Expectations of a new opt‐out system of consent for deceased organ donation in England: A qualitative interview study

Abstract Introduction In 2020 England moved to an opt‐out deceased donation law. We aimed to investigate the views of a mixed stakeholder group comprising people with kidney disease, family members and healthcare practitioners towards the change in legislation. We investigated the expected impacts of the new legislation on deceased‐donor and living‐donor transplantation, and views on media campaigns regarding the law change. Methods We undertook in‐depth qualitative interviews with people with kidney disease (n = 13), their family members (n = 4) and healthcare practitioners (n = 15). Purposive sampling was used to ensure diversity for patients and healthcare practitioners. Family members were recruited through snowball sampling and posters. Interviews were audio‐recorded and transcribed verbatim. Transcripts were analysed using thematic analysis. Results Three themes with six subthemes were identified: (i) Expectations of impact (Hopeful patients; Cautious healthcare professionals), (ii) Living‐donor transplantation (Divergent views; Unchanged clinical recommendations), (iii) Media campaigns (Single message; Highlighting recipient benefits). Patients expected the law change would result in more deceased‐donor transplant opportunities. Conclusions Clinicians should ensure patients and families are aware of the current evidence regarding the impact of opt‐out consent: expectations of an increased likelihood of receiving a deceased‐donor transplant are not currently supported by the evidence. This may help to prevent a decline in living‐donor transplantation seen in other countries with similar legislation. Media campaigns should include a focus on the impact of organ receipt. Patient or Public Contribution Two patient representatives from the Kidney Disease Health Integration Team, Primrose Granville and Soumeya Bouacida, contributed to the content and design of the study documents.


| INTRODUCTION
The number of individuals waiting for an organ transplant in the United Kingdom is greater than the number of organs available for transplant. 1 Before 2015, all the countries of the United Kingdom operated under an 'opt-in' system in which individuals who wished to donate their organs after death actively registered on the organ donor register. In 2015, Wales became the first country in the United Kingdom to introduce 'opt-out' legislation. In this system, individuals who do not wish to donate their organs after death register this by 'opting-out'. Individuals who have not 'opted-out' are presumed to consent to donation. Opt-out legislation was implemented in England in May 2020, in Scotland in March 2021 and a public consultation is underway in Northern Ireland.
A recent comparison of organ donation and transplantation rates in 35 countries found no strong evidence of a difference between opt-in and opt-out countries. 2 However, countries with opt-out legislation had fewer living organ donors per million population (pmp) than those with opt-in legislation (4.8 vs. 15.7 pmp). 2 Most livingdonor transplants are kidney transplants, with a minority liver, lung and intestinal. In general, outcomes for living-donor transplants are better than for deceased-donor transplants with respect to both transplant and patient survival. 1,3-10 Living organ donation is associated with risks to the donor, but these are small. Perioperative mortality is estimated to be 0.01%-0.03% [11][12][13] in living kidney donation and 0.2% in living liver donation. 14,15 Survival at 11 years is comparable for liver donors, kidney donors and matched nondonors (mortality at 11 years 1.2%, 1.2% and 1.4%, respectively). 15 The reasons behind the observed association between opt-out legislation and lower rates of living donation are not well understood. In the context of an opt-out system, potential donors, transplant candidates and healthcare practitioners may perceive living donation (and the accompanying risks) as unacceptable or unnecessary if they anticipate an increased likelihood of receiving a deceased-donor organ. 16 The aim of this qualitative interview study was to investigate the views of people with kidney disease, family members and healthcare practitioners on the change to opt-out legislation in England. We aimed to investigate (i) the expected impacts of the change in legislation, including with respect to living donation and living-donor transplantation, (ii) whether the expected impacts of the change in legislation would affect decision-making regarding living-donation and transplantation, and (iii) views on the focus of media campaigns accompanying the change in the law. Findings will help to ensure healthcare interactions and media campaigns address the expectations and concerns of these relevant stakeholders. Understanding the impact of the legislation on patients and healthcare professionals' transplant decision-making may allow intervention to prevent a reduction in living-donor transplants that has been observed in other countries.

| MATERIALS AND METHODS
The study was undertaken at two English hospitals (a transplanting centre and a transplant referring centre). Semi-structured qualitative interviews were undertaken with English-speaking adults aged ≥18 years and <75 years, from the following groups: 1. People with advanced kidney disease (chronic kidney disease stages 4 and 5, and those receiving kidney replacement therapy).
2. Family members of people with advanced kidney disease including living donors.
3. Healthcare practitioners who work in nephrology and transplantation.
Individuals who lacked the mental capacity to consent to participation were not included.
Patients were invited to participate by post, in person and through posters in outpatient clinics and haemodialysis units. Purposive sampling of patient participants was undertaken to ensure diversity in sex, age, ethnicity, kidney disease history and socioeconomic status. Family members were recruited via hospital posters and by 'snowball sampling' through participants with kidney disease.
Healthcare practitioners were invited to participate by Chief Investigator (P. K. B.) via email, and were purposively sampled to ensure diversity in sex, age, ethnicity and clinical role.
Interviews were undertaken by P. K. B., an academic nephrologist with formal training and experience in qualitative research methodology. She was known to healthcare practitioners but was not known to any of the patients or family participants. Patient and family participants were told in the study information sheet that P. K. B. is a kidney doctor and researcher working at the University of Bristol.
This study was undertaken as part of another larger study: the topic guides are provided (Supporting Information Material-example topic guides). Participants were asked about their expectations of the impact of the change in legislation on donation rates, and whether their expectations would change their behaviours. Interviews were either undertaken over the telephone or face-to-face at a location of the participant's choosing. Written consent for participation was provided at the time of face-to-face interviews. For telephone interviews, verbal consent was recorded and written consent was confirmed via post. Participant demographic data were collected at the time of the interview. A £20 voucher for participation was given to all participants.
Interviews were audio-recorded, transcribed verbatim, and analysed using inductive thematic analysis, 17 as described by Braun and Clarke. 18 Anonymized transcripts were uploaded to NVivo software 19 for analysis. All transcripts were coded by P. K. B. and a subset inductively and independently analysed by two other researchers (M. A.-T. an Academic Clinical Fellow in renal medicine, and H. L., an MRes student in Health Sciences Research). Codes and any discrepancies were discussed to maximize rigour, reliability and reflexivity. Data collection and analysis were conducted concurrently, employing an iterative approach. The sample size was determined by reaching theoretical theme saturation when few or no new relevant data were identified in successive interviews. 20 Saturation was assessed with respect to the sample of mixed stakeholders, not to subsamples within. The report was written with reference to the consolidated criteria for reporting qualitative studies (COREQ). 21 The study received Health Research Authority and NHS Research Ethics Committee approval (Reference 19/WM/0320).

| RESULTS
Thirty-three of Ninety-two (36%) invited individuals agreed to participate (Table 1)   Two patient participants explained how the change in legislation was more consistent with individual preferences. They thought that people who wanted to donate often failed to act to confirm this, whereas those who objected to donation were more likely to act to avoid donation: I think if somebody's not happy to donate anything he will say that…so better is the law which has assumed you have agreed…that will be better because, for 'I think if somebody's not happy to donate anything he will say that…so better is the law which has assumed you have agreed…that will be better because, for example a lot of people want to do something but they are too lazy to! I know by me, because sometimes I think "Oh that it is worth to do that, but maybe tomorrow". And tomorrow I can die!' (ID28/Patient) 'Yes I mean I thought that they were doing the pilot scheme where they were having an opt in rather than opt out and I thought that was a great idea…And the thing is like, you'll probably find then that we're a lot more likely to get kidneys for the rarer types of patients and another thing I've noticed is like, ethnic minorities tend to struggle to get donations because of the size of their communities and things like religion and things that stop them from. So I mean this would just improve chances for people like that as well'. (ID30/Patient)

Cautious healthcare professionals
'I don't think there is going to be a sudden rush of kidneys because people are going to be saying "Woohoo, they haven't opted out therefore we can whip their kidneys out"'. (ID07/Transplant nurse or coordinator) '…everybody still knows that if at the end the family says no, it says no…I don't really think it is going to make any difference'. (ID20/Transplant nurse or coordinator) 'The quality of the kidneys are not necessarily going to be all good either, so…I don't anticipate that I'll change my practice when it's on the opt-out legislation, and the likely 10

| Expectations of impact: Cautious healthcare professionals
The only patient who felt the change in the law would have no impact attributed this view to a conversation with a healthcare professional.
In keeping with this, all healthcare professionals interviewed had low   In 1997 Brazil introduced an opt-out law. 25 Despite not being required, in practice almost all surgeons asked for family approval before removing organs. As a result, the government added a new paragraph to the law, stating that doctors should get permission from relatives before organ retrieval. However, part of the Brazilian population feared that their organs would be removed even before they were clinically dead, and many responded by registering as nondonors. As a result, in 1998 the law was abolished and Brazil returned to an opt-in law. 26 In contrast, Spain introduced an opt-out system in 1979 27,28 and is an international leader in rates of deceased donation. 29 However, Spain operates a 'soft opt-out' system, and rather than the high donation rates being attributed to the law,