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.

IntroductionThe Human Transplantation (Wales) Act 2013 (the Act) introduced a ‘soft opt-out’ system of organ donation on 1 December 2015. Citizens are encouraged to make their organ donation decision known during their lifetime. In order to work, the Act and media campaign need to create a context, whereby organ donation becomes the norm, and create a mechanism for people to behave as intended (formally register their decision; consider appointing a representative; convey their donation decision to their families and friends or do nothing—deemed consent). In addition, family members/appointed representatives need to be able to put their own views aside to support the decision of their loved one. The aim of this study is to evaluate initial implementation, outcomes and impact on families and appointed representatives who were approached about organ donation during the first 18 months.Methods and analysisProspective mixed-method coproductive study undertaken with National Health Service Blood and Transplant (NHSBT), and multiple patient/public representatives. The study is designed to collect information on all cases who meet specified criteria (≥18 years, deceased person voluntarily resident in Wales and died in Wales or England) whose family were approached between 1 December 2015 and 31 June 2017). Data for analysis include: NHSBT routinely collected anonymised audit data on all cases; Specialist Nurse in Organ Donation (SNOD) completed anonymised form for all cases documenting their perception of the families’ understanding of the Act, media campaign and outcome of the donation approach; questionnaires and depth interviews with any family member or appointed representative (minimum 50 cases). Additional focus groups and interviews with SNODs. Anonymised donation outcomes and registration activity reports for Wales provide additional context.Ethics and disseminationApproved by NHSBT Research, Innovation and Technology Advisory Group on 23 October 2015; Wales Research Ethics Committee 5 (IRAS190066; Rec Reference 15/WA/0414) on 25 November 2015 and NHSBT R&D Committee (NHSBT ID: AP-15–02) on 24 November 2015.RegistrationThe protocol is registered on the Health and Care Research Wales Clinical Research Portfolio. Study ID number 34396, www.ukctg.nihr.ac.uk

Background Wales introduced a soft opt-out organ donation system on 1st December 2015 with the aim of improving consent rates. In the first 18 months consent rates improved but the difference could not solely be attributed to the soft opt-out system when compared with similar improvements in consent rates in other UK nations. Methods We conducted an 18 month post-intervention qualitative process evaluation involving 88 family members of 60/211 potential organ donor cases, and 19 professionals. Views and experiences of Specialist Nurses in Organ Donation who implemented the new system and family members who were involved in decision making were collected to see how their respective behaviours impacted on implementation. Data collection included interviews, focus groups and qualitative questionnaire data. Results Implementation was considered a success by Specialist Nurses in Organ Donation. The bespoke retraining programme and responsive approach to addressing initial implementation issues were identified as examples of best practice. Specialist Nurses in Organ Donation were valued by family members. Six implementation issues had an impact on consent rates – the media campaign had gaps, the system was more complex, challenges in changing professional behaviours, inability to obtain the required standard of evidence from family members to overturn a donation decision, increased complexity of consent processes, and additional health systems issues. Conclusion This is the first comprehensive process evaluation of implementing a soft opt-out system of organ donation. Specific elements of good implementation practice (such as investment in the retraining programme and the responsiveness of Specialist Nurses in Organ Donation and managers to feedback) were identified. The key message is that despite retraining, nursing practice did not radically change overnight to accommodate the new soft opt-out system. Policy makers and health service managers should not assume that nurses simply need more time to implement the soft-out as intended. Additional responsive modification of processes, ongoing training and support is required to help with implementation as originally intended. Scotland, England and the Netherlands are introducing soft opt-out systems. There is an opportunity to learn from initial implementation in Wales, by acknowledging gaps, good practice and opportunities to further improve processes and nursing practices. Electronic supplementary material The online version of this article (10.1186/s12913-019-4266-z) contains supplementary material, which is available to authorized users.

Background Co‐production of research into public health services has yet to demonstrate tangible benefits. Few studies have reported the impact of co‐production on research outcomes. The previous studies of organ donation have identified challenges in engaging with public organizations responsible, gaining ethical approval for sensitive studies with the recently bereaved and difficulty in recruiting bereaved family members who were approached about organ donation. Objective To address these challenges, we designed the first large co‐productive observational study to evaluate implementation of a new system of organ donation in Wales. This paper outlines the co‐productive strategies that were designed to overcome known methodological challenges and reports what impact they had on resolving these challenges. Design Two‐year co‐produced study with multiple stakeholders with the specific intention of maximizing engagement with the National Health Service arm in Wales responsible for organ donation, and recruitment of bereaved family members whose perspectives are essential but commonly absent from studies. Setting and participants NHS Blood and Transplant, Welsh Government and multiple patient and public representatives who served as co‐productive partners with the research team. Results Co‐productive strategies enabled a smooth passage through four different ethics processes within the 10‐week time frame, family member recruitment targets to be surpassed, sharing of routinely collected data on 100% of potential organ donor cases and development of further research capacity and capability in a critically under researched area. Discussion and conclusion Although expensive and time consuming, co‐production was effective and added value to research processes and study outcomes.

In an attempt to improve organ donation rates, some countries are considering moving from “opt‐in” systems where citizens must express their willingness to be an organ donor, to “opt‐out” systems where consent is presumed unless individuals have expressed their wishes otherwise, by, for example, joining an “opt‐out” register. In Wales—a part of the United Kingdom—the devolved government recently legislated for an “opt‐out” system. For the change to be effective, a public awareness campaign was critical to the policy's success. Using quantitative and qualitative content analysis, we explored media coverage of the change to better understand the relationship between the state, policy actors, media and the public when such policy changes take place. Our findings illustrate how a state communication campaign can effectively set the media agenda within which we saw a degree of interdependency created with the state using the media to promote policy, and the media relying on the state for credible information. Yet we also found that the media is not uncritical and observed how it uses its autonomy to influence policy setting. Over the period of study, we found that a change in tone and view towards deemed consent organ donation has taken place in the media. However, while this may influence or reflect public attitudes, it is yet to be seen whether the media campaign translates into behavioural change that will result in increases in organ donations.