The potential for eye donation from hospice and palliative care clinical settings in England: a retrospective case note review of deceased patients' records

There is a need to identify additional routes of supply for ophthalmic tissue in the UK. This paper reports the findings from a national study exploring the potential for eye donation (ED) from three Hospice Care (HC) and three Hospital Palliative Care Services (HPC) in England. The objectives addressed in this paper are i.) to establish the size and describe the clinical characteristics of the potential eye donor population across six clinical sites; ii.) to identify challenges for clinicians in applying the standard ED criteria for assessing patient eligibility. Retrospective assessment of 1199 deceased patient case notes, 601 Hospice Care and 598 Hospital Palliative Care services, against current eye donation criteria. Clinicians’ assessments were then evaluated against the same criteria. by specialists based at the National Health Service Blood and Transplant Tissue Services division (NHSBT-TS). Results of the assessment and evaluation are reported as descriptive statistics (numerical data). Free-text comment boxes facilitated clarification and/or justification of review and evaluation decisions. 46% (n = 553) of 1199 deceased patients’ notes were agreed as eligible for eye donation (Hospice care settings = 56% (n = 337); Palliative care settings = 36% (n = 216). For all eligible cases (n = 553) the option of ED was recorded as being raised with family members in only 14 cases (3%). Significant potential exists for eye donation from the clinical sites in this study. This potential is not currently being realised.

criteria. Clinicians' assessments were then evaluated against the same criteria. by specialists based at the National Health Service Blood and Transplant Tissue Services division (NHSBT-TS). Results of the assessment and evaluation are reported as descriptive statistics (numerical data). Free-text comment boxes facilitated clarification and/or justification of review and evaluation decisions. 46% (n = 553) of 1199 deceased patients' notes were agreed as eligible for eye donation (Hospice care settings = 56% (n = 337); Palliative care settings = 36% (n = 216). For all eligible cases (n = 553) the option of ED was recorded as being raised with family members in only 14 cases (3%). Significant potential exists for eye donation from the Abstract There is a need to identify additional routes of supply for ophthalmic tissue in the UK. This paper reports the findings from a national study exploring the potential for eye donation (ED) from three Hospice Care (HC) and three Hospital Palliative Care Services (HPC) in England. The objectives addressed in this paper are i.) to establish the size and describe the clinical characteristics of the potential eye donor population across six clinical sites; ii.) to identify challenges for clinicians in applying the standard ED criteria for assessing patient eligibility. Retrospective assessment of 1199 deceased patient case notes, 601 Hospice Care and 598 Hospital Palliative Care services, against current eye donation

Introduction
The need for corneal tissue-global and UK contexts Globally, the estimated number of people who are visually impaired is reported (by WHO databases) to be 285 million, with 39 million individuals recorded as blind, and 246 million recorded as having low vision (Pascolini and Mariotti 2012). According to authors Pascolini and Mariotti (2012) over 10 million of those people reported as blind have bilateral corneal blindness, which could be restored with a corneal transplant, however these individuals do not have access to the benefits of sight saving and sight restoring transplantation surgery due to a short fall in the supply of ophthalmic tissue (cornea and sclera) that is only available via eye donation (ED).
According to the Royal National Institute of Blind (RNIB), over two million people in the UK are living with sight loss (RNIB & Specsavers 2016) caused by conditions such as Keratoconus and Fuchs' Corneal Dystrophy, which can be treated if eye tissue is available (e.g. by corneal transplantation and reconstructive surgery). Eye tissue is also needed for research into a wide variety of eye diseases, for example, endothelial failure post cataract surgery (Pascolini and Mariotti 2012; Gain et al. 2016). The RNIB reports that approximately 5000 corneal transplants are required annually in the UK to address disease and injury resulting in sight loss, with costs to the UK economy (unpaid carer burden and reduced employment rates) reported as £4.34 billion annually (RNIB & Specsavers 2016). Critically, this organisation predicts that by 2050, the number of people with sight loss will double to nearly four million.(RNIB & Specsavers 2016) It is, therefore, imperative that the tissue needed to intervene in these conditions via corneal transplantation, reconstructive surgery, glaucoma surgery and research into the causes and treatment of eye disease is available.

The unique and specific case of eye donation (ED)
Addressing barriers to ED require attention to the unique and specific challenges that are associated with this specific form of donation; for example, why do family members of organ donors frequently reject ED despite agreeing to other organs (and tissues)? Data from UK-based studies over the past five years indicate that personal views of potential donors and family decision makers are influential in triggering a decline when ED is proposed (Bracher et al. 2021). Prominent concerns include potential for disfigurement (Lawlor and Kerridge 2011), beliefs compatible with eyes being needed in the afterlife, and/or that eyes as 'windows to the soul' are an essential aspect of a person even after death (Lawlor and Kerridge 2014). Eye donation is also known to elicit specific disgust-type responses in some patients and family members, characterised as an 'ick factor' attended by feelings of squeamishness in respondents (O'Carroll et al. 2011), that is not observed in other forms of donation.

Optimising the supply of ophthalmic tissue for use in sigh-saving and sight restoring surgery and medical research
The National Health Services Blood and Transplant (NHS BT) Tissue and Eye Services (TES) Bank in Speke, Liverpool, which supplies most but not all eyes for surgical purposes in the UK, aims to achieve a weekly stock of 350 eyes so that they can provide 70 eyes every working day for use in surgery or research. From April 2021 -March 2022 donation of eyes from all sources (solid organ donation, tissue donation) generated 4555 eyes from 2286 donors (National health Service Blood and Transplants 2021) equating to only 13 eyes per day and 88 eyes available per week. These levels are not supplying sufficient tissue necessary for the 5000 corneal transplants required each year for conditions such as Keratoconus, Fuchs' Corneal Dystrophy and endothelial failure post cataract surgery (Gaum et al. 2012). The actual number of people waiting for a corneal transplant is difficult to confirm as there is no centralised waiting list for patients who need a corneal transplant (unlike in solid organ donation where there is a centralised waiting list, and the actual need may therefore be greater.
A further pressure on the nationally reported donation rate of 4555 eyes is that approximately 30% of donated eyes will be discarded due to infection/ viruses, with supply further compromised by a 28-day limit to storage requiring disposal of tissue thereafter.

Current UK routes of ophthalmic tissue supply
There are currently two potential routes of supply for eye tissue in the UK: Route 1: Eye donation from solid organ donors-Eye donation from solid organ donors (EPSOD) continues to prove problematic, with slow progress in increasing supply from this specific cohort of donors. For example, EPSOD generated 446 eyes between 1 April 2019 and 31 March 2020 (NHSBT 2020).
Route 2: Eye donation from deaths outside of ICU/ED environments-Unlike tissues such as heart valves, bone, tendons, and skin (where a cancer diagnosis is a contraindication) eye tissue can be considered for donation due to the avascular status of the cornea. Current data indicates that approx. 258,900 deaths in hospital (Office for National Statistics 2021) and 25,498 annual deaths in hospices (Office for Health Improvement and Disparities, 2020), could potentially supply eye tissue. However, from April 2021 to March 2022 NHSBT TES only received 443 referrals from 63 hospice locations with 293 of those referrals generating eyes. Therefore, on average, these 63 hospices referred seven donors to NHSBT TES. As there are 208 hospices across the UK, there is great room for improvement. Increasing supply is a key strategic aim for NHSBT TES with other professional bodies including the Royal College of Ophthalmology (Royal College of Ophthalmologists 2013), NHSBT TES OtAG (NHS-BT Organ and Tissue Advisory Group (OTAG), expressing the need for research into the barriers to eye donation and new supply routes.

Data collection
Eligibility for eye donation was assessed against criteria specified by NHSBT-TES (see Table 1) that constitute a list of contraindications barring the use of eye tissue in transplant operations. Our intention was for reviewers (clinical co-applicants) to assess patients against the ED criteria, and for members of the clinical support team at NHSBT TES to evaluate the assessments and confirm whether the patient was 'eligible', 'ineligible', or 'uncertain', for ED. Using this methodology, we could illustrate the 'actual' potential for ED in each research site. Each clinical principal investigator (CPI) (JS, CF, CR, SM, AH, JW) was asked to assess 200 deceased patient notes from their site, from the previous two years against these criteria. Clinical principal investigators completed a data collection proforma in Microsoft Excel. Proformas incorporated both closed responses and free-text (written) options. Free-text options aimed to identify contraindications that were particularly challenging for CPIs to assess with respect to ED eligibility (and thereby identify areas potential information and/or training needs). Clinical principal investigators then returned completed proformas to the study team (MJB) for missing data checks.

Data analysis
Proformas submitted to the study team (MJB) were then circulated for evaluation by specialist colleagues NHSBT Tissue Services (MB and JJ), using an evaluation proforma developed by the team (also completed using Microsoft Excel). 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 assessment, 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 population and review completion characteristics
Clinical principal investigators at the six clinical sites (three Hospice Care (HC) and three Hospital Palliative Care (HPC) sites completed retrospective note review of 1199 deceased patients' notes for patients who had died between February 2019-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), and HPC median deaths per year was 513 (range = 250-1984). Notes review assessment was completed between January 2020-March 2021, with evaluation taking place between March 2020-August 2021. The mean time required for review was 21.3 min per case (SD = 45.4, range = 12.5-27).

Results deceased patient note review
Agreement rate on eligibility for referral to NHSBT-TES The total agreement rate (where assessor and evaluator made the same decision), whether eligible, ineligible, or uncertain re eligibility for potential eye donation was 81% (n = 972 of 1199 total case. Differences in outcome of eligibility assessments between assessors 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 note reviewed in HC settings the agreement rate was 79%, (n = 475 cases) and of the 598 deceased patients' notes reviewed in HPC settings the agreement rate was 83%, (n = 497).

Potential for ED
Forty six percent (n = 553) of all deceased patients' notes were agreed by assessor and evaluator as eligible for ED. Twenty-four percent (n = 289) of patients' notes were agreed as ineligible and 11% (n = 130) were logged as uncertain (assessor and evaluator agreed that further information would be needed to determine eligibility).

Record of request for ED, 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%). Approaches to family members to discuss ED was recorded in only 13 cases (2%). Referral to NHSBT -TES for ED was recorded in 14 cases (3% of all cases) with 11 cases recorded for HC (3%) and three cases (1%) for HPC settings.

Differences in assessemnt for potential eye donors from HC and HPC settings from retrospective note review
This section describes numbers and types of differing assessments between clinical assessors and evaluators as a basis for identifying and clarifying the information support needs of HC and HPC staff, in assessing eligibility for ED via clinical records. Differences in outcome of eligibility assessments between assessors and evaluators occurred in 19% (n = 227/1199) of cases.

Differences in assessment 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 sub-sections describe types of difference in assessment outcome.

Differences in assessment outcome where the reviewer determined eligibility for referral
Of all cases, 34 (15% of total differences in assessment) involved clinical assessors determining eligibility, while the evaluator determined ineligibility or uncertainty. Of these cases, the majority (n = 28) involved miscellaneous reasons (e.g., 'active ocular infection', 'Raynauds Syndrome') assessed as not being contraindications for ED by the clinical assessor but assessed as such by the evaluator.

Differences in assessment outcome where the reviewer determined ineligibility for referral
Forty-three percent (n = 97) of differences in assessment outcome for all cases involved clinical assessors determining 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. 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% (n = 26) of further cases in this category the clinical assessor had assessed the patients 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 clinicians indicating 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).