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Clinical Trial
. 2023 Jun 27;7(12):2772-2783.
doi: 10.1182/bloodadvances.2022008360.

Determinants of low health-related quality of life in patients with myelodysplastic syndromes: EUMDS Registry study

Affiliations
Clinical Trial

Determinants of low health-related quality of life in patients with myelodysplastic syndromes: EUMDS Registry study

Igor Stojkov et al. Blood Adv. .

Abstract

Patients with myelodysplastic syndromes (MDS) frequently experience a significant symptom burden, which reduces health-related quality of life (HRQoL). We aimed to identify determinants of low HRQoL in patients recently diagnosed with MDS, for guiding early intervention strategies. We evaluated longitudinal data in 2205 patients with MDS during their first year after diagnosis. Median values of EQ-5D 3-level (EQ-5D-3L) index (0.78) and visual analog scale (VAS) score (0.70) were used as thresholds for low HRQoL. In addition, the 5 dimensions of EQ-5D-3L were analyzed for impairments (any level vs "no problem" category). After multiple imputation of missing values, we used generalized estimating equations (GEE) to estimate odds ratios (OR) for univariable determinant screening (P < .15), and to subsequently derive multivariable models for low HRQoL with 95% confidence intervals (CI). Multivariable GEE analysis showed the following independent determinants (OR, 95% CI) for low EQ-5D index: increased age (60-75 years: 1.33, 1.01-1.75; >75: 1.84, 1.39-2.45), female sex (1.70, 1.43-2.03), high serum ferritin level (≥1000 vs ≤300 μg/L: 1.41, 1.06-1.87), comorbidity burden (per unit: 1.11, 1.02-1.20), and reduced Karnofsky performance status (KPS, per 10 units: 0.62, 0.58-0.67). For low VAS score, additional determinants were transfusion dependence (1.53, 1.03-2.29), low hemoglobin <10 g/dL (1.34, 1.12-1.61), and high body mass index (≥30 vs 23-29.9 kg/m2: 1.26, 1.02-1.57). Sex, KPS, comorbidity burden, hemoglobin count, and transfusion burden were determinants for all EQ-5D dimensions. Low HRQoL is determined by multiple factors, which should be considered in the management and shared decision making of patients with MDS. This trial was registered at www.clinicaltrials.gov as #NCT00600860.

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Conflict of interest statement

Conflict-of-interest disclosure: C.V.M. is a project manager of the EUMDS Registry, and is funded from the EUMDS (educational grants from Novartis Pharmacy B.V. Oncology Europe, Amgen Limited, Celgene International, Janssen Pharmaceuticals, and Takeda Pharmaceuticals International) and MDS-RIGHT (grant from EU’s Horizon 2020 program) project budgets. D.J.C. received honoraria and support for meetings from Celgene LTD, AbbVie LTD, Gilead, Jazz Pharma, and Takeda UK. F.E. provides consultancy for Amgen, AbbVie, Janssen, Takeda, and Novartis; received research support (to his institution) from AbbVie, Amgen, Novartis, all unrelated to this work. G.F.S. consults for and/or in the advisory board of AbbVie, Amgen, Astellas, Böehringer-Ingelheim, Celgene/Bristol Myers Squibb (BMS), Helsinn Healthcare, Hoffmann – La Roche, Janssen – Cilag, Novartis, Onconova, and Takeda; is a speaker at Celgene/BMS, Hoffmann - La Roche, Novartis, and Takeda; and received research support from Celgene/BMS, Hoffmann – La Roche, Janssen – Cilag, and Novartis. I.K. received research funding from Celgene Corporation, Novartis Hellas and Janssen; received honoraria from Novartis Hellas, Janssen Hellas and Genesis Pharma Hellas. K.M. served in the advisory board for AbbVie, BMS, lecture fees from AbbVie, BMS, and Teva. P.F. received research funding (as GFM chairman) from AbbVie, Agios, Celgene/BMS, Jazz, and Novartis. R.S. received honoraria from and held membership on the board of directors or an advisory committee of Celgene and Novartis; received research funding from Teva. T.d.W. received research funding from Amgen, Celgene, Janssen, Novartis, and Takeda. U.G. is a speaker at honorarium Celgene, Novartis; received institutional research support from Celgene, Novartis; serves on the advisory board of Celgene. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Determinants of low HRQoL – univariable analyses. Presented are the univariable analyses of the determinants of low EQ-5D index value and of low EQ-5D VAS score. ORs are colored if P value < .15 and gray if P value > .15. ∗At least 1 unit RBC transfusion for a surveillance time of 8 weeks before the HRQoL assessment; ∗∗Average number of RBC transfusions per month since the last visit or since the MDS diagnosis; ∗∗∗Progression to higher IPSS-R risk group. HCT-CI, hematopoietic cell transplantation-specific comorbidity index; IPSS-R (vs VL/L), all remaining IPSS-R groups vs very low/low risk.
Figure 2.
Figure 2.
Determinants of impaired EQ-5D-3L dimensions - univariable analyses. Presented are the univariable analyses of the determinants of impaired dimensions of the EQ-5D questionnaire. ORs are colored if P value < .15 and gray if P value > .15. ∗At least 1 unit RBC transfusion for a surveillance time of 8 weeks before the HRQoL assessment; ∗∗Average number of RBC transfusions per month since the last visit or since the MDS diagnosis; ∗∗∗Progression to higher IPSS-R risk group. HCT-CI, hematopoietic cell transplantation-specific comorbidity index; IPSS-R (vs VL/L), all remaining IPSS-R groups vs very low/low risk.

References

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