05.02 - Monitoring Airway Disease 11497 Multiple Breath Washout (MBW) training, certification and quality control during the iBEST-1 trial in bronchiectasis (BE). Bronchiectasis, Lung function testing K. O'Neill1, M. M. Tunney2, G. Angyalosi3, C. Haworth4, M. R. Loebinger5, J. M. Bradley6, J. Stuart Elborn7 1Wellcome-Wolfson Institute for Experimental Medicine, Queen's University - Belfast (United Kingdom), 2School of Pharmacy, Queen's University - Belfast (United Kingdom), 3Novartis Pharma AG - Basel (Switzerland), 4Cambridge Centre for Lung Infection, Papworth Hospital - Cambridge (United Kingdom), 5Host Defence Unit, Royal Brompton Hospital, Imperial College London, - London (United Kingdom), 6Wellcome-Wolfson Institute for Experimental Medicine, Clinical Research Facility - Belfast (United Kingdom), 7Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast; Host Defence Unit, Royal Brompton Hospital, Imperial College London - London (United Kingdom) Background: Lung clearance index (LCI) measured by MBW, is an exploratory endpoint in iBEST-1. MBW set up requires staff training, certification and central “over-reading” for data quality control. Evaluation of these processes is essential to inform the inclusion of LCI in future BE studies. Objectives: To summarise the time duration between MBW training & certification and the proportion of tests excluded after over-reading. Methods: Twenty-seven sites are participating in the LCI sub-study. MBW training was a 1 day face to face session, eLearning tool and mentoring support. Certification required the submission of 8/10 valid tests. Once certified, sites submitted trial MBW data for assessment by a trained “over-reader” using pre-defined criteria (Jensen et al. 2016, PLOS ONE). Results: Training: 20/27 sites completed training. Six had previously completed training & certification. One site was unable to participate (language barrier). Of the 20 sites that completed training, 12/20 (60%) were MBW naive. 13/20 (65%) completed certification with a mean (range) time since training of 6 (4-14) months. Certification for 6/20 sites is on-going with a mean (range) time since training of 10 (3-17) months. One site dropped out (no equipment space). Over-reading: To date, 146 tests from 10 sites have been submitted. 52/146 (36%) tests were excluded, most commonly due to leak, irregular breathing pattern and technical issues. Conclusions: Sites require a mean of 6 months to train and certify in MBW testing for BE trials. The study is on-going to determine the support necessary to minimise test exclusion. Support received from EU/EFPIA IMI-JU iABC grant n° 115721.
|Number of pages||2|
|Publication status||Accepted - 05 Jun 2018|
|Event||European Respiratory Society International Congress 2018: Paris, 2018 - Paris, France, Paris, France|
Duration: 15 Sep 2018 → 19 Sep 2018
|Conference||European Respiratory Society International Congress 2018|
|Period||15/09/2018 → 19/09/2018|