Dose‐escalation strategies which use subgroup information

Dose‐escalation trials commonly assume a homogeneous trial population to identify a single recommended dose of the experimental treatment for use in future trials. Wrongly assuming a homogeneous population can lead to a diluted treatment effect. Equally, exclusion of a subgroup that could in fact benefit from the treatment can cause a beneficial treatment effect to be missed. Accounting for a potential subgroup effect (ie, difference in reaction to the treatment between subgroups) in dose‐escalation can increase the chance of finding the treatment to be efficacious in a larger patient population. A standard Bayesian model‐based method of dose‐escalation is extended to account for a subgroup effect by including covariates for subgroup membership in the dose‐toxicity model. A stratified design performs well but uses available data inefficiently and makes no inferences concerning presence of a subgroup effect. A hypothesis test could potentially rectify this problem but the small sample sizes result in a low‐powered test. As an alternative, the use of spike and slab priors for variable selection is proposed. This method continually assesses the presence of a subgroup effect, enabling efficient use of the available trial data throughout escalation and in identifying the recommended dose(s). A simulation study, based on real trial data, was conducted and this design was found to be both promising and feasible.     

An Employment Project as a Route to Social Inclusion for People with Learning Difficulties?

Government policy to reduce social exclusion focuses on increasing employment opportunities and incentives, especially for disadvantaged groups. This paper discusses the findings of an evaluation of a project in the North West of England for people with learning difficulties, which sought to create opportunities for paid and/or integrated employment. The findings suggest that this goal can be undermined by many factors such as the isolation of social care services from employers and the disinclination of service organisations to include users, carers and staff in the development of new service approaches. Social welfare policies also mitigate against this aim, by failing to enable providers to translate the rhetoric of social inclusion into a reality. We discuss some of the obstacles preventing people with learning difficulties from inclusion into mainstream employment, by considering their impact upon the achievements of the North West project.     

Reviewing Respite Services: some lessons from the literature

Although the community care reforms raised the profile of respite services for adults with learning disabilities, little is known about the character of respite provision in Britain. This lack of information is compounded by the way the literature about respite is dispersed across user groups and is often restricted to particular types of services or to specific localities. In order to highlight some of the key issues associated with respite, this paper draws on a wide range of literature. Regardless of differences in terms of the service user groups, common themes are identified which are relevant to service planning and provision for adults with learning disabilities. The paper discusses these themes and argues that a break with the traditional notion of respite as primarily a way to relieve carer burden is long overdue. Adopting the perspective of the primary service users affords the opportunity to re-think respite services.