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The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trialThe research team at the two participating sites will approach patients with severe DED for this study. Recruitment will take place over 12 months and we expect to recruit 60 patients in total. The primary outcome of this feasibility study is to estimate the proportion of eligible patients approached who consent to and comply with study procedures including treatment regimen and completion of required questionnaires. The secondary outcome measures, although not powered for in this feasibility, include corneal inflammation (assessed by the Oxford corneal staining guide), patient pain and symptoms scores (assessed by the Ocular Surface Disease Index Score), and objective signs of DED as indicated by visual acuity (assessed by Schirmer's test, tear break-up time, lower and/or upper tear meniscus height measurement). Other secondary outcomes include patients' quality of life (assessed using the validated EQ-5D-5L Questionnaire), cost to the National Health Service (NHS) and patient (assessed via use of NHS services and privately purchased over-the-counter treatment related to DED) and safety measure of pressure within the eye (assessed by the Intraocular Pressure (IOP) Score). This protocol and any subsequent amendments, along with any accompanying material provided to the participant in addition to any advertising material used in this trial have been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference: 17/EE/0508). Written approval from the committee was obtained and subsequently submitted to the respective Trust's Research and Development (R&D) office with final NHS R&D approval obtained. Data obtained from this study will be published in a suitable peer-review journal and will also presented at international ophthalmic conferences including the American Academy of Ophthalmology, the Royal College of Ophthalmology Annual Congress, the Association for Research and Vision and Ophthalmology, and the European Society of Cataract and Refractive Surgery. Information will be provided to patient groups and charities such as the Sjogren's Society and the Royal National Institute of Blind People. This will also be shared with the study participants as well as with relevant patient groups and charities. NCT03395431; Pre-results. Patients with severe dry eye disease (DED) often have limited treatment options with standard non-surgical management focused on the use of artificial tears for lubrication and anti-inflammatory drugs. However, artificial tears do not address the extraordinary complexity of human tears. Crudely, human tears with its vast constituents is essentially filtered blood. Blood and several blood-derived products including autologous serum, have been studied as tear substitutes. This study proposes to test the use of whole, fresh, autologous blood obtained from a finger prick for treatment of severe DED. METHODS AND ANALYSIS ETHICS AND DISSEMINATION TRIAL REGISTRATION NUMBER INTRODUCTION
Time, timing, talking and training: findings from an exploratory action research study to improve quality of end of life care for minority ethnic kidney patientsBackground. With an ageing and increasingly diverse population at risk from rising levels of obesity, diabetes and cardiovascular disease, including kidney complications, there is a need to provide quality care at all stages in the care pathway including at the end of life and to all patients. Aim. This study purposively explored South Asian patients’ experiences of kidney end of life care to understand how services can be delivered in a way that meets diverse patient needs. Methods. Within an action research design 14 focus groups (45 care providers) of kidney care providers discussed the recruitment and analysis of individual interviews with 16 South Asian kidney patients (eight men, eight women). Emergent themes from the focus groups were analysed thematically. The research took place at four UK centres providing kidney care to diverse populations: West London, Luton, Leicester and Bradford. Results. Key themes related to time and the timing of discussions about end of life care and the factors that place limitations on patients and providers in talking about end of life care. Lack of time and confidence of nurses in areas of kidney care, individual attitudes and workforce composition influence whether and how patients have access to end of life care through kidney services. Conclusion. Training, team work and time to discuss overarching issues (including timing and communication about end of life) with colleagues could support service providers to facilitate access and delivery of end of life care to this group of patients.