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, Annastazia E., Tufail, Adnan, Bunce, Catey, Keane, Pearse A., Kernohan, Ashleigh, Robinson, Emily, Jaber, Alijazy, Sadiq, Saqlain, Harper, Robert, Lawrenson, John, Vale, Luke, Waterman, Heather ORCID: https://orcid.org/0000-0001-7052-2734, Douiri, Abdel and Balaskas, Konstantinos 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. 10.1136/bmjopen-2021-049411

Preview

PDF - Published Version Available under License Creative Commons Attribution Non-commercial. Download (928kB) | Preview

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Healthcare Sciences
Additional Information:	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/
Publisher:	BMJ Publishing Group
ISSN:	2044-6055
Date of First Compliant Deposit:	9 June 2021
Date of Acceptance:	15 February 2021
Last Modified:	05 May 2023 16:17
URI:	https://orca.cardiff.ac.uk/id/eprint/141824

Citation Data

Cited 1 time in Scopus. View in Scopus. Powered By Scopus® Data

Actions (repository staff only)

Edit Item