Estimating a Minimal Important Difference for the EQ-5D-5L Utility Index in Dialysis Patients.

OBJECTIVES: The EQ-5D-5L is a commonly used health-related quality of life instrument for evaluating interventions in patients receiving dialysis; however, the minimal important difference (MID) that constitutes a meaningful treatment effect for this population has not been established. This study aims to estimate the MID for the EQ-5D-5L utility index in dialysis patients. METHODS: 6-monthly EQ-5D-5L measurements were collected from adult dialysis patients between April 2017 and November 2020 at a renal network in Sydney, Australia. EQ-VAS and Integrated Palliative care Outcome Scale Renal symptom burden scores were collected simultaneously and used as anchors. MID estimates for the EQ-5D-5L utility index were derived using anchor-based and distribution-based methods. RESULTS: A total of 352 patients with ≥1 EQ-5D-5L observation were included, constituting 1127 observations. Mean EQ-5D-5L utility index at baseline was 0.719 (SD ± 0.267), and mean EQ-5D-5L utility decreased over time by -0.017 per year (95% CI -0.029 to -0.006, P = .004). Using cross-sectional anchor-based methods, MID estimates ranged from 0.073 to 0.107. Using longitudinal anchor-based methods, MID for improvement and deterioration ranged from 0.046 to 0.079 and -0.111 to -0.048, respectively. Using receiver operating characteristic curves, MID for improvement and deterioration ranged from 0.037 to 0.122 and -0.074 to -0.063, respectively. MID estimates from distribution-based methods were consistent with anchor-based estimates. CONCLUSIONS: Anchor-based and distribution-based approaches provided EQ-5D-5L utility index MID estimates ranging from 0.034 to 0.134. These estimates can inform the target difference or "effect size" for clinical trial design among dialysis populations.

Impact of Renal Supportive Care on Symptom Burden in Dialysis Patients: A Prospective Observational Cohort Study.

CONTEXT: Symptom burden is a strong predictor of reduced health-related quality of life and survival in patients with end-stage kidney disease. Renal supportive care (RSC) is a comprehensive approach shown to benefit symptoms in nondialysis conservatively managed patients, although its role in dialysis patients has not been reported. OBJECTIVES: This study aimed to investigate the impacts of RSC intervention on symptoms in dialysis patients. METHODS: Dialysis patients who were referred to an RSC clinic for symptom control between April 2010 and December 2017 were followed prospectively. Symptoms were scored using the Integrated Palliative care Outcomes Scale-Renal Inventory. Change in symptoms was analyzed at three visits and at final RSC visit within the study period. Correlation and linear regression were used to assess for effect modifiers. RESULTS: A total of 127 dialysis patients attended the RSC clinic for symptom management. Median age was 74 years, 62% males, median dialysis vintage was 2.2 years, and median-modified Charlson Comorbidity Index was 7. Mean combined physical and emotional symptom score at baseline was 17.5 (SD 9.6), the most overwhelming/severe symptoms being difficulty sleeping (35%), pain (31%), lack of energy (31%), poor mobility (24%), and itch (22%). Eighty patients had follow-up to at least three RSC visits (median 3.1 months). There was significant improvement in combined physical and emotional symptom score during three clinic visits (18.1 vs. 14.2; mean change -3.8; 95% CI -5.7 to -1.9; P < 0.001), with greatest improvement in symptom scores for the five most severe symptoms (each P < 0.001). Follow-up of these 80 patients to final RSC visit (median 13.0 months) showed sustained reduction in mean combined physical and emotional symptom score (18.1 vs. 14.4; mean change -3.7; 95% CI -5.6 to -1.7; P < 0.001). These changes occurred without change in dialysis delivery. CONCLUSION: RSC intervention that focuses on symptom control and patient-centered care is associated with improved total and individual symptom burden in dialysis patients. This supports a role for RSC as a management adjunct in these patients.