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, Suzanne Hurd, Jeffery M. Drazen, Elliot Israel, Bill McGarry, James E. Fish, Stephen P. Peters, Janice Kubis, Robert F. Lemanske, Christine Sorkness, Kathy Cox, Stanley J. Szefler, Juno Pak, Homer A. Boushey, Steven C. Lazarus, John V. FahyTheresa Ward, Juliann K. Martel, Elizabeth A. Mauger, Clifford W. Zwillich

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)396-402
Number of pages7
JournalAmerican journal of respiratory and critical care medicine
Volume156
Issue number2 I
DOIs
StatePublished - 1997

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Fingerprint Dive into the research topics of 'Quality control of peak flow meters for multicenter clinical trials'. Together they form a unique fingerprint.

  • Cite this

    Irvin, C. G., Martin, R. J., Chinchilli, V. M., Kunselman, S. J., Cherniack, R. M., Hurd, S., Drazen, J. M., Israel, E., McGarry, B., Fish, J. E., Peters, S. P., Kubis, J., Lemanske, R. F., Sorkness, C., Cox, K., Szefler, S. J., Pak, J., Boushey, H. A., Lazarus, S. C., ... Zwillich, C. W. (1997). Quality control of peak flow meters for multicenter clinical trials. American journal of respiratory and critical care medicine, 156(2 I), 396-402. https://doi.org/10.1164/ajrccm.156.2.9609054