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Validation of a Patient–Reported Outcome Measure in Parkinson’s Disease

Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: The Patient-Reported Outcomes in Parkinson’s Disease (PRO-PD) scale is a 35-item visual analog measure designed to quantify symptom severity across motor and non-motor domains. Developed as a continuous, patient-centered outcome, PRO-PD captures patient-perceived change over time and is suitable for remote longitudinal assessment. This study evaluated the psychometric properties of PRO-PD across two independent datasets, in-cluding reliability, validity, factor structure, and minimal clinically important change (MCIC), and assessed its relevance to nutrition- and lifestyle-focused research. Methods: Convergent validity was evaluated in a cross-sectional clinical dataset (n = 46) using established clinician-rated and patient-reported instruments, including Hoehn and Yahr, Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire-39 (PDQ-39), Montreal Cognitive Assessment (MoCA), and PROMIS measures. Internal con-sistency, temporal stability, factor structure, and known-groups validity were assessed in a large remote-monitoring cohort (n = 2,612). MCID thresholds were estimated in a longitudinal sub-sample (n = 390) using anchor-based methods, multinomial regression, and receiver operating characteristic analyses. Joint modeling (two-stage procedure) approach was applied to model the sensitivity of PRO-PD change in time to the binary diet factors evolution in time. Results: PRO-PD demonstrated strong convergent validity with established clinical measures, excellent internal consistency (Cronbach’s α = 0.93–0.95), and good test–retest reliability (ICC = 0.78 overall; 0.89 at 6 months). Confirmatory testing of a previously proposed eight-factor structure showed suboptimal fit, leading to a parsimonious four-factor solution (Cognitive, Autonomic, Motor, Psycho-Emotional) explaining 47.6% of variance. PRO-PD scores increased significantly with advancing disease duration and stage. MCID thresholds were +53.5 points for worsening and −78.5 points for improvement (AUC = 0.63–0.71), with greater sensitivity for detecting deterioration than improvement. Joint modeling further demonstrated sensitivity of PRO-PD to baseline dietary behaviors and dietary change over time. Conclusions: These findings support PRO-PD as a psychometrically robust, low-burden out-come measure suitable for remote monitoring and for use across nutrition, nutraceutical, and pharmacologic intervention studies, including in early PD where traditional scales may lack sensitivity.
Source: Nutrients
Language: English
Subfield: Neurology
Field: Medicine
Open Access status: gold
Estimated APC paid: $3,499
OpenAlex ID: W7143963779
FWCI: 4.297
Cites: 14
Cited by: 1
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