Longitudinal Change in Quality of Life in Neurological Disorders Measures Over 3 Years in Patients With Early Parkinson's Disease

Background The Quality of Life in Neurological Disorders (Neuro-QoL) is a publicly available health-related quality-of-life measurement system. Objective The aim of this study was to evaluate the utility of Neuro-QoL item banks as outcome measures for clinical trials in Parkinson's disease. Methods An analysis of Neuro-QoL responsiveness to change and construct validity was performed in a multicenter clinical trial cohort. Results Among 310 participants over 3 years, changes in five of eight Neuro-QoL domains were significant (P < 0.05) but very modest. The largest effect sizes were seen in the cognition and mobility domains (0.35-0.39). The largest effect size for change over the year in which levodopa was initiated was -0.19 for lower extremity function-mobility. For a similarly designed clinical trial, estimated sample size required to demonstrate a 50% reduction in worsening ranged from 420 to more than 1000 participants per group. Conclusions More sensitive tools will be required to serve as an outcome measure in early Parkinson's disease. (c) 2021 International Parkinson and Movement Disorder Society

Automated summary

The Neuro-QoL item banks showed limited utility as outcome measures in clinical trials for Parkinson's disease, indicating the need for more sensitive tools.