Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).

Katherine O'Neill, Michael Tunney, G Angyalosi, Charles S Haworth, Michael R Loebinger, Judy Bradley, Joseph Elborn

Research output: Contribution to conferenceAbstract

8 Downloads (Pure)

Abstract

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.
Original languageEnglish
Pages1-2
Number of pages2
Publication statusAccepted - 05 Jun 2018
EventEuropean Respiratory Society International Congress 2018: Paris, 2018 - Paris, France, Paris, France
Duration: 15 Sep 201819 Sep 2018

Conference

ConferenceEuropean Respiratory Society International Congress 2018
CountryFrance
CityParis
Period15/09/201819/09/2018

Fingerprint

Bronchiectasis
Certification
Quality Control
Lung
Biomedical Research
Reading
Communication Barriers
Organized Financing
Cross Infection
Switzerland
United Kingdom
Respiration
Equipment and Supplies
Research

Keywords

  • Bronchiectasis
  • Lung
  • Function
  • Testing

Cite this

O'Neill, K., Tunney, M., Angyalosi, G., Haworth, C. S., Loebinger, M. R., Bradley, J., & Elborn, J. (Accepted/In press). Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).. 1-2. Abstract from European Respiratory Society International Congress 2018, Paris, France.
O'Neill, Katherine ; Tunney, Michael ; Angyalosi, G ; Haworth, Charles S ; Loebinger, Michael R ; Bradley, Judy ; Elborn, Joseph. / Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE). Abstract from European Respiratory Society International Congress 2018, Paris, France.2 p.
@conference{6c64c894862946d88eced0182ddff5db,
title = "Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).",
abstract = "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.",
keywords = "Bronchiectasis, Lung, Function, Testing",
author = "Katherine O'Neill and Michael Tunney and G Angyalosi and Haworth, {Charles S} and Loebinger, {Michael R} and Judy Bradley and Joseph Elborn",
year = "2018",
month = "6",
day = "5",
language = "English",
pages = "1--2",
note = "European Respiratory Society International Congress 2018 : Paris, 2018 ; Conference date: 15-09-2018 Through 19-09-2018",

}

O'Neill, K, Tunney, M, Angyalosi, G, Haworth, CS, Loebinger, MR, Bradley, J & Elborn, J 2018, 'Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).', European Respiratory Society International Congress 2018, Paris, France, 15/09/2018 - 19/09/2018 pp. 1-2.

Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE). / O'Neill, Katherine; Tunney, Michael; Angyalosi, G; Haworth, Charles S; Loebinger, Michael R; Bradley, Judy; Elborn, Joseph.

2018. 1-2 Abstract from European Respiratory Society International Congress 2018, Paris, France.

Research output: Contribution to conferenceAbstract

TY - CONF

T1 - Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).

AU - O'Neill, Katherine

AU - Tunney, Michael

AU - Angyalosi, G

AU - Haworth, Charles S

AU - Loebinger, Michael R

AU - Bradley, Judy

AU - Elborn, Joseph

PY - 2018/6/5

Y1 - 2018/6/5

N2 - 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.

AB - 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.

KW - Bronchiectasis

KW - Lung

KW - Function

KW - Testing

M3 - Abstract

SP - 1

EP - 2

ER -

O'Neill K, Tunney M, Angyalosi G, Haworth CS, Loebinger MR, Bradley J et al. Multiple Breath Washout (MBW) training, certification and quality control during the iBEST - 1 trial in bronchiectasis (BE).. 2018. Abstract from European Respiratory Society International Congress 2018, Paris, France.