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.

Learoyd, A. E., Tufail, A., Bunce, C. , Keane, P. A., Kernohan, A., Robinson, E., Jaber, A., Sadiq, S., Harper, R. A., Lawrenson, J. ORCID: 0000-0002-2031-6390, Vale, L., Waterman, H., Douiri, A., Balaskas, K. & FENETRE study group, (2021). 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.. BMJ Open, 11(5), e049411. doi: 10.1136/bmjopen-2021-049411

Abstract

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.

Publication Type:	Article
Additional Information:	© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
Subjects:	R Medicine > RC Internal medicine R Medicine > RE Ophthalmology
Departments:	School of Health & Psychological Sciences > Optometry & Visual Sciences