An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

Pamela Tunji-Ajayi; Eilidh M. Duncan; Kate Gillies

doi:10.1016/j.jclinepi.2020.03.011

An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

Pamela Tunji-Ajayi, Eilidh M. Duncan, Kate Gillies^*

^*Corresponding author for this work

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

6 Citations (Scopus)

Abstract

Objectives
This study investigated trial consultations to identify whether and to what extent discussions of retention are present.

Study Design and Setting
This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).

Results
Forty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.

Conclusion
This study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.

Original language	English
Pages (from-to)	49-58
Number of pages	10
Journal	Journal of Clinical Epidemiology
Volume	123
Early online date	27 Mar 2020
DOIs	https://doi.org/10.1016/j.jclinepi.2020.03.011
Publication status	Published - Jul 2020

Keywords

Clinical trials
Retention
Communication
Informed consent

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Cite this

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title = "An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations",

abstract = "ObjectivesThis study investigated trial consultations to identify whether and to what extent discussions of retention are present.Study Design and SettingThis embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).ResultsForty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.ConclusionThis study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.",

keywords = "Clinical trials, Retention, Communication, Informed consent",

author = "Pamela Tunji-Ajayi and Duncan, {Eilidh M.} and Kate Gillies",

note = "Acknowledgments The authors would like to acknowledge the trial participants, Surgeons and Research Nurses for agreeing to be audio-recorded as part of the main trial. Thanks also to Professor Craig Ramsay and Mr Irfan Ahmed the Chief Investigators of the trial. Thanks also to Karen Innes the Trial Manager and Becky Bruce the Data Coordinator for their support of the study. Ethics approval and consent to participate: This study was approved through the parent trial from NHS North of Scotland Research Ethics Committee (16/NS/0053). Informed consent was obtained from all participants. Declarations of interest: None. Role of funding source: KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). 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.",

year = "2020",

month = jul,

doi = "10.1016/j.jclinepi.2020.03.011",

language = "English",

volume = "123",

pages = "49--58",

journal = "Journal of Clinical Epidemiology",

issn = "0895-4356",

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T1 - An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

AU - Tunji-Ajayi, Pamela

AU - Duncan, Eilidh M.

AU - Gillies, Kate

N1 - Acknowledgments The authors would like to acknowledge the trial participants, Surgeons and Research Nurses for agreeing to be audio-recorded as part of the main trial. Thanks also to Professor Craig Ramsay and Mr Irfan Ahmed the Chief Investigators of the trial. Thanks also to Karen Innes the Trial Manager and Becky Bruce the Data Coordinator for their support of the study. Ethics approval and consent to participate: This study was approved through the parent trial from NHS North of Scotland Research Ethics Committee (16/NS/0053). Informed consent was obtained from all participants. Declarations of interest: None. Role of funding source: KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). 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 - 2020/7

Y1 - 2020/7

N2 - ObjectivesThis study investigated trial consultations to identify whether and to what extent discussions of retention are present.Study Design and SettingThis embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).ResultsForty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.ConclusionThis study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.

AB - ObjectivesThis study investigated trial consultations to identify whether and to what extent discussions of retention are present.Study Design and SettingThis embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).ResultsForty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.ConclusionThis study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.

KW - Clinical trials

KW - Retention

KW - Communication

KW - Informed consent

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U2 - 10.1016/j.jclinepi.2020.03.011

DO - 10.1016/j.jclinepi.2020.03.011

M3 - Article

C2 - 32229250

VL - 123

SP - 49

EP - 58

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -

An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

Abstract

Keywords

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