**3. Bioethical deliberation model for VCA**

In a general sense, the bioethical deliberation model encompasses the steps for evaluation (through the assessment of deliberative capacity and receiver and offering capacity) and the elements for deliberation and design of strategies (third phase) aligned with the criteria that define success in VCA. For the evaluation phase both for the patient and the healthcare team, it addresses the elements and necessary conditions to, in the negative sense, prevent, resist, and cope with flaws in the corresponding dimension and stakeholder. In the positive sense, it explores the elements and necessary conditions to operate based on maxims that correspond to the greatest good sought by each dimension of the model. In this sense, the aim is to *protect* (negative sense) against factors that distort the optimal functioning of the dimension and *promote* (positive sense) the maximum expression of the good sought by the factor.

Next, a more detailed description will be provided regarding the elements and necessary conditions for evaluating the deliberative capacity and receiver and offering capacity in both the negative and positive sense. Subsequently, the dimension or phase of deliberation and design will be discussed (**Figure 2**).

#### **3.1 Deliberative capacity**

Deliberative capacity encompasses the principles of autonomy and justice.

*Defining Success and Ethical Decision-Making in Vascularized Composite Allotransplantation… DOI: http://dx.doi.org/10.5772/intechopen.112296*

#### **Figure 2.**

*Bioethical deliberation model for VCA. Note: Bioethical deliberation model. + = positive sense (promote); − = negative sense (protect).*

#### *3.1.1 Patient*

In relation to the patient, it refers to their ability to autonomously deliberate and choose whether to undergo VCA, taking into account the capacity to prevent, resist, and overcome limitations in their autonomy (negative sense), and to effectively express the will through decision-making capacity, clarity in weighing risks and benefits, among others (positive sense).

The assessment of the patient's deliberative capacity involves comprehensive psychiatric and psychological evaluations aimed at evaluating the autonomy of their will and deferential vulnerability. It is important to recognize the current lack of standardized tools to assess this vulnerability accurately. Therefore, there is an urgent need to develop reliable scales that measure the proposed self-relationships and examine their relationship with autonomy in decision-making. However, as previously described, a qualitative method based on self-relationships is proposed to evaluate deferential vulnerability, which directly impacts decision-making (and consequently compromises consent) and could obstacle treatment adherence. We propose and continue to develop a theoretical framework informed by a Kantian interpretation of Honneth's Recognition Theory [18, 19] (Farías-Yapur, under review), as described in the Autonomy section. This section provides a practical proposal for evaluating self-relationships, which is schematically illustrated in **Figure 3**. It incorporates Honneth's practical self-correlations and interprets them through the notion of Dignity according to Kant, which provides the normative content upon which the practical self-correlations are defined. Furthermore, it is contrasted with the possible expression of the self-relationships in the context of oppressive socialization.

To assess patients' self-relationships and the influence of public perception on their self-worth, we suggest considering some key dimensions. This will primarily be achieved through clinical interviews, where we will explore the presence of selfrespect or its absence (evident in shame, self-rejection, etc.) in events where there

#### **Figure 3.**

*Evaluating self-relationships. Note: SR = self-respect, SW = self-worth, it is observed that under the context of oppressive socialization, self-esteem determines self-worth, and there is an absence of self-respect, leading to a high presence of shame and probable fear of self-esteem injuries [25]. The key questions proposed, although preliminary and not exhaustive, are briefly shown in blue to guide the clinical interview. We can anticipate that the critical variable is the presence or absence of self-respect.*

have been injuries to the patient's self-esteem or in critical situations such as suicidal ideation or attempts. Monitoring shame carefully serves as an important indicator of potential risk factors for depression and suicidality [25, 26], and may also act as a powerful motivator for seeking VCA, such as face transplantation, as a means of restoration [5].

In clinical interviews, there are four complementary thematic axes that focus on specific elements of the patient's discourse, aimed at understanding the functioning of their practical self-relationships and the potential threat of self-esteem to selfworth. The first thematic axis consists of evidence that the deterioration of selfesteem impairs self-worth, indicating an absence of self-respect. The second thematic axis incudes exploring the impact of deteriorating self-esteem on suicide risk (and identifying mechanisms that prevented suicide such as competing ideas, support networks, etc.). It is important to understand the main causes of suicidal ideation and the resources the patient used to prevent it, as this may provide indications of self-respect. It is noteworthy that several patients seeking VCA face-transplantation have a need derived from trauma resulting from unsuccessful suicide attempts. However, it is important to understand the main causes of these attempts and, based on that information, determine whether they are related to the effects of oppressive socialization or responses to significant impairments to their resilience. The third thematic axis is investigating the independence of self-worth from self-esteem. This involves exploring whether the patient's self-worth remains intact despite a decline

#### *Defining Success and Ethical Decision-Making in Vascularized Composite Allotransplantation… DOI: http://dx.doi.org/10.5772/intechopen.112296*

in self-esteem in various events, potentially due to self-respect. Finally, assessing the presence of self-esteem as a complementary positive self-relationship to self-worth. It is important to note that self-esteem only poses a risk when self-respect is lacking, and it is possible to have a healthy self-esteem and self-worth. Self-esteem, being socially influenced, is related to a sense of transcendence, such as helping other patients prevent risks that led to accidents requiring VCA, among others. As mentioned earlier, throughout this evaluation, special attention should be given to the experience of shame, which is a significant emotional and attitudinal response associated with devaluing self-worth.

The proposed schema suggests conducting a similar assessment of the patient's family to determine whether there is oppressive socialization within the family that causes the patient to perceive a lack of social recognition as an indicator of low dignity. This may result in pressure, albeit well-intentioned, for the patient to undergo an intervention requiring lifelong immunosuppressants.

In addition to measuring autonomy to validate informed consent, it is crucial to delve into the patient's primary motivations that guide their consideration of VCA as a suitable strategy. This comprehensive evaluation aims to uncover their expectations regarding the potential impact of VCA on various dimensions of their objective resilience. Understanding these motivations is paramount, as they shed light on the patient's main objectives and aspirations for a better quality of life. Examining these motivations provides valuable insights into the feasibility of their attainment, alternative approaches to achieving them, potential implications for treatment adherence in the event of failure, and other pertinent considerations that inform the decision-making process. By considering these factors, healthcare professionals can better understand the patient's perspective and tailor the approach to VCA accordingly.

#### *3.1.2 Healthcare team*

Regarding the healthcare team, deliberative capacity refers to their ability to engage in ethical deliberation that is just and unbiased, by having the skills to, in a negative sense, prevent, resist, and overcome flaws in their judgment. It involves being sensitive to biases, understanding the critical dimensions of objective resilience, possessing deliberation skills, and adhering to protective principles such as respect for physical life and totality. Additionally, in a positive sense, it entails promoting the skills to deliberate and actively practice justice through the principles of sociability and subsidiarity, freedom and responsibility, and totality.

While psychiatric evaluations have been recommended for team members to ensure their deliberative capacity, in Mexico we propose conducting an evaluation of fundamental attitudes and key concepts for bioethical deliberation to provide evidence-based training. Some key aspects to evaluate include Moral Competence, Moral Teamwork, Moral Action, Notions of objective resilience as multisystemic and as the basement of quality of life, among others.

To assess the state of each of these aspects within the healthcare team, the following instruments are used: the Euro-MCD 2.0 Instrument is utilized to measure participants' perception of their own abilities such as moral sensitivity, analytical skills, virtuous attitude, open dialog, supportive relationships, moral decision-making, and responsible care. As the principles of Personalistic Bioethics are proposed as integral to the practice of justice and subsequent deliberation and design, the agreement with Personalistic principles is also evaluated.

#### **3.2 Receiver and offering capacity**

Regarding the dimension of the receiver and offering capacity, concerning the patient's receiver capacity, it is crucial to note that without an environment with accessible and relevant resources available to solve problems or promote individual and social development, their achievement, no matter how motivated the patient may be, will be impossible. In that sense, a significant part of evaluating the patient's receiver capacity goes beyond their individual resources or attitudes, etc., and instead asks about the environment and how it should be for the person to recover and adapt from adversity or to achieve flourishing.

In the negative sense, the evaluation considers the elements and necessary conditions to prevent, resist, and overcome adversities derived from VCA, such as everything required to achieve treatment adherence. This level of resilience corresponds to *recovery* and has an effect on the patient's objective resilience of *non-maleficence*. On the other hand, in a positive sense, the evaluation examines the elements and necessary conditions for positive *adaptation* to the patient's life circumstances with VCA, corresponding to a level of resilience higher than recovery and an effect of VCA on the patient's objective resilience and quality of life of *beneficence*.

#### *3.2.1 Patient*

To achieve an increase in objective resilience and quality of life, both at the recovery and adaptation/transformation levels, it is necessary to consider the protective and risk factors present in the multiple systems in which the patient operates. For this purpose, a comprehensive evaluation of the patient's objective resilience involves conducting a multisystemic psychosocial assessment, recognizing that resilience is a complex process that operates within various interconnected systems, including the individual themselves.

While there are existing psychosocial evaluation tools such as the PACT, TERS, and SIPAT instruments [27–30], we supplement their use with clinical interviews guided by a framework developed by Farías-Yapur et al. [6], as these instruments mainly evaluate individual and some microsystem aspects, while neglecting others, such as those specific to developing countries (which is a risk factor for successful patient outcomes). The guide incorporates Bronfenbrenner's Theory of Social Ecology [11], which includes six proposed systems (individual, microsystem, mesosystem, exosystem, macrosystem, and chronosystem), along with Ungar's three resilience process components (availability, accessibility, and meaningfulness of resources necessary for preventing, resisting, and overcoming adversity). An exploratory literature review was conducted, paying special attention to whether the framework and traditional instruments covered psychosocial risk factors that explained failed VCA cases. To include risk factors not reported in the literature and specific to the Mexican context, a semi-structured interview was developed to explore the experiences of patients who had undergone VCA in the corresponding country, in order to understand the obstacles and strategies across the proposed dimensions during their pre and post-surgical treatment.

By utilizing this framework, the evaluation process enables the identification of multisystemic risk and protective factors that impact treatment adherence, a critical behavior for the success of transplantation. A preliminary review of the multisystemic protective and risk factors is shown in **Figure 4**, taken from Farías-Yapur, A. [6].

*Defining Success and Ethical Decision-Making in Vascularized Composite Allotransplantation… DOI: http://dx.doi.org/10.5772/intechopen.112296*


#### **Figure 4.**

*Exploratory review of risk and protective factors to promote treatment adherence as a critical variable for recovery. Note: As shown, in this case, the review and interviews were conducted with previous VCA patients to identify risk and protective factors for achieving treatment adherence. However, the dependent (desired) variable can be any other variable, and the reflection can be approached with the same orientation and classification.*

Based on the developed classification mode, the factors of interest described in the literature, the risk factors that explain transplant failures, the semi-structured interviews conducted with arm transplant patients in Mexico, as well as the factors that are not described but correspond to proposed dimensions, a multisystemic psychosocial assessment guide was developed, where the factors to be evaluated corresponding to each proposed dimension in Farías-Yapur et al. [6] are presented in the form of subitems and questions.

In addition to the multisystemic approach, administering quality of life measures is helpful to estimate subjective notions of well-being, as well as expectations for its improvement. Useful measures include the SF-36 QoL [9] scale, as well as the WHOQOL [8]. Based on information gathered by the aforementioned assessments, a simplified representation of the effect of VCA on critical domains is desirable, such that it helps improve bioethical deliberation regarding patient candidacy, as well as to better tailor specific domains to improve patient candidacy. An example of this (**Figure 5**) could involve a visual representation where the height of the blue line informs about the potential effect of VCA on the current objective resilience of the patient. This visualization provides a clearer understanding of the impact of VCA on the patient's overall well-being and aids in decision-making processes.

#### *3.2.2 Healthcare team*

Regarding the offering capacity of the healthcare team, in a negative sense, we inquire about the necessary elements and conditions to prevent, resist, and overcome

#### **Figure 5.**

*Estimation of the effect of VCA on objective resilience (not real data). Note: Estimated effects are based on the assumption of receiving VCA with current objective resilience.*

obstacles to patient treatment adherence (recovery, non-maleficence). In a positive sense, we explore the elements and conditions required to achieve the transformation of the system and environment that influence the overall resilience of the population (which corresponds to the highest level of impact and increase in multisystemic resilience).

As part of the systems with which the patient interacts from a multisystemic perspective, we have the microsystem of the healthcare team itself, whose interaction with the other relevant systems constitutes the mesosystem. The proposed approach involves examining whether the system has access to the necessary and accessible resources to successfully carry out VCA and create conditions that enable patients to overcome adversities.

It has been reported that the quality of collaboration within the healthcare team is a crucial factor that predicts patient success [31]. According to Babiker et al. [32], "an effective team is one where the team members, including the patients, communicate with each other, as well as merging their observations, expertise, and decisionmaking responsibilities to optimize patients' care." The general institutional capacity of the team can be assessed, and a useful tool for this is the Clinical Sustainability Assessment Tool [33]. In addition to assessing institutional capacity on its own, factors related to the internal functioning of the microsystem in terms of communication, mesosystemic communication (with the patient and support networks), and the integration of information from all involved parties must be evaluated.

Based on the multisystemic psychosocial assessment guide and the preliminary guide to support the evaluation of institutional capacity developed by the Bioethics Team of the VCA Subcommittee (Anneke Farías Yapur, Juan Manuel

*Defining Success and Ethical Decision-Making in Vascularized Composite Allotransplantation… DOI: http://dx.doi.org/10.5772/intechopen.112296*

Palomares, Marieli de los Ríos Uriarte, Elvira Llaca García) the following domains are proposed for evaluation: 1) Comprehensive treatment, common goals, updated information; 2) Communication with the patient; 3) Integration of all involved services, including the patient.

In the context of comprehensive treatment, effective communication, and integration of all involved services, participants are presented with a series of statements to gauge their agreement levels. These statements cover various aspects, such as common goals, shared understanding of success for each patient, established processes for case analysis, and addressing doubts from all stakeholders. Furthermore, communication with the patient emphasizes clear dissemination of relevant information, thorough explanation of treatment implications involving consultative services, ensuring clarity about the next steps, understanding the purpose of each treatment element and phase, identifying and resolving obstacles to treatment adherence, and actively involving the patient in the treatment design. Additionally, the integration of all involved services aimed to establish clear short-term and long-term goals, define transplant success in alignment with bioethical principles, ensure a comprehensive understanding of the quality of life among patients, families, and physicians, establish and evolve transplant goals over time, and communicate both short-term and long-term objectives.

Based on the results obtained, training programs are designed for the subcommittee, and improvements are designed and implemented in the patient-familyhealthcare team mesosystem.

#### **3.3 Bioethical deliberation and subsequent design**

Finally, in the phase of bioethical deliberation and design of the next steps, the entire healthcare team is involved, and the results obtained during the previous phase are considered. Deliberation and the design of the next steps are based on the personalistic principles of respect for physical life, the principle of totality, solidarity and subsidiarity, and freedom and responsibility.

One crucial aspect of this deliberation is identifying any maleficence effects that may arise in specific domains of the patient's resilience. These red flags serve as indicators to explore alternative designs that, at the very least, do not worsen the patient's objective resilience. For instance, the economic impact of VCA on personal finances is a significant consideration. If it is determined that the financial burden of VCA is negative, proceeding with may not be feasible, unless sustainability is guaranteed. Therefore, it is essential to ensure that all dimensions of objective resilience predict a minimum effect of non-maleficence, although it is important to note that nonmaleficence alone would not justify the pursuit of VCA, given the promise to enhance the patient's quality of life.

To illustrate and simplify data, we represent effects on objective resilience domains in terms of an ordinal scale to denote beneficence if the line touches the outer circle, non-maleficence if it stays in the middle circle, and maleficence if it touches the center, as shown in **Figure 5**.

To foster resilience and mitigate potential negative impacts, strategies that promote the former should be incorporated into the design. This may include interventions such as healthcare inclusion and work inclusion, which can have positive effects on the patient's overall well-being and adherence to treatment sustainability. Collaborating with professionals such as social workers, psychologists, legal experts, and occupational therapists is crucial in designing and implementing resilience-promoting interventions. Occupational therapists, in particular, play a vital role in helping individuals regain and enhance their functional abilities, independence, and overall well-being, making their involvement essential in the VCA process.
