Geriatricians’ standpoint of the informed consent process among patients with Alzheimer’s disease

Abstract

Many gray areas remain regarding patients’ capacity to consent, despite the existence of laws in that regard. Decision-making capacity is lost in some patients, as dementia progresses. This study investigates the geriatricians’ understanding of the principle of autonomy and their perception of the decision-making capacity (DMC) testing among patients with (Alzheimer’s disease (AD). The secondary aim was to propose an algorithm for a reliable, comprehensive, and valid assessment of DMC. A cross-sectional descriptive study was designed to empirically collect data via an e-survey. Geriatricians were approached via a phone call, to provide them with study-specific information. Those who accepted to participate received a link to the study’s survey via e-mail. Among the eligible geriatricians, 75% had completed the e-survey, with a mean of 14.7 ± 9.6 years of experience. More than half of the geriatricians failed to recognize that assessing the patients’ DMC is an integral component of the informed consent (IC) process. Yet, 88.9% assessed the DMC of their patients with AD using different modalities. However, the majority were unable to justify their judgment of DMC based on the tools they have selected. Lebanese geriatricians have 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.

Keywords:

• Autonomy
• Informed Consent
• Decision-making Capacity
• Alzheimer’s Disease

PUBLIC INTEREST STATEMENT

Many gray areas remain regarding patients’ capacity to consent, despite the existence of laws with that regard. Decision-making capacity is lost in some patients, as dementia progresses. This study touches on interesting issues like the lack of understanding of pivotal concepts such as autonomy and decision-making capacity among geriatricians evaluating patients with Alzheimer’s Disease (AD). The secondary aim was to propose an algorithm for a reliable, comprehensive, and valid assessment of DMC. The findings of this study show that Lebanese geriatricians have demonstrated a poor understanding of the concept of autonomy and failed to recognize the need for the DMC assessment as a component of the Informed Consent’s process. Moreover, they were unable to select adequate tools to assess and judge the DMC of their patients with AD.

1. Background

The decline in the global fertility rates, combined with the increase in life expectancy is causing an increase in the global aging population (Fakhro, 2018). Alzheimer’s disease (AD) is a degenerative brain disease and the most common cause of dementia among older adults (Karlawish et al., 2002). 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 (Koonrungsesomboon et al., 2015). Autonomy is “a person’s ability and opportunity to make decisions relating to his/her wishes” (Rosin & Dijk, 2005), or “an act of self-determination exercised by a competent person” (Kim, 2012). As determined by Belmont’s report, the autonomy principle requires three elements to validate the process of informed consent (IC): (1) disclosure of sufficient relevant information for decision-making, (2) patient’s comprehension, and (3) voluntariness (Koonrungsesomboon et al., 2015).

As dementia progresses, it leads to several functional and cognitive alterations, making patients vulnerable, and reducing their quality of life (Gilbert et al., 2017). In practice, one of the most significant components of vulnerability among these patients is the loss of the decision-making capacity (DMC) (Gilbert et al., 2017; Lord et al., 2015). 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 (Hirschman et al., 2005). 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 (Gilbert et al., 2017).

The “comprehension” element of the informed consent, requires an adequate understanding of the provided information (Koonrungsesomboon et al., 2015)^, and a capacity to make a decision (Siegel et al., 2014). It is noteworthy that even though capacity is dependent on cognition, it is not the same as cognition (Hegde & Ellajosyula, 2016). 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 (Hegde & Ellajosyula, 2016). It would be preferable to use the MMSE in conjunction with other tests to improve the patient’s comprehension of the tasks (Hegde & Ellajosyula, 2016). Furthermore, cognitive function and decisional ability might vary with time. This fact warrant consideration since it might affect the judgment of DMC (Hegde & Ellajosyula, 2016; Hughes, 2001). Therefore, during the evaluation process of patients with dementia, it is important to assess their cognitive capacities, and decisional abilities, at a specific time and context (Siegel et al., 2014).

DMC is evaluated through a two-steps process. At first, the clinician assesses a person’s decisional abilities, then judges the patient’s capacity to take a specific decision (e.g., consent) (Hegde & Ellajosyula, 2016). The consensus is that DMC is based on four different aptitudes, which are, the ability to choose, understand, appreciate, and reason (Gilbert et al., 2017). Understanding reflects 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 (Gilbert et al., 2017). It is noteworthy that no single test exists that could be considered as the gold standard for DMC assessment (Karlawish et al., 2002). However, the MacArthur Competency Assessment Tool (MacCAT) is the most commonly used and the best validated semi-structured interview to assess the DMC (Karlawish et al., 2002). Moreover, MacCAT assesses a person’s capacity to make a choice, understand, appreciate, and reason (Karlawish et al., 2002).

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 (Gilbert et al., 2017).

Geriatricians’ standpoint on the application of the ethical principle of autonomy among persons with AD has not been 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.

2. Methods

2.1. 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 confidentiality reasons, all collected data (logged, analysed) were kept in a concealed place (password-protected computer) and reviewed only by the principal investigator.

2.2. Participants and selection criteria

It is noteworthy that there is a major deficit in the number of physicians specialized in geriatrics in Lebanon (Abyad, 1995). 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).

Figure 1. Flowchart representing the recruitment pool

2.3. 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 LSGM received a phone call from the primary investigator to provide information related to the study. The geriatricians who accepted to enroll received a link via e-mail to the study’s survey. The participants were followed up twice a week, for a month, to ensure that they have 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.

2.4. 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].

2.5. Section two: Autonomy

This section was designed to capture the geriatricians’ understanding of the ethical concept of autonomy (Table 1).

Table 1. Questions related to section two: autonomy

Question 1 Which among the following statement(s) reflect on the principle of “Autonomy”?

An act of self-determination exercised by a competent person. An ability and opportunity to make decisions related to the patient’s own wishes. In the case of confirmed incompetence, and no emergency, the decision is taken by a legal surrogate defined by a “person of trust” that reflect the patient’s wishes. In the case of confirmed incompetence, and no emergency, the decision is taken by the treating Physician. None of the above.

Question 2 Is the process of “Informed Consent” of patients with AD, considered a must in the research or clinical settings? Yes No

Question 3 Does legislation exist in Lebanon regarding the process of “Informed Consent”? Yes No

Question 4 Select the necessary element(s) as required by the process of “Informed consent”.

Adequate disclosure of information. A context-free of undue influence, allowing the patient to make a voluntary choice. Confirmation of a patient’s capacity to take a decision.

2.6. 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 defined as “a person’s performance on measures of decision-making abilities” (Karlawish et al., 2002). Capacity was also defined as “a person’s ability to make a particular decision at a specific time or in a specific situation” (Hegde & Ellajosyula, 2016). The term “competency” was defined as being “the judgment that a person’s capacity is adequate to make the decision in question” (Karlawish et al., 2002), 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 first question (Table 2), he/she was systematically directed to submit their answers and finish the survey.

Table 2. Questions related to section three: decision-making capacity

Question 1	Do you test for decision-making capacity (DMC) among your patients with AD?
Yes No
Question 2	How do you measure the DMC of your patients with AD?
Mini-mental state examination (MMSE). MacArthur Competency Assessment Tool for clinical research or Treatment respectively (MacCAT-CR or MacCAT-T). Other (narrative answer).
Question 3	How do you determine if your patient with AD has an adequate decision-making ability based on the above scores of the DMC testing?
Narrative answer

2.7. 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.

3. Results

Twelve geriatricians successfully fulfilled 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 mixed 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 fields other than geriatrics (internal medicine, family medicine, endocrinology, and metabolism), completed afterwards their training in gerontology, and eventually joined the LSGM.

Figure 2. Distribution of geriatricians’ practice areas

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).

Figure 3. Distribution of geriatricians’ work settings

Less than half (33.3%) of the geriatricians were able to correctly identify the statements that reflect 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 decision-making incapacity was confirmed, decision-making is taken by a surrogate defined by a “person of trust” who reflect 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 identified 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 confirmation 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).

Table 3. Representation of the modalities used by the geriatricians to assess decision-making capacity

Tool	Percentage (%)
The University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)	25
MacCAT (CR or T)	12.5
MMSE	37.5
Clinical judgment	25

4. 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) (Epstein, 2008).

The findings of this study revealed that less than half of the geriatricians were able to correctly identify the statements that reflect 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 confirmed, decision-making is done by a surrogate defined by a “person of trust” that reflects the patient’s wishes. This was similar to a study conducted by Tarabey et al. (2018) (Tarabey et al., 2018), 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 findings of a Lebanese national survey conducted by Abou-Mrad (2008) (Abou-Mrad, 2008) 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) (Appelbaum, 2007) 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 benefits. 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) (Comité Consultatif National Libanais d’ Ethique, 2019). Moreover, more than half of the geriatricians (66.7%) failed to recognize that “a confirmation 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 (Jeste et al., 2007). Therefore, making a judgment based on only one assessment method (i.e. MMSE) would be erroneous (Jeste et al., 2007). However, the study’s findings 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) (Appelbaum, 2007) 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 (Appelbaum, 2007).

Regarding the final 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 justified by the fact that the MacCAT tool does not establish a cut-off score for capacity, and the validity of the final judgment will depend on other clinical variables combined with the clinician judgment (Appelbaum, 2007). Moreover, the UBACC seems interesting for routine practice due to its simplicity, relevance, and applicability in older patients (Jeste et al., 2007). 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 final determination of capacity (Gilbert et al., 2017). Similarly, the sole use of clinical expertise to make a judgment of the patients’ DMC was shown to be imprecise (Jeste et al., 2007).

4.1. Algorithm for the decision-making capacity assessment process

The findings of this study set a motivation to propose a set of recommendations to improve and standardize the assessment of DMC. The decision of an impaired DMC should rely on the severity of the cognitive impairment, psychological and behavioral symptoms of dementia, context, decision that needs to be taken, and risk-benefit ratio of the various options (Hegde & Ellajosyula, 2016). Accordingly, in practice, this involves subjecting patients who are facing more serious procedures and therapies, to a more rigorous process of DMC testing (Álvaro, 2012) (Table 4).

Table 4. Sliding scale approach grading. Modified from Álvaro (2012)(Álvaro, 2012)

	Decisions	Competency
Standard 1	Consent where risk/benefit balance is favourable	LOW
	Refusal where risk/benefit balance is unfavourable
Standard 2	Consent or refusal where risk/benefit balance is unclear	MODERATE
Standard 3	Acceptance where risk/benefit balance is unfavourable	HIGH
	Refusal where risk/benefit balance is favourable

Strict guidelines may promote the principle of justice through ensuring consistency, meaning, they allow treating similar cases in the same way by implementing a process that results in a reliable assessment of DMC (Siegel et al., 2014). Yet, these guidelines can impede the clinician’s ability to tailor adequate care based on the patient’s circumstances, values, and medical history (Siegel et al., 2014). Adopting policies that are too flexible, that rely solely on the clinician experience and personal judgment, tend to compromise on reliability and with it the ethics of justice (Siegel et al., 2014).

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 (Luis et al., 2009; Mast & Gerstenecker, 2010). MoCA evaluates different types of cognitive abilities (Luis et al., 2009; Mast & Gerstenecker, 2010). Furthermore, when a cut-off score (23) was used, both sensitivity and specificity were excellent (0.96 and 0.95, respectively) (Nasreddine et al., 2005). 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 (Charland, 2011). 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 confidant or adviser to the DMC process, may help the patient in making an educated decision (Appelbaum, 2007).

It is noteworthy that the “Understanding” capacity is affected the earliest, followed by reasoning and appreciation while making a “choice” is preserved the longest (Jeste et al., 2007). The simplified three-item questionnaire (cut-off of 2.5), showed a sensitivity of 100% and specificity of 77.3% when compared to MacCAT-CR on the testing of the “Understanding subscale”. This finding suggests that this tool might allow healthcare professionals to screen for those with an understanding deficit, which will save time and requires less training than the MacCAT tool (Jeste et al., 2007; Palmer et al., 2005).

When feasible, it is suggested that patients are assessed several times before labeling them as lacking DMC (Epstein, 2008). However, if despite such efforts, the patient’s incapacity to make a decision persists, a proxy must be sought (Appelbaum, 2007). In emergencies, physicians can decide on behalf of the patient, under the presumption that a reasonable person would have consented to such treatment (Appelbaum, 2007). 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; alleviating patients’ anxiety; and taking into account lucid intervals, financial coverage (Hughes, 2001), and any disease that may interfere with DMC.

4.2. Study’s limitation

This study was unable to recruit all the participants despite the high participation rate. The geriatricians who refused to participate might have different perceptions than those who participated. This fact might affect the study’s results. Moreover, the findings of this study cannot be generalized to other medical specialties in Lebanon.

5. Conclusion

The study findings 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.

Moreover, clinical experience combined with neuropsychological testing (MoCA), and a capacity testing screening tool (The simplified three-item questionnaire), in a particular context, and weighed against the benefit to the risk ratio, should be considered to optimize the DMC assessment process. If a deficit appeared in the “understanding” capacity, the use of the MacCAT tool is recommended.

If despite such efforts, the patient’s decisional incapacity persists, a proxy must be sought. Finally, in emergencies, physicians can provide the appropriate decision that would warrant the patient’s best interest.

Ethics Approval and Consent to Participate

Ethical approval was acquired from the Lebanese University institutional review board (IRB). Moreover, the consent obtained from the participants was systematically approved by their participation in the study.

Notes on contributions

FMA, conceptualized and designed this study, collected the data and their management; FMA contributed to the statistical analyses; FMA, analyzed and interpreted the data; FMA, drafted the manuscript, and made the final approval of the version to be published.

Acknowledgements

I would like to thank the Lebanese Society for Geriatric Medicine, presided by Dr. Nazem K. Bassil, for the support provided regarding the data related to geriatricians.

Data availability statement:

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

The author received no direct funding for this research.

Notes on contributors

Mohammed Ali Fakhro

Dr. Mohammed Ali Fakhro is a senior researcher who is involved in the study of the geriatric population from a multitude of angles. Dr. Fakhro is interested in the movement aspect of the older population and studies ways to keep them independent to flow with the concept of active aging. Moreover, Dr. Fakhro searches for ways in the realm of public health to provide ways to keep older adults physically active. More recently, Dr. Fakhro started to explore and dig deeper to find means for respecting the older adults’ wishes during their involvement as participants in the research settings. Therefore, Dr. Fakhro has conducted this paper to investigate the geriatricians’ understanding of the ethical principle of autonomy and decision-making capacity among patients with Alzheimer’s disease. This paper targets the legislators to put the existing law that respects the informed consent process (574/2004) into force, and to expand the testing of patients with compromised capacity to ensure the respect of their autonomy.