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Increase in recruitment upon integration of trial into a clinical care pathway: an observational study

INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment nu...

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Autores principales: Yip, Kay Por, Gompertz, Simon, Snelson, Catherine, Willson, Jeremy, Madathil, Shyam, Huq, Syed SA, Rauf, Farrukh, Salmon, Natasha, Tengende, Joyce, Tracey, Julie, Cooper, Brendan, Filby, Kay, Ball, Simon, Parekh, Dhruv, Dosanjh, Davinder P S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261886/
https://www.ncbi.nlm.nih.gov/pubmed/34230034
http://dx.doi.org/10.1136/bmjresp-2021-000967
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author Yip, Kay Por
Gompertz, Simon
Snelson, Catherine
Willson, Jeremy
Madathil, Shyam
Huq, Syed SA
Rauf, Farrukh
Salmon, Natasha
Tengende, Joyce
Tracey, Julie
Cooper, Brendan
Filby, Kay
Ball, Simon
Parekh, Dhruv
Dosanjh, Davinder P S
author_facet Yip, Kay Por
Gompertz, Simon
Snelson, Catherine
Willson, Jeremy
Madathil, Shyam
Huq, Syed SA
Rauf, Farrukh
Salmon, Natasha
Tengende, Joyce
Tracey, Julie
Cooper, Brendan
Filby, Kay
Ball, Simon
Parekh, Dhruv
Dosanjh, Davinder P S
author_sort Yip, Kay Por
collection PubMed
description INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers. METHODS: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP. RESULTS: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence. DISCUSSION: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.
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spelling pubmed-82618862021-07-23 Increase in recruitment upon integration of trial into a clinical care pathway: an observational study Yip, Kay Por Gompertz, Simon Snelson, Catherine Willson, Jeremy Madathil, Shyam Huq, Syed SA Rauf, Farrukh Salmon, Natasha Tengende, Joyce Tracey, Julie Cooper, Brendan Filby, Kay Ball, Simon Parekh, Dhruv Dosanjh, Davinder P S BMJ Open Respir Res Respiratory Research INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers. METHODS: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP. RESULTS: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence. DISCUSSION: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial. BMJ Publishing Group 2021-07-06 /pmc/articles/PMC8261886/ /pubmed/34230034 http://dx.doi.org/10.1136/bmjresp-2021-000967 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Respiratory Research
Yip, Kay Por
Gompertz, Simon
Snelson, Catherine
Willson, Jeremy
Madathil, Shyam
Huq, Syed SA
Rauf, Farrukh
Salmon, Natasha
Tengende, Joyce
Tracey, Julie
Cooper, Brendan
Filby, Kay
Ball, Simon
Parekh, Dhruv
Dosanjh, Davinder P S
Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title_full Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title_fullStr Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title_full_unstemmed Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title_short Increase in recruitment upon integration of trial into a clinical care pathway: an observational study
title_sort increase in recruitment upon integration of trial into a clinical care pathway: an observational study
topic Respiratory Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261886/
https://www.ncbi.nlm.nih.gov/pubmed/34230034
http://dx.doi.org/10.1136/bmjresp-2021-000967
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