Clinical global impressions in Alzheimer's clinical trials.
アルツハイマーの臨床試験の臨床全体的な印象。
Int Psychogeriatr. 1996; 8; 277-88; discussion 288-90;
Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, USA.
Abstract
This article reviews the history of Clinical Global Impressions of Change (CGIC) instruments, their use and limitations in clinical trials of Alzheimer's disease, and the development of the National Institute on Aging's Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC). Originally, CGICs were simple and unstructured instruments that asked a clinician to rate change over the duration of a clinical trial. The method, however, failed to consistently detect treatment effects, leading to the development of more structured and subsequently validated approaches, such as the Clinician Interview-Based Impression Scale (CIBI) and the ADCS-CGIC. Both are currently used in clinical trials. The implications and importance of choosing an appropriate global rating are discussed.
最初は、CGICsは、臨床医に臨床試験の継続の間変化を評価するよう依頼した、単純なおよび構造化されていない器具であった。
しかしながら、方法は一貫して治療効果を検出するのに失敗した。
そして、より構造化およびその後確認されたアプローチ(例えばClinician Interview-Based Impression Scale(CIBI)とADCS-CGIC)の開発に至った。
両方とも、現在臨床試験で使われる。
適切な全体的な評価を選択することの意味と重要性は、検討される。