@article{eab7f062d8dd45b48e6f82d57a824636,
title = "Longitudinal Change in Quality of Life in Neurological Disorders Measures Over 3 Years in Patients with Early Parkinson's Disease",
abstract = "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.",
keywords = "Neuro-QoL, Parkinson's disease, measurement, quality of life",
author = "Connie Marras and Mills, {Kelly A.} and Shirley Eberly and David Oakes and Chou, {Kelvin L.} and Matthew Halverson and Parashos, {Sotirios A.} and Tarolli, {Christopher G.} and Lai, {Jin Shei} and Nowinsky, {Cindy J.} and Oksana Suchowersky and Farbman, {Eric S.} and Shulman, {Lisa M.} and Tanya Simuni",
note = "Funding Information: Dr. Connie Marras received research support as a site investigator for the STEADY‐PD III study. She is a consultant for Grey Matter Technologies and receives financial compensation as a steering committee member from The Michael J. Fox Foundation and the Parkinson's Foundation (US). She received research grants from The Michael J. Fox Foundation, Canadian Institutes of Health Research, Parkinson's International Parkinson and Movement Disorders Society, and as a site investigator for clinical trials sponsored by Theravance Inc., The Michael J. Fox Foundation, and Centogene. Funding Information: Dr. Kelvin L. Chou received research support as a site investigator in the STEADY‐PD III study. Dr. Chou received research funding from the NIH (NS107158), Parkinson Study Group, Voyager Therapeutics, and Neuraly. He has served as a consultant for Accordant, CNS Ratings, and Watermark Research Partners, Inc. and received royalties from UpToDate and Springer Publishing. Funding Information: Dr. Oksana Suchowersky received research support as a site investigator for the STEADY‐PD III study. She has received research grants from Wave Life Sciences and Roche and is financially supported by the University of Alberta Toupin Foundation. Funding Information: This study was conducted with financial support from National Institutes of Neurological Disorders and Stroke (NINDS) grants U01NS080818 and U01NS080840. Funding Information: Dr. Lisa M. Shulman received research support as an investigator in the STEADY‐PD III study. Dr. Shulman receives research funding from the NIH (1R01AG059651–01 and 1R01AG059651‐03S1), The Maryland Innovation Initiative, The Rosalyn Newman Foundation, and the Eugenia and Michael Brin Family. She receives royalties from Oxford University Press and Johns Hopkins University Press. Funding Information: Shirley Eberly's work on this project was supported by grants from the NIH. Over the past 12 months she has also received research support from Vaccinex Inc., The Michael J. Fox Foundation, and Grey Matter Technologies. Funding Information: Dr. Cindy J. Nowinski received research support from the NIH as a coinvestigator on the original Neuro‐QoL development project. Dr. Nowinski receives research funding from the NIH (UG3NS105562, U2CAG060426, U2CAG057441, 75N94019D00005) and the FDA (UG3FD006794). Funding Information: Dr. Kelly A. Mills received research support for involvement in the STEADY‐PD III study. Dr. Mills receives research funding from the National Institutes of Health (NIH)/NINDS (1K23NS101096‐01A1), Global Kinetics Corporation, and the RMS Foundation. Funding Information: Full financial disclosure for the previous 12 months: research support from The Parkinson's Foundation and the Park Nicollet Foundation; royalties from Oxford University Press; shareholder: Abbott; consultancies: AbbVie. Publisher Copyright: {\textcopyright} 2021 International Parkinson and Movement Disorder Society",
year = "2021",
month = aug,
doi = "10.1002/mds.28641",
language = "English (US)",
volume = "36",
pages = "1979--1983",
journal = "Movement Disorders",
issn = "0885-3185",
publisher = "John Wiley and Sons Inc.",
number = "8",
}