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Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study
Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

Background: Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. Methods: A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach. Results: Responses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: 'security and transparency'; 'inclusivity and engagement'; 'human interaction'; 'obstacles and risks'; and 'potential benefits'. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants. Conclusions: Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

Clinical trials unit, Digital tool, Participant recruitment, Participant retention, Qualitative, Survey
1745-6215
Blatch-Jones, Amanda
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Nuttall, Jacqueline
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Bull, Abby
392ffd4a-38bc-4a80-abd9-cfdfc05c3ada
Worswick, Louise
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Mullee, Mark
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Peveler, Robert
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Falk, Stephen
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Tape, Neil
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Hinks, Jeremy
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Lane, Athene J.
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Wyatt, Jeremy C.
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Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Blatch-Jones, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Nuttall, Jacqueline
154aec0a-05f2-4379-918e-9c36767fdc4c
Bull, Abby
392ffd4a-38bc-4a80-abd9-cfdfc05c3ada
Worswick, Louise
c776b523-c340-4c7c-bf27-1c8a6f97c2c1
Mullee, Mark
fd3f91c3-5e95-4f56-8d73-260824eeb362
Peveler, Robert
93198224-78d9-4c1f-9c07-fdecfa69cf96
Falk, Stephen
6bda4f5d-d5b0-4558-89d3-9e32cacf202a
Tape, Neil
50c0ba22-e35e-490d-b2d8-420b8c4cc2c7
Hinks, Jeremy
8d997f2b-107a-43e5-bb60-828e551105b9
Lane, Athene J.
6683aef1-075d-471f-9c9f-b561a2a3902e
Wyatt, Jeremy C.
8361be5a-fca9-4acf-b3d2-7ce04126f468
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d

Blatch-Jones, Amanda, Nuttall, Jacqueline, Bull, Abby, Worswick, Louise, Mullee, Mark, Peveler, Robert, Falk, Stephen, Tape, Neil, Hinks, Jeremy, Lane, Athene J., Wyatt, Jeremy C. and Griffiths, Gareth (2020) Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study. Trials, 21 (1), [304]. (doi:10.1186/s13063-020-04234-0).

Record type: Article

Abstract

Background: Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. Methods: A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach. Results: Responses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: 'security and transparency'; 'inclusivity and engagement'; 'human interaction'; 'obstacles and risks'; and 'potential benefits'. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants. Conclusions: Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

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Using digital tools in the recruitment and retention - Accepted Manuscript
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Accepted/In Press date: 9 March 2020
Published date: 3 April 2020
Additional Information: Publisher Copyright: © 2020 The Author(s).
Keywords: Clinical trials unit, Digital tool, Participant recruitment, Participant retention, Qualitative, Survey

Identifiers

Local EPrints ID: 438124
URI: http://eprints.soton.ac.uk/id/eprint/438124
ISSN: 1745-6215
PURE UUID: f938db75-e475-43ec-8a4a-d7210e1710f6
ORCID for Amanda Blatch-Jones: ORCID iD orcid.org/0000-0002-1486-5561
ORCID for Louise Worswick: ORCID iD orcid.org/0000-0003-1184-5722
ORCID for Robert Peveler: ORCID iD orcid.org/0000-0001-5596-9394
ORCID for Jeremy C. Wyatt: ORCID iD orcid.org/0000-0001-7008-1473
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 02 Mar 2020 17:30
Last modified: 17 Mar 2024 03:40

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Contributors

Author: Jacqueline Nuttall
Author: Abby Bull
Author: Louise Worswick ORCID iD
Author: Mark Mullee
Author: Robert Peveler ORCID iD
Author: Stephen Falk
Author: Neil Tape
Author: Jeremy Hinks
Author: Athene J. Lane
Author: Jeremy C. Wyatt ORCID iD

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