Am. J. Respir. Crit. Care Med., Volume 156, Number 2, August 1997, 396-402

Quality Control of Peak Flow Meters for Multicenter Clinical Trials

CHARLES G. IRVIN, RICHARD J. MARTIN, VERNON M. CHINCHILLI, SUSAN J. KUNSELMAN, REUBEN M. CHERNIACK, and The Asthma Clinical Research Network (ACRN)

The Departments of Medicine, National Jewish Center for Immunology and Respiratory Medicine, University of Colorado, Denver, Colorado; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Thomas Jefferson University, Philadelphia, Pennsylvania; University of Wisconsin, Madison, Wisconsin; University of California at San Francisco, San Francisco, California; Milton S. Hershey Medical Center, Hershey, Pennsylvania; National Heart, Lung, and Blood Institute, Bethesda, Maryland

Although peak expiratory flow (PEF) measurements are recommended for monitoring and assessing treatment of asthmatic patients, and widely employed to assess outcome in clinical trials and epidemiologic studies, information about performance of peak flow meters (PFM) under field conditions is lacking. We describe a simple testing system consisting of a testing chamber, a spirometer, and a calibration syringe to evaluate the relative accuracy or median relative bias (MRB), precision, or interquartile range (IQR) of the mini-Wright PFM. The relative accuracy ranged from 4.4 to 13.2% (mean, 4.1%) and the precision from 0.06 to 11.5% (mean, 1.2%). Durability of this PFM was assessed during a 26-wk clinical trial in 255 asthmatic subjects at five centers. Seventy-one PFM (19.9%) were identified as having failed to meet acceptance criteria, predominantly because of loss of relative accuracy, by the clinics at follow-up visits (n = 36), and by the Data Coordinating Center on retrospective review of quality control measurements submitted by the clinics (n = 35). This study indicates that a simple device can be used to evaluate the relative accuracy and precision of a given PFM and to ensure the quality of PEF measurements during a clinical trial. To the extent that one can extrapolate these data to other devices, our findings indicate that the failure rate of PFM over time can be high, indicating that quality control of a PFM over time is absolutely essential in clinical trials as well as in routine clinical care.

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