Defining Success and Ethical Decision-Making in Vascularized Composite Allotransplantation: A Bioethical Deliberation Model

Abstract

This chapter explores the intricate bioethical considerations surrounding Vascularized Composite Allotransplantation (VCA) and proposes a bioethical deliberation model. The primary focus is on defining success criteria for VCA and fostering ethical decision-making to enhance patient outcomes. The chapter delves into critical variables to define beneficence, non-maleficence, autonomy, and justice and their role in shaping the success of VCA procedures. The significance of assessing both receiver and institutional capacities is emphasized, along with the importance of objective resilience, deferential vulnerability, and decisional capacity in evaluating patient eligibility. Furthermore, the healthcare team’s capacity for ethical deliberation and the resources required to support patient resilience are explored. By addressing these crucial factors, the proposed bioethical deliberation model aims to align VCA practices with the principles of beneficence, non-maleficence, autonomy, and justice. This chapter offers valuable insights into the ethical dimensions of VCA and provides a framework that can contribute to improved patient care and treatment outcomes.

1. Introduction

Vascularized Composite Allotransplantation (VCA) is a surgical technique aimed at transplanting multiple tissues as a single functional unit, such as skin, muscles, nerves, and bone, with the objective of enhancing the quality of life. Despite significant advancements in surgical techniques, several bioethical challenges remain to be addressed. These challenges encompass various aspects, including the economic burdens associated with the procedure [1], the potential risks of long-term immunosuppressive therapy, such as increased susceptibility to malignancy [2], and the occurrence of acute and chronic rejection [3, 4]. Moreover, the autonomy of patients in choosing a non-life-saving intervention [5] and the adequacy of psychosocial evaluation tools developed primarily in developed countries [6] are important considerations in the ethical discourse surrounding VCA. Additionally, bioethical concerns extend to the capacity of healthcare teams to effectively manage VCA cases and the need to balance patient suitability for the procedure with the capacity of the country and healthcare system to support such interventions. Finally, definitions regarding transplant success are not straightforward [7]. Although it is true that definitions of transplant success may vary depending on each individual, we believe there must be core domains upon which individual traits can be accommodated.

To address these important considerations, it is crucial to define the success criteria for VCA and establish a framework for evaluating patients, healthcare systems, and the bioethical aspects involved. This chapter aims to examine the bioethical considerations in VCA and propose a preliminary bioethical deliberation model. To achieve this, first, we will try to define success criteria for VCA procedures, based on critical variables that operationalize the principles of beneficence, non-maleficence, autonomy, and justice. Based on the definition of success, a bioethical deliberation model is proposed to evaluate Deliberative Capacity (to attend to the criteria of Autonomy and Justice), as well as Receiver-Offering Capacity (to attend to the criteria of Nonmaleficence and Beneficence), both on patients and healthcare teams. By addressing these bioethical considerations and providing a clear framework for decision-making, the aim is to ensure that VCA procedures are conducted in an ethically responsible manner, considering the well-being of patients and the integrity of healthcare systems.

2. Towards a definition of success in VCA

To approach a comprehensive definition of success in VCA, it is essential to consider the four fundamental principles of beneficence, nonmaleficence, autonomy, and justice, with critical variables serving as a solid foundation for defining and operationalizing these principles.

2.1 Non-maleficence and beneficence

To precisely define the concept of beneficence in the context of VCA, it is essential to revisit the procedure’s bioethical justification: the enhancement of quality of life. Quality of life is intricately tied to the processes of multisystemic resilience, which enables individuals and their support networks to cope with adversity and continue pursuing their goals and aspirations despite challenges.

The focus on resilience as a key variable for success should guide bioethical deliberation. We propose to pay special focus on Objective Resilience, as an indicator that encompasses both key multisystemic resilience domains, as well as important quality of life domains as measured by the WHOQOL [8] and SF-36 [9]. Therefore, it is important to define what multisystemic and objective resilience entails.

2.1.1 Multisystemic resilience

According to Ungar [10], resilience is a complex and multisystemic phenomenon that extends beyond individual characteristics. It recognizes that an individual’s ability to navigate and overcome adversity is intricately tied to the availability, accessibility, and meaningfulness of critical resources within various systems that encompass different domains of life that directly or indirectly impact an individual’s ability to navigate and overcome adversity. According to Bronfenbrenner’s Theory of Social Ecology [11], these systems include the individual, their close support networks such as family and healthcare teams (microsystem), the interactions between different microsystems (mesosystem), broader social structures that influence meso- and microsystemic relationships (exosystem), cultural norms, laws, and customs (macrosystem), and the temporal dimension within which these systems interact and change (cronosystem).

This multisystemic perspective allows individuals or communities to engage in processes of recovery, adaptation, and transformation. Recovery, as described by Ungar [10], involves returning to a state equal to or better than before the adversity. It signifies the ability to regain equilibrium and restore functioning after experiencing challenges. Adaptation, on the other hand, refers to the process of positively adjusting to changes brought about by adversity. It entails developing new strategies, skills, and perspectives to effectively cope and thrive in the face of challenges. Lastly, transformation occurs when systems are improved as a result of navigating and overcoming adversity. It signifies the potential for growth, innovation, and positive change within individuals, communities, and even larger societal structures.

2.1.2 QoL-objective resilience

Resilience, at any level, is achieved through the availability, accessibility, and meaningfulness of critical resources within multiple systems. This inherently multisystemic nature of resilience forms the foundation for objective resilience. Objective resilience, as emphasized in the bioethical deliberation model, encompasses both immediate contextual domains that directly support QoL—such as support network’s material stability, access to environment, independence in relation to physical and emotional limitations, and social functioning—as well as individual domains, such as physical pain, physical energy, physical limitations, psychological well-being, psychological limitations, and individual material stability. These dimensions provide a comprehensive understanding of an individual’s overall functioning and the impact of different factors on their quality of life.

By considering these factors, objective resilience serves as a critical material variable that underpins the moral justification of VCA. The underlying promise of VCA is to improve resilience via the increase of availability, accessibility, or meaningfulness of critical resources both for objective resilience domains, as well as those of multisystemic resilience. Thus, defining transplant success involves increasing objective and multisystemic resilience not only in terms of recovery, primarily through treatment adherence, but also in the patient’s adaptation and the transformation of the healthcare system.

2.2 Autonomy

Autonomy, a fundamental principle of bioethics, plays a vital role in informed consent and medical practice. Autonomy is characterized by self-governance and personal causation, reflecting an individual’s ability to make autonomous choices. Respecting patient autonomy plays a crucial role in defining the success of a transplant as it recognizes their ability to deliberate and make decisions regarding their treatment [12]. Autonomy forms the foundation for informed consent to be considered valid [13, 14, 15]. Several factors must be evaluated by practitioners to determine the validity of patients’ informed consent, including competence, disclosure, comprehension, voluntariness, and agreement [13].

Psychological assessments are commonly used to assess the capacity of transplant candidates to provide informed consent. However, these assessments primarily focus on cognitive vulnerabilities that may impede understanding. While voluntariness and agreement are essential aspects of informed consent, the psychological factors involved are often overlooked due to their challenging measurability and susceptibility to deferential vulnerability: pressures that prompt patients to “accede to the perceived desires of certain others notwithstanding an inner reticence to do so” [16]. Such vulnerability—among others—compromise consent. Despite its relevance, currently, psychosocial evaluations of patient candidacy do not specifically address the assessment of autonomy in relation to deferential vulnerabilities [17]. To bridge this gap, we propose and continue developing a theoretical framework (under review) informed by a Kantian interpretation of Honneth’s Recognition Theory [18, 19], emphasizing the importance of self-relationships and human dignity. This framework is complemented by Figure 1, which shows key moments of the theory, as well as indicators for its observation.

Figure 1.

Bioethical principles in the bioethical deliberation model. Note: QOL-objective resilience is at the center, overlapping with both autonomy of the patient, and justice of the healthcare team. QOL-objective resilience has three levels: Recovery (non-maleficence), adaptation (beneficence), and transformation (beneficence). Autonomy is divided into positive and negative freedom. Some further annotations are included per domain.

According to Honneth’s Theory of Recognition [18, 19], essential self-relationships precede autonomous functioning and include self-trust, self-respect, and self-esteem. Although these definitions highlight relevant social values, we believe that it is important to also think about the self-relationships described through the light of a Kantian vision to further highlight a non-movable value—human dignity. The concept of value necessitates a comparison between objects based on a criterion that bestows worth. In Western culture, self-worth adjustment typically occurs through two distinct avenues. The first involves oppressive socialization, where individuals conform to societal standards of beauty, wealth, and intelligence. This process leads to the development of “contingent self-esteem” also named “contingent self-worth, “ which depends on meeting specific standards of excellence as outlined by interpersonal or intrapsychic expectations. Alternatively, Kant would argue that self-worth should be based on the unchanging axiom of dignity, which allows no degrees and remains an absolute value despite an individual’s failure to meet social standards.

Self-relationships are closely connected to self-worth, which can be understood through the concepts of dignity and respect. Respect, based on Kantian principles, involves treating others as ends rather than means [20] and refraining from abusing someone’s vulnerable position in which he or she may be treated as if they were undeserving of dignity—for reasons such as those conveyed by oppressive socialization [21]. Self-respect refers to the ability to treat oneself with dignity and recognize one’s absolute value, which cannot be achieved or lost based on external standards or failures. Trust emerges as the expectation that arises from respecting dignity despite flaws, helping to maintain one’s worth even when faced with shortcomings. Self-trust is the expectation that one’s dignity will be defended and treated with respect by oneself, irrespective of societal expectations or oppressive standards, such as those related to beauty—that oppressively subjugate people’s self-recognition of dignity and worth. Self-esteem is a psychological measure of how individuals perceive their relational value and social acceptance by others, as proposed by the sociometer theory [22]. It involves adopting the perspectives and judgments of others, and it fluctuates based on accomplishments and social recognition [23]. It is determined by what is deemed socially valuable or repugnant [24].

The argument goes as follows: if a patient seeks a VCA to increase self-esteem (via diminished social rejection), and so to conceal his or her notion of low self-worth, deferential vulnerability to accept the risks of receiving a transplant is likely to be present. Ways to assess deferential vulnerability are proposed later in the chapter.

2.3 Justice

Justice, as a critical component of transplant success, extends beyond equitable resource allocation to include sensitivity to factors that can bias and impede fair deliberation. We believe transplant success should imply a just bioethical debate that considers objective resilience as the foundation of quality of life and be free of oppressive socialization biases (societal norms, values, and prejudices that may unfairly influence individuals’ beliefs, choices, and opportunities [21]). Under oppressive socialization, medical professionals may face external expectations to offer VCA as a solution to patients, even when it may not be the most appropriate or beneficial option. These pressures can stem from societal beliefs regarding beauty standards, the desire to showcase medical advancements, economic considerations, among others. On the other hand, oppressive socialization can perpetuate biases that may unconsciously influence the medical team’s perception of patients, potentially leading to unequal treatment, disregard for patient autonomy, or inappropriate candidate selection. It is important to recognize and address these biases to ensure fair and just decision-making processes.

Overall, justice as a component of transplant success requires not only fair resource allocation but also a commitment to promoting objective resilience and ensuring that ethical deliberations are free from oppressive socialization biases.

After operationalizing each principle, we can say that transplant success in the context of VCA involves a procedure that is autonomously chosen by the patient and fairly allocated by the healthcare team. It aims to effectively promote patient objective resilience, while also addressing the patient’s main motivations and facilitating recovery, adaptation, and transformation.

Based on the proposed definition of transplant success, a process is proposed that seeks to evaluate and promote the conditions for the possibility of transplant success. For this, the bioethical deliberation model has been outlined. This model encompasses an assessment of both the patient’s and the healthcare system’s capacity, focusing on two dimensions: deliberative capacity and receiver-offering capacity. By evaluating these aspects, the model aims to ensure a thorough and comprehensive evaluation process that upholds the principles of beneficence, non-maleficence, autonomy, and justice. It seeks to minimize the impact of oppressive socialization biases and promote a fair and ethical approach to decision-making in VCA.

In this chapter, the elements of the bioethical deliberation model are described both for patients and healthcare teams. In addition, methods or tools for the evaluation or exploration of the domains are described or proposed for either the patient or the healthcare teams.

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).

Figure 2.

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

3.1 Deliberative capacity

Deliberative capacity encompasses the principles of autonomy and justice.

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.

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.

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 self-respect or its absence (evident in shame, self-rejection, etc.) in events where there 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 self-worth. The first thematic axis consists of evidence that the deterioration of self-esteem 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 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, 28, 29, 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].

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 sub-items 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.

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.

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 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 decision-making 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 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-family-healthcare 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 non-maleficence 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.

3.4 Case example

The evaluation process begins with a thorough assessment of the patient’s autonomy and deferential vulnerability through clinical and psychiatric interviews, as described in the corresponding section. A comprehensive multisystemic evaluation is then carried out to estimate the potential effect of the transplant on the patient’s objective resilience and quality of life. This evaluation encompasses various domains, as summarized in Table 1, and takes into account the estimated effects on objective resilience as depicted in Figure 5. Table 1 presents the main domains with key information regarding the presence of risk factors or contraindications. This information allows us to quickly review the patient’s current systems’ resilience and the expected impact of VCA on patient objective resilience.

Main Motivations: elements, hypothetical failure situation	themes
Decision-making capacity (mental examination, psychiatric disorders, vulnerability of deference-autonomy).	No contraindications.
Material (financial situation, hospital debt, social insurance).	Risk factor.
Support network + (availability of the network, type of support, sustainable timeframe).	Available, practical, emotional, economic, medium-term (risk factor if there is no job reintegration or stable support program - long term).
Support network - (obstacles to coherence and meaning of treatment, network exhaustion, long-term support, financial sustainability).	Risk factor.
Linkage between microsystems (patient-family, healthcare team, clear and timely communication).	Risk factor.
Quality of Life (SF, WHOQOL).	Determining factor: theme
Estimated Impact on Objective Resilience.	Beneficial for most dimensions, but a risk factor for individual material stability and support network.

Table 1.

Summary of a preliminary multisystemic psychosocial evaluation.

Preliminary deliberations with the subcommittee are guided by fundamental principles such as respect for physical life, totality, subsidiarity, and freedom and responsibility. Respect for physical life serves as a boundary when considering interventions. Totality emphasizes that any intervention will affect the entirety of the person’s life domains. The principle of subsidiarity is crucial as it calls for a generous attitude, especially in developing countries and when working with vulnerable populations. Finally, freedom and responsibility highlight the notion of being free yet accountable for all aspects of life.

Aligned with these principles, deliberations are held to define the next steps after discussing the current risk factors that predict harm as an effect of VCA. Strategies are proposed to improve patient candidacy and the effect of VCA on the patient’s objective resilience and quality of life. For example, enlisting the patient for job security. As the patient’s candidacy evaluation progresses, ongoing evaluations and training sessions are provided to the healthcare team and VCA subcommittee, tailored to the Mexican context. Additionally, continuous assessment of the capacity to offer VCA is conducted, allowing for iterative improvements in processes, with the ultimate goal of achieving transformation and optimizing outcomes.

It is expected that after systematically following the proposed bioethical deliberation model, the conclusion would be that the patient has autonomously deliberated with knowledge and understanding of the risks and benefits, without a determining pressure to conform to social expectations, and that they desire VCA as a practical strategy to achieve their goals. In addition to having the capacity to weigh and decide, in the case of a successful transplant, it is expected that the patient actively engages to enhance their understanding and deliberative capacity, and they co-create the therapeutic strategy with the healthcare team. On the other hand, a successful VCA case also entails that the individual, as well as their environment, has availability and access to critical resources to 1) prevent, resist, and overcome adversities related to VCA treatment (thus achieving non-maleficence recovery) and 2) positively adapt to their life circumstances with VCA (resulting in a beneficial effect). Additionally, a successful VCA case implies that the healthcare system has the necessary means to ensure non-maleficence and recovery in the patient’s objective resilience and to guarantee beneficence and adaptation in the patient’s objective resilience and quality of life. Finally, it also signifies that the healthcare system has the necessary mechanisms to improve and transform the system and the conditions that improve the multisystemic resilience of the population.

4. Discussion

In the realm of VCA, ethical deliberation plays a pivotal role in safeguarding the well-being of patients and guiding healthcare systems. To address the intricate considerations surrounding VCA and foster informed and ethical decision-making processes, the proposed bioethical deliberation model represents a significant advancement.

Built upon the fundamental principles of beneficence, non-maleficence, autonomy, and justice, as well as the principles of Personalist Bioethics, the model is crafted to align with the bedrock of ethical healthcare practices. By focusing on three key dimensions, namely deliberative capacity, reception-offering capacity, and the deliberation & subsequent design phase, the model provides a robust framework for evaluating and promoting the readiness and suitability of both the patient and the healthcare system for VCA.

At the heart of the model lies the recognition of objective resilience as a critical determinant of success and a catalyst for patient well-being. Objective resilience encapsulates an individual’s capacity to navigate, withstand, and triumph over adversities, thereby enhancing their overall quality of life. By adopting a multisystemic approach to assess objective resilience, the model enables a comprehensive evaluation that takes into account the interconnectedness of various systems contributing to an individual’s resilience.

In conclusion, the proposed bioethical deliberation model offers a structured and comprehensive approach to evaluate VCA procedures, facilitate ethical decision-making, and elevate patient care and treatment outcomes. By thoughtfully considering the critical variables that define beneficence, non-maleficence, autonomy, and justice, this model provides valuable insights into navigating the intricacies of the ethical landscape surrounding VCA. Ultimately, the model serves as a guiding compass for enhancing the well-being of both patients and healthcare systems, exemplifying the ethical aspirations of the VCA field.