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

Abstract 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...

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Bibliographic Details
Published in:Journal of clinical epidemiology 2016-08, Vol.76, p.166-174
Main Authors: Realpe, Alba, Adams, Ann, Wall, Peter, Griffin, Damian, Donovan, Jenny L
Format: Article
Language:English
Subjects:
Biomedical Research
Clinical medicine
Consultation
Design
Epidemiology
Feasibility studies
Femoracetabular Impingement - surgery
Femoroacetabular impingement
Hip impingement
Hospitals
Humans
Internal Medicine
Medical research
Original
Orthopedics
Patient Education as Topic - methods
Patient Selection
Patients
Pilot Projects
Program Development
Qualitative research
Randomized Controlled Trials as Topic - methods
Recruitment to randomized controlled trials
Surgery
United Kingdom
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Summary:Abstract 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.
ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2016.02.002