Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials.

Objective: Develop and obtain content validity of a new tool for Evaluating and Classifying the Severity of Adverse Events for Psychotherapeutic Clinical Trials (EVAD).

Method: Study of the development process of EVAD in four stages: (1) identify the domain and concept definition through a literature review, (2) instrument design, (3) expert judgment of the EVAD items through Gwent's concordance coefficient, and (4) applicability.

Results: In the absence of a consistent conceptual framework of adverse events in psychotherapeutic clinical trials, we have developed a framework and defined it.