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

成人对成人活体肝移植知情同意的质量

• 批准号: 8089174
• 负责人: Elisa J Gordon
• 金额: $ 7.63万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8089174
• 关键词: Adult; Bioethics Consultants; Cessation of life; Clinical; Clinical Research; Cohort Studies; Communication; Comprehension; Conflict (Psychology); Consent; Consent Forms; Documentation; Empirical Research; Ensure; Ethicists; Ethics; Evaluation; Feeling; Goals; Health; Health Personnel; Individual; Informed Consent; Institute of Medicine (U.S.); Interview; Knowledge; Life; Liver; Liver Failure; Living Donor Liver Transplantation; Living Donors; Measures; Medical; Methods; Modeling; Nonmaleficence; Operative Surgical Procedures; Organ; Outcome; Patient-Centered Care; Patients; Policy Maker; Process; Readiness; Regrets; Reporting; Risk; Screening procedure; Site; Surgeon; Surveys; Testing; Time; Transplantation; United States National Institutes of Health; Universities; Validation; clinical practice; evaluation/testing; expectation; experience; improved; innovation; instrument; liver transplantation; pressure; prevent; programs; research clinical testing; response; sound; tool

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.

描述（申请人提供）：自1998年以来，为了应对肝脏移植物的严重短缺，成人间活体肝移植（ALDLT）在美国得到了越来越多的应用。1许多移植临床医生，伦理学家，政策制定者担心活体肝脏捐献者（LD）严重的健康风险，因为他们不会经历直接的医疗利益，而且对肝脏供体的长期结果知之甚少。伦理问题仍然是关于目前的知情同意过程是否充分告知LD关于ALDLT，保持他们的自主权，并确保他们的自愿同意。 研究报告称，LD不理解向他们披露的有关ALDLT的信息，并且有未满足的信息需求和未满足的期望。LD还报告说，由于需要肝移植的患者除了一定的死亡之外别无选择，因此他们感到捐赠的压力过大。为了让外科医生在伦理上进行移植手术，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，目前的做法并不需要任何正式的评估捐助者的理解，并没有工具存在正式评估知情同意在此或任何其他临床情况下的充分性。测量个体捐赠者对知情同意过程中提供的信息的理解有助于优化获得LD知情同意的伦理实践，并防止通过手术造成不必要的伤害。 本研究的目的是开发和试点测试一种新的供体知情同意工具（EDICT）的评价，以评估个体供体在ALDLT知情同意过程中的理解。该研究将采用Joffe用于评估临床研究知情同意书理解的工具。定性和定量的方法，包括同意书审查和采访和调查与生物伦理学家，临床医生和肝脏捐赠者将用于经验验证适应的工具。具体目标是：（1）开发一个简单的工具来测量潜在肝脏供体对ALDLT知情同意的实际（客观）和感知（主观）理解;（2）在肝脏供体候选人中进行试点测试EDICT。 EDICT将是有价值的，以确定在ALDLT知情同意过程中的LD的理解问题。EDICT在识别个体供体理解缺陷和促进进一步有针对性的供体-临床医生沟通以改善ALDLT知情同意过程的能力方面具有创新性。EDICT还可以通过提供捐赠可以道德地进行的保证来使移植中心受益。该提案将听取移植临床医生对经验研究的呼吁，以确保活体肝脏供体为ALDLT提供充分的知情同意，指导LDLT项目提供符合伦理的临床实践，并为ALDLT的知情同意提供信息标准。通过提供伦理上最佳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。 公共卫生关系：本研究的目的是开发一种新的工具（供体知情同意评估工具（EDICT）），用于测量活体肝供体候选人在成人间活体肝移植知情同意过程中的理解。该工具将有助于通过识别活体供肝者的理解缺陷和促进有针对性的供肝者-临床医生沟通来改善活体供肝的知情同意过程。促进道德上最佳的知情同意程序将有助于向移植临床医生提供保证，即捐赠可以道德地进行，促进活体肝脏捐赠计划，并帮助挽救生命。