Correlation between Unified Parkinson’s Disease Rating Scale and Global Impression of Change Scales (P1.198)

Abstract

Objective: The primary objective of this study is to prospectively determine the correlation of changes in Unified Parkinson's disease Rating Scale (UPDRS) with patient global impressions of change (PGIC) and secondary objective is to correlate changes in UPDRS with the Clinician Global Improvement (CGI-I). Background: A clinically important difference (CID) is the amount of change on a specific measure that patients can recognize and value. Traditionally, a change in The UPDRS scores of 20-30% has been considered clinically meaningful. Although a clinical trial may identify small but statistically significant differences in an outcome measure such as UPDRS, a percentage change can be difficult to interpret and may have minimal relevance to clinical decisionmaking and understanding patient's own perception of change. In a recent analysis, a change of 3 to 5 points on the UPDRS has been suggested to be the minimal CID. To our knowledge, there is no published data on the correlation between changes in UPDRS and patient rated improvement scales in a prospective analysis. Methods: This prospective, single-center study was started upon IRB approval and currently is ongoing and will end upon enrollment of 500 measurements. The PGIC form is self reported and the physician performs a CGI-I assessment. The UPDRS is rated by a separate blinded rater. At the baseline visit, UPDRS will be performed. Subsequently, for each subject, the UPDRS, PGIC, and CGI-I assessments will be performed at each follow-up visit within 12 weeks after the baseline visit. Subject data from up to 3 clinic visits (including baseline visit) will be included in the data analysis. Results: Data collected will include patient demographics (identifying information, gender, PD duration, medication and deep brain stimulation settings, psychiatric history, PD symptoms), PGIC, CGI-I scores and UPDRS. Conclusions: This prospective analysis is currently going on and as today total of 96 subjects have been enrolled. Total of 200 measurements have been performed. The result of this study will provide more insight into the patient's perspective of PD.