PURPOSE: Real-world evidence on the impact of forced expiratory volume in one second (FEV(1)) and exacerbations on health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD) is sparse especially with regard to GOLD ABCD groups. This study investigates how changes in FEV(1) and exacerbations affect generic and disease-specific HRQoL in COPD patients over one year. METHODS: Using German claims data and survey data, we classified 3016 COPD patients and analyzed their health status by GOLD groups AB and CD. HRQoL was measured with the disease-specific COPD assessment test (CAT) and the visual analog scale (VAS) from the generic Euro-Qol 5D-5L. We applied change score models to assess associations between changes in FEV(1) (≥100 mL decrease/no change/≥100 mL increase) or the development of severe exacerbations with change in HRQoL. RESULTS: FEV(1) decrease was associated with a significant but not minimal important difference (MID) deterioration in disease-specific HRQoL (mean change [95% CI]: CAT +0.74 [0.15 to 1.33]), while no significant change was observed in the generic VAS. Experiencing at least one severe exacerbation also had a significant impact on CAT deterioration (+1.58 [0.52 to 2.64]), but again not on VAS. Here, GOLD groups AB showed not only a statistically but also a clinically relevant MID deterioration in CAT (+2.1 [0.88 to 3.32]). These particular patient groups were further characterized by a higher probability of being male, having a higher mMRC and Charlson index, and a lower probability of having higher FEV(1) or BMI values. CONCLUSION: FEV(1) decline and the occurrence of ≥1 severe exacerbation are significantly associated with overall deterioration in disease-specific HRQoL. Preventing severe exacerbations particularly in patients without previous severe exacerbations (ABCD groups A and B) may help to stabilize the key patient-reported outcome HRQoL.
- Stöber, A.
- Lutter, J. I.
- Schwarzkopf, L.
- Kirsch, F.
- Schramm, A.
- Vogelmeier, C. F.
- Leidl, R.
Keywords
- Copd
- exacerbation
- forced expiratory volume in 1 second
- health-related quality of life
- longitudinal study
- real-world evidence
- Ingelheim, CSL Behring, grants from Chiesi, GlaxoSmithKline, Grifols, and Menarini,
- grants from Novartis, Nuvaira, and MedUpdate, outside the submitted work. Prof. Dr.
- Reiner Leidl reports grants from Innovation Fund, Federal Joint Committee, Germany,
- during the conduct of the study. The authors declare that they have no other
- competing interests.
