Treatment of age-related macular degeneration with aflibercept using a treat, extend and fixed protocol; A 4-year study of treatment outcomes, durability, safety and quality of life (An extension to the MATE randomised controlled trial).

PURPOSE: Data are limited pertaining to the long-term benefits of aflibercept treatment for neovascular age-related macular degeneration (nAMD). The aim of this study was to provide outcomes, safety, durability and quality-of-life data with aflibercept using a modified treat, extend and fixed regime over 4 years. METHODS: Prospective, multicentre, single cohort observational study of treatment-naïve nAMD participants treated with aflibercept as 2-year extension of the MATE-trial that compared early and late Treat-and-Extend for 2 years. Refracted ETDRS best corrected visual acuity (BCVA), central retinal thickness (CRT), treatment interval and adverse events were assessed. Quality-of-life was measured using the Macular Disease Dependent Quality of Life (MacDQoL) and Macular Disease Treatment Satisfaction Questionnaires (MacTSQ). RESULTS: Twenty-six of 40 participants completing the MATE-trial were enrolled with 20 completing the total 4-year study. Mean BCVA was 60.7 at Month 0 and 64.8 ETDRS letters at Month 48 while CRT decreased from 423.7 µm to 292.2 µm. Five participants discontinued treatment due to inactivity. The mean number of treatments and visits for the remaining participants was 27 and 30.0, respectively, with treatment intervals extended to 12 weeks in four participants at Month 48. Both AMD-specific QoL and treatment satisfaction remained stable between Months 0 and 48 and mean BCVA significantly correlated with AMD-specific QoL scores at Months 12, 24 and 48. CONCLUSIONS: Results suggest that BCVA can be maintained over 48 months when following a treat-extend-and-fix regimen of aflibercept with intervals out to 12 weeks, while maintaining AMD-specific QoL and treatment satisfaction.

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

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.

A systematic review of barriers and enablers that health professionals experience to the delivery of type 2 diabetes care for adults with severe mental illness.

BACKGROUND: People with severe mental illness have a heightened risk for type 2 diabetes. They also experience poorer outcomes, including more diabetes complications, more emergency admissions, lower quality of life and excess mortality. AIMS: This systematic review aimed to identify health professionals' barriers to and enablers of delivering and organising type 2 diabetes care for people with severe mental illness. METHODS: Searches were conducted in Medline, EMBASE, PsycInfo, CINAHL, OVID Nursing, Cochrane Library, Google Scholar, OpenGrey, PsycExtra, Health Management Information Consortium and Ethos in March 2019, with updates in September 2019 and January 2023. There were no restrictions on study design, but studies were excluded if they did not include the perspective of health professionals or were not in English. Barriers and/or enablers of type 2 diabetes care for people with a severe mental illness were organised using the theoretical domains framework with additional inductive thematic coding. RESULTS: Twenty-eight studies were included in the review. Overall, eight domains were identified as important with barriers and enablers identified at individual, interpersonal and organisational levels. CONCLUSIONS: Focussing on providing a collaborative healthcare environment which actively supports type 2 diabetes care, fostering improved communication both between professionals and service users, ensuring clear boundaries around roles and responsibilities as well as individual skill and knowledge support alongside confidence building all offer opportunities to improve type 2 diabetes care.

A Systematic Review of Training Interventions for Emergency Department Providers and Psychosocial Interventions delivered by Emergency Department Providers for Patients who self-harm.

OBJECTIVES: People who self-harm frequently present to the emergency department (ED) and are treated by generalist healthcare staff with no specialist mental health training. We systematically reviewed (i) training interventions for generalist ED providers and (ii) psychosocial interventions delivered predominantly by generalist ED providers for people who self-harm. METHOD: Five databases were searched for studies reporting on training interventions for generalist ED staff (at least 50% of the sample needed to be generalist ED staff) or psychosocial interventions for people who self-harm delivered predominantly by generalist ED staff. No limitations were placed regarding study design/country. Narrative synthesis was conducted. RESULTS: Fifteen studies from high-income countries were included. Nine studies of moderate methodological quality evaluated training for generalist ED providers (n = 1587). Six studies of good methodological quality evaluated psychosocial interventions for adults who self-harm (n = 3133). Only one randomized controlled trial was identified. Training was linked with pre-post improvements in staff knowledge, and less consistently with improvement in skills, attitudes, and confidence. Evidence on patient outcomes was lacking. Patient-level interventions involving common suicide prevention strategies-safety planning and follow-up contact-were consistently linked to pre-post reductions in suicide attempts. Effects on treatment engagement and psychiatric admissions were unclear. CONCLUSIONS: There is a clear need for further RCTs to improve the evidence base for ED generalist providers managing patients with self-harm. Evidence supports potential benefits of training for improving staff knowledge, attitudes, and skills, and of safety planning and follow-up contact for reducing repeat suicide attempts. HIGHLIGHTSMore RCTs are needed to improve the evidence base for ED providers managing self-harmSafety planning and follow up contacts are linked to reductions in repeat suicide attemptsFuture research should investigate the impact of staff training on patient outcomes.