Christine de la Loge1, Béatrice Tugaut1, Fatoumata Fofana1, Jérémy Lambert1, Michael Hennig2, Uta Tschiesner3, Mitra Vahdati-Bolouri4, Afisi Segun Ismaila5, Yogesh Suresh Punekar6. 1. Mapi, Patient-Centered Outcomes, Lyon, France. 2. Biostatistics and Epidemiology, GlaxoSmithKline, Munich, Germany. 3. Former employee of GlaxoSmithKline, Munich, Germany. 4. Research and Development, Global Respiratory Franchise, GlaxoSmithKline, Brentford, United Kingdom. 5. Value Evidence and Outcomes, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina; Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. 6. Value Evidence and Outcomes, GlaxoSmithKline, Brentford, United Kingdom.
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.
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.
Entities:
Keywords:
FEV1; SGRQ; TDI; copd; correlation; exacerbation; linear regression; meta-analysis; patient-reported outcomes; systematic literature review
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