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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

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posted on 2024-03-06, 09:54 authored by Henry David Jeffry Hogg, Katie Brittain, Dawn Teare, James Talks, Konstantinos Balaskas, Pearse Keane, Gregory Maniatopoulos
IntroductionNeovascular 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 analysisSingle-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 disseminationNHS 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.

Funding

A mixed methods validation of technology enhanced macula services

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History

Citation

BMJ Open 2023;13:e069443

Author affiliation

School of Business

Version

  • VoR (Version of Record)

Published in

BMJ Open

Volume

13

Issue

2

Publisher

BMJ

issn

2044-6055

eissn

2044-6055

Acceptance date

2023-01-16

Copyright date

2023

Available date

2024-03-06

Language

en

Deposited by

Professor Gregory Maniatopoulos

Deposit date

2024-03-04

Rights Retention Statement

  • No

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