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Multiple breath washout in bronchiectasis clinical trials: is it feasible?
BACKGROUND: Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central “over-reading” for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies. AIMS: To assess the outcomes of a MBW training, certification...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7553113/ https://www.ncbi.nlm.nih.gov/pubmed/33083441 http://dx.doi.org/10.1183/23120541.00363-2019 |
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author | O'Neill, Katherine Ferguson, Kathryn Cosgrove, Denis Tunney, Michael M. De Soyza, Anthony Carroll, Mary Chalmers, James D. Gatheral, Timothy Hill, Adam T. Hurst, John R. Johnson, Christopher Loebinger, Michael R. Angyalosi, Gerhild Haworth, Charles S. Jensen, Renee Ratjen, Felix Saunders, Clare Short, Christopher Davies, Jane C. Elborn, J. Stuart Bradley, Judy M. |
author_facet | O'Neill, Katherine Ferguson, Kathryn Cosgrove, Denis Tunney, Michael M. De Soyza, Anthony Carroll, Mary Chalmers, James D. Gatheral, Timothy Hill, Adam T. Hurst, John R. Johnson, Christopher Loebinger, Michael R. Angyalosi, Gerhild Haworth, Charles S. Jensen, Renee Ratjen, Felix Saunders, Clare Short, Christopher Davies, Jane C. Elborn, J. Stuart Bradley, Judy M. |
author_sort | O'Neill, Katherine |
collection | PubMed |
description | BACKGROUND: Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central “over-reading” for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies. AIMS: To assess the outcomes of a MBW training, certification and central over-reading programme. METHODS: MBW training and certification was conducted in European sites collecting lung clearance index (LCI) data in the BronchUK Clinimetrics and/or i-BEST-1 studies. The blended training programme included the use of an eLearning tool and a 1-day face-to-face session. Sites submitted MBW data to trained central over-readers who determined validity and quality. RESULTS: Thirteen training days were delivered to 56 participants from 22 sites. Of 22 sites, 18 (82%) were MBW naïve. Participant knowledge and confidence increased significantly (p<0.001). By the end of the study recruitment, 15 of 22 sites (68%) had completed certification with a mean (range) time since training of 6.2 (3–14) months. In the BronchUK Clinimetrics study, 468 of 589 (79%) tests met the quality criteria following central over-reading, compared with 137 of 236 (58%) tests in the i-BEST-1 study. CONCLUSIONS: LCI is feasible in a bronchiectasis multicentre clinical trial setting; however, consideration of site experience in terms of training as well as assessment of skill drift and the need for re-training may be important to reduce time to certification and optimise data quality. Longer times to certification, a higher percentage of naïve sites and patients with worse lung function may have contributed to the lower success rate in the i-BEST-1 study. |
format | Online Article Text |
id | pubmed-7553113 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-75531132020-10-19 Multiple breath washout in bronchiectasis clinical trials: is it feasible? O'Neill, Katherine Ferguson, Kathryn Cosgrove, Denis Tunney, Michael M. De Soyza, Anthony Carroll, Mary Chalmers, James D. Gatheral, Timothy Hill, Adam T. Hurst, John R. Johnson, Christopher Loebinger, Michael R. Angyalosi, Gerhild Haworth, Charles S. Jensen, Renee Ratjen, Felix Saunders, Clare Short, Christopher Davies, Jane C. Elborn, J. Stuart Bradley, Judy M. ERJ Open Res Original Articles BACKGROUND: Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central “over-reading” for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies. AIMS: To assess the outcomes of a MBW training, certification and central over-reading programme. METHODS: MBW training and certification was conducted in European sites collecting lung clearance index (LCI) data in the BronchUK Clinimetrics and/or i-BEST-1 studies. The blended training programme included the use of an eLearning tool and a 1-day face-to-face session. Sites submitted MBW data to trained central over-readers who determined validity and quality. RESULTS: Thirteen training days were delivered to 56 participants from 22 sites. Of 22 sites, 18 (82%) were MBW naïve. Participant knowledge and confidence increased significantly (p<0.001). By the end of the study recruitment, 15 of 22 sites (68%) had completed certification with a mean (range) time since training of 6.2 (3–14) months. In the BronchUK Clinimetrics study, 468 of 589 (79%) tests met the quality criteria following central over-reading, compared with 137 of 236 (58%) tests in the i-BEST-1 study. CONCLUSIONS: LCI is feasible in a bronchiectasis multicentre clinical trial setting; however, consideration of site experience in terms of training as well as assessment of skill drift and the need for re-training may be important to reduce time to certification and optimise data quality. Longer times to certification, a higher percentage of naïve sites and patients with worse lung function may have contributed to the lower success rate in the i-BEST-1 study. European Respiratory Society 2020-10-13 /pmc/articles/PMC7553113/ /pubmed/33083441 http://dx.doi.org/10.1183/23120541.00363-2019 Text en Copyright ©ERS 2020 http://creativecommons.org/licenses/by-nc/4.0/This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Original Articles O'Neill, Katherine Ferguson, Kathryn Cosgrove, Denis Tunney, Michael M. De Soyza, Anthony Carroll, Mary Chalmers, James D. Gatheral, Timothy Hill, Adam T. Hurst, John R. Johnson, Christopher Loebinger, Michael R. Angyalosi, Gerhild Haworth, Charles S. Jensen, Renee Ratjen, Felix Saunders, Clare Short, Christopher Davies, Jane C. Elborn, J. Stuart Bradley, Judy M. Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title | Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title_full | Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title_fullStr | Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title_full_unstemmed | Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title_short | Multiple breath washout in bronchiectasis clinical trials: is it feasible? |
title_sort | multiple breath washout in bronchiectasis clinical trials: is it feasible? |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7553113/ https://www.ncbi.nlm.nih.gov/pubmed/33083441 http://dx.doi.org/10.1183/23120541.00363-2019 |
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