1. Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema and new vesseLs in Diabetic retinopathy (EMERALD)
- Author
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Lois, N, Cook, J, Aldington, S, Waugh, N, Mistry, H, Sones, W, McAuley, D, Aslam, T, Bailey, C, Chong, V, Ghanchi, F, Scanlon, P, Sivaprasad, S, Steel, D, Styles, C, McNally, C, Rice, R, Prior, L, Azuara-Blanco, A, and Group, Emerald Study
- Subjects
Cost-Benefit Analysis ,Multimodal Imaging ,0302 clinical medicine ,Protocol ,Multicenter Studies as Topic ,Medicine ,health economics ,Prospective Studies ,Fluorescein Angiography ,medical retina ,Medicine(all) ,organisational development ,030503 health policy & services ,public health ,Health technology ,Workload ,General Medicine ,Diabetic retinopathy ,Middle Aged ,diabetic retinopathy ,Evaluation Studies as Topic ,0305 other medical science ,Tomography, Optical Coherence ,Papilledema ,Adult ,medicine.medical_specialty ,Adolescent ,education ,Young Adult ,03 medical and health sciences ,SDG 3 - Good Health and Well-being ,Diabetes mellitus ,Humans ,Intensive care medicine ,Aged ,Multimodal imaging ,Research ethics ,Diabetic Retinopathy ,Health economics ,business.industry ,Public health ,RA645.D54 ,medicine.disease ,Ophthalmology ,Cross-Sectional Studies ,Diabetes Mellitus, Type 1 ,Diabetes Mellitus, Type 2 ,030221 ophthalmology & optometry ,RE ,business ,qualitative research - Abstract
IntroductionDiabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) are the major causes of sight loss in people with diabetes. Due to the increased prevalence of diabetes, the workload related to these complications is increasing making it difficult for Hospital Eye Services (HSE) to meet demands.Methods and analysisEffectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD) is a prospective, case-referent, cross-sectional diagnostic study. It aims at determining the diagnostic performance, cost-effectiveness and acceptability of a new form of surveillance for people with stable DMO and/or PDR, which entails multimodal imaging and image review by an ophthalmic grader, using the current standard of care (evaluation of patients in clinic by an ophthalmologist) as the reference standard. If safe, cost-effective and acceptable, this pathway could help HES by freeing ophthalmologist time. The primary outcome of EMERALD is sensitivity of the new surveillance pathway in detecting active DMO/PDR. Secondary outcomes include specificity, agreement between new and the standard care pathway, positive and negative likelihood ratios, cost-effectiveness, acceptability, proportion of patients requiring subsequent full clinical assessment, unable to undergo imaging, with inadequate quality images or indeterminate findings.Ethics and disseminationEthical approval was obtained for this study from the Office for Research Ethics Committees Northern Ireland (reference 17/NI/0124). Study results will be published as a Health Technology Assessment monograph, in peer-reviewed national and international journals and presented at national/international conferences and to patient groups.Trial registration numberNCT03490318andISRCTN10856638.
- Published
- 2019