What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives
Abstract Background Retention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on retention has focussed on understanding the actions of participants who decide to remain or withdraw from trial participation and developing interve...
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Format: | Article |
Language: | English |
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BMC
2022-08-01
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Series: | BMC Medical Research Methodology |
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Online Access: | https://doi.org/10.1186/s12874-022-01708-4 |
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author | Taylor Coffey Eilidh Duncan Heather Morgan Katie Gillies |
author_facet | Taylor Coffey Eilidh Duncan Heather Morgan Katie Gillies |
author_sort | Taylor Coffey |
collection | DOAJ |
description | Abstract Background Retention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on retention has focussed on understanding the actions of participants who decide to remain or withdraw from trial participation and developing interventions to target improvements. To better understand how trial staff may influence participants to remain or withdraw from trials, it is important to explore the experiences of staff that recruit and retain said participants and how the process of recruitment impacts retention. Methods Two qualitative interview studies informed by the Theoretical Domains Framework (TDF) were conducted with staff involved in various stages of clinical trials. The first set of interviews were focussed on staff perceptions about why participants failed to be retained and what helped to keep others engaged in trials, but also explored more generally what strategies or factors contributed to retention in trials. The second set of interviews were focussed on staff perceptions specifically about the recruitment and informed consent process and how that may influence trial retention. All interviews were analysed using the TDF and assigned to relevant behavioural domains according to perceived barriers/facilitators of the target behaviour. Belief statements were generated, summarising the narrative content of related responses within these behavioural domains. These belief statements were further analysed for themes that captured higher order relationships between separate beliefs within and between behavioural domains. Results Twenty-five participants (9 retention staff and 16 recruitment staff) were interviewed. Themes describing the barriers/facilitators to retention broadly, and to communication of retention information at consent, were generated. Four themes on retention broadly and six themes on communication of retention information at consent were identified. Overall, beliefs within all fourteen TDF domains populated these themes. Conclusions This study explored staff perspectives on retention and how they interpret their behaviour as contributing to retention success. Perspectives varied considerably but several key themes regarding communication were seen consistently. Specific barriers and facilitators within these findings will serve to guide the design of a behavioural intervention aimed at addressing issues within retention. Findings contribute to a notable gap in the literature on staff behaviour in trials and on retention generally. |
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format | Article |
id | doaj.art-b081fbda5f634a7385ca9d12bebe9b58 |
institution | Directory Open Access Journal |
issn | 1471-2288 |
language | English |
last_indexed | 2024-04-14T03:00:32Z |
publishDate | 2022-08-01 |
publisher | BMC |
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series | BMC Medical Research Methodology |
spelling | doaj.art-b081fbda5f634a7385ca9d12bebe9b582022-12-22T02:15:56ZengBMCBMC Medical Research Methodology1471-22882022-08-0122112810.1186/s12874-022-01708-4What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectivesTaylor Coffey0Eilidh Duncan1Heather Morgan2Katie Gillies3Health Services Research Unit, Health Sciences Building, University of AberdeenHealth Services Research Unit, Health Sciences Building, University of AberdeenInstitute of Applied Health Sciences, University of AberdeenHealth Services Research Unit, Health Sciences Building, University of AberdeenAbstract Background Retention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on retention has focussed on understanding the actions of participants who decide to remain or withdraw from trial participation and developing interventions to target improvements. To better understand how trial staff may influence participants to remain or withdraw from trials, it is important to explore the experiences of staff that recruit and retain said participants and how the process of recruitment impacts retention. Methods Two qualitative interview studies informed by the Theoretical Domains Framework (TDF) were conducted with staff involved in various stages of clinical trials. The first set of interviews were focussed on staff perceptions about why participants failed to be retained and what helped to keep others engaged in trials, but also explored more generally what strategies or factors contributed to retention in trials. The second set of interviews were focussed on staff perceptions specifically about the recruitment and informed consent process and how that may influence trial retention. All interviews were analysed using the TDF and assigned to relevant behavioural domains according to perceived barriers/facilitators of the target behaviour. Belief statements were generated, summarising the narrative content of related responses within these behavioural domains. These belief statements were further analysed for themes that captured higher order relationships between separate beliefs within and between behavioural domains. Results Twenty-five participants (9 retention staff and 16 recruitment staff) were interviewed. Themes describing the barriers/facilitators to retention broadly, and to communication of retention information at consent, were generated. Four themes on retention broadly and six themes on communication of retention information at consent were identified. Overall, beliefs within all fourteen TDF domains populated these themes. Conclusions This study explored staff perspectives on retention and how they interpret their behaviour as contributing to retention success. Perspectives varied considerably but several key themes regarding communication were seen consistently. Specific barriers and facilitators within these findings will serve to guide the design of a behavioural intervention aimed at addressing issues within retention. Findings contribute to a notable gap in the literature on staff behaviour in trials and on retention generally.https://doi.org/10.1186/s12874-022-01708-4Clinical trialsRetentionTheoretical domains frameworkBehavioural scienceQualitative interviewsTrial staff |
spellingShingle | Taylor Coffey Eilidh Duncan Heather Morgan Katie Gillies What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives BMC Medical Research Methodology Clinical trials Retention Theoretical domains framework Behavioural science Qualitative interviews Trial staff |
title | What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives |
title_full | What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives |
title_fullStr | What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives |
title_full_unstemmed | What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives |
title_short | What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives |
title_sort | what influences communication about retention in randomised trials a multi trial theory based analysis exploring trial staff perspectives |
topic | Clinical trials Retention Theoretical domains framework Behavioural science Qualitative interviews Trial staff |
url | https://doi.org/10.1186/s12874-022-01708-4 |
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