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

Katherine O'Neill, Kathryn Ferguson, Denis Cosgrove, Michael M. Tunney, Anthony De Soyza, Mary Carroll, James D. Chalmers, Timothy Gatheral, Adam T. Hill, John R. Hurst, Christopher Johnson, Michael R. Loebinger, Gerhild Angyalosi, Charles S. Haworth, Renee Jensen, Felix Ratjen, Clare Saunders, Christopher Short, Jane C. Davies, J. Stuart ElbornJudy M. Bradley

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Abstract

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
Number of pages10
JournalERJ Open Research
Volume6
Issue number4
DOIs
Publication statusPublished - 13 Oct 2020

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