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Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant.

ABSTRACT: Importance: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. Objective: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. Main Outcomes and Measures: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. Results: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. Conclusions and Relevance: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.

SUBMITTER: DeRoos LJ

PROVIDER: S-EPMC6777259 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant.

DeRoos Luke J LJ Marrero Wesley J WJ Tapper Elliot B EB Sonnenday Christopher J CJ Lavieri Mariel S MS Hutton David W DW Parikh Neehar D ND

JAMA network open 20191002 10

<h4>Importance</h4>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.<h4>Objective</h4>To simulate the potential implications of a presumed consent policy in the United States.<h4>Design, setting, and participants</h4>In a decision analytical model, a simulation model was developed using cohort data from January 1, 2004, to De ...[more]

PMID: 31577360

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Project description:BackgroundPosthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries.MethodsWe surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive.ResultsMean(SD) age was 32(9) year, 27% were males, 50% were patients' companions, 60% had???college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p?<?0.001), donor-only informed consent (5[3,7], p?<?0.001), and presumed consent (7[3,10], p?<?0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p?<?0.001, and 5[3,8], p?<?0.001; for donor-or-surrogate informed consent to 7[5,9], p?<?0.001, and 5[3,7], p?=?0.004; and for donor-only informed consent to 8[6,10], p?<?0.001, and 5[3,7], p?=?0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p?=?0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p?<?0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p?<?0.001), and less preferred mandated choice with medical incentive option (7[4,9] vs. 5[2,7], p?<?0.001). There was no association between consenting options ranking scores and age, health status, education level, or knowing an organ donor or recipient.ConclusionsWe conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference.

Project description:Background: Organ shortage is still a world-wide problem, resulting in long waiting lists for kidney, liver, and heart transplant candidates across many transplant centers globally. This has resulted in the move toward presumed consent to increase deceased organ donation rates. However, there remains a paucity of literature on public attitude and barriers regarding the opt-out system, with existing studies limited to Western nations. Therefore, this study aimed to understand public sentiment and different barriers toward organ donation from the perspective of Singapore, a highly diverse and multiethnic Asian society. Methods: A cross-sectional community semi-structured interview was conducted in a public housing estate in Singapore. Pilot test was undertaken before participants were interviewed face-to-face by trained personnel. All statistical evaluations were conducted using Stata. The χ2-test compared subgroups based on patient characteristics while multivariable logistic regression identified predictors of willingness to donate/ assent. Effect estimates were quantified using odds ratio (OR). Findings: Out of 799 individuals, 85% were agreeable to organ donation after death and 81% were willing to assent to donations of family members' organs, which declined by 16% (p < 0.001) after a clinical scenario was presented. Demographic factors including ethnicity, education, marital, and employment status affected willingness to donate and assent. Knowledge correlated significantly with willingness to donate and assent. In particular, knowledge regarding brain death irreversibility had the strongest correlation (AOR 2.15; 95% CI 1.60-2.89). Conclusions: Organ donation rates remain low albeit presumed consent legislation, due to patient-level barriers, including but not limited to knowledge gaps, cultural values, religious backgrounds, and emotional impact at relatives' death. To effectively boost donor rates, it is crucial for policy makers to invest in public education and improve transplant provisions and family protocols.

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Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant.

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Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant.

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