Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2020
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
_version_ 1783593537847164928
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
work_keys_str_mv AT oneillkatherine multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT fergusonkathryn multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT cosgrovedenis multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT tunneymichaelm multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT desoyzaanthony multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT carrollmary multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT chalmersjamesd multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT gatheraltimothy multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT hilladamt multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT hurstjohnr multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT johnsonchristopher multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT loebingermichaelr multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT angyalosigerhild multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT haworthcharless multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT jensenrenee multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT ratjenfelix multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT saundersclare multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT shortchristopher multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT daviesjanec multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT elbornjstuart multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible
AT bradleyjudym multiplebreathwashoutinbronchiectasisclinicaltrialsisitfeasible