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

Abstract

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.

‘It’s like being conscripted, one volunteer is better than 10 pressed men’: A qualitative study into the views of people who plan to opt‐out of organ donation

“…This remains a considerable issue under opt‐out laws. In a recent study which analysed transplant data from Wales, a number of notable findings regarding family consent under opt‐out laws were reported (Noyes et al , ). The findings revealed that when an opt‐in decision was registered, 16.4% of families overrode their loved ones recorded decision and refused consent for donation.…”

“…To date, 6% of the Welsh population have opted out of the donor register. It is noteworthy, however, that a recent analysis of routine transplant figures from Wales found that 16.5% of potential donors had expressed the decision to opt‐out of organ donation (Noyes et al , ). Only a small proportion of these individuals had actively registered their opt‐out decision, with the vast majority (76%) of individuals verbally expressing their opt‐out decision to family members.…”

Designing a co‐productive study to overcome known methodological challenges in organ donation research with bereaved family members

“…The study was awarded a national prize for the co‐production element. The study provides new insights and understanding about implementation of a soft opt‐out system of organ donation from the perspective of family members and professionals (See Box for summary of empirical study results) …”

“…The study provides new insights and understanding about implementation of a soft opt-out system of organ donation from the perspective of family members and professionals (See Box for summary of empirical study results). 11,12 Co-production worked well but it was an expensive research cost both in terms of resources (putting on events and activities) and…”

“…However, motivating and en- Box 2 Brief summary of empirical results from the before and after study and embedded process evaluation. 11,12 The big picture concerning consent rates…”