| Autor: |
Mejía-Castrejón, Jessica, Sierra-Madero, Juan Gerardo, Belaunzarán-Zamudio, Pablo Francisco, Fresan-Orellana, Ana, Molina-López, Alejandro, Álvarez-Mota, Atenea Betzabé, Robles-García, Rebeca |
| Předmět: |
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| Zdroj: |
Psychotherapy Research; Apr2024, Vol. 34 Issue 4, p475-489, 15p |
| Abstrakt: |
Develop and obtain content validity of a new tool for Evaluating and Classifying the Severity of Adverse Events for Psychotherapeutic Clinical Trials (EVAD). 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. 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 (p < 0.001). Final version of EVAD were applied to three participants for 7 weeks. Overall EVAD seems to be clear and meaningful for participants. EVAD is a semistructured interview based on a consistent conceptual framework, and proven content validity following the most important guidelines described in the literature. ClinicalTrials.gov identifier: NCT03878186. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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