title: The design and implementation of a study to investigate the effectiveness of community vs hospital eye service follow-up for patients with neovascular age-related macular degeneration with quiescent disease.
abstract: 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.
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Taylor
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: L J
authors.initials: LJ
authors.lastname: Scott
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: C A
authors.initials: CA
authors.lastname: Rogers
authors.affiliation: Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.
authors.forename: A
authors.initials: A
authors.lastname: Muldrew
authors.affiliation: Centre for Public Health, The Queen's University of Belfast, Belfast, UK.
authors.forename: D
authors.initials: D
authors.lastname: O'Reilly
authors.affiliation: Nuffield Department of Population Health, Health Economic Research Centre, University of Oxford, Oxford, UK.
authors.forename: S
authors.initials: S
authors.lastname: Wordsworth
authors.affiliation: Unit of Health Care Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: N
authors.initials: N
authors.lastname: Mills
authors.affiliation: Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.
authors.forename: R
authors.initials: R
authors.lastname: Hogg
authors.affiliation: Nuffield Department of Population Health, Health Economic Research Centre, University of Oxford, Oxford, UK.
authors.forename: M
authors.initials: M
authors.lastname: Violato
authors.affiliation: Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
authors.forename: S P
authors.initials: SP
authors.lastname: Harding
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, London, UK.
authors.forename: T
authors.initials: T
authors.lastname: Peto
authors.affiliation: Unit of Health Care Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: D
authors.initials: D
authors.lastname: Townsend
authors.affiliation: Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.
authors.forename: U
authors.initials: U
authors.lastname: Chakravarthy
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: B C
authors.initials: BC
authors.lastname: Reeves
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use; D003153:Community Health Services / Q000458:organization & administration*; D003266:Continuity of Patient Care; D003695:Delivery of Health Care / Q000592:standards*; D005500:Follow-Up Studies; D006284:Health Plan Implementation; D006801:Humans; D008505:Medical Staff, Hospital / Q000458:organization & administration*; D009313:National Health Programs; D009885:Ophthalmology / Q000193:education; D009907:Optometry / Q000193:education; D018579:Patient Selection; D010781:Photography; D012015:Reference Standards; D012107:Research Design; D018401:Sample Size; D041623:Tomography, Optical Coherence; D006113:United Kingdom; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D057135:Wet Macular Degeneration / Q000175:diagnosis* / Q000188:drug therapy
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A