Quality control of spirometry testing in the registry for patients with severe α 1-antitrypsin deficiency

James K. Stoller, A (Sonia) Buist, Benjamin Burrows, Ronald G. Crystal, Robert J. Fallat, Kevin McCarthy, Mark D. Schluchter, Norman T. Soskel, Rebecca Zhang

Research output: Contribution to journalArticle

35 Scopus citations


As part of the multicenter National Heart, Lung, and Blood Institute registry of patients with severe deficiency of α 1-antitrypsin with 1,129 enrollees, this report describes measures undertaken to achieve high-quality FEV 1 measurements, the rates of satisfying reproducibility and acceptability criteria, and clinical features of participants unable to achieve reproducible FEV 1 values at baseline. Spirograms were performed both before and after an inhaled bronchodilator in enrollees followed up at 37 participating clinical centers. Using a reproducibility criterion of <100 mL or 5% (whichever greater), high reproducibility rates for FEV 1 measurements at baseline were observed for both prebronchodilator (95.0% of 1,090 sessions) and postbronchodilator measurements (95.7% of 1,077 sessions). Using the more recently published reproducibility criterion of ≤200 mL, reproducibility rates were even higher. Eighty-four percent of clinical centers submitted FEV 1 values that satisfied reproducibility criteria for at least 90% of spirograms. Also, the mean coefficient of variation for prebronchodilator FEV 1 values measured over serial visits separated by up to 9 months was 5.6% for participants with baseline FEV 1 55 to 90% predicted. This degree of reproducibility is similar to that observed in the Lung Health Study. Rates of satisfying acceptability criteria for prebronchodilator spirograms were lower, almost universally (98% of tests) due to failure to achieve end-of-test criteria (which usually required 15 s of expiration in this population with mean FEV 1=42.6±29.6% [SD] predicted). Multivariate logistic regression models show that clinical correlates of failure to achieve reproducible prebronchodilator FEV 1 efforts include symptoms of chronic wheeze, chronic cough, and chronic phlegm, and the degree of airflow obstruction. We conclude that highly reproducible FEV 1 measurements are achievable in a population with severe airflow obstruction despite the additional challenges posed by testing in multiple centers on a variety of spirometers. Furthermore, the difficulty of satisfying end-of-test criteria in a large cohort with severe airflow obstruction did not preclude achieving high rates of reproducibility for FEV 1 measurements. Finally, our study confirms prior observations that failure to achieve reproducible efforts is associated with the presence of pulmonary symptoms and the degree of airflow obstruction. Thus, excluding patients with nonreproducible FEV 1 efforts from epidemiologic studies would bias results by including only healthier participants.

Original languageEnglish (US)
Pages (from-to)899-909
Number of pages11
Issue number4
Publication statusPublished - 1997



  • α -antitrypsin deficiency
  • acceptability
  • emphysema
  • quality control
  • spirometry

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Stoller, J. K., Buist, A. S., Burrows, B., Crystal, R. G., Fallat, R. J., McCarthy, K., ... Zhang, R. (1997). Quality control of spirometry testing in the registry for patients with severe α 1-antitrypsin deficiency. Chest, 111(4), 899-909.