RANDOM ALLOCATION OR ALLOCATION AT RANDOM - PATIENTS PERSPECTIVES OF PARTICIPATION IN A RANDOMIZED CONTROLLED TRIAL

Objectives To explore trial participants' understandings of randomisat ion. Design In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews w ere recorded on audio tape and fully transcribed. Data were analysed b y comparing transcripts and describing emergent themes, using a ground ed theory approach. Setting The CLasP study comprises three linked mul ticentre, pragmatic randomised controlled trials evaluating the effect iveness and cost effectiveness of laser therapy standard surgery and c onservative management for men with lower urinary tract symptoms or ur inary retention, or both, related to benign prostatic disease. Subject s 20 participants in the CLasP study were interviewed. Sampling was pu rposeful: men were included from each of the treatment arms, the two m ajor centres, and at different points in the trial. Interventions and outcome measures Interviews used a checklist of topics to encourage pa rticipants to describe their experiences. Narratives concerning random isation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Results Most part icipants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many foun d the concept of randomisation difficult, however, and developed alter native lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms cau sed confusion. Conclusions The provision of clear and accurate patient information is important, but this alone will not ensure consistent i nterpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them full y enough to give bury informed consent