Evidence map›Paper›PMID 37081576›Full record

ArticlePilot and feasibility studies2023

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

Archana Airody, Heidi A Baseler, Julie Seymour, Victoria Allgar, Rajarshi Mukherjee, Louise Downey, Sushma Dhar-Munshi, Sajjad Mahmood, Konstantinos Balaskas, Theo Empeslidis and 5 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Archana AirodyAcademic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK. a.airody@nhs.net.
Heidi A BaselerDepartment of Psychology, University of York, York, UK.
Julie SeymourHull York Medical School, University of Hull, Hull, UK.
Victoria AllgarPeninsula Medical School, University of Plymouth, Plymouth, UK.
Rajarshi MukherjeeLeeds Teaching Hospital NHS Foundation Trust, Leeds, UK.
Louise DowneyHull and East Yorkshire NHS Trust, Hull, UK.
Sushma Dhar-MunshiKings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust, Sutton-in-Ashfield, UK.
Sajjad MahmoodUniversity of Manchester, Manchester, UK.
Konstantinos BalaskasNIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.
Theo EmpeslidisLeicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, UK.
Rachel L W HansonAcademic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK.
Tracey DoreyResearch and Development, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, UK.
Tom SzczerbickiResearch and Development, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, UK.
Sobha SivaprasadNIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.
Richard P GaleAcademic Unit of Ophthalmology, York & Scarborough Teaching Hospitals NHS Foundation Trust, York, YO31 8HE, UK.
York Teaching Hospital NHS Foundation Trust · GBUniversity of York · GBHull and East Yorkshire Hospitals NHS Trust · GBLeeds Teaching Hospitals NHS Trust · GBLeicester Royal Infirmary · GBNIHR Moorfields Biomedical Research Centre · GBSherwood Forest Hospitals NHS Foundation Trust · GBUniversity College London · GBUniversity of Hull · GBUniversity of Manchester · GBUniversity of Plymouth · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesIn 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/

methodsForty-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.

resultsThe 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.

conclusionThis 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.

Indexed as

Mixed methodologyNeovascular age-related macular degenerationPilotRandomised controlled trial

Identifiers

PMID37081576
PMCPMC10116669
OpenAlexW4366594145

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.