title: A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented.
abstract: How a randomized 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 or not.
  
  
  
  Ninety-two consultations with 60 new patients were recorded and analyzed during a pilot RCT comparing surgical and nonsurgical interventions for hip impingement. Recordings were analyzed 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 as follows: (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: (1) responding to patients' concerns and (2) showing confidence. The pilot study was successful, with 70% (n = 60) of patients approached across nine centers 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.
authors.affiliation: Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.
authors.forename: Alba
authors.initials: A
authors.lastname: Realpe
authors.affiliation: Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.
authors.forename: Ann
authors.initials: A
authors.lastname: Adams
authors.affiliation: Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Wall
authors.affiliation: Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom. Electronic address: Damian.Griffin@warwick.ac.uk.
authors.forename: Damian
authors.initials: D
authors.lastname: Griffin
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, Bristol, United Kingdom.
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
mesh_terms: D035843:Biomedical Research; D057925:Femoracetabular Impingement / Q000601:surgery*; D006801:Humans; D010353:Patient Education as Topic / Q000379:methods*; D018579:Patient Selection; D010865:Pilot Projects; D016730:Program Development; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D006113:United Kingdom
keywords: Consultation; Femoroacetabular impingement; Hip impingement; Orthopedics; Qualitative research; Recruitment to randomized controlled trials