Empirical estimation of disutilities and decision thresholds for composite endpoints

Data de publicação:

Autores da FMUP

  • Bernardo Manuel De Sousa Pinto

    Autor

  • Rafael José Monteiro Da Silva Vieira

    Autor

  • Renato Ivo Ferreira Da Silva

    Autor

  • André De Sousa Ferreira

    Autor

  • António De Almeida E Sousa Cardoso Fernandes

    Autor

Participantes de fora da FMUP

  • Bognanni, Antonio
  • Gil-Mata, Sara
  • Xie, Feng
  • Bonovas, Stefanos
  • Piovani, Daniele
  • Morgano, Gian Paolo
  • Lourenco-Silva, Nuno
  • Piggott, Thomas
  • Wiercioch, Wojtek
  • Neumann, Ignacio
  • Bedbrook, Anna
  • Yepes-Nunez, Juan Jose
  • Klimek, Ludger
  • Zuberbier, Torsten
  • Fonseca, Joao A.
  • Bousquet, Jean
  • Schuenemann, Holger J.

Unidades de investigação

Abstract

Objectives: The evaluation of health benefits and harms of an intervention with GRADE Evidence to Decision (EtD) frameworks includes judgments if the effects are ``trivial,''''small,''''moderate,''or ``large.''Such judgments ideally require the a priori establishment of decision thresholds (DTs), whose empirical derivation for single outcomes has been previously described. In this article, we provide a methodological approach to estimate DTs for composite endpoints based on disutilities. Study Design and Setting: We generated an approach that involves the computation of pooled disutilities, in which the disutility of each outcome comprised in the composite endpoint is weighted by the respective relative frequency. We also applied a modeling approach based on probability distributions to account for uncertainty in the estimates. We present a practical example of the determination of DTs associated with the development of at least one adverse event following treatment with intranasal medications for rhinitis that we used in the Allergic Rhinitis and its Impact on Asthma guidelines. Results: We provide the methodological steps of a modeling-based approach to compute pooled disutilities and, as a result, DTs for composite endpoints. We have developed a webtool (https://compositedt.med.up.pt/) that allows for a simple implementation of the proposed approach. Applying our approach to a practical example, we concluded that rhinitis nasal medications, compared to placebo, were associated with a trivial harm from adverse events. Conclusion: We propose an approach for estimating DTs for composite endpoints, which may be particularly valuable whenever composite endpoints are used for clinical research, clinical practice, and decision-making. (c) 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

Dados da publicação

ISSN/ISSNe:
0895-4356, 1878-5921

Journal of Clinical Epidemiology  Elsevier USA

Tipo:
Article
Páginas:
-
Link para outro recurso:
www.scopus.com

Documentos

  • Não há documentos

Métricas

Filiações mostrar / ocultar

Keywords

  • Composite endpoints; Decision thresholds; Disutilities; GRADE; Guidelines; Meta-analysis

Proyectos asociados

Post-marketing Surveillance Study of the Effectiveness and Safety of New Oral Antivirals for Outpatients With Mild-moderate COVID-19 (ESOA-19) - NCT05894603

Investigador Principal: Renato Ivo Ferreira da Silva

Estudo Observacional Académico (ESOA-19) . 2022

Seroprevalence of SARS-CoV-2 and assessment of epidemiologic determinants in Portuguese municipal workers

Investigador Principal: Bernardo Manuel De Sousa Pinto

Estudo Clínico Académico (SARS-CoV-2) . 2021

Citar a publicação

Partilhar a publicação