Diagnostic accuracy of direct ophthalmoscopy for detection of diabetic retinopathy using fundus photographs as a reference standard

2014 ◽  
Vol 8 (2) ◽  
pp. 96-101 ◽  
Author(s):  
Shahid Ahsan ◽  
Abdul Basit ◽  
Kazi Rumana Ahmed ◽  
Liaquat Ali ◽  
Fariha Shaheen ◽  
...  
2020 ◽  
Vol 36 (2) ◽  
Author(s):  
Muhammad Saleh Memon ◽  
Shahid Ahsan ◽  
Muhammad Fahadullah ◽  
Khalida Parveen ◽  
Sumaira Salim ◽  
...  

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.


Diabetology ◽  
2022 ◽  
Vol 3 (1) ◽  
pp. 1-16
Author(s):  
Sílvia Rêgo ◽  
Matilde Monteiro-Soares ◽  
Marco Dutra-Medeiros ◽  
Filipe Soares ◽  
Cláudia Camila Dias ◽  
...  

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.


2019 ◽  
Author(s):  
Choon Han Tan ◽  
Bhone Myint Kyaw ◽  
Helen Smith ◽  
Colin S Tan ◽  
Lorainne Tudor Car

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.


2020 ◽  
Author(s):  
Jo-Hsuan Wu ◽  
Tin-Yan Alvin Liu ◽  
Wan-Ting Hsu ◽  
Jennifer Hui-Chun Ho ◽  
Chien-Chang Lee

BACKGROUND Standardly diagnosed by human experts, the high prevalence of diabetic retinopathy (DR) warrants a more efficient screening method. Although machine learning (ML)-based automated DR diagnosis has gained attention due to recent approval of IDx-DR, performance of this tool has not be examined systematically, and the best ML technique for utilization in real-world setting has not been discussed. OBJECTIVE To examine systematically the overall diagnostic accuracy of ML in diagnosing DR of different categories based on color fundus photographs and to determine the state-of-the-art ML approach. METHODS Published studies in PubMed and EMBASE were searched from inception to June, 2020. Studies were screened for relevant outcomes, publication types, and data sufficiency, and a total of 60 (2.8%) out of 2128 studies were retrieved after study selection. Extraction of data was performed by 2 authors according to PRISMA, and the quality assessment was performed according to QUADUS-2. Meta-analysis of diagnostic accuracy was pooled using a bivariate random-effects model. The main outcomes included diagnostic accuracy, sensitivity, and specificity of ML in diagnosing DR based on color fundus photographs, as well as the performances of different major types of ML algorithms. RESULTS The primary meta-analysis included 60 color fundus photograph studies (445,175 interpretations). Overall, ML demonstrated high accuracy in diagnosing DR of various categories, with a pooled AUROC from 0.97 (95% CI: 0.96, 0.99) to 0.99 (95%CI: 0.98, 1.00). The performance of ML in detecting more-than-mild DR (mtmDR) was robust (Sen: 0.95, AUROC: 0.97), and by subgroup analyses, we observed that robust performance of ML was not limited to benchmark datasets (Sen: 0.92; AUROC: 0.96) but could be generalized to images collected in clinical practice (Sen: 0.97; AUROC: 097). Neural network was the most widely utilized method, and the subgroup analysis revealed a pooled AUROC of 0.98 (95% CI: 0.96, 0.99) for studies that utilized neural networks to diagnose mtmDR. CONCLUSIONS This meta-analysis demonstrated high diagnostic accuracy of ML algorithms in detecting diabetic retinopathy on color fundus photographs, suggesting that state-of-the-art, ML-based DR screening algorithms are likely ready for clinical applications. However, a significant portion of the earlier published studies had methodology flaws, such as the lack of external validation and presence of spectrum bias. The results of these studies should be interpreted with caution.


2018 ◽  
Vol 102 (11) ◽  
pp. 1471-1476 ◽  
Author(s):  
Martha McKenna ◽  
Tingting Chen ◽  
Helen McAneney ◽  
Miguel Angel Vázquez Membrillo ◽  
Ling Jin ◽  
...  

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.


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

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.


2016 ◽  
Vol 51 (6) ◽  
pp. 498-499 ◽  
Author(s):  
Chelsey M. Toney ◽  
Kenneth E. Games ◽  
Zachary K. Winkelmann ◽  
Lindsey E. Eberman

Reference/Citation: Mugunthan K, Doust J, Kurz B, Glasziou P. Is there sufficient evidence for tuning fork tests in diagnosing fractures? A systematic review. BMJ Open. 2014;4(8):e005238. Clinical Question: Does evidence support the use of tuning-fork tests in the diagnosis of fractures in clinical practice? Data Sources: The authors performed a comprehensive literature search of AMED, CAB Abstracts, CINAHL, EMBASE, MEDLINE, SPORTDiscus, and Web of Science from each database's start to November 2012. In addition, they manually searched reference lists from the initial search result to identify relevant studies. The following key words were used independently or in combination: auscultation, barford test, exp fractures, fracture, tf test, tuning fork. Study Selection: Studies were eligible based on the following criteria: (1) primary studies that assessed the diagnostic accuracy of tuning forks; (2) measured against a recognized reference standard such as magnetic resonance imaging, radiography, or bone scan; and (3) the outcome was reported using pain or reduction of sound. Studies included patients of all ages in all clinical settings with no exclusion for language of publication. Studies were not eligible if they were case series, case-control studies, or narrative review papers. Data Extraction: Potentially eligible studies were independently assessed by 2 researchers. All relevant articles were included and assessed for inclusion criteria and value using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool, and relevant data were extracted. The QUADAS-2 is an updated version of the original QUADAS and focuses on both the risk of bias and applicability of a study through a series of questions. A third researcher was consulted if the 2 initial reviewers did not reach consensus. Data for the primary outcome measure (accuracy of the test) were presented in a 2 × 2 contingency table to show sensitivity and specificity (using the Wilson score method) and positive and negative likelihood ratios with 95% confidence intervals. Main Results: A total of 62 citations were initially identified. Six primary studies (329 patients) were included in the review. The 6 studies assessed the accuracy of 2 tuning-fork test methods (pain induction and reduction of sound transmission). The patients ranged in age from 7 to 84 years. The prevalence of fracture in these patients ranged from 10% to 80% using a reference standard such as magnetic resonance imaging, radiography, or bone scan. The sensitivity of the tuning-fork tests was high, ranging from 75% to 92%. The specificity of the tuning-fork tests had a wide range of 18% to 94%. The positive likelihood ratios ranged from 1.1 to 16.5; the negative likelihood ratios ranged from 0.09 to 0.49. Conclusions: The studies included in this review demonstrated that tuning-fork tests have some value in ruling out fractures. However, strong evidence is lacking to support the use of current tuning-fork tests to rule in a fracture in clinical practice. Similarly, the tuning-fork tests were not statistically accurate in the diagnosis of fractures for widespread clinical use. Despite the lack of strong evidence for diagnosing all fractures, tuning-fork tests may be appropriate in rural and remote settings in which access to the gold standards for diagnosis of fractures is limited.


2017 ◽  
Vol 2017 ◽  
pp. 1-14 ◽  
Author(s):  
Mathilde M. Goudot ◽  
Anne Sikorav ◽  
Oudy Semoun ◽  
Alexandra Miere ◽  
Camille Jung ◽  
...  

Purpose. To evaluate the capacity of OCT angiography (OCTA) for detecting infraclinical lesions in parafoveal capillaries in diabetic patients without diabetic retinopathy (DR). Methods. This prospective observational cross-sectional case-control study analyzed the superficial and deep capillary plexuses (SCP and DCP) on macular OCTA scans (3 × 3 mm) centered on the fovea. We compared 22 diabetic patients (34 eyes included) without DR diagnosis on color fundus photographs, with 22 age- and gender-matched nondiabetic controls (40 eyes included). Qualitative analysis concerned morphological ischemic capillary alterations. Quantitative analysis measured foveal avascular zone (FAZ) size, parafoveal capillary density, and enlargement coefficient of FAZ between SCP and DCP. Results. Neither the qualitative nor quantitative parameters were significantly different between both groups. No microaneurysms or venous tortuosity was observed in any of the analyzed images. On the SCP, the mean FAZ area was 0.322 ± 0.125 mm2 in diabetic patients and 0.285 ± 0.150 mm2 in controls, P=0.31. On the DCP, the mean FAZ area was 0.444 ± 0.153 mm2 in cases and 0.398 ± 0.138 mm2 in controls, P=0.20. Conclusion. OCTA did not detect infraclinical qualitative or quantitative differences in parafoveal capillaries of diabetic patients without DR in comparison with nondiabetic controls.


2019 ◽  
Vol 23 (40) ◽  
pp. 1-194 ◽  
Author(s):  
Alasdair MJ MacLullich ◽  
Susan D Shenkin ◽  
Steve Goodacre ◽  
Mary Godfrey ◽  
Janet Hanley ◽  
...  

Background Delirium is a common and serious neuropsychiatric syndrome, usually triggered by illness or drugs. It remains underdetected. One reason for this is a lack of brief, pragmatic assessment tools. The 4 ‘A’s test (Arousal, Attention, Abbreviated Mental Test – 4, Acute change) (4AT) is a screening tool designed for routine use. This project evaluated its usability, diagnostic accuracy and cost. Methods Phase 1 – the usability of the 4AT in routine practice was measured with two surveys and two qualitative studies of health-care professionals, and a review of current clinical use of the 4AT as well as its presence in guidelines and reports. Phase 2 – the 4AT’s diagnostic accuracy was assessed in newly admitted acute medical patients aged ≥ 70 years. Its performance was compared with that of the Confusion Assessment Method (CAM; a longer screening tool). The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes. The method used was a prospective, double-blind diagnostic test accuracy study in emergency departments or in acute general medical wards in three UK sites. Each patient underwent a reference standard delirium assessment and was also randomised to receive an assessment with either the 4AT (n = 421) or the CAM (n = 420). A health economics analysis was also conducted. Results Phase 1 found evidence that delirium awareness is increasing, but also that there is a need for education on delirium in general and on the 4AT in particular. Most users reported that the 4AT was useful, and it was in widespread use both in the UK and beyond. No changes to the 4AT were considered necessary. Phase 2 involved 785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4) years, 45% were male, 99% were white and 9% had a known dementia diagnosis. The 4AT (n = 392) had an area under the receiver operating characteristic curve of 0.90. A positive 4AT score (> 3) had a specificity of 95% [95% confidence interval (CI) 92% to 97%] and a sensitivity of 76% (95% CI 61% to 87%) for reference standard delirium. The CAM (n = 382) had a specificity of 100% (95% CI 98% to 100%) and a sensitivity of 40% (95% CI 26% to 57%) in the subset of participants whom it was possible to assess using this. Patients with positive 4AT scores had longer lengths of stay (median 5 days, interquartile range 2.0–14.0 days) than did those with negative 4AT scores (median 2 days, interquartile range 1.0–6.0 days), and they had a higher 12-week mortality rate (16.1% and 9.2%, respectively). The estimated 12-week costs of an initial inpatient stay for patients with delirium were more than double the costs of an inpatient stay for patients without delirium (e.g. in Scotland, £7559, 95% CI £7362 to £7755, vs. £4215, 95% CI £4175 to £4254). The estimated cost of false-positive cases was £4653, of false-negative cases was £8956, and of a missed diagnosis was £2067. Limitations Patients were aged ≥ 70 years and were assessed soon after they were admitted, limiting generalisability. The treatment of patients in accordance with reference standard diagnosis limited the ability to assess comparative cost-effectiveness. Conclusions These findings support the use of the 4AT as a rapid delirium assessment instrument. The 4AT has acceptable diagnostic accuracy for acute older patients aged > 70 years. Future work Further research should address the real-world implementation of delirium assessment. The 4AT should be tested in other populations. Trial registration Current Controlled Trials ISRCTN53388093. 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. 23, No. 40. See the NIHR Journals Library website for further project information. The funder specified that any new delirium assessment tool should be compared against the CAM, but had no other role in the study design or conduct of the study.


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