Quality of Informed Consent for Adult-to-Adult Living Donor Liver Transplantation

描述（由申请人提供）：自1998年以来，为了应对肝移植的严重短缺，成人对成人活体肝移植（ALDLT）在美国得到越来越多的应用许多移植临床医生、伦理学家和政策制定者都对活体肝供体（LDs）面临严重健康风险的伦理问题感到担忧，因为他们不会获得直接的医疗益处，而且对肝供体的长期预后知之甚少。目前的知情同意程序是否充分告知lld有关aldt的信息，保持他们的自主权，并确保他们的自愿同意，这些伦理问题仍然存在。研究报告称，ld不理解向他们披露的关于ALDLT的信息，并且没有满足信息需求和期望。ld还报告说，由于需要肝移植的患者除了死亡之外别无选择，因此感到不适当的捐献压力。为了使外科医生合乎道德地进行移植手术，必须有证据表明ld了解有关ALDLT过程的信息，并自主决定接受相关风险。然而，目前的实践并不需要对捐赠者的理解进行任何正式评估，也没有工具来正式评估在这种或任何其他临床情况下知情同意的充分性。衡量个体捐赠者对知情同意过程中提供的信息的理解程度，有助于优化获得ldds知情同意的道德实践，并防止手术带来的不必要伤害。本研究的目的是开发和试点测试一种新的捐赠者知情同意评估工具（EDICT），以评估个人捐赠者在ALDLT知情同意过程中的理解程度。该研究将采用Joffe用于评估临床研究中知情同意理解的工具。定性和定量方法，包括对同意书的审查以及与生物伦理学家、临床医生和肝脏捐赠者的访谈和调查，将用于经验验证调整后的工具。具体目标是：(1)开发一个简短的工具来衡量潜在的肝脏捐赠者对ALDLT知情同意的实际（客观）和感知（主观）理解；(2)在肝供候选者中试行EDICT。在ALDLT知情同意过程中，EDICT对于识别ld的理解问题将是有价值的。EDICT的创新之处在于它能够识别个体供体在理解方面的缺陷，并促进进一步有针对性的供体-临床医生沟通，以改善ALDLT的知情同意过程。这项法令还可能使移植中心受益，因为它保证了捐赠可以合乎道德地进行。该提案将响应移植临床医生对经验研究的呼吁，以确保活体肝脏供体对活体肝移植提供充分的知情同意，指导活体肝移植项目提供合乎伦理的临床实践，并为活体肝移植的知情同意标准提供信息。通过提供道德上最优的知情同意程序来减少移植临床医生的担忧，应该促进和扩大活体肝脏捐赠计划，并帮助挽救生命。

DESCRIPTION (provided by applicant): Adult-to-adult living donor liver transplantation (ALDLT) has been increasingly utilized in the US since 1998 in response to the dramatic shortage of liver grafts.1 Many transplant clinicians, ethicists, and policy-makers are concerned about the ethics of subjecting living liver donors (LDs) to serious health risks because they will experience no direct medical benefits and little is known about long-term liver donor outcomes. Ethical questions remain about whether the current informed consent process adequately informs LDs about ALDLT, maintains their autonomy, and assures their voluntary consent. Studies report that LDs do not comprehend the information disclosed to them about ALDLT and have unmet information needs and unmet expectations. LDs also report feeling undue pressure to donate since patients in need of a liver transplant have no alternative to transplantation other than certain death. In order for surgeons to ethically proceed with transplant surgery, there must be evidence that LDs understand the information about the ALDLT process and have made an autonomous decision to undergo the associated risks. However, current practice does not entail any formal assessment of a donor's comprehension and no tools exist to formally assess the adequacy of informed consent in this or any other clinical contexts. Measuring individual donor's comprehension of information provided in the informed consent process could help to optimize the ethical practice of obtaining informed consent for LDs and prevent unnecessary harm through surgery. The objective of this study is to develop and pilot test a new Evaluation of Donor Informed Consent Tool (EDICT), to assess individual donor comprehension during the ALDLT informed consent process. The study will adapt the tool that Joffe used to assess comprehension in informed consent for clinical research. Qualitative and quantitative methods, including consent form review and interviews and surveys with bioethicists, clinicians, and liver donors will be used to empirically validate the adapted tool. The specific aims are to: (1) Develop a brief tool to measure potential liver donors' actual (objective) and perceived (subjective) comprehension in informed consent for ALDLT; and (2) Pilot-test EDICT among liver donor candidates. EDICT will be valuable for identifying comprehension problems of LDs during the ALDLT informed consent process. EDICT is innovative in its ability to identify individual donor deficits in comprehension and prompt further targeted donor-clinician communications to improve the ALDLT informed consent process. EDICT may also benefit transplant centers by providing assurances that the donation may ethically proceed. This proposal will heed transplant clinicians' call for empirical research to ensure that living liver donors provide adequate informed consent for ALDLT, to guide LDLT programs in offering ethically sound clinical practice, and to inform standards for informed consent for ALDLT. Reducing transplant clinicians' concerns by providing an ethically optimal informed consent process should promote and expand living liver donor programs and help save lives. PUBLIC HEALTH RELEVANCE: The objective of this study is to develop a new tool (Evaluation of Donor Informed Consent Tool (EDICT)) that measures living liver donor candidates' comprehension in the informed consent process for adult-to-adult living donor liver transplantation. This tool will help to improve the informed consent process for living liver donation by identifying living donors' comprehension deficits and prompting targeted donor-clinician communication. Promoting an ethically optimal informed consent process will help to provide assurances to transplant clinicians that the donation may ethically proceed, promote living liver donor programs, and help save lives.