Industrial and Operations Engineering, University of Michigan, Ann Arbor.
Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor.
JAMA Netw Open. 2019 Oct 2;2(10):e1912431. doi: 10.1001/jamanetworkopen.2019.12431.
Presumed consent, or an opt-out organ transplant policy, has been adopted by many countries worldwide to increase organ donation. The implication of such a policy for transplants in the United States is uncertain, however.
To simulate the potential implications of a presumed consent policy in the United States.
DESIGN, SETTING, AND PARTICIPANTS: In a decision analytical model, a simulation model was developed using cohort data from January 1, 2004, to December 31, 2014, in the Organ Procurement and Transplantation Network Standard Transplant Analysis and Research files. All US patients (n = 524 359) who were on the waiting list for at least 1 solid organ and all deceased organ donors during the study period were included in the analyses. All data and statistical analyses were performed from January 30, 2019, to July 31, 2019.
Increase in the organs available for donation and life-years gained associated with a 5%, 15%, or 25% increase in deceased donors, based on the published changes from a presumed consent policy.
This study considered 524 359 unique candidates (aged ≥18 years; 320 908 [61.2%] male) for a solid organ transplant from January 1, 2004, to December 31, 2014. With a base case scenario of a 5% presumed consent-associated increase in donors, the removals (owing to death or illness) from the waiting list for all organs would have an associated 3.2% to 10.4% mean reduction, depending on the random or ideal allocation of new organs to patients on the waiting list. Sensitivity analyses showed that waiting list removals could be decreased up to 52%; however, this reduction was not enough to completely eliminate waiting list removals during the study period. The biggest estimated increases in annual life-years gained associated with a presumed consent policy were in kidney transplant candidates (95% CIs by deceased donor increase: 5% increase, 3440-3466 years; 15% increase, 10 321-10 399 years; 25% increase, 17 201-17 332 years) and liver transplant candidates (95% CIs by deceased donor increase: 5% increase, 898-905 years; 15% increase, 2693-2714 years; 25% increase, 4448-4523 years). Adoption of a presumed consent policy could result in a 4295-year (95% CI, 4277-4313 years) to 11 387-year (95% CI, 11 339-11 435 years) increase in life-years, accounting for the survival advantages associated with a transplant.
In this study, presumed consent was estimated to be associated with modest but important improvement in the number of organ transplants and increases in life-years gained for patients awaiting an organ transplant. Further consideration and even debate about the ethical and public policy implications of a presumed consent policy are warranted.
推定同意，或默认器官捐献政策，已被世界上许多国家采用，以增加器官捐献。然而，这种政策对美国的移植意味着什么还不确定。
模拟在美国实行推定同意政策的潜在影响。
设计、设置和参与者：在决策分析模型中，使用从 2004 年 1 月 1 日至 2014 年 12 月 31 日在器官采购和移植网络标准移植分析和研究文件中的队列数据开发了一个模拟模型。在研究期间，所有至少有一个实体器官等待名单的美国患者（n=524359）和所有已故器官捐献者都包括在分析中。所有数据和统计分析均于 2019 年 1 月 30 日至 7 月 31 日进行。
根据发表的推定同意政策变化，与 5%、15%或 25%的已故供体增加相关的可供捐赠的器官数量和增加的生命年。
这项研究考虑了 524359 名独特的候选人（年龄≥18 岁；320908[61.2%]男性）从 2004 年 1 月 1 日到 2014 年 12 月 31 日接受实体器官移植。在一个 5%的推定同意相关供体增加的基本情况下，所有器官的等待名单清除（由于死亡或疾病）将导致平均减少 3.2%至 10.4%，这取决于新器官在等待名单上的患者的随机或理想分配。敏感性分析表明，等待名单清除率可降低 52%；然而，这一减少量不足以在研究期间完全消除等待名单清除。与推定同意政策相关的估计最大的年度生命年增加是在肾移植候选者中（95%置信区间按已故供体增加：5%增加，3440-3466 年；15%增加，10321-10399 年；25%增加，17201-17332 年）和肝移植候选者（95%置信区间按已故供体增加：5%增加，898-905 年；15%增加，2693-2714 年；25%增加，4448-4523 年）。采用推定同意政策可能会导致生命年增加 4295 年（95%置信区间，4277-4313 年）至 11387 年（95%置信区间，11339-11435 年），这考虑到与移植相关的生存优势。
在这项研究中，推定同意被估计与器官移植数量的适度但重要的改善以及等待器官移植的患者的生命年增加有关。需要进一步考虑，甚至是关于推定同意政策的伦理和公共政策影响的辩论。
