title: Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder views.
abstract: BACKGROUND
  Randomised 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  We 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Mental Health Foundation, Sea Containers House, 20 Upper Ground, London SE1 9QB, UK. Drobotham@mhf.org.uk
authors.forename: Dan
authors.initials: D
authors.lastname: Robotham
authors.forename: Michael
authors.initials: M
authors.lastname: King
authors.forename: Anton
authors.initials: A
authors.lastname: Canagasabey
authors.forename: Sophie
authors.initials: S
authors.lastname: Inchley-Mort
authors.forename: Angela
authors.initials: A
authors.lastname: Hassiotis
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D017028:Caregivers / Q000523:psychology*; D032882:Comprehension; D006233:Persons with Disabilities / Q000523:psychology*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000523:psychology*; D006301:Health Services Needs and Demand; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent; D008607:Intellectual Disability / Q000523:psychology / Q000628:therapy*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010465:Perception; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012945:Social Values; D006113:United Kingdom; D055815:Young Adult