Randomized Controlled Trials in People with ID Sample Clauses

Randomized Controlled Trials in People with ID. The revised guidance recommended greater consideration of alternatives to randomized controlled trials in complex interventions. There have been very few randomized controlled trials involving people with ID (Xxxxxxxxx & Xxxxxxx, 2010). Xxxxxxxx et al. (2011) highlighted the under-recruitment or high dropout rates of people with ID in these studies. Xxxxxx et al. (2005) described factors that act as barriers to using this study design including paid carers acting as 'gatekeepers' and lack of understanding of the methodology among service users and carers. Xxxxxx- Xxxxxxxx et al. (2009) argued that stakeholders in specialist ID services can be hostile to randomized controlled trials. Although some service users with ID may understand some aspects of randomized controlled trials (Xxxxxx et al. 2006) it may be that pharmacological studies are easier to be understood and supported by them and their carers compared to relatively more complex interventions. Xxxxxxxx et al. (2011) elicited the perceptions of professionals, carers and service users about randomized controlled trials and found generally positive views except for concerns about capacity and resources. Understanding of the methodology though, for example about random allocation to intervention and control groups, was poor among service users and some carers. Randomized controlled trials are certainly desirable to strengthen the evidence base of services for people with ID and mental health problems but they need to be considered in a balanced way. They need to be given a proper foundation and often this will necessitate evidence from study designs further back in the research continuum as occurred in this MD (Res) research programme.
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