Article ; Online: Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials.
Psychotherapy research : journal of the Society for Psychotherapy Research
2023 Volume 34, Issue 4, Page(s) 475–489
Abstract: 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 ... ...
| Abstract | 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. We have designed EVAD items and their complementary tool for rating adverse events. Content validation by expert judges resulted in CVR = 1.0 for each item and CVI = 0.79 in sufficiency, 0.76 in clarity, 0.91 in coherence and 0.95 in relevance for all items ( Conclusions: EVAD is a semistructured interview based on a consistent conceptual framework, and proven content validity following the most important guidelines described in the literature. Trial registration: ClinicalTrials.gov identifier: NCT03878186. |
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| MeSH term(s) | Humans ; Surveys and Questionnaires ; Reproducibility of Results |
| Language | English |
| Publishing date | 2023-08-08 |
| Publishing country | England |
| Document type | Review ; Journal Article |
| ZDB-ID | 1080323-3 |
| ISSN | 1468-4381 ; 1050-3307 |
| ISSN (online) | 1468-4381 |
| ISSN | 1050-3307 |
| DOI | 10.1080/10503307.2023.2239448 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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