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Evaluation of a new model of care for people with complications of diabetic retinopathy : The EMERALD Study
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EMERALD Study Group (Including: Lois, Noemi, Cook, Jonathan A., Wang, Ariel, Aldington, Stephen, Mistry, Hema, Maredza, Mandy, McAuley, Danny, Aslam, Tariq, Bailey, Clare, Chong, Victor, Ganchi, Faruque, Scanlon, Peter, Sivaprasad, Sobha, Steel, David H., Styles, Caroline, Azuara-Blanco, Augusto, Prior, Lindsay and Waugh, Norman). (2021) Evaluation of a new model of care for people with complications of diabetic retinopathy : The EMERALD Study. Ophthalmology, 128 (4). pp. 561-573. doi:10.1016/j.ophtha.2020.10.030
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WRAP-Evaluation-new-model-care-people-complications-diabetic-Mistry-2020.pdf - Accepted Version - Requires a PDF viewer. Available under License Creative Commons Attribution Non-commercial No Derivatives 4.0. Download (1176Kb) | Preview |
Official URL: https://doi.org/10.1016/j.ophtha.2020.10.030
Abstract
Objectives
The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]), which require frequent and life-long follow-up, have markedly increased hospital demands. Resulting delays in the evaluation/treatment of patients are leading to sight loss. Strategies to increase capacity of medical retina clinics are urgently needed. EMERALD tested diagnostic accuracy, acceptability and costs of a new health care pathway for people with previously treated DME/PDR.
Design
Prospective, multicentric, case-referent, cross-sectional, diagnostic accuracy study, undertaken in 13 hospitals in the United Kingdom.
Participants
Adults with type 1 or 2 diabetes and previously successfully treated DME/PDR who, at the time of enrolment, had active or inactive disease.
Methods
A new health care pathway entailing multimodal imaging (spectral domain optical coherence tomography [SD-OCT] for DME, and 7-field Early Treatment Diabetic Retinopathy Study [ETDRS] and ultra-wide-field fundus images [UWF] for PDR) interpreted by trained non-medical staff (ophthalmic graders) to detect re-activation of disease was compared with the current standard care (ophthalmologists face-to-face examination).
Main outcome measures
Primary outcome: sensitivity of the new pathway. Secondary outcomes: specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, with inadequate images/indeterminate findings.
Results
The new pathway had sensitivity of 97% (95% confidence interval [CI] 92-99%) and specificity of 31% (95% CI 23-40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS (85%, 95% CI 77-91%; 48%; 95% CI 41-56%, respectively) or UWF (83%, 95% CI 75-89%; 54%; 95% CI 46-61%, respectively) were comparable. For detection of high risk PDR sensitivity and specificity were higher when using UWF images (87%, 95% CI 78-93%; 49% 95% CI 42-56%, respectively for UWF, versus 80%, 95% CI 69-88%; 40% CI 34-47%, respectively, for 7-field ETDRS). Participants preferred ophthalmologist’s assessments; in their absence, wished immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard care, the new pathway could save £1,390/100 DME visits and between £461-£1,189/100 PDR visits.
Conclusion
The new ophthalmic grader pathway has acceptable sensitivity and would release resources. Users’ suggestions should guide implementation
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > RC Internal medicine R Medicine > RD Surgery R Medicine > RE Ophthalmology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
| Library of Congress Subject Headings (LCSH): | Diabetes -- Complications -- Treatment, Diabetes -- Complications -- Diagnosis, Surgical clinics | ||||||||
| Journal or Publication Title: | Ophthalmology | ||||||||
| Publisher: | Elsevier Inc. | ||||||||
| ISSN: | 0161-6420 | ||||||||
| Official Date: | April 2021 | ||||||||
| Dates: |
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| Volume: | 128 | ||||||||
| Number: | 4 | ||||||||
| Page Range: | pp. 561-573 | ||||||||
| DOI: | 10.1016/j.ophtha.2020.10.030 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access | ||||||||
| RIOXX Funder/Project Grant: |
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