FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial
,
Martin McKibbin,
Catey Bunce,
Adnan Tufail,
Heather Waterman,
Pearse A Keane,
Aled Jones,
Luke Vale,
Praveen J Patel,
Konstantinos Balaskas,
Abdel Douiri,
John Lawrenson,
Claire Bailey,
Faruque Ghanchi,
Richard P Gale,
Robin Hamilton,
Robert Harper,
Simon Read,
Emily Robinson,
Sajjad Mahmood,
Dawn Sim,
Janet Peacock,
Annastazia E Learoyd,
Ashleigh Kernohan,
Alijazy Jaber,
Saqlain Sadiq,
Serena Salvatore
Affiliations
Institute of Inflammation and Ageing, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Martin McKibbin
Catey Bunce
Primary Care and Public Health Sciences, Kings College London, London, UK
Adnan Tufail
2Medical Retina Department, Moorfields Eye Hospital NHS Trust, London, UK
Heather Waterman
3 Healthcare Sciences, Cardiff University, Cardiff, UK
Pearse A Keane
6 Institute of Ophthalmology, University College London, London, UK
Aled Jones
School of Nursing and Midwifery, Faculty of Health, University of Plymouth, Plymouth, UK
Luke Vale
4 Newcastle University, Newcastle upon Tyne, UK
Praveen J Patel
7 NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK
Konstantinos Balaskas
NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust, London, UK
Abdel Douiri
School of Population Health and Environmental Sciences, King`s College London, London, UK
John Lawrenson
Dvision of Optometry and Visual Science, City University of London, London, UK
Claire Bailey
Faruque Ghanchi
Richard P Gale
Robin Hamilton
Moorfields Eye Hospital, Moorfields Eye Hospital NHS Foundation Trust, London, UK
Robert Harper
Manchester Royal Eye Hospital, Manchester Academic Health Sciences Centre, Manchester, UK
Simon Read
Emily Robinson
School of Population Health & Environmental Sciences, King’s College London, London, UK
Sajjad Mahmood
Dawn Sim
NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK
Janet Peacock
Annastazia E Learoyd
School of Population Health and Environmental Sciences, King`s College London, London, UK
Ashleigh Kernohan
4 Newcastle University, Newcastle upon Tyne, UK
Alijazy Jaber
NIHR Biomedical Reserch Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
Saqlain Sadiq
NIHR Biomedical Reserch Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
Objective Management of age-related macular degeneration (AMD) places a high demand on already constrained hospital-based eye services. This study aims to assess the safety and quality of follow-up within the community led by suitably trained non-medical practitioners for the management of quiescent neovascular AMD (QnAMD).Methods/design This is a prospective, multisite, randomised clinical trial. 742 participants with QnAMD will be recruited and randomised to either continue hospital-based secondary care or to receive follow-up within a community setting. Participants in both groups will be monitored for disease reactivation over the course of 12 months and referred for treatment as necessary. Outcomes measures will assess the non-inferiority of primary care follow-up accounting for accuracy of the identification of disease reactivation, patient loss to follow-up and accrued costs and the budget impact to the National Health Service.Ethics and dissemination Research ethics approval was obtained from the London Bloomsbury Ethics Committee. The results of this study will be disseminated through academic peer-reviewed publications, conferences and collaborations with eye charities to insure the findings reach the appropriate patient populations.Trial registration number NCT03893474.
