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Background  Diabetic retinopathy (DR) is one of the most important causes of blindness worldwide, especially in developed countries. In diabetic patients, periodic examination of the back of the eye using a nonmydriatic camera has been widely demonstrated to be an effective system to control and prevent the onset of DR. Convolutional neural networks have been used to detect DR, achieving very high sensitivities and specificities.    Objective  The objective of this is paper was to develop an artificial intelligence (AI) algorithm for the detection of signs of DR in diabetic patients and to scientifically validate the algorithm to be used as a screening tool in primary care.    Methods  Under this project, 2 studies will be conducted in a concomitant way: (1) Development of an algorithm with AI to detect signs of DR in patients with diabetes and (2) A prospective study comparing the diagnostic capacity of the AI algorithm with respect to the actual system of family physicians evaluating the images. The standard reference to compare with will be a blinded double reading conducted by retina specialists. For the development of the AI algorithm, different iterations and workouts will be performed on the same set of data. Before starting each new workout, the strategy of dividing the set date into 2 groups will be used randomly. A group with 80% of the images will be used during the training (training dataset), and the remaining 20% images will be used to validate the results (validation dataset) of each cycle (epoch). During the prospective study, true-positive, true-negative, false-positive, and false-negative values will be calculated again. From here, we will obtain the resulting confusion matrix and other indicators to measure the performance of the algorithm.    Results  Cession of the images began at the end of 2018. The development of the AI algorithm is calculated to last about 3 to 4 months. Inclusion of patients in the cohort will start in early 2019 and is expected to last 3 to 4 months. Preliminary results are expected to be published by the end of 2019.    Conclusions  The study will allow the development of an algorithm based on AI that can demonstrate an equal or superior performance, and that constitutes a complement or an alternative, to the current screening of DR in diabetic patients.    International Registered Report Identifier (IRRID)  PRR1-10.2196/12539

Artificial Intelligence for the Detection of Diabetic Retinopathy in Primary Care: Protocol for Algorithm Development