The state-of-the-art and the main ethical challenge Left Ventricular Assist Devices (LVADs) represent an innovative alternative treatment for patients affected by advanced heart failure. If, on the one hand the implant prolongs life expectancy, on the other hand many collateral effects may occur during follow up. Given the complexities involved from device activation, a caretaker (generally, a family member) responsible for the everyday management of the therapy, should always accompany the patient. Since a LVAD completely changes both the patient’s and his/her caregiver’s lifestyles, a multidisciplinary team should supervise the development of the therapeutic relationship from the early stages of the decision making to the follow up. In 2013, the International Guidelines for the management of Mechanical Circulatory Supports (MCS) claimed that the peculiarity of the LVAD implant requires the involvement of the caregiver during the patient’s decision-making process. In other words, since the caregiver is responsible for the patient’s well-being, during the decisionmaking process, obtaining the consent from the former is as necessary as obtaining it from the latter. The heterogeneous composition of the pre-implant phase leads us to reflect on the nature of the consent expressed by the patient’s autonomy. Moreover, we must thoroughly evaluate the role of every step of the decision-making process and their compatibility with the patient’s self-determination. The main ethical challenge is to show whether and how the patient's consent may maintain his/her autonomous nature despite the presence of “external” factors involved in the decision-making process. Empirical study In order to explore the components of the consent process, the De Gasperis Cardio Center (ASST Grande Ospedale Metropolitano, Niguarda (MI), Italy) developed a survey to submit to the patients selected for a LVAD implant. Three months after the implant, the patients will receive a second survey. Trials are planned from May 2019 to July 2020. Contrary to expectations, only eight patients underwent the implant and six of them answered to the second survey. Three components of the decision-making process have been analyzed: i) the understanding of the clinical information provided by healthcare professionals; ii) the role of emotions, with a particular focus on fear of dependence on the device and impact on the caretaker; iii) the value attributed to the relationships with the caregiver and the clinicians. We obtained some interesting results, even though statistical analysis has revealed that the survey needs some revisions for future empirical explorations. First, the experience of the device confirms the information received before undergoing the implant: patients show that they have received all necessary communications for a follow-up visit with the LVAD. During follow-up visits, in general patients felt less intimidated by their dependence on the device and on their caretaker. This was a marked difference in emotions from the decision-making process. Stress also seemed reduced in comparison to the decision-making phase. Emotions were, in general, more positive during the follow-up visit. Finally, with regards to the role of relationships, the results confirm that both before and after the implant the value attributed to the bound with the caretaker and the team was very significant for patients: relationship is the component that, in the survey, presented the highest score. The moral turning point: the relational approach in the consent process. We suggest that the relational approach to the notion of autonomy might best translate the complex nature of patient consent. Far from considering it as a fixed event, we propose to consider consent as an ongoing process, defined by time, the context, and the relationships that shape it. Through a literature review, our aim is to show how the notion of relational autonomy is embodied in the clinical practice, in the context of decision-making. During this process, we highlight that the caretaker becomes the third element of the traditional patient-clinician relationship: a shared space of understanding and mutual recognition is established, forming the foundation of the development of every deliberation. Thanks to the ethics by Paul Ricoeur, our last aim is to show how Ricoeurian prudence fits the motion of practical wisdom, which needs the relational context to develop: in this direction, we then show how individual autonomy should be conceived in relational terms. Considering consent as the last word of a path the patient realizes with both the caretaker and healthcare providers, we propose Ricoeurian prudence as the key to understanding the application of the notion of “relational autonomy” in the clinical practice of patient decision-making.

Il consenso dei pazienti candidati ad un dispositivo di assistenza ventricolare sinistra (LVAD): Una riflessione etica sulla nozione di autonomia relazionale nel contesto sanitario / Sara Roggi - : . , 2021. ((33. ciclo, Anno Accademico 2019/2020.

Il consenso dei pazienti candidati ad un dispositivo di assistenza ventricolare sinistra (LVAD): Una riflessione etica sulla nozione di autonomia relazionale nel contesto sanitario

sara roggi
2021

Abstract

The state-of-the-art and the main ethical challenge Left Ventricular Assist Devices (LVADs) represent an innovative alternative treatment for patients affected by advanced heart failure. If, on the one hand the implant prolongs life expectancy, on the other hand many collateral effects may occur during follow up. Given the complexities involved from device activation, a caretaker (generally, a family member) responsible for the everyday management of the therapy, should always accompany the patient. Since a LVAD completely changes both the patient’s and his/her caregiver’s lifestyles, a multidisciplinary team should supervise the development of the therapeutic relationship from the early stages of the decision making to the follow up. In 2013, the International Guidelines for the management of Mechanical Circulatory Supports (MCS) claimed that the peculiarity of the LVAD implant requires the involvement of the caregiver during the patient’s decision-making process. In other words, since the caregiver is responsible for the patient’s well-being, during the decisionmaking process, obtaining the consent from the former is as necessary as obtaining it from the latter. The heterogeneous composition of the pre-implant phase leads us to reflect on the nature of the consent expressed by the patient’s autonomy. Moreover, we must thoroughly evaluate the role of every step of the decision-making process and their compatibility with the patient’s self-determination. The main ethical challenge is to show whether and how the patient's consent may maintain his/her autonomous nature despite the presence of “external” factors involved in the decision-making process. Empirical study In order to explore the components of the consent process, the De Gasperis Cardio Center (ASST Grande Ospedale Metropolitano, Niguarda (MI), Italy) developed a survey to submit to the patients selected for a LVAD implant. Three months after the implant, the patients will receive a second survey. Trials are planned from May 2019 to July 2020. Contrary to expectations, only eight patients underwent the implant and six of them answered to the second survey. Three components of the decision-making process have been analyzed: i) the understanding of the clinical information provided by healthcare professionals; ii) the role of emotions, with a particular focus on fear of dependence on the device and impact on the caretaker; iii) the value attributed to the relationships with the caregiver and the clinicians. We obtained some interesting results, even though statistical analysis has revealed that the survey needs some revisions for future empirical explorations. First, the experience of the device confirms the information received before undergoing the implant: patients show that they have received all necessary communications for a follow-up visit with the LVAD. During follow-up visits, in general patients felt less intimidated by their dependence on the device and on their caretaker. This was a marked difference in emotions from the decision-making process. Stress also seemed reduced in comparison to the decision-making phase. Emotions were, in general, more positive during the follow-up visit. Finally, with regards to the role of relationships, the results confirm that both before and after the implant the value attributed to the bound with the caretaker and the team was very significant for patients: relationship is the component that, in the survey, presented the highest score. The moral turning point: the relational approach in the consent process. We suggest that the relational approach to the notion of autonomy might best translate the complex nature of patient consent. Far from considering it as a fixed event, we propose to consider consent as an ongoing process, defined by time, the context, and the relationships that shape it. Through a literature review, our aim is to show how the notion of relational autonomy is embodied in the clinical practice, in the context of decision-making. During this process, we highlight that the caretaker becomes the third element of the traditional patient-clinician relationship: a shared space of understanding and mutual recognition is established, forming the foundation of the development of every deliberation. Thanks to the ethics by Paul Ricoeur, our last aim is to show how Ricoeurian prudence fits the motion of practical wisdom, which needs the relational context to develop: in this direction, we then show how individual autonomy should be conceived in relational terms. Considering consent as the last word of a path the patient realizes with both the caretaker and healthcare providers, we propose Ricoeurian prudence as the key to understanding the application of the notion of “relational autonomy” in the clinical practice of patient decision-making.
device, heart, consent, autonomy, relationship
Il consenso dei pazienti candidati ad un dispositivo di assistenza ventricolare sinistra (LVAD): Una riflessione etica sulla nozione di autonomia relazionale nel contesto sanitario / Sara Roggi - : . , 2021. ((33. ciclo, Anno Accademico 2019/2020.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11383/2120084
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