Achieving Consensus on High Risk Donor to Improve Access to Organ Transplants

描述（由申请人提供）：克服可用于移植的器官严重短缺的一种潜在方法是使用具有与传播HIV、HBV和HCV风险增加相关的风险因素的供体，尽管目前进行了筛查。这种由献血者造成的传播风险非常低（每10，000名献血者中有0.035至300.6例未检测到的感染），并取决于献血者风险因素、感兴趣的病毒和所用的筛查试验。尽管风险很低，但在美国不同器官类型和不同地区使用这些器官的情况存在显著差异。其中一些变异性可能是由于代表不可接受的风险水平的变化，将供体分类为风险增加的变化，以及提供者和候选人对来自风险增加的供体的器官所构成的风险程度的了解的变化。最佳的筛选，以减轻风险之间的生活捐助者尚未正式建立和移植后的后续活动，从生活或死亡的捐助者与艾滋病毒，乙型肝炎病毒和丙型肝炎病毒传播的风险增加的相关因素还没有被检查在标准化的方式。因此，在最佳利用来自具有风险因素和有限数据的捐赠者的器官以指导未来政策决定方面存在挑战。因此，我们提议召开一次会议，召集实体器官移植领域的领导人，审查研究结果和循证信息。会议将就疾病传播风险增加的活体和已故供体的最佳评估和分类达成共识，此外还将对这些供体的器官接受者进行最佳知情同意和移植后评估，以改善这些器官的结果，质量，获取和利用。审查结果和共识意见将公布，以向更广泛的移植界成员传播这一信息。此外，该小组还将制定合理的研究议程或战略，以研究：HIV、HBV和HCV传播风险增加的供体的最佳定义，减轻传染病传播的活体供体的最佳评估，最佳时机，内容，考虑接受来自感染风险增加的捐赠者的器官的候选人知情同意的方法，接受捐赠者器官的受者感染传播的风险增加。 公共卫生相关性：该项目将资助一次会议，汇集实体器官移植领域的领导人，审查关于最佳评估和疾病传播风险增加的捐赠者分类的研究结果和循证信息，以及对这些捐赠者器官接受者的最佳知情同意和移植后评估。这项工作的目标是改善这些器官的结果、质量、获取和利用，并制定一份共识文件，将这一信息传播给更广泛的移植界成员。此外，该小组将确定与疾病传播风险增加的捐赠者有关的实体器官移植实践和交付中的问题，并将制定合理的研究议程或研究这些问题的战略。

DESCRIPTION (provided by applicant): One potential approach to overcome the significant shortage of organs available for transplantation is the use of donors with risk factors that are associated with increased risk of transmitting HIV, HBV, and HCV despite current screening practices. This risk of transmission posed by such donors is exceptionally low (ranging from 0.035 to 300.6 undetected infections per 10,000 donors) and dependent upon the donor risk factor, virus of interest, and screening tests utilized. Despite this low risk, there is significant variability in the use of such organs by organ type and across regions of the United States. Some of this variability may be the result of variations in what represents an unacceptable level of risk, variations in classification of donors as increased risk, and variations of knowledge about the extent of risk posed by organs from increased risk donors by the providers and candidates. Optimal screening to mitigate risk among living donors has not been formally established and post-transplant follow-up from recipients of living or deceased donors with factors associated with increased risk of HIV, HBV, and HCV transmission has not been examined in standardized way. As a result, there are challenges to optimal use of organs from donors with risk factors and limited data to guide future policy decisions. We therefore proposed a conference to bring together leaders in the field of solid organ transplantation to review research findings and evidence-based information. The conference will develop a consensus about the optimal evaluation and classification of living and deceased donors at increased risk of disease transmission in addition to optimal informed consent and post-transplant evaluation of recipients of organs from such donors with the goal of improving the outcomes, quality, access to, and utilization of such organs. The reviewed findings and consensus opinions will be published to disseminate this information to members of the wider transplant community. Further, the group will also develop a rational research agenda or strategy for studying: the optimal definition of donors at increased risk of transmission of HIV, HBV, and HCV, the optimal evaluation of living donors to mitigate against infectious disease transmission, the optimal timing, content, and method of informed consent of candidates considering accepting an organ from a donor at increased risk of infection and the optimal evaluation of recipients of organs from donors at increased risk of infection transmission. PUBLIC HEALTH RELEVANCE: This project will fund a conference to bring together leaders in the field of solid organ transplantation to review research findings and evidence-based information about optimal evaluation and classification of donors at increased risk of disease transmission in addition to optimal informed consent and post-transplant evaluation of recipients of organs from such donors. The goal of this effort is to improve the outcomes, quality, access to, and utilization of such organs and produce a consensus document to disseminate this information to members of the wider transplant community. Further, the group will define issues and problems in the practice and delivery of solid organ transplant related to donors at increased risk of disease transmission and will develop a rational research agenda or strategy for studying these problems.