[The development and validation of a new comprehensive self-completing questionnaire for symptoms in Parkinson's disease (MASAC-PD 31)].

BACKGROUND: Patients with Parkinson's disease (PD) suffer from various symptoms. In order to identify untreated symptoms within the limited time of a clinical interview, we developed a new self-completing questionnaire (MASAC-PD 31). The questionnaire consists of two parts (5 domains, 31 items); Part I intended at rating the motor symptoms and activities of daily living (ADL) during both "on" and "off" periods, and Part II aimed at screening and assessing mainly the non-motor symptoms, such as sleep-related difficulties, autonomic symptoms, cognition, mood and others. The purpose of this study was to evaluate the validity, reliability, and clinical usefulness of the questionnaire. SUBJECTS AND METHODS: Based on the number of valid answers in a pilot trial, MASAC-PD 31 was refined by improving the expression and layout. Of the initially enrolled 107 patients attending three hospitals, 102 patients were included in the final analysis. Correlations of the scores on the MASAC-PD 31 with other clinical scales were evaluated. A second trial consisting of 57 participants was conducted a month later to assess the test-retest reproducibility of the questionnaire. RESULTS: The average time needed to complete MASAC-PD 31 was 17 min (range: 3-90 min). Each of the domains in Part I showed high internal consistency (Cronbach's alpha: 0.663 for "on" motor) and strong correlations with preexisting indices (Spearman's correlation coefficient: 0.547, 0.544, and 0.571 for "on" motor against "on" UPDRS, PDQ-39, and Schwab & England ADL scale, respectively). The questions in the Part II domains also showed strong correlations with preexisting scales. Most of the items showed high reproducibility (weighted kappa coefficient) and consistency. CONCLUSION: This new comprehensive questionnaire was shown to be valid and reliable for assessing the motor disability in patients with PD. Moreover, it may be useful in clinical management for identifying clinically unrecognized symptoms, especially non-motor problems.