PT  - JOURNAL ARTICLE
AU  - O'Neill, Katherine
AU  - Ferguson, Kathryn
AU  - Cosgrove, Denis
AU  - Tunney, Michael M.
AU  - De Soyza, Anthony
AU  - Carroll, Mary
AU  - Chalmers, James D.
AU  - Gatheral, Timothy
AU  - Hill, Adam T.
AU  - Hurst, John R.
AU  - Johnson, Christopher
AU  - Loebinger, Michael R.
AU  - Angyalosi, Gerhild
AU  - Haworth, Charles S.
AU  - Jensen, Renee
AU  - Ratjen, Felix
AU  - Saunders, Clare
AU  - Short, Christopher
AU  - Davies, Jane C.
AU  - Elborn, J. Stuart
AU  - Bradley, Judy M.
TI  - Multiple breath washout in bronchiectasis clinical trials: is it feasible?
AID  - 10.1183/23120541.00363-2019
DP  - 2020 Oct 01
TA  - ERJ Open Research
PG  - 00363-2019
VI  - 6
IP  - 4
4099  - http://openres.ersjournals.com/content/6/4/00363-2019.short
4100  - http://openres.ersjournals.com/content/6/4/00363-2019.full
SO  - erjor2020 Oct 01; 6
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