Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study
Background: Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands. Objective: The objective was to evaluate the diagnostic performance, cost-effec...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2021-05-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta25320 |
| _version_ | 1818730870129819648 |
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| author | Noemi Lois Jonathan Cook Ariel Wang Stephen Aldington Hema Mistry Mandy Maredza Danny McAuley Tariq Aslam Clare Bailey Victor Chong Faruque Ghanchi Peter Scanlon Sobha Sivaprasad David Steel Caroline Styles Augusto Azuara-Blanco Lindsay Prior Norman Waugh |
| author_facet | Noemi Lois Jonathan Cook Ariel Wang Stephen Aldington Hema Mistry Mandy Maredza Danny McAuley Tariq Aslam Clare Bailey Victor Chong Faruque Ghanchi Peter Scanlon Sobha Sivaprasad David Steel Caroline Styles Augusto Azuara-Blanco Lindsay Prior Norman Waugh |
| author_sort | Noemi Lois |
| collection | DOAJ |
| description | Background: Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands. Objective: The objective was to evaluate the diagnostic performance, cost-effectiveness and acceptability of a new pathway using multimodal imaging interpreted by ophthalmic graders to detect reactivation of diabetic macular oedema/proliferative diabetic retinopathy in previously treated patients. Design: This was a prospective, case-referent, cross-sectional diagnostic study. Setting: The setting was ophthalmic clinics in 13 NHS hospitals. Participants: Adults with type 1 or type 2 diabetes with previously successfully treated diabetic macular oedema/proliferative diabetic retinopathy in one/both eyes in whom, at the time of enrolment, diabetic macular oedema/proliferative diabetic retinopathy could be active or inactive. Methods: For the ophthalmic grader pathway, review of the spectral domain optical coherence tomography scans to detect diabetic macular oedema, and seven-field Early Treatment Diabetic Retinopathy Study/ultra-wide field fundus images to detect proliferative diabetic retinopathy, by trained ophthalmic graders. For the current standard care pathway (reference standard), ophthalmologists examined patients face to face by slit-lamp biomicroscopy for proliferative diabetic retinopathy and, in addition, spectral domain optical coherence tomography imaging for diabetic macular oedema. Outcome measures: The primary outcome measure was sensitivity of the ophthalmic grader pathway to detect active diabetic macular oedema/proliferative diabetic retinopathy. The secondary outcomes were specificity, agreement between pathways, cost–consequences, acceptability and the proportion of patients requiring subsequent ophthalmologist assessment, unable to undergo imaging and with inadequate quality images/indeterminate findings. It was assumed for the main analysis that all patients in whom graders diagnosed active disease or were ‘unsure’ or images were ‘ungradable’ required examination by an ophthalmologist. Results: Eligible participants with active and inactive diabetic macular oedema (152 and 120 participants, respectively) and active and inactive proliferative diabetic retinopathy (111 and 170 participants, respectively) were recruited. Under the main analysis, graders had a sensitivity of 97% (142/147) (95% confidence interval 92% to 99%) and specificity of 31% (35/113) (95% confidence interval 23% to 40%) to detect diabetic macular oedema. For proliferative diabetic retinopathy, graders had a similar sensitivity and specificity using seven-field Early Treatment Diabetic Retinopathy Study [sensitivity 85% (87/102), 95% confidence interval 77% to 91%; specificity 48% (77/160), 95% confidence interval 41% to 56%] or ultra-wide field imaging [sensitivity 83% (87/105), 95% confidence interval 75% to 89%; specificity 54% (86/160), 95% confidence interval 46% to 61%]. Participants attending focus groups expressed preference for face-to-face evaluations by ophthalmologists. In the ophthalmologists’ absence, patients voiced the need for immediate feedback following grader’s assessments, maintaining periodic evaluations by ophthalmologists. Graders and ophthalmologists were supportive of the new pathway. When compared with the reference standard (current standard pathway), the new grader pathway could save £1390 per 100 patients in the review of people with diabetic macular oedema and, depending on the imaging modality used, between £461 and £1189 per 100 patients in the review of people with proliferative diabetic retinopathy. Conclusions: For people with diabetic macular oedema, the ophthalmic grader pathway appears safe and cost saving. The sensitivity of the new pathway to detect active proliferative diabetic retinopathy was lower, but may still be considered acceptable for patients with proliferative diabetic retinopathy previously treated with laser. Suggestions from focus group discussions should be taken into consideration if the new pathway is introduced to ensure its acceptability to users. Limitations: Lack of fundus fluorescein angiography to confirm diagnosis of active proliferative diabetic retinopathy. Future work: Could refinement of the new pathway increase its sensitivity to detect proliferative diabetic retinopathy? Could artificial intelligence be used for automated reading of images in this previously treated population? Trial registration: Current Controlled Trials ISRCTN10856638 and ClinicalTrials.gov NCT03490318. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 32. See the NIHR Journals Library website for further project information. |
| first_indexed | 2024-12-17T23:08:39Z |
| format | Article |
| id | doaj.art-3be2a88fc6be41d99a1f0bdbacc990f2 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-17T23:08:39Z |
| publishDate | 2021-05-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-3be2a88fc6be41d99a1f0bdbacc990f22022-12-21T21:29:11ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242021-05-01253210.3310/hta2532015/42/08Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy studyNoemi Lois0Jonathan Cook1Ariel Wang2Stephen Aldington3Hema Mistry4Mandy Maredza5Danny McAuley6Tariq Aslam7Clare Bailey8Victor Chong9Faruque Ghanchi10Peter Scanlon11Sobha Sivaprasad12David Steel13Caroline Styles14Augusto Azuara-Blanco15Lindsay Prior16Norman Waugh17The Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast, UKCentre for Statistics in Medicine, University of Oxford, Oxford, UKCentre for Statistics in Medicine, University of Oxford, Oxford, UKGloucestershire Hospitals NHS Foundation Trust, Gloucester, UKWarwick Medical School, University of Warwick, Coventry, UKWarwick Medical School, University of Warwick, Coventry, UKThe Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast, UKThe Manchester Academic Health Science Centre, Manchester Royal Eye Hospital and Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UKBristol Eye Hospital, Bristol, UKRoyal Free Hospital NHS Foundation Trust, London, UKBradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Bradford, UKGloucestershire Hospitals NHS Foundation Trust, Gloucester, UKNational Institute for Health Research Moorfields Biomedical Research Centre, London, UKSunderland Eye Infirmary, Sunderland, UKQueen Margaret Hospital, Dunfermline, UKCentre for Public Health, Queen’s University Belfast, Belfast, UKCentre for Public Health, Queen’s University Belfast, Belfast, UKWarwick Medical School, University of Warwick, Coventry, UKBackground: Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands. Objective: The objective was to evaluate the diagnostic performance, cost-effectiveness and acceptability of a new pathway using multimodal imaging interpreted by ophthalmic graders to detect reactivation of diabetic macular oedema/proliferative diabetic retinopathy in previously treated patients. Design: This was a prospective, case-referent, cross-sectional diagnostic study. Setting: The setting was ophthalmic clinics in 13 NHS hospitals. Participants: Adults with type 1 or type 2 diabetes with previously successfully treated diabetic macular oedema/proliferative diabetic retinopathy in one/both eyes in whom, at the time of enrolment, diabetic macular oedema/proliferative diabetic retinopathy could be active or inactive. Methods: For the ophthalmic grader pathway, review of the spectral domain optical coherence tomography scans to detect diabetic macular oedema, and seven-field Early Treatment Diabetic Retinopathy Study/ultra-wide field fundus images to detect proliferative diabetic retinopathy, by trained ophthalmic graders. For the current standard care pathway (reference standard), ophthalmologists examined patients face to face by slit-lamp biomicroscopy for proliferative diabetic retinopathy and, in addition, spectral domain optical coherence tomography imaging for diabetic macular oedema. Outcome measures: The primary outcome measure was sensitivity of the ophthalmic grader pathway to detect active diabetic macular oedema/proliferative diabetic retinopathy. The secondary outcomes were specificity, agreement between pathways, cost–consequences, acceptability and the proportion of patients requiring subsequent ophthalmologist assessment, unable to undergo imaging and with inadequate quality images/indeterminate findings. It was assumed for the main analysis that all patients in whom graders diagnosed active disease or were ‘unsure’ or images were ‘ungradable’ required examination by an ophthalmologist. Results: Eligible participants with active and inactive diabetic macular oedema (152 and 120 participants, respectively) and active and inactive proliferative diabetic retinopathy (111 and 170 participants, respectively) were recruited. Under the main analysis, graders had a sensitivity of 97% (142/147) (95% confidence interval 92% to 99%) and specificity of 31% (35/113) (95% confidence interval 23% to 40%) to detect diabetic macular oedema. For proliferative diabetic retinopathy, graders had a similar sensitivity and specificity using seven-field Early Treatment Diabetic Retinopathy Study [sensitivity 85% (87/102), 95% confidence interval 77% to 91%; specificity 48% (77/160), 95% confidence interval 41% to 56%] or ultra-wide field imaging [sensitivity 83% (87/105), 95% confidence interval 75% to 89%; specificity 54% (86/160), 95% confidence interval 46% to 61%]. Participants attending focus groups expressed preference for face-to-face evaluations by ophthalmologists. In the ophthalmologists’ absence, patients voiced the need for immediate feedback following grader’s assessments, maintaining periodic evaluations by ophthalmologists. Graders and ophthalmologists were supportive of the new pathway. When compared with the reference standard (current standard pathway), the new grader pathway could save £1390 per 100 patients in the review of people with diabetic macular oedema and, depending on the imaging modality used, between £461 and £1189 per 100 patients in the review of people with proliferative diabetic retinopathy. Conclusions: For people with diabetic macular oedema, the ophthalmic grader pathway appears safe and cost saving. The sensitivity of the new pathway to detect active proliferative diabetic retinopathy was lower, but may still be considered acceptable for patients with proliferative diabetic retinopathy previously treated with laser. Suggestions from focus group discussions should be taken into consideration if the new pathway is introduced to ensure its acceptability to users. Limitations: Lack of fundus fluorescein angiography to confirm diagnosis of active proliferative diabetic retinopathy. Future work: Could refinement of the new pathway increase its sensitivity to detect proliferative diabetic retinopathy? Could artificial intelligence be used for automated reading of images in this previously treated population? Trial registration: Current Controlled Trials ISRCTN10856638 and ClinicalTrials.gov NCT03490318. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 32. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/hta25320diabetesdiabetic macular oedemaproliferative diabetic retinopathyophthalmic gradersfollow-upophthalmic photographersultra-wide field imagesspectral domain optical coherence tomographysd-oct7 field etdrs imagesearly treatment diabetic retinopathy imagespathway |
| spellingShingle | Noemi Lois Jonathan Cook Ariel Wang Stephen Aldington Hema Mistry Mandy Maredza Danny McAuley Tariq Aslam Clare Bailey Victor Chong Faruque Ghanchi Peter Scanlon Sobha Sivaprasad David Steel Caroline Styles Augusto Azuara-Blanco Lindsay Prior Norman Waugh Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study Health Technology Assessment diabetes diabetic macular oedema proliferative diabetic retinopathy ophthalmic graders follow-up ophthalmic photographers ultra-wide field images spectral domain optical coherence tomography sd-oct 7 field etdrs images early treatment diabetic retinopathy images pathway |
| title | Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study |
| title_full | Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study |
| title_fullStr | Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study |
| title_full_unstemmed | Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study |
| title_short | Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study |
| title_sort | multimodal imaging interpreted by graders to detect re activation of diabetic eye disease in previously treated patients the emerald diagnostic accuracy study |
| topic | diabetes diabetic macular oedema proliferative diabetic retinopathy ophthalmic graders follow-up ophthalmic photographers ultra-wide field images spectral domain optical coherence tomography sd-oct 7 field etdrs images early treatment diabetic retinopathy images pathway |
| url | https://doi.org/10.3310/hta25320 |
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