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Quality control of spirometry: a lesson from the BRONCUS trial
R Pellegrino1, M Decramer, C P O van Schayck
1Centro di Fisiopatologia Respiratoria e di Studio della Dispnea, Azienda Ospedaliera S. Croce e Carle, 12100 Cuneo, Italy. pellegrino.r@ospedale.cuneo.it
The European Respiratory Journal
|December 2, 2005
Summary
The quality control program ensured high-quality spirometry in the Bronchitis Randomized on N-acetylcysteine (NAC) Cost-Utility Study. This maintained lung function assessments over three years for chronic obstructive pulmonary disease patients.
Area of Science:
- Pulmonary Medicine
- Clinical Trials
- Quality Control
Background:
- Chronic obstructive pulmonary disease (COPD) management requires accurate lung function monitoring.
- The Bronchitis Randomized on N-acetylcysteine (NAC) Cost-Utility Study evaluated N-acetylcysteine (NAC) efficacy in COPD patients.
- Ensuring high-quality spirometry is crucial for reliable trial outcomes.
Purpose of the Study:
- To describe and evaluate the quality control program for spirometry in the NAC trial.
- To assess the maintenance of spirometry quality over a 3-year study period.
- To identify factors potentially affecting spirometry quality.
Main Methods:
- Implementation of a structured spirometry scoring system (0-6).
- Analysis of 314 spirometries from 243 patients using linear regression.
- Retrospective review of 345 additional spirometries for specific patient subgroups.
Main Results:
- Mean spirometry quality score was high (5.63+/-0.83).
- Quality remained consistent over time, with minimal decline (slope -0.0001).
- Spirometries with significantly elevated forced expiratory volume in one second showed slightly lower quality.
Conclusions:
- The quality control program was effective in achieving and maintaining high-quality spirometry.
- Sustained spirometry performance supports the reliability of the NAC trial's findings.
- Attention to specific spirometry measurements (e.g., high FEV1) is recommended.