scholarly journals Implementation and Evaluation of a Mobile Retinal Image Acquisition System for Screening Diabetic Retinopathy: Study Protocol

Diabetology ◽  
2022 ◽  
Vol 3 (1) ◽  
pp. 1-16
Author(s):  
Sílvia Rêgo ◽  
Matilde Monteiro-Soares ◽  
Marco Dutra-Medeiros ◽  
Filipe Soares ◽  
Cláudia Camila Dias ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Image Quality ◽  
Diagnostic Accuracy ◽  
Test Results ◽  
Reference Standard ◽  
Fundus Camera ◽  
Patients With Diabetes ◽  
Image Acquisition System ◽  
Technical Evaluation ◽  
Aided Diagnosis

Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.

scholarly journals Diagnostic Accuracy of Direct Ophthalmoscopy and Non-Mydriatic Retinal Photography by Trained Optometrists for Screening of Diabetic Retinopathy

2020 ◽  
Vol 36 (2) ◽  
Author(s):  
Muhammad Saleh Memon ◽  
Shahid Ahsan ◽  
Muhammad Fahadullah ◽  
Khalida Parveen ◽  
Sumaira Salim ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Predictive Value ◽  
Fundus Photography ◽  
Slit Lamp ◽  
Reference Standard ◽  
Cross Sectional ◽  
Fundus Camera ◽  
Retinal Photography ◽  
Direct Ophthalmoscopy

Purpose:  To determine the reliability of direct ophthalmoscopy and Non-Mydriatic fundus photography for screening of Diabetic Retinopathy by optometrist. Study Design:  Observational, cross sectional. Place and Duration of Study:  Al-Ibrahim eye hospital, Karachi from October to December 2018. Material and Methods:  All individuals with type 2 diabetes of≥ 40 years of age were screened for diabetic retinopathy (DR) by two trained optometrists and an ophthalmologist. First Optometrist used Non Mydriatic Fundus Camera (NMFC) and second optometrist used direct ophthalmoscopy (DO) after dilating the pupils. Final examination was done by the Ophthalmologist with slit lamp using Volk fundus lens which was considered as reference standard. Every investigator was kept unaware of the findings of others. Results:  A total of 698 eyes of 349 respondents were screened. Ophthalmologist could not make decision by bio microscopy in 44 (6.3%) individuals as compared to 128 (18.3%) by 1st optometrist by NMFC and 142 (20.3%) by 2nd optometrist with DO. Diabetic retinopathy (DR) was diagnosed in 1493 (21.4%) with slit lamp, in 1172 (16.8%) with NMFC and in 1333 (19.1%) with DO. Sensitivity of NMFC was 76% and that of DO was 64.8%. Specificity of NMFC was 97.45% and that of DO was 96.63%.  Positive predictive value (PPV) of NMFC was 89.33% and that of DO was 84.3% Negative predictive value (NPV) of NMFC was 93.33% and that of DO was 90.7%. Conclusion:  NMFC is recommended tool for DR screening; but DO by well-trained optometrist can be reliable where neither ophthalmologist nor NMFC is available.

scholarly journals Use of Smartphones to Detect Diabetic Retinopathy: Scoping Review and Meta-Analysis of Diagnostic Test Accuracy Studies (Preprint)

2019 ◽  
Author(s):  
Choon Han Tan ◽  
Bhone Myint Kyaw ◽  
Helen Smith ◽  
Colin S Tan ◽  
Lorainne Tudor Car
Keyword(s):  
Diabetic Retinopathy ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Sensitivity And Specificity ◽  
Meta Analysis ◽  
Diagnostic Test Accuracy ◽  
Fundus Photography ◽  
Diabetic Patients ◽  
Test Accuracy ◽  
Reference Standard

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.

On Diagnostic Accuracy in Audiology: Central Site of Lesion and Central Auditory Processing Disorder Studies

2016 ◽  
Vol 27 (02) ◽  
pp. 141-156 ◽  
Author(s):  
Andrew J. Vermiglio
Keyword(s):  
Diagnostic Accuracy ◽  
Auditory Processing ◽  
Auditory Processing Disorder ◽  
Central Auditory Processing ◽  
Index Test ◽  
Test Results ◽  
Reference Standard ◽  
Central Auditory Processing Disorder ◽  
Target Condition ◽  
Independent Verification

Background: In the field of audiology a test protocol (index test) is used to determine the presence or absence of a target condition. The value of an index test rests in its diagnostic accuracy. Results from an index test must be verified through the use of a reference standard. The clinician and researcher should determine the quality and applicability of diagnostic accuracy studies. The Standards for Reporting of Diagnostic Accuracy (STARD) statement was published in response to the low quality of research conducted across many fields of study. It provides guidelines for the development and interpretation of diagnostic accuracy studies. Purpose: The primary purpose of this article is to assess the degree to which the main principles of diagnostic accuracy studies are used for the detection of central auditory nervous system lesions and a central auditory processing disorder (CAPD). The secondary purpose is to compare the design of these studies to select key guidelines from the STARD statement. The third purpose of this article is to present an argument against the reassignment of diagnostic accuracy values of a particular index test for one target condition (e.g., a central site of lesion) to a different target condition (e.g., a CAPD). Results: A review of diagnostic accuracy literature on the detection of a central site of lesion reveals the use of a reference standard for the independent verification of the index test results. However, diagnostic accuracy studies involving index tests for the detection of a CAPD show that independent verification of index test results is nonexistent or at best questionable. Conclusion: For a particular index test, while the diagnostic accuracy for detection of a central site of lesion may have been determined appropriately, it is inappropriate to reassign these diagnostic accuracy values to a different diagnostic target such as a CAPD.

scholarly journals Handheld fundus camera performance, image quality and outcomes of diabetic retinopathy grading in a pilot screening study

2021 ◽  
Author(s):  
Anna‐Maria Kubin ◽  
Joonas Wirkkala ◽  
Antti Keskitalo ◽  
Pasi Ohtonen ◽  
Nina Hautala
Keyword(s):  
Diabetic Retinopathy ◽  
Image Quality ◽  
Fundus Camera ◽  
Screening Study ◽  
Quality And Outcomes

scholarly journals Diagnostic Accuracy of Detecting Diabetic Retinopathy by Using Digital Fundus Photographs in the Peripheral Health Facilities of Bangladesh: Validation Study (Preprint)

2020 ◽  
Author(s):  
Tahmina Begum ◽  
Aminur Rahman ◽  
Dilruba Nomani ◽  
Abdullah Mamun ◽  
Alayne Adams ◽  
...  
Keyword(s):  
Risk Factors ◽  
Diabetic Retinopathy ◽  
Diagnostic Accuracy ◽  
Validation Study ◽  
Gold Standard ◽  
Health Facilities ◽  
Receiver Operating Curve ◽  
Diabetic Retinopathy Screening ◽  
Patients With Diabetes ◽  
Retinopathy Screening

BACKGROUND Diabetic retinopathy can cause blindness even in the absence of symptoms. Although routine eye screening remains the mainstay of diabetic retinopathy treatment and it can prevent 95% of blindness, this screening is not available in many low- and middle-income countries even though these countries contribute to 75% of the global diabetic retinopathy burden. OBJECTIVE The aim of this study was to assess the diagnostic accuracy of diabetic retinopathy screening done by non-ophthalmologists using 2 different digital fundus cameras and to assess the risk factors for the occurrence of diabetic retinopathy. METHODS This validation study was conducted in 6 peripheral health facilities in Bangladesh from July 2017 to June 2018. A double-blinded diagnostic approach was used to test the accuracy of the diabetic retinopathy screening done by non-ophthalmologists against the gold standard diagnosis by ophthalmology-trained eye consultants. Retinal images were taken by using either a desk-based camera or a hand-held camera following pupil dilatation. Test accuracy was assessed using measures of sensitivity, specificity, and positive and negative predictive values. Overall agreement with the gold standard test was reported using the Cohen kappa statistic (κ) and area under the receiver operating curve (AUROC). Risk factors for diabetic retinopathy occurrence were assessed using binary logistic regression. RESULTS In 1455 patients with diabetes, the overall sensitivity to detect any form of diabetic retinopathy by non-ophthalmologists was 86.6% (483/558, 95% CI 83.5%-89.3%) and the specificity was 78.6% (705/897, 95% CI 75.8%-81.2%). The accuracy of the correct classification was excellent with a desk-based camera (AUROC 0.901, 95% CI 0.88-0.92) and fair with a hand-held camera (AUROC 0.710, 95% CI 0.67-0.74). Out of the 3 non-ophthalmologist categories, registered nurses and paramedics had strong agreement with kappa values of 0.70 and 0.85 in the diabetic retinopathy assessment, respectively, whereas the nonclinical trained staff had weak agreement (κ=0.35). The odds of having retinopathy increased with the duration of diabetes measured in 5-year intervals (<i>P</i>&lt;.001); the odds of having retinopathy in patients with diabetes for 5-10 years (odds ratio [OR] 1.81, 95% CI 1.37-2.41) and more than 10 years (OR 3.88, 95% CI 2.91-5.15) were greater than that in patients with diabetes for less than 5 years. Obesity was found to have a negative association (<i>P</i>=.04) with diabetic retinopathy. CONCLUSIONS Digital fundus photography is an effective screening tool with acceptable diagnostic accuracy. Our findings suggest that diabetic retinopathy screening can be accurately performed by health care personnel other than eye consultants. People with more than 5 years of diabetes should receive priority in any community-level retinopathy screening program. In a country like Bangladesh where no diabetic retinopathy screening services exist, the use of hand-held cameras can be considered as a cost-effective option for potential system-wide implementation. CLINICALTRIAL Not applicable

scholarly journals Image Quality and Diagnostic Accuracy of a Handheld Nonmydriatic Fundus Camera

2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Tai-Chi Lin ◽  
Yueh-Hua Chiang ◽  
Chih-Lu Hsu ◽  
Long-Sheng Liao ◽  
Yi-Ying Chen ◽  
...  
Keyword(s):  
Image Quality ◽  
Diagnostic Accuracy ◽  
Fundus Camera

scholarly journals Accuracy of trained rural ophthalmologists versus non-medical image graders in the diagnosis of diabetic retinopathy in rural China

2018 ◽  
Vol 102 (11) ◽  
pp. 1471-1476 ◽  
Author(s):  
Martha McKenna ◽  
Tingting Chen ◽  
Helen McAneney ◽  
Miguel Angel Vázquez Membrillo ◽  
Ling Jin ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Diagnostic Accuracy ◽  
Low Income ◽  
Medical Image ◽  
Southern China ◽  
Rural China ◽  
Reference Standard ◽  
Middle Income ◽  
Medical Background ◽  
The Uk

Background/aimsTo determine the diagnostic accuracy of trained rural ophthalmologists and non-medical image graders in the assessment of diabetic retinopathy (DR) in rural China.MethodsConsecutive patients with diabetes mellitus were examined from January 2014 to December 2015 at 10 county-level facilities in rural Southern China. Trained rural ophthalmologists performed a complete eye examination, recording diagnoses using the UK National Diabetic Eye Screening Programme (NDESP) classification system. Two field, mydriatic, 45° digital photographs were made by nurses using NDESP protocols and graded by trained graders with no medical background using the NDESP system. A fellowship-trained retina specialist graded all images in masked fashion and served as reference standard.ResultsAltogether, 375 participants (mean age 60±10 years, 48% men) were examined and 1277 images were graded. Grader sensitivity (0.82–0.94 (median 0.88)) and specificity (0.91–0.99 (median 0.98)), reached or exceeded NDESP standards (sensitivity 80%, specificity 95%) in all domains except specificity detecting any DR. Rural ophthalmologists’ sensitivity was 0.65–0.95 (median 0.66) and specificity 0.59–0.95 (median 0.91). There was strong agreement between graders and the reference standard (kappa=0.84–0.87, p<0.001) and weak to moderate agreement between rural doctors and the reference (kappa=0.48–0.64, p<0.001).ConclusionThis is the first study of diagnostic accuracy in DR grading among non-medical graders or ophthalmologists in low-income and middle-income countries. Non-medical graders can achieve high levels of accuracy, whereas accuracy of trained rural ophthalmologists is not optimal.

scholarly journals Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brian D. Nicholson ◽  
Gail Hayward ◽  
Philip J. Turner ◽  
Joseph J. Lee ◽  
Alexandra Deeks ◽  
...  
Keyword(s):  
Public Health ◽  
Diagnostic Accuracy ◽  
Real Time ◽  
Point Of Care ◽  
Reference Standards ◽  
Test Results ◽  
Reference Standard ◽  
Point Of Care Testing ◽  
Antibody Testing ◽  
Community Based

Abstract Background The aim of RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR). Methods RAPTOR-C19 incorporates a series of prospective observational parallel diagnostic accuracy studies of SARS-CoV2 POCTs against laboratory and composite reference standards in patients with suspected current or past SARS-CoV2 infection attending community settings. Adults and children with suspected current SARS-CoV2 infection who are having an oropharyngeal/nasopharyngeal (OP/NP) swab for laboratory SARS-CoV2 reverse transcriptase Digital/Real-Time Polymerase Chain Reaction (d/rRT-PCR) as part of clinical care or community-based testing will be invited to participate. Adults (≥ 16 years) with suspected past symptomatic infection will also be recruited. Asymptomatic individuals will not be eligible. At the baseline visit, all participants will be asked to submit samples for at least one candidate point-of-care test (POCT) being evaluated (index test/s) as well as an OP/NP swab for laboratory SARS-CoV2 RT-PCR performed by Public Health England (PHE) (reference standard for current infection). Adults will also be asked for a blood sample for laboratory SARS-CoV-2 antibody testing by PHE (reference standard for past infection), where feasible adults will be invited to attend a second visit at 28 days for repeat antibody testing. Additional study data (e.g. demographics, symptoms, observations, household contacts) will be captured electronically. Sensitivity, specificity, positive, and negative predictive values for each POCT will be calculated with exact 95% confidence intervals when compared to the reference standard. POCTs will also be compared to composite reference standards constructed using paired antibody test results, patient reported outcomes, linked electronic health records for outcomes related to COVID-19 such as hospitalisation or death, and other test results. Discussion High-performing POCTs for community use could be transformational. Real-time results could lead to personal and public health impacts such as reducing onward household transmission of SARS-CoV2 infection, improving surveillance of health and social care staff, contributing to accurate prevalence estimates, and understanding of SARS-CoV2 transmission dynamics in the population. In contrast, poorly performing POCTs could have negative effects, so it is necessary to undertake community-based diagnostic accuracy evaluations before rolling these out. Trial registration ISRCTN, ISRCTN14226970

scholarly journals Use of Smartphones to Detect Diabetic Retinopathy: Scoping Review and Meta-Analysis of Diagnostic Test Accuracy Studies

10.2196/16658 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16658
Author(s):  
Choon Han Tan ◽  
Bhone Myint Kyaw ◽  
Helen Smith ◽  
Colin S Tan ◽  
Lorainne Tudor Car
Keyword(s):  
Diabetic Retinopathy ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Sensitivity And Specificity ◽  
Meta Analysis ◽  
Diagnostic Test Accuracy ◽  
Fundus Photography ◽  
Diabetic Patients ◽  
Test Accuracy ◽  
Reference Standard

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.

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