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危险因素的供体，尽管目前的筛查做法与传播HIV， HBV和HCV的风险增加有关。这类捐赠者造成的传播风险极低（每10,000名捐赠者中未被发现的感染为0.035至300.6），取决于捐赠者的风险因素、感兴趣的病毒和所使用的筛查试验。尽管风险很低，但在美国不同的器官类型和不同的地区，这类器官的使用存在显著的差异。其中一些差异可能是由于以下方面的差异造成的：代表不可接受的风险水平的差异，将供体分类为风险增加的差异，以及供体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差异。在活体供体中降低风险的最佳筛查尚未正式建立，移植后对与HIV、HBV和HCV传播风险增加相关因素的活体或已故供体受者的随访尚未以标准化的方式进行检查。因此，对具有风险因素和指导未来政策决策的数据有限的捐赠者的器官的最佳使用存在挑战。因此，我们提议召开一次会议，汇集实体器官移植领域的领导者，回顾研究成果和循证信息。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，以及对此类供体器官受者的最佳知情同意和移植后评估，目的是改善此类器官的结果、质量、获取和利用。审查结果和共识意见将被公布，以向更广泛的移植社区成员传播这一信息。此外，该小组还将制定合理的研究议程或研究策略：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，考虑接受感染风险增加的供体器官的候选人知情同意的最佳时机、内容和方法，以及感染传播风险增加的供体器官接受者的最佳评估。

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.