PSYCHOMETRIC EVALUATION OF THE EQ-5D-5L IN SEPSIS PATIENTS
Author(s)
Juliana Schmidt, MSc, Dennis Grothe, MSc, Ole Marten, PhD, Simone Kreimeier, PhD, Wolfgang Greiner, PhD.
Bielefeld University, Bielefeld, Germany.
Bielefeld University, Bielefeld, Germany.
OBJECTIVES: The overall aim was to test the psychometric properties (feasibility, floor and ceiling effects, convergent and known-groups validity, and responsiveness) of the EQ-5D-5L in critically ill sepsis patients. Secondary aims were to (1) compare self- and proxy-reported assessments, and (2) evaluate longitudinal stability of these properties.
METHODS: We used data from a randomized controlled trial including patients with sepsis or septic shock from intensive care units (ICU) in 24 hospitals in Germany. The EQ-5D-5L was assessed at baseline and 90- and 180-days follow-up. The Sequential Organ Failure Assessment (SOFA) score and Charlson Comorbidity Index (CCI) were also assessed. Response distribution, feasibility (missing values) and floor/ceiling effects, convergent (Spearman correlation) and known-groups validity (Wilcoxon test/Kruskal-Wallis Test) were evaluated. Responsiveness will be determined by effect size and standardized response mean.
RESULTS: The sample included n=389 participants (mean age 64.2 ± 15.0 years; 61.1% female). Baseline missingness per dimension was low (0.3-1.4 %), and completion rates were high for the descriptive system (97.2%) and the EQ VAS (97.5%) and remained high at follow-up. No profile-level floor or ceiling effects were identified.Baseline floor effects occurred in mobility (62.4%), self-care (57.5%), and usual activities (69.0%). Ceiling effects at 180 days emerged for self-care and anxiety/depression (both 50.7%). Correlations between the EQ-5D-5L and SOFA as well as CCI were weak (r = -0.049 to 0.078). The EQ-5D-5L dimensions showed strong correlations with their corresponding VR-36 domains. The index did not discriminate between clinically distinct patient groups (age, sex, SOFA score, ICU length of stay (p > 0.05)).
CONCLUSIONS: Floor and ceiling effects likely reflected clinical trajectory rather than instrument limitations. Convergent and known-groups validity were limited, potentially due to small sample size and mortality-related skewness. Further analyses (responsiveness, additional known-groups, comparison with VR-36) are planned.
METHODS: We used data from a randomized controlled trial including patients with sepsis or septic shock from intensive care units (ICU) in 24 hospitals in Germany. The EQ-5D-5L was assessed at baseline and 90- and 180-days follow-up. The Sequential Organ Failure Assessment (SOFA) score and Charlson Comorbidity Index (CCI) were also assessed. Response distribution, feasibility (missing values) and floor/ceiling effects, convergent (Spearman correlation) and known-groups validity (Wilcoxon test/Kruskal-Wallis Test) were evaluated. Responsiveness will be determined by effect size and standardized response mean.
RESULTS: The sample included n=389 participants (mean age 64.2 ± 15.0 years; 61.1% female). Baseline missingness per dimension was low (0.3-1.4 %), and completion rates were high for the descriptive system (97.2%) and the EQ VAS (97.5%) and remained high at follow-up. No profile-level floor or ceiling effects were identified.Baseline floor effects occurred in mobility (62.4%), self-care (57.5%), and usual activities (69.0%). Ceiling effects at 180 days emerged for self-care and anxiety/depression (both 50.7%). Correlations between the EQ-5D-5L and SOFA as well as CCI were weak (r = -0.049 to 0.078). The EQ-5D-5L dimensions showed strong correlations with their corresponding VR-36 domains. The index did not discriminate between clinically distinct patient groups (age, sex, SOFA score, ICU length of stay (p > 0.05)).
CONCLUSIONS: Floor and ceiling effects likely reflected clinical trajectory rather than instrument limitations. Convergent and known-groups validity were limited, potentially due to small sample size and mortality-related skewness. Further analyses (responsiveness, additional known-groups, comparison with VR-36) are planned.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
MSR132
Topic
Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
PRO & Related Methods
Disease
Infectious Disease (non-vaccine)