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