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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
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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 Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School |
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| 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: |
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| 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 | ||||||
| Funder: | National Institute for Health Research (Great Britain) (NIHR) | ||||||
| Grant number: | 10/41/02 (NIHR) |
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