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.

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.
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DOI:
10.1136/bmjopen-2021-055845
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发表时间:
2022-02-01
期刊:
影响因子:
2.9
通讯作者:
Balaskas K
Balaskas K
中科院分区:
医学3区
文献类型:
--
作者:
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

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近年来,英国对眼科护理服务的需求激增。由于很大一部分患者被转诊到医院眼科服务(HES)进行诊断和疾病管理,转诊过程导致错误诊断和获得适当治疗的延误。一个潜在的解决方案是一个远程眼科数字转诊路径连接社区验光和HES。爱马仕研究(视网膜疾病社区验光转诊的远程眼科启用和人工智能就绪转诊路径:一项具有关联诊断准确性研究的群集随机优效性试验)是一项群集随机临床试验,旨在评价社区验光和HES之间远程眼科转诊路径治疗视网膜疾病的有效性。嵌套在爱马仕中的是一项诊断准确性研究,该研究评估了人工智能(AI)决策支持系统(DSS)用于自动诊断和转诊建议的准确性。一项实施后的观察性子研究、试验内经济评估和离散选择实验将评估在现实生活环境中实施这两种数字技术的可行性。将在英国的24个验光实践中招募疑似视网膜疾病的患者,接受眼科检查和光学相干断层扫描(OCT)扫描。验光实践将被随机分配到标准护理或远程眼科。主要结局是与远程眼科转诊途径相比,当前转诊途径中假阳性转诊(不必要的HES访视)的比例。OCT扫描将由AI DSS解释,AI DSS提供诊断和转诊决策,AI诊断研究的主要结局是Moorfields-DeepMind AI系统做出的转诊决策的诊断准确性。次要结果涉及不适当的转诊率,成本效益分析和人机交互(HCI)分析。从伦敦-布罗姆利研究伦理委员会获得伦理批准(REC 20/LO/1299)。研究结果将通过眼科学,卫生服务研究和HCI的学术期刊报道。ISRCTN 18106677(方案V.1.1)。
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. 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. 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. ISRCTN18106677 (protocol V.1.1).
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