Target Product Profile for a Machine Learning–Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study

Trystan Macdonald   ^{1, 2, 3} , MBChB ;   Jacqueline Dinnes   ³ , MSc, PhD ;   Gregory Maniatopoulos   ⁴ , PhD ;   Sian Taylor-Phillips   ⁵ , PhD ;   Bethany Shinkins   ⁵ , PhD ;   Jeffry Hogg   ⁶ , MBBS, MRes ;   John Kevin Dunbar   ⁷ , MBChB ;   Ameenat Lola Solebo   ^{8, 9} , PhD ;   Hannah Sutton   ¹⁰ , BA ;   John Attwood   ¹¹ , MA ;   Michael Pogose   ¹² , MSc ;   Rosalind Given-Wilson   ¹³ , MBBS ;   Felix Greaves   ^{14, 15} , PhD ;   Carl Macrae   ¹⁶ , PhD ;   Russell Pearson   ¹⁷ , PhD ;   Daniel Bamford   ⁷ , MA ;   Adnan Tufail   ^{9, 18} , MD ;   Xiaoxuan Liu   ^{1, 2, 3 *} , PhD ;   Alastair K Denniston   ^{1, 2, 3, 19, 20 *} , PhD

¹ Ophthalmology Department, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham National Health Service Foundation Trust, Birmingham, United Kingdom

² Academic Unit of Ophthalmology, Institute of Inflammation and Aging, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom

³ National Institute for Health and Care Research Birmingham Biomedical Research Centre, Birmingham, United Kingdom

⁴ School of Business, University of Leicester, Leicester, United Kingdom

⁵ Warwick Medical School, University of Warwick, Coventry, United Kingdom

⁶ Population Health Sciences Institute, Faculty of Medical Sciences, The University of Newcastle upon Tyne, Newcastle, United Kingdom

⁷ NHS England, Leeds, United Kingdom

⁸ Population Policy and Practice, University College London Great Ormond Street Institute of Child Health, London, United Kingdom

⁹ Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom

¹⁰ Lay member, Oxford, United Kingdom

¹¹ Alder Hey Children’s Hospital, Alder Hey Children’s Hospital NHS Foundation Trust, Liverpool, United Kingdom

¹² Hardian Health, London, United Kingdom

¹³ St. George’s University Hospitals National Health Service Foundation Trust, London, United Kingdom

¹⁴ National Institute for Health and Care Excellence, London, United Kingdom

¹⁵ Faculty of Medicine, School of Public Health, Imperial College London, London, United Kingdom

¹⁶ Nottingham University Business School, University of Nottingham, Nottingham, United Kingdom

¹⁷ Medicines and Healthcare Products Regulatory Agency, London, United Kingdom

¹⁸ Institute of Ophthalmology, University College London, London, United Kingdom

¹⁹ Centre for Regulatory Science and Innovation, Birmingham Health Partners, Birmingham, United Kingdom

²⁰ National Institute for Health and Care Research Biomedical Research Centre at Moorfields and University College London Institute of Ophthalmology, London, United Kingdom

*these authors contributed equally