Multiple breath washout in bronchiectasis clinical trials: is it feasible?

Katherine O'Neill, Kathryn Ferguson, Denise Cosgrove, Michael Tunney, A De Soyza, M Carroll, J.D Chalmers, T Gatheral, AT Hill , JR Hurst , C Johnson , C Johnson , M. R. Loebinger, G. Angyalosi, C. S. Haworth, R Jensen, C Saunders, C Short, J.C. Davies, Stuart ElbornJudy Bradley

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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.
Original languageEnglish
Article number00363-2019
JournalERJ Open Research
Issue number4
Publication statusPublished - 13 Oct 2020


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