METHOD FOR ACCURATELY ASSESSING DISEASE SEVERITY IN CLINICAL TRIALS CONCERNING PSYCHOPATHOLOGY

摘要

PROBLEM TO BE SOLVED: To provide a method for accurately assessing the disease severity in clinical trials concerning psychopathology.SOLUTION: The method for accurately assessing the disease severity in clinical trials concerning psychopathology comprises the steps of: generating audiovisual, confirmed and patient-observer-linked records of interviews between observers and patients; presenting a confirmed record for review to one or more reference observers; asking the reference observer or the observers to score the disease or symptom severity according to an evaluation scale, on the basis of observation on the confirmed record; and making the scores based on the patient-observer records by the reference observer or the reference observers available to the corresponding observers. Thus, the confirmed record is generated from the interview held by the patient and the observer in order that the observer scores to evaluate the intervention effectiveness. Further, in the series of the steps, the method includes a step of asking the observer to adjust or integrate the scores in order to use them for obtaining an integrated score.