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Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar

The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitm...

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Autores principales: Farmer, Chris, Santer, Ellie, West, Alan, Darby, John, Rees-Roberts, Melanie, Doulton, Timothy, MacInnes, Douglas, O'Driscoll, Jamie, Borthwick, Rachel, Pellatt-Higgins, Tracy, Gousia, Katerina, Short, Vanessa, Swift, Pauline A, Wiles, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10030278/
https://www.ncbi.nlm.nih.gov/pubmed/36931669
http://dx.doi.org/10.1136/bmjopen-2022-068204
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author Farmer, Chris
Santer, Ellie
West, Alan
Darby, John
Rees-Roberts, Melanie
Doulton, Timothy
MacInnes, Douglas
O'Driscoll, Jamie
Borthwick, Rachel
Pellatt-Higgins, Tracy
Gousia, Katerina
Short, Vanessa
Swift, Pauline A
Wiles, Jonathan
author_facet Farmer, Chris
Santer, Ellie
West, Alan
Darby, John
Rees-Roberts, Melanie
Doulton, Timothy
MacInnes, Douglas
O'Driscoll, Jamie
Borthwick, Rachel
Pellatt-Higgins, Tracy
Gousia, Katerina
Short, Vanessa
Swift, Pauline A
Wiles, Jonathan
author_sort Farmer, Chris
collection PubMed
description The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of ‘lockdown’ requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study.
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spelling pubmed-100302782023-03-22 Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar Farmer, Chris Santer, Ellie West, Alan Darby, John Rees-Roberts, Melanie Doulton, Timothy MacInnes, Douglas O'Driscoll, Jamie Borthwick, Rachel Pellatt-Higgins, Tracy Gousia, Katerina Short, Vanessa Swift, Pauline A Wiles, Jonathan BMJ Open Communication The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of ‘lockdown’ requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study. BMJ Publishing Group 2023-03-17 /pmc/articles/PMC10030278/ /pubmed/36931669 http://dx.doi.org/10.1136/bmjopen-2022-068204 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Communication
Farmer, Chris
Santer, Ellie
West, Alan
Darby, John
Rees-Roberts, Melanie
Doulton, Timothy
MacInnes, Douglas
O'Driscoll, Jamie
Borthwick, Rachel
Pellatt-Higgins, Tracy
Gousia, Katerina
Short, Vanessa
Swift, Pauline A
Wiles, Jonathan
Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title_full Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title_fullStr Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title_full_unstemmed Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title_short Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
title_sort delivering clinical studies of exercise in the covid-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10030278/
https://www.ncbi.nlm.nih.gov/pubmed/36931669
http://dx.doi.org/10.1136/bmjopen-2022-068204
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