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

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.

SUBMITTER: O'Neill K

PROVIDER: S-EPMC7553113 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

O'Neill Katherine K Ferguson Kathryn K Cosgrove Denis D Tunney Michael M MM De Soyza Anthony A Carroll Mary M Chalmers James D JD Gatheral Timothy T Hill Adam T AT Hurst John R JR Johnson Christopher C Loebinger Michael R MR Angyalosi Gerhild G Haworth Charles S CS Jensen Renee R Ratjen Felix F Saunders Clare C Short Christopher C Davies Jane C JC Elborn J Stuart JS Bradley Judy M JM

ERJ open research 20201013 4

<h4>Background</h4>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.<h4>Aims</h4>To assess the outcomes of a MBW training, certification and central over-reading programme.<h4>Methods</h4>MBW training and certification was conducted in European sites collecting lung clearance index (LCI) data in the BronchUK Clinimetrics a ...[more]

PMID: 33083441

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Project description:BackgroundRespiratory involvement defines the clinical outcome of neuromuscular diseases (NMD). The lung clearance index (LCI) is a marker of lung ventilation inhomogeneity and indicates small airway disease. It is determined by mulitple breath washout lung function (MBW). The merit of LCI is undisputed for primary lung diseases like cystic fibrosis, but its role in NMD is unclear.MethodsWe investigated the role of MBW in patients with NMD and the effect of two different tracer gases and cough assist devices on the LCI. Patients and controls performed MBW with nitrogen (N2) and sulfur hexafluoride (SF6), whereas the latter analysis was repeated after the use of a cough assist device in the NMD group. LCI was compared to forced vital capacity (FVC) and peak cough flow (PCF).Results24 NMD patients (12 Duchenne Muscular Dystrophy, 8 Spinal Muscular Atrophy, 4 other NMDs) and 15 healthy controls were enrolled. In the NMD group, overall LCI N2 was higher than LCI SF6 (9.67 ± 1.56 vs. 8.71 ± 1.47; mean ± SD; p < 0.033). In controls, LCI N2 did not differ significantly from LCI SF6 (7.03 ± 0.37 vs. 7.05 ± 0.67; p = 0.882). Both LCI N2 and LCI SF6 were significantly higher in NMD patients as in controls (9.67 ± 1.56 vs. 7.03 ± 0.37, p < 0.001, and 8.71 ± 1.478.65 vs. 7.05 ± 0.67, p < 0.001). In the NMD group, both LCI N2 and LCI SF6 showed a negative correlation to FVC (r = - 0.525; p = 0.008 and r = - 0.526; p = 0.008, respectively) and PCF (r = - 0.590; p = 0.002 and r = - 0.641; p = 0.001, respectively). LCI N2 and LCI SF6 correlated well in the NMD group. LCI SF6 did not change significantly after the use of the cough assist in NMD patients (n = 22; 8.65 ± 1.52 pre vs. 8.79 ± 2.03 post, p = 0.667).ConclusionLung involvement of patients with neuromuscular diseases goes beyond weakness of respiratory muscles. MBW with both N2 and SF6 is suitable to detect ventilation inhomogeneity in NMD patients with respiratory impairment. Cough assist devices with low to moderate pressure levels do not immediately improve the LCI.

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

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

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