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."

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

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