A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented

Alba Realpe, Ann Adams, Peter Wall, Damian Griffin, Jenny Donovan

Research output: Contribution to journalArticle (Academic Journal)peer-review

25 Citations (Scopus)
261 Downloads (Pure)


Objectives: 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.
Study Design and Setting: 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.
Results: 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 5 60) of patients approached across nine centers agreeing to take part in the RCT, so that the full-scale trial was funded.
Conclusion: The six-step model provides a promising framework for successful recruitment to RCTs. Further testing of the model is now required.
Original languageEnglish
Pages (from-to)166-174
Number of pages9
JournalJournal of Clinical Epidemiology
Early online date17 Feb 2016
Publication statusPublished - Aug 2016

Structured keywords

  • ConDuCT-II
  • Centre for Surgical Research


  • Recruitment to randomized controlled trials
  • Orthopedics
  • Hip impingement
  • Femoroacetabular impingement
  • Consultation
  • Qualitative research


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