Imperial College London
Alternate

ProfessorJaneDavies

Faculty of Medicine, National Heart & Lung Institute

Professor of Paediatric Respirology & Experimental Medicine
 
 
 
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Contact

 

+44 (0)20 7594 7973j.c.davies

 
 
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Assistant

 

Mrs Gina Rivellini +44 (0)20 7594 7986

 
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Location

 

G44Emmanuel Kaye BuildingRoyal Brompton Campus

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Summary

 

Publications

Citation

BibTex format

@article{Saunders:2020:10.1016/j.jcf.2019.11.006,
author = {Saunders, C and jensen, R and Robinson, PD and Stanojevic, S and Klingel, M and Short, C and Davies, J and Ratjen, F},
doi = {10.1016/j.jcf.2019.11.006},
journal = {Journal of Cystic Fibrosis},
pages = {602--607},
title = {Integrating the multiple breath washout test into international multicentre trials},
url = {http://dx.doi.org/10.1016/j.jcf.2019.11.006},
volume = {19},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundThe lung clearance index (LCI), derived from the Multiple Breath Washout (MBW) test, is sensitive to treatment effects and compared with spirometry has higher feasibility in younger children and requires smaller sample sizes. As a result, the LCI has been endorsed by the European CF Society Clinical Trials Network for use as a primary outcome measure in CF clinical trials.MethodsHere we describe the implementation of standardised protocols for MBW test performance, data collection and quality control to successfully incorporate LCI as a novel outcome measure in a large multicentre phase III clinical trial.ResultsThree regional (North America (NA), Europe (EU), Australia (AUS)) central over-reading centres (CORC) were established to provide a collaborative platform for MBW training, certification and quality control of data.One hundred and thirty-two naïve operators from 53 sites across NA, EU and AUS were successfully trained and certified to perform MBW testing.  Incorporation of a re-screening opportunity in the study protocol resulted a final screening feasibility rate of 93%, success remained high throughout the study resulting in an overall feasibility of MBW study data of 88.1% (1107/1257). MBW test acceptability was similar between geographical regions: NA (88%), EU (89%) and AUS (89%).ConclusionWith this approach we achieved high MBW test feasibility and sustained collection of good quality data, demonstrating the utility of LCI as an effective primary endpoint in the first international phase III clinical trial to report LCI as the primary outcome.
AU  - Saunders,C
AU  - jensen,R
AU  - Robinson,PD
AU  - Stanojevic,S
AU  - Klingel,M
AU  - Short,C
AU  - Davies,J
AU  - Ratjen,F
DO  - 10.1016/j.jcf.2019.11.006
EP  - 607
PY  - 2020///
SN  - 1569-1993
SP  - 602
TI  - Integrating the multiple breath washout test into international multicentre trials
T2  - Journal of Cystic Fibrosis
UR  - http://dx.doi.org/10.1016/j.jcf.2019.11.006
UR  - http://hdl.handle.net/10044/1/75279
VL  - 19
ER  -
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