Quality control of peak flow meters for multicenter clinical trials. The Asthma Clinical Research Network (ACRN).
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 inter-quartile 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.
Irvin
C G
CG
Department of Medicine, National Jewish Center for Immunology and Respiratory Medicine, University of Colorado, Denver 80206, USA.
Martin
R J
RJ
Chinchilli
V M
VM
Kunselman
S J
SJ
Cherniack
R M
RM
D001249:Asthma / Q000175:diagnosis; D002138:Calibration / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D004868:Equipment Failure / Q000706:statistics & numerical data; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards* / Q000706:statistics & numerical data; D010366:Peak Expiratory Flow Rate; D011786:Quality Control; D015203:Reproducibility of Results; D012129:Respiratory Function Tests / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D013147:Spirometry / Q000295:instrumentation / Q000706:statistics & numerical data; D013997:Time Factors