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

作者：Realpe Alba; Adams Ann; Wall Peter; Griffin Damian^*; Donovan Jenny L

来源：Journal of Clinical Epidemiology, 2016, 76: 166-174.

DOI：10.1016/j.jclinepi.2016.02.002

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

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 = 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.

• 出版日期2016-8