Abstract

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. 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.

Highlights

  • Organ transplant is a life-saving and cost-effective intervention for patients with organ failure.[1]

  • The biggest estimated increases in annual life-years gained associated with a presumed consent policy were in kidney transplant candidates and liver transplant candidates

  • Adoption of a presumed consent policy could result in a 4295-year to 11 387-year increase in life-years, accounting for the survival advantages associated with a transplant

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Summary

Introduction

Organ transplant is a life-saving and cost-effective intervention for patients with organ failure.[1]. Current mechanisms for expanding the donor pool include increasing donor registrations, using extended criteria donors, and promoting living donor transplant. Optimizing the donor yield requires the use of best practices and emerging technologies (eg, machine perfusion) in donor consent and organ retrieval.[4,5,6] Even with these mechanisms, the donor pool is limited and will likely shrink in coming years because of changing US demographics and population health (eg, obesity prevalence, aging population), further exacerbating the disparity between donors and recipients.[7,8]

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