Eye donation from palliative and hospice care contexts: the EDiPPPP mixed-methods study

Data management and analysis (interview, focus group and observational data)

Following data collection, audio data from interviews and focus groups were passed to two university-approved (and contracted) transcribers who generated transcripts from an audio source. Anonymised transcription data from interviews and focus groups, and material gathered through observations, were managed and analysed using ATLAS.ti software39 following a study-specific process guided by the five-level QDA method. 40

The five-level QDA method applied to all interview, focus group and observational data of HCPs, patients, and carers

The five-level method provides a framework for planning and conduct of data management, analysis and audit trail maintenance for qualitative and mixed-methods projects (Figure 3). This approach proposes two initial stages (levels) of planning (strategy) in which project objectives are defined (level 1), and specific analytic tasks relating to these objectives are identified (level 2). This is followed by an intermediary stage (level 3) in which analytic tasks are then translated into specific software operations. Following the strategic and intermediary stages, two further levels are specified with respect to use of software tools: level four involves use of single or straightforward software operations for given analytic tasks, while level five involves generating more complex (constructed) operations which may involve multiple software operations (the fifth level may not be necessary in all projects). Though the process follows a broad progression, as indicated in Figure 3, this is not strictly linear but can involve several repeated cycles across a project, in which activities at stages four and five amend study objectives (level 1) and/or analytic tasks (level 2). This framework was used in iterative development of the data management and analysis processes used in the EDiPPPP project, as discussed in the following sections.

FIGURE 3.

Components of the five-level method (images reproduced from Silver and Woolf, 201641 p. 101. n.b. permission for replication of image gained from Routledge books 1 August 2020).

Data management and analysis within the EDiPPPP project

At level 1, study objectives included in analysis are: Objective 2: to map the donation climate of each research; Objective 3: identify factors (attitudinal, behavioural) that enable or challenge service providers to consider and propose the option of ED as part of EoLC planning from a local and national perspective, and Objective 4: identify service users’ views regarding the option of ED and the propriety of discussing ED as part of admission procedures or as part of EoLC planning conversations.

At level 2, specific analytic tasks (T) were defined in relation to the objectives and data collection activities defined at stage 1, and then translated into specific software tools (either simple or complex).

T1 – Initial familiarisation and verification of data prior to loading into ATLAS.ti (software) involved reading and checking of transcripts received from transcribers against the recorded audio. The aims of this task were to verify the integrity of transcripts relative to the source audio, ensure anonymisation throughout the document and allow researchers to familiarise themselves with the data prior to beginning content analysis in ATLAS.ti (T3). These tasks were completed using Microsoft Word (Microsoft Corporation, Redmond, WA, USA) (transcriptions) and Windows Media player (audio) software.

T2 – Load and organise data into ATLAS.ti. Data were loaded into ATLAS.ti software and stored using a combination of document group (categories into which sources can be loaded for organisation) and code functions (codes are identifiers that can be applied to sources, or parts of sources, within ATLAS.ti providing an index to facilitate data management and analysis). 40 Document groups were used to organise data according to relevant attributes (e.g. site ID, participant group, work package/stage and demographic characteristics). Codes (and code groups) were used to identify parts of documents relating to specific areas of interest (e.g. specific domains and questions from interview schedules, study objectives). This process created a data structure and index for navigation, which facilitated content analysis conducted at T3.

T3 – Content analysis of organised data to address study Objectives 2–4. Content analysis of qualitative data involves identification of analytically relevant content, and organisation of these observations into categories of interest through the application of codes. 42 Both inductive codes (as derived from observations of the data) and deductive codes (applied from a pre-determined framework such as a theory, or observation schedule)42 were applied in EDiPPPP analysis. For example, T3 step 1 (Table 5) codes were aligned with components of the objective and organised into a code group covering the whole objective (see Column 3: Code group). These codes were then applied to transcription data across the data set that related to study Objective 2.

T3, step 2 involved using the coded data from step 1 in combination with demographic codes applied at T2, to subset observations of interest by objective component and participant type. This was performed using Smart Codes, a feature of ATLAS.ti that allows data to be automatically assigned to codes based on a set of specific criteria. For example, where data had been assigned both an objective code and demographic code [e.g. the smart code (SmC) SmC1a-Obj2-Identification of Eligibility + HCP (FL) will return data coded at the code Obj2 – Identification of Eligibility and any codes within the code group HCP (FL) Focus Group/Interview Questions (HCPF)].

T3, step 3 involved inductive coding of data to provide more detailed description of content. This process proceeded sequentially through collections of data created by smart codes created at step 2. The researcher responsible for data collection within each site type took primary responsibility for analysis of resulting data (BMS for HC settings, MJB for HPC). The research team held regular meetings to discuss development of codes (i.e. new codes, revisions to codes, grouping, combinations/consolidation, etc.) and recorded relevant analytic decisions affecting interpretation in written notes attached to codes within ATLAS.ti. Subsamples of coded data were also shared with the project chief investigator (TLS), who provided further feedback on development of the descriptive coding framework.

This inductive descriptive process resulted in a set of codes derived from, and applied across, the entire data set (i.e. across objectives and participant groups). In combination with those created through deductive processes at steps one and two of T3, descriptive codes supported the of findings of this report, as described in step five below.

T3, step 4 involved the addition of further codes to allow findings to be mapped to general stages of the ED pathway: for example, Pre-referral (to NHSBT); Referral; Retrieval (of eye tissue); Post-donation; and All (for observations affecting the entire pathway). This additional deductive coding allowed for greater flexibility in exploration of and reporting from the coded data set at step five.

T3, step 5 involved reporting of descriptive analysis. This involved establishing a reporting structure in Microsoft Word in relation to each of the study objectives, their constituent components and findings relating to specific site and participant types within each of these areas (reflecting the data index created by the combination of deductive and inductive coding processes).

Supply of eye tissue is a global concern

Low levels of eye tissue are a global issue. 3 Studies from Brazil,44 France,45 the USA,46 Canada,47 Australia48 and the Netherlands49 report barriers such as low levels of referral (to retrieval services) for ED outside of areas where organ donation is carried out; negative attitude towards ED held by HCPs across a variety of care settings;48–52 and lack of knowledge among the general public regarding the needs for and uses of eye tissue for transplant and research. 53,54 There are low levels of support for this option on the Organ Donor Register (ODR) with ED being the most ‘restricted’ option (individuals can restrict which organ and tissue they would donate) on the ODR. 55 There is also evidence of HCP reluctance to raise the issue of tissue donation as part of usual EoLC discussions56–59 despite national guideline recommendations,8,60–62 and a failure to recognise potential donors due to poor knowledge among HCPs of the medical contraindications and donor suitability criteria. 63,64

Perceptions of service providers in palliative and hospice care settings towards eye donation

Healthcare providers are reported to be generally favourable towards ED, perceiving it as worthwhile. 34,47,65 Authors report that although participants felt uncomfortable discussing ED, the majority felt it was their professional responsibility to do so. 64 Authors exploring the attitudes, knowledge, practice and experiences of corneal donation across a sample of 410 HCPs respondents reported that 70% (291/410) perceived corneal donation as a rewarding opportunity for patients and/or their families, with 82% (345/410) indicating that corneal donation was compatible with their personal beliefs. 34 Furthermore, survey findings indicate that 42% (8/14) of doctors who had raised the issue of ED reported that, based on their experience, the option of ED was perceived by patients and family members as a way of giving something back to society. 66

Practice of service providers in HC and HPC in raising the option of eye donation

While HCPs often acknowledge that ED is worthwhile, evidence indicates that discussing ED is not common practice,58,65,67,68 with two surveys, including HCPs, reporting that 92% (92/100) and 93% (399/431) never or rarely raise the subject of corneal donation with patients or relatives. 34,65

Research surveying HCPs within a large UK HC setting reported that 90% of 434 staff hardly ever, or never, initiated discussions regarding corneal donation with their patients or families. 34 Other authors surveying 76 hospice staff, reported that while 49/76 (65.3%) of the staff would discuss donation if the topic was raised by relatives, ‘only one respondent reported routinely discussing the issue’ (p. 100) with family members. 35

Healthcare professionals’ reasons for not initiating conversations about ED with patients include: concerns about the impact on patients and families (i.e. potential for distress),50,58,69 perception that donation is not part of hospice culture, and the personal significance of eyes making such conversations potentially detrimental with respect to maintaining a supportive environment within the hospice,70 and a perception that donation requests could cause patients and their families physical and psychological harm. 64 However, service evaluation data from other HC settings indicate that 86% (12/14) of doctors reported that conversations did not cause additional distress with 57% (8/14) reporting that the conversations about ED were perceived by patients and families as a positive outcome from the death. 68

Service providers knowledge: assets and deficits

Healthcare professionals report knowledge deficits as barriers to raising the option of ED, including not having sufficient knowledge about the process of ED44,46,47,64 and the eligibility criteria for ED,45,48,49 and lacking confidence to initiate ED conversations. 35,50–52 While evidence confirms the facilitative impact of education and training, and that a willingness to discuss donation is positively associated with knowledge about the process of ED (referral and retrieval), and being aware of local policy and guidance,58,71 training is not a guarantee that ED would be discussed. 34

Palliative care service users’ perceptions of eye donation

Evidence about what patients feel towards discussing ED is in short supply. However, one study72 reported that HCP introduction of the topic of ED at admission to an HC setting did not elicit concerns from family members (e.g. distress or concern at the option being raised). HCPs at this site also indicated that both patients and families were not aware that they could donate. These findings are supported by work from co-applicants to the EDiPPPP study, reporting that patients within HC settings were in favour of having discussions about ED,36,73 and that some patients changed their minds regarding ED (from negative to positive) after a conversation. 65,73 Patients are reported to be willing to participate in discussions about the option of ED, but were unaware of the option of ED or assumed that they were ineligible. 65 Furthermore, participating patients were motivated to be eye donors and felt positive about the possibility of helping others. 65,73

A survey of inpatients65 found that the majority of participants, that is 73% (8/11), reported that they did not find it upsetting to discuss ED and that asking about donation enabled them to make an informed decision about donation. A further potentially important finding is that participants reported their preference to talk about ED while they were still well, rather than when deteriorating. 73

Comments from nursing logs after the introduction of an admission script that included questions about ED indicated that the patients (n = 121) and families were not aware of their eligibility to donate their eyes, but they were not concerned about the topic of ED being mentioned during admission. 66 Furthermore, nurses were positive about introducing the option of donation at admission in view of these findings. 66

Publications that reported family/carer attitudes towards donation found a lack of awareness of their dying family member’s eligibility to be a potential eye donor. 58,66 Findings indicated a range of beliefs including that donation was right, that it is a social duty to donate and that it would be ‘wasteful’ not to. 74 Family members’ decision to decline ED was based on the prior stated wishes of the patient not to donate or the family’s uncertainty about the patient’s wishes. 68,74

However, retrieved publications indicate that HC and HPC patients are generally unaware about ED and eligibility criteria. For example, in two studies, patients thought they could transmit their cancer to recipients via donated corneal tissue,73,75 or that their eyes would not be good enough for use in transplantation. 65,73,75 Furthermore, next of kin (NoK) are unaware that their dying family member with cancer could donate their eyes. 74 Retrieved evidence further indicates that not knowing the beliefs/wishes of the deceased regarding ED is a key barrier to increasing ED. 68,74

Commentary on findings – literature review

Little evidence exploring barriers and facilitators to ED from palliative and hospice care settings was available before 2001, with a limited range of study designs/evidence synthesis methodologies being adopted in the reported empirical work (see Appendix 1). The UK has generated most literature, with comparatively little literature from other countries and cultures. The USA and India reportedly supply 55% of all corneas available globally,3 and it is surprising that there is no literature from these countries.

Although the evidence available includes representation from relevant participant groups (i.e. patients, family members and healthcare providers), sample sizes are frequently small; however, the themes generated by the retrieved publications speak to recurring barriers and facilitators. To date, the available literature base is very slim with a lack of high-quality primary research adopting mixed methods of investigation/exploration that would support practice and policy development.

The retrieved evidence indicates that patients and family members are not averse to, nor distressed by, discussions around the option of ED; however, as with all end-of-life discussions, timing is key. Evidence supports the benefits in ‘introducing’ this issue at admission with this discussion being merely to assess donation status. 66

Key findings from the review were that studies that reported retrospective note reviews (n = 3) indicated that the potential for ED from HC settings was: 52/100 (52%),67 67/77 (87%) and 30/85 (35%)65 of deceased patients, while in HPC settings the potential was 229/704 (32%). 56 These figures are of concern as they clearly show that large numbers of potential donors are being cared for in HC settings in particular and that these potential sources of supply are not being realised.

This review highlights a number of key barriers to increasing ED from HC and HPC settings, including:

• reluctance of HCPs to raise this issue to avoid causing perceived distress to patients and their NoK

• evidenced knowledge deficits related to the process of ED in these settings

• lack of awareness on the part of patients and family members about their own or their relative’s eligibility, donation options and wishes in relation to these.

In the next chapter, we begin our exploration of issues raised in our discussion thus far, reporting on the results of our retrospective review of deceased patient case notes from six partner sites, in order to develop a detailed and systematic understanding of the potential for ED from HPC and HC settings in the UK.

Data collection

Eligibility for ED was assessed against criteria specified by NHSBT-TES (see Report Supplementary Material 2) that constitute a list of contraindications (conditions) barring the use of eye tissue in transplant operations. If patient case notes were assessed as indicating that the patient had any of the contraindications listed, then the patient would be assessed ineligible for referral for ED. Assessment of HPC or HC case notes alone can only ever provide evidence sufficient to satisfy the referral threshold, as further checks would be carried out by NHSBT-TES prior to retrieval if a patient were referred to them. Therefore, when referring to eligibility with respect to the outcome of the EDiPPPP notes review, this always refers to the threshold needed to refer to NHSBT-TES for final determination of ED eligibility.

Each clinical principal investigator (JS, CF, CR, SM, AH, JW) (from here on reviewers) was asked to assess 200 of their sites’ deceased patient notes from the previous 2 years against eligibility criteria (with FJ, SG, NS and KG also contributing to clinical review at these sites). Reviewers completed a data collection proforma in Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). 76

Proformas incorporated both closed responses and free-text (written) options (see Report Supplementary Material 3). Free-text fields were intended to capture issues not covered by closed measures, with free-text options aiming to identify contraindications that were particularly challenging for reviewers to assess with respect to ED eligibility (and thereby identify areas potential information and/or training needs).

Video guidance on proforma completion was provided to reviewers, providing an on-demand reference (created using OBS Studio screen recording software). 77 Reviewers then returned completed proformas to the study team for missing data checks (MJB). Sharing of proformas was undertaken using the University of Southampton’s secure filesharing service (SafeSend).

Data analysis

Proformas submitted to the study team (MJB) were then circulated for evaluation by specialist colleagues at NHSBT-TES (MB and JJ), using an evaluation proforma developed by the team [also completed using Microsoft Excel (see Report Supplementary Material 4)]. Evaluation was intended to assess agreement between reviewer and evaluator regarding patient eligibility for referral to NHSBT-TS for ED with respect to established criteria.

Numerical data underwent descriptive statistical analysis to identify numbers and proportions of cases deemed eligible/ineligible. Data were also interrogated with respect to differences in the assessment between reviewers and evaluators, with free-text comment boxes offering the option to comment on the decision made. All percentage figures have been rounded up or down to full numbers following the usual convention in reporting.

Site characteristics

Clinical reviewers at the six partner sites completed retrospective note reviews of 1199 (missing data on one case) deceased patients’ notes for patients who had died between February 2019 and March 2021. Median deaths per year for all sites for this period was 429 (range = 120–1984 deaths per year). For HC settings, the median number of deaths per year was 250 (range = 120–386), while for HPC, median deaths per year was 513 (range = 250–1984). Notes review was completed between January 2020 and March 2021, with evaluation taking place between March 2020 and August 2021. The mean time required for review was 21.3 minutes per case (SD = 45.4; range = 12.5–27).

Sample demographics

For all cases (n = 1199), mean age at death was 73.4 years (SD = 13.8; range = 21–105; Figure 4). For HC settings, mean age at death was 68.9 years (SD = 12.6; range = 21–98), while for HPC this was 77.9 years (SD = 13.5; range = 21–150). Female cases represented 47.9% of the total (HC = 48%; HPC = 48%). ‘White British’ was the recorded ethnicity in 82% of total cases. Ethnic diversity was slightly higher in HC settings compared with HPC (HC = 74.0% ‘White British’ vs. HPC = 88% White British) (for full reporting of deceased patient demographics and characteristics see Report Supplementary Material 5).

FIGURE 4.

Age at death by site type.

Agreement rate on eligibility for referral to NHSBT-TES

The total agreement rate (i.e. where reviewer and evaluator agreed the same outcome, whether eligible, ineligible or uncertain re: eligibility) was 81% [n = 972 of 1199 total case (one missing case)]. Differences in outcome of eligibility assessments between reviewers and evaluators occurred in 19% (n = 227 of 1199 total cases).

Agreement rate on eligibility for referral to NHSBT-TES by site

Of the 601 deceased patients’ notes reviewed in HC the agreement rate was 79%, n = 475 cases and of the 598 deceased patients’ notes reviewed in HPC the agreement rate was 83%, n = 497.

Potential for eye donation

Forty-six per cent of (n = 553 of 1199) deceased patients’ notes were agreed by reviewer and evaluator as eligible. Twenty-four per cent (n = 289) of patients’ notes were agreed as ineligible and 11% (n = 130) were logged as uncertain (i.e. the reviewer and evaluator both indicated that further information would be needed to determine eligibility).

Potential for eye donation by site

Of the 601 deceased patients’ notes reviewed from HC settings, 56% (n = 337) were agreed as eligible, 13% (n = 77) ineligible, with 10% (n = 62) requiring further information. Of the 598 deceased patients’ notes reviewed from HPC settings, 36% (n = 216) were agreed as eligible, 35% (n = 212) of cases ineligible and 12% (n = 68) requiring further information.

Record of request for eye donation, family approach and referral to NHSBT from deceased patients’ notes

For all eligible cases (n = 553) the option of ED was recorded as being raised in only 14 cases (3%). In 337 of the eligible cases in HC, the referral rate was 8 cases (2%), and in 216 of the eligible cases in HPC, it was 6 cases (3%). Approaches to family members to discuss ED was recorded in only 13 cases (2%). There were 6 cases recorded for HC (2%) and 7 cases in HPC (3%). Referral to NHSBT-TES for ED was recorded in 14 cases (3% of all cases) with 11 cases recorded for HC (3%) and 3 cases (1%) for HPC. Finally, the ODR status of the patient was recorded in the case notes in only 5 cases (< 1% of total cases – HC = < 1%, 2 cases; HPC = < 1%, 3 cases).

Contraindications for eye donation

For all cases, ‘Intrinsic Eye Disease’ was the most frequent contraindication reported (33%, n = 391 total cases), followed by ‘Neurodegenerative disorders’ (19%, n = 229), ‘Malignancies’ (8%, n = 99), ‘Other’ contraindications (7%, n = 86) and ‘Infections’ (8%, n = 10) (Figure 5).

FIGURE 5.

Contraindications by site type.

Frequencies for occurrence of contraindication types across HC and HPC sites were comparable (i.e. within a < 5% range of the other), except in the case of ‘Neurodegenerative disorders’ where the proportion of excluded cases was 17% higher in HPC settings compared with HC (11%) (see Report Supplementary Material 6 for full reporting of contraindications by site type).

Disagreement rate from retrospective note review

This section describes numbers and types of differing assessments between reviewers and evaluators as a basis for identifying and clarifying the information support needs of HC and HPC staff, in assessing eligibility for ED through clinical records. Differences in outcome of eligibility assessments between reviewers and evaluators occurred in 19% (n = 227/1199) of cases.

Disagreement rate on eligibility for referral to NHSBT-TES by site

Of the 601 notes reviewed and evaluated for HC settings, there was a disagreement rate of 21% (n = 125 cases), and of the 598 notes reviewed and evaluated for HPC a disagreement rate of 17% (n = 102 cases). The following subsections describe types of difference in assessment outcome. Reviewer decisions are reported first, followed by evaluator decisions in response.

Differences in assessment outcome where the reviewer determined eligibility for referral

Of all cases, 34 (15% of total differences in assessment) involved reviewer determination of eligibility, while the evaluator determined ineligibility or uncertainty (i.e. more information needed – HC, n = 26; HPC, n = 8). Of these cases, the majority (n = 28) involved miscellaneous reasons (e.g. ‘active ocular infection’, ‘Raynaud syndrome’) assessed as not being contraindications for ED by the reviewer but assessed as such by the evaluator.

Differences in assessment outcome where the reviewer determined ineligibility for referral

Forty-three per cent (n = 97) of differences in assessment outcome for all cases involved reviewer determination of ineligibility for ED (HC, n = 32; HPC, n = 65). Of these, 67% (n = 65) involved evaluator assessment that there were no contraindications to exclude ED referral (i.e. that the reviewer had identified factors that would not exclude a patient for ED, or that key information on which to base an ineligibility decision was missing; HC, n = 16; HPC, n = 49). For example, in 31% (n = 30) of cases in this category, reviewers had excluded a patient on the basis of ocular- or vision-related factors (i.e. cataracts, retinopathy, ‘vision impairment due to stroke’), none of which were assessed as contraindications by the evaluator.

In 27% of further cases in this category (n = 26), the reviewer had assessed the patient’s age as exceeding the upper age cut-off for ED; however, evaluators indicated that absence of excluding ocular history or other contraindications meant the patient would be eligible for referral to NHSBT. The remaining 10% of cases in this category (n = 10) involved miscellaneous reasons for ineligibility (e.g. ‘renal transplant’, ‘confusion’) assessed by the evaluator as insufficient grounds for determining ineligibility.

Differences in assessment outcome where the reviewer indicated uncertainty regarding eligibility for referral

Additional differences were found in 96 cases (HC = 67; HPC = 29) with differences in assessment where reviewers had indicated uncertainty regarding eligibility for referral (e.g. ‘unsure if myelodysplasia is a contraindication’), while evaluators indicated either eligibility (n = 51 cases all sites; HC = 34; HPC = 17) or ineligibility (n = 45 cases all sites; HC = 33; HPC = 12).

In 16 cases (HC, n = 13; HPC, n = 3) evaluators determined eligibility, while reviewers indicated uncertainty based on potential issues with eye tissue (e.g. ‘cataract surgery’, ‘ocular issues in posterior chamber of the eye’). Thirty-five further cases (HC = 21; HPC = 14) involved evaluator determination of eligibility where reviewers had indicated uncertainty for miscellaneous reasons (e.g. ‘history of asbestos exposure’, ‘Autism’). All cases in which evaluators determined ineligibility (all sites, n = 45; HC, n = 33; HPC, n = 12) involved reviewer uncertainties that were determined to be grounds for ineligibility by evaluators (reasons were miscellaneous).

Cases in which no cause of death was available

In 18 cases, no cause of death was logged on the reviewer proforma, of which 11 resulted in evaluator determination of ineligibility due to a lack of cause of death; 5 were assessed as requiring further information regarding eligibility; and 2 were assessed as eligible for referral with a note that cause of death could be determined after referral through contact with the coroner or pathologist.

Sampling strategy (interviews and focus groups with HCP-Str/Man and HCP-FL participants)

As an aim for data collection was to explore the current clinical practice and preferences of HCPs related to ED (e.g. if, when and how a conversation about ED should be initiated with patients and/or their families/carers), two main participant types were targeted for recruitment: HCP-Str/Man participants were those actually or potentially in positions to affect organisational behaviour relating to ED (e.g. design and implementation of clinical/practice guidelines), while HCP-FL participants were those actually or potentially involved in processes relating to ED (e.g. advance care planning conversations with patients), but who typically would not be involved in strategic or managerial activities relating to ED.

Understanding current practice as it is enacted within organisations is a key aim of the EDiPPPP study, and it is essential to developing evidence-based complex interventions that can be adapted and scaled across different services. 33 Therefore, first steps were to establish who the people were that we needed to talk to so that we gained an understanding of differing organisational cultures and ED climate.

Mapping eye donation pathways at partner sites

Through discussions with NHSBT-TES colleagues, we identified four generic processes forming the core of the ED pathway, which could be expected to exist at all sites in some form and in which HCPs would be involved. This framework provided a foundation for discussions with PIs at partner sites and construction of a purposive sampling frame by which both HCP-Str/Man and HCP-FL participants who were actually or potentially involved in these different processes could be identified. Processes included:

• Advance care planning (ACP) – processes relating to plans for EoLC, including wishes for donation.

• Identification of eligibility for ED – processes within the organisation relating to identification of patient eligibility for ED (prior to contact with NHSBT).

• Referral of eligible patients to NHSBT – processes relating to referral of potentially eligible patients to NHSBT for further assessment and potential retrieval of eye tissue post-mortem.

• Retrieval of eye tissue – processes relating to facilitation of retrieval from eligible donors.

Discussions with PIs were held via video conference, using a whiteboard to log results of discussion regarding specific areas/services to target within the organisation (for HCP-FL recruitment) and specific individuals within HCP-Str/Man roles. Figure 6 provides an example outcome of these discussions from one HPC site. This example outlines a range of departments and areas within the organisation (indicated by square boxes) that were understood by the PI to be actually or potentially involved in activities relating to the ED pathway (indicated by coloured lines corresponding to each of the four generic stages illustrated in Figure 6). In addition, specific role groups (indicated by circular boxes) were also identified and linked to different domains. These processes and resulting diagrams were then used to identify areas for interview and focus group recruitment for HCP Str/Man and HCP-FL participants.

FIGURE 6.

Reconstructed example outcome of planning discussion for HCP-FL recruitment at a HPC site (n.b. square boxes denote candidate departments or areas for recruitment; circles indicate specific role groups; coloured lines indicate potential involvement).

Resulting diagrams also functioned as starting points for investigation of relations between current understanding of service structure as perceived by the PI (i.e. PI understandings of who does what within their organisation in relation to the four generic stages of the ED pathway), and findings from interviews and researcher observation (i.e. do findings support and/or challenge the model of organisational structure agreed in recruitment discussions with PIs?). The significance of this to observations of clinical practice is discussed in the findings section.

Approach and recruitment process (interviews and focus groups with HCP-Str/Man and HCP-FL participants)

Approaches to HCP-Str/Man participants or to gatekeepers within areas of interest (e.g. Heads of Services) were made by the PI responsible for the specific partner site, who provided the participant information sheet (PIS). Contact details of potential participants were shared with the study team (MJB, BMS) via secure systems. Responsible researchers contacted interested participants to discuss the study and confirm participation. All study materials (e.g. letters of invitation, PIS, reply slips) were (where possible) shared with potential participants via electronic means (e.g. e-mail). In instances where this was not possible, information was mailed to the participant following a telephone conversation with the study team. All recruitment data, including demographic information and completed consent documents, were held securely on University of Southampton servers.

Once agreement was in place for the interview to commence, the responsible researcher (MJB or BMS) explained the consent process (i.e. that consent to participate would be audio recorded before the interview commenced). The researcher then read out the consent form over the telephone asking the participant to respond by stating ‘Yes/No’ or ‘I agree/disagree’ to the relevant questions. The researcher recorded (electronically) the responses of the participants on the consent form, adding a countersignature and date of consent.

Electronically returned consent forms were stored in a secure location within the EDiPPPP project drive on the University of Southampton systems, to which only the study team had access. Hard copies of returned consent forms were scanned and saved to the same folder, then shredded and disposed of securely.

Data collection: interviews and focus groups with HCP-Str/Man and HCP-FL participants

Interview schedules (see Report Supplementary Material 8: HCP-Str/man interview schedule, v2, 20 March 2019) and focus group guides (see Report Supplementary Material 9: HCP-FL Focus Group and interview guide, v2, 2 March 2019) were informed by the Rapid Assessment of hospital Procurement barriers in Donation (RAPiD),78 and the available literature.

Direct in-person observation of eye donation-related clinical practice (sites S01 and S02, pre-COVID-19)

Prior to the change in protocol (18 March 2020), observations were carried out at S01 and S02 over a 5-day period (Monday–Friday) by responsible researchers assigned to respective site types: HC (BMS) and HPC (MJB). Information gained from interviews, focus groups and naturally occurring talk informed observation of practice. For example, an interview response indicating uncertainty as to the availability of patient information leaflets for ED in publicly accessible areas of the clinical site led to further investigations by the researcher as to whether this material was in fact available. Data collection also involved identification, observation and (where appropriate) collection of materials relating to ED practice (e.g. images of publicly available information, copies of blank example process documents relating to ED).

The observation schedule (see Report Supplementary Material 10: Direct observation of ED-related practice topic guide, v1, 4 April 2019) was informed by areas of inquiry identified in the RAPiD assessment tool aimed at identifying institutional policies, procedures and other documents that facilitated evaluation of the informational climate (e.g. whether or not clear policies and procedures exist regarding ED; what information is available for patients, carers and HCPs regarding ED; what formal institutional support existed to support ED) of the site.

Observations (both in-person and remote following change to protocol) were thus informed by ongoing interviews and provided a forum to explore congruence between beliefs and knowledge about ED practice, and observable practice. Both data streams also informed a web-based audit of information on ED currently available on public-facing sites. Results and implications for service development (commentary) for each of these activities are presented below.

Outcome of recruitment

Planned targets for recruitment to interviews at each site were: 36 completed interviews total (6 per site) with HCP-Str/Man participants; and 2 focus groups per site (involving a maximum of 12 participants across both groups) with HCP-FL participants. Following the change to protocol and non-substantial ethics amendment (ERGO ID 59185) in March 2020, targets for HCP-FL participants were revised to a maximum of 10 interviews per site. In total, 105 HCPs participated: 38 HCPs in strategic/managerial roles took part (20 in HC settings, 18 in HPC settings), 67 HCP-FL participants were involved in either focus groups (28 participants) or interviews (39 participants), with 30 participants in HC settings and a further 37 in HPC settings (Table 6). For full participant demographics (see Report Supplementary Material 11).

Knowledge – eligibility and referral

Most HCPs (managerial and frontline, in both HC and HPC settings) did not know how many people are in need of a corneal transplant in the UK:

ʻNo, sorry, If I’m really honest, no, because it’s not something that I … I kind of … falls into my … what I’m required to do at work on a … on a regular basis. So, no, I haven’t if I’m really honest.’

(HCPI00504, HPC, Cancer Care HCP)

ʻOh, gosh. No, I don’t know. I wouldn’t … I’m rubbish with figures like that I imagine a lot though. I should … I should because my husband works for (society) which is a society for the blind. We have a lot of blind clients but, I … yeah, I don’t know that information.’

(HCPL00104, HPC, Cancer Care HCP)

ʻHaven’t got the foggiest but before you asked that question, I was just thinking what we could do with this [information], and there maybe is one and I’ve never looked, but a website where it actually shows how many people need corneas, how many corneas have actually been donated and whether we’re actually supplying enough. And that’s, that’s not just to this hospice, but to all hospital and hospices across the country.’

(HCPI00201, HC)

HCPs also had varying levels of knowledge regarding the eligibility criteria that a patient needs to meet to become a potential ED. For some HCPs’, their knowledge base was informed by previous experience of organ and/or tissue donation processes through, for example, work in co-ordination roles for research and/or transplant activity:

ʻSo, I might get this wrong (laughing) so, you have to bear with me. So, obviously I know where patients have cancer they are … there are certain things they can’t donate but, I was under the impression the eyes were different so they would be able to donate their eyes. So, I would imagine it’s quite a high percentage of patients that could donate eyes or they can donate corneas.’

(HCPI00406, HPC, Cancer Care HCP)

ʻNot off the top of my head. No (laughing) … There’s so many. Eye disease would be a contraindication. I don’t know. Cancer always seems to be a contraindication but normally that should be fine for eyes. So, I … I would refer to the palliative care team who do it if I had to.’

(HCPI00402, HPC, Cancer Care HCP)

ʻPatients who have brain metastasis or brain primaries, if I remember rightly, are the ones that can’t donate their eyes. Most of the other cancer patients can. From memory I think I would have to, well no I would have check with regards to the haematological cancers, but certainly somebody with a prostate cancer or a lung cancer without widespread metastasis would be fine. There’s a slight limit on age, but I think it’s, I think it’s seventy-five or eighty-five, it’s really a lot older than you might think and to be honest, if a patient asked me, I don’t start with, well I would go through a conversation about what that entails if that’s what they’re asking.’

(HCPI00201, HC)

Yes, there’s a … a standard [eligibility] criteria that comes on the boxes and it’s also found online and on the websites. Mainly it’s any undiagnosed neurological disorders. Neurological disorders of unknown aetiology, tumours, intraocular tumours, corneal damage, corneal scarring, cerebral tumours and certain blood-borne viruses, CJD as well.

(HCPI00304, HPC, Organ and Tissue Donation HCP)

Many HCP respondents in both HC and HPC settings also indicated that they would refer to either their institutional intranets or the NHSBT national website as a source of information on eligibility criteria for ED.

Further key knowledge gaps included what a HCP needed to do to refer a patient for ED to NHSBT-TES. Most HCPs could not describe a specific established process for referring a patient, but some were aware of actions that they may need to undertake in order to do so (e.g. access patient records for identification of prior wishes and evaluation of potential eligibility, contact NHSBT-TES if the option of ED was chosen by the patient and/or family):

ʻI don’t know, that would be, I suppose that would be hopefully something that I’d be, that would be something that if we did train on it would be something that we’d be maybe made aware of I think because that would be, I would just follow a process I would imagine. I seem to think there was something from my very vague memory because I’m sure it’s only been this one page that I can think of that I think there was like a, a flow chart almost with a phone number on so that we just had to contact them, I think, but that’s, I mean this is like, I’m really having to rack my brains to think about how we did it.’

(HCPL00601, HC)

ʻHow would I go about referring somebody for eye donation, I would probably at the moment contact one of our education nurses here and find out the process or one of our research nurses might have information, there might be a clinical guideline, I’d have to have a look on our clinical guidelines, I might ask a colleague at the moment about how to go about that, our lead might have some insight, or I might ring UHL the hospitals organ donation team and find out how I could go about it.’

(HCPL00103, HC)

ʻSo, if someone has said they would like to donate their corneas, or a family has sort of given consent on behalf of someone who isn’t able to, we put it in their notes that at the point of death the [team members] should phone the NHS-BT number and we try and sort of reiterate that in every entry. The electronic records in the hospital don’t have a front screen like we do … so here in the hospice, we’ve got sort of a … a home page so that when you log in to someone’s notes you can put alerts on and it’s very obvious that someone wants to be a cornea donator. In the hospital, it’s sort … gets lost and you might put an entry but then three days later you’d have to scroll back several pages to find that entry. So, we’d copy and paste that throughout and try and make sure it’s on the nursing handover for the ward nurses at the point of death if that happens within the hospital. For them to call the NHSBT number and it goes from there.’

(HCPI00202, HPC, Palliative Medicine)

Behaviours – role-specific responsibilities, timing of eye donation-related conversations within end-of-life care pathways

When asked about who should raise the issue of ED, most participants indicated that any HCP could, in principle, be able to lead conversations; however, this was often accompanied by more specific commentary indicating that medical staff and senior nursing staff (e.g. Clinical Nurse Specialists) should be in the driving seat in terms of overall implementation and co-ordination of processes across the pathway:

ʻI think that we all have some kind of responsibility and, I think, on the protocol it does say that. That any nurse in healthcare profession can have this conversation with them. However, when they see the palliative team, they are already thinking. They’re already on that kind of mindset to have this kind of discussions. And the palliative team are already talking about them with this and about what they want to do with the family, and they give support to all of them. So, it’s just easier even for the kind of work that they do to introduce the conversation.’

(HCPF00102, HPC, Acute Care)

ʻYeah. I think, the palliative care team could. We’ve got very confident nurses and their … confident palliative care doctors as well.’

(HCPL00406, HPC, Bereavement Services)

ʻThat’s a really good question and something that is quite difficult because it has to be the person that has the right knowledge around the subject but it also has to be a person that is sensitive in their approach to how they discuss things and as I said to you before I think sometimes, not through any fault of their own but how they’re taught, doctors and medical professionals, can, can sometimes come across as a little insensitive and I think it’s just the way that they’re taught to ask questions. So, I don’t know if it would be most appropriate from them. Perhaps it might be a good thing to come from the nursing team because they are very good at that empathy and that, you know, taking their time with the patients, I don’t know whether that, that could be a priority, or perhaps maybe the team leaders like the nurses in charge could potentially support with them discussions?’

(HCPFL00203, HC)

Most HCP participants indicated that ED discussions should be undertaken as early as possible in the patient’s dying trajectory, or as part of advanced or EoLC planning:

ʻI guess, ideally before they come here [to the hospice], I think that, you know, seventy per cent of our patients will die on admission, well not on admission but, you know, during their stay here. So, I don’t think hospices should be the people who should be having that conversation hours or days before death, ideally it should be a conversation that is part of advanced planning, if the person hasn’t already stated their preferences when they did their driving licence for instance. So, I think it, it can be a question for, I mean when I go to my GP, I will have, he will have or she will have, lots and lots of information on me, you know, actually because I have at some point registered with that GP, given all my information, that information is updated and so therefore, I would hope as we move, move forward that, that’s a fundamental question that’s asked right at the outset. So, so it avoids these conversations, later on in someone’s life.’

(HCPI00601, HC)

ʻYeah. So, I think, it’s best to have these conversations earlier on because, I think, you should involve the patient in it from the earliest point because actually if you then do it at the point that the patient’s unable to communicate or has capacity to make that decision, you’re then relying on next of kin and actually their choices may not be the same as what the patients where they may never have discussed it. So, they may not know. And, I think, if people don’t know they err on the side of not having it occurring rather than: ‘let’s do it’. So, for me, it’s part of that good care of recognising someone towards the end of their life and discussions should be had at that point.’

(HCPI00102, HPC, Senior Manager)

ʻI think, it’s probably at this point when we hit the palliative care phase and, again, that’s a bit of an open-ended time span. So, you know, those conversations can be held quite … we can talk about the sort of last year of life which, again, is say not a precise science that those conversations can be held at any point where you’re starting to have in that year what we call sort of advance care planning and you’re talking about how … where the patient wants to die, what they would like to do. And at that point, is something where you could introduce that conversation so. And we tend to have those roughly in the last year of life.’

(HCPI00402, HPC, Cancer Care HCP)

There was no clear consensus on ‘when’ the option of ED should be raised and ‘who’ should raise the issue of ED. The majority of HCPs in both HC and HPC settings indicated ED was not a routine behaviour.

ʻSo, I don’t think I’ve ever talked to patients about it because I’m in an emergency physician so, it’s usually, in my experience, unplanned death. If you see what I mean. But family members, its usually them that raise it with me and therefore they usually respond well to knowing it’s a possibility.’

(HCPI00502, HPC, Senior Emergency Medic with additional trust executive role)

ʻI think I’m probably guilty of not broaching it on a routine basis, so I recognise the importance of offering the option to patients but maybe find it difficult to shoehorn that into kind of my regular day to day work. I think one of the reasons for agreeing to participate in the study was maybe to challenge myself a little bit about why I don’t discuss it or have the kind of, for me reflections on, you know, what that’s about and whether I should be doing something differently going forward, was maybe something I hope to achieve out of this research interview in some ways.’

(HCPL00103, HC)

ʻSo, we have had one or two occasions whereby patients have requested to have their eyes donated and tissue donated, and we have followed through the process, it’s been very clear, because they’ve had all the documentation, we’ve just phoned the number and then it’s been taken care of from that. I think at the moment it’s very dependent on whether the family or the patient have thought about it, a lot of patients say, you know, they thought about donating their organs and they’ve been told that they can’t donate their organs because of their progression and their type of disease with the cancer, so we sort of very clearly try to talk through it around what our policy says around eye and tissue donation.’

(HCPI00301, HC)

Healthcare professionals are generally reluctant to discuss ED and we sought to establish what they perceived as barriers to raising this issue with patients. Responses indicated concerns about their knowledge base and capability in two main areas: (1) raising the topic with patients/families; (2) the propriety of raising the topic in end-of-life conversations which focus on the needs of the patient (e.g. symptom management):

ʻAnything that would prevent me doing it? As of the moment, the reasons that would prevent me doing it is the lack of knowledge probably and as well as a lack of knowledge, the other … patients that I would … I wouldn’t raise it with, I think, it would depend on the level of distress with the family.’

(HCPI00204, HPC, Palliative Care)

ʻI can think of a number of circumstances. We’ve recently had a gentleman who was hugely distressed, wasn’t able to engage even about his pain, I can’t imagine trying to manoeuvre a conversation about something like that, it would be inappropriate. I think that it was too late to have that conversation. I think that there would be people who would have delirium, a dementia, who it would be difficult to explain what you meant perhaps, so there would be groups of patients. And as I said whilst we have an obligation there are points that would have happened before, where other people may have been able to have those conversations, and it may be that we’re not at the right, we’re not in a place where we can do that now, for some people.’

(HCPI00501, HC)

ʻYou know they might come into us to, to help with symptom management and then if we suddenly start talking about organ donation, you would, you would be steering the conversation away from the priority to them at that time. But we do tend to do end-care planning where we go through a booklet and in that booklet they give the patient the booklet when they come for an initial appointment we’ll give them the booklet and we’ll tell them to take it home and have a read and then come back and ask us questions and I’m almost certain organ donation is in that booklet, it’s an advanced care planning booklet. And more often than not they would come back and say well actually I’ve been looking at donor, you know like, not specifically eye donation, I think we just look at it as in, you know, organ donation.’

(HCPI00105, HC)

In response to questions exploring factors that may help to overcome perceived barriers, and/or embed ED into service as routine practice, many respondents indicated the need for specific knowledge and communication skills to support the conversation, particularly where this may involve raising the topic among other aspects of EoLC planning:

ʻI think, if it’s … if it’s advertised well and there is sufficient information provided to people as well as people who are making the approach in a proper sensitive manner but also have the knowledge to be able to explain all aspects of it, I think, it should … it normally goes down very well indeed.’

(HCPI00304, HPC, Organ and Tissue Donation HCP)

ʻIf you can have the conversation in a certain way if you’ve got the skill to have that conversation. And often the problem with communication is going, goes wrong with the way it’s approached. So, I think that you can have conversations about donation, however, I have still got a block in my own practice or my experience to work out where it fits in the trajectory for somebody, so and what I mean by that is, amidst all the things that people are dealing with it’s hard to work out how to introduce this as a question because it can feel about somebody else and not about them.’

(P00501, HC)

ʻI think, from what I hear in teaching sessions and from the concerns we hear from district nurses about their end-of-life training, I think it’s medical professions in general are frightened to make people cry, or they’re frightened that somebody will find something upsetting and will cry or be upset, probably though, they will worry that somebody will make a complaint against them as well. And despite the best will in the world, the NHS is still very much a blame culture rather than a learn from errors or learn from complaints. So that’s what I see anyway. So, I think its fear of upsetting people, it’s not about a particular conversation itself.’

(HCPI00201, HC)

Internal processes – guidance and institutional policy

To assess what support information was available, including information that might fill knowledge gaps, HCP-interviewed participants were asked about availability of organisational policies, guidelines or procedural documentation that governed or could be used to inform ED practice (produced either by their institution or other professional/national bodies). Some HPC-based HCPs referred in general terms to the presence of such documents on their organisational intranets, whereas hospice-based HCPs were uniformly unaware of policy or guidance documents.

ʻYeah, we do have a tissue donation policy. Organ donation tissue/organ because, I think, it covers both areas … it’s on our policy so, if anybody wanted to see it is on there.’

(HCPI00102, HPC, Lead Nurse)

ʻI’d go on … the hospital intranet which has all the guidelines on it. So, I’d pull it up from there.’

(HCPI00202, HPC, Palliative Medicine)

ʻSo, it’s mentioned in quite a lot of guidelines that we should be offering eye donation. So, things like the last days of life guideline, care after death guideline. It’s mentioned in those. I think, there is also a … oh, what’s the name of the committee? The … the transplant committee which will have guidelines about who … about offering donation. And, I think, it’s mentioned in that as well.’

(HCPI00202, HPC, Palliative Medicine)

ʻI imagine there are but … and that they will be on … we record everything on (hospital) health pathways … all our policies. So, I can’t imagine that there isn’t. And, I think, it would be fairly easy to locate. And if I couldn’t locate it on either (hospital) health pathways or the Trust intranet site, I would probably ‘phone critical care and ask them.’

(HCPI00204, HPC, Palliative Care)

ʻWe don’t, we just, we basically have a few leaflets that our local nurse from (The Trust), and it’s probably over a year ago since we last had contact with her because I know she was on maternity leave, and she just, when we had like a Dying Matters Week and Death Café, and she came to that and brought us some information on organ donation. Don’t have anything specific, it’s just if somebody approached us about organ donation, we would look through these leaflets that were given and direct in the right place, or we would ring up to find out for them. To be honest, we don’t get that many patients asking us.’

(HCPI00105, HC)

HCPs were also asked if they were aware of a donation link person [to NHSBT-orange tissue donation and transplantation (OTDT) or TES]. In HPC settings, HCPs indicated a general awareness of a link person for organ or tissue donation in general [a clinical lead in organ donation (CLOD) or specialist nurse in organ donation (SNOD)], but hospice-based HCPs did not have the support of a link person:

ʻI believe there is but, I can’t remember her name. There is. There is. And, I know, it’s some areas like ED [Emergency Department] and ITU also have nurses that have a heightened … like a link role in it so that they’re more involved in it. So that they are … they try and spread the word a little bit more. So, for example, in ED, you know, there’s a nurse that has more interest so, she makes sure all the bereavement packs are put together and within their own in-house training they talk about that a little bit more. I don’t think we have that role on the wards, but we do have that in ED.’

(HCPI00102, HPC, Lead Nurse)

ʻSo, through our CLOD and our SNODs. So, our CLOD sends out all the information … so, the CLOD is our clinician obviously in charge and then our SNOD is our specialist nurse. So, we … we get all the updates from them by e-mails, regular e-mails, but also regular meetings to discuss donation at our consultant meetings.’

(HCPI00206, HPC, Acute Medicine)

ʻWell, I mean, there’s nobody specifically that’s designated that, to answer your question directly, but there must, there must be somebody, one of the clinical team, presumably one of the consultants, who would be involved in this and they may have a bit more knowledge on this than I would.’(HCPI00405, HC)

Internal processes – training needs

HCPs were asked if they had received any in-service training specifically about ED. While some HCPs working in the HPC reported that training about organ and tissue donation was being provided by Specialist Nurses in Organ Donation, no specific training focused on ED was being provided in either HPC or HC settings:

ʻNot that I’m aware of. I’ve been here eight … I’ve only been in this Trust eighteen months. I’ve not had anything. I don’t know if there’s anything. There’s nothing on induction.’

(HCPI00102, HPC, Lead Nurse)

ʻYeah. So, in the hospital [PI has] done quite a lot. Both sort of general scale. So, sort of to all the consultant body and then at various nursing training days. And obviously having her as part of the team has meant that we’ve sort of had ongoing in-house training from her. So, yes, there has been.’

(HCPI00202, HPC, Palliative Medicine)

ʻSo, probably about maybe about five, six years ago we did have some good education around donation and what was possible, and we agreed to have information on the ward in relation to that. I wonder if that may now have got lost.’

(HCPI00101, HC)

ʻI don’t, I can’t say for certain, I do monitor the education programme, but I’m not recalling anything per se, but and I think many years ago I can, I think I remember somebody coming to talk about eye donation, but that was a long time ago and I’m not aware of anything recently. But I’m probably not privileged to know everything that goes on in education training here.’

(HCPI00601, HC)

ʻSo, there is an education group across the managed clinical network who would, it would be part of their role to deliver training. Otherwise, there isn’t any specific training or education on it, so it’s, it’s a bit of that kind of by word of mouth, by accident, which again is one of the problems that there’s no formalised education about it. So, staff when they start, would get trained in using the documentation that we have, and that might in that training, you might spot that there’s something about organ donation in there, but there isn’t any specific training at all around it, so, you know, nobody’s taking that responsibility.’

(HCPI00505, HC)

Institutional policies and availability of ED-specific guidance

Findings from HCP interviews (WP1S2, see Chapter 5) and the national survey of HCPs (WP2S3, see Chapter 6) both indicate widespread assumptions among participants that relevant guidance to support ED pathways is available within their organisation. Typically, this was referred to as being held within institutional policies, and/or on institutional intranets; however, responses were often very general and offered little or no detail on if, where and at what level of detail such guidance existed. To explore this further in relation to our partner sites, we asked PIs to search their intranets and other sources of policy and guidance information, to determine what material was currently available to govern, guide and support ED. PIs undertook searches of trust intranets, as well as other documentary repositories, and contacted relevant colleagues in services that may hold or be aware of such information (e.g. bereavement services).

Information, guidance and policy at hospital palliative care service sites

One HPC (S02) provided a ‘best practice’ example of embedding ED processes within their service. Clinical partners at this site indicated that evaluation of eligibility for corneal donation was embedded within their admissions process in two stages. Firstly, patient records were screened on admission by the team secretary using a bespoke screening tool to exclude those with common contraindications for ED (Table 7). Secondly, patients who did not present with a common contraindication were discussed in multidisciplinary team (MDT) meetings to determine the acceptability/feasibility of raising the option with the patient and/or family as part of ACP.

Those who were assessed suitable for this option to be raised had an NHSBT Gift of Sight79 public information leaflet included in their ACP documentation to support a potential discussion. Progress along the pathway was tracked according to a staging system which was recorded in the patient’s care record (Figure 7). This site also indicated that bereavement services had access to printed information for families regarding corneal donation. This site had a hospice located at the Trust, and clinicians rotated between the hospital trust and the hospice. The hospice website, as well as guidance regarding organ and tissue donation, included specific information on corneal donation. Practice from this site has informed aspects of the proposed intervention and the hospice website was the benchmark against which we assessed other hospice website content in the web-based public information audit carried out to investigate the level of ED-related information available to patients and carers accessing hospice care.

FIGURE 7.

Staging system in place at alliance site to track HPC patient progress across ED pathway.

Two further sites (S04 and S06) both provided policy guidance and available information regarding donation. In both cases, HPC services had access to literature regarding corneal donation which could be shared with patients and families,79 as well as cards provided by NHSBT for staff with details of how to refer patients for donation.

At both sites, observation of MDT was attempted via Microsoft Teams; however, in both cases, technical issues linked to social distancing in situ (e.g. ability of the responsible researcher to hear speakers in the room that they were observing remotely) prevented this from being completed successfully. Both sites indicated that evaluation of eligibility and appropriateness of raising the option of ED with patients/families was not embedded as a regular process in MDT meetings (one site provided a document describing the standard MDT process, in which donation was not present). Both sites provided institutional policy documents covering donation, both of which referred exclusively to organs and did not refer to eyes. Both sites also provided institutional policies relating to bereavement and care after death, both of which contained single mentions of corneal donation in general terms as one potential tissue for donation but did not provide further guidance.

Information, guidance and policy at hospice care service sites

None of the HC sites had any processes whereby patients were routinely screened for eligibility for ED, nor was ED part of the admission questions for any site. Sites provided access to patient-facing literature, none of which mentioned ED. One site (S01) had extensive support facilities with a range of groups for patients and carers to access, but nothing was included that related to tissue or ED. This site had ‘Dying matters’ leaflets available that mention organ donation and a ‘Future Planning your wishes’ document that patients can complete to ensure that paramedic teams know what the patient has agreed with their clinical team. This document also included the question: ‘I wish to discuss tissue donation further with my clinical team’ (inviting ‘Yes’ or ‘No’ tick box answers). It is not clear who monitors these documents or who would ensure that a discussion about tissue donation has taken place [as the form guides the patient to hand a copy of the form to their general practitioner (GP) receptionist]. However, one benefit of this system is that once completed, the information is included in the patient’s summary care record, which is proposed to be available to emergency teams in particular. Despite comprehensive information regarding EoLC planning (writing ACPs, Wills and a section titled ‘Key considerations for end-of-life care’), nothing in this material directly addresses tissue or ED.

One site (S03) had an information leaflet ‘Factsheet about Eye Donation for corneal transplant’ accessible via their website requiring effort by a patient trying to access information as it was one of 38 leaflets. This site did advertise the EDiPPPP study in their patient-facing locations, but no information about donation was observable (at site set-up visit) or shared with researchers when observations could no longer be undertaken. Site (S05) had a leaflet ‘Organ Donation’ within their planning ahead section of their website. The leaflet did not mention tissue or ED.

There was a notable difference in the availability of ED-related information at HC sites compared with HPC. Firstly, while specific information about ED was available in HPC sites, it was absent from all but one HC site. One reason for this may be that information about organ donation is more likely to be part of standard EoLC planning processes in HPC (as some palliative care patients may be able to donate solid organs), whereas this is far less likely in HC settings. The fact that patients in palliative care settings shared with us their understanding or perception that they could not donate organs (due to cancer, which is correct) may have resulted from conversations stimulated by said information with the outcome that the patient is told they cannot be an organ donor, without the follow-on conversation that they can be an eye donor.

Observations of MDT meetings at HC sites were not available, but PIs reported that evaluation of eligibility and appropriateness of raising the option of ED with patients/families was not embedded as a regular process in MDT meetings.

Search strategy – national audit of hospice web pages

Hospices in the UK were identified through a members list provided by our Hospice UK, listing 208 member hospices in the UK, of which all had public-facing websites. Each hospice web page in this list was searched using the Google search engine in April 2021 using the following strategy: site: [INSERT HIGHEST LEVEL HOSPICE WEB DOMAIN ADDRESS] organ OR tissue OR cornea OR eye AND donation. Results from this search process were used to identify whether the website contained: Information about organ donation; Information about tissue donation; Information about ED; Guidance for HCPs; Guidance for Patients/Carers. Results were collated using Microsoft Excel76 [see Report Supplementary Material 12: Hospice website audit (completed 10 January 2022)].

Search strategy – audit of web-based national guidance to inform evaluation of eligibility for eye donation and referral to NHSBT

In response to observations from HCP interviews and national survey responses indicating that the NHSBT website was understood to be a source of information on eligibility criteria/contraindications for ED, the EDiPPPP team attempted to assess the availability, quantity and quality of this information. Site-specific searches of the NHSBT website were conducted in March 2021 (repeated July 2022) using the Google search engine, with the following terms: site: www.nhsbt.nhs.uk cornea OR eligibility OR contraindications.

Search outcomes – national audit of hospice web pages

Of the 208 hospice websites in the UK, only 10 hospices in England and one hospice in Wales had specific information (in leaflet or infographics form) about the option of ED. Three HC websites in Northern Ireland mentioned Organ Donation in the advanced planning document on their websites, with no information about ED. One of the 14 HC websites in Scotland mentioned organ donation (one sentence), and 1 of the 12 HC website in Wales had comprehensive information about ED; however, the information regarding the age cut-off for ED was incorrect (site says 96 years of age when cut-off at the time as specified by NHSBT-TES was 85 and 364 days).

Search outcomes – audit of web-based national guidance to inform evaluation of eligibility for eye donation and referral to NHSBT

The team also sought web-based national guidance on eligibility, referral and retrieval processes to which clinicians could refer. This was especially important as both interview/focus group and survey responses (see Chapter 6) indicated expectation on the part of clinicians that this information would be available if they needed it. The EDiPPPP team could find no such information on eligibility, referral or retrieval processes on either the NHSBT public websites or those of other national bodies (except for an e-mail address and telephone number listed on the NHSBT website for enquiries regarding referral).

These findings indicate a low level of information available to the public, patients and carers about ED as an end-of-life option for those who might be seeking information about hospice care. There is also no publicly available web-based information on eligibility, referral or retrieval that clinicians can refer to, despite many expecting this to be the case. The absence of expected information sources constitutes a significant potential barrier to raising, discussing and facilitating ED discussions in EoLC settings. As public campaigns have been shown to be effective in raising awareness about the need for donation as reported in an analysis of the impact of the deemed consent legislation in Wales,80 these information gaps should be priority areas for service development.

Data collection for secondary analysis

Prior to EDiPPPP study commencement, the CI (TLS) had been in contact with clinicians (JW, CF, CR, SM), who joined the study as co-applicants, and who had carried out empirical work (published and unpublished) to request access to their work for secondary analysis of primary data to inform survey tool development. 34–36 This work was shared and was the base data for synthesis as all studies had applied a survey design.

Survey instrument development – data synthesis and integration

Questionnaire data from primary studies and interim findings from interviews, focus groups and observations conducted as part of WP1S2 were mapped (MJB/BMS) to the study domains and grouped into three of four domains comprising the EDiPPPP study’s foci: practice, preferences and perceptions. Version one of the survey was reviewed by TLS, who provided feedback and comments resulting in additional items and demographic data in version two, which was created as an online survey using the Microsoft Forms online survey system. 81

Version two of the questionnaire was independently reviewed by co-applicant (MM) who recommended minor amendments (grammar, typos, flow of questions) which were accepted and integrated into the final version (Three) of the questionnaire. The final agreed version of the questionnaire was produced (MJB, BMS, MM, TLS) and piloted with PIs (CR, JS). The final instrument included 61 questions (see Report Supplementary Material 13: National Survey questionnaire). Surveys were completed anonymously, with respondents asked not to provide institutional or other information that could potentially identify themselves, patients or carers.

Response rate and completion time

One hundred and fifty-six participants completed the online survey representing an 8% response rate (of n = 1894 approached). Of these, 63% (n = 98) indicated working within HC settings, while 37% (n = 58) indicated HPC. One hundred and three participants responded following the first round of e-mail contact, with a further 53 responding after the second round of e-mails. Median completion time was 16 minutes and 12 seconds (IQR = 10:28–23:46).

Sample demographics

For all participants, 65% (n = 101) were aged between 40 and 59 years, with a further 30% (n = 46) aged 18–39 (Figure 8), 83% (n = 129) identified as female, and 87% (n = 136) identified as White British ethnicity (age and ethnicity characteristics were similar for both HC and HPC groups).

FIGURE 8.

National survey participant age groups by site type. n.b. in two cases, participants used the ‘other’ response to indicate that they worked across both HC and HPC settings – in one case, the participant’s free-text responses referred exclusively to HPC-related services (e.g. services ‘within a trust’, ‘tissue retrieval teams’) and were therefore counted as part of the HPC group; the other case contained HC-specific free-text comments, and was counted as part of that set).

In terms of professional roles, for all participants, 33% (n = 52) identified as a Consultant in Palliative Medicine, 25% (n = 39) as a Palliative Care Physician, 21% (n = 33) with a Managerial/Head of Service role, 11% (n = 17) as a Senior Nurse, 6% with other clinical services (e.g. Counselling, Physiotherapy, ACP Facilitator, Specialist Pharmacist), 4% (n = 6) as Healthcare Assistants, 1% (n = 2) as Nurses (excluding senior roles) and 1% (n = 1) as being in an Administrative/Clerical role (Figure 9).

FIGURE 9.

National survey participant role by site type.

In this section, results from the national survey are reported in relation to Objectives 1–3.

Perceptions of healthcare professionals regarding propriety and feasibility of discussing eye donation with patients and/or families

Participants were asked to indicate their response (i.e. ‘Agree’, ‘Unsure’ or ‘Disagree’) in relation to a series of statements regarding the option of ED being raised with patients and families (Table 9). Seventy-three per cent (n = 114) of total participants disagreed with the statement ‘discussing ED is too distressing for a patient and/or their family’. Sixty-one per cent (n = 95) of total participants agreed that they ‘feel confident in starting a conversation about ED with a patient and/or their family’. Sixty-three per cent (n = 99) of total participants agreed with the statement ‘[E]ye donation should be discussed routinely with eligible patients and/or their families’.

Seventy-three per cent (n = 114) of participants indicated that they disagreed with the statement ‘[i]t is not my role to raise the option of ED with patients and/or their families’. Ninety-three per cent (n = 145) of total participants agreed with the statement ‘[i]t is important that patients know that they may be eligible for ED’. Finally, 50% of participants agreed or were uncertain in relation to the statement ‘I am concerned about how patients and/or family members might respond to the option of ED being raised with them’, while 50% of the remaining total participants (n = 78) disagreed with this statement.

Raising and discussing the topic of eye donation with patients and families

Participants were asked a series of questions relating to raising and discussing the topic of ED (Table 10).

In response to the question, ‘Which of the following best describes your current practice?’, 44% (n = 68) of total participants indicated that they discuss the option ‘only when the subject is raised by patients or families’ with 22% indicating that they ‘never discuss ED with patients or families’. Thirteen per cent (n = 20) of total participants indicated that they ‘routinely discuss [this option] with patients and family members.

Responding to the question, ‘At what point in a patient’s care should the option of ED be discussed? (Please select all that apply)’, a majority (80%, n = 125) of total participants indicated that this should occur ‘during advanced care planning’, 46% (n = 71) ‘during in-patient stay’, 46% (n = 72) ‘during admission’, 35% (n = 55) ‘before admission’ and 28% (n = 44) ‘at first assessment by palliative care services’.

Forty-eight per cent (n = 75) of total participants had not raised the option of ED with a family member in the past year, while 35% (n = 55) had raised the issue between one and five times. Ten per cent (n = 16) had raised the issue between 6 and 15 times, while 7% (n = 10) had raised the issue 15 times or more.

Questions 31 and 32 explored experiences of discussing ED with patients and/or families. The following findings are limited to those participants who indicated that they had experience of discussing ED with patients or family members (n = 115). Eighty-eight per cent (n = 101) of these (n = 115) participants had discussed ED with family pre death of a patient, with 20% (n = 23) reporting post-death discussions with family.

In response to the question, ‘reflecting back on the last time you discussed ED with a patient and/or relative, how did you feel having that conversation’, 60% (n = 69) of participants indicated that they were ‘very’ or ‘somewhat’ comfortable, and 28% (n = 32) indicated that they were ‘neither comfortable nor uncomfortable’. A further 12% (n = 14) of participants indicated that they were ‘somewhat’ or ‘very’ uncomfortable.

Responding to the question: ‘Who do you think should raise the issue of ED with a patient or family member?’ (Please select all that apply):

• Twenty-six per cent (n = 41) indicated ‘it is my role’, 26% (n = 40) indicated that it was someone else’s role from within the palliative care specialist team (‘other palliative care specialist’ (e.g. CNS).

• Twenty per cent (n = 31) indicated that ‘the GP should have this conversation’.

• Seventeen per cent (n = 26) indicated ‘a donation specialist’.

• Fourteen per cent (n = 22) indicated ‘the consultant referring to Palliative Care’.

• Sixty-nine per cent (n = 108) of total participants selected ‘all of the above’ (indicating all previous responses in this list).

Of the 21 participants using the ‘Other’ option to provide a free-text comment, most responses (n = 14) were compatible with raising the issue being a general responsibility for staff across the pathway, for example:

ʻWhoever is comfortable having ACP discussions or whoever the patient chooses to have that discussion with.’

(Consultant in Palliative Medicine, HPC setting)

Availability of clinical guidance and information to support eye donation conversations with patients/families

Participants were asked a series of questions regarding their access to guidance and support information regarding ED conversations (Table 11). Almost half of survey participants (46%, n = 61) indicated that their clinical setting does not ‘have clinical guidelines in written form that include ED’, with a further 37% of participants indicating that this information does exist at their site. Twenty-two participants selected ‘Other’ in response to this question, of which 17 indicated that they were ‘Unsure’ whether clinical guidelines existed and a further 5 indicated that guidelines were in preparation or referred to some other form of information.

Sixty-one per cent of participants (n = 81) indicated that their clinical setting had ‘information in written form that staff can refer to if ED was raised by a patient or family member’, while 25% of participants (n = 33) indicated that this information is not available at their site. Of 19 participants selecting ‘Other’, 13 indicated uncertainty as to availability of this information.

Most participants (61%, n = 81) indicated that their setting does not ‘include ED in its admission documentation’, whereas 32% of participants indicated that ED was included in admission documentation at their site. Of 19 participants giving ‘Other’ type responses, 13 were uncertain whether this information was included in admission documentation at their site.

Knowledge and experience relating to eye donation

To assess HCPs’ current knowledge base regarding ED, we included a short section ‘flash quiz’, exploring three key questions about the ED pathway. Content analysis was performed on the free-text responses to categorise them by type, with results summarised in Table 12. Responses to the question ‘how long after death can ED take place?’ indicated that just over half of all participants (53%, n = 83 of 156) understood that ED can take place up to 24 hours after death. Eighteen per cent of participants (n = 28 of 156) indicated that they did not know the time limit, with a greater proportion of HC respondents (22%, n = 22 of 98) selecting this option when compared with HPC (10%, n = 6 of 58).

When asked to identify definite contraindications for ED (in free-text responses), infections were most commonly indicated (41%, n = 63 of 156 responses), followed by cancers (35%, n = 54) and neurological conditions (31%, n = 48). When asked what should happen before ED can take place, 37% (n = 57 of 156) of participants indicated that either patient or family consent was required, while 12% (n = 19) indicated that a blood sample is required.

Availability and experience of training and resources to support eye donation

Participants were asked about the training received and where information about ED is held in their organisation (Table 13). Sixty-nine per cent of total respondents (n = 108) indicated that they knew where to find information about ED if needed; however, a majority also responded indicating that they had not received any in-service training about ED (61%, 95/156). Of those who had received training (n = 61), 44% received it from their hospital or hospice with a further 56% having received training from other sources. In addition, 54% of participants (n = 33 of 61) indicated that the training was undertaken at least 24 months previously.

Finally, 72% (n = 44 of 61) of participants who had completed training reported that this had ‘provided [them] with the information [they] needed to be confident in discussing ED with patients/family members’, with 25% (n = 15) indicating that this has been provided ‘somewhat’. Two further participants indicated that their training had not provided information necessary to give them sufficient confidence in these discussions.

To explore the content and quality of the training completed by participants (n = 61), we asked if they had any comments on the positive or negative aspects of the training they received. Twenty-two participants provided free-text responses, which indicated several areas of need: eligibility criteria, the process of ED, communication skills, change in legislation and how to access the ODR.

ʻI definitely feel a refresher and update for the whole service would be very welcome’

ʻI really don’t know what I don’t know. I am rusty on how to start the conversation, how to instruct a patient, what to say to the family about the process, the eligibility criteria, the register, etc.’

ʻTraining around communication with families’

ʻI would need training in all aspects. my current knowledge is rudimentary’

‘The process for eye donation where I now work, as it will differ from my previous job’

In addition, several participants highlighted the positive effect on training alongside the need for additional measures to embed ED within routine care in the long run.

ʻIt has a brief effect on practice and then it fades!’

ʻEveryone is very enthusiastic but it has not been effectively implemented’

ʻIt was the impetus to promote corneal donation in our hospice’

ʻGenerally, the training has been useful for me and the feedback of my training to other staff has been very positive. We have researched our donation project and audited it and the staff feedback questionnaire was very positive about the process’

Identification and eligibility criteria

Potential participants were identified from existing clinic lists by PIs at partner sites. Eligible participants were patients or families/carers of those currently (or previously in the case of families/carers) under the care of HC or HPC services, aged 18 years or over, who had capacity to provide informed consent and to participate in the interview (in English). For those families/carers who were bereaved but may have been willing to discuss their experiences, approach for participation was at the discretion of the site PI.

Recruitment (sites S03–S06)

Following the ethics amendment (ERGO ID 59185) and change to protocol, approaches to potential participants continued to be made through PIs or their delegates in the first instance. The PI discussed the study with potential participants, and (participant-willing) shared their contact details with the research team.

Contact details of potential participants were shared with the study team (MJB, BMS) via secure systems. Team members contacted interested participants to discuss the study and agree next steps for providing study information. All study materials (e.g. letters of invitation, PISs, reply slips) were shared with potential participants via electronic means (e.g. e-mail). In instances where this was not possible, information was mailed to the participant following a telephone conversation with the study team.

Once agreement was in place for the interview to commence, the responsible researcher (MJB or BMS) explained the consent process (i.e. that consent to participate would be audio recorded before the interview commenced). The researcher then read out the consent form over the telephone asking the participant to respond by stating ‘Yes/No’ or ‘I agree/disagree’ to the relevant questions. The researcher recorded (electronically) the responses of the participants on the consent form, adding a countersignature and date of consent.

Electronically returned consent forms were stored in a secure location within the EDiPPPP project drive on the University of Southampton systems, to which only the study team had access. Hard copies of returned consent forms were scanned and saved to the same folder, then shredded and disposed of securely.

Data collection

Interview and focus group schedules for data collection were informed by the literature base and the RAPiD tool for identification of barriers to donor information and referral. 78 Interview schedules involved questions mapped to the following areas of interest: Perceptions (of ED and related processes); Propriety (of whether this topic should be discussed with patients); and Preferences (related to who should raise the issue of ED, when should these conversation take place and who should make decisions about ED) (see Report Supplementary Material 14: Patient interview schedule, v2, 20 March 2019, for patient interview schedule and Report Supplementary Material 15: Carer interview and focus group guide, v2, 20 March 2019, for carer interview schedule).

Data management and analysis

Data management and analysis for interviews with patients and carers followed the same process as for HCPs, as described in Chapter 2.

Outcome of recruitment – patients and carers

Thirty-nine patients (21 HC, 18 HPC) completed interviews. Most participants (90%, n = 35) were aged 50 years or older, with 24% (n = 9) aged 80 years or over. Fifty-four per cent of participants were female, a further 54% were in a relationship (i.e. ‘Married’ or ‘In a partnership’), 85% (n = 33) were of White British ethnicity and 69% (n = 27) were retired from work (Table 18).

Twenty three carers completed interviews (13 HC, 10 HPC). Most participants (83%, n = 19) were aged 50–79 years. Seventy-four per cent of participants (n = 17) were female, 83% (n = 19) were a spouse or partner of an HC or HPC patient, 91% (n = 21) were of White British ethnicity and 74% (n = 17) were retired from work (see Table 18).

Perceptions regarding the option of eye donation

The perceptions domain of EDiPPPP relates to individual attitudes, views, opinions and experiences about donation generally and ED specifically.

Perceptions – patients

Patients being cared for in HC and HPC settings were asked about their views regarding donation in general, before being asked about ED specifically. Most patients were positive about donation, while for a minority, the issue of donation did not align with their personal or faith-based views. For those who were positive about donation in general, a key motivating factor was the opportunity to help other people, aligned with a belief that the donated tissues would not be needed by the donor after their death:

ʻYes, I am quite happy for donation … to donate my body and/or any organ that needs … that’s needed for anyone. Yes. Well, I won’t need them. So, they could be useful for somebody else. I’m quite happy for that.’

(P00302, HPC Patient)

ʻI’m not going to be about (laughing). If I can help somebody else then … then, I’m quite happy to do that.’

(P00406, HPC Patient)

ʻI’ve never, I’m not one for donating, I’ve always thought I’ve been against it like really ... Sorry I’ve never thought about it really in depth. Yes, that’s all I could think of really, I’ve never thought about it.’

(P00305, HC Patient)

ʻI don’t mind other people donating and I would, but my faith doesn’t allow me to, we have to be cremated and I wouldn’t want to leave bits of me out of being cremated, you know, a little bit like those Egyptians, I mean they even took their stuff with them in case, you know, this is what the thinking is, I mean if you’re going to go down that road, then you want to go the whole of you or none of you.’

(P00903, HC Patient)

Patients were asked if they were aware about the option of ED before they had been approached to be part of the EDiPPPP study. Most patients were unaware of the specific option of ED, with those that were aware either unclear how they became aware, or providing indications of general awareness through media sources:

ʻNot a lot really. No, I can’t really, I don’t really know that much about it … obviously, you know, if somebody’s passed away and the donation, same as the donation for any other parts, kidneys or anything like that, I’d assume that the eye donation is the same thing.’

(P00703, HC Patient)

ʻNever heard of it, my personal view was, this is what my perception was, that if you detach the eye from the retinae or the optic nerve or something, the whole thing does not work and I hear a lot about organ donations, specifically kidneys and livers and this kind of thing but never have I seen in any advert on television or any kind of media [on] eye donation.’

(P00903, HC Patient)

ʻYeah. Yeah, but more in a … a comic book scientific sort of like manner. Well, what it … yeah, there was a record in 1977 called … by the Adverts called: ‘Gary Gilmore’s Eyes’ and it was about someone had a … a … an eye transplant and then you … with this merging his eyes called Gary Gilmore and it was taking over their … their mind.’

(P00604, HPC Patient)

ʻI didn’t know it existed, no, I really didn’t.’

(P00201, HC Patient)

ʻIt was (name) that came in. Yeah, (about the study) because when I had cancer the first time … I used to be a blood donor and, I was told that: ‘you can’t get involved in anything once you’ve got cancer’. So, of course, that all had to stop.’

(P00602, HPC Patient)

Patients were asked about their views regarding ED. Most participants specifically mentioned that they would be willing to consider ED, with a minority having some reservations linked to a lack of awareness as to whether or not they would be eligible to donate given their health status:

ʻI just thought that when we go, I don’t think your eyes are going to be any good to you but they’re going to do good for somebody else. And when I see people that … you know, like TV programmes where children are going blind and … and it … it just … it puts it all into perspective and that it seems to have … sort of lately, there’s a lot of adverts about children losing their sights and so … and, I thought, you know: ‘don’t be selfish’ and that’s … that’s … and it’s … it … it didn’t take long to change my mind, if I’m honest. So, I … that’s how I felt about it so.’

(P00404, HPC Patient)

ʻI’m fully in favour of that. At eighty-four, I didn’t think much of my organs would be any good so I was quite surprised to find that eyes can still be used even at this age, which was a rather nice thought for me, because I thought well if and when something happens to me, I can still be of use to somebody else in this world then that would be a very positive.’

(P00401, HC Patient)

ʻI’m all for it, I think yes, we should all … we don’t need them, we don’t need the parts anymore so why not let somebody else have a better quality of life.’

(P00605, HC Patient)

ʻI think, what happens to you after you’ve died is irrelevant. I really do, after all they’re only going to burn you, so if you keep your eyes, they’re not going to do you any good. That’s my general view on that particular topic.’

(P00201, HC Patient)

ʻBefore I got diagnosed with cancer, I thought it was a very good idea, no matter what part of your body you were donating, but as long as you were a match to the other person. For me now, having cancer, I don’t know whether my organs would be any good for anybody else.’

(P00603, HC Patient)

Within the group of patients reporting reservations regarding ED, some indicated that their reticence was due to beliefs that the eyes would be needed in the afterlife, or that they wanted to be buried whole:

ʻThe eyes though have a little bit more difficulty and I think it’s the same for most people. They can cope with the idea of, because their hearts stopped and whatever, that those type of our organs can be used, but when it comes to eyes, it’s a bit more, oh dear, what happens on the other side? This is how I see it. I do believe that there is life after death and giving my corneas up, then how am I going to see, what am I going to see with, that I find quite scary.’

(P00101, HC)

ʻMy personal views are I’m a Christian so, even though I believe that when I die it’s my shell that’s left, I’m quite … I … I want to be buried whole really. Part of me would like to donate but the other part of me wants to be buried whole. I don’t want to be cremated definitely. I’ve already arranged my funeral. So, that side of it is all sorted out. So, my feelings are … and your eyes are very personal, I think. Personally, I wouldn’t want my eyes donated. I’d probably say yes to a lot of my innards if … you know, if they were needed. But it’s not for me. Not the … the eye donation. Possibly the other organs. But really, I think, I want to be buried whole unfortunately. I feel bad saying it really because we’re all encouraged to do it as medical people and as … generally as a public, we’re all encouraged to do it anyway because there’s not enough organ donation on … you know, people on the register. So, I do feel a bit guilty about that really but, yeah, that’s it.’

(P00202, HPC)

Perceptions – carers

Carers were also asked what their views were regarding donation in general, followed by their views about ED specifically:

ʻYeah. Well (laughing), my husband had for many years a donor card and, I wasn’t for it because I … I’m … I’m not happy about the idea. Somebody whom I love being dissected if you know what I mean (laughing). So, I wasn’t for a donation in those days at the beginning but, I respect his wishes. You know if he wants to do that, you know, I’m fine with it now. I had time to think about it and accept it although originally, I … I wouldn’t have and if you would have his eyes and that, I don’t want to know what you’re going to do with it. I’m sorry (laughing), it might seem a bit blasé but, I … I don’t want to know what you’re going to do with his … I don’t mind if he makes the donation. It’s up to him but, I wouldn’t want to know about it. I … I … I’d find it emotionally a bit draining, I think, and I’m worried about having nightmares about it as well (laughing).’

(C00506, HPC Carer)

ʻMe, personally, my thoughts are … that when I’m dead, that basically my body is just … you know, the carcass of … of what I was and that if there’s anything of any use to anybody, including my eyes, anything ... what’s the point of just burning me when … if … if there’s bits of me that could keep somebody else alive? So, you know, personally I think, it’s really important.’

(C00206, HPC Carer)

ʻWell I’m a, I’m a very strong believer in organ donation, I have family members who have actually received organs, which has actually made it, you know, brought it home even more to me and yes, and I don’t see why eyes or anything in fact should be at stake, so I wouldn’t have a problem at all if someone was to ask me if one of my relatives could, or we could donate eyes.’

(C00401, HC Carer)

ʻI, I don’t think there’s a problem with it at all because I believe once, once somebody’s passed away then basically, you know, the body’s just not human any more, so if, if any of the parts can be put to good use to help people who are alive and require those parts, then I think there’s nothing wrong with transplanting things.’

(C00305, HC Carer)

While carer participants from the HPC and HC settings perceived organ donation in a positive light, some expressed reservations about ED specifically, while others did not see that ED was any different from organ donation:

ʻI’m completely for it. I … although it’s interesting that the eye donation … because it’s such a personal aspect of a person’s, you know, make-up, physical make-up, it’s actually one of the … one of the few areas where I would have some reservations, I think. But with all other non-identifiable organs, I … I one hundred per cent believe it’s a great thing and … and needs to happen …’

(C00402, HPC Carer)

Yeah, funny enough, I’ve been thinking about this since this cropped up [invitation to participate in the study] and … to see how I would personally feel about eye donation because, as I say, I don’t have a problem in … in general with donation at all but obviously, eyes are, I suppose, a little bit more personal if you … if you … because … because you can see them and I … I started to think would it matter to me or not? And as I’ve had time to think about it, no, I don’t think it would matter if my eyes were taken from me because I’m not going to need them. So, I’d be happy … I … I’ve decided now, I would actually be happy to donate my eyes.

(C00106, HPC Carer)

ʻI don’t quite understand why the difference to do with eyes as anywhere else (laughs) if you’re really willing to give your body, you’re willing to give every part of it that might be useful. I mean, my personal … my eyes I can’t imagine that they’d be used, of use to anyone, but they might be (laughs) because I’m so short sighted, I’ve got lots of, you know, so I can’t imagine they’d be any use, but I would expect if I had offered my body for organ donation that eyes would be part of that.’

(C00103, HC Carer)

ʻWell, personally I don’t think it’s an issue for the reasons I’ve given, because obviously once, once a person’s died that’s just flesh and blood I don’t think there’s, the person has any feelings or it’s actually the person that we, we associate with the person that we know, it’s just, it’s just a corpse so the corpse is going to get buried or cremated, it’s a waste of body parts if the body parts could be used to help somebody else.’

(C00305, HC Carer)

Carers were asked about their awareness of ED. There was a general level of awareness, mainly from the media, but not from the clinical or health-related sources:

ʻWell, I … I … yeah, because as far as I was concerned, you could … there’s so much of somebody that you can … that can be donated to help somebody else. Yeah. So, I’m sure I’d heard of eyes being donated.’

(C00102, HPC Carer)

ʻGenera l … general information through TV and media stuff. Yeah, I just … no, I don’t actually … it’s something. Certainly, corneal transplants I’ve heard of.’

(C00202, HPC Carer)

ʻNo, I hadn’t given it a thought and, I hadn’t had it … it’s not very wide-spread. Like your saying: ‘how many people leave these donations?’ and: ‘you’re only doing a drop in the ocean’. So, no, I hadn’t realised that.’

(C00406, HPC Carer)

ʻWell, when I first read the information sheet, I thought, woah eyes, yes right. I didn’t realise it was the whole eye, because I asked the doctor there, the consultant, is it your whole eye or is it just your lens or what and she said ‘no it’s the whole eye’. And I said is it before death or after death. After death. So, in the short time, because I only saw her yesterday, so in the short time of thinking about this I, I think it’s a good idea and I, I would be comfortable with it, but I would, I would like to have known about it for longer and I think it’s the surprise of it coming along, you know.’

(C00205, HC Carer)

ʻI think, I think I just heard about it on the news or some article there being the concerns about some people not wanting to, they were alright to offer their other organs but for some reason they didn’t seem very keen on donating their eyes.’

(C00305, HC Carer)

Commentary – perceptions

Findings from interviews indicated that patients and carers held positive views towards donation, and the majority were also positive about ED when asked. For those who had reservations, their views resonated with findings from extant literature indicating that eyes may be needed in the afterlife,5,6 or that the idea of ED may be perceived as unpleasant,4 stimulating the ‘ick response’ or feelings of squeamishness. 7 However, what is clear from findings is that almost all patient and carer participants were not aware about this option, and believed that a patient with a cancer diagnosis could not be an eye donor. In fact, most patients were surprised that they could donate their eyes due to their age (i.e. believing themselves too old) or believing that other health conditions would prevent this. For those patients and carers who were positive about ED, the general view was that if the eyes could be of use to someone else, that would be a good thing.

Propriety – patients

In view of research indicating a view that the issue of ED should not be raised with patients moving towards their end of life (proposed by HCPs and some family members),38,41 patient participants were asked whether the option of ED should be offered to patients under the care of palliative care and hospice care services:

ʻYes, I think, everybody should be asked if they want to do it because sometimes … it’s not something you think about. Even when you know you’re … not going to be here for much longer … It … might be the one thing that they want to … to donate and they don’t want to donate anything else. So, if you ask them it’s … it’s up to them, isn't it? It’s their choice.’

(P00404, HPC Patient)

ʻOh yes, I do. I do. Yes. Yes, it is … for the least they’re … they’re … they’re given the opportunity to say yes or no. I was going to say that you … obviously, it’s try … trying to pick the right moment to bring it up which … that’s the difficulty, I suppose. But I … in my experience, I would say that the … the sooner the better to bring it up.’

(P00804, HPC Patient)

ʻI am quite forward planned. I like, you know, to know it’s ticked off and then I can relax knowing that what I want no one else is gonna have to deal with when I pass away. You know, I don’t want my friends to have to worry about that because, I haven’t got any family anymore and, I’ve not been very well.’

(P00202, HPC)

ʻYes, because it makes you feel that you’ve given something back which is worthwhile, you know.’

(P00201, HC)

ʻI think possibly, I think a lot of people wouldn’t be thinking about eye donation, they’re thinking of hearts and lungs and all that, and some people don’t like the idea of the eyes, I’m not quite sure why but I think maybe it should be discussed a little bit more than just on the donating form sort of thing, or people in that position should be asked a little bit more about it perhaps. So yes, I think it’s not well known enough that even over eighties, they can still use your eyes, I don’t know whether the government’s new ruling that you have to opt out of being donated, rather than opt in, does that include eyes, I don’t know.’

(P00401, HC)

Propriety – carers

Carers were also asked if this topic should be raised with their family member as part of end-of-life planning:

ʻAbsolutely when … when they go into palliative care, they’ve already been asked all … all the other questions of: ‘how … how do you feel about … if … if your heart stops, do you want to be revived?’. All those things. So, why isn’t that just an extra question in there? What … I don’t understand … I really don’t understand where there’s a problem there. If you’re going to go into palliative care, you don’t go into palliative care without being asked all the right questions, I would hope. And that’s just another question.’

(C00202, HPC)

ʻI guess … I guess it … it’s probably on a case-by-case basis because it all depends on how aware that individual patient is of being … of the … you know, the prognosis for them. You know, in the case of my Dad, I would say he perhaps doesn’t really understand what’s happening and therefore … yeah, it has to be informed consent, I suppose, as … as with any medical decision. So … so, yeah, I … I think, where a patient is able to cope emotionally with a decision of that nature then, I think, it … I think, it’s … the … I think, it’s a good thing.’

(C00402)

ʻYou see at end of life, I would imagine there may be other things that appear to the individual that’s coming to end of their life as being more important. But at the same time, I would have thought it would have given a lot of people a lot of strength to think that they’re still participating in a social activity that’s really going to benefit someone else. So, clearly there are exceptions to prove the rule, but I would imagine as long as the person delivering the information has an empathetic, caring delivery system, I personally wouldn’t see any issue with it whatsoever.’

(C00101, HC)

ʻI think the timing is crucial, you see if you ask somebody when they’re, they’re loved one is in a hospice or about to die, you know, will you donate your eyes, I would think that’s the last thing they want to actually think about at that point. It needs to be, have been agreed or, or accepted at a much earlier stage I think, so that some of the emotion around it is taken away because my own personal view is that I, I, my family know that I was willing to donate before it became, is it law, is that the right way to say it? Before it became law, I was willing to donate anyway … So, in terms of eye donation for people in hospices and things, it is about the timing of when that question is asked or when that expectation is understood … I know that I myself prior to that new legislation was down as a donor and anything worth having they’re welcome to. So, yes, I personally would be quite aggrieved if my useful parts were not put to use if I were to have an untimely death and everyone who knows me is aware of that, so there’d be no excuse for it not to happen.’

(C00205, HC)

In view of research indicating that HCPs are reluctant to raise the issue of donation as part of care planning,33,38,41 carer participants were asked if they thought that HCPs should raise this issue with patients and/or families. All carers indicated that the topic should be raised, and acknowledging that this would be perceived as a challenging conversation:

ʻI don’t see a problem raising it, except personal. If someone’s got a personal reluctance, I’m not sure we can do much about that because you’re not … you … there’s no way you want to legislate for it therefore maybe they could … if … if need be … effectively pass the buck and actually say: ‘look, I’m not prepared to do this’. But the … there’s usually a team so, there must be someone on the team that will do it.’

(C00202, HPC Patient)

ʻYes, I … I do actually. I mean, recently the issue was raised. [HUSBAND] had to go into hospital and he was … it was raised about arranging a DNR. Well, if you can do something of that nature and obviously you know what that is, it … then I don’t see why it couldn’t be raised about how people feel about donating their eyes or any other part of their body after their death.’

(C00106, HPC Patient)

ʻI can understand that I’m sure an awful lot of people are particularly sensitive about eyesight, or so I’ve been led to believe. I can understand why but if providers need more training or assistance to help them better meet the needs. It’s a discussion, if it’s all part of, end of life, I have no real experience of it personally, but end-of-life discussions I can’t imagine it’s an easy conversation to have, but it’s still part of an important process to go through, I would imagine. I mean it’s not just another thing, but it’s all encompassed in a well-delivered empathetic, kindly environment I really don’t see any issue with it personally.’

(C00101, HC Patient)

ʻAgain, I think it, it’s a very, very, very difficult subject to broach and it’s also a difficult subject for certain healthcare professionals to approach the person about. And then, you know, this patient comes in, they’re clearly not well, they make them comfortable, they do what they’ve got to do, but that’s it, nothing else is talked about … So I just think, I think people need, they need to be, I know there’s an organ, organ donation team that, you know, collect organs because as I say we’ve had this with the family, but I don’t think there’s enough special, just we say specialist healthcare professionals out there, trained in awkward conversation. Because again, it’s a conversation that, you know, somebody asks you, and you think actually, no, I can’t deal with this, you know, you’ve got too much going on and yes, you know, you have lost that opportunity if you like, but that family are aware. And it could be a couple of days down the line that you think actually, do you know what, that makes so much sense.’

(C00401, HC Patient)

Commentary – propriety

All but one patient and all carers participating in this research indicated that ED should be an agenda item for discussions as part of ongoing care planning. Participants acknowledged that not everyone would want to have this discussion, and that the conversation must be introduced at an appropriate time; however, there was no clear consensus from participants as to what constitutes ‘appropriate timing’.

Patients across the data set made comments about not knowing about the option of ED, or being told they could not be a donor due to their clinical condition despite being in favour of donation and, for some, being blood donors or registering organ and/or tissue donors during their lifetime. The view reported by HCPs and family members in previous research that raising this topic would be distressing is not supported in the data set. Findings indicate that patients should be asked about their preferences, and if they do not want to discuss the topic, they will say so.

Preferences – patients

Interviews with patient participants indicated that none of them (100%) had been approached about the option of ED in their current clinical care context or in previous settings. We asked patients their preferences with respect to who they thought should raise the issue of ED, participants indicated a range of views:

ʻI think the nurses that are looking after them, I mean I’ve been in the hospice twice and the nurses in the hospice are a cut above and they know how to treat a person. I think they know generally if you’re talking about it whether or not the patient would be willing to do that.’

(P00105, HC Patient)

ʻIt doesn’t necessarily have to be a doctor, but they have to be like a nurse practitioner or something like that or somebody who knows about the body because if you had a social worker for instance saying how, about this, they wouldn’t really be able to answer the question would they. Because people would wander off the subject and go on to other questions about medical things.’

(P00201, HC Patient)

ʻI think, it should be the consultant.’

(P00304, HPC Patient)

ʻI think, it should be … the doctor … Nurses have enough sort of dealing with the pain and upset of it all without having to bring something like that up.’

(P00404, HPC Patient)

Patients were asked about their preference as to when the option of ED should be raised:

ʻProbably quite early on, I would have thought. Yeah. Just to get … plant the seed. I mean, like I’ve said, I’ve seen here when it’s been talked … not with eyes obviously but in general and people get angry. So, I would probably want to plant the seed early on and just mention, you know … start it off a little bit, you know, and … so, I would say early on. Yeah. I think, … in somebody’s care plan oh yeah … raise the discussion, definitely.’

(P00202, HPC Patient)

ʻObviously, it’s got to be done when the person is compos mentis it’s got to be while the patient is of reasonable sound and mind, you know.’

(P00502, HPC Patient)

ʻThe right time for me, may not be the right time for you or for Mary or Jane or Sarah. The right time for everybody is different, some people won’t be able to discuss it at all. It’s a really deep, provoking question, when is the right time. I don’t have an answer for that, I really don’t. At the moment, now is the right time, while I’m still of perfectly sound mind and before I’m too weak to be able to think about things and decide, so, but that’s how I feel. But I do, I think, I think places like the [day centre] should attempt to have discussions about donation with all patients and maybe it should be a question on their enrolment type form that they have the discussion with people very early on.’

(P00101, HC Patient)

Patients were asked who should make any decision regarding ED, themselves or their family members, whose decision should take priority and whether they felt that their family/carers would be supportive of their decision:

ʻIn my particular case, no. It’s my decision and … but I haven’t got children so, it … it is totally my decision.’

(P00602, HPC Patient)

ʻIf I hadn’t got the donor card then, they [family should decide]. With the donor card, I think, it’s got nothing really to do with them.’

(P00402, HPC Patient)

ʻSo, I’ve seen it enough times to know what the reaction is and having seen that reaction I can imagine what the reaction is of families when they’re asked will you donate your loved one’s corneas. And it shouldn’t be the loved ones [family members] who make that decision. It’s not their decision to make, it’s the patient’s decision and in order to get that patient’s decision is the discussions need to take place, much, much earlier than they do and it’s the same with any other organ.’

(P00101, HC Patient)

ʻWell, I guess if I’ve made it clear that I want organs to be donated then they shouldn’t be able to override that.’

(P00103, HC Patient)

ʻI think ultimately it should be my decision, but if I’m not able to make that decision then yes, they have the right to make that decision on my behalf. But if I have got, if I am able to make that decision then it’s my choice, nobody’s else’s and it’s not up to anybody else.’

(P00605, HC Patient)

ʻBecause if I’ve made the decision while I’m alive to donate my organs or my eyes, my wishes should be respected and carried out, it’s my wish.’

(P00705, HC Patient)

Very few patients thought that their family would not support their decision, but no patients had discussed ED with their family member at the time of data collection:

ʻNo, I don’t … I don’t think they will feel the same as me. I think, they … they have a bit of an aversion to it. Yeah. So, I … they definitely don’t think the same, I’m sure.’

(P00302, HPC Patient)

ʻI’ve never had the discussion with the family regarding donation, but I know we’ve just, not long had a new law come in that’s saying you’re all on the donor register list, but you have to then ring if you want to take yourself off. Although I haven’t rang, I’ve also had the conversation with family regarding it and it’s probably something I should do, I am terminal, to help other people that would be something that I would feel, I’m doing something, but obviously I would need to make family aware if the doctor does ask you that question then this is what I’ve said. But, yes, I’ve not yet had that conversation, but I probably should.’

(P00603, HC Patient)

ʻOur daughter has very set … distinct views on subjects. She doesn’t … won’t let you persuade her without, you know, a competent argument/discussion/debate so. And my wife, I think, she’ll go more with the sort of gut feel. So, I suspect that she’d probably say: ‘no’ being she still wants to be stuck in a hole in the ground and, I don’t see the point of that at all. We haven’t got that many holes left. I think I’m going to go home and start writing it down. Maybe that’s maudlin, I don’t know, don’t think so, I think it’s being practical, I really do think I’m being practical because I don’t want them, to make that decision and potentially arguing over the decision.’

(P00101, HC Patient)

Patients were asked what their preferences were related to information about ED donation, with responses varying in both qualitative content (e.g. whether about eligibility criteria, processes for retrieval) and level of detail:

ʻFor me, definitely a pamphlet (laughing) or … or even a little book because even though I might be dead, I’d like to know what’s going to happen and how it was done. And then to know what’s then going to … how the recipient receives it and how long it … the healing process is or, you know, the chance of it working and the chance of failure because I know it doesn’t always work and it can … with the lens it can cloud and all kinds of things.’

(P00202, HPC Patient)

ʻThey would want to know, one, that is it possible to use for all ages, they would want to know what exact part can be used or not used, they would want to know whether it would be, although it would be a bit too late by then for that person, they would want to know what sort of intrusion it would amount to, you know …. Say they are going to be buried or cremated or something, What part would be seen or not seen …. They would want to know how long such a part would last, like, you know, in other body parts they put it in these packs with ice or freeze it in nitrogen, you know, like cells, like sperm cells for example, would an eye organ be utilised like that, would it last that long. Would it have to be repetitively rejuvenated, would there be rejection in the new person receiving it. And that’s my question, you see, it doesn’t explain to me why do you need to take the whole of the eye out if you just need the cornea?’

(P00903, HC Patient)

ʻI don’t think I, to be quite honest, I don’t think I need any information apart from the fact that I would need to know if there was a form that I could fill in to donate my eyes or any parts, that I could actually fill in and send so that you can look after that paperwork in the event of my death, raise, raise it at that point.’

(P00301, HC Patient)

ʻAbout … like how useful it would be going to somebody else, the opportunity of giving somebody else sight maybe or things like that, teaching and even for doctors to practice on and learn.’

(P00705, HC Patient)

ʻYes, I … I would have to look into it a little bit … a little bit more because, as I say, I know very little … well, I virtually know nothing about the actual system itself. How would it work? Would it work … obviously, how long I’ve got … how long will it last before it becomes useless? Because it only lasts … lasts for a certain amount of time, doesn’t it?’

(P00502, HPC Patient)

Preferences – carers

Of note is that none of the carers who participated in the study had been involved in a discussion about ED; we therefore asked carers about their preferences regarding who they thought should raise the issue of ED:

ʻWell, I think, possibly the palliative care people are … are the very best to do that. They deal with death all the time, you know, and they spend a lot of time with their patient.’

(C00406, HPC)

ʻI think, it would be the person … probably the consultants. I think … yeah, I think, it would be the most senior person in charge of that person’s care.’

(C00402, HPC)

ʻIt should be a trained healthcare professional. I think, or it could, yes, somebody coming in from the outside specifically to, to do that would, perhaps if somebody was not convinced or had special questions you could bring in some, a specialist in that area to explain things. I think a healthcare professional, I mean most people working, particularly in palliative care, or, I mean most consultants are trained to give bad news, you know, but this is a positive thing that can come out of the bad news.’

(C00103, HC)

ʻGood question. Probably, probably the doctor or the consultant who’s dealing specifically with the patient, the person that has the final say on the patient’s medication and the patient’s treatment because they’ll have a, I would imagine, they’ll have full access to the patient’s notes and the case.’

(C00305, HC)

Carers were asked about their preference as to when the option of ED should be raised with a patient/family member. Carers in HPC and HC agreed that ED should be raised early in the EoLC pathway, with the caveat that this would depend on the patient’s clinical condition:

ʻMy general thought, I think it’s something along with all organ donation that should be discussed at the early stage really in peoples’ care at the hospice. Yes, we’ve had conversations with L*F* who is a consultant at the hospice and I guess coming from a point of view where we’re quite open to organ donation it, it would seem perfectly natural. But I gather, you know, I would understand if people would feel shocked by that at an early stage, but for us it would have been fine to have been asked.’

(C00103, HC)

ʻIt should be raised with the patient when they decide that … that … I mean, they’re … they’re thinking about palliative care. Right at that earliest possible moment to say: ‘this is a … ’. You’re doing it all … you’re doing it already. You’re saying: ‘listen, if you’re … if you go into cardiac arrest, do we re … do we revive you?’. And they’re saying: ‘no’ basically. So, why not say at the … ‘if … if we get into a situation where you … you do pass then why … why not … what about donation?’. I don’t see a problem with that.’

(C00202, HPC)

ʻI don’t know, I don’t really know, it just, I think it depends on the health of the patient, if they’re well enough to discuss it at that time, I think it’s just, you’ve just got to wait and see when it is right for the actual patient, which I know, I know that’s difficult but if they think, they could just mention it and if they sort of shy away then you don’t probably say anything, I think it just depends on the individual at the time.’

(C00303, HC)

In view of commentary from the literature indicating that availability of information about donation could negatively impact the aimed-for tranquil environment of palliative care setting, we asked carers what their preferences would be about information being available in the form of leaflets, posters, etc. Carers agreed that information on ED should be available to patients and carers/families, regardless of whether they supported the option being raised directly with patients. Some carers felt that the topic should first be raised in a conversation:

ʻI suppose [information about], just how … how are they used and how are they … I mean, are they used to donate to other people? Are they used for research? Are they used for both? That’s more probably my questions on that. And … how does it help a person.’

(C00106, HPC)

ʻI think there should. Yes. There should be some … there should be information. I mean … and if the information is done right at the start of the diagnosis programme … procedure, you know, then it would be … it would give people longer to get used to the idea.’

(C00502, HPC)

ʻI think it needs to be, it needs to be discussed, you know, probably needs to be mentioned, it needs to, let me think, it probably needs to be, an overall leaflet or pamphlet, a general sort of introduction to it just for the patient and family to get some background knowledge of it before the actual consultant starts to discuss it initially and then once they’ve discussed it with the patient and family if the patient needs the family to hear, you know, to discuss it, then the, you know, the consultant could then go into greater detail. But I think basically a leaflet of some sort to give an overall view, you know, like a general guidance and what it’s all about, a brief chat, explanation with the consultant would supplement the information in the pamphlet and the consultant would come back once the patient has had time to read and digest and think about the pamphlet information, then they could take it further. Obviously if at that time, having done all that the patient turns round and says, well no I’ve heard the facts and the information and it’s not something I want, then obviously that would be the end of it, but if the patient’s actually read the information and given it some thought and decided to continue with it, that would be the time that the consultant could then go into greater detail and answer their questions if necessary.’

(C00305, HC)

As the level of public awareness is reported to influence donation decision-making, we asked carers if they knew how many people are in need of a corneal transplant in the UK? No carers were aware prior to participation in EDiPPPP, with one participant stating that they only became aware when they read the Participant Information Sheet for the study:

ʻNot really no to be honest I, I don’t really know.’

(C00301, HC)

ʻDid I read there are five thousand a year is it and there’s only three and a half thousand donations?’

(C00101, HC)

Participant identification and recruitment

The aim of recruitment for the TEC was to ensure panel composition reflected the diversity of stakeholders represented in the ED process. These included:

• clinicians from Hospital and HC settings

• representatives of national and regional healthcare bodies with responsibility for/involvement in ED

• representatives of national and regional organisations supporting and/or representing:

  • patients and carers receiving EoLC

  • families of donors

  • patients waiting for or in receipt of a corneal transplant.

• steering group members

• PPI representative

• research team members.

Participants were identified for approach through a range of routes, including:

• study co-applicants

• invited representatives from:

  • HC and HPC professional networks

  • patient and donor family support organisations

  • regional and national bodies involved in ED.

• contacts encountered through research activities in WP1 and 2, or who had made unsolicited contact with the study team to express interest in the EDiPPPP study (via CRN, viewing study website, etc.).

Transparent expert consultation participants

Thirty-two participants were formally invited to participate in the TEC. Invitations were sent by e-mail with a personal paragraph indicating the specific relevance of the potential participant’s expertise to the TEC and including the PIS.

Twenty-three participants initially agreed to take part in the EDiPPPP TEC, of which 21 finally took part. Establishing a TEC panel during COVID-19 restrictions was challenging, with some potential participants subsequently becoming unavailable due to clinical pressure/demands at short notice.

To facilitate engagement and efficient use of time, participants were grouped into two panels aligned to their expertise or role: Group 1: Education, Training and Awareness (ETA), Group 2: Process and Technical (PT). Participants and the rationale for grouping of participants are presented in Table 19.

Preparation for transparent expert panels

Interim findings from across the study were collated into two panel focused reports and one overview document. Each report followed the same outline: role of the report (including the questions to be answered by that group) followed by the summary of findings outlined under the study domains (potential, practice, perceptions).

• Report 1. ETA. The goal of this group was to confirm key areas for organisational, logistical and individual practice change with respect to education and training of HCPs in relation to ED, and public awareness campaigns to inform patients, families and the wider public.

• Report 2. PT. The goal of this group was to confirm key areas for organisational, logistical and individual practice change with respect to local and national processes, systems and resources to support implementation of ED.

Prior to the TEC, clinical PIs had also received site-specific feedback on the outcome of ED eligibility assessment for their sample of patients in the notes review. This information informed discussion of current knowledge and processes for evaluation of ED eligibility and the challenges faced by clinical PIs in undertaking eligibility screening against the current ED criteria.

Convening the transparent expert panel meeting

Participant availability was assessed via Doodle online availability polls and once dates were confirmed participants received meeting documents via e-mail 2 weeks ahead of the meeting (to facilitate review of documents ahead of the meeting):

• agenda and joining instructions via Microsoft Teams including guidance of panel membership and use of break out rooms

• a consent form for completion and return prior to the consultation meeting

• TEC documents:

  • interim findings summary report (see Appendix 8)

  • interim findings PowerPoint

  • ETA-report (see Appendix 9)

  • PT report (see Appendix 10)

  • a copy of the study protocol.

Conduct of transparent expert panels

Both TEC panels took place via Microsoft Teams and were video-recorded with the consent of participants for the purpose of review of commentary by the study team. The TEC was chaired by TLS, with BMS monitoring the group chat, and MJB providing technical support and accessing further study information as requested by participants.

Both groups began with introductions of group members, and a restatement of the guidance for participation and functions of Microsoft Teams. Participants were then asked to review the questions for discussion and indicate any suggested additions or amendments (none were provided in either group). TEC panels then proceeded to discussion of agreed questions, which were:

• For the ETA panel:

  1. What key activities are necessary to inform: education, training and public awareness raising initiatives?

  2. For all activities in all EDiPPPP study domains:

     1. What specific content is needed? (e.g. education/training focus points; key public awareness messages).

     2. What form should this content take? (e.g. online information, e-learning or in-person training, format of public awareness campaigns).

• For the PT panel:

  1. What processes need to be generated or amended in response to the findings of this report?

  2. What technical resources (e.g. IT, clinical knowledge base) are needed to support these processes?

Due to its size and composition, the ETA panel was split into two (see Table 19), which ran concurrently to consider the questions in relation to two specific areas: Public Awareness and Education and Training. Following the parallel discussions, the groups reconvened as a single panel to discuss their thoughts with the wider group. For the PT group, questions were discussed as a single panel group.

Collation and synthesis of findings

Meetings were audio- and video-recorded using Microsoft Teams software, and recordings were subject to inductive content analysis42 using Microsoft Excel. The first step in this process was to produce written notes based on participant comments to study findings. The second step involved categorising notes to create a taxonomy of general areas of agreement on what was needed to enable behaviour change (e.g. Staff Training and Awareness), which were highlighted as IP for service development.

Table 20 provides an example illustration of this process for one of the IP identified from discussion notes from the ETA panel in response to study findings regarding the lack of information about ED for patients and carers at study sites. This table shows the study findings in the left-hand column, meeting notes [with initials indicating the speaker(s) and a timestamp indicating the start point at which this observation was identified] in the middle column and finally the right-most column describes the intervention point that was derived from the notes and areas of concern that map to it.

Education, Training and Awareness transparent expert panel

Following discussion of findings, panel members identified four key areas for behaviour and practice change regarding education, training and awareness of ED: Information resources (staff); Institutional policies and procedures (local); Public Awareness; and Staff Training and Awareness. Eight intervention points were identified relating to these areas of concern, which are described in Table 21.

Process and technical transparent expert panel

Following discussion of findings, panel members identified two broad areas for behaviour and practice change: ER and communication with patients and family/carers. Seven intervention points were agreed regarding ER (Table 22) and seven for Communication with Patients and Families/Carers (CPF; Table 23).

Theoretical underpinnings applied to intervention design

Despite guidance from the UK Medical Research Council recommending the use of theory in the development, planning and evaluation of complex interventions,33 many intervention designers do not use existing frameworks as a basis for intervention development. 85,86 A key finding from the EDiPPPP study is that behaviour change needs to occur at both an individual and organisational level and therefore early on in the research process we reassessed the applicability of theory that we had proposed to apply during analysis, and following a review of the literature related to models of behaviour change, the COM-B behaviour change model24 was chosen to inform analysis and our thinking as we developed component parts of the intervention (Figure 10). This model assisted in articulating the contextually specific, necessary, practical, psychological and organisational actions and processes that are required to support behaviour change with the aim of enabling the current potential for ED in hospice care settings to be realised and end the supply deficit.

FIGURE 10.

The COM-B factors. 87

Authors33,88 recommend that any model should be able to map those mechanisms that underpin change, for example physical, psychological, environmental. These concepts align with the domains of EDiPPPP: Potential, Practice, Preferences, Perceptions, which, in combination, reflect the donation climate of an institution. The COM-B model is proposed to articulate what needs to change in order for a behaviour change intervention to be effective with authors proposing that the COM-B model ‘identifies three factors that need to be present for any behaviour to occur: Capability (C), Opportunity (O) and Motivation (M). 24 These factors interact over time so that behaviour can be seen as part of a dynamic system with positive and negative feedback loops’. 87 Each of the factors in Figure 11 can influence each other. For example, a lack of capability can reduce motivation to undertake a behaviour and therefore opportunities to enact the behaviour will be avoided. Likewise, a perceived lack of opportunity to enact a behaviour may reduce motivation and over time impact perceptions of capability (you lose it if you don’t use it).

FIGURE 11.

COM-B aligned to intervention STEPS.

Aligning COM-B with EDiPPPP domains and intervention STEPS

Figure 11 illustrates how COM-B components align with the study domains (Potential, Practice, Preferences and Perceptions), how the COM-B components are defined and how the TEC intervention points align with the STEPS.

Capability: Currently, most HCPs do not feel that they are capable of facilitating ED as they lack knowledge and skills to ‘identify’ potential donors, ‘assess’ potential donors, ‘approach’ potential donors’ and complete associated tasks facilitating ED. Perceptions of capability will influence HCPs motivation to enact behaviours and undermine recognition of ‘triggers’ that stimulate opportunities to engage in the behaviour of raising the option of ED. The knowledge and skills deficit at potential ED sites must be assessed and addressed to bring about change (Intervention STEP 1).

Opportunity: HCPs lack opportunities to embed ED as organisations do not have routinised processes to identify potential donors or discuss potential donors at a team level and therefore no one ‘is allocated’ to engage in a discussion with the patient. Systems do not facilitate knowledge of the patient’s ODR status, and the NHSBT-TES website does not provide clinically up-to-date information that is accessible to clinicians. Opportunity supports motivation to engage in a behaviour and acts as a de-motivator if opportunities are not visible (routine) and not accessible (requiring extensive extra work). Opportunity to raise the option of ED needs to become habitual, emotionally rewarding and easy to enact. The formal and informal ‘opportunities’ to raise ED must be identified and agreed in order for change to occur and be maintained (Intervention STEPS 2 and 3).

Motivation: Many HCPs are motivated to include ED in end-of-life planning conversations and patients are motivated to have these conversations, but HCPs are de-motivated by their reported lack of capability (knowledge and skills) and opportunity (lack of accessible systems). Motivation will be reduced in situations where individuals perceive they lack competence as this often leads to lack of confidence, especially in situations that are new, or in which the individual has little experience (the confidence/competence feedback loop) for as Bandura states, ‘Unless people believe they can produce desired results (in this case raising the issue of ED) and forestall detrimental ones by their actions (e.g. negative reactions by patients or family member, increased workload), they have little incentive to act or to persevere in the face of difficulties’. 88:p179 The barriers that de-motivate and facilitators that motivate ED-related behaviours in potential ED sites must be analysed and understood in order to bring about change (Intervention STEPS 2 and 3).

Service users report that they have the capability to make decisions and are motivated to engage in conversations in view of positive perceptions of the benefits of ED, but currently they are not provided with the opportunity to discuss this option. Opportunities to inform (awareness raising) service users of the option of ED are lacking (at local service and national levels), which undermine capability and motivation. The opportunities to raise awareness and inform patients and carers of the option of ED within HC and HPC must be assessed and addressed in order to bring about change (Intervention STEPS: 1, 2, 3, 4) Furthermore, evidence-based public awareness-raising initiatives at the national level need to be developed, implemented and evaluated. 33

STEP 1: Establish processes to ensure identification, assessment against eligibility criteria and referral of potential donors.

The first requirement to increase the supply of ED from hospice sites is the systematic assessment of the donation climate (potential and organisational readiness) of each hospice that NHSBT-TES aims to partner with. Partnerships should be formalised with service-level agreements outlining responsibility and financial assistance and aligned with the site becoming an affiliated ED site. Assessment is needed due to the fact that, as evidenced in this report, if the site has high potential but low readiness, referral and donation rates will not increase. If there is high readiness and low potential, referral and donation rates will also not increase.

STEP 2: Initiatives to underpin organisational capability, motivation and opportunity to embed ED in routine practice

Sustained leadership and liaison are key to embedding ED in hospice care settings. This was well demonstrated in Site (02) where the RSPTD and clinical lead have developed a robust working relationship and flexible systems including baseline assessment of patients entering the clinical site for ED against five criteria (see Table 7), with those patients meeting the criteria ‘tagged’ for discussion in the clinical MDT. This model of ongoing assessment of all patients entering the clinical site is recommended to ensure that assessment becomes and embedded ‘routine’ behaviour. We recommend that NHSBT-TES makes a financial contribution (as part of contractual arrangements of a service-level agreement) to the agreed affiliated hospice site to support ongoing assessment of patients against eligibility criteria. This is important as most hospices receive little monies from the NHS. Analysis of Hospice Account reports (covering all charitable hospices in England) indicates that ‘statutory funding covered around 37% (median) of charity expenditure’ for financial years 2011/12 through 2017/18. 89 Liaison is essential and should be provided by the site-specific RSPTD who would have responsibility for ‘Engaging ‘with lead clinicians (nursing, medical, education), encouraging the inclusion of ED in all clinical development agendas and attending MDT meetings; ‘Enabling’ the site leadership team to ‘Embed’ ED into routine EoLC planning, via ‘Encouraging’ staff to engage with centrally generated informatics regarding current stock levels, use of eye tissue, etc., engagement with centrally developed and validated training resources; and to ‘Exemplify’ ‘via delivery of compelling narratives and consistent evidence-based messages’90 including the perceptions of patients that ED is a ‘safe topic to raise’ to underpin ongoing motivation to include ED in EoLC planning.

Compelling narratives are available from the recently developed blogs and videos from the NHSBT marketing team,91,92 but this alone will not change behaviours as busy HCPs may only ‘peripherally process’93 the message embedded in the resource. However, if these resources are included in in-person education sessions and simulations, the target audience is more likely to ‘closely scrutinise’ the messages.

Likewise, with service users who are not aware of the option, need for and benefits to others of ED, these resources need to be part of a guided session on ED, where potential donors can ask questions stimulated by the videos. Resources for service users should include ‘leaflets’ (as reported) providing basic information regarding ED that service users could share with family members, and aligned with in-person sessions for maximum impact as multimodal information is reported as being more effective in stimulating behaviour change. 83

Ongoing monitoring and evaluation of ED sites is essential in maintaining donation potential. As noted in the findings, most HCPs had not received any training or guidance in the previous 24 months and while some were aware of the new deemed consent legislation, HCPs were not clear on how this should inform their practice. This is a key role for the RSPTD who should be undertaking an annual potential donor audit (of potential, referrals, outcomes, education undertaken, etc.) that is shared with the strategic ED Hospice implementation working party.

STEP 3: Education and training initiatives to underpin individual capability, motivation and opportunity to embed ED in routine practice

An evidence-based, context informed, educational strategy has been generated (Figure 13), which has been shared with the strategic team at NHSBT-TES and is aimed at individual HCP development. The evidence-based strategy indicates the content needed at each of the steps within it. As is shown in Figure 13, the expectation is that:

FIGURE 13.

Logic model of stepped education strategy for implementation.

• educational resources (baseline-level training) will be embedded in induction programmes for all new staff joining the hospice

• with (intermediate-level training) being shared with those healthcare professionals who as part of their clinical role undertake EoLC planning discussions. Currently, this role is undertaken by medical practitioners at either consultant or registrar level, specialty doctors and clinical nurse specialists

• a final suite of resources (advanced training) will be developed which would guide chief Executives of hospices in how to set up, monitor and evaluate service and contract with NHSBT-TES

• RSPTD will be responsible for implementing training and education and will be responsible for the development, delivery, monitoring and amendment of the centrally agreed, validated, evidence-based educational strategy (supported by NHSBT education and research team)

• resources should be evaluated on a yearly basis and presented to the strategic ED Hospice implementation working party, and Hospice ED education and training working party for review and, if needed, further intervention.

STEP 4: Development, monitoring, assessment of context-specific public awareness initiatives

Current NHSBT-TES practice regarding eye donation in hospice care settings

In view of the findings that there is evidenced potential for ED across the hospice and palliative care services involved in this study, but with the greater potential in the hospice care settings, the proposed intervention is planned for implementation by NHSBT-TES into four hospice care settings from October 2022. The sites are geographically located within the remit of one of four retrieval teams currently available in England.

Currently, NHSBT-TES does not strategically select palliative care ED sites (other than to work more closely with those within the geographic location of retrieval teams); no assessment of potential or organisation readiness is carried out. Five (three at start of EDiPPPP) RSPTDs currently provide support to hospices across large geographic locations (North West and North Wales; London and South East; South West and South Wales; and Cheltenham and Gloucester). In view of the intervention steps, NHSBT-TES needs to invest in this team increasing their number to maximise implementation. ED numbers will also be limited if the agreed tissue cannot be retrieved and so NHSBT-TES need to review this resource also. Currently, there are four retrieval teams; however, if as stated in this report, there is an increasing number of hospices referring patients (increases stimulated by the EDiPPPP study presentations at local and national conferences) from 41 hospices (March 2021) to 63 hospices (March 2022), this increase will put pressure on these teams in facilitating retrieval. Lack of retrieval is a key de-motivator as if HCPs have approached family members, and the tissue cannot be retrieved, they are unlikely to raise this option going forward. Furthermore, if family members are informed that despite their deceased family member agreeing to ED, this was not completed, this story will stay with them and act as a negative ‘narrative’ shared on social media platforms.

Currently, 63 hospices in England are generating, on average, only seven referrals each to NHSBT-TES annually. 94 The current model is not a robust process for increasing the supply of eye tissue in the current climate of demand and limited supply and therefore we recommend STEPS to NHSBT-TES as this model takes into account the complexity that any intervention in this context needs to consider in designing an intervention that is adaptable and scalable.

COVID-19 pandemic

The impact of the COVID-19 pandemic cannot be overstated as almost all aspects of the study were impacted by the disruption to clinical services (and the research team) caused by the COVID-19 pandemic. While the EDiPPPP study has generated a complex intervention, this has not been pilot tested, while components of it, the EEDAC and OREDAC tools, have undergone proof-of-concept testing. A pilot study testing the intervention, implemented by NHSBT-OTDT, is due to commence in March 2023.

Arranging PSC and PI meetings was especially challenging as everyone’s time was compromised. To make the best use of time, we developed all presentations as recorded presentations that were sent to PSC members ahead of all meetings so that they could review and prepare questions and comments beforehand. Meetings were limited to key agenda items and Q and A.

Methodology

An innovative, and what was initially proving to be an extremely informative, element of study design (participant observation in clinical sites) had to cease having taken place at only two sites due to restrictions in access across healthcare setting in the UK imposed by the COVID-19 pandemic. This was frustrating as those PIs who experienced an embedded researcher were very positive about this data collection method as it streamlined the identification of, recruitment to and undertaking of interviews and focus groups. Primarily, this method provided access to the context of care and practice facilitating independent observation of processes and the informational climate that became less visible to researchers as the study progressed.

Likewise, we are confident that the pressures on, and changes to working practices, experienced by HCPs contributed to the 8% response rate in the national survey. The fact that Hospice UK sent out the survey on their COVID hospice contact list (being accessed only by their COVID link) was a factor in low response and a learning note for future research. Despite this low response rate, the depth of information provided in the free-text option of the survey was indicative of HCPs making time to engage in questions about a topic that they see as an important element of their care provision.

Search strategy development

An initial search of PubMed was conducted using the terms ‘Eye [Medical Subject Heading (MeSH)] AND Tissue Donation [MeSH]’. The search was limited to articles published during or after the establishment of the UK Corneal Transplant service. Results (190 articles) did not include several key articles known to the review team, and therefore a set of 23 verified articles which met inclusion criteria (the development set) and were compiled and checked for indexing in PubMed. Of these, only five (28%) were retrieved by the initial search, and further exploration of PubMed indices was undertaken to identify reasons for non-retrieval and inform search strategy development.

Investigations revealed that 17 of 18 development set articles were not retrieved by the initial search as they were not indexed under the MeSH term ‘Eye [MeSH]’, despite six including eye-related terms in the title and/or abstract. The remainder contained eye-relevant material in the full text, but not in the title, abstract, keywords or other metadata visible to searches. As the lack of consistency in indexing of eye-related studies was found using MeSH terms, further searches only applied plain text and Boolean operators.

Final agreed search terms were repeated across five additional databases returning a total of 4322 records from all sources (see Table 2).