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Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19

BACKGROUND: Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victori...

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Autores principales: Milton, Shakira, McIntosh, Jennifer, Boyd, Lucy, Karnchanachari, Napin, Macrae, Finlay, Emery, Jon David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424147/
https://www.ncbi.nlm.nih.gov/pubmed/34496930
http://dx.doi.org/10.1186/s13063-021-05567-0
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author Milton, Shakira
McIntosh, Jennifer
Boyd, Lucy
Karnchanachari, Napin
Macrae, Finlay
Emery, Jon David
author_facet Milton, Shakira
McIntosh, Jennifer
Boyd, Lucy
Karnchanachari, Napin
Macrae, Finlay
Emery, Jon David
author_sort Milton, Shakira
collection PubMed
description BACKGROUND: Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020. MAIN BODY: We originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies. CONCLUSION: We developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic.
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spelling pubmed-84241472021-09-08 Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19 Milton, Shakira McIntosh, Jennifer Boyd, Lucy Karnchanachari, Napin Macrae, Finlay Emery, Jon David Trials Commentary BACKGROUND: Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020. MAIN BODY: We originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies. CONCLUSION: We developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic. BioMed Central 2021-09-08 /pmc/articles/PMC8424147/ /pubmed/34496930 http://dx.doi.org/10.1186/s13063-021-05567-0 Text en © The Author(s) 2021 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 Commentary
Milton, Shakira
McIntosh, Jennifer
Boyd, Lucy
Karnchanachari, Napin
Macrae, Finlay
Emery, Jon David
Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title_full Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title_fullStr Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title_full_unstemmed Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title_short Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19
title_sort commentary: pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to covid-19
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424147/
https://www.ncbi.nlm.nih.gov/pubmed/34496930
http://dx.doi.org/10.1186/s13063-021-05567-0
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