key: cord-0425632-guqi6xf9
authors: Gopal, B.; Titi-Lartey, O. A.; Fernandes, P.; Noubani, N.-E.; Blatherwick, E.; Said, D.; Dua, H. S.; Ting, D. S. J.
title: Evaluation of Junior Doctors Knowledge of Corneal Donation and the New Opt-Out System in England
date: 2021-03-08
journal: nan
DOI: 10.1101/2021.03.04.21252895
sha: 7bf9a0bde477833fc4a73c6691fb390c8adc3f91
doc_id: 425632
cord_uid: guqi6xf9

Objectives: To evaluate the knowledge of corneal donation and the new opt-out system among junior doctors in the East Midlands, UK. Methods: This was a cross-sectional study performed during June-September 2020. A 26-item questionnaire-based survey was disseminated to all 340 junior doctors working in the East Midlands, UK. Relevant data, including participants background, knowledge of corneal donation and the new opt-out system introduced in England, were analysed. Results: A total of 143 responses were received (response rate=42.1%). Nineteen (13.3%) junior doctors had previously discussed about corneal donation. The majority (100, 69.9%) of them perceived the importance of obtaining consent for corneal donation as junior doctors, but only 24 (16.8%) felt comfortable in discussing corneal donation. The knowledge of corneal donation was low, with a mean correct response rate of 33.3+/-20.8%. Only 28 (19.6%) doctors were aware of the 24-hour death-to-enucleation time limit. The majority (116, 81.1%) of doctors would consider certifying a death on the ward quicker if they knew it could potentially compromise the quality of corneas. Most (103, 72%) doctors were aware of the new opt-out system but only 56 (39.2%) doctors correctly stated that donation can only proceed with family consent. Conclusion: Junior doctors working at the frontline services serve as valuable members in contributing to the process of obtaining consent for organ/tissue donation. Our study highlights the lack of knowledge of corneal donation and the opt-out system amongst junior doctors in the UK. Targeted postgraduate training during the induction process may potentially enhance the donation rate.

According to the most recent WHO report, corneal blindness represents the 5 th leading cause of blindness and visual impairment globally, affecting around 6 million of the population. 1, 2 Any significant insult to the cornea, secondary to infection, trauma, degeneration, inflammation or nutritional deficiency, can potentially lead to irreversible corneal opacity, culminating in visual impairment and blindness. 2 Corneal transplantation or keratoplasty serves as the mainstay of treatment in restoring vision in patients affected by corneal opacity. 3 It is the most commonly performed transplantation worldwide, with >40000 cases and >3000 cases being performed annually in the US and the UK, respectively. 3 With the continual refinement in surgical techniques and understanding of the immunology in corneal transplantation, the long-term outcomes of corneal transplants have significantly improved in the recent decades. [4] [5] [6] However, the success of corneal transplantation has been persistently challenged by the global shortage of donor cornea tissues. This issue is further exacerbated by the recent COVID-19 pandemic due to the significant decrease in potential eye donors. 7 Gain et al. 8 recently conducted a global survey and reported that there was only 1 cornea available for 70 needed in the world, highlighting the need for increased effort in improving the eye donation rate and availability of donor corneas.

To date, a number of key barriers to corneal donation have been highlighted in the literature.

One of the most common issues is related to the concern of disfigurement following corneal donation. 9, 10 Another important barrier to corneal donation is the lack of awareness and knowledge of corneal donation amongst the general public. [10] [11] [12] In addition, staff may feel uncomfortable or unconfident in discussing corneal donation with the patients and the relatives. 13 To address the constant deficit of donor corneas, various countries have considered and implemented a range of initiatives and research programmes, including campaigns to increase public awareness of corneal donation, introduction of telephone . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint consent, refinement in the eye retrieval and eye banking systems, and development of corneal cell-based therapy. [14] [15] [16] [17] [18] On 20 th May 2020, England has implemented an opt-out system, also known as the Max and Keira's Law, with an aim to improve the rate of organ and tissue donation, 19 , 20 joining countries such as Spain, France and Italy, and many others. Under the new, soft opt-out system, all adults in England are now assumed to be willing organ and tissue donors unless they have registered their intent otherwise. However, the process of eye donation remains largely unchanged as consent from the family members of the decreased is still required before retrieval can proceed. Wales is currently operating on a "deemed consent" system, which is similar to an opt-out system, and Scotland is expected to implement the opt-out system in March 2021.

Junior doctors working at frontline services, particularly those who work in intensive care, oncology and palliative care units, may serve as valuable members to the multi-disciplinary team in contributing to the process of organ and tissue donations. Hakeem et al. 21 previously conducted an online survey assessing the knowledge of organ donation and transplantation among the junior doctors in the UK and demonstrated that 84% of the doctors felt inadequate in discussing organ and tissue donation with the potential donors or their family members. Nonetheless, the knowledge of corneal donation among junior doctors in the UK in the context of the recently introduced opt-out system and its impact has not been explored.

Our study aimed to evaluate the knowledge of corneal donation and the opt-out system among the junior doctors in the UK.

This was a cross-sectional study performed between 28 June 2020 and 29 September 2020.

A 26-item questionnaire-based survey, using an online platform (Google Forms), was distributed to the junior doctors / house officers (within the first 3 years of medical practice) . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) 

Statistical analysis was performed using SPSS version 26.0 (IBM SPSS Statistics for Windows, Armonk, NY, USA). All continuous data were presented as mean ± standard deviation (SD). Comparison between groups was conducted using Pearson's Chi square or

Fisher's Exact test where appropriate for categorical variables and unpaired T test or Mann-Whitney U test for continuous variables. A total of 13 questions were asked to evaluate the knowledge of corneal (and tissue) donation. For analytic purpose, junior doctors were divided into two groups based on the number of correct answers provided, namely <50% . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint correct response (i.e. 0-6 correct answers) and >50% correct response (i.e. 7-13 correct answers). P-value of <0.05 was considered statistically significant.

Of all 340 junior doctors, 143 survey responses were received, yielding a response rate of 42.1%. The majority of them were Foundation Year 1 doctors (83, 58.0%), followed by Foundation Year 2 doctors (50, 35%) and others (10, 7.0%; Table 1 ).

The amount of previous undergraduate teaching on ophthalmology was 11.4 ± 12.1 days 

The mean number of discussions of corneal donation held between the junior doctors and the potential donors or their family members was 0.2 ± 0.6 (ranged, 0-4), with the majority (124, 86.7%) of junior doctors having never held any discussion on corneal donation ( Table   2 ). However, 100 (69.9%) of them felt that it was important to know how to obtain consent for corneal donation as a junior doctor. Only 24 (16.8%) doctors felt comfortable in discussing corneal donation with the family members and only 6 (4.2%) junior doctors felt that they had received adequate undergraduate training to discuss corneal donation. The most common source of information on corneal donation was obtained from the internet (71, 49.7%), followed by undergraduate teaching (43, 30.1%) and health professionals (32, 22.4%).

. CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint

The knowledge of corneal (and tissue) donation, including 3 items on ocular conditions and 10 items on general health or systemic conditions, among the junior doctors is summarised in Figure 1 .

Overall, the mean correct response rate was 31.9 ± 20.4% (ranged, 0-76.9%). With regard to knowledge of ocular contraindications to corneal donation (3 items), the mean correct response rate was 33.3 ± 30.9 (ranged, 0-100%). Only <30% of the junior doctors knew that previous cataract surgery, glaucoma and macular diseases were not contraindications to corneal donation.

In terms of knowledge on general health or systemic conditions for corneal donation, the mean correct response rate was 42.2 ± 26.5 (ranged, 0-70.0%). The most common correct response was related to question on blood borne infections (90, 62.9%), followed by general health diseases such as diabetes and chronic obstructive pulmonary disease (67, 46.8%), death of unknown cause (37.8%), and haematological malignancies (37.8%). Only 28 (19.6%) and 51 (35.7%) junior doctors were correct about the 24-hour death-to-enucleation and the ideal 6-hour death-to-body chilling time limit (for tissue donation). Forty (28.0%) junior doctors were correct that there was no age limit for corneal donation.

The knowledge of corneal donation was not found to be significantly associated with the amount of undergraduate ophthalmology teaching (p=0.19), previous ophthalmology rotation (p=0.71), previous experience in discussing corneal donation (p=0.73), and willingness to donate their own corneas (p=0.16; Table 3 ).

The majority (103, 72%) of junior doctors were aware of the recently introduced opt-out organ and tissue donation system in England. In the event of family members refusing to . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) 

With regard to views on certifying death, 116 (81.1%) junior doctors would consider certifying a death on the ward quicker if they knew it could compromise the quality of corneas. 

To the best of our knowledge, this represents the first study examining the views and knowledge of corneal donation and the new opt-out system among junior doctors in the UK.

We observed that only 17% of the junior doctors felt comfortable in discussing corneal donation with the potential donors or their family members. This is likely related to the low amount of ophthalmology teaching provided during the undergraduate curriculum in the UK, as shown in our survey (a mean of 11.4 days) and previous studies. 23, 24 In addition, the lack of knowledge of corneal donation among the junior doctors, reflected by ~33% correct responses to the questions on eligibility for corneal donation, further affected their confidence and competence in discussing corneal donation with the family members.

Currently, in the UK, consent for corneal donation is primarily obtained by a team of welltrained, specialised nurses from the National Referral Centre (NRC) embedded within the NHSBT. This process takes place as soon as the death has been certified and notified to the NRC. Although junior doctors working at frontline services are not expected to obtain consent for corneal donation in the UK, they are the key multi-disciplinary members who have daily contact with the patients and potential organ/tissue donors and may therefore play an important role in the process of organ and tissue donations (see Figure 2 for the eye and tissue donation process in England). 25 In addition, junior doctors are usually the key members in discussing the advance directives such as "Do not attempt cardiopulmonary resuscitation (DNACPR)" with the family members. Therefore a successful relationship of trust has already been built throughout the process of care, which could improve the conversion rate of corneal donation. 26 Our study showed that around 13% of the junior doctors had been involved in the discussion of corneal donation with the family members, and this figure is likely to increase under the new opt-out system. Studies have shown that prior knowledge of corneal donation serves as an important factor in influencing the willingness of donating the corneas. 9, 27 Therefore, if an earlier discussion on corneal donation can be held between the junior doctors and potential donors or their family . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint members, the chances of corneal donation can be potentially improved when it comes to the stage of formal consenting by the NRC.

The National Health Service Blood and Transplant (NHSBT) has set a 24-hour cut-off interval between death and retrieval of donor corneas and the body should preferably be refrigerated. 22 For other tissues, it is also recommended that the body should be refrigerated within an ideal window of 6 hours after death and the procurement of tissues needs to be completed within 24-48 hours. 22 If not refrigerated, the tissues (excluding corneas) will then need to be retrieved within 12 hours of death due to the risk of tissue contamination. As the responsibility of certifying death often rests on the junior doctors, they play a vital role in determining the promptness in death certification and subsequent eye retrieval, which has an important influence on the suitability and quality of the donor corneas. 28 Patel et al. 29 demonstrated that, in the event of long death-to-enucleation interval (i.e. >12 hours), the quality of donor corneas such as endothelial cell density was better if the corneas were refrigerated. Another study similarly observed a positive effect of early body refrigeration on the transplant suitability of the donor corneas. 30 In the UK, the mean interval of death-to-enucleation was around 17-18 hours based on a previous North East England study. 15 Therefore junior doctors should be encouraged to ensure timely certification to allow for early refrigeration of the body to preserve the quality of tissues, including the donor corneal tissues. In our study, we demonstrated that only 20% and 36% of the junior doctors were aware of the 24-hour death-to-enucleation and the ideal 6-hour death-to-body refrigeration time limit, respectively. However, 81% of them would consider certifying deaths on the ward quicker if they knew the delay could potentially compromise the quality of tissues and corneas. 28 Therefore, it would be useful to improve the awareness of the tissue retrieval guideline among the junior doctors and relevant healthcare workers who are involved in the process of corneal donation.

. CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The UK currently operates on a 'soft opt-out' system whereby all adults are assumed to be organ and tissue donors. However, donation cannot be proceeded without the consent of family members of the deceased patient. Therefore, the implementation of an opt-out system . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted March 8, 2021. ; https://doi.org/10.1101/2021.03.04.21252895 doi: medRxiv preprint

Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis

Infectious keratitis: An update on epidemiology, causative microorganisms, risk factors, and antimicrobial resistance

Corneal transplantation

Immune reactions after modern lamellar (DALK, DSAEK, DMEK) versus conventional penetrating corneal transplantation

Changing trends in keratoplasty in the West of Scotland: a 10-year review

Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty

One threat, different answers: the impact of COVID-19 pandemic on cornea donation and donor selection across Europe

Eye donation in north India: Trends, awareness, influences and barriers

Attitudes and Perception Towards Eye Donation in Patients with Corneal Disease: A Case-controlled Population-based Study

Awareness and attitudes toward corneal donation: challenges and opportunities

Obstacles to corneal donation amongst hospice inpatients: a questionnaire survey of multi-disciplinary team member's attitudes, knowledge, practice and experience

Impact of telephone consent and potential for eye donation in the UK: the Newcastle Eye Centre study

Changing trend in the utilisation rate of donated corneas for keratoplasty in the UK: The North East England Study

Eye donation and eye banking in India

Rates of and Experiences with Corneal Donation at the University Hospital Tübingen From

Translational and Regulatory Challenges of Corneal Endothelial Cell Therapy: A Global Perspective

Organ donation: England will have "opt-out" system from

International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity

A Systematic Review of Opt-out Versus Opt-in Consent on Deceased Organ Donation and Transplantation (2006-2016)

An imperative need to change organ donation and transplant curriculum results of a nationwide United kingdom junior doctor survey

Ophthalmology teaching in medical schools: a survey in the UK

Undergraduate ophthalmology education -A survey of UK medical schools

Interprofessional collaboration among junior doctors and nurses in the hospital setting

Organ Donation as a Collective Action Problem: Ethical Considerations and Implications for Practice

Knowledge and attitudes toward corneal donation among Singaporean youth: a cross-sectional study

Factors that influence the suitability of human organ-cultured corneas

Study of death to preservation time and its impact on utilisation of donor corneas

Effect of Body Refrigeration Time on Cornea Donor Tissue