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Ophthalmology
Protocol
Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD)
  1. Noemi Lois1,
  2. Jonathan Cook2,
  3. Stephen Aldington3,
  4. Norman Waugh4,
  5. Hema Mistry4,
  6. William Sones5,
  7. Danny McAuley6,
  8. Tariq Aslam7,
  9. Claire Bailey8,
  10. Victor Chong9,
  11. Faruque Ghanchi10,
  12. Peter Scanlon11,
  13. Sobha Sivaprasad12,
  14. David Steel13,14,
  15. Caroline Styles15,
  16. Christine McNally16,
  17. Rachael Rice16,
  18. Lindsay Prior17,
  19. Augusto Azuara-Blanco18
  20. On behalf of the EMERALD Study Group
    1. 1 Ophthalmology, Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University, Belfast, UK
    2. 2 NDORMS, University of Oxford, Oxford, UK
    3. 3 Gloucester Hospitals NHS Foundation Trust, Gloucester, UK
    4. 4 The Division of Health Sciences, University of Warwick, Warwick, UK
    5. 5 NDORMS, University of Oxford, Oxford, UK
    6. 6 Wellcome-Wolfson Institute for Experimental Medicine, Queens University, Belfast, UK
    7. 7 The Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
    8. 8 Ophthalmology Department, Bristol Eye Hospital, Bristol, UK
    9. 9 Ophthalmology, Royal Free Hospital NHS Foundation Trust, London, UK
    10. 10 Ophthalmology, Bradford Royal Infirmary, Bradford, West Yorkshire, UK
    11. 11 Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK
    12. 12 NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, London
    13. 13 Sunderland Eye Infirmary, Sunderland, UK
    14. 14 Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK
    15. 15 Ophthalmology, Queen Margaret Hospital, Fife, UK
    16. 16 Northern Ireland Clinical Trials Unit, Belfast, UK
    17. 17 Queen’s University Belfast, Belfast, UK
    18. 18 Centre for Public Health, Queen’s University, Belfast, UK
    1. Correspondence to Prof. Noemi Lois; n.lois{at}qub.ac.uk

    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 ISRCTN10856638.

    • diabetic retinopathy
    • health economics
    • medical retina
    • public health
    • qualitative research
    • organisational development

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjopen-2018-027795

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      Footnotes

      • Contributors NL conceived the study and drafted the protocol which was refined with input from JC, SA, NW, HM, WS, DMcA, TA, CB, VC, FG, PS, SS, DS, CS, LP and AA-B; JC and NL determined the sample size for the study and JC, WS and NL determined the statistical analysis plan. NW and HM planned the cost-effectiveness evaluation. LP designed and planned the focus group discussions and will carry them out. CM, RR and AJ provided management coordination and data management to the study. NL, AS, CB, DS, FG, GM, HE, NA, SF, SS, SA, PHS, TA will recruit and evaluate patients for the study. All authors reviewed the manuscript, provided input to it and approved the final submitted version.

      • Funding This project was funded by the NIHR (Health Technology Assessment programme) (project number 13/142/04).

      • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Neither the Sponsor nor the Funder had any role on the study design; collection, management, analysis and interpretation of data; writing of this manuscript or in the decision to submit this manuscript for publication.

      • 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.

      • Ethics approval Ethics approval was obtained from the Office for Research Ethics Committees Northern Ireland (ORECNI-17/NI/0124).

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators EMERALD Study Group: Ahmed Saad, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust; Augusto Azuara-Blanco, Queen’s University and Royal Victoria Hospital, Belfast H&SC Trust; Caroline Styles, Queen’s Margaret Hospital, Fife; Christine McNally, Andrew Jackson and Rachael Rice, Northern Ireland Clinical Trials Unit; Clare Bailey, Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust; Danny McAuley, Queen’s University and Royal Victoria Hospital, Belfast H&SC Trust; David H Steel, Sunderland Eye Infirmary, City Hospitals Sunderland NHS Foundation Trust; Faruque D Ghanchi, Bradford Teaching Hospitals NHS Trust; Geeta Menon, Frimley Park Hospital NHS Foundation Trust; Haralabos Eleftheriadis, Kings College Hospital NHS Foundation Trust; Hema Mistry, Warwick University; Jonathan Cook and William Sones, Centre for Statistics in Medicine, University of Oxford; Lindsay Prior, Centre for Public Health, Queens University, Belfast; Nachiketa Acharya, Sheffield Teaching Hospitals NHS Foundation Trust; Noemi Lois, Queen’s University and Royal Victoria Hospital Belfast H&SC Trust; Norman Waugh, Warwick University; Rachael Rice, Northern Ireland Clinical Trials Unit; Samia Fatum, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust; Sobha Sivaprasad, Moorfields Eye Hospital NHS Foundation Trust; Stephen Aldington and Peter H Scanlon, Gloucestershire Hospitals NHS Foundation Trust; Tariq M Aslam, Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust; Victor Chong, Royal Free Hospital NHS Foundation Trust, London. Clinical sites participating in recruitment: The Belfast Health and Social Care Trust, Belfast, Northern Ireland; Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation Trust; Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust; Frimley Park Hospital NHS Foundation Trust; Gloucestershire Royal Hospital, Gloucestershire Hospitals NHSF Trust; James Cook University Hospital, South Tees Hospitals NHS Foundation Trust;Kings College Hospital NHS Foundation Trust; Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust; Moorfields Eye Hospital NHS Foundation Trust; John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust; Queen Margaret Hospital, Fife; Sheffield Teaching Hospitals NHS Foundation Trust; Sunderland Eye Infirmary, City Hospitals Sunderland NHS Foundation Trust. EMERALD is currently recruiting. The first trial participant was recruited in October 2017. Trial Management Group: Professor Noemi Lois (Chief Investigator), Professor Augusto Azuara-Blanco, Mr Steve Aldington, Dr Danny McAuley, Mr Peter Scanlon, Mr Lindsay Prior, Mrs Clare Newall, Mrs Michelle McGaughey, Mrs Christine McNally, Miss Rachael Rice, Mr Andrew Jackson, Mr Jonathan Cook, Mr William Sones, Professor Norman Waugh, Dr Hema Mistry, Mr Mark Wilson, Mrs Nuala Hannaway, Mrs Catherine Campbell. Trial Steering Committee: Mr John Norrie (Chair); Mr David Owens; Mrs Florence Findlay-White; Mr Winfried Amoaku; Miss Yemisi Takwoingi. The roles and responsibilities of the TSC can be found in https://www.nihr.ac.uk/funding-and-support/documents/funding-for-research-studies/how-to-apply/NETSCC_Project_Oversight_Groups_Guidance.pdf. A study Data and Ethics Monitoring Committee was not deemed necessary given the extremely low risk of this diagnostic study. Trial Sponsor: The Belfast Health and Social Care Trust, Belfast, Northern Ireland. Contact person: Ms Alison Murphy; alison.murphy@belfasttrust.hscni.net.

      • Author note Authorship policy: An author is considered someone who has made a substantive intellectual contribution to the study and the relevant report.

      • Patient consent for publication Not required.