PMID- 9279215
OWN - NLM
STAT- MEDLINE
DCOM- 19970918
LR  - 20071115
IS  - 1073-449X (Print)
IS  - 1073-449X (Linking)
VI  - 156
IP  - 2 Pt 1
DP  - 1997 Aug
TI  - Quality control of peak flow meters for multicenter clinical trials. The Asthma 
      Clinical Research Network (ACRN).
PG  - 396-402
AB  - 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.
FAU - Irvin, C G
AU  - Irvin CG
AD  - Department of Medicine, National Jewish Center for Immunology and Respiratory 
      Medicine, University of Colorado, Denver 80206, USA.
FAU - Martin, R J
AU  - Martin RJ
FAU - Chinchilli, V M
AU  - Chinchilli VM
FAU - Kunselman, S J
AU  - Kunselman SJ
FAU - Cherniack, R M
AU  - Cherniack RM
LA  - eng
GR  - U10 HL-51831/HL/NHLBI NIH HHS/United States
GR  - U10 HL-51834/HL/NHLBI NIH HHS/United States
GR  - U10 HL-51843/HL/NHLBI NIH HHS/United States
GR  - etc.
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
SB  - IM
MH  - Asthma/diagnosis
MH  - Calibration/standards
MH  - Clinical Trials as Topic/*standards/statistics & numerical data
MH  - Equipment Failure/statistics & numerical data
MH  - Humans
MH  - Multicenter Studies as Topic/*standards/statistics & numerical data
MH  - Peak Expiratory Flow Rate
MH  - Quality Control
MH  - Reproducibility of Results
MH  - Respiratory Function Tests/*instrumentation/standards/statistics & numerical data
MH  - Spirometry/instrumentation/statistics & numerical data
MH  - Time Factors
EDAT- 1997/08/01 00:00
MHDA- 1997/08/01 00:01
CRDT- 1997/08/01 00:00
PHST- 1997/08/01 00:00 [pubmed]
PHST- 1997/08/01 00:01 [medline]
PHST- 1997/08/01 00:00 [entrez]
AID - 10.1164/ajrccm.156.2.9609054 [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):396-402. doi: 
      10.1164/ajrccm.156.2.9609054.