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.
Author
Han, Ji Eun DianaLiu, Xiaoxuan
Bunce, Catey
Douiri, Abdel
Vale, Luke
Blandford, Ann
Lawrenson, John
Hussain, Rima
Grimaldi, Gabriela
Learoyd, Annastazia E
Kernohan, Ashleigh
Dinah, Christiana
Minos, Evangelos
Sim, Dawn
Aslam, Tariq
Patel, Praveen J
Denniston, Alastair K
Keane, Pearse A
Balaskas, Konstantinos
Publication date
2022-02-01Subject
Ophthalmology
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Introduction: Recent 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 analysis: The 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 dissemination: Ethical 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 number: ISRCTN18106677 (protocol V.1.1).Citation
Han JED, Liu X, Bunce C, Douiri A, Vale L, Blandford A, Lawrenson J, Hussain R, Grimaldi G, Learoyd AE, Kernohan A, Dinah C, Minos E, Sim D, Aslam T, Patel PJ, Denniston AK, Keane PA, Balaskas K. 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. BMJ Open. 2022 Feb 1;12(2):e055845. doi: 10.1136/bmjopen-2021-055845Type
ArticleAdditional Links
http://bmjopen.bmj.com/PMID
35105593Journal
BMJ OpenPublisher
BMJ Publishing Groupae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2021-055845