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. 2016 Mar 15;3(2):519-538.
doi: 10.15326/jcopdf.3.2.2015.0152.

Relationship Between FEV1 and Patient-Reported Outcomes Changes: Results of a Meta-Analysis of Randomized Trials in Stable COPD

Christine de la Loge  1 , Béatrice Tugaut  1 , Fatoumata Fofana  1 , Jérémy Lambert  1 , Michael Hennig  2 , Uta Tschiesner  3 , Mitra Vahdati-Bolouri  4 , Afisi Segun Ismaila  5 , Yogesh Suresh Punekar  6
Affiliations

Relationship Between FEV1 and Patient-Reported Outcomes Changes: Results of a Meta-Analysis of Randomized Trials in Stable COPD

Christine de la Loge et al. Chronic Obstr Pulm Dis. .

Abstract

Background: This meta-analysis assessed the relationship between change from baseline (CFB) in spirometric measurements (trough forced expiratory volume in 1 second [FEV1] and FEV1 area under the curve [AUC]) and patient-reported outcomes (St. George's Respiratory Questionnaire total score [SGRQ] CFB, Transition Dyspnea Index [TDI] and exacerbation rates) after 6-12 months' follow-up, using study treatment-group level data. Methods: A systematic literature search was performed for randomized controlled trials of ≥24 weeks duration in adults with chronic obstructive pulmonary disease (COPD). Studies reporting ≥1 spirometric measurement and ≥1 patient-reported outcome (PRO) at baseline and at study endpoint were selected. The relationships between PROs and spirometric endpoints were assessed using Pearson correlation coefficient and meta-regression. Results: Fifty-two studies (62,385 patients) were included. Primary weighted analysis conducted at the last assessment showed a large significant negative correlation (r, -0.68 [95% confidence interval (CI); -0.77, -0.57]) between trough FEV1 and SGRQ. Improvement of 100 mL in trough FEV1 corresponded to a 5.9 point reduction in SGRQ. Similarly, a reduction of 4 points on SGRQ corresponded to 40 mL improvement in trough FEV1 (p<0.001). The weighted correlation coefficients of trough FEV1 with TDI, exacerbation rate (all) and exacerbation rate (moderate/severe) at last assessment point were 0.57, -0.69 and -0.57, respectively (all p<0.05). For the analyses excluding placebo groups, the correlations of FEV1 with SGRQ and TDI were lower but significant. Conclusions: A strong association exists between changes in spirometric measurements and changes in PROs.

Keywords: FEV1; SGRQ; TDI; copd; correlation; exacerbation; linear regression; meta-analysis; patient-reported outcomes; systematic literature review.

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Conflict of interest statement

YSP, MH, M V-B and ASI are employees of GlaxoSmithKline and hold stock in GlaxoSmithKline. UT was an employee of GlaxoSmithKline at the time of this study and held stock in GlaxoSmithKline. BT, FF, and JL are employed by Mapi and were paid consultants to GlaxoSmithKline. CdL works as an independent consultant and was paid by Mapi to participate in this study. All authors contributed to the conception and design of the study. CdL, BT, FF and JL contributed to data acquisition and analysis. All authors contributed to data analysis and interpretation.

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