Short-term impact of introducing a soft opt-out organ donation system in Wales: before and after study.

Objectives To determine the short-term impact of a soft opt-out organ donation system on consent rates and donor numbers. Design Before and after observational study using bespoke routinely collected data. Setting National Health Service Blood and Transplant. Participants 205 potential organ donor cases in Wales. Interventions The Act and implementation strategy. Primary and secondary outcomes Consent 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. Results The 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 (chi(2) 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) (chi(2) 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. Conclusion This 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.