Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD)

Noemi Lois, Jonathan Cook, Stephen Aldington, Norman Waugh, Hema Mistry, William Sones, Danny McAuley, Tariq Aslam, Claire Bailey, Victor Chong, Faruque Ghanchi, Peter Scanlon, Sobha Sivaprasad, David Steel, Caroline Styles, Christine McNally, Rachael Rice, Lindsay Prior, Augusto Azuara-Blanco, EMERALD Study Group, Ahmed Saad, Augusto Azuara-Blanco, Caroline Styles, Christine Mcnally, Andrew Jackson, Rachael Rice, Clare Bailey, Danny Mcauley, David H Steel, Faruque D Ghanchi, Geeta Menon, Haralabos Eleftheriadis, Hema Mistry, Jonathan Cook, William Sones, Lindsay Prior, Nachiketa Acharya, Noemi Lois, Norman Waugh, Rachael Rice, Samia Fatum, Sobha Sivaprasad, Stephen Aldington, Peter H Scanlon, Tariq M Aslam, Victor Chong, Noemi Lois, Augusto Azuara-Blanco, Steve Aldington, Danny Mcauley, Peter Scanlon, Lindsay Prior, Clare Newall, Michelle Mcgaughey, Christine Mcnally, Rachael Rice, Andrew Jackson, Jonathan Cook, William Sones, Norman Waugh, Hema Mistry, Mark Wilson, Nuala Hannaway, Catherine Campbell, John Norrie, David Owens, Florence Findlay-White, Jonathan Cook, William Sones, Winfried Amoaku, Yemisi Takwoingi, Noemi Lois, Jonathan Cook, Stephen Aldington, Norman Waugh, Hema Mistry, William Sones, Danny McAuley, Tariq Aslam, Claire Bailey, Victor Chong, Faruque Ghanchi, Peter Scanlon, Sobha Sivaprasad, David Steel, Caroline Styles, Christine McNally, Rachael Rice, Lindsay Prior, Augusto Azuara-Blanco, EMERALD Study Group, Ahmed Saad, Augusto Azuara-Blanco, Caroline Styles, Christine Mcnally, Andrew Jackson, Rachael Rice, Clare Bailey, Danny Mcauley, David H Steel, Faruque D Ghanchi, Geeta Menon, Haralabos Eleftheriadis, Hema Mistry, Jonathan Cook, William Sones, Lindsay Prior, Nachiketa Acharya, Noemi Lois, Norman Waugh, Rachael Rice, Samia Fatum, Sobha Sivaprasad, Stephen Aldington, Peter H Scanlon, Tariq M Aslam, Victor Chong, Noemi Lois, Augusto Azuara-Blanco, Steve Aldington, Danny Mcauley, Peter Scanlon, Lindsay Prior, Clare Newall, Michelle Mcgaughey, Christine Mcnally, Rachael Rice, Andrew Jackson, Jonathan Cook, William Sones, Norman Waugh, Hema Mistry, Mark Wilson, Nuala Hannaway, Catherine Campbell, John Norrie, David Owens, Florence Findlay-White, Jonathan Cook, William Sones, Winfried Amoaku, Yemisi Takwoingi

Abstract

Introduction: Diabetic 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 analysis: Effectiveness 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 dissemination: Ethical 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 number: NCT03490318 and ISRCTN:10856638.

Keywords: diabetic retinopathy; health economics; medical retina; organisational development; public health; qualitative research.

Conflict of interest statement

Competing interests: NL, NW, AA-B, HM, DMcA, TA: none; CB: has been ad hoc advisor for Alcon, Bayer, Novartis, Alimera Sciences and Allergan; VC is a part-time employee of Boehringer Ingelheim International GmBH (BII), Germany; this study, however, is not being undertaken as part of the employment with BII and, thus, the content of this manuscript is not endorsed by BII. VC has also received speaker fees from Quantel Medical, France; SS has received research grants, travel feeds and attended advisory board meetings of Novartis, Bayer, Roche, Allergan, Heidelberg Engineering, Optos and Boehringer Ingelheim; DS acted as consultant to Alcon, attended advisory boards for Novartis and Bayer and received research funding from Bayer and Alcon. PS has attended Advisory Boards for Allergan, Roche, Boehringer and Bayer; his department has received Educational, Research or Audit Grants from Allergan, Novartis and Bayer.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Summary of ophthalmic grader pathway. DMO, diabetic macular oedema; PDR, proliferative diabetic retinopathy; SD-OCT, spectral domain optical coherence tomography.
Figure 2
Figure 2
Study flow chart. DMO, diabetic macular oedema; ETDRS, early treatment diabetic retinopaty study; PDR, proliferative diabetic retinopathy; OCT, optical coherence tomography.

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