Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT.

Background: Licensed ranibizumab (0.5 mg/0.05 ml Lucentis; Novartis International AG, Basel, Switzerland) and aflibercept (2 mg/0.

Clinical Effectiveness of Intravitreal Therapy With Ranibizumab vs Aflibercept vs Bevacizumab for Macular Edema Secondary to Central Retinal Vein Occlusion: A Randomized Clinical Trial.

Importance: The comparative clinical effectiveness of ranibizumab, aflibercept, and bevacizumab for the management of macular edema due to central retinal vein occlusion (CRVO) is unclear.

Objective: To determine whether intravitreal aflibercept or bevacizumab compared with ranibizumab results in a noninferior mean change in vision at 100 weeks for eyes with CRVO-related macular edema.

Design, Setting, And Participants: This prospective, 3-arm, double-masked, randomized noninferiority trial (Lucentis, Eylea, Avastin in Vein Occlusion [LEAVO] Study) took place from December 12, 2014, through December 16, 2016, at 44 UK National Health Service ophthalmology departments.

Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality.

'Assumptions are made and most assumptions are wrong' (Albert Einstein) Clinical trial conduct must be consistent with trial design, yet conducting the trial according to plan remains a major challenge.We discuss the importance of optimal co-applicant team formation in trial leadership, appropriate delegation of tasks and staff supervision arrangements. Finally, we discuss five standard documents which we believe require particular attention.

Dementia and Imagination: a mixed-methods protocol for arts and science research.

Introduction: Dementia and Imagination is a multidisciplinary research collaboration bringing together arts and science to address current evidence limitations around the benefits of visual art activities in dementia care. The research questions ask: Can art improve quality of life and well-being? If it does make a difference, how does it do this-and why? Does it have wider social and community benefits?

Methods And Analysis: This mixed-methods study recruits participants from residential care homes, National Health Service (NHS) wards and communities in England and Wales. A visual art intervention is developed and delivered as 1×2-hour weekly group session for 3 months in care and community settings to N=100 people living with dementia.

REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

Background: Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.

Methods: This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group.

Self- and Carer-Rated Pain in People With Dementia: Influences of Pain in Carers.

Context: Although pain is frequent in people with dementia (PwD), evidence on the prevalence and factors influencing ratings of pain in dementia is limited. Carer variables are often associated with bias in proxy ratings of pain, but few studies have examined the role of caregiver pain in influencing these ratings.

Objectives: This study explored the prevalence of pain in PwD in a large U.

The use of the EQ-5D as a measure of health-related quality of life in people with dementia and their carers.

Purpose: To assess the acceptability, validity and inter-rater agreement of self- and family carer proxy ratings of the EQ-5D as a generic health-related quality of life (HRQOL) measure, in people with mild to moderate dementia (PwD) living in the community. A secondary aim was to identify the most important factors influencing self- and family carer proxy ratings of HRQOL, distinguishing between spouse and adult child caregiver ratings.

Methods: Cross-sectional study of 488 dyads using the EQ-5D.

Qualitative exploration of the suitability of capability based instruments to measure quality of life in family carers of people with dementia.

Background. In an ageing population, many individuals find themselves becoming a carer for an elderly relative. This qualitative study explores aspects of quality of life affected by caring for a person with dementia, with the aim of identifying whether capability based questionnaires are suitable for measuring carer quality of life.

Self and carer perspectives of quality of life in dementia using the QoL-AD.

Objective: Quality of life (QoL) is one of the most important outcomes in improving well-being in people with dementia (PwD). The primary aim of the present study was to compare self and carer ratings of QoL in PwD and to identify the most important factors influencing self and carer ratings.

Methods: We conducted a cross-sectional analytic study of 488 dyads using the Quality of Life in Alzheimer's Disease scale, demographics, data on self-rated health, and clinical characteristics.

Health economics research into supporting carers of people with dementia: a systematic review of outcome measures.

Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups.

The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial.

Background: Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions.

Methods/design: This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting.

A systematic review of the cost-effectiveness of interventions for supporting informal caregivers of people with dementia residing in the community.

Background: Dementia places a huge demand on healthcare services; however, a large proportion of the cost is borne by informal caregivers. With the number of people affected by dementia set to increase in the future, there is a need for research to consider the effects of interventions on informal caregivers as well as on the individuals with dementia. This paper seeks to systematically review the existing evidence on the cost-effectiveness of interventions to support informal caregivers of people with dementia residing in the community.

Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol.

Background: The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication has negative side-effects. Reminiscence groups, run by professionals and volunteers, which use photographs, recordings and other objects to trigger personal memories are probably the most popular therapeutic approach to working with people with dementia, but there is little evidence for their effectiveness and cost-effectiveness.

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units.

Background: There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest.

Comparative assessment of migrant farm worker health in conventional and organic horticultural systems in the United Kingdom.

This study describes the self-reported health and well-being status of field and packhouse workers in UK vegetable horticulture, and tests the null hypothesis that there is no difference in the self-reported health of workers on organic and conventional horticultural farms. The majority of those sampled were migrant workers (93%) from Bulgaria, Latvia, Lithuania, Poland, Russia and the Ukraine. More than 95% of the respondents were aged 18-34 and recruited through university agricultural faculties in East European or employed via UK agencies.

Economic evaluation of treatments for children with severe behavioural problems.

Background: Disruptive behaviour disorders, including conduct disorder, affect at least 10% of children and are the most common reasons for referral to children's mental health services. The long-term economic impact on society of unresolved conduct disorder can exceed pound sterling 1 million for one individual over their lifetime.

Aims Of The Study: The aim of this study was to estimate, from a multi-sectoral service perspective, the longer term cost-effectiveness of an intensive practice based parenting programme for children with severe behavioural problems as compared to a standard treatment, on a pilot basis.

Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial.

Background: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended.