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How much is the lack of retention evidence costing trial teams in Ireland and the UK?

BACKGROUND: Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidenc...

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Autores principales: Murphy, Ellen, Shiely, Frances, Treweek, Shaun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097420/
https://www.ncbi.nlm.nih.gov/pubmed/35550607
http://dx.doi.org/10.1186/s13063-022-06223-x
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author Murphy, Ellen
Shiely, Frances
Treweek, Shaun
author_facet Murphy, Ellen
Shiely, Frances
Treweek, Shaun
author_sort Murphy, Ellen
collection PubMed
description BACKGROUND: Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. METHODS: We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. RESULTS: Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included “data collection scheduled with routine care” (€900–€32,503.25), “a timeline of participant visits for sites”—with integrated participant reminder (€304.74–€14,803.70), and “routine site visits by CTU staff” and “investigator meetings face to face”, both costing (€777.67–€14,753.48). Others such as “telephone reminders for questionnaire response” (€34.58–€568.62), “a timeline of participant visits for sites”—site reminder alone (€79.18–€112.23), and “targeted recruitment of sites/GPs” (€30–€1620) were less costly compared to the other strategies. DISCUSSION: The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority. CONCLUSION: More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06223-x.
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spelling pubmed-90974202022-05-13 How much is the lack of retention evidence costing trial teams in Ireland and the UK? Murphy, Ellen Shiely, Frances Treweek, Shaun Trials Methodology BACKGROUND: Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. METHODS: We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. RESULTS: Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included “data collection scheduled with routine care” (€900–€32,503.25), “a timeline of participant visits for sites”—with integrated participant reminder (€304.74–€14,803.70), and “routine site visits by CTU staff” and “investigator meetings face to face”, both costing (€777.67–€14,753.48). Others such as “telephone reminders for questionnaire response” (€34.58–€568.62), “a timeline of participant visits for sites”—site reminder alone (€79.18–€112.23), and “targeted recruitment of sites/GPs” (€30–€1620) were less costly compared to the other strategies. DISCUSSION: The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority. CONCLUSION: More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06223-x. BioMed Central 2022-05-12 /pmc/articles/PMC9097420/ /pubmed/35550607 http://dx.doi.org/10.1186/s13063-022-06223-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Methodology
Murphy, Ellen
Shiely, Frances
Treweek, Shaun
How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title_full How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title_fullStr How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title_full_unstemmed How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title_short How much is the lack of retention evidence costing trial teams in Ireland and the UK?
title_sort how much is the lack of retention evidence costing trial teams in ireland and the uk?
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097420/
https://www.ncbi.nlm.nih.gov/pubmed/35550607
http://dx.doi.org/10.1186/s13063-022-06223-x
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