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Use of smartphones for detecting diabetic retinopathy: a protocol for a scoping review of diagnostic test accuracy studies.

ABSTRACT: INTRODUCTION:Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of impaired vision in adults worldwide. Early detection and treatment for DR could improve patient outcomes. Traditional methods of detecting DR include the gold standard Early Treatment Diabetic Retinopathy Study seven standard fields fundus photography, ophthalmoscopy and slit-lamp biomicroscopy. These modalities can be expensive, difficult to access and require involvement of specialised healthcare professionals. With the development of mobile phone technology, there is a growing interest in their use for DR identification as this approach is potentially more affordable, accessible and easier to use. Smartphones can be employed in a variety of ways for ophthalmoscopy including the use of smartphone camera, various attachments and artificial intelligence for obtaining and grading of retinal images. The aim of this scoping review is to determine the diagnostic test accuracy of various smartphone ophthalmoscopy approaches for detecting DR in diabetic patients. METHODS AND ANALYSIS:We will perform an electronic search of MEDLINE, Embase and Cochrane Library for literature published from 2000 onwards. Two reviewers will independently analyse studies for eligibility and assess study quality using the QUADAS-2 tool. Data for a 2?2 contingency table will be extracted. If possible, we will pool sensitivity and specificity data using the random-effects model and construct a summary receiver operating characteristic curve. In case of high heterogeneity, we will present the findings narratively. Subgroup analysis and sensitivity analysis will be performed where appropriate. ETHICS AND DISSEMINATION:This scoping review aims to provide an overview of smartphone ophthalmoscopy in DR identification. It will present findings on the accuracy of smartphone ophthalmoscopy in detecting DR, identify gaps in the literature and provide recommendations for future research. This review does not require ethical approval as we will not collect primary data.

SUBMITTER: Tan CH

PROVIDER: S-EPMC6924876 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Use of smartphones for detecting diabetic retinopathy: a protocol for a scoping review of diagnostic test accuracy studies.

Tan Choon Han CH Quah Willie-Henri WH Tan Colin S H CSH Smith Helen H Tudor Car Lorainne L

BMJ open 20191208 12

<h4>Introduction</h4>Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of impaired vision in adults worldwide. Early detection and treatment for DR could improve patient outcomes. Traditional methods of detecting DR include the gold standard Early Treatment Diabetic Retinopathy Study seven standard fields fundus photography, ophthalmoscopy and slit-lamp biomicroscopy. These modalities can be expensive, difficult to access and require invo ...[more]

PMID: 31818832

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Project description:BACKGROUND:Diabetic retinopathy (DR), a common complication of diabetes mellitus, is the leading cause of impaired vision in adults worldwide. Smartphone ophthalmoscopy involves using a smartphone camera for digital retinal imaging. Utilizing smartphones to detect DR is potentially more affordable, accessible, and easier to use than conventional methods. OBJECTIVE:This study aimed to determine the diagnostic accuracy of various smartphone ophthalmoscopy approaches for detecting DR in diabetic patients. METHODS:We performed an electronic search on the Medical Literature Analysis and Retrieval System Online (MEDLINE), EMBASE, and Cochrane Library for literature published from January 2000 to November 2018. We included studies involving diabetic patients, which compared the diagnostic accuracy of smartphone ophthalmoscopy for detecting DR to an accurate or commonly employed reference standard, such as indirect ophthalmoscopy, slit-lamp biomicroscopy, and tabletop fundus photography. Two reviewers independently screened studies against the inclusion criteria, extracted data, and assessed the quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, with disagreements resolved via consensus. Sensitivity and specificity were pooled using the random effects model. A summary receiver operating characteristic (SROC) curve was constructed. This review is reported in line with the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies guidelines. RESULTS:In all, nine studies involving 1430 participants were included. Most studies were of high quality, except one study with limited applicability because of its reference standard. The pooled sensitivity and specificity for detecting any DR was 87% (95% CI 74%-94%) and 94% (95% CI 81%-98%); mild nonproliferative DR (NPDR) was 39% (95% CI 10%-79%) and 95% (95% CI 91%-98%); moderate NPDR was 71% (95% CI 57%-81%) and 95% (95% CI 88%-98%); severe NPDR was 80% (95% CI 49%-94%) and 97% (95% CI 88%-99%); proliferative DR (PDR) was 92% (95% CI 79%-97%) and 99% (95% CI 96%-99%); diabetic macular edema was 79% (95% CI 63%-89%) and 93% (95% CI 82%-97%); and referral-warranted DR was 91% (95% CI 86%-94%) and 89% (95% CI 56%-98%). The area under SROC curve ranged from 0.879 to 0.979. The diagnostic odds ratio ranged from 11.3 to 1225. CONCLUSIONS:We found heterogeneous evidence showing that smartphone ophthalmoscopy performs well in detecting DR. The diagnostic accuracy for PDR was highest. Future studies should standardize reference criteria and classification criteria and evaluate other available forms of smartphone ophthalmoscopy in primary care settings.

Project description:ObjectivesTo compare the accuracy of trained level 1 diabetic retinopathy (DR) graders (nurses, endocrinologists and one general practitioner), level 2 graders (midlevel ophthalmologists) and level 3 graders (senior ophthalmologists) in Vietnam against a reference standard from the UK and assess the impact of supplementary targeted grader training.DesignDiagnostic test accuracy study.SettingSecondary care hospitals in Southern Vietnam.ParticipantsDR training was delivered to Vietnamese graders in February 2018 by National Health Service (NHS) UK graders. Two-field retinal images (412 patient images) were graded by 14 trained graders in Vietnam between August and October 2018 and then regraded retrospectively by an NHS-certified reference standard UK optometrist (phase I). Further DR training based on phase I results was delivered to graders in November 2019. After training, a randomised subset of images from January to October 2020 (115 patient images) was graded by six of the original cohort (phase II). The reference grader regraded all images from phase I and II retrospectively in masked fashion.Primary and secondary outcome measuresSensitivity was calculated at the two different time points, and χ2 was used to test significance.ResultsIn phase I, the sensitivity for detecting any DR for all grader groups in Vietnam was low (41.8-42.2%) and improved in phase II after additional training was delivered (51.3-87.2%). The greatest improvement was seen among level 1 graders (p<0.001), and the lowest improvement was observed among level 3 graders (p=0.326). There was a statistically significant improvement in sensitivity for detecting referable DR and referable diabetic macular oedema between all grader levels. The post-training values ranged from 40.0 to 61.5% (including ungradable images) and 55.6%-90.0% (excluding ungradable images).ConclusionsThis study demonstrates that targeted training interventions can improve accuracy of DR grading. These findings have important implications for improving service delivery in DR screening programmes in low-resource settings.

Project description:IntroductionStandards for Reporting of Diagnostic Accuracy Study (STARD) was developed to improve the completeness and transparency of reporting in studies investigating diagnostic test accuracy. However, its current form, STARD 2015 does not address the issues and challenges raised by artificial intelligence (AI)-centred interventions. As such, we propose an AI-specific version of the STARD checklist (STARD-AI), which focuses on the reporting of AI diagnostic test accuracy studies. This paper describes the methods that will be used to develop STARD-AI.Methods and analysisThe development of the STARD-AI checklist can be distilled into six stages. (1) A project organisation phase has been undertaken, during which a Project Team and a Steering Committee were established; (2) An item generation process has been completed following a literature review, a patient and public involvement and engagement exercise and an online scoping survey of international experts; (3) A three-round modified Delphi consensus methodology is underway, which will culminate in a teleconference consensus meeting of experts; (4) Thereafter, the Project Team will draft the initial STARD-AI checklist and the accompanying documents; (5) A piloting phase among expert users will be undertaken to identify items which are either unclear or missing. This process, consisting of surveys and semistructured interviews, will contribute towards the explanation and elaboration document and (6) On finalisation of the manuscripts, the group's efforts turn towards an organised dissemination and implementation strategy to maximise end-user adoption.Ethics and disseminationEthical approval has been granted by the Joint Research Compliance Office at Imperial College London (reference number: 19IC5679). A dissemination strategy will be aimed towards five groups of stakeholders: (1) academia, (2) policy, (3) guidelines and regulation, (4) industry and (5) public and non-specific stakeholders. We anticipate that dissemination will take place in Q3 of 2021.

Project description:BackgroundThe evidence on diagnostic test accuracy (DTA) of diabetic retinopathy (DR) screening utilising photographic studies by non-ophthalmologist personnel in low and middle-income country (LMIC) settings is scarce. We aimed to assess DTA of DR screening using a nonmydriatic hand-held digital camera by trained general physicians in a non-ophthalmic setting.MethodsThis study is a validation of a screening intervention. We selected 700 people with diabetes (PwDM) > 18 years of age, not previously screened or treated for DR, presenting at a tertiary medical clinic in Sri Lanka. Two-field retinal imaging was used to capture fundus images before and after pupil dilatation, using a hand-held non-mydriatic (Visuscout 100®-Germany) digital retinal camera. The images were captured and graded by two trained, masked independent physician graders. The DTA of different levels of DR was assessed comparing physician's grading with a retinologist's clinical examination by mydriatic bio-microscopy, according to a locally adopted guideline.ResultsSeven hundred eligible PwDM were screened by physician graders. The mean age of participants was 60.8 years (SD ±10.08) and mean duration of DM was 9.9 years (SD ±8.09). Ungradable image proportion in non-mydriatic imaging was 43.4% (either eye-31.3%, both eyes 12.1%). This decreased to 12.8% (either eye-11.6%, both eyes-1.2%) following pupil dilatation. In comparison to detection of any level of DR, a referable level DR (moderate non-proliferative DR and levels above) showed a higher level of DTA. The sensitivity of the defined referable DR was 88.7% (95% CI 81.7-93.8%) for grader 1 (positive predictive value [PPV] 59.1%) and 92.5% (95% CI 86.4-96.5%) for grader 2 (PPV 68%), using mydriatic imaging, after including ungradable images as screen positives. The specificity was 94.9% (95% CI 93.6-96.0%) for grader 1 (negative predictive value [NPV] 99%) and 96.4% (95% CI 95.3-97.3%) for grader 2 (NPV 99.4%).ConclusionsThe Physicians grading of images from a digital hand-held non-mydriatic camera at a medical clinic, with dilatation of pupil of those who have ungradable images, provides a valid modality to identify referable level of DR. This could be a feasible alternative modality to the existing opportunistic screening to improve the access and coverage.Trial registrationCurrent Controlled Trials ISRCTN47559703 . Date of Registration 18th March 2019, Retrospectively registered.

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Use of smartphones for detecting diabetic retinopathy: a protocol for a scoping review of diagnostic test accuracy studies.

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Use of smartphones for detecting diabetic retinopathy: a protocol for a scoping review of diagnostic test accuracy studies.

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