Why trials lose participants: a multi-trial investigation of participants’ perspectives using the theoretical domains framework

Rumana Newlands; Eilidh Duncan; Justin Presseau; Shaun Treweek; Louisa Lawrie; Peter Bower; Jim Elliott; Jill J Francis; Graeme MacLennan; Margaret Ogden; Mary Wells; Miles D Witham; Bridget Young; Kate Gillies

doi:10.1016/j.jclinepi.2021.03.007

Why trials lose participants: a multi-trial investigation of participants’ perspectives using the theoretical domains framework

Rumana Newlands, Eilidh Duncan, Justin Presseau, Shaun Treweek, Louisa Lawrie, Peter Bower, Jim Elliott, Jill J Francis, Graeme MacLennan, Margaret Ogden, Mary Wells, Miles D Witham, Bridget Young, Kate Gillies^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

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Abstract

Objectives

To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics.

Study design and setting

We invited participants (n=607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semi-structured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behaviour the domain relevance threshold was set at >75% of participants mentioning the domain.

Results

Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviours of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants’ knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behaviour.. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only.

Conclusion

This is the first study informed by behavioural science to explore trial participants’ accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.

Original language	English
Pages (from-to)	P1-13
Number of pages	13
Journal	Journal of Clinical Epidemiology
Volume	137
Early online date	12 Mar 2021
DOIs	https://doi.org/10.1016/j.jclinepi.2021.03.007
Publication status	Published - 1 Sept 2021

Bibliographical note

Acknowledgments
We would like to thank all of the participants who volunteered and gave up their time to contribute to this study. We would also like to thank all of the teams linked to the host trials we worked with to help identify potential participants.

Funding
This research is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Depart- ment [HIPS/16/46]. KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project [MR/L01193X/1]. MDW acknowledges support from the NIHR Newcastle Biomedical Research Centre. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) to support MW.
The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.

Keywords

randomised trials
retention
follow up
behaviour
theory

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Cite this

Newlands, R., Duncan, E., Presseau, J., Treweek, S., Lawrie, L., Bower, P., Elliott, J., Francis, J. J., MacLennan, G., Ogden, M., Wells, M., Witham, M. D., Young, B., & Gillies, K. (2021). Why trials lose participants: a multi-trial investigation of participants’ perspectives using the theoretical domains framework. Journal of Clinical Epidemiology, 137, P1-13. https://doi.org/10.1016/j.jclinepi.2021.03.007

Newlands, R, Duncan, E, Presseau, J, Treweek, S , Lawrie, L, Bower, P, Elliott, J, Francis, JJ, MacLennan, G, Ogden, M, Wells, M, Witham, MD, Young, B & Gillies, K 2021, 'Why trials lose participants: a multi-trial investigation of participants’ perspectives using the theoretical domains framework', Journal of Clinical Epidemiology, vol. 137, pp. P1-13. https://doi.org/10.1016/j.jclinepi.2021.03.007

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abstract = "ObjectivesTo use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics.Study design and settingWe invited participants (n=607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semi-structured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behaviour the domain relevance threshold was set at >75% of participants mentioning the domain.ResultsSixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviours of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants{\textquoteright} knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behaviour.. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only.ConclusionThis is the first study informed by behavioural science to explore trial participants{\textquoteright} accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.",

keywords = "randomised trials, retention, follow up, behaviour, theory",

author = "Rumana Newlands and Eilidh Duncan and Justin Presseau and Shaun Treweek and Louisa Lawrie and Peter Bower and Jim Elliott and Francis, {Jill J} and Graeme MacLennan and Margaret Ogden and Mary Wells and Witham, {Miles D} and Bridget Young and Kate Gillies",

note = "Acknowledgments We would like to thank all of the participants who volunteered and gave up their time to contribute to this study. We would also like to thank all of the teams linked to the host trials we worked with to help identify potential participants. Funding This research is funded by the Chief Scientist Office of the Scottish Government{\textquoteright}s Health and Social Care Depart- ment [HIPS/16/46]. KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project [MR/L01193X/1]. MDW acknowledges support from the NIHR Newcastle Biomedical Research Centre. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) to support MW. The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish. ",

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AU - Newlands, Rumana

AU - Duncan, Eilidh

AU - Presseau, Justin

AU - Treweek, Shaun

AU - Lawrie, Louisa

AU - Bower, Peter

AU - Elliott, Jim

AU - Francis, Jill J

AU - MacLennan, Graeme

AU - Ogden, Margaret

AU - Wells, Mary

AU - Witham, Miles D

AU - Young, Bridget

AU - Gillies, Kate

N1 - Acknowledgments We would like to thank all of the participants who volunteered and gave up their time to contribute to this study. We would also like to thank all of the teams linked to the host trials we worked with to help identify potential participants. Funding This research is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Depart- ment [HIPS/16/46]. KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project [MR/L01193X/1]. MDW acknowledges support from the NIHR Newcastle Biomedical Research Centre. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) to support MW. The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.

PY - 2021/9/1

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N2 - ObjectivesTo use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics.Study design and settingWe invited participants (n=607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semi-structured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behaviour the domain relevance threshold was set at >75% of participants mentioning the domain.ResultsSixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviours of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants’ knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behaviour.. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only.ConclusionThis is the first study informed by behavioural science to explore trial participants’ accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.

AB - ObjectivesTo use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics.Study design and settingWe invited participants (n=607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semi-structured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behaviour the domain relevance threshold was set at >75% of participants mentioning the domain.ResultsSixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviours of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants’ knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behaviour.. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only.ConclusionThis is the first study informed by behavioural science to explore trial participants’ accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.

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KW - behaviour

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DO - 10.1016/j.jclinepi.2021.03.007

M3 - Article

SN - 0895-4356

VL - 137

SP - P1-13

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

Why trials lose participants: a multi-trial investigation of participants’ perspectives using the theoretical domains framework

Abstract

Bibliographical note

Keywords

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