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Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Trials volume 16, Article number: O21 (2015) | Download Citation

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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.

Author information

Affiliations

  1. University of Warwick, Coventry, UK

    • Alba Realpe
    • , Ann Adams
    • , Peter Wall
    •  & Damian Griffin

  2. University of Bristol, Bristol, UK

    • Jenny L Donovan

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Corresponding author

Correspondence to Alba Realpe.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Keywords

  • Information Sharing
  • Thematic Analysis
  • Routine Practice
  • Clinical Context
  • Pilot Phase

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