Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study

Katherine O'Neill; Gokul R. Lakshmipathy; Kathryn Ferguson; Denise Cosgrove; Adam T. Hill; Michael Loebinger; Mary Carroll; James Chalmers; Timothy Gatheral; Chris Johnson; Anthony DeSoyza; John R. Hurst; Ian Bradbury; J. Stuart Elborn; Judy M. Bradley

doi:10.1016/j.rmed.2018.10.030

Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study

Katherine O'Neill (Lead / Corresponding author), Gokul R. Lakshmipathy, Kathryn Ferguson, Denise Cosgrove, Adam T. Hill, Michael Loebinger, Mary Carroll, James Chalmers, Timothy Gatheral, Chris Johnson, Anthony DeSoyza, John R. Hurst, Ian Bradbury, J. Stuart Elborn, Judy M. Bradley

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Abstract

Introduction: Multiple Breath Washout (MBW) to measure Lung Clearance Index (LCI) is increasingly being used as a secondary endpoint in multicentre bronchiectasis studies. LCI data quality control or “over-reading” is resource intensive and the impact is unclear.

Objectives: To assess the proportion of MBW tests deemed unacceptable with over-reading, and to assess the change in LCI (number of turnovers), LCI coefficient of variation (CV%) and tidal volume (VT) CV% results after over-reading.

Methods: Data were analysed from 250 MBW tests (from 98 adult bronchiectasis patients) collected as part of the Bronch-UK Clinimetrics study in 5 UK centres. Each MBW test was over-read centrally using pre-defined criteria. MBW tests with <2 technically valid and repeatable trials were deemed unacceptable to include in analysis. In accepted tests, values for LCI, LCI CV% and VT CV% before and after over-reading, were compared.

Results: Insufficient data was collected in 10/250 tests. With over-reading, 30/240 (12%) were deemed unacceptable to include in analysis. In those accepted tests, overall the change in LCI, LCI CV% and VT CV% with over-reading was not statistically significant. When MBW new sites were compared to MBW expert sites, the change in LCI with over-reading was significantly greater in MBW new sites (p = 0.047). Data suggests that over-reading could be important up to at least 12 months post initiation of MBW activity.

Conclusion: MBW over-reading was important in this study as 12% of tests were considered unacceptable. Over-reading improved test result accuracy in sites new to MBW.

Original language	English
Pages (from-to)	206-211
Number of pages	6
Journal	Respiratory Medicine
Volume	145
Early online date	1 Nov 2018
DOIs	https://doi.org/10.1016/j.rmed.2018.10.030
Publication status	Published - Dec 2018

Keywords

Bronchiectasis
Lung clearance index
Multiple breath washout
Over-reading
Quality control

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

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10.1016/j.rmed.2018.10.030

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© 2018. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Accepted author manuscript, 647 KBLicence: CC BY-NC-ND

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O'Neill, K., Lakshmipathy, G. R., Ferguson, K., Cosgrove, D., Hill, A. T., Loebinger, M., Carroll, M., Chalmers, J., Gatheral, T., Johnson, C., DeSoyza, A., Hurst, J. R., Bradbury, I., Elborn, J. S., & Bradley, J. M. (2018). Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study. Respiratory Medicine, 145, 206-211. https://doi.org/10.1016/j.rmed.2018.10.030

@article{303c49e7ca574a63a48984b6630c1014,

title = "Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study",

abstract = "Introduction: Multiple Breath Washout (MBW) to measure Lung Clearance Index (LCI) is increasingly being used as a secondary endpoint in multicentre bronchiectasis studies. LCI data quality control or “over-reading” is resource intensive and the impact is unclear. Objectives: To assess the proportion of MBW tests deemed unacceptable with over-reading, and to assess the change in LCI (number of turnovers), LCI coefficient of variation (CV%) and tidal volume (VT) CV% results after over-reading. Methods: Data were analysed from 250 MBW tests (from 98 adult bronchiectasis patients) collected as part of the Bronch-UK Clinimetrics study in 5 UK centres. Each MBW test was over-read centrally using pre-defined criteria. MBW tests with <2 technically valid and repeatable trials were deemed unacceptable to include in analysis. In accepted tests, values for LCI, LCI CV% and VT CV% before and after over-reading, were compared. Results: Insufficient data was collected in 10/250 tests. With over-reading, 30/240 (12%) were deemed unacceptable to include in analysis. In those accepted tests, overall the change in LCI, LCI CV% and VT CV% with over-reading was not statistically significant. When MBW new sites were compared to MBW expert sites, the change in LCI with over-reading was significantly greater in MBW new sites (p = 0.047). Data suggests that over-reading could be important up to at least 12 months post initiation of MBW activity.Conclusion: MBW over-reading was important in this study as 12% of tests were considered unacceptable. Over-reading improved test result accuracy in sites new to MBW.",

keywords = "Bronchiectasis, Lung clearance index, Multiple breath washout, Over-reading, Quality control",

author = "Katherine O'Neill and Lakshmipathy, {Gokul R.} and Kathryn Ferguson and Denise Cosgrove and Hill, {Adam T.} and Michael Loebinger and Mary Carroll and James Chalmers and Timothy Gatheral and Chris Johnson and Anthony DeSoyza and Hurst, {John R.} and Ian Bradbury and Elborn, {J. Stuart} and Bradley, {Judy M.}",

year = "2018",

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doi = "10.1016/j.rmed.2018.10.030",

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publisher = "W.B. Saunders Ltd",

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O'Neill, K, Lakshmipathy, GR, Ferguson, K, Cosgrove, D, Hill, AT, Loebinger, M, Carroll, M, Chalmers, J, Gatheral, T, Johnson, C, DeSoyza, A, Hurst, JR, Bradbury, I, Elborn, JS & Bradley, JM 2018, 'Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study', Respiratory Medicine, vol. 145, pp. 206-211. https://doi.org/10.1016/j.rmed.2018.10.030

TY - JOUR

T1 - Quality control for multiple breath washout tests in multicentre bronchiectasis studies

T2 - Experiences from the BRONCH-UK clinimetrics study

AU - O'Neill, Katherine

AU - Lakshmipathy, Gokul R.

AU - Ferguson, Kathryn

AU - Cosgrove, Denise

AU - Hill, Adam T.

AU - Loebinger, Michael

AU - Carroll, Mary

AU - Chalmers, James

AU - Gatheral, Timothy

AU - Johnson, Chris

AU - DeSoyza, Anthony

AU - Hurst, John R.

AU - Bradbury, Ian

AU - Elborn, J. Stuart

AU - Bradley, Judy M.

PY - 2018/12

Y1 - 2018/12

N2 - Introduction: Multiple Breath Washout (MBW) to measure Lung Clearance Index (LCI) is increasingly being used as a secondary endpoint in multicentre bronchiectasis studies. LCI data quality control or “over-reading” is resource intensive and the impact is unclear. Objectives: To assess the proportion of MBW tests deemed unacceptable with over-reading, and to assess the change in LCI (number of turnovers), LCI coefficient of variation (CV%) and tidal volume (VT) CV% results after over-reading. Methods: Data were analysed from 250 MBW tests (from 98 adult bronchiectasis patients) collected as part of the Bronch-UK Clinimetrics study in 5 UK centres. Each MBW test was over-read centrally using pre-defined criteria. MBW tests with <2 technically valid and repeatable trials were deemed unacceptable to include in analysis. In accepted tests, values for LCI, LCI CV% and VT CV% before and after over-reading, were compared. Results: Insufficient data was collected in 10/250 tests. With over-reading, 30/240 (12%) were deemed unacceptable to include in analysis. In those accepted tests, overall the change in LCI, LCI CV% and VT CV% with over-reading was not statistically significant. When MBW new sites were compared to MBW expert sites, the change in LCI with over-reading was significantly greater in MBW new sites (p = 0.047). Data suggests that over-reading could be important up to at least 12 months post initiation of MBW activity.Conclusion: MBW over-reading was important in this study as 12% of tests were considered unacceptable. Over-reading improved test result accuracy in sites new to MBW.

AB - Introduction: Multiple Breath Washout (MBW) to measure Lung Clearance Index (LCI) is increasingly being used as a secondary endpoint in multicentre bronchiectasis studies. LCI data quality control or “over-reading” is resource intensive and the impact is unclear. Objectives: To assess the proportion of MBW tests deemed unacceptable with over-reading, and to assess the change in LCI (number of turnovers), LCI coefficient of variation (CV%) and tidal volume (VT) CV% results after over-reading. Methods: Data were analysed from 250 MBW tests (from 98 adult bronchiectasis patients) collected as part of the Bronch-UK Clinimetrics study in 5 UK centres. Each MBW test was over-read centrally using pre-defined criteria. MBW tests with <2 technically valid and repeatable trials were deemed unacceptable to include in analysis. In accepted tests, values for LCI, LCI CV% and VT CV% before and after over-reading, were compared. Results: Insufficient data was collected in 10/250 tests. With over-reading, 30/240 (12%) were deemed unacceptable to include in analysis. In those accepted tests, overall the change in LCI, LCI CV% and VT CV% with over-reading was not statistically significant. When MBW new sites were compared to MBW expert sites, the change in LCI with over-reading was significantly greater in MBW new sites (p = 0.047). Data suggests that over-reading could be important up to at least 12 months post initiation of MBW activity.Conclusion: MBW over-reading was important in this study as 12% of tests were considered unacceptable. Over-reading improved test result accuracy in sites new to MBW.

KW - Bronchiectasis

KW - Lung clearance index

KW - Multiple breath washout

KW - Over-reading

KW - Quality control

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DO - 10.1016/j.rmed.2018.10.030

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C2 - 30509710

SN - 0954-6111

VL - 145

SP - 206

EP - 211

JO - Respiratory Medicine

JF - Respiratory Medicine

ER -

Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study

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