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: 8259739
• 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 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8259739
• 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; public health relevance; 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(由申请人提供)：成人到成人活体供体肝移植(ALDLT)自1998年以来在美国得到越来越多的应用，以应对肝脏移植的严重短缺。1许多移植临床医生、伦理学家和政策制定者担心让活体肝脏捐赠者(LD)面临严重健康风险的道德问题，因为他们不会体验到直接的医疗好处，而且对肝脏捐赠者的长期结果知之甚少。伦理问题仍然存在，即目前的知情同意程序是否充分地向LDS通报了ALDLT，保持了他们的自主权，并确保了他们的自愿同意。研究报告说，法律援助机构不理解向他们披露的关于法律援助和培训的信息，有未得到满足的信息需求和未得到满足的期望。LDS还报告说，由于需要肝脏移植的患者除了死亡之外别无选择，他们感到了不必要的捐献压力。为了让外科医生合乎道德地进行移植手术，必须有证据表明，LDS了解有关ALDLT过程的信息，并已做出自主决定，承担相关风险。然而，目前的做法不需要对捐赠者的理解进行任何正式评估，也不存在正式评估知情同意在这种或任何其他临床情况下的充分性的工具。衡量个人捐赠者对知情同意过程中提供的信息的理解程度，有助于优化为LDS获得知情同意的道德做法，并防止通过手术造成不必要的伤害。这项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ALDLT知情同意过程中个人对捐赠者的理解。这项研究将采用Joffe用于评估临床研究知情同意中的理解力的工具。定性和定量方法，包括同意书审查和对生物伦理学家、临床医生和肝脏捐赠者的采访和调查，将被用于经验性验证适应的工具。具体目的是：(1)开发一个简单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；以及(2)在候选肝脏捐赠者中进行试点试验。法令对于在ALDLT知情同意过程中发现LDS的理解问题将是有价值的。EDICT的创新之处在于，它能够识别个体捐赠者在理解方面的缺陷，并促使进一步有针对性的捐赠者-临床医生沟通，以改进ALDLT知情同意程序。法令还可能使移植中心受益，因为它保证捐赠可以在道德上进行。这项提案将响应移植临床医生对经验性研究的呼吁，以确保活体肝脏捐赠者为ALDLT提供足够的知情同意，指导LDLT项目提供合乎道德的临床实践，并告知ALDLT的知情同意标准。通过提供伦理上最优的知情同意程序来减少移植临床医生的担忧，应该会促进和扩大活体肝脏捐赠者计划，并有助于挽救生命。 公共卫生相关性：这项研究的目的是开发一种新的工具(供者知情同意评估工具(EDICT))来衡量活体肝脏捐赠者候选人在成人到成人活体供体肝移植的知情同意过程中的理解。这一工具将有助于改善活体肝脏捐赠的知情同意程序，识别活体捐赠者的理解缺陷，并促进有针对性的捐赠者与临床医生的沟通。促进道德上最优的知情同意程序将有助于向移植临床医生提供保证，即捐赠可以在道德上进行，促进活体肝脏捐赠者计划，并帮助拯救生命。

项目成果

Live liver donors' information needs: A qualitative study of practical implications for informed consent.

活肝捐赠者的信息需求：对知情同意的实际影响的定性研究。

• DOI: 10.1016/j.surg.2016.04.022
• 发表时间: 2016-09
• 期刊: Surgery
• 影响因子: 3.8
• 作者: Gordon EJ;Mullee J;Skaro A;Baker T
• 通讯作者: Baker T