Geriatricians’ Standpoint of the Informed Consent Process Among Patients with Alzheimer's Disease: The Lebanese Context

Abstract


Background
The decline in the global fertility rates, combined with the increase in life expectancy is causing the global population to age rapidly 1 .Alzheimer's disease (AD) is a degenerative brain disease and the most common cause of dementia among older adults 2 .
According to Alzheimer's Disease International organization 2015's statistics, 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.
Autonomy, also known as respect for persons, is a fundamental ethical principle in healthcare 3 .Autonomy is "a person's ability and opportunity to make decisions relating to his/her wishes" 4 , or "an act of self-determination exercised by a competent person" 5 .As determined by Belmont's report, the autonomy principle requires three elements to validate the process of informed consent (IC): (1)   disclosure of su cient relevant information for decision-making, (2) patient's comprehension, and (3) voluntariness 3 .
As dementia progresses, it leads to several functional and cognitive alterations, making patients vulnerable, and reducing their quality of life 6 .In practice, one of the most signi cant components of vulnerability among these patients is the loss of the decisionmaking capacity (DMC) 6,7 .Evaluation of the patients' capacity to consent to either a treatment or participating in a trial, is a dilemma that commonly emerges during the patients' management process 8 .It is critical to carefully assess the patients' DMC since the loss of this capacity can affect their autonomy, what have considerable legal or ethical consequences 6 .
The "comprehension" element of the informed consent, requires an adequate understanding of the provided information 3, and a capacity to make a decision 9 .It is noteworthy that even though capacity is dependent on cognition, it is not the same as cognition 10 .For instance, high scores on Mini-Mental State Examination (MMSE) may indicate a better decision-making ability, however, a normal MMSE does not rule out impaired capacity 10 .It would be preferable to use the MMSE in conjunction with other tests to improve the patient's comprehension of the tasks 10 .Furthermore, cognitive function and decisional ability might vary with time.This fact warrant consideration since it might affect the judgment of DMC 10,11 .Therefore, during the evaluation process of patients with dementia, it is important to assess their cognitive capacities, and decisional abilities, at a speci c time and context 9 .
DMC is evaluated through a two-steps process.At rst, the clinician assesses a person's decisional abilities, then judges the patient's capacity to take a speci c decision (e.g., consent) 10 .The consensus is that DMC is based on four different aptitudes, which are, the ability to choose, understand, appreciate, and reason 6 .Understanding re ects the ability to know the meaning of disclosed information.Appreciation describes the ability to recognize that that information applies to the person.Reasoning describes the ability to compare and describe alternative options and their consequences.Choice describes the ability to consistently select a decision 6 .It is noteworthy that no single test exists that could be considered as the gold standard for DMC assessment 2 .However, the MacArthur Competency Assessment Tool (MacCAT) is the most commonly used and the best validated semi-structured interview to assess the DMC 2 .Moreover, MacCAT assesses a person's capacity to make a choice, understand, appreciate, and reason 2 .
An objective and comprehensive evaluation of patients with dementia eliminates the doubt as to the validity of the consent and ensures that the inclusion of subjects to clinical trials or the administration of treatment is ethical and respectful of their rights 6 .
Geriatricians' standpoint of the application of the ethical principle of autonomy among patients with AD was not yet studied in the Lebanese context.Therefore, the primary aim of this study was to investigate the geriatricians' understanding of the principle of autonomy and their perception of the DMC testing as part of the IC process among patients with AD.The secondary aim was to propose an algorithm for a reliable, comprehensive, and systematic assessment of the DMC.

Design
To serve the study's aims, a cross-sectional descriptive e-survey was designed for data collection.Ethical approval was obtained from the Lebanese University institutional review board (IRB).For con dentiality reasons, all collected data (logged, analysed) were kept in a concealed place and reviewed only by the principal investigator.

Participants and selection criteria
It is noteworthy that there is a major de cit in the number of physicians specialized in geriatrics in Lebanon 12 .Moreover, Lebanese geriatricians who are members of the Lebanese Society for Geriatric Medicine (LSGM), constituted the target population of this study.Only geriatricians who worked with patients having AD either clinically or through research and practicing within Lebanese territories were invited to participate in this study (Figure 1).

Procedure
Google Forms platform was utilized to create an e-survey to collect the geriatricians' data.Furthermore, contact information about geriatricians, members of the LSGM, was requested and obtained from the Lebanese Order of Physicians in Beirut.
Each member of the Society was approached via a phone call, where study-speci c information was delivered.Those who accepted to participate received a link to the study's survey via e-mail.Moreover, follow-up phone calls were conducted twice a week, over a whole month, to make sure that the geriatricians completed the survey.Geriatricians' implied consent was obtained with the completion of the survey.It is noteworthy, that geriatricians' participation was fully voluntary and they had the freedom to withdraw from the survey whenever they wanted to.
The survey started with a brief introduction to the study.The introduction described the current situation regarding aging and the increased prevalence of dementia among the elderly.It also drew attention to the ethical issues that might arise in treating patients with AD, or by including them as potential participants in research studies.The aim of the study was followed in the next part.The remaining section of the survey included: (a) section one, socio-demographic data; (b) section two, autonomy; (c) and section three, decision-making capacity.Section two: autonomy.This section was designed to capture the geriatricians' understanding of the ethical concept of autonomy (Table 1).
Section three: decision-making capacity.
At the beginning of this section, a clear distinction between both of the concepts of capacity and competency was provided.The term "capacity" was de ned as "a person's performance on measures of decision-making abilities" 2 .Capacity was also de ned as "a person's ability to make a particular decision at a speci c time or in a speci c situation" 10 .The term "competency" was de ned as being "the judgment that a person's capacity is adequate to make the decision in question" 2 , and by "a legal capacity that is determined by a judge in a court, where it is a threshold requirement imposed by society for an individual to retain decision-making power in a particular activity or set of activities".Three questions were designed to investigate the geriatricians' standpoint regarding the DMC's assessment in this section (Table 2).If the geriatrician answered "No" on the rst question (Table 2), he/she was systematically directed to submit their answers and nish the survey.

Statistical Analysis
Data were analyzed using the Statistical Package for the Social Sciences (SPSS) Version 21.0 for Windows.Descriptive statistics (mean, standard deviation, proportions) were calculated for the geriatricians' answers on the sections of (a) socio-demographic, (b) autonomy, (c) and DMC.

Results
Twelve geriatricians successfully ful lled the selection criteria.However, only nine agreed to participate.The majority of geriatricians who participated in this study were males (66.7%).The mean of geriatricians' experience recorded was 14.7 ± 9.6 years.More than half (55.6%) of the geriatricians pursued mixt areas of practice (academic + clinical + research + administrative + consultation) (Figure 2).It's noteworthy that all geriatricians who participated in the study had an initial specialization in elds other than geriatrics (internal medicine, family medicine, endocrinology, and metabolism), completed afterwards their training in gerontology, and eventually joined the LSGM.
Most of the geriatricians (66.6%) recruited for this study worked in a mixt setting.The majority (44.4%) worked in a university hospital, specialized geriatrics center, and private clinic at the same time (Figure 3).
Less than half (33.3%) of the geriatricians were able to correctly identify the statements that re ect the principle of autonomy.
Among those who failed to do so, the majority (75%) didn't recognize that in case of no-emergency, and when the patient's decisionmaking incapacity was con rmed, decision-making is taken by a surrogate de ned by a "person of trust" who re ect the patient's wishes.All of the geriatricians agreed that the process of acquiring the IC among patients with AD is a must in the research or clinical settings.Yet, no one successfully identi ed all the necessary criteria that constitute the IC process (Question 4, Table 1), and only 66.7% knew that legislation for IC exists in Lebanon.
Moreover, more than half of the geriatricians (66.7%) failed to recognize that "a con rmation of a patient's capacity to make a decision" is required by the process of IC, and only one geriatrician recognized that disclosing the information is necessary.The results showed that the majority (88.9%) of the participants assessed DMC among their patients with AD, and they have used only one method in doing so (Table 3).Furthermore, the geriatricians had different considerations to determine whether or not their patients with AD had adequate capacity.Among those who used the MMSE test (37.5%)(Table 3), they have selected different cut-offs to judge their patient as having adequate DMC (score above 20; 24; and 25).The remaining geriatricians couldn't justify their judgment (Table 3).

Discussion
Ethically, it is every person's right to make their own decisions.Embedded in this right, is the freedom to make healthcare-related decisions.The imposition of limits is a complicated issue, particularly in healthcare, where the practitioner must demonstrate whether or not the patient has the adequate capacity to decide (i.e.consent to treatment or research participation) 13 .
The ndings of this study revealed that less than half of the geriatricians were able to correctly identify the statements that re ect the principle of autonomy.While the remaining geriatricians didn't recognize that in case of no-emergency and when the patient's decision-making incapacity was con rmed, decision-making is done by a surrogate de ned by a "person of trust" that re ects the patient's wishes.This was similar to a study conducted by Tarabey et al. ( 2018) 14 , where psychiatrists had a poor understanding of the concept of autonomy.
All geriatricians in this study agreed on the need for IC among patients with AD in both research or clinical settings.However, no one was able to denote all the necessary criteria required by the IC's process.This fact was supported by the ndings of a Lebanese national survey conducted by Abou-Mrad (2008) 15 who highlighted the absence of the informed consent process in around 83% of Lebanese hospitals.It is noteworthy that only one participant knew that disclosing adequate information to patients, is directly linked to the process of IC.Appelbaum (2007)  16 has stated that physicians must prove good communication skills in ways that patients understand, and not just tell patients about a proposed procedure or therapy and its risks and bene ts.Furthermore, not all of the geriatricians (66.7%) were knowledgeable of the fact that legislation exists in Lebanon regarding the process of IC (Law 574/2004, patients' rights, and informed consent) 17 .Moreover, more than half of the geriatricians (66.7%) failed to recognize that "a con rmation of a patient's competency to make a decision", is required by the process to IC.Yet, all but one of the geriatricians assessed the DMC of their patients with AD.This reveals a severe mismatch between common knowledge and common practice.
Assessing for DMC is used to determine the extent of an individual's ability to make a decision 18 .Therefore, making a judgment based on only one assessment method (i.e.MMSE) would be erroneous 18 .However, the study's ndings showed that all of the geriatricians relied on only one method to assess the DMC, either a tool or their clinical experience.For instance, some had chosen the MMSE and had selected different cut-offs (scores above 20; 24, and 25) to judge that their patients possess an adequate DMC.
Appelbaum (2007) 16 stated that when scores of less than 19 were presented, the MMSE has been found to correlate with clinical judgments of incapacity.However, studies vary in suggesting that scores of 23 to 26 or higher are strongly indicative of competence 16 .
Regarding the nal judgment of the DMC, geriatricians were unable to make a clear judgment when they used either of MacCAT-CR/MacCAT-T, University of California, San Diego Brief Assessment of Capacity to Consent (UBACC), or their clinical experience solely.This is justi ed by the fact that the MacCAT tool does not establish a cut-off score for capacity, and the validity of the nal judgment will depend on other clinical variables combined with the clinician judgment 16 .Moreover, the UBACC seems interesting for routine practice due to its simplicity, relevance, and applicability in older patients 18 .Therefore, it is potentially useful for screening purposes and might identify the need for a more comprehensive decisional capacity assessment, rather than come up with a nal determination of capacity 6 .Similarly, the sole use of clinical expertise to make a judgment of the patients' DMC was shown to be imprecise 18 .

Study's Limitation
This study was unable to recruit all the participants despite the high participation rate.Therefore, the geriatricians who refused to participate might have different perceptions than those who participated.This fact might affect the study's results.

Conclusion
The study ndings showed that the Lebanese geriatricians demonstrated a poor understanding of the concept of autonomy and failed to recognize the need for the DMC assessment as a component of the IC's process.Moreover, they were unable to select adequate tools to assess and judge the DMC of their patients with AD.

Algorithm for the Decision-making Capacity Assessment Process
A secondary aim of the study was to propose an algorithm for a reliable, comprehensive, and systematic assessment of the DMC.It is noteworthy that the decision of an impaired DMC should rely on the severity of the cognitive impairment, the decision that needs to be taken, and the risk-bene t ratio of the various options 10 .Accordingly, in practice, this involves subjecting patients who are facing more serious procedures and therapies, to a more rigorous process of DMC testing (Table 4).Substantive criticism takes place when the assessment of DMC relies exclusively on the patients' cognitive processes while discarding their emotions since emotions often provide a valid reason for action 23 .Furthermore, strategies to alleviate a patient's fear and anxiety should be considered, since it might interfere with his/her ability to attend to and process information.Therefore, introducing a known and trusted con dant or adviser to the DMC process, may help the patient in making an educated decision 16 .Moreover, the clinician must ensure that contextual and personal factors are taken into consideration, to enable the patients to make the appropriate decisions.This includes: spending time educating patients, and their families; ensuring that patients adequately understand the disclosed information; and taking into account lucid intervals, nancial coverage 11 , and any disease that may interfere with DMC.
Regarding cognitive testing, the Montreal Cognitive Assessment (MoCA) tool outmatched the MMSE due to its high sensitivity in the early detection of dementia, mild cognitive impairment, and AD 20,21 .MoCA evaluates different types of cognitive abilities 20,21 .
Furthermore, when a cut-off score of ( 23) was used, both sensitivity and speci city were excellent (0.96 and 0.95, respectively) 22 .
It is noteworthy that the "Understanding" capacity is affected the earliest, followed by reasoning and appreciation while making a "choice" is preserved the longest 18 .The simpli ed three-item questionnaire (cut-off of 2.5), showed a sensitivity of 100% and speci city of 77.3% when compared to MacCAT-CR on the testing of the "Understanding subscale".This nding suggests that this tool might allow healthcare professionals to screen for those with an understanding de cit, which will save time and requires less training than the MacCAT tool 18,24 .
Therefore, clinical experience combined with neuropsychological testing "MoCA", and a capacity testing screening tool "The simpli ed three-item questionnaire" should be considered to optimize the DMC testing process.If a de cit appeared in the "understanding" capacity, then the use of the MacCAT tool is recommended.
When feasible, it is suggested that patients are assessed several times before labeling them as lacking DMC 13 .However, if despite such efforts, the patient's incapacity to make a decision persists, a proxy must be sought 16 .In emergencies, physicians can decide on behalf of the patient, under the presumption that a reasonable person would have consented to such treatment 16 Section one: socio-demographic data.This section intended to collect socio-demographic data related to the geriatricians, such as their years of experience, their gender, and their area(s) of practice [(a) academic, (b) research, (c) clinical, (d) administrative, or (e) consultation].The last question was related to the clinical/research practice setting (s) [(a) university-hospital, (b) private clinic, (c) or specialized geriatric center].

Figures
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Figure 2 Distribution
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Figure 2 Distribution
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Figure 3 Distribution
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Table 3 .
Representation of the modalities used by the geriatricians to assess decision-making capacity.The University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 25

Table 4 .
19iding scale approach grading.Modified from Álvaro (2012)19.Consent where risk/benefit balance is favourable LOW 2.Refusal where risk/benefit balance is unfavourable Standard 2 Consent or refusal where risk/benefit balance is unclear MODERATE Standard 3 1.Acceptance where risk/benefit balance is unfavourable HIGH 2.Refusal where risk/benefit balance is favourable