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