heuristics) that often ignore critical information. These strategies can lead to an under- or overestimation of risks and confusion with treatment options.97,98 Importantly, individuals will also perceive risks differently for their children or for others than they would for themselves.98,99
While these observations may be troubling in the context of achieving informed consent, physicians can facilitate decision-making by considering not only the decision itself but also how that decision meets the patient’s values and needs. As Ubel and Loewenstein97 point out, “To meet the moral goals of informed consent, physicians need to find a method to combine patients’ values with medical facts in a way that produces superior medical decisions.” Involving patients in their own healthcare decisions has been shown to improve understanding, satisfaction, and outcomes.100,101 Individuals who feel that their emotional and informational needs have not been met are far more likely to complain, be dissatisfied with their care, or, indeed, to sue.102 Establishing a rapport with the patient, respecting their concerns, and taking time for discussion and answering questions will go a long way to improve patient satisfaction, reduce the potential for litigation, and validate the anesthesiologist’s importance as a healthcare provider.103 This latter point is particularly important given that the percentage of patients who believe that anesthesiologists are actually medically qualified ranges from 50-88.7%.103,104
Consent and authorization
Currently, the CMPA, Medicare and the Joint Commission in the U.S., and the Association of Anaesthetists of Great Britain and Ireland22,105 do not require a separate written consent form for general anesthesia, only that there is a discussion between the anesthesiologist and the patient and that consent is documented in the medical record. During this discussion, usually on the day of surgery, the anesthesiologist is required to evaluate the patient, discuss the proposed nature of treatment, describe the expected risks and benefits of both the proposed and any alternative treatments, and obtain verbal consent.
Many institutions, however, do require a separate signed consent form for specific procedures, e.g., obstetric anesthesia. In one survey, 47% of U.S. anesthesiologists reported obtaining separate written consent for obstetric anesthesia compared with only 22% among their U.K. counterparts.106 For general anesthesia, however, combined surgical-anesthesia consent forms are often used and typically signed in the presence of surgical personnel. Recently, however, there has been renewed discussion in both North America and the U.K. regarding the pros and cons of separate (from surgical) consent forms that are specific to anesthesia.22,105,107 Proponents of separate anesthesia-specific consent forms argue that only anesthesiologists have the expertise to present information about anesthesia.22,105,108,109 As Marco commented, “Do we as practitioners of the medical specialty of anesthesiology believe it appropriate to allow ‘consent’ for anesthesia to be an afterthought of the general surgical consent?”105 Moore goes on to suggest that “having a surgeon obtain consent for anesthesia is not only inadequate consent but also demonstrates a lack of respect for the specialty of anesthesiology.”110 Furthermore, Marcucci et al. suggest that consent for anesthesia requires greater cognitive capacity than consent for surgery and, as such, should be obtained separately by anesthesiologists.107 Tait et al. recently showed that parental recall of anesthesia information was greater when the consent document was presented by anesthesia personnel rather than by surgical providers.45 The effectiveness of procedure-specific consent forms over conventional forms has also been shown.111,112
Opponents of separate anesthesia-specific consent forms believe that the preoperative discussion is sufficient and that presenting a written consent form at this time hinders the consent process. Others suggest that getting a signed consent for anesthesia on the day of surgery is an extra step requiring more administrative effort and added cost113 and, furthermore patients do not remember much of the information anyway.16,52 Furthermore, they argue that there is no evidence to support such a practice and that a signature on a consent form guarantees neither understanding nor protection against litigation.113,114 Indeed, Waisel29 believes that focusing on the legal requirements of consent “suffocates the purpose of the anesthesia informed consent process to satisfy the decision-makers’ needs”.
Documentation
Regardless of obtaining a consent signature, it is important to retain a record that a discussion took place and that the patient understood the information at the time it was given. This is important in light of a U.K. survey showing that anesthesiologists are generally poor at recording discussions on informed consent.115 This is certainly not unique to the U.K.; a survey from Japan showed that only 59.9% of anesthesia departments kept records documenting that informed consent had been obtained.33 Marco105 notes that “The issue is not whether there is a separate consent for anesthesia care, but how it is documented.” Without this documentation, it may be difficult for the doctor to argue in court that informed consent had actually been obtained. Although issues relating to informed consent as the primary allegation are rare in anesthesia-related lawsuits (< 1%), anesthesia consent was found to be inadequate in 22% of cases in the U.S. Anesthesia Closed Claims Project.116 As such, these inadequacies are often brought into play as secondary allegations in malpractice claims. Although the degree of documentation will likely vary with the situation, CMPA guidelines suggest, at minimum, a record of what the patient was told in terms of the procedures to be performed, the risks (minor and major), any questions or concerns that were raised and how they were addressed, an assessment of the patient’s or surrogate’s understanding, and any additional information or leaflets given to the patient.94
In summary, informed consent for anesthesia presents a unique situation both in terms of the time allotted for disclosure and the fact that routine anesthesia does not typically offer options. Nevertheless, this in no way diminishes the importance of consent as a means to inform the patient regarding their anesthetic care. Indeed, because of the somewhat perfunctory nature of the patient encounter, it is perhaps doubly important that anesthesiologists are able to optimize their message by providing information that is relevant to the individual patient and that enhances their understanding.
Despite the debate regarding the need for written informed consent for anesthesia, the literature reinforces the importance of the fundamental doctor-patient interaction. Indeed, regardless of one’s view on how informed consent for anesthesia should be obtained, it is critical that the discussion with the patient be meaningful and not simply a box to be ticked. This discussion must be guided by the need to inform the patient and to meet their individual needs, not simply as a means to satisfy any legal requirements. Meaningful discussions with the patient are crucial to the ethical intent of the informed consent process and to affirm the patient’s perceptions of the anesthesiologist as a respected and indispensible member of the perioperative team.
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Alan R. Tait conceived the idea for this article and wrote all drafts of the manuscript. Magnus K. Teig reviewed the background literature and was responsible for critically reviewing the manuscript for intellectual content and for editing all drafts. Alan R. Tait and Terri Voepel-Lewis reviewed the literature. Voepel-Lewis was involved in substantive manuscript preparation including critically reviewing and editing all drafts of the manuscript.
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Tait, A.R., Teig, M.K. & Voepel-Lewis, T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anesth/J Can Anesth 61, 832–842 (2014). https://doi.org/10.1007/s12630-014-0188-8
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DOI: https://doi.org/10.1007/s12630-014-0188-8