Development of standard clinical endpoints for use in dengue interventional trials: introduction and methodology

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dc.creatorJaenisch, Thomas
dc.creatorHendrickx, Kim
dc.creatorErpicum, Martin
dc.creatorAgulto, Liane
dc.creatorTomashek, Kay M.
dc.creatorDempsey, Walla
dc.creatorSiqueira Júnior, João Bosco
dc.creatorMarks, Morgan A.
dc.creatorFay, Michael P.
dc.creatorLaughlin, Catherine
dc.date.accessioned2025-01-22T10:52:42Z
dc.date.available2025-01-22T10:52:42Z
dc.date.issued2018
dc.description.abstractBackground: As increasing numbers of dengue vaccines and therapeutics are in clinical development, standardized consensus clinical endpoint definitions are urgently needed to assess the efficacy of different interventions with respect to disease severity. We aimed to convene dengue experts representing various sectors and dengue endemic areas to review the literature and propose clinical endpoint definitions for moderate and severe disease based on the framework provided by the WHO 2009 classification. Methods: The endpoints were first proposed and discussed in a structured expert consultation. After that, the Delphi method was carried out to assess the usefulness, validity and feasibility of the standardized clinical disease endpoints for interventional dengue research. Results: Most respondents (> 80%) agreed there is a need for both standardized clinical endpoints and operationalization of severe endpoints. Most respondents (67%) felt there is utility for moderate severity endpoints, but cited challenges in their development. Hospitalization as a moderate endpoint of disease severity or measure of public health impact was deemed to be useful by only 47% of respondents, but 89% felt it could bring about supplemental information if carefully contextualized according to data collection setting. Over half of the respondents favored alignment of the standard endpoints with the WHO guidelines (58%), but cautioned that the endpoints could have ramifications for public health practice. In terms of data granularity of the endpoints, there was a slight preference for a categorical vs numeric system (e.g. 1–10) (47% vs 34%), and 74% of respondents suggested validating the endpoints using large prospective data sets. Conclusion: The structured consensus-building process was successful taking into account the history of the debate around potential endpoints for severe dengue. There is clear support for the development of standardized endpoints for interventional clinical research and the need for subsequent validation with prospective data sets. Challenges include the complexity of developing moderate disease research endpoints for dengue.
dc.identifier.citationJAENISCH, Thomas et al. Development of standard clinical endpoints for use in dengue interventional trials: introduction and methodology. BMC Medical Research Methodology, [s. l.], v. 18, e134, 2018. DOI: 10.1186/s12874-018-0601-z. Disponível em: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-018-0601-z. Acesso em: 20 jan. 2025.
dc.identifier.doi10.1186/s12874-018-0601-z
dc.identifier.issn1471-2288
dc.identifier.urihttp://repositorio.bc.ufg.br//handle/ri/26421
dc.language.isoeng
dc.publisher.countryOutros
dc.publisher.departmentInstituto de Patologia Tropical e Saúde Pública - IPTSP (RMG)
dc.rightsAcesso Aberto
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectDengue
dc.subjectSevere dengue
dc.subjectEndpoints
dc.subjectStandardization
dc.subjectValidation
dc.subjectDELPHI
dc.subjectVaccine
dc.subjectTherapeutic
dc.subjectIntervention
dc.subjectPathophysiology
dc.subjectEpidemiology
dc.titleDevelopment of standard clinical endpoints for use in dengue interventional trials: introduction and methodology
dc.typeArtigo

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