Showing posts with label opt in. Show all posts
Showing posts with label opt in. Show all posts

Wednesday, March 11, 2020

Compensation for kidney donors? Opt in or opt out? The BBC and The Rift revisit the debates.(featuring Sally Satel and Frank McCormick)

The BBC covers the shortage of transplantable organs, and reviews the debate about compensating living organ donors, among other possibilities. Of particular interest is their discussion of 'opt-in' versus 'opt-out' systems for registering potential deceased donors, given the recent experience with the change in Wales.

Should organ donors be paid? The heavy toll of US kidney shortage
By Henri Astier


"Many countries, notably in continental Europe, have tried boosting the supply of dead donors through a "presumed consent" approach. Such a system, also known as "opt out", automatically places people on a national register of donors unless they choose not to be.

"All US states, by contrast, have "opt-in" laws. Would switching to "opt out" make a big difference? International studies suggest not. Spain, which has presumed consent, is only slightly ahead of the US in the number of transplants relative to its population; France and Belgium, with similar legislation in place, have fewer transplants.

"Wales is currently the only part of the UK with an opt-out system - England is due to follow suit later this year. But the Welsh did not see an increase in organ donations after it changed its law in 2015.
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And here's another forum for the compensation debate, at The Rift (featuring Sally Satel and Frank McCormick [click on his name next to Sally's] on the pro-compensation side...)
SHOULD ORGAN DONORS RECEIVE FINANCIAL COMPENSATION?

Wednesday, January 22, 2020

Alex Chan on deceased organ donation policy, in JAMA

Alex Chan comments on an earlier article in JAMA:
US Organ Donation Policy
Alex Chan, January 21, 2020

"To the Editor Ms Glazier and Mr Mone touted the success of the current opt-in organ donation system and argued for focusing on increasing registered donors to 75% of the adult population.1 A challenge is the intrinsic difficulty of such a task: more coordinated promotional efforts and new incentives like giving registered donors priority on organ waiting lists would likely be required.

"Even if such an increase in donor registration is possible, another challenge is the extent to which transplant centers recover organs from registered donors. Although the number of registered donors is more than half of the US population, only 36.3% of possible donors become actual donors.2 This loss of approximately one-third of registered donors suggests that obstacles to recovery of organs, such as family objection, transplant center rejections of imperfect organs, and OPO performance, are pivotal. Anecdotal evidence suggests that rejections of imperfect organs account for approximately 10% to 20%,2 leaving 10% to 20% of the loss still unaccounted for. Family consent or its lack may be a big part of the gap.
...
"Furthermore, 2 of the 3 states with the highest donor registration rates (Montana, 93%; Washington, 89%) have lower-than-average actual donation rates,1,2 but states like Nevada and Pennsylvania with registration rates lower than 50% have actual donation rates much higher than the national average.2 This suggests that registration is only part of the solution, and the ability of OPOs to obtain family consent and convert registrations into donations can bound the effectiveness of the current system."

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Here's the earlier post, about the article on which Alex is commenting

Wednesday, August 14, 2019

Wednesday, October 16, 2019

Rates of organ donation in countries with presumed consent versus those with explicit consent

Here's an illuminating figure from the 2018 paper
Sonya Norris, Legal and Social Affairs Division, 2018-02-14

Figure 5 - Deceased Organ Donor Rates (per million population), Consent Regimes and Number of Donors in Selected Countries, 2015


Presumed consent (opt-out) countries are graphed in yellow, and explicit consent (opt in) countries in blue.  Given the confusing and often confused discussion of those two regimes, it's noteworthy that both regimes appear near both the top and the bottom of the graph, i.e. there are both high and low donation rate countries using each donation regime.

Wednesday, August 14, 2019

How is the U.S. opt in system of organ donation doing compared to an opt out system? Alex Glazier and Tom Mone in JAMA

Alex Glazier and Tom Mone run, respectively, the big Organ Procurement Organizations (OPOs) in New England and Southern California.

Success of Opt-In Organ Donation Policy in the United States
Alexandra Glazier, JD, MP1; Thomas Mone, MS
JAMA. Published online August 8, 2019. doi:10.1001/jama.2019.9187

"Over the past 5 years, the United States has experienced a 30% increase in deceased organ donors, from 8269 in 2013 to 10 722 in 2018,1 although the number or organs available for transplant still does not meet the increasing need.
...
"The US practice of opt-in donation presents 2 opportunities for organ donation. The primary path to donation in the United States is through donor registries and is uniquely successful compared with other countries, with more than 152 million registered donors, representing 54% of the US adult population.2 A registered individual provides legally binding permission for donation at the time of death, and family does not have the right to override this decision. Current US practice is to proceed with a registered donation if medically suitable, even over family objection.3 The ability to move forward based on the donor’s affirmative decision is ethically supported and consistent with autonomy as a central principle in US health care decision-making. It is also in alignment with successfully maximizing opt-in policy and the UAGA state laws. The second path to donation in the United States is surrogate authorization of organ donation from an unregistered individual (ie, who has not registered as an organ donor) at the time of that individual’s death. The successful implementation of US opt-in is thus accomplished by a legal framework that is well-aligned with donation practices.
...
"Proponents of an opt-out system for the United States may have some misunderstandings about the performance and utility of the current opt-in US system. Requiring an affirmative donation decision through opt-in policies is also aligned with the US cultural emphasis on individual rights and autonomy principles that is not achieved in the opt-out international experience. As identified below, the US opt-in system donation rates routinely exceed those of the best performing opt-out international countries.
...
"In 2018, the US overall organ donation rate was 38.1 donors per 10 000 deaths, second among reporting countries only to Spain (which has an opt-out donation policy). Six individual US states had rates that were higher than Spain, and US states comprised 43 of the top 50 jurisdictions. Furthermore, in the opt-in jurisdictions, the mean donation rate was 27% higher than rates in opt-out jurisdictions (32.6 vs 25.6 donors per 10 000 deaths, respectively). The data demonstrate that opt-in policies in the United States are associated with higher organ donation rates than some countries with opt-out policies as the legal default.
...
"If the United States moved to a similar opt-out policy, the percentage of potential donors opting out combined with family objections would need to be quite small to realize any gains in donation performance. There is also the real potential for the donation rate to decline, as evidenced in Wales, which continues to have below-average international levels and most recently in the Netherlands, where an increasing number of people (currently 31%) have opted out.
...
"The United States has experienced significant growth in deceased organ donors and continues to have one of the best donation rates in the world. Nevertheless, the critical need for organ transplant is not met. International data suggest that the most effective donation authorization strategy for the United States is to build on the current opt-in system that demonstrably works and to increase the number of registered donors from today’s 54% to 75% or higher. Doing so would be an accomplishment that would increase available organs for donation and save thousands of lives.


HT: Alex Chan

Sunday, June 30, 2019

Organ donation by opt-out versus opt-in deceased donor registration (no significant effect on transplants)

In the June issue of Kidney International, there's a meta-study of organ transplantation rates in opt out versus opt in countries, that finds "no significant difference in deceased donation or solid organ transplantation activity between opt-out versus opt-in countries.":

Comparison of organ donation and transplantation rates between opt-out and opt-in systems
Adam Arshad,  Benjamin Anderson, and Adnan Sharif
Kidney International (2019) 95, 1453–1460

Abstract:
Studies comparing opt-out and opt-in approaches to organ donation have generally suggested higher donation and transplantation rates in countries with an opt-out strategy. We compared organ donation and transplantation rates between countries with opt-out versus opt-in systems to investigate possible differences in the contemporary era. Data were analysed for 35 countries registered with the Organisation for Economic Co-operation and Development (17 countries classified as opt-out, 18 classified as opt-in) and obtained organ donation and transplantation rates for 2016 from the Global Observatory for Donation and Transplantation. Compared to opt-in countries, opt-out countries had fewer living donors per million population (4.8 versus 15.7, respectively) with no significant difference in deceased donors (20.3 versus 15.4, respectively). Overall, no significant difference was observed in rates of kidney (35.2 versus 42.3 respectively), non-renal (28.7 versus 20.9, respectively), or total solid organ transplantation (63.6 versus 61.7, respectively). In a multivariate linear regression model, an opt-out system was independently predictive of fewer living donors but was not associated with the number of deceased donors or with transplantation rates. Apart from the observed difference in the rates of living donation, our data demonstrate no significant difference in deceased donation or solid organ transplantation activity between opt-out versus opt-in countries. This suggests that other barriers to organ donation must be addressed, even in settings where consent for donation is presumed.

Large image of Figure 1. 

Saturday, April 13, 2019

Nova Scotia moves towards presumed consent for organ donation

The CBC is following the story:
Nova Scotia's opt-out organ donation move sparks mixed reaction
Bioethicist wonders whether rule would fit Canada's multicultural society

"Nova Scotia's decision to make all adults in the province potential organ donors unless they opt out has sparked a backlash from some Canadians.

"The goal is to increase organ donations from deceased donors to save lives of more recipients. Nova Scotia is striving to raise donation rates above 20 per cent, levels found in European countries such as Spain, officials said. About 90 per cent of Canadians say they support organ and tissue donation but less than 20 per cent have made plans to donate.

"Under presumed consent, the default decision is to donate organs on death. But families would continue to be approached to confirm the donor's wishes, said Dr. Stephen Beed, medical director for Nova Scotia's critical care organ donation program.
...
"The question is whether it's a good fit for Canadian society, said Kerry Bowman, a bioethicist at the University of Toronto.

"My first concern would be, this is a multicultural society and there are cultures and religions that really have a lot of concern about either organ donation or the steps before organ donation or the definition of death," Bowman said.

"For instance, Bowman said, the Catholic Church is very supportive of organ donation but sees presumed consent as problematic because it reduces the autonomous decision to give."
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Earlier from CBC:
Nova Scotia to become 1st in North America with presumed consent for organ donation.  Province will take 12 to 18 months after bill passes to prepare for changes
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A related post

Saturday, April 6, 2019

Saturday, April 6, 2019

Deceased organ donation: comparison of opt-in versus opt-out countries

From Kidney International
Article in Press



Studies comparing opt-out and opt-in approaches to organ donation have generally suggested higher donation and transplantation rates in countries with an opt-out strategy. We compared organ donation and transplantation rates between countries with opt-out versus opt-in systems to investigate possible differences in the contemporary era. Data were nalysed for 35 countries registered with the Organisation for Economic Co-operation and Development (17 countries classified as opt-out, 18 classified as opt-in) and obtained organ donation and transplantation rates for 2016 from the Global Observatory for Donation and Transplantation. Compared to opt-in countries, opt-out countries had fewer living donors per million population (4.8 versus 15.7, respectively) with no significant difference in deceased donors (20.3 versus 15.4, respectively). Overall, no significant difference was observed in rates of kidney (35.2 versus 42.3 respectively), non-renal (28.7 versus 20.9, respectively), or total solid organ transplantation (63.6 versus 61.7, respectively). In a multivariate linear regression model, an opt-out system was independently predictive of fewer living donors but was not associated with the number of deceased donors or with transplantation rates. Apart from the observed difference in the rates of living donation, our data demonstrate no significant difference in deceased donation or solid organ transplantation activity between opt-out versus opt-in countries. This suggests that other barriers to organ donation must be addressed, even in settings where consent for donation is presumed.

Wednesday, January 16, 2019

Organ donation in Germany

Spiegel.de has the story:
Nach langem Abwärtstrend, Zahl der Organspender deutlich gestiegen
(GT: After a long downward trend, the number of organ donors has increased significantly)

"Last year, 955 people left organs for other critically ill patients after their death, as the German Foundation for Organ Transplantation (DSO) announced. That was an increase of nearly 20 percent compared to 2017 with 797 donors and the first major increase since 2010.
...
"a discussion on new organ donation rules has started in parliament across parliamentary boundaries. So far, withdrawals are only allowed with expressly agreed consent, but many postpone the occupation with this topic again and again.

"Spahn is therefore campaigning for a "double contradiction solution" ["doppelte Widerspruchslösung"]. Accordingly, everyone is automatically considered a donor. One should be able to say no to this, otherwise - as a double barrier - relatives would have to be asked. In an open debate in the Bundestag at the end of November broad reservations against such a new regulation became clear.

"Instead, a group led by Greens leader Annalena Baerbock and left-leaning boss Katja Kipping suggests a mandatory recurring query, such as collecting new passports or identity cards - with the option of not yet deciding."
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HT: Rosemarie Nagel

Tuesday, October 9, 2018

Family consent and opt-in versus opt-out organ donation

Here's a contribution to the discussion on how opt-out versus opt-in deceased donor laws might impact transplantation (as opposed to just registration) in countries in which family consent is needed before a deceased person's organs are donated.

 2018 Aug 16. doi: 10.1037/xap0000183. [Epub ahead of print]

Underlying wishes and nudged choices.

Abstract

Is the inferred preference of a deceased relative to donate his or her organs stronger when the choice was made under a mandated rather than under an automatic default (i.e., nudged choice) legislative system? The answer to this is particularly important, because families can, and do, veto the choices of their deceased relatives. In three studies, we asked American and European participants from countries that have either a default opt-in or a default opt-out system to take on the role of a third party to judge the likelihood that an individual's "true wish" was to actually donate his or her organs, given that the decedent was registered to donate on the organ donation register. In each study participants were randomly assigned to one of four organ donation legislative systems (default opt-in, default opt-out, mandated choice, mandatory). Overall, regardless of which country participants came from, they perceived the donor's underlying preference to donate as stronger under the default opt-in and mandated choice systems as compared with the default opt-out and mandatory donor systems. We discuss the practical issues that result from using default systems in the domain of organ donation and propose potential ways to ameliorate the uncertainty around inferences of underlying preference from a nudged choice. 
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HT Axel Ockenfels

Saturday, August 11, 2018

Presumed consent: too early to declare failure, but cautions are plentiful

Frank McCormick points out a recent report in the journal Health Policy indicating that the Welsh move from opt-in to opt-out or ('deemed consent') for deceased organ donation has not so far been successful at raising transplant rates:

Welsh 2013 deemed consent legislation falls short of expectations
by Jordan Alexander Parsons

"Abstract: Wales, in 2013, was the first country in the United Kingdom to pass legislation introducing presumed (or deemed) consent for organ donation, and remains the only one. It was introduced in an attempt to increase the number of life-saving transplants taking place in the UK, in a move that policy makers hoped would mirror Spain’s success. More recently, pressure has been mounting for England to follow suit, with a public consultation currently in progress. However, the Welsh system has been far from a success, raising the question of why campaigners are so adamant that it should be replicated. Before the Welsh Government introduced the Human Transplantation (Wales) Act there had been no strong evidence to suggest it would make a difference, with countries boasting both high organ donation rates and presumed consent legislation demonstrating no clear causal relationship between the two facts. In addition, a recent report evaluating the Act has highlighted its failure to improve donation rates, and has even presented some potentially concerning statistics that may suggest a negative impact. This paper first considers presumed consent in other countries – Spain and Brazil – before illustrating the underwhelming progression of Wales’ new system and the need to look to other options."

Here's a paragraph that strikes me as important, because family consent is important in Wales, and automatic inclusion on the deceased donor registry reduces the signal value that the deceased wished to be a donor:

"Under the Welsh system, the deceased is deemed to have consented to donation unless (1) a decision as to donation by the deceased is in force, (2) the deceased had appointed a person or persons to make the decision on their behalf, or (3) a relative of friend of long standing objects on the basis of views held by the deceased and it is reasonable to assume the objection is accurate [2]. It is down to the medical team to determine whether a relative’s objection is their own, or one based on the views of the deceased. Unsurprisingly, doctors have not shown willing to challenge these objections, despite their legal right to; they consider it inappropriate to go against the wishes of the family."
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Here is a related article, which raises other potential problems:
Presumed consent will not automatically lead to increased organ donation
Sharif, Adnan
Kidney International , Volume 94 , Issue 2 , 249 - 251

"a review of the latest available data (2016) from the Global Observatory on Donation and Transplantation suggests no significant difference in overall transplantation activity between presumed versus explicit consent countries, with increased deceased organ donor rates balanced by decreased living donor rates among presumed consent countries (Table 1). Whether the consent process is presumed or explicit has no bearing on many inter-related factors that influence organ donation rates. For example, Coppen et al.4 observed a strong correlation between mortality rates and organ donation numbers (Spearman’s r = 0.81, P < 0.01) and that, after controlling for differences in relevant mortality rates, there was no significant influence of presumed versus explicit consent on organ donation rates."

Table 1 Organ donation and transplantation activity
ParameterPresumed consent (mean ± SD per million population)Explicit consent (mean ± SD per million population)P value
Kidney (deceased)30.9 ± 15.122.6 ± 11.10.078
Kidney (living)4.8 ± 2.616.9 ± 8.4<0 .001="" td="">
Liver (deceased)12.9 ± 8.510.1 ± 5.30.265
Liver (living)0.4 ± 0.92.7 ± 5.30.107
Heart4.8 ± 3.53.1 ± 2.60.108
Lung3.5 ± 4.04.2 ± 2.80.543
Pancreas1.6 ± 1.61.4 ± 1.00.579
Overall transplant activity59.1 ± 30.758.9 ± 23.40.982

Wednesday, January 4, 2017

France introduces opt-out policy on organ donation

The Guardian has the story:
France introduces opt-out policy on organ donation
Change in law means consent for organs to be removed is presumed unless person joins official ‘refusal register’

"France has reversed its policy on organ donations so that all people could become donors on their death unless they join an official register to opt out.
The new law presumes consent for organs to be removed, even if it goes against the wishes of the family.
Until 1 January, when the legislation took effect, unless the person who had died had previously expressed a clear wish for or against donation, doctors were required to consult relatives who, in almost a third of cases, refused.
Those who do not want all or any of their organs to be used must now put their name on a “refusal register” – so far 150,000 people have signed up. The authorities have promised to make it easier for those who wish to refuse by allowing them to join the register online instead of by registered post.
Alternatively, those vehemently opposed to their organs being used can leave a signed document with their next-of-kin or transmit their wish orally to relatives who must make a written declaration of non-consent to doctors at the time of death. The process is explained on the agency’s Facebook page.
In November, the French Agence de la Biomédecine released a film, Déjà-vu2, aimed at encouraging 15- to 25-year-olds to agree to organ donation.
The European Union has highlighted the lack of organs for transplant and the increasing number of patients on waitings lists worldwide. Its figures claim that in 2014, 86,000 people were waiting for organ donations in EU states, Norway and Turkey, and 16 people were dying every day while waiting for a transplant.

In the UK, doctors lament one of the lowest consent rates in Europe, as well as a shortage of donors from black or Asian communities. A record number of organs were donated and transplanted in the UK in 2015-16, but the rate remains short of the target of 80% by 2020. The biggest obstacle remains relatives’ opposition, who have vetoed transplants even from registered donors.
NHSBT, which is responsible for the NHS organ donor register and for matching and allocating donor organs, said it was considering further steps it could take when approaching families to ensure more potential donors’ decisions were not vetoed.
One option would be to no longer ask the next-of-kin to confirm consent or authorisation. Their permission is not required by law if someone has registered a decision to donate on the NHS organ donor register.
Families in Scotland are already required to complete a retraction form to record why they overturned a relative’s decision to donate. NHSBT said a similar form be introduced across the UK."

HT: Frank McCormick

Thursday, May 22, 2014

Opt out system for organ donors? Scotland opts to wait for evidence

The Scotsman has the story: Warning over opt-out organ system in Scotland

"MOVING to an opt-out system of organ donation in Scotland would “not necessarily” lead to more transplant operations taking place, the public health minister has said.

Michael Matheson insisted the Scottish Government was still “unconvinced” about making such a change.

He spoke out as Holyrood debated a petition backed by more than 20,000 people calling on ministers to introduce an opt-out system for organ donation.

Wales is introducing an new system of deemed consent at the end of next year, where organs can be taken for transplant unless people have made it clear they do not wish this to happen after their death.

Mr Matheson told MSPs the Scottish Government would monitor the situation in Wales to see what impact the change had.

But he stated: “It would be fair to say we remain unconvinced that we should make any move to introduce an opt-out system right now.

“I want to make sure that we keep this issue under review and learn from what happens in Wales, but we are making great progress here in Scotland with the programme of activity we have under way.”

The minister added: “People believe opt-out will mean more organs will become available but our own experts tell us this is not necessarily the case.

“Opt-out means increasing the proportion of the population on the organ donor register but you don’t need to be on the organ donor register to be a donor. Over the last five years, 62% of all donors in Scotland are not on the donor register.

“The real issue that limits the number of donors is the number of people who die in circumstances where donation is possible.

“Unfortunately, to become an organ donor you really have to die in intensive care, and only about 1% of deaths in Scotland occur in these circumstances. Sadly that’s something opt-out in itself can not change.”

Mr Matheson said the US had a higher organ donation rate than Scotland but did not have an opt-out system while Sweden has an opt-out system, but has a lower donation rate than Scotland.

“There is no single thing that will bring about the revolution in donation rates,” Mr Matheson said.

He stressed the Scottish Government was “committed to increasing organ donations in Scotland”, adding: “I don’t believe any other country in the UK can say it has done more on this agenda in the last five years than what has happened here in Scotland.”

He told how Scotland had almost doubled the number of organ donors in the last six years, adding there had been a 62% rise in transplants being carried out - the highest increase in the UK.

Meanwhile, there has been a 25% reduction in the transplant waiting list since 2006-07, Mr Matheson said.

He told MSPs: “We’re making the best progress in the UK. We’re seeing more donors and we’re delivering more transplants and we’re saving more lives as a result.

“We will keep on review how the opt-out process progresses in Wales, but while we are making the sort of progress we have delivering here in Scotland over recent years, I believe it is prudent and appropriate that we should wait to see what happens in Wales before we start to introduce significant legislative change here in Scotland.”

Thursday, January 16, 2014

Organ donor registration in Israel

Judd Kessler and I just got this email from Jacob Lavee (about whom I've written before), with good news that he kindly gave me permission to post:

Dear Al and Judd,

Just a short note to let you know that the Israeli Minister of Health has adopted this week my recommendation to establish by law the modified mandated choice model based upon your work, whereby the issuing or renewal of an ID, passport or driving license will be conditional upon answering the question of becoming a registered donor to which only a positive answer will be given as an option or else the “Continue” button will be selected. It seems that, contrary to my previous worries, the entire registration for these documents is currently being done online and therefore there should be no technical issues to implement this model.

Thank you guys for providing the proof of concept which I cited to the ministerial committee.

This model will be added upon the prioritization model, which is already implemented by law.


Jay
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The work Jay is referring to is a paper, currently out for review at a journal that doesn't like prepublication on the web, "Don’t Take ‘No’ For An Answer: An experiment with actual organ donor registrations," which finds, in a study of the online MA state organ donor registry, that requiring potential donors to choose either "yes" or "no" when asked if they wish to be on the donor registry does not increase registrations, and seems likely to reduce the rate of donations by next of kin when the deceased is unregistered.