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<p>Abstract</p> <p>Background</p> <p>Interactions between spirometry and patient-reported outcomes in COPD are not well understood. This systematic review and study-level analysis investigated the relationship between changes in FEV₁and changes in health status with bronchodilator therapy.</p> <p>Methods</p> <p>Six databases (to October 2009) were searched to identify studies with long-acting bronchodilator therapy reporting FEV₁and health status, dyspnoea or exacerbations. Mean and standard deviations of treatment effects were extracted for each arm of each study. Relationships between changes in trough FEV₁and outcomes were assessed using correlations and random-effects regression modelling. The primary outcome was St George's Respiratory Questionnaire (SGRQ) total score.</p> <p>Results</p> <p>Thirty-six studies (≥3 months) were included. Twenty-two studies (23,654 patients) with 49 treatment arms each contributing one data point provided SGRQ data. Change in trough FEV₁and change in SGRQ total score were negatively correlated (r = -0.46, p < 0.001); greater increases in FEV₁were associated with greater reductions (improvements) in SGRQ. The correlation strengthened with increasing study duration from 3 to 12 months. Regression modelling indicated that 100 mL increase in FEV₁(change at which patients are more likely to report improvement) was associated with a statistically significant reduction in SGRQ of 2.5 (95% CI 1.9, 3.1), while a clinically relevant SGRQ change (4.0) was associated with 160.6 (95% CI 129.0, 211.6) mL increase in FEV₁. The association between change in FEV₁and other patient-reported outcomes was generally weak.</p> <p>Conclusions</p> <p>Our analyses indicate, at a study level, that improvement in mean trough FEV₁is associated with proportional improvements in health status.</p>