Taylor J, Scott L J, Rogers C A, Muldrew A, O'Reilly D, Wordsworth S, Mills N, Hogg R, Violato M, Harding S P, Peto T, Townsend D, Chakravarthy U, Reeves B C
Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.
Eye (Lond). 2016 Jan;30(1):68-78. doi: 10.1038/eye.2015.170. Epub 2015 Oct 9.
IntroductionStandard treatment for neovascular age-related macular degeneration (nAMD) is intravitreal injections of anti-VEGF drugs. Following multiple injections, nAMD lesions often become quiescent but there is a high risk of reactivation, and regular review by hospital ophthalmologists is the norm. The present trial examines the feasibility of community optometrists making lesion reactivation decisions.MethodsThe Effectiveness of Community vs Hospital Eye Service (ECHoES) trial is a virtual trial; lesion reactivation decisions were made about vignettes that comprised clinical data, colour fundus photographs, and optical coherence tomograms displayed on a web-based platform. Participants were either hospital ophthalmologists or community optometrists. All participants were provided with webinar training on the disease, its management, and assessment of the retinal imaging outputs. In a balanced design, 96 participants each assessed 42 vignettes; a total of 288 vignettes were assessed seven times by each professional group.The primary outcome is a participant's judgement of lesion reactivation compared with a reference standard. Secondary outcomes are the frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists.DiscussionThis trial addresses an important question for the NHS, namely whether, with appropriate training, community optometrists can make retreatment decisions for patients with nAMD to the same standard as hospital ophthalmologists. The trial employed a novel approach as participation was entirely through a web-based application; the trial required very few resources compared with those that would have been needed for a conventional randomised controlled clinical trial.
引言
新生血管性年龄相关性黄斑变性(nAMD)的标准治疗方法是玻璃体内注射抗血管内皮生长因子(VEGF)药物。多次注射后,nAMD病变通常会静止,但有很高的再激活风险,医院眼科医生定期复查是常规做法。本试验探讨社区验光师做出病变再激活决策的可行性。
方法
社区与医院眼科服务有效性(ECHoES)试验是一项虚拟试验;针对包含临床数据、彩色眼底照片和基于网络平台显示的光学相干断层扫描图像的病例 vignettes 做出病变再激活决策。参与者为医院眼科医生或社区验光师。所有参与者都接受了关于该疾病、其管理以及视网膜成像输出评估的网络研讨会培训。在平衡设计中,96名参与者每人评估42个病例 vignettes;每个专业组对总共288个病例 vignettes 进行了七次评估。
主要结局是参与者与参考标准相比对病变再激活的判断。次要结局是威胁视力错误的频率;对特定病变成分的判断;参与者对其关于主要结局决策的自我评估信心;验光师而非眼科医生进行随访的成本效益。
讨论
本试验解决了英国国家医疗服务体系(NHS)的一个重要问题,即经过适当培训后,社区验光师能否为nAMD患者做出与医院眼科医生相同标准的再治疗决策。该试验采用了一种新颖的方法,因为参与完全通过基于网络的应用程序进行;与传统随机对照临床试验所需资源相比,该试验所需资源极少。