Development of standard clinical endpoints for use in dengue interventional trials: introduction and methodology
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2018
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Background: 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.
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Dengue, Severe dengue, Endpoints, Standardization, Validation, DELPHI, Vaccine, Therapeutic, Intervention, Pathophysiology, Epidemiology
Citação
JAENISCH, 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.