
The Library
A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented
Tools
Realpe, Alba, Adams, Ann, Wall, Peter D. H., Griffin, Damian R. and Donovan, Jenny (2016) A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented. Journal of Clinical Epidemiology . S0895-4356(16)00107-4. doi:10.1016/j.jclinepi.2016.02.002 ISSN 0895-4356.
![]() |
PDF
WRAP_PIIS0895435616001074.pdf - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (760Kb) |
Official URL: http://dx.doi.org/10.1016/j.jclinepi.2016.02.002
Abstract
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.
Item Type: | Journal Article | ||||||
---|---|---|---|---|---|---|---|
Subjects: | R Medicine > RA Public aspects of medicine | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||||
Library of Congress Subject Headings (LCSH): | Clinical trials, Orthopedics, Hip joint | ||||||
Journal or Publication Title: | Journal of Clinical Epidemiology | ||||||
Publisher: | Elsevier Inc. | ||||||
ISSN: | 0895-4356 | ||||||
Official Date: | February 2016 | ||||||
Dates: |
|
||||||
Number of Pages: | 9 | ||||||
Article Number: | S0895-4356(16)00107-4 | ||||||
DOI: | 10.1016/j.jclinepi.2016.02.002 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Funder: | National Institute for Health Research (Great Britain) (NIHR) | ||||||
Grant number: | 10/41/02 (NIHR) |
Request changes or add full text files to a record
Repository staff actions (login required)
![]() |
View Item |
Downloads
Downloads per month over past year