Learoyd, Annastazia E; Tufail, Adnan; Bunce, Catey; Keane, Pearse A; Kernohan, Ashleigh; Robinson, Emily; Jaber, Alijazy; Sadiq, Saqlain; Harper, Robert; Lawrenson, John; +5 more... Vale, Luke; Waterman, Heather; Douiri, Abdel; Balaskas, Konstantinos; 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. ISSN 2044-6055 DOI: https://doi.org/10.1136/bmjopen-2021-049411
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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.
Item Type | Article |
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Faculty and Department | Faculty of Public Health and Policy > Dept of Health Services Research and Policy |
PubMed ID | 33980536 |
Elements ID | 212111 |
Official URL | http://dx.doi.org/10.1136/bmjopen-2021-049411 |
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Filename: Learoyd-etal-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.pdf
Licence: Creative Commons: Attribution-Noncommercial 4.0
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