Safety and efficacy of an artificial intelligence-enabled decision tool for treatment decisions in neovascular age-related macular degeneration and an exploration of clinical pathway integration and implementation: protocol for a multi-methods validation study.

INTRODUCTION: Neovascular age-related macular degeneration (nAMD) management is one of the largest single-disease contributors to hospital outpatient appointments. Partial automation of nAMD treatment decisions could reduce demands on clinician time. Established artificial intelligence (AI)-enabled retinal imaging analysis tools, could be applied to this use-case, but are not yet validated for it. A primary qualitative investigation of stakeholder perceptions of such an AI-enabled decision tool is also absent. This multi-methods study aims to establish the safety and efficacy of an AI-enabled decision tool for nAMD treatment decisions and understand where on the clinical pathway it could sit and what factors are likely to influence its implementation. METHODS AND ANALYSIS: Single-centre retrospective imaging and clinical data will be collected from nAMD clinic visits at a National Health Service (NHS) teaching hospital ophthalmology service, including judgements of nAMD disease stability or activity made in real-world consultant-led-care. Dataset size will be set by a power calculation using the first 127 randomly sampled eligible clinic visits. An AI-enabled retinal segmentation tool and a rule-based decision tree will independently analyse imaging data to report nAMD stability or activity for each of these clinic visits. Independently, an external reading centre will receive both clinical and imaging data to generate an enhanced reference standard for each clinic visit. The non-inferiority of the relative negative predictive value of AI-enabled reports on disease activity relative to consultant-led-care judgements will then be tested. In parallel, approximately 40 semi-structured interviews will be conducted with key nAMD service stakeholders, including patients. Transcripts will be coded using a theoretical framework and thematic analysis will follow. ETHICS AND DISSEMINATION: NHS Research Ethics Committee and UK Health Research Authority approvals are in place (21/NW/0138). Informed consent is planned for interview participants only. Written and oral dissemination is planned to public, clinical, academic and commercial stakeholders.

Theorising the shift to video consulting in the UK during the COVID-19 pandemic: Analysis of a mixed methods study using practice theory.

We studied video consulting in the National Health Service during 2020-2021 through video interviews, an online survey and online discussions with people who had provided and participated in such consultations. Video consulting had previously been used for selected groups in limited settings in the UK. The pandemic created a seismic shift in the context for remote consulting, in which video transformed from a niche technology typically introduced by individual clinicians committed to innovation and quality improvement to offering what many felt was the only safe way to deliver certain types of healthcare. A new practice emerged: a co-constitution of technology and healthcare made possible by new configurations of equipment, connectivity and physical spaces. Despite heterogeneous service settings and previous experiences of video consulting, we found certain kinds of common changes had made video consulting possible. We used practice theory to analyse these changes, interpreting the commonalities found in our data as changes in purpose, material arrangements and a relaxing of rules about security, confidentiality and location of consultations. The practice of video consulting was equivocal. Accounts of, and preferences for, video consulting varied as did the extent to which it was sustained after initial take-up. People made sense of video consulting in different ways, ranging from interpreting video as offering a new modality of healthcare for the future to a sub-optimal, temporary alternative to in-person care. Despite these variations, video consulting became a recognisable social phenomenon, albeit neither universally adopted nor consistently sustained. The nature of this social change offers new perspectives on processes of implementation and spread and scale-up. Our findings have important implications for the future of video consulting. We emphasise the necessity for viable material arrangements and a continued shared interpretation of the meaning of video consulting for the practice to continue.