Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder viewsReportar como inadecuado




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Trials

, 12:144

First Online: 09 June 2011Received: 14 February 2011Accepted: 09 June 2011DOI: 10.1186-1745-6215-12-144

Cite this article as: Robotham, D., King, M., Canagasabey, A. et al. Trials 2011 12: 144. doi:10.1186-1745-6215-12-144

Abstract

BackgroundRandomised controlled trials RCTs are the gold standard of evidence-based practice in medicine but they have had limited influence in the field of intellectual disabilities. Previous literature suggests that participants and professionals have limited tolerance for this type of research methodology. However, it is not known how well service users, carers and other health professionals understand and accept the need for RCTs, and why it is important for individuals with intellectual disabilities to be included in this kind of research.

MethodsWe examined individual perceptions of RCTs in 51 participants 18 carers, 6 service users and 27 professionals using semi-structured interviews. A framework approach was adopted in the analysis of data.

ResultsWe found that participants had concerns about capacity and resource allocation but held positive views towards this type of research methodology. Understanding of the principles behind RCTs was poor amongst service users and a minority of carers, but mediated by previous exposure to research for professionals.

ConclusionsThe social validity of RCTs in intellectual disabilities may be compromised by lack of understanding of the design and the on-going concerns about obtaining informed consent especially in incapacitated adults. However, the overall finding that the need for this form of research was seen in a positive light suggests that there is a turning point in the perceptions of stakeholders working in intellectual disabilities services. We recommend that researchers include on-going education on RCT design during trials, tailoring it to all stakeholders with emphasis on strong service user and care involvement. This could be a pivotal element in improving acceptability of, and recruitment to RCTs.

List of abbreviationsRCTRandomised Controlled Trial

REBILDThe Randomised Evaluation of a Behaviour Intervention for Learning Disabilities

TAUTreatment as usual.

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Autor: Dan Robotham - Michael King - Anton Canagasabey - Sophie Inchley-Mort - Angela Hassiotis

Fuente: https://link.springer.com/







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