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Titolo:
QUALITY-CONTROL OF PEAK FLOW METERS FOR MULTICENTER CLINICAL-TRIALS
Autore:
IRVIN CG; MARTIN RJ; CHINCHILLI VM; KUNSELMAN SJ; CHERNIACK RM; HURD S; DRAZEN JM; ISRAEL E; MCGARRY B; FISH JE; PETERS SP; KUBIS J; LEMANSKE RF; SORKNESS DC; COX K; SZEFLER SJ; PAK J; BOUSHEY HA; LAZARUS SC; FAHY JV; WARD T; MARTEL JK; MAUGER EA; ZWILLICH CW;
Indirizzi:
UNIV DENVER,DEPT MED,NATL JEWISH CTR IMMUNOL & RESP MED,1400 JACKSON ST DENVER CO 80206 BRIGHAM & WOMENS HOSP,DEPT MED BOSTON MA 02115 HARVARD UNIV,SCH MED,DEPT MED BOSTON MA 00000 THOMAS JEFFERSON UNIV,DEPT MED PHILADELPHIA PA 19107 UNIV WISCONSIN,DEPT MED MADISON WI 00000 UNIV CALIF SAN FRANCISCO,DEPT MED SAN FRANCISCO CA 00000 PENN STATE UNIV,MILTON S HERSHEY MED CTR,DEPT MED HERSHEY PA 17033 NHLBI,DEPT MED BETHESDA MD 20892 CHAIRMAN STEERING COMM DENVER CO 00000 NHLBI WASHINGTON DC 00000 DATA COORDINATING CTR HERSHEY PA 00000
Titolo Testata:
American journal of respiratory and critical care medicine
fascicolo: 2, volume: 156, anno: 1997,
pagine: 396 - 402
SICI:
1073-449X(1997)156:2<396:QOPFMF>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Soggetto:
ACCURACY; FLOWMETERS; REPRODUCIBILITY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
14
Recensione:
Indirizzi per estratti:
Citazione:
C.G. Irvin et al., "QUALITY-CONTROL OF PEAK FLOW METERS FOR MULTICENTER CLINICAL-TRIALS", American journal of respiratory and critical care medicine, 156(2), 1997, pp. 396-402

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, orinterquartile 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 Centeron retrospective review of quality control measurements submitted by the clinics (n = 35). This study indicates that a simple device can beused 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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 13/07/20 alle ore 17:04:51