REFINING THE MEASUREMENT OF MOTOR AND NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE PATIENTS WITH FLUCTUATING SYMPTOMS

Author(s)

Buck PO1, White MK2, Castelli-Haley J1, Rendas-Baum R31Teva Neuroscience, Kansas City, MO, USA, 2QualityMetric Incorporated, Lincoln, RI, USA, 3QualityMetric Health Outcomes Solutions, Lincoln, RI, USA

OBJECTIVES: Parkinson’s disease (PD) is the second most prevalent neurodegenerative disorder in the US. The Scales for Outcomes in Patients with Parkinson’s disease Diary Card (SCOPA-DC) is a daily diary designed to measure motor impairment in PD patients with fluctuating symptoms. Consistent with the FDA’s final guidance on patient-reported outcome measures, this study aimed to evaluate the content validity of the SCOPA-DC in the US and determine the feasibility of adding items that measure non-motor symptoms using qualitative techniques. METHODS: A literature review identified the most dominant non-motor symptoms experienced by PD patients with fluctuating symptoms. Three focus groups were conducted with PD patients (n=24) to identify themes that specifically addressed the study objectives. The original SCOPA-DC was modified based on findings from the literature review and patient input. A fourth focus group (n=9) consisted of a cognitive debriefing of the revised SCOPA-DC that included additional items and modified structure based upon the previous results. RESULTS: Findings from the focus groups demonstrated support for the content of the original SCOPA-DC, generally finding it to be clear and intuitive, despite difficulties with some item definitions, time frames, and response labels. With respect to non-motor symptoms, seven domains were consistently mentioned: fatigue, concentration/memory, anxiety, pain, difficulty swallowing, frequent urination, and sweating. The cognitive debriefing focus group reported that the revised SCOPA-DC format was easier to use, provided better focus on the items and time frames, and more adequately captured experiences throughout the day as compared to the original. CONCLUSIONS: Non-motor symptoms occur frequently in PD patients with fluctuating symptoms and have a significant impact on health-related quality of life. A reliable and validated patient-reported daily diary may improve the ability to describe PD progression by accurately measuring both motor and non-motor symptoms. Additional quantitative research is needed to evaluate the psychometric properties of the revised SCOPA-DC.

Conference/Value in Health Info

2010-05, ISPOR 2010, Atlanta, GA, USA

Value in Health, Vol. 13, No. 3 (May 2010)

Code

PND25

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Neurological Disorders

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