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. 2011 Apr 8;12(1):40.
doi: 10.1186/1465-9921-12-40.

Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review

Marie Westwood  1 , Jean Bourbeau, Paul W Jones, Annamaria Cerulli, Gorana Capkun-Niggli, Gill Worthy
Affiliations

Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review

Marie Westwood et al. Respir Res. .

Abstract

Background: 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 FEV1 and changes in health status with bronchodilator therapy.

Methods: Six databases (to October 2009) were searched to identify studies with long-acting bronchodilator therapy reporting FEV1 and 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 FEV1 and outcomes were assessed using correlations and random-effects regression modelling. The primary outcome was St George's Respiratory Questionnaire (SGRQ) total score.

Results: 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 FEV1 and change in SGRQ total score were negatively correlated (r = -0.46, p < 0.001); greater increases in FEV1 were 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 FEV1 and other patient-reported outcomes was generally weak.

Conclusions: Our analyses indicate, at a study level, that improvement in mean trough FEV1 is associated with proportional improvements in health status.

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Figures

Figure 1
Figure 1
Flow of studies through the review process. Abbreviations: MEDLINE, medical literature analysis and retrieval system online; EMBASE, Excerpta Medica database; CRD, Centre for Reviews and Dissemination; DARE, Database of Abstracts of Reviews of Effects; HTA, Health Technology Assessment; GIN, Guidelines International Network.
Figure 2
Figure 2
Scatter plot of mean change in FEV1, for all treatments (LAMA, LABA, LAMA+LABA) and placebo versus change in SGRQ total score at a study level for all study period.
See this image and copyright information in PMC

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