Abstract

Objective: Currently 1/12 of the world’s population has diabetes mellitus (DM), many are or will be screened by having retinal images taken. This current study aims to compare the DAPHNE software’s ability to detect DR in three different European populations compared to human grading carried out at the Moorfields Eye Hospital Reading Centre (MEHRC). Participants: Retinal images were taken from participants of the HAPIEE study (Lithuania, n=1014), the PAMDI study (Italy, n=882) and the MARS study (Germany, n=909). Methods: All anonymized images were graded by human graders at MEHRC for the presence of DR. Independently, and without any knowledge of the human grader’s results, the DAPHNE software analysed the images and divided the participants into DR and no-DR groups. Main outcome measures: The primary outcomes were sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DAPHNE software with regards to the identification of DR or no-DR on retinal images as compared to the human grader as reference standard. Results: A total of 2805 participants were enrolled from the three study sites. The sensitivity of the DAPHNE software was above 93% in all three studies specificity was above 80%, the PPV was above 28% and the NPV was not below 98.8% in any of the studies. The DAPHNE software did not miss any vision-threatening DR. The areas under the curve (AUC) for all three studies were above 0.96. DAPHNE reduced manual human workload by 70% but had a total false positive rate of 63%. Conclusions: The DAPHNE software showed to be reliable to detect DR on three different European populations, using three different imaging settings. Further testing is required to see scalability, performance on live DR screening systems and on camera settings different to these studies.

Highlights

  • Worldwide, the number of patients with Diabetes Mellitus (DM) is expected to increase from 177 million in 2000 to 366 million by 2030 [1] while the International Diabetes Federation (IDF) estimates as many as 592 million with DM by 2035

  • The sensitivity of the DAPHNE software was above 93% in all three studies specificity was above 80%, the positive predictive value (PPV) was above 28% and the negative predictive value (NPV) was not below 98.8% in any of the studies

  • Moorfields Eye Hospital Reading Centre (MEHRC) detected 94 referable Diabetic Retinopathy (DR) cases giving a prevalence of 9.3%

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Summary

Introduction

The number of patients with Diabetes Mellitus (DM) is expected to increase from 177 million in 2000 to 366 million by 2030 [1] while the International Diabetes Federation (IDF) estimates as many as 592 million with DM by 2035. Detection of Diabetic Retinopathy (DR) relies on detailed examination of the retina either using a slitlamp eye examination method or analysis of fundus images. This latter one is usually done by human graders; let it be in population based studies or in DR screening programmes. In many countries current recommendation is to screen for DR in patients with DM annually. Population based studies generate large image sets, and the analysis of these is crucial for understanding trends in disease detection and progression and to inform policy in the relevant countries. With the advent of portable imaging technologies, the amount of retinal imaging generated is likely to increase

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