Quality control for multiple breath washout tests in multicentre bronchiectasis studies: Experiences from the BRONCH-UK clinimetrics study - 15/01/19
, Gokul R. Lakshmipathy a, Kathryn Ferguson b, Denise Cosgrove b, A.T. Hill c, 1, Michael R. Loebinger d, 1, Mary Carroll e, 1, J.D. Chalmers f, 1, Timothy Gatheral g, 1, Chris Johnson h, 1, Anthony DeSoyza i, 1, John R. Hurst j, 1, Ian Bradbury k, J.S. Elborn a, d, 1, 2, Judy M. Bradley a, 1, 2Abstract |
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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Lung Clearance Index is emerging as a potential endpoint in bronchiectasis. |
• | Data quality control or “over-reading” avoids the inclusion of invalid data. |
• | MBW experience influences result accuracy. |
Keywords : Bronchiectasis, Multiple breath washout, Lung clearance index, Over-reading, Quality control
Plan
Vol 145
P. 206-211 - décembre 2018 Retour au numéro
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