Informed consent is the process by which patients agree to a medical procedure or treatment with regard to their health care. The process includes an appropriate discussion between the clinician and the patient, and covers all relevant aspects of the proposed treatment.
To consent to a medical procedure, a patient must 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 (informed element); be free from coercion (voluntary element); and have medical decision-making capacity (competence element), that is the capacity to understand and communicate, to reason and deliberate and the possession of a set of values and goals.1 Every adult patient is legally assumed to be competent. However, failure to detect incompetence is quite common,2 and if any doubt exists, capacity should be assessed using specific tools. An ideal clinical cognitive assessment tool for the anaesthesiologist should be brief and reliable, easy to use, replicable and facilitate documentation, should require a short administration time and, possibly, require no formal training.2,3 In daily practice, anaesthesiologists need an easily performed tool to assess patients’ competence/capacity, especially in the elderly population. (Competence is a term widely adopted in American legal writing and corresponds to the term mental capacity in British legal writing; in the text, they are used interchangeably.)
There are no formal guidelines from anaesthesia societies for the assessment of capacity to consent to treatment, although several criteria for assessing competency have been suggested in the literature.2,4 To identify capacity impairment, the assessment should integrate three components: information acquired from observing and talking to the patient, information acquired from talking with caregivers and information from standardised tests.
During the visit, the elderly patient is in an unfamiliar environment, and very often the underlying disease can lead to confusion and agitation. To improve the patient's perception, the visit should be performed in a room with adequate lighting and minimal distracting stimuli. During the visit, the presence of a known and trusted confidant or adviser (e.g. family member, caregiver) may improve the patient's decision-making capacity. There might be communication difficulties, due to level of education, hearing or visual impairment (that affect communication even when cognition is intact) or expressive aphasia. All reversible causes of incapacity should be removed and correction of presumed sensory deficits should be made. As understanding is a key step in the cognitive process leading to a decision, clinicians need to explain the procedure repeatedly, speaking more slowly or louder and answering all questions. Measures that improve understanding 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 caregivers, health educators, quizzing patients, multiple disclosure sessions) to improve understanding of the medical information.5
Forms of dementing illnesses affecting cognition can be suspected when patients reveal impaired fluency of language, are vague with dates and sequence of events, repeat phrases or have a tendency to dwell on distant events.6 Patients with loss of interest, poor concentration, forgetfulness, negative outlook with feelings of hopelessness and diminished capacity for enjoyment can suffer depression which results in lesser cognitive capacity, and for patients with diminished but not permanently impaired cognitive capacity, participation in the decision-taking process constitutes a heavy burden.6 Patients with some degree of mental impairment are still capable of participating in medical decision-making and should be treated using their opinion. The anaesthesiologist can assume that the patient has decision-making capacity when he/she is able to describe, in his/her own words, the important features of the discussion, including his/her medical condition and the indications, benefits, risks and alternatives. Where any doubts exist, capacity needs to be evaluated, because consent obtained from an incompetent patient is invalid.1
Cognitive assessment may involve examination of higher cortical functions, particularly memory, attention, orientation, language, executive function (planning activities) and praxis (sequencing of activities). Over the year, various interviews and rating scales have been developed to assess decisional capacity to consent to medical treatment.2,4,7 Although the quest for a simple neuropsychological instrument to screen patients for impaired capacity has not yielded consistent findings, an easily performed and useful tool is the Mini–Mental State Examination (MMSE).8
The MMSE is a brief bedside screening test of patients’ cognitive status and has been found to correlate with clinical judgements of incapacity.8,9 It may be administered by physicians, nurses and also by lay interviewers; it does not require formal training and takes less than 10 min to complete. The scores range from 0 to 30, with lower scores indicating decreasing cognitive function: specifically, a MMSE score of 0 to 17 increases the likelihood of lack of capacity, a score of 18 to 23 indicates mild cognitive impairment, whereas a score of 24 to 30 significantly reduces the likelihood of incapacity.9 The MMSE, corrected for the level of education, can identify patients at the high and low ends of the range of capacity, especially among elderly persons with some degree of cognitive impairment. The MMSE quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time. Although the MMSE was not developed for assessing decision-making capacity, it has been compared with expert evaluation for assessment of capacity and the test performs reasonably well.2,9,10 It is objective, allows the evaluation of patients who are unable to complete more detailed cognitive tests and provides a score easily exploitable by the anaesthesiologist, who is already accustomed to categorising patients based on straightforward scores, such as American Society of Anesthesiologists’ physical status, Glasgow Coma Score or Acute Physiology and Chronic Health Evaluation score, to mention a few.
In patients with a low MMSE score, suggesting likelihood of lack of capacity,9 informed consent must be provided by a legal representative to be valid, and the anaesthesiologist must request a surrogate decision-maker. In some cases, individuals who are likely to lose capacity may assign a surrogate who will take on an increasingly active role in decision-making, if the patient declines treatment. In the presence of an advance directive indicating a treatment choice, a person selected by the patient can make a decision on his/her behalf. In the absence of an advance directive, a substitute is assigned according to the laws and jurisdiction of the country involved (Table 1).
Acknowledgements relating to this editorial
Assistance with the editorial: none.
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Conflicts of interest: none.
Comment from the Editor: this Editorial is part of the ‘Anaesthesiology and ethics’ series that is edited by Professor Stefan De Hert.
1. Grisso T, Appelbaum PS. Assessing competence to consent to treatment: a guide for physicians and other health professionals. New York: Oxford University Press; 1998.
2. Sessums LL, Zembrzuska H, Jackson JL. Does this patient have medical decision-making capacity? JAMA
3. [No authors listed]. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Psychiatric Association. Am J Psychiatry
4. Glass KC. Refining definitions and devising instrument: two decades of assessing mental competence. Int J Law Psychiatry
5. Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc
6. Young J, Meagher D, MacLullich A. Cognitive assessment of older people. BMJ
7. Dunn LB, Nowrangi MA, Palmer BW, et al. Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry
8. Folstein MF, Folstein SE, McHugh PR. Mini–mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res
9. Etchells E, Darzins P, Silberfeld M, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med
10. Kim SY, Karlawish JH, Caine ED. Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr Psychiatry