Statistical Analysis for Rating Scale in Clinical Trials.

ABSTRACT

In psychiatry clinical trials, an instrument or questionnaire with rating scale is often used to access safety and efficacy of a test treatment under investigation. Statistical analysis based on the collected rating scale is then performed a determine whether there is an improvement in endpoint change from baseline mean scale. This approach needs on absolute change, however, may not actually reflect the performance of the test treatment under study because the change, which may be considered of clinically importance, may fall within the same category in terms of disease severity such as mild, moderate, and severe. In this case, it is suggested, in addition to absolute change approach, a categorical shift analysis be considered to determine whether the endpoint change from baseline has resulted in an improvement in categorical shift, in terms of disease severity shift e.g., from severe to mild or moderate. In this article, we explore the relationship between absolute change approach and categorical shift analysis based on rating scales for assessment of test treatment under study.