Controlled donation after circulatory determination of death (DCD) is responsible for the largest quantitative increase in deceased donation of all organs in Canada,1 and has the potential to increase heart transplantation. Two methods have been developed and used to allow recovery and transplantation of the DCD heart in the United Kingdom (UK),2 one of which is also used in Australia.3 The limited international experience reported until 31 March 2019 (n = 105 in adults) shows good short-medium-term outcomes for both methods, though long-term outcomes remain unknown. In addition, a number of ethical concerns regarding the definition of death4 and the quality of DCD hearts remain regularly debated in the academic literature.2

In October 2018, Canadian Blood Services and Trillium Gift of Life Network partnered to host a consensus-building meeting for DCD heart donation and transplantation, engaging both donation and transplantation professionals to create a medical, legal, and ethical framework for Canadian practice (manuscript in preparation). It was a two-day, face-to-face meeting with a multidisciplinary group of participants. A steering committee (including five authors of this paper: A.H., L.H., L.W., C.G., and S.S.) was formed to lead this meeting.

The process of heart donation and transplantation using DCD is complex as the donor is declared dead by circulatory criteria and resumption of circulation is contemplated.5 Examination of the related medical, legal, and ethical issues requires a comprehensive understanding of various stakeholder perspectives. The potential impact on policy and practice requires expert opinions and perspectives of not only the medical, legal, and bioethics communities but also of the individuals most directly impacted by this process: patients and their families. Policy-makers and guideline-developers are increasingly urged by quality standards to include the perspectives of these groups when developing, implementing, and using evidence-informed health advice.6,7,8

Recent research on the impact of patient engagement on clinical practice guideline development reports that early and continued engagement of patients partners influences guideline development, including the scope, patient-relevant topic inclusion, outcome selection, recommendation development, implementation, and dissemination.9 Full engagement of patient partners has positive impacts.10 Like the practice itself, stakeholder consensus-building on the topic of DCD is continuously developing. We sought with this project to measure and analyze the impact of including patient and family partners in this emergent process.

Specifically, we aim to: 1) provide a detailed description of methods used to create a patient partner strategy with full participation in the consensus-building meeting for the framework of heart donation following DCD, 2) describe how patient partners improved the consensus-building project, and 3) share lessons learned by both researchers and partners through this process.

It is our hope that in sharing these details we can encourage others planning consensus-building activities around emergent medical practices to consider the benefits of similar engagement.

Methods

The patient engagement process used for this project was based on best practices as described by Rashid et al.11 We take the definition of patients to refer to people with personal experience of a disease, condition, or service (patients, consumers, or users); their caregivers or family members; and people representing a collective group of patients or caregivers. Engagement refers to consultation (gathering information from patients/public through literature, surveys, or qualitative research); participation (two-way information exchange between patients/the public and other experts); or communication (tailoring information to patients/the public).12

Data for this project comprised the detailed notes, observations, and reflections made by the steering committee throughout the design and implementation of the patient partnership strategy, audio-recordings, and anonymous written feedback obtained during the consensus-building meeting, and post-meeting written reflections and focus group discussions with patient partners. Patient partners additionally completed a post-meeting questionnaire which was developed in consultation with patient partners from another initiative.13 The questionnaire contained eleven questions in total and invited reflections on general impressions (Appendix 1). All study data were made available in qualitative (textual) form and were analyzed by A.H. and A.V.B. using applied thematic coding.14,15 Identified themes were reviewed with the patient partners to ensure accuracy.

The William Osler Health Centre Research Ethics Board provided ethical review and approval (6 November 2018) for administration and analysis of the patient partner questionnaire. Approval for use and analysis of anonymous meeting feedback forms and audio-recordings was provided by participant waiver at the meeting.

Results

Building the patient partnership strategy

Methods used to build the patient partnership strategy for this consensus-building meeting included recruitment, preparation, support, inclusion, and debriefing. Throughout each stage, a single point person (C.G.) maintained primary contact with patient partners.

Recruitment

Patient partners were invited to be involved in the early planning of the consensus-building meeting. A convenience sample of heart transplant recipients and family members who consented to organ or tissue donation by DCD on behalf of their loved one was identified by Canadian Blood Services, Trillium Gift of Life Network, the Canadian Donation and Transplantation Research Program, and local physicians in the UK and Nova Scotia. A member of the Steering Committee (C.G. or L.W.) initiated contact by email or telephone to explain the project and the proposed process.

Patient partners were provided with project details via email and invited to participate in an introductory teleconference (see Appendix 2). Patient partners were provided with choices regarding desired engagement, from emailed or video comments to full meeting attendance. All patient partners who were contacted opted to participate in the meeting in person. Six patient partners attended the consensus-building meeting. The group included three donor family members who had provided consent for DCD on behalf of their loved one who had died (H.B., D.B., J.T.), two heart transplant recipients (S.B., E.T.) who received their hearts from donors following death by neurologic criteria (one of whom was relisted for transplant at the time of the consensus-building process and subsequently received a second transplant), and one heart transplant recipient from the UK who received his heart from a DCD donor (T.S.).

There was a clear understanding from the outset that participation at the meeting might increase access to heart transplantation, improved opportunities for donor families, and ultimately more lives saved. For a transplant recipient supported by the medical community in their difficult journey through end-stage heart failure for over ten years:

“Participating in the meeting provided an opportunity to give back to the community that saved my life.” (E.T., heart transplant recipient, Patient and Family Partner Experience Questionnaire.)

The desire to help was the most motivating factor for patient partner participation.

Preparation prior to consensus-building meeting

Following agreement to participate, patient partners were provided with detailed information about patient partner engagement (see Appendix 3). A videoconference was scheduled three weeks prior to the consensus meeting to review the agenda and discuss plans for patient partner participation, including as members of an expert panel. Given the sensitive nature of discussions surrounding organ donation after death, the steering committee was concerned about the emotional well-being of the patient partners. Family members who had consented to donation had recently experienced significant loss. During pre-meeting discussions, patient partners and supporting members of the steering committee acknowledged the emotions that may arise throughout discussions about dying and the process of deceased organ donation. This experience was normalized, and full support was ensured throughout. On the eve of the meeting, the patient partners were invited to dinner with a member of the steering committee (C.G.) as an opportunity to build interpersonal relationships and resolve remaining concerns or questions.

Support during consensus-building meeting

All meeting participants were reminded of the diversity of the audience and were asked to avoid colloquial language in their commentary. The two-day consensus-building meeting involved input from a multidisciplinary, sex- and geographic-balanced group of 53 participants, including patient partners, physicians, nurses, surgeons, policy-makers, organ donation and transplantation administrators, international experts, and bioethics and legal representatives. The meeting was organized as a series of plenary discussions, panels, and small-group discussion activities (see eAppendix in the Electronic Supplementary Material). A reception took place at the end of the first day.

In addition to participation in small-group and plenary discussions, patient partners contributed as panel members for a discussion entitled, “Learning from Patients and Families”, during which they described their relevant experiences with organ donation and transplantation and explained why they accepted the invitation to participate in the consensus-building meeting. The floor was then opened to questions from other meeting participants, facilitating a rich discussion.

One patient partner (E.T.), was asked to participate in the “Listening for Research” group given his research background. This group was convened to keep track of potential research ideas arising from the meeting.

At each break and at the end of the first day, a member of the steering committee with education and experience in supporting patient partners and families during emotionally challenging times (C.G.) debriefed with patient partners to offer support and further normalize responses. At the end of the second day, the patient partners were invited to reflect on their experience at the meeting by sharing their thoughts with the larger group. All patient partners agreed that the expert support offered by the steering committee members (C.G., L.H., L.W.) was essential to ensuring their participation was effective and meaningful. As a direct result of the preparatory work and early engagement, in addition to the ongoing support offered at every juncture, the patient partners felt confident to contribute to even the most complex discussions.

After the consensus-building meeting

Following the meeting, the patient partners participated in a teleconference focus group to describe their learning and reflections, facilitated by their completion of a pre-teleconference questionnaire. In addition, one family partner (D.B.) was also a member of an “Expert Review Group” for the consensus-building meeting and is an author of the manuscript in preparation on DCD heart guidance in Canada.

Impact on consensus-building for heart donation after DCD

The perspectives shared by patient partners throughout the consensus-building meeting were powerful and contributed towards building collective consensus. Inclusion of patient partners led to discussions and interactions that benefitted all meeting participants, including: 1) inclusion of interdisciplinary perspectives, 2) simplification and clarity around complex concepts, and 3) introduction of gratitude and honour as guiding concepts.

Inclusion of interdisciplinary perspectives

Including patient partners in this meeting was part of a strategy to involve a broad range of stakeholders. Many participants felt that interdisciplinary participation and discussion contributed to the success of the meeting:

“Different viewpoints presented, family/patient especially” (Anonymous feedback #12).

“Of course, the active and courageous participation of donor families and transplant recipients enriched our discussions” (Anonymous feedback #32).

“The diversity of professionals and patient/family participants. Having such a diverse group from all stakeholders will help to cover all aspects (pros/cons) of DCD heart donation. I felt it was a well-rounded discussion for both days (including “after hours”)” (Anonymous feedback #9).

Involving patient partners in the diverse group of meeting participants, including the invitation of patient partners to join discussions “after hours,” contributed to a consensus that is representative of the many, and sometimes conflicting, perspectives involved in heart donation after DCD.

Simplification of complex concepts

“Patients and families [bring] things back to a clear simple focus” (anonymous feedback #15).

Inclusion of patient partners improved all meeting participants’ understanding of topics related to DCD heart donation and greatly enriched the resulting discussions and recommendations. For example, one point raised during discussion was the need to prevent brain reperfusion after death when restarting the heart and circulation in the deceased donor’s body, a process required in one proposed heart donation protocol (normothermic regional perfusion). The rationale and mechanism(s) used for preventing brain reperfusion are complex, and it remains unclear how to confirm the absence of brain reperfusion.4 One patient partner (J.T.) was able to draw on his professional experience as an electrician, bringing forward the similarities of blood flow in vascular circuits to the current flow in electrical circuits. J.T. shared an electrician safe-work practice called “lock out tag out”, which is used during construction and maintenance to eliminate potential flow of electricity and isolate electrical hazards so work can proceed in a safe manner. The “lock out tag out” process is followed by the appropriate downstream testing to ensure 100% confidence that all potential electrical flow has been eliminated. J.T.’s analogy offered tremendous clarity to meeting participants, as they immediately aligned the “lock out tag out” principles with protecting the brain from perfusing blood supply during normothermic reperfusion.

Patient partners provided insights on important considerations related to the critical need for clarity in communication surrounding heart donation after DCD. Some clinically trained meeting participants felt that donor families should receive detailed information about the heart recovery process at the bedside, specifically the rationale and mechanism(s) for preventing brain reperfusion. Patient partners, however, felt strongly that this information would likely exceed what the average family would want to or be equipped to comprehend. Patient partners suggested that while bedside care providers must be comfortable explaining all donation-related information, they should tailor what is shared in accordance with the donor family’s preference. This was surprising to many of the other participants without lived experience.

Clarity regarding death determination would not have been possible without patient partners, who confirmed that making the decision to donate organs signifies acceptance of a loved one’s death. Patient partners informed meeting participants that after the decision to donate has been made, families want to be able to trust the medical system to facilitate the donation and transplantation process to save as many other lives as possible.

“The exact process of how Collin’s organs were going to be retrieved was not explained in detail to me, and I did not need to know this. I trusted the team completely. I actually prayed Collin would pass away quickly after life support was removed to ensure more organs could be retrieved to help more people. I had come to terms with Collin’s death…I never once thought he might come back to me or would miraculously wake up” (D.B., donor family, Patient and Family Partner Experience Questionnaire).

The active involvement of engaged patient partners in the consensus-building meeting facilitated the generation of clarity surrounding otherwise complex and challenging concepts.

Gratitude and honour

The patient partners were consistently clear about the gratitude they felt for being asked to participate and to share their perspectives, which helped to underscore the significance of the consensus-building meeting. Patient partners felt honoured to be part of such a far-reaching healthcare system project. Donor families in particular were grateful for the impact their participation had on their healing process and the opportunity to continue the legacy of their loved ones:

“We knew that consenting to donation was the right thing to do for William and our family, but actually saying the words and making the official decision to donate is hard, regardless of your preconceived feelings on donation. Participating in this consensus forum gave us the opportunity to reflect and confirmed for us that we made the right decision. Having that validation to move forward has been essential for us in our continued journey to heal.” (H.B., donor family, Patient & Family Partner Experience Questionnaire)

“Sharing Collin’s story has helped my kids and I heal from our grief and helped us to keep Collin’s memory alive in our hearts and minds. I want to try to help others…realize that donating their loved one’s organs will help them in their grief and honour their loved one.” (D.B., donor family, Patient & Family Partner Experience Questionnaire)

Heart transplant recipients found it beneficial to meet donor families and express their gratitude. As one transplant recipient articulated,

“This unique experience was likely as close as I will come to meeting my donor family” (E.T., heart transplant recipient, Patient & Family Partner Experience Questionnaire).

One donor family commented on how powerful it was to not only interact with healthy transplant recipients but to receive their appreciation:

“Meeting the heart recipients at this meeting and having them say thank you to me for being a donor family was very emotional for me. I no longer felt the need to hear thank you from Collin’s recipients; I knew they woke up every day appreciating what they were given” (D.B., donor family, Patient & Family Partner Experience Questionnaire).

These moments of sharing between donor families and transplant recipients introduced an element of responsibility to consensus-building proceedings. As one participant included in their anonymous feedback, many felt that it was “an honour to be involved. Refreshed my passion on the work we do,” (anonymous feedback #15). Facilitation of difficult and emotional conversations such as donor family–transplant recipient meetings and discussions helped contribute to consensus-building.

Lessons learned from patient partnership

Patient partners agreed that their contributions at the meeting were not only important to the success of the process and critical to re-centering complex discussions regarding DCD heart donors and recipients but were also personally beneficial. Several patient partners were inspired through interactions with others during the meeting to become advocates for donation and transplantation. One patient partner (J.T.) registered his consent to donate all organs and tissues, something he had previously opted out of. Two patient partners went on to join the organ and tissue donation committee at their local hospital (J.T., H.B.), while another has continued to share her donation experience at numerous healthcare professional conferences (D.B.).

Though some patient partners attended the meeting expecting to benefit, others only realized the positive repercussions of personal connection, story sharing, and participation in system improvement during and after the meeting.

In the anonymous post-meeting evaluation, the inclusion of patient/family partners, the diversity of stakeholders and opinions, and the interactive process were most frequently identified as high value. In fact, 19 out of 40 (48%) respondents indicated the component of the meeting they liked most was the participation and perspectives of the patient partners:

“The donors’ and recipients’ heartfelt stories—the reason why we do this” (Anonymous feedback #14).

“Involving the patient partners was critical to this type of expert guidance workshop” (Anonymous feedback #6).

The perspectives of patient partners informed the acceptable risk of moving forward with DCD heart transplantation in Canada despite limited data on outcomes. Given the uncertainties, there was a discussion about whether transplant surgeons should have the ability to refuse hearts from DCD donors without discussion with heart transplant candidates. The idea that this would occur without consulting the patient was troubling for patient partners:

“I am now 50 years old, I don’t need the best heart possible; I need a better heart than the one failing me. I just want to stay alive and see my sons realize their dreams” (S.B., heart transplant recipient in need of a second transplant, meeting notes).

One patient partner who received a DCD heart transplant explained his reason for agreeing to participate in the new program in the UK:

“If you had two tunnels, and one had a speck of light at the end of it [a DCD heart], and one was completely black [not getting a heart at all], which one would you choose?” (T.S., DCD heart transplant recipient, meeting notes).

Several transplant professionals reflected on how these comments gave them “permission” to accept less than perfect grafts or increased margin of risk when performing DCD heart transplantation.

Although meeting participants were aware that opinions and personal experiences from six patient partners were not representative of the entire donor or recipient position, the presence of interdisciplinary perspectives were instrumental in shaping an initial statement about DCD hearts in Canada. Inclusion of patient partners was found to be mutually beneficial, as patient partners obtained a meaningful channel for advocacy, and surgeons and physicians were able to reaffirm “the reason why we do this.”

Discussion

Our results show a successful collaboration with patient partners to create the medical, legal, and ethical framework for DCD heart donation and transplantation in Canada. The methods used for patient engagement allowed the fostering and sharing of mutual benefits for patient partners and for a strong consensus-building process. The presence of both donation and transplant recipient perspectives led to important discussions about what a recipient might be willing to ask of a donor family, and what a donor family might expect of a recipient. This dynamic was exceptionally powerful and led to a more complete understanding of all perspectives. Our findings suggest that a broad interprofessional audience can engage with properly prepared and supported patient partners to strengthen and focus dialogue throughout an interdisciplinary consensus-building meeting even at very early stages of policy formation.

A systematic review of involving patient partners in the planning and development of healthcare concluded that patients and families have contributed to a wide variety of such initiatives, but that the impact of participation on the quality and effectiveness of services is unknown.16 Our findings show that the engagement of patient partners led to the inclusion of interdisciplinary perspectives, simplification and clarity of complex concepts, and the introduction of gratitude and honour as guiding principles for a process that was felt to be mutually beneficial for all meeting participants. These results are consistent with the findings of a qualitative systematic review of patient partners’ involvement in improvement initiatives10 and a scoping review of current practice for engaging patient partners as co-researchers in health research.17 Both studies reported that for maximum benefit of patient engagement, support and training is essential.

Studies of patient engagement in health research have identified a number of potential barriers: length of the process and training, transportation, frequency of meetings, time constraints, and a lack of specific funding for engagement purposes.18 We overcame these challenges during planning and facilitation of the consensus-building process. The time commitment required of patient partners was significant, but they were able to make an informed decision about their level of engagement. In addition, both patient partners and other meeting participants were motivated to invest time in engagement because of the personal and professional benefits.

Several authors have identified concerns that some forms of patient engagement may appear tokenistic at times and thus portray a false sense of inclusiveness, ultimately devaluing patient contributions.17,18,19 In contrast, our experience shows that patient partners were instrumental to consensus-building discussions, providing insight and perspectives that resonated with all stakeholders. There may be an increased risk of “tokenism” if the time and effort to engage, educate, and prepare patient partners is not provided.

Similar to the experience of another Canadian initiative that included patient engagement for research in organ donation,19 grief experienced by family members of deceased donors is an additional challenge for initiatives such as ours. It is not uncommon for family members whose loved one became a deceased donor to experience enduring emotional trauma.20 It is tempting for healthcare professionals to want to protect patients and families. Nevertheless, it is also clear that grief can be jointly managed with patient partners through a patient-centred process of preparation, checking-in, and following-up, as we have shown. The inclusion of not just one but three family members was also an important strategy to further support patient participation in this context.

The lack of inclusion of patient partners and healthcare professionals opposed to organ and tissue donation and transplantation is an important limitation of this initiative. In addition, we included one DCD heart recipient from a UK program but did not have a participant with experience in Australia. All meeting participants, including the patient partners, were generally considered supporters of the current donation and transplantation system, a bias acknowledged at the meeting.

Conclusions

Our analysis and report of patient partner and meeting participant experiences of a consensus-building meeting about planning for DCD heart donation and transplant in Canada shows that patient partner contributions were invaluable. With advanced preparation and both in- and post-meeting support, our process of engagement allowed patient partners to participate effectively and contribute to discussions of complex topics in the realm of organ donation and transplantation. Patient engagement in policy decision-making improves the consensus-building process by ensuring the outputs of these collaborative efforts remain focused on the patients and families they serve.