RT Journal Article
SR Electronic
T1 Multiple breath washout in bronchiectasis clinical trials: is it feasible?
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00363-2019
DO 10.1183/23120541.00363-2019
VO 6
IS 4
A1 O'Neill, Katherine
A1 Ferguson, Kathryn
A1 Cosgrove, Denis
A1 Tunney, Michael M.
A1 De Soyza, Anthony
A1 Carroll, Mary
A1 Chalmers, James D.
A1 Gatheral, Timothy
A1 Hill, Adam T.
A1 Hurst, John R.
A1 Johnson, Christopher
A1 Loebinger, Michael R.
A1 Angyalosi, Gerhild
A1 Haworth, Charles S.
A1 Jensen, Renee
A1 Ratjen, Felix
A1 Saunders, Clare
A1 Short, Christopher
A1 Davies, Jane C.
A1 Elborn, J. Stuart
A1 Bradley, Judy M.
YR 2020
UL http://openres.ersjournals.com/content/6/4/00363-2019.abstract
AB 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.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 optimise data quality https://bit.ly/2WZ4L1e