Realpe, Alba, Adams, Ann, Wall, Peter D. H., Griffin, Damian R. and Donovan, Jenny (2015) What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs. Trials, 16 (Suppl 2). O21. doi:10.1186/1745-6215-16-S2-O21 ISSN 1745-6215.

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Abstract

Objective:

The mode of delivery of trial information is a key determinant of recruitment to randomised controlled trials (RCTs), which can be modified in order to encourage patients to participate. This paper presents the development and initial validation of a simple six-step model to support recruitment.

Study design and setting:

92 recruitment 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 pioneered in previous studies. Analysis of recordings continued during the full-scale trial.

Results:

The pilot study was successful, with 70% of patients approached across 9 centres agreeing to take part in the RCT, and the full-scale trial has achieved 75% recruitment in 19 centres. A simple six-step model providing a framework for good recruitment practice was developed at the pilot phase and then validated, and tested in the main trial. The model enabled recruiters to explain the design and conduct of the RCT and provide reassuring information for patients in the context of consultations very different from routine practice.

Conclusion:

The six-step model provides a useful framework for recruitment to RCTs. It encourages the implementation of good RCT recruitment practice and provides strategies to support recruiters. The model requires further testing in a wide range of RCTs and clinical contexts.

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 > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials
Journal or Publication Title:	Trials
Publisher:	Biomed Central
ISSN:	1745-6215
Official Date:	16 November 2015
Dates:	Date Event 16 November 2015 Published
Volume:	16
Number:	Suppl 2
Number of Pages:	1
Page Range:	O21
DOI:	10.1186/1745-6215-16-S2-O21
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Funder:	National Institute for Health Research (Great Britain) (NIHR)

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