Publications by authors named "Ben Hardwick"

Background: Randomised controlled trials (RCTs) often struggle with recruitment and many need extensions which leads to delayed implementation of effective interventions. Recruitment to complex intervention trials have similar difficulties. Alongside this, the COVID-19 pandemic had a major impact upon trial recruitment.

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Introduction: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group.

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Oral supplementation with L-citrulline, which is sequentially converted to L-arginine then nitric oxide, improves vascular biomarkers and reduces blood pressure in non-pregnant, hypertensive human cohorts and pregnant mice with a pre-eclampsia-like syndrome. This early-phase randomised feasibility trial assessed the acceptability of L-citrulline supplementation to pregnant women with chronic hypertension and its effects on maternal BP and other vascular outcomes. Pregnant women with chronic hypertension were randomised at 12-16 weeks to receive 3-g L-citrulline twice daily (n = 24) or placebo (n = 12) for 8 weeks.

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Introduction: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).

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Background: Uveitis associated with juvenile idiopathic arthritis is a cause of major ocular morbidity. A substantial proportion of children are refractory to systemic methotrexate and TNF inhibitors. Our aim was to study the safety and efficacy of tocilizumab in children with juvenile idiopathic arthritis-associated uveitis refractory to both methotrexate and TNF inhibitors.

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Background: People with advanced dementia who live and die in nursing homes experience variable quality of life, care and dying. There is a need to identify appropriate, cost-effective interventions that facilitate high-quality end-of-life care provision.

Objectives: To establish the feasibility and acceptability to staff and family of conducting a cluster randomised controlled trial of the Namaste Care intervention for people with advanced dementia in nursing homes.

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Article Synopsis
  • The study aimed to assess the long-term effects of adalimumab treatment in children with uveitis linked to juvenile idiopathic arthritis (JIA-U) after discontinuation of the trial medication in the SYCAMORE trial.
  • Researchers examined the medical records of 28 participants over a period of up to 5 years, focusing on uveitis activity, treatment changes, visual outcomes, complications, and adverse events.
  • Results showed that most participants resumed adalimumab treatment due to active JIA-U after stopping the investigational drug, and while one case resulted in a vision loss, the overall visual acuity measurements were largely positive.
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Article Synopsis
  • - The study examines the effectiveness, safety, and cost-effectiveness of adalimumab combined with methotrexate against a placebo with methotrexate in treating refractory uveitis in children with juvenile idiopathic arthritis (JIA).
  • - Conducted as a randomized, double-blind, placebo-controlled trial across multiple UK centers, it involved patients aged 2-18 with ongoing JIA-associated uveitis despite optimized methotrexate treatment.
  • - The primary goal was to measure the time to treatment failure using a specific scoring system, while also evaluating the economic impact based on quality-adjusted life-years (QALY) gained from the NHS perspective.
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Background: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of intraocular inflammation (uveitis). In the initial stages of mild-moderate inflammation uveitis is asymptomatic.

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Introduction: Many people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia.

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Purpose: To investigate the cost effectiveness of adalimumab in combination with methotrexate, compared with methotrexate alone, for the management of uveitis associated with juvenile idiopathic arthritis (JIA).

Design: A cost-utility analysis based on a clinical trial and decision analytic model.

Participants: Children and adolescents 2 to 18 years of age with persistently active uveitis associated with JIA, despite optimized methotrexate treatment for at least 12 weeks.

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Learning theorists posit two reinforcement learning systems: model-free and model-based. Model-based learning incorporates knowledge about structure and contingencies in the world to assign candidate actions with an expected value. Model-free learning is ignorant of the world's structure; instead, actions hold a value based on prior reinforcement, with this value updated by expectancy violation in the form of a reward prediction error.

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Background: Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis.

Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis.

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Background: Despite optimal therapy, many children with Crohn's disease (CD) experience growth retardation. The objectives of the study are to assess the feasibility of a randomised control trial (RCT) of injectable forms of growth-promoting therapy and to survey the attitudes of children with CD and their parents to it.

Methods: A feasibility study was carried out to determine study arms, sample size and numbers of eligible patients.

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Background: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of inflammation of the uvea in the eye (uveitis). Overall, 20% to 25% of paediatric uveitis is associated with JIA.

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