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Quality control of spirometry: a lesson from the BRONCUS trial

¹ Centro di Fisiopatologia Respiratoria e di Studio della Dispnea , Azienda Ospedaliera S Croce e Carle, Cuneo, and ⁵ Respiratory Division, Ospedale Rasori Parma, Parma, and ⁶ Servizio di Pneumologia, Azienda Ospedaliera "G. Rummo", Benevento, and ⁸ Zambon Group, Bresso-Milano, Milan, Italy. ² Respiratory Division, University Hospital, Katholieke Universiteit Leuven, Leuven, and ⁷ University Hospital, Antwerp, Belgium. ³ Dept of General Practice, Maastricht University, Maastricht, and ⁴ Dept of Pulmonary Diseases, University Medical Centre Nijmegen, The Netherlands.

CORRESPONDENCE: R. Pellegrino, Centro di Fisiopatologia Respiratoria e di Studio della Dispnea, Azienda Ospedaliera S. Croce e Carle, 12100 Cuneo, Italy. Fax: 39 0171616798. E-mail: pellegrino.r{at}ospedale.cuneo.it

Keywords: Chronic obstructive pulmonary disease, N-acetylcysteine, quality control, spirometry

Received: March 7, 2005
Accepted August 1, 2005

This report describes the quality control programme used within the Bronchitis Randomized on N-acetylcysteine (NAC) Cost-Utility Study, a trial designed to assess the decline in lung function, exacerbation rate, health status, and cost-effectiveness with NAC or a placebo in 523 patients with chronic obstructive pulmonary disease over a 3-yr period.

Spirometry was scored from 0 (worst quality) to 6 (best quality). The mean score of 314 spirometries from 243 patients evaluated during the trial was 5.63±0.83. Linear regression analysis of the scores of 47 participating centres plotted against the time at which spirometries were performed yielded an intercept of 5.7±0.5 and a slope of -0.0001±0.001, which suggests that the initial high quality was maintained over time.

Retrospective examination of a further 345 postbronchodilator spirometries from 208 patients with a forced expiratory volume at one second exceeding the mean individual value recorded over the study in excess of 20% revealed a slightly lower quality of the start-of-test manoeuvre compared with the 314 spirometries.

In conclusion, these findings would suggest that the quality control programme is likely to have helped achieve and maintain long-term spirometry performance in the Bronchitis Randomized on N-acetylcysteine (NAC) Cost-Utility Study trial. Special care should be paid to the spirometries whose forced expiratory volume in one second values exceed the mean value.

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