ObjectivesTo determine the short-term impact of a soft opt-out organ donation system on consent rates and donor numbers.DesignBefore and after observational study using bespoke routinely collected data.SettingNational Health Service Blood and Transplant.Participants205 potential organ donor cases in Wales.InterventionsThe Act and implementation strategy.Primary and secondary outcomesConsent rates at 18 months post implementation compared with 3 previous years, and organ donor numbers 21 months before and after implementation. Changes in organ donor register activity post implementation for 18 months.ResultsThe consent rate for all modes of consent was 61.0% (125/205), showing a recovery from the dip to 45.8% in 2014/2015. 22.4% (46/205) were deemed consented donors: consent rate 60.8% (28/46). Compared with the 3 years before the switch there was a significant difference in Welsh consent rates (χ2 p value=0.009). Over the same time period, rest of the UK consent rates also significantly increased from 58.6% (5256/8969) to 63.1% (2913/4614) (χ2 p value<0.0001), therefore the Wales increase cannot be attributed to the Welsh legislation change. Deceased donors did not increase: 101 compared with 104. Organ donation registration increased from 34% to 38% with 6% registering to opt-out.ConclusionThis is the first rigorous initial evaluation with bespoke data collected on all cases. The longer-term impact on consent rates and donor numbers is unclear. Concerns about a potential backlash and mass opting out were not realised. The move to a soft opt-out system has not resulted in a step change in organ donation behaviour, but can be seen as the first step of a longer journey. Policymakers should not assume that soft opt-out systems by themselves simply need more time to have a meaningful effect. Ongoing interventions to further enhance implementation and the public’s understanding of organ donation are needed to reach the 2020 target of 80% consent rates. Further longitudinal monitoring is required.

Summary Organ transplantation saves and transforms lives. Failure to secure consent for organ retrieval is widely regarded as the single most important obstacle to transplantation. A soft opt‐out system of consent for deceased organ donation was introduced into Wales in December 2015, whilst England maintained the existing opt‐in system. Cumulative data on consent rates in Wales were compared with those in England, using a two‐sided sequential procedure that was powered to detect an absolute difference in consent rates between England and Wales of 10%. Supplementary risk‐adjusted logistic regression analysis examined whether any difference in consent rates between the two nations could be attributed to variations in factors known to influence UK consent rates. Between 1 January 2016 and 31 December 2018, 8192 families of eligible donors in England and 474 in Wales were approached regarding organ donation, with overall consent rates of 65% and 68%, respectively. There was a steady upward trend in the proportion of families consenting to donation after brain death in Wales as compared with England and after 33 months, this reached statistical significance. No evidence of any change in the donation after circulatory death consent rate was observed. Risk‐adjusted logistic regression analysis revealed that by the end of the study period the probability of consent to organ donation in Wales was higher than in England ( OR [95% CI ] 2.1 [1.26–3.41]). The introduction of a soft opt‐out system of consent in Wales significantly increased organ donation consent though the impact was not immediate.

Background. Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system. Methods. This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members. Results. Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process. Conclusions. We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system’s most valuable resource: public trust.

Cathy Miller, Louise Hubner ( louise.hubner@nhsbt.nhs.uk ), Sonya Paterson, Bobbee Cotter, Phil Walton, Helen Bentley, and Claire Roberts, of NHS Blood and Transplant

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