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Browsing by Subject "LVAD"

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    Informed consent in the context of left ventricular assist device use as destination therapy (LVAD-DT): A systematic review and ethical analysis
    (2020-09) Friedman, James
    Background: The circumstances surrounding the informed consent process for accepting LVAD-DT are incredibly complex and discretely nuanced from individual to individual. Additionally, the population requiring this powerful technology continues to grow, and those receiving it are living much longer. The gaps between client experiences and expectations prior to LVAD-DT consideration and after LVAD-DT implantation, and the evolving legal and ethical underpinnings influencing clinicians and health care more generally indicate a critical need for review and assessment of the degree to which current practice conforms to the standard(s) of informed consent, and the level to which that application can be sustained. The primary aim of this proposed systematic review then is to identify and understand the standard(s) of informed consent applied in the context of LVAD-DT. A secondary aim is to determine the degree to which informed consent in this context conforms to the accepted standard(s). A third aim is to recommend guidelines for undertaking informed consent in a way that better addresses the needs and interests of individuals receiving LVAD-DT. Methods: This report is a systematic review of the LVAD-DT and ethics literature, and ethical analysis of the application of informed consent in the context of LVAD-DT. Two related but distinct literature reviews will be undertaken. Findings: Four important findings with regard to the practice of informed consent were identified: 1) the broadest perception of the purpose of informed consent is to inform the client, not foster and facilitate autonomy; 2) clinicians lack adequate understanding or insight about the amount and type of information required or preferred by the individual client, as well as how that information is preferred to be shared with them; 3) This lack of understanding or insight undermines the practice of informed consent and adversely affects care delivery and outcomes; 4) The quality of informed consent may be closely associated with the quality and depth of relationship between client and clinician. Conclusions: Although all centers offering LVAD-DT comply with the currently accepted practice of informed consent, there are significant concerns about the usefulness of that model in this context. Joan Tronto’s (2009) informed consent as a grant of authority is a model of empowered choice that is more conducive to the goal of fostering and facilitating client autonomy than the currently accepted practice of informed consent. Key words: standards of informed consent, left ventricular assist device-destination therapy, LVAD-DT, and LVAD
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    Left ventricular assist device therapy: family caregivers' stress, perceived burden and quality of life.
    (2011-04) Petty, Michael Glenn
    Background: Individuals implanted with left ventricular assist devices (LVADs) as bridge to transplant or as destination therapy expect to be discharged home. Responsibility for providing care to those patients has fallen almost exclusively to family caregivers. Yet there is a paucity of research on the experience of family caregivers of LVAD patients. This study assessed the burden and quality of life (QOL) of caregivers over a period of up to 6 months. The influence of stress and select demographic variables on those outcomes was also evaluated. Methods: Subjects recruited from a single LVAD center in the upper Midwest were required to be > 18 years old, the identified primary caregiver of an LVAD patient, and able to read and write English. Each was asked to complete a questionnaire at baseline and again at 2, 6, 14 and 22 weeks after the baseline measure. Measures included demographics, the Caregiver Distress Scale, the Caregiver Involvement Instrument, the Caregiver Burden Assessment, the Cantril Ladder scale, the CES-D, and the SF-12. Results: A total of 46 subjects provided data for analysis. The average caregiver was a 58 year old Caucasian female spouse of a bridge-to-transplant patient with a HeartMate II living with the patient and one other adult with an average income of $40,000-$59,999. Stress was mildly to moderately elevated over the entire period. Baseline burden was measured at levels that warranted intervention in up to 41% of participants, but decreased steadily over time (p=.04). Sixty to eighty-five percent of subjects reported below average quality of life that was largely static across the study. Stress was negatively correlated with QOL. (p=.004) Conclusions: Interventions to reduce stress are most likely to improve caregiver quality of life.