Opt out organ donation: a rapid evidence review

4. Factors associated with successful opt out legislation

This section examines the evidence on factors that been associated with successful opt out legislation. However it is important to note that many of these studies are limited as they are based on association rather than cause and therefore the results should be treated carefully.

4.1 Family support and the role of family

The following section provides a brief overview of evidence about the role of the family in organ donation and how this could potentially be improved further.

In both opt in and soft opt out systems the family ^[7] can play a central role in ensuring that organ donation is successful. Indeed, the Welsh Government conducted an international evidence review of the role of families and concluded that it was one of the most crucial factors in promoting organ donation and ensuring that it takes place (The Welsh Government, 2012). This is particularly true where the deceased has made no clear wish/decision with regards to organ donation as the decision often falls to the family. Even where a clear wish has been expressed by the deceased to donate, the family can in practice still overrule this (although there is no legal right for them to do so, clinicians would be unwilling to proceed against the family's wishes). Indeed, in Scotland in around 1 in 10 cases in 2017/18 where a patient had joined the ODR, their family members would not allow the donation to proceed (Walker, et al., 2013). Nonetheless, authorisation rates in Scotland and the rest of the UK (including in Wales following the introduction of opt out) are continually significantly higher where the patient was on the ODR than where they were not. This suggests opting in will remain an important factor in deciding whether or not donation is authorised, regardless of whether there is an opt in or opt out system.

The literature highlights numerous ways to improve how families can be involved in organ donation and how to raise rates of authorisation. One of the central elements of this is awareness by the family of their loved one's wishes. There is clear evidence that demonstrates that the families are much more likely to authorise organ donation when the wishes of the deceased are well known (Walker, et al., 2013) (Sque & Long, 2003). Use of the ODR plays a key role here, which will be further discussed in section 4.9. As concluded by the Welsh Government, a crucial element to increasing awareness of an individual's wishes is to promote and improve family conversations. Key strategies for doing this have been to make family conversations easier, more attractive/timely and by highlighting the social benefits of being a donor (The Welsh Government, 2012).

The discussion process informing a family's decision on whether to proceed with donation is highlighted consistently as an important factor in increasing the proportion of families allowing donation to proceed and ensuring an informed decision. Increasing understanding of the organ donation process and addressing concerns with regards to disfigurements of the deceased have both been highlighted as important. There is also evidence of the importance of involving specialist, trained staff in conversations, particularly at an early stage (Sque & Long, 2003). In addition to this confidence in staff and previous experience of the health care professional is essential (The Welsh Government, 2012). Ultimately families have to be both educated about organ donation and content with the processes before organ donation can proceed.

4.2 Impact of soft opt out on family authorisation

As stated above, in soft opt out systems the decision of the family is one of the most important factors in influencing donation. The evidence base is fairly limited in examining the potential impact of opt out on family authorisation. (Sque & Long, 2003) conducted an unrepresentative survey and found that the vast majority of respondents felt that opt out would promote conversations amongst family members. As previously discussed, there is also encouraging evidence from the recent Welsh impact evaluation, where consent rates have increased since the introduction of opt out, although it is impossible to establish if this is due to opt out directly. However, a Dutch experimental study conducted in a laboratory setting indicated that when authorisation was presumed by staff that family consent for donation was actually lower. Caution should, however, be applied when applying these results to the real world.

Overall the evidence base is mixed, but there is clearly encouraging emerging evidence from the fairly comparable context of Wales. The impact of opt out and the associated changes on the proportion of cases where families respect their loved one's decision (whether that is deemed or express self-authorisation) should become clearer over time here and it will be important to monitor these closely.

4.3 Infrastructure

Infrastructure improvements that support organ donation and transplant appear to be important factor(s). For example, Spain has one of the highest rates of organ donation in the world and operates an opt out system. Whilst there are a range of complex factors that have contributed to this result, infrastructure changes are believed to have made an essential contribution to increasing organ donation and transplantation. For example, it was a decade after implementation of opt out in Spain that donation rates began to rise; this occurred concurrently with the establishment of new infrastructure (Organ Donation Taskforce, 2008). Further evidence to support the importance of infrastructure comes from certain regions of Italy, who adopted a similar model of Spanish infrastructure saw organ donation double (Willis, 2014). One study claims that the biggest increase in organ donation, under opt out, in Austria, was driven by infrastructure changes, such as the use of full time transplant coordinators (Rithalia, et al., 2009). In 2008 the UK Organ Donation Taskforce at the time prioritised improvements in infrastructure over a move to opt out, implementing a range of changes based on the models used in Spain. Overall it is clear that high quality infrastructure is crucial regardless of the type of organ donation system in place.

4.4 The importance of public awareness

Public awareness of opt out also appears to be an important factor in increasing willingness to donate in opt out systems.

An international comparison study found that when people were aware of their nation's legislation, the proportion of people who were willing to donate their organs was greater in opt out (85.2%) than opt in (81.7%) countries. By contrast, when people were not aware of their nation's legislation, there was no difference in people's willingness to donate their organs in opt in (58.6%) and opt out (59.2%) countries (Shepherd, et al., 2014). A robust study by Mossialos et al (2008) found that greater awareness of the legislation was associated with an increased willingness to donate both your own and a family member's organs at an individual level (Mossialos, 2008). In Chile there was a decrease in family authorisation, which is likely to have driven subsequent falls in donation following the implementation of opt out legislation (Dominguez, 2013). A key factor cited is that 70% of the population were unaware of the legislation change (amongst other factors, such as actual and perceived corruption). This is however based on case study evidence of limited robustness.

The Welsh Government has invested in public awareness raising campaigns to support the implementation of opt out. Before implementation in 2012, approximately 60% of the public were aware of the pending legislation change. This increased after implementation to a peak of 84% in 2016 (The Welsh Government, 2017). However, the Welsh impact evaluation found that this had dropped slightly in 2017. This highlights the importance of continued awareness raising campaigns.

Whilst further robust evidence is required to firmly establish this, there is overall encouraging evidence to suggest that awareness of the legislation is likely to be an significant factor in ensuring an effective opt out system. Therefore robust regular monitoring of public awareness will be important to support an potential opt out system.

4.5 The importance of public attitudes towards opt out

There is some limited evidence that indicates public attitudes to opt out systems are likely to be an important factor that contributes to the effectiveness of opt out legislation to increase deceased donation. Several case studies (Shepherd, et al., 2014) (Organ Donation Taskforce, 2008) have cited the significance of a lack of public support (which was caused by a range of varying factors) for opt out, where the legislation was not effective. In France ^[8] there was significant negative media coverage of opt out legislation when the corneas were removed from a young man, despite medical professionals acting within the law. Moreover, the Brazilian Government had to withdraw their opt out legislation due to public concerns (Csillag, 1998). The negative public attitudes in these nations were seen as being due to mistrust towards medical professionals and this was possibly one of the key concerns of the UK Organ Donation Taskforce, which recommended that opt out should not be introduced in the UK. This remains unclear as Shepherd et al (2014) highlight that further empirical evidence is needed to determine if public attitudes and medical mistrust vary between opt in and opt out countries (Shepherd; O'Carroll and Ferguson, 2014). Nevertheless, it is important to consider the potential risks opt out poses in terms of trust in the NHS.

The Welsh Government systematic review highlighted the importance of public attitudes in effectively increasing organ donation (The Welsh Government, 2012). Regular monitoring of attitudes is therefore an important consideration. Strategies to encourage people to donate (such as media campaigns) and public education are seen as beneficial in addressing concerns and fostering positive public attitudes (Wright, 2007).

As mentioned in the introduction to this report, the majority of adults in Scotland are likely to be supportive of the principle of opt out. A recent (2016) TNS omnibus survey found that 59% agreed that "everyone should be presumed to be willing to be a donor unless they register a wish otherwise" ^[9] . As previously mentioned UK surveys suggest attitudes to opt out have improved over time, however there is no clear Scottish data to establish a trend. In 2004 a survey indicated that 53% of the Scottish population opposed doctors automatically being allowed to take organs for transplant (Haddow, 2006), but generalisations are of limited relevance to the soft opt out system proposed in Scotland.

Rest of the UK

There is a wider range of data available at the UK level. A range of surveys show that, at this level, support for opt out has been increasing over time. Before 2000, it was likely that the majority did not support opt out legislation, but since then support has increased to an average of 60% as shown by a systematic review of four studies (Rithalia, et al., 2009) (Coad, et al., 2013).

To support the implementation of opt out, the Welsh Government has conducted multiple surveys of public attitudes. In 2012, before implementation, 49% supported opt out and this had risen to 71% by 2016. The recent 2017 impact evaluation concluded that support for the soft opt out system remained high (The Welsh Government, 2017). At the time of writing this review the UK government was analysing but had not published the results of its own consultation on opt out organ donation and therefore this analysis was not available.

Attitudes of ethnic and religious groups

Whilst there is broad support for opt out, it is important to note likely differences between certain groups. Key differences by religious and ethnic group are further explored in section 5.

4.7 Staff training, attitudes and awareness

Medical staff play a particularly prominent role in increasing organ donation (Glasper, 2018). This section therefore examines medical professionals' attitudes and awareness, as well as how to support them in the implementation of opt out. It primarily draws on the findings from the Welsh impact evaluation of opt out, but also examines the international context. Where possible, distinctions are made between staff that work directly with organ donors and their families, and staff that do not (although much of the literature does not make this distinction).

This review identified no existing data with regards to Scottish NHS staff attitudes towards opt out systems of organ donation. There is a need for further research here and it is recommended that the Scottish Government continues to monitor this as it becomes available. It did however identify a significant amount of research on Welsh NHS staff.

The Welsh Government commissioned a survey to explore the attitudes and awareness of NHS staff in Wales due to the change. A baseline survey was conducted pre and post implementation (which covered a wide range of staff, not just those involved in donation). A majority of staff supported the change before implementation (71%) and this increased to 89% post implementation. The survey also identified that most staff felt the move to opt out would have little impact on them. Staff awareness of the change was fairly high before implementation (89%) and increased to 96% post implementation (The Welsh Government, 2017). Both awareness and self-related knowledge increases were highest amongst staff that did not work directly with organ donors ( e.g. GPs and nurses outwith critical care units). The increase in both awareness and attitudes highlights the importance of information campaigns in educating staff not familiar with organ donation to increase awareness.

There were several key findings from the Welsh impact evaluation that highlighted how staff could be supported. It stressed the importance of ensuring that NHS staff have a clear understanding and good level of knowledge of the new opt out system. Despite high levels of awareness the report highlighted that NHS staff benefited from further training, such as in approaching the organ donation conversation with the family (The Welsh Government, 2017) (although this would only be relevant for staff working in critical care areas). A high emphasis was placed on this, with continuous monitoring recommended.

International evidence also supports the notion that training of key health service staff is important to support the change to and implementation of opt out. Research conducted in Belgian hospitals found that confidence, along with knowledge, is important in effectively communicating with families about the organ donation process. Increasing staff knowledge and improving their confidence may lead to a higher authorisation rate (Pelleriaux, et al., 2008). Sula et al (2012) found that education, donor management and how to communicate with families should be part of the specialist training of health care professionals (Smudla, et al., 2012). Further to this, a Greek study also found that staff education for health service staff was also key to gaining support from the public and increasing organ donation (Symvoulakis, 2014).

Therefore from the international evidence it is clear that communication and knowledge is important to support legislation and system change. Ultimately when there is staff support, there is more likely to be a greater understanding of organ donation amongst families and thus donation is more likely to be authorised. The evidence base highlights the importance of continuous training and education to support the implementation of opt out.

4.8 Communication and media campaigns

This section examines the evidence regarding the use of media campaigns to raise awareness and educate the public about opt out. Media and communication campaigns are an essential way of raising the profile of organ donation and are frequently used to raise the profile of organ donation more widely. The Welsh systematic review concludes that where opt out legislation is implemented, communication and campaigns are likely to be important factors in the legislation's success (The Welsh Government, 2012).

There is a limited evidence base about how media and communication campaigns for organ donation can be improved and this is an area where further research is needed. A study by Cameron et al (2013), in the US, describe a move to use Facebook to raise awareness of organ donation (online). They reported that the organ donation rates in the US were very low and after the Facebook campaign began there was an increase in the number of people who registered to be a donor. This increase was seen in the 12 days following the campaign (Cameron, et al., 2013).

Another US study looked at using written letters to raise awareness of their register (Feeley, Quick and Lee, 2016). The letters were sent to select parts of the American adult population, with some letters sent by state officials and others not. They found that overall the letters alone outperformed brochures (as well as use of a combination of brochures and letters). Registration rates were higher when direct mail letters were written by officials affiliated with state departments. Feeley et al (2016) reported that this was an inexpensive campaign and was beneficial for increasing the number of people registering. Encouraging people to register is still important in opt out as it is likely to increase authorisation to donate.

This section examines the evidence regarding the use of a register to increase organ donation and support opt out. As highlighted, increased registrations do not equate proportionately to increased donations and, in opt out systems, not registering your wishes is considered an active choice to donate. We have chosen to consider the impact of opt out on the register as registering one's decision is likely to increase authorisation for donation and therefore eventually the number of successful donations.

As discussed in section 1, Shepherd et al found that family members were much more likely to be willing to permit the donation of their loved one's organs when the patient had registered to be a donor (Shepherd & O'Carroll, 2014). In general, the number of people signing up to the register is positively associated with a higher number of organ donors in soft opt out countries. For instance, Bigel (2010) found that use of a dual register (where someone can both opt in or opt out as opposed to only opting in) was positively associated with a higher number of donors (Bilgel, 2013).

Nevertheless, this relationship is more complex than it first appears. Bigel (2010) also identified that in hard opt out countries, that not having a register was also positively associated with higher number of donors. For soft opt out systems, only use of a dual register ^[10] was positively associated with higher number of donors. For example, a single registry ^[11] that still required family authorisation was not associated with an increase in deceased donation rates. Both hard and soft opt out systems have the potential to be successful and this study highlights the probable importance of the interaction between family support and ODR type.

The evidence examined suggests that use of a dual ODR is likely to be beneficial in soft opt out systems. However, it is important to highlight that these studies only identify an association and therefore any conclusions about a causal impact are highly limited. Again, further robust research is needed to establish the interaction between ODR types and opt out systems. It is also important to highlight that Ugar found that individuals are much less likely to register their preferences on the ODR in presumed consent countries (Ugar, 2015). This suggests the continued importance of promoting the use of a register in opt out countries.