Andrea Marini Padovani

Background: Parkinson’s disease (PD) substantially affects health-related quality of life (HRQoL). The EQ-5D-5 L is a preference-based patient-reported outcome measure that supports cross-condition comparison and health-economic evaluation, but its measurement properties have not been established in people with PD in Italy. This study evaluated short-term reproducibility and construct validity through a priori hypothesis testing; score distributions and inter-dimensional associations were also described. Methods: This cross-sectional psychometric study included a 48-hour retest component. Participants completed the EQ-5D-5 L, the Parkinson’s Disease Questionnaire-39 (PDQ-39), and the 12-item Short Form Health Survey (SF-12). Short-term reproducibility was assessed using quadratic-weighted Cohen’s kappa and exact agreement for the five dimensions and single-measures, two-way random-effects, absolute-agreement intraclass correlation coefficients for the EQ-Index and EQ-VAS. Construct validity was examined using prespecified directional and magnitude hypotheses tested with Spearman correlations; Pearson correlations were used as sensitivity analyses. Post hoc analyses examined routine-care clinical measures and ordered motor-severity categories. Results: Eighty participants completed the questionnaires, and 60 underwent retesting. Fifty-nine distinct health states were observed, with one participant reporting full health. Agreement was high for the EQ-Index (ICC = 0.901, 95% CI 0.840–0.940) and EQ-VAS (ICC = 0.938, 95% CI 0.899–0.963), whereas dimension-level kappa ranged from 0.632 to 0.916. All 20 directional hypotheses were confirmed, but only 6 of the 16 prespecified magnitude criteria were met. The strongest associations were observed with PDQ-39 Mobility (ρ = −0.786 and − 0.781), PDQ-39 Activities of Daily Living (ρ = −0.671 and − 0.685), and the SF-12 Physical Component Summary (ρ = 0.730 and 0.639) for the EQ-Index and EQ-VAS, respectively. In post hoc analyses, both summary scores declined monotonically across externally defined mild, moderate, and severe motor-severity categories (both p < 0.001). Conclusions: The Italian EQ-5D-5 L showed high short-term reproducibility for its summary scores and evidence supporting selected aspects of construct validity, particularly convergence with physical functioning and daily activities. Evidence for discrimination from more distant HRQoL domains was limited, and the post hoc clinical findings require prospective confirmation. The instrument may complement disease-specific measures in group-level research and health-economic evaluation, but these findings do not support its use for monitoring change in individual patients.

Background: Rehabilitation assessment is increasingly integrated into medico legal practice to complement traditional impairment based evaluations with functional and multidimensional approaches. Wearable sensors offer objective measurements of joint range of motion, but their relationship with clinical outcome measures requires further investigation. Objective: To examine the construct validity of sensor based range of motion measurements by analyzing their association with commonly used rehabilitation outcome measures in a medico legal population. Methods: A cross sectional study was conducted on individuals with traumatic injuries. Joint range of motion of the shoulder, hip, knee, and ankle was assessed using XClinic wearable inertial sensors and expressed as a percentage of physiological reference values. Participants also completed validated outcome measures assessing balance, lower and upper limb function, fatigue, and kinesiophobia. Construct validity was evaluated through Pearson correlation analysis. Results: Sixty seven participants were included. Significant correlations were observed between sensor derived range of motion and multiple functional domains. Shoulder mobility was associated with work related disability, fatigue, and movement avoidance. Hip range of motion showed consistent associations with balance, lower limb function, and pain related activity limitations. Knee mobility demonstrated relationships with knee specific outcomes, balance, and lower extremity function, with additional links to fatigue and kinesiophobia in specific movements. Ankle range of motion showed more selective associations, particularly with balance, lower limb function, and specific psychological and fatigue related aspects. Conclusion: Sensor based range of motion assessment demonstrates meaningful relationships with functional and psychosocial outcomes, supporting its construct validity. These findings suggest its potential role as a complementary tool for multidimensional evaluation in rehabilitation and medico legal contexts.

Background: Multiple Sclerosis (MS) significantly affects physical, cognitive, and psychosocial functioning, leading to impaired Health-Related Quality of Life (HRQoL). The EQ-5D-5 L is a widely used generic patient-reported outcome measure (PROM) to assess HRQoL across health conditions. However, its psychometric properties have not been fully established in Italian people with MS (PwMS). This study aimed to evaluate the reliability and validity of the Italian EQ-5D-5 L in PwMS, supporting its applicability in clinical and research contexts. Methodology: A cross-sectional psychometric validation study was conducted in accordance with COSMIN guidelines. Participants were recruited from an Italian tertiary MS center based on the following inclusion criteria: age ≥ 18 years, confirmed MS diagnosis according to the 2017 McDonald criteria, fluency in Italian, and ability to provide informed consent and independently complete the questionnaire. Eligible participants completed the Italian EQ-5D-5 L and the MSQOL-54 in person. Test-retest reliability was assessed via Intraclass Correlation Coefficients (ICC) after a 48-hour interval in clinically stable participants, construct validity through Pearson’s correlations with MSQOL-54 domains, and known-groups validity by ANOVA and t-tests across disability levels (EDSS), employment status, and physiotherapy engagement. Results: Sixty-nine PwMS (55% female; mean age 49 ± 13 years) were included. The EQ-5D-5 L showed high test–retest reliability (ICC range = 0.81–0.95). Strong correlations supported construct validity, particularly between the EQ-Index and the Physical Health Composite Score ( r = 0.76, p < 0.001) and between the EQ-VAS and the Overall Quality of Life item ( r = 0.71, p < 0.001). Known-groups validity was confirmed, with higher HRQoL scores among participants with mild disability (EDSS 0–3.5) and those employed (both p < 0.001). Conclusions: The Italian EQ-5D-5 L showed satisfactory reliability and construct validity in PwMS, supporting its use as a generic measure of HRQoL in clinical and research settings. The relatively small sample size, particularly in the test–retest subgroup, should be considered when interpreting these findings. Additional measurement properties, including content validity, were not specifically evaluated in the present study. Complementary use with MS-specific instruments remains advisable to capture domains such as fatigue and cognitive function.