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）：自 1998 年以来，为了应对肝移植的严重短缺，美国越来越多地采用成人对成人活体肝移植 (ALDLT)。1 许多移植临床医生、伦理学家和政策制定者都担心活体肝捐赠者 (LD) 面临严重健康风险的伦理问题，因为他们不会获得直接的医疗益处，而且对长期肝捐赠者知之甚少。 结果。目前的知情同意程序是否足以让 LD 充分了解 ALDLT、​​维护他们的自主权并确保他们自愿同意，仍然存在伦理问题。 研究报告称，LD 不理解向他们披露的有关 ALDLT 的信息，并且信息需求和期望未得到满足。 LD 还报告说，他们感受到了过度的捐献压力，因为需要肝移植的患者除了死亡之外别无选择。为了使外科医生能够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，并自主决定承担相关风险。然而，目前的做法并不需要对捐赠者的理解进行任何正式评估，也没有工具可以正式评估在此或任何其他临床背景下知情同意的充分性。衡量个体捐献者对知情同意过程中提供的信息的理解程度有助于优化 LD 获得知情同意的道德实践，并防止手术造成不必要的伤害。 本研究的目的是开发并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 用于评估临床研究知情同意理解程度的工具。定性和定量方法，包括同意书审查以及对生物伦理​​学家、临床医生和肝脏捐赠者的访谈和调查，将用于对改编后的工具进行实证验证。具体目标是： (1) 开发一个简短的工具来衡量潜在肝脏捐赠者对 ALDLT 知情同意的实际（客观）和感知（主观）理解； (2) 在肝脏捐献者候选者中进行 EDICT 试点测试。 EDICT 对于在 ALDLT 知情同意过程中识别 LD 的理解问题非常有价值。 EDICT 的创新之处在于，它能够识别个人捐赠者的理解缺陷，并促进进一步有针对性的捐赠者与临床医生的沟通，以改善 ALDLT 知情同意流程。 EDICT 还可以通过保证捐赠可以合乎道德地进行而使移植中心受益。该提案将关注移植临床医生的实证研究呼吁，以确保活体肝脏捐献者为 ALDLT 提供充分的知情同意，指导 LDLT 项目提供符合伦理道德的临床实践，并为 ALDLT 知情同意标准提供信息。通过提供道德上最佳的知情同意程序来减少移植临床医生的担忧，应促进和扩大活体肝脏捐赠计划并有助于拯救生命。 公共健康相关性：本研究的目的是开发一种新工具（供者知情同意工具评估（EDICT）），用于衡量活体肝供者候选者对成人对成人活体供者肝移植知情同意过程的理解程度。该工具将通过识别活体捐献者的理解缺陷并促进有针对性的捐献者与临床医生的沟通，帮助改善活体肝脏捐献的知情同意流程。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保证捐赠可以道德地进行，促进活体肝脏捐赠计划，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