According to the Population Reference Bureau’s 2018 population data sheet, the global fertility rate was declining for the past few decades, yet remaining high enough to allow for continual population growth. This fact combined with the increase in life expectancy is causing the global population to age rapidly1.
Alzheimer’s disease (AD) is a degenerative brain disease and the most common cause of dementia among elderly2. According to the 2015 dementia-related statistics, published by the Alzheimer’s Disease International, an estimated 46.8 million people worldwide are living with dementia, and this number will almost double every 20 years to reach 75 million by 2030. Extensive research efforts were undertaken to improve the status and management of AD, despite the ethical challenges that it holds2. Moreover, these ethical dilemmas are magnified when the research is invasive, burdensome, and with unexpectable risks2,3.
“Respect for Persons” is one of the principles defined by the report of Belmont in 1979, for biomedical research. This principle identifies three elements to validate the informed consent (IC) process: (1) disclose sufficient relevant information for decision-making, (2) patient’s comprehension, and (3) voluntariness4. Voluntariness means that the patient should take a decision without being subjected to coercion or undue influence4. This reflects the principle of autonomy which is defined in the literature as “a person’s ability and opportunity to make decisions relating to his/her own wishes”5, or as “an act of self-determination exercised by a competent person”3. In a democratic society, many independent people are autonomous, but not all people with autonomy are necessarily independent. A person who is bound to a wheelchair can still exercise the power to order someone to carry his wishes. The appearance of dependency and its connotation are often misinterpreted as a loss of autonomy, and this can lead to unethical behavior5.
On the other hand, comprehension concept of the IC process, require that the person understand adequately the information provided4, and has the capacity to make the decision in question6. Capacity evaluation is a two-step process, where the clinician starts by assessing a person's decisional abilities, followed by a judgment regarding the patient’s capacity to make a particular decision (e.g., consent)7. Decision-making capacity (DMC) must be assessed in relation to the particular decision a patient needs to make at the time the decision needs to be made7. A common dilemma that might emerge during the management process, occur during the DMC testing, to either consent to treatment or participate in research trials8.
When a clinician makes a judgment of impaired capacity, his decision should rely on the severity of the cognitive impairment, context, decision that needs to be taken, and risk-benefit ratio of the various options7. Hughes (2001)9 stated that “it is important to see the person as one who is acting and interacting in a cultural-historical context in which he/she is embedded’’. This could imply that even if the people suffer from dementia, they are not automatically detached from their historical origin and, until they reach a vegetative state of total unawareness of their surroundings, they should be considered as retaining some extent of autonomy5. Moreover, Hegde et al. (2016)7 stated that capacity, though dependent on cognition, is not the same as cognition. Moreover, both of cognitive function and decisional ability might vary with time for any individual. Therefore, clinicians must take notable considerations to understand the relationship between these two parameters as it has a significant impact on their judgment of DMC7.
For instance, high scores on Mini-Mental State Examination (MMSE) may indicate better decision-making ability, however, a normal MMSE does not rule out impaired capacity, and i would be preferable to use the MMSE in conjunction with other tests to improve the patient's comprehension of the tasks7. On the other hand, a promising alternative to the MMSE due to its high sensitivity to early detection of dementia and mild cognitive impairment (MCI) is the Montreal Cognitive Assessment (MoCA) scale10. MoCa is a rapid screening instrument for mild cognitive dysfunction. MoCA evaluates different types of cognitive abilities and showed to outperformed the MMSE among both MCI and AD with high sensitivity (1.00)11. However, specificity was observed to be lower than that of the MMSE although still high (0.87)11. Moreover, when a cut score of 23 was used, both sensitivity and specificity were excellent (0.96 and 0.95, respectively)12.
It is noteworthy that there is currently no single test, that could be considered as the gold standard for capacity assessment2. MacArthur Competency Assessment Tool (MacCAT) is currently the most used and the best validated semi-structured interview that assesses a person’s capacity to choose, understand, appreciate, and reason2. However, it requires adequate training to use and is time-consuming13. Moreover, the validity of the final judgment of DMC depends on the use of other clinical variables and clinician values since the MoCa does not establish a cutoff for capacity14. On the other hand, a more recent tool, the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice due to its simplicity, relevance, and applicability in older patients13. Yet, this tool does not evaluate the capacity to express a choice. The UBACC is a potentially useful instrument for screening to identify those who are in need of more comprehensive decisional capacity assessment, and not to come up with final judgments15. Moreover, many clinicians or researchers use solely their clinical experience to judge patients’ DMC, however, this approach is imprecise13.
In practice, a combination of clinician’s judgment with a structured capacity interview and neuropsychological tests that include executive function tests, that assess decisional ability would be ideal7.
On the other hand, as the disease progresses, most people with dementia lose their capacity to make some important decisions, so potential friends, family, caregivers or other proxies are often involved in DM and advocating for their wishes16.
To our knowledge, the issue of IC and the principle of autonomy among the geriatric population is not yet studied in the Lebanese context. Therefore, the primary objective is to investigate the Geriatricians’ standpoint regarding the DMC of their patients with AD, regarding the consent for research trial and/or therapeutic participation. The secondary objective is to propose an algorithm for a reliable, comprehensive, and valid assessment of the DMC.