title: Conducting randomised controlled trials: finding better ways to explain research to people with anti-social personality disorder who have low literacy levels.
abstract: BACKGROUND
  The involvement of people with anti-social personality disorder (ASPD) in clinical trials is necessary to developing effective treatment. Low literacy level, however, may be a barrier to their understanding and therefore their engagement in research.
  
  
  OBJECTIVE
  Our aim was to find a preferred and most easily understandable way of communicating about research participation with men who have ASPD.
  
  
  METHODS
  Twenty-five men with ASPD who were using mental health services, research experienced and research naïve participated in the study. Literacy levels were assessed. A list of research terms was generated, and statements were developed to ascertain if the terms were understood. The research terms were 'randomisation', 'informed consent', 'confidentiality' and a research question 'why carry out research?' The participants ranked their preferred way of explaining these terms and the method of communicating these.
  
  
  RESULTS
  Those with research experience understood the research terms better. The research naïve and the research experienced men differed in literacy level. Those with below average literacy preferred shorter wordings of research terms than those with average literacy and answered fewer questions correctly. The majority stated a preference for discussion with a researcher before agreeing to take part in research. The least preferred communication methods were those that relied on technology.
  
  
  CONCLUSIONS
  Researchers should be able to find and use terms that are readily understood and do so. Low literacy levels impair understanding of research terms.
authors.affiliation: Mental Health and Wellbeing, University of Glasgow, Academic Centre, Gartnavel Royal Hospital, Glasgow, UK. kate.davidson@glasgow.ac.uk
authors.forename: Kate M
authors.initials: KM
authors.lastname: Davidson
authors.forename: Carolyn J
authors.initials: CJ
authors.lastname: Espie
authors.forename: Claire
authors.initials: C
authors.lastname: Lammie
mesh_terms: D000328:Adult; D000987:Antisocial Personality Disorder / Q000523:psychology*; D003142:Communication; D003219:Confidentiality; D004522:Educational Status; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic