Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Katie Gillies; Shaun Treweek; Cherish  Boxall

doi:10.1177/26320843221106961

Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Katie Gillies, Shaun Treweek, Cherish Boxall^* (Corresponding Author)

^*Corresponding author for this work

University of Southampton

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

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Abstract

Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research.

Methods
In November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings.

Results
125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them.

Conclusions
This study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.

Original language	English
Pages (from-to)	121-126
Number of pages	6
Journal	Research Methods in Medicine & Health Sciences
Volume	3
Issue number	4
Early online date	8 Jun 2022
DOIs	https://doi.org/10.1177/26320843221106961
Publication status	Published - 1 Sept 2022

Bibliographical note

Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the Trials Methodology Research Partnership (MR/S014357/1). 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.

Data Availability Statement

Supplemental Material
Supplement material for this article is available in online.

Keywords

planning the research
recruitment and retention
retention and compliance
SWAT
trial conduct

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10.1177/26320843221106961Licence: CC BY

Boxall_etal_RMMHS_Studies_Within_A_VoR
This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
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Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
Boxall, C. (Creator), Treweek, S. (Creator) & Gillies, K. (Creator), SAGE Journals, 2022
DOI: 10.25384/sage.c.6037102.v1, https://sage.figshare.com/collections/Studies_within_a_trial_priorities_to_improve_the_evidence_to_inform_recruitment_and_retention_practice_in_clinical_trials/6037102/1
Dataset
Supplemental Material - Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
Boxall, C. (Creator), Treweek, S. (Creator) & Gillies, K. (Creator), SAGE Journals, 2022
DOI: 10.25384/sage.20032795.v1, https://sage.figshare.com/articles/dataset/Supplemental_Material_-_Studies_within_a_trial_priorities_to_improve_the_evidence_to_inform_recruitment_and_retention_practice_in_clinical_trials/20032795/1
Dataset

Cite this

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title = "Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials",

abstract = "Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research.MethodsIn November 2020, registered SWATs in the SWAT repository store were extracted and categorised into {\textquoteleft}recruitment{\textquoteright}, {\textquoteleft}retention{\textquoteright} or {\textquoteleft}other{\textquoteright} based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings.Results125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them.ConclusionsThis study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.",

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note = "Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the Trials Methodology Research Partnership (MR/S014357/1). 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.",

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N1 - Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the Trials Methodology Research Partnership (MR/S014357/1). 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.

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N2 - Trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research.MethodsIn November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings.Results125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them.ConclusionsThis study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work.

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KW - SWAT

KW - trial conduct

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SP - 121

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JO - Research Methods in Medicine & Health Sciences

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Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

Fingerprint

Datasets

Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Supplemental Material - Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials

Cite this