Teleophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease (HERMES): a Cluster Randomised Superiority Trial with a linked Diagnostic Accuracy Study—HERMES study report 1—study protocol

Abstract

IntroductionRecent years have witnessed an upsurge of demand in eye care services in the UK. With a large proportion of patients referred to Hospital Eye Services (HES) for diagnostics and disease management, the referral process results in unnecessary referrals from erroneous diagnoses and delays in access to appropriate treatment. A potential solution is a teleophthalmology digital referral pathway linking community optometry and HES.Methods and analysisThe HERMES study (Teleophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease: a cluster randomised superiority trial with a linked diagnostic accuracy study) is a cluster randomised clinical trial for evaluating the effectiveness of a teleophthalmology referral pathway between community optometry and HES for retinal diseases. Nested within HERMES is a diagnostic accuracy study, which assesses the accuracy of an artificial intelligence (AI) decision support system (DSS) for automated diagnosis and referral recommendation. A postimplementation, observational substudy, a within-trial economic evaluation and discrete choice experiment will assess the feasibility of implementation of both digital technologies within a real-life setting. Patients with a suspicion of retinal disease, undergoing eye examination and optical coherence tomography (OCT) scans, will be recruited across 24 optometry practices in the UK. Optometry practices will be randomised to standard care or teleophthalmology. The primary outcome is the proportion of false-positive referrals (unnecessary HES visits) in the current referral pathway compared with the teleophthalmology referral pathway. OCT scans will be interpreted by the AI DSS, which provides a diagnosis and referral decision and the primary outcome for the AI diagnostic study is diagnostic accuracy of the referral decision made by the Moorfields-DeepMind AI system. Secondary outcomes relate to inappropriate referral rate, cost-effectiveness analyses and human–computer interaction (HCI) analyses.Ethics and disseminationEthical approval was obtained from the London—Bromley Research Ethics Committee (REC 20/LO/1299). Findings will be reported through academic journals in ophthalmology, health services research and HCI.Trial registration numberISRCTN18106677 (protocol V.1.1).

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“…Optical coherence tomographic (OCT) angiography is a noninvasive imaging technology that may generate angiograms at precise depths within the retina as well as visualize the microvasculature in real time [ 34 ]. A British study published in 2021 assessed an AI decision support system with the use of OCT scanning of retinal pictures to identify the digital referral path, providing evidence of the contributing reasons and difficulties of adopting the digital path in real life, with the goal of helping to eliminate unnecessary referrals [ 35 ]. To boost doctors’ faith in AI systems to make accurate diagnoses, some AI systems must be written as interpretable programs [ 36 ].…”

Protocol for a qualitative study to explore acceptability, barriers and facilitators of the implementation of new teleophthalmology technologies between community optometry practices and hospital eye services

“…A substudy will also be conducted as part of the trial that integrates the trial data to assess the diagnostic accuracy of an AI DSS (the Moorfields-DeepMind algorithm) for the automated referral recommendation for retinal disease. Detailed methods of the HERMES study are described elsewhere 31. The qualitative research element presented in this paper will run across both studies to provide evidence on implementation.…”

“…Detailed methods of the HERMES study are described elsewhere. 31 The qualitative research element presented in this paper will run across both studies to provide evidence on implementation.…”