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Published online before print January 7, 2009
Eur Respir J 2009, doi:10.1183/09031936.00091208
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ORIGINAL ARTICLE

Quality control of DLco instruments in global clinical trials

R. Jensen 1, M. Leyk 2, R. Crapo 1, D. Muchmore 2, P.Y. Berclaz 2*

1 LDS Hospital, Pulmonary Division, Salt Lake City, UT, 84143
2 Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA

* To whom correspondence should be addressed. E-mail: berclaz.pi{at}lilly.com.


  Abstract

High inter- and intra-laboratory variability exists for the single-breath diffusing capacity of the lung for carbon monoxide (DLco) test. To detect small changes in diffusing capacity in multi-centre clinical trials, accurate measurements are essential. This study assessed whether regular DLco simulator testing maintained or improved instrument accuracy and reduced variability in multi-centre trials.

The 125 pulmonary function testing (PFT) laboratories that participated in clinical trials for AIR® Inhaled Insulin validated and monitored the accuracy of their DLco measuring devices by using a DLco simulator, which creates known target values for any device. Devices measuring a simulated DLco different from target by >3 mL·min-1·mmHg-1 failed testing and were serviced. Device accuracy was assessed over time and with respect to differences in several variables.

Initially, 31 (25%) laboratories had a DLco device that failed simulator testing. After fixing or replacing devices, 124 (99%) laboratories had passing devices. The percentage of failed tests significantly decreased over time. Differences in geographical region, device type, breath-hold time, temperature and pressure were not associated with meaningful differences in DLco device accuracy.

Regular DLco simulator testing allows PFT laboratories to maintain the accuracy of their DLco measurements leading to reduced variability across laboratories in multi-centre clinical trials.

Keywords:  Accuracy, inhaled insulin, multi-centre trials, quality control, single-breath diffusing capacity of the lung for carbon monoxide (DLco), simulator




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