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

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dc.contributor.affiliationMedical, Dental and Health Sciences, Universidad Nacional Autónoma de México, Mexico City, Mexico
dc.contributor.emailreberobles@imp.edu.mx, reberobles@hotmail.com (Rebeca Robles)
dc.creatorMejía-Castrejón, Jessicaes_ES
dc.creatorSierra-Madero, Juan Gerardoes_ES
dc.creatorBelaunzarán-Zamudio, Pablo Franciscoes_ES
dc.creatorFresan-Orellana, Anaes_ES
dc.creatorMolina-López, Alejandroes_ES
dc.creatorÁlvarez-Mota, Atenea Betzabées_ES
dc.creatorRobles-García, Rebecaes_ES
dc.creator.identificadorhttps://orcid.org/0000-0002-4252-1571 (Mejía-Castrejón, Jessica)
dc.creator.identificadorhttps://orcid.org/0000-0002-1177-5843 (Sierra-Madero, Juan Gerardo)
dc.creator.identificadorhttps://orcid.org/0000-0003-4775-4734 (Belaunzarán-Zamudio, Pablo Francisco)
dc.creator.identificadorhttps://orcid.org/0000-0001-9160-6988 (Fresan-Orellana, Ana)
dc.creator.identificadorhttps://orcid.org/0000-0003-0946-9684 (Molina-López, Alejandro)
dc.creator.identificadorhttps://orcid.org/0000-0001-6612-4397 (Álvarez-Mota, Atenea Betzabé)
dc.creator.identificadorhttps://orcid.org/0000-0001-5958-7393 (Robles-García, Rebeca)
dc.date2024
dc.date.accessioned2025-03-10T18:49:51Z
dc.date.accessioned2026-03-27T15:31:14Z
dc.date.available2025-03-10T18:49:51Z
dc.date.issued2024
dc.date.published2024
dc.descriptionObjective: 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 (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. 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.es_ES
dc.formatPDFes_ES
dc.identifierJC28DIEP23es_ES
dc.identifier.doi10.1080/10503307.2023.2239448
dc.identifier.eissn1468-4381
dc.identifier.issn1050-3307
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
dc.identifier.placeInglaterra
dc.identifier.urihttps://doi.org/10.1080/10503307.2023.2239448
dc.identifier.urihttps://repositorio.inprf.gob.mx/handle/123456789/8234
dc.language.isoenges_ES
dc.publisherRoutledgees_ES
dc.relation34(4):475-489
dc.relation.jnabreviadoPSYCHOTHER RES
dc.relation.journalPsychotherapy Research
dc.rightsAcceso Cerradoes_ES
dc.subject.kwAdverse events
dc.subject.kwEvaluation
dc.subject.kwPsychotherapy
dc.subject.kwClinical trials
dc.subject.kwPatient safety
dc.subject.kwFramework
dc.titleDevelopment and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trialses_ES
dc.typeArtículoes_ES

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