How a randomised controlled trial (RCT) is explained to patients is a key determinant of recruitment to that trial. This study developed and implemented a simple six-step model to fully inform patients and to support them in deciding whether to take part.Ninety-two consultations with 60 new patients were recorded and analysed during a pilot RCT comparing surgical and non-surgical interventions for hip impingement. Recordings were analysed using techniques of thematic analysis and focused conversation analysis.Early findings supported the development of a simple six-step model to provide a framework for good recruitment practice. Model steps are: 1) Explain the condition; 2) Reassure patients about receiving treatment; 3) Establish uncertainty; 4) Explain the study purpose; 5) Give a balanced view of treatments and 6) Explain study procedures. There are also two elements throughout the consultation: i) Responding to patients' concerns and ii) showing confidence. The pilot study was successful, with 70% (n= 60) of patients approached across 9 centres agreeing to take part in the RCT, so that the full-scale trial was funded.The six-step model provides a promising framework for successful recruitment to RCTs. Further testing of the model is now required.
展开▼
