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

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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.

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Official URL: http://dx.doi.org/10.1016/j.jclinepi.2016.02.002

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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:
DateEvent
February 2016Published
12 February 2016Accepted
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)

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