No man is good enough to govern another man without the other’s consent.
Introduction
The requirement of informed consent for treatment is based on the principle of respect for autonomy. This moral principle requires that the individual patient should be regarded as an autonomous decision-maker about his/her situation, his/her options and the risks involved concerning any choice (see Chapter 44).
‘‘Informed consent’’ in medicine is the process by which a patient agrees to a procedure or a treatment. The process includes an appropriate discussion between the clinician and the patient, and covers all relevant aspects of the proposed treatment. The discussion is usually documented in the patient’s chart. Even though the formal signed consent form in the chart is not a universal legal requirement, the discussion is mandatory.
Consent is valid if it is given voluntarily by an appropriately informed, competent patient. Anesthesiologists and intensivists, like all other doctors, are legally and ethically obliged to seek consent from a patient before medical intervention wherever possible.
In order to consent to a medical procedure, a patient must:
1. receive accurate, meaningful and relevant information regarding the nature and purpose of the treatment, as well as the risks, benefits and alternatives to the proposed therapy, including no treatment
2. be free from coercion
3. have medical decision-making capacity, that is the capacity to understand and communicate, the capacity to reason and deliberate, and the possession of a set of values and goals (Grisso and Appelbaum 1998).
Older patients can be particularly vulnerable in the informed consent process, and clinicians should facilitate the process as much as possible. Decision-making capacity may be compromised by cognitive impairment, dementia and depression, which have a high prevalence in the elderly population (see Chapter 6). Cognitive ageing is difficult to define, hard to measure and impossible to predict; however, a negative influence of age upon cognitive capacity has been frequently reported in the literature. This makes informed consent in the elderly a challenging issue that requires the optimal combination of deep knowledge of the legal and ethical aspects and adequate communication skills.
How to Manage the Discussion with the Elderly Patient
When obtaining consent from the elderly patient, the physician must bear in mind two important issues:
1. Is this patient able to give informed consent?
2. Is there a way I can promote this patient’s ability to give informed consent?
Obtaining answers to these questions can be hard in the case of the geriatric surgical patient. Indeed, a systematic review of the literature has reported diminished understanding of informed consent information in patients with older age and less formal education (Sugarman et al. 1998).
Clinicians should facilitate the consent process by using effective strategies to improve communication in the elderly. The information must be understood by the patient, since understanding is a key step in the process leading to decision-making. There might be communication difficulties, due to level of education; the clinician needs to explain the procedure repeatedly, speaking more slowly/louder, if necessary, and answer all questions.
There are simple measures that can improve understanding, which include: disclosure of information using simple and direct language, giving information in small units, using assessment methods that are less dependent on verbal expression, using a variety of novel formats (e.g., storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions) to improve understanding of the medical information (Sugarman et al. 1998).
To facilitate the patient’s perception, a correction of presumed sensory deficits should be made, including provision of glasses and/or hearing aids (see Chapter 7). The old patient can become afraid because of being in an unfamiliar environment; noise and artificial lighting, disturbance of routine sleeping and eating habits or underlying disease can lead to confusion and agitation. The visit should be performed in a room with minimal distracting stimuli. When reversible problems interfere with the informed consent process, physicians are ethically required to try to reverse or mitigate these factors. When fear, anxiety or language barriers appear to interfere with the ability to process the information during the visit, the presence of a known and trusted confidant or adviser (e.g., a family member) may help the patient to make competent judgments. In the majority of cases, elderly patients are able to reach reasonable risk-taking decisions to the same degree as young adults (Stanley 1984); however, some may no longer have decision-making capacity because of learning disabilities, depression, brain injury and other forms of dementing illnesses affecting cognition (see Chapter 6).
Assessing Competence/Decision-making Capacity1
Assessing competence in the geriatric population can be a complex task, and the treating doctor needs to decide whether the patient is either competent to decide or incompetent. In medicine, a patient’s decision-making capacity includes the ability to communicate and make logical decisions based on the information provided, to understand their current medical status or condition, and options for medical care, and to communicate their choice.
Before disclosure of information, the patient should be assessed for his/her ability to understand the information, and communicate his/her wishes to the physician. Patients lack decision-making capacity if they cannot understand and remember the information provided, cannot use the information when considering their decision and are unable to make a decision whether to consent to, or refuse, treatment.
Capacity is influenced by a variety of factors, including situational, psychosocial, medical, psychiatric and neurological factors (Holzer et al. 1997). Some patients lack capacity for specific periods of time, such as when critically ill, but not permanently. Decision-making capacity may be compromised by incipient dementia, and patients with Alzheimer’s disease have high rates of incompetence with regard to such decisions (Kim et al. 2002).
The assessment of capacity to consent to treatment should integrate three components: information acquired from observing and talking to the patient, information acquired from talking with caregivers and information from the results of standardized assessment tools.
To date, the quest for a simple neuropsychological instrument to screen patients for impaired capacity has not yielded consistent findings. Although there has been ongoing debate regarding competence assessment, all clinicians should be familiar with how to assess capacity, and a simple instrument would facilitate the identification of patients who may require more detailed assessment. Asking the patient to rephrase the plan and risks can help assess understanding; however, interviews, formal algorithm and rating scales have been devised to assess capacity for cognitive assessment (Jones and Holden, 2004), and the use of a structured approach to assess decision-making capacities can be very helpful.
An ideal clinical tool should be brief, reliable and facilitate documentation of the four capacity abilities: understanding the information regarding the proposed treatment and its risks and benefits, appreciating treatment methods and their consequences, reasoning about the different treatment options and communicating a choice (Table 10.1) (APA 1998, Sessums et al. 2011).
Understanding. The patient needs to recall conversations about treatment, to make the link between causal relationships, and to process probabilities for outcomes. He/she must understand the known risks and benefits of the treatment and its alternative. Problems with memory, attention span, and intelligence (capability to understand) can affect the understanding.
Appreciation. The patient should be able to appreciate his/her clinical situation, his/her illness, treatment options and likely outcomes as things that will affect him/her directly. A lack of appreciation usually stems from denial based on lack of capability to understand, or emotion, or a delusion that the patient is not affected by this situation the same way and will have a different outcome.
Rationalization or reasoning. The patient needs to be able to weigh the risks and benefits of the treatment options presented in order to come to a conclusion in keeping with his/her goals and best interests, as defined by his/her personal set of values. The patient must demonstrate the ability to both ask and answer appropriate questions relating to the decision. Rationalization/ reasoning often is affected in psychosis, depression, anxiety, phobias, delirium and dementia.
Communication. The patient needs to be able to express a treatment choice, and this decision needs to be stable enough for the treatment to be implemented. Changing the decision in itself would not bring a patient’s capacity into question, so long as the patient is able to explain the rationale behind it. Frequent changes in the decision, however, could suggest underlying psychiatric disorders or extreme indecision, which could bring capacity into question.
| Component | Patient’s role | Physician’s approach | Sample questions | Impaired in |
|---|---|---|---|---|
| Understanding | Recall information, link causal relationships, process general probabilities | Encourage patient to paraphrase his/her view of the information | Can you tell me: how you view the current situation? The possible benefits/risks of the treatment? | Problems with memory, attention span, intelligence |
| Appreciation | Identify illness, treatment options and consequences of treatment options | Ask patient to describe the disease, the proposed treatment, and likely outcomes | What do you believe is wrong with your health? What treatment do you think would help? What other options do you have? | Delusional disorder or pathologic levels of distortion or denial |
| Rationalization | Weigh risks and benefits to come to a conclusion in keeping with patient’s goals | Ask the patient to compare risk vs. benefits of the proposed treatment and alternatives | What made you choose option “A”? Why do you think option “A” is better than option “B”? | Depression, psychotic thought disorder, anxiety, phobia, delirium, dementia |
| Communication | Express a treatment choice | Ask patient which treatment option he/she prefers | Have you decided whether to get “A” or “B” treatment? | Psychiatric disorders, pathologic indecision |
Patients with some degree of mental impairment are still capable of participating in medical decision-making and should not be treated against their will. Asking the patient to rephrase the information received (e.g., plan and risks of the anesthetic procedure) can help to assess capacity; however, the use of a structured approach to assess decision-making capacities can be very helpful.
The demented patient
Dementia – in all its forms, from Alzheimer’s disease to vascular dementia and dementia with Lewy bodies – is continuously increasing among older patients. Data from the World Health Organization for Western Europe report a prevalence of dementia of 1.6% in patients aged 60 to 64 years, and up to 43.1% in patients older than 90 years. This scenario is expected to become even more challenging as a consequence of the global population aging. In reference to surgery and anesthesia, this situation is a source of major concern among professionals, especially regarding the optimal therapeutic choice and how to best preserve and respecte the person’s rights.
There is wide consensus that the clinical and ethical appropriateness of a surgical treatment should be evaluated in the light of the advantages offered by surgery in terms of both quality of life (QoL) and lifespan. However, as reported with a case of bowel obstruction occurring in a demented patient, a wide variation can been observed in the approach to the same situation from different operators (Gallagher and Clark 2002).
The general opinion that surgery in demented patients should, in principle, be avoided or limited to lifesaving procedures, because these patients are more prone to develop postoperative complications, needs to be tempered with the increasing evidence that complication prevention in geriatric surgery first requires the knowledge and practice of optimal perioperative management principles (Alcorn and Foo 2016). Moreover, several reports indicate that, in the demented patient, surgeries offering improvement in sensory abilities, such as cataract removal, contribute to improve QoL and reduce decline in both memory and executive functioning (Lerner et al. 2014).
In reference to informed consent, all the steps mentioned above (understanding, appreciation, rationalization or reasoning, communication) may present varying degrees of difficulty in cases of dementia or major cognitive impairment. In such situations, after experiencing the advantages offered by measures aimed at increasing understanding and communication, a further step is represented by the involvement of relatives and caregivers. Where advance directives have been given, they provide a valid reference point to interpret the patient’s preferences and choices. In other cases, the choice is devolved to surrogate decision-makers and/or criteria derived from nation-based law provisions (see Legal aspects below).
In times where increasing importance is being attributed to principles of autonomy and respect, the diffusion of practices like advance directives – given in times of preserved cognitive function – or identification of surrogate decision-makers at the early stages of cognitive impairment represent important tools for both patients and doctors dealing with the elderly undergoing surgery, anesthesia and intensive care.
Clinical tools to assess competence
There has been ongoing debate regarding competence assessment, and to date, the quest for a simple neuropsychological instrument to screen patients for impaired capacity has not yielded consistent findings.
MacArthur Competence Assessment Tool-Treatment
In a review describing structured assessment of capacity in adult patients, Dunn et al. (2006) identified 23 instruments, 15 of which could be suitable for assessing capacity to consent to medical treatment. The authors demonstrated that each instrument has limitations, and as a general recommendation they suggested the MacArthur Competence Assessment Tools for Treatment (MacCAT-T), given its comprehensiveness and the supporting psychometric data (Dunn et al. 2006).
The MacCAT-T may provide reliable and valid estimates of patients capacities (Grisso et al. 1997) and is a semi-structured interview that takes approximately 20 min for anesthesiologists/intensivists with experience with the format (Appelbaum 2007). The MacCAT-T is used to assess the four major abilities related to competence to consent to treatment: communication, understanding, appreciation and rationalization (Table 10.1). The MacCAT-T has been validated in the broadest population, is probably one of the most clinically useful tools currently available and is among the few instruments for which extensive training materials are available.
It is not designed as a stand-alone tool to determine capacity and is intended to be used in conjunction with clinical assessment. Unfortunately, the MacCAT-T tool does not give a global rating, and lacks a predetermined cutoff separating capacity and incapacity.
Aid to Capacity Evaluation (ACE)
A review by Sessums et al. (2011), searching for a valid, reliable and clinically useful tool for assessing and documenting patient’s capacity, indicates the Aid to Capacity Evaluation (ACE) to be the best evaluation tool, the only instrument evaluated against a gold standard with consistent correlation with validation studies and robust test characteristics (Sessums et al. 2011).
The purpose of the ACE is to help clinicians systematically estimate capacity when a patient needs to make a medical decision (Etchells et al. 1999). It is based on the actual decision the patient is facing and uses the patient’s medical situation and diagnosis or treatment decision. The ACE is a structured interview that assesses understanding of the problem, the treatment proposed, treatment alternatives, the option to refuse treatment, possible consequences of the decision and the effect of an underlying mental disorder (major depression and psychosis) on the decision. Based on the answers, the examiner gives an overall impression of “definitely capable,” “probably capable,” “probably incapable” or “definitely incapable” (Etchells et al. 1999). The ACE can be performed in less than 30 minutes (Sessums et al. 2011), is available for free online (www.jointcentreforbioethics.ca/tools/ace_download.shtml; last accessed March 2017), and includes training materials and a manual that provides objective criteria for scoring responses.
Mini Mental State Examination (MMSE)
When the patient’s ability to understand information is questionable, cognitive assessment may be performed using the Mini Mental State Examination (MMSE). This brief screening test has been found to correlate with clinical judgments of incapacity (Raymont et al. 2004), and it may have some use in identifying patients at the high and low ends of the range of capacity, especially among elderly persons with some degree of cognitive impairment (Mungas et al. 1996, Kim et al. 2002).
The MMSE quantitatively assesses the severity of cognitive impairment, and documents cognitive changes occurring over time. The scores range from 0 to 30, with lower scores indicating decreasing cognitive function: specifically, an MMSE score of 0 to 17 increases the likelihood of incapacity, a score of 18 to 23 indicates mild cognitive impairment, while a score of 24 to 30 significantly reduces the likelihood of incapacity (Etchells et al. 1999). Low scores on these examinations, however, do not preclude the ability to undertake treatment-related decisions, and consultation (psychiatrist, geriatrician, ethicist) may be necessary. The test has been translated into several languages, its administration takes only a few minutes and is simple to use. Copyright protection is now enforced, and the Mini-Mental State Examination must be purchased from the publishers (www.parinc.com; last accessed March 2017).
Screening methods for cognitive impairment suitable for the anesthesiologist should be simple and easy to use, be replicable and should require a short administration time and, possibly, no formal training. According to these criteria, the MMSE represents the most useful clinical tool for the anesthesiologist to assess capacity.
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