The MATE trial: a multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration.

Autor: Airody A; Academic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK. a.airody@nhs.net., Baseler HA; Department of Psychology, University of York, York, UK.; Hull York Medical School, University of York, York, UK., Seymour J; Hull York Medical School, University of Hull, Hull, UK., Allgar V; Peninsula Medical School, University of Plymouth, Plymouth, UK., Mukherjee R; Leeds Teaching Hospital NHS Foundation Trust, Leeds, UK., Downey L; Hull and East Yorkshire NHS Trust, Hull, UK., Dhar-Munshi S; Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust, Sutton-in-Ashfield, UK., Mahmood S; University of Manchester, Manchester, UK., Balaskas K; NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK., Empeslidis T; Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, UK., Hanson RLW; Academic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK., Dorey T; Research and Development, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, UK., Szczerbicki T; Research and Development, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, UK., Sivaprasad S; NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK., Gale RP; Academic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK.; Hull York Medical School, University of York, York, UK.
Jazyk: angličtina
Zdroj: Pilot and feasibility studies [Pilot Feasibility Stud] 2023 Apr 20; Vol. 9 (1), pp. 63. Date of Electronic Publication: 2023 Apr 20.
DOI: 10.1186/s40814-023-01288-0
Abstrakt: Background/objectives: In healthcare research investigating complex interventions, gaps in understanding of processes can be filled by using qualitative methods alongside a quantitative approach. The aim of this mixed-methods pilot trial was to provide feasibility evidence comparing two treatment regimens for neovascular age-related macular degeneration (nAMD) to inform a future large-scale randomised controlled trial (RCT).
Subjects/methods: Forty-four treatment-naïve nAMD patients were followed over 24 months and randomised to one of two treatment regimens: standard care (SC) or treat and extend (T&E). The primary objective evaluated feasibility of the MATE trial via evaluations of screening logs for recruitment rates, nonparticipation and screen fails, whilst qualitative in-depth interviews with key study staff evaluated the recruitment phase and running of the trial. The secondary objective assessed changes in visual acuity and central retinal thickness (CRT) between the two treatment arms.
Results: The overall recruitment rate was 3.07 participants per month with a 40.8% non-participation rate, 18.51% screen-failure rate and 15% withdrawal/non-completion rate. Key themes in the recruitment phase included human factors, protocol-related issues, recruitment processes and challenges. Both treatment regimens showed a trend towards a visual acuity gain at month 12 which was not maintained at month 24, whilst CRT reduced similarly in both regimens over the same time period. These were achieved with one less treatment following a T&E regimen.
Conclusion: This mixed-methodology, pilot RCT achieved its pre-defined recruitment, nonparticipation and screen failure rates, thus deeming it a success. With some minor protocol amendments, progression to a large-scale RCT will be achievable.
(© 2023. The Author(s).)
Databáze: MEDLINE
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