Robust Adaptive Incorporation of Historical Control Data in a Randomized Trial of External Cooling to Treat Septic Shock - Inria - Institut national de recherche en sciences et technologies du numérique Access content directly
Journal Articles Bayesian Analysis Year : 2021

Robust Adaptive Incorporation of Historical Control Data in a Randomized Trial of External Cooling to Treat Septic Shock

Abstract

This paper proposes randomized controlled clinical trial design to eval-uate external cooling as a means to control fever and thereby reduce mortality in patients with septic shock. The trial will include concurrent external cooling and control arms while adaptively incorporating historical control arm data. Bayesian group sequential monitoring will be done using a posterior comparative test based on the 60-day survival distribution in each concurrent arm. Posterior inference will follow from a Bayesian discrete time survival model that facilitates adap-tive incorporation of the historical control data through an innovative regression framework with a multivariate spike-and-slab prior distribution on the histori-cal bias parameters. For each interim test, the amount of information borrowed from the historical control data will be determined adaptively in a manner that re-flects the degree of agreement between historical and concurrent control arm data. Guidance is provided for selecting Bayesian posterior probability group-sequential monitoring boundaries. Simulation results elucidating how the proposed method borrows strength from the historical control data are reported. In the absence of historical control arm bias, the proposed design controls the type I error rate and provides substantially larger power than reasonable comparators, whereas in the presence bias of varying magnitude, type I error rate inflation is curbed.
Fichier principal
Vignette du fichier
20-BA1229.pdf (1.17 Mo) Télécharger le fichier
Origin : Publisher files allowed on an open archive

Dates and versions

hal-03864768 , version 1 (16-12-2023)

Licence

Attribution

Identifiers

Cite

Thomas Murray, Peter Thall, Frederique Schortgen, Pierre Asfar, Sarah Zohar, et al.. Robust Adaptive Incorporation of Historical Control Data in a Randomized Trial of External Cooling to Treat Septic Shock. Bayesian Analysis, 2021, 16 (3), ⟨10.1214/20-BA1229⟩. ⟨hal-03864768⟩
35 View
2 Download

Altmetric

Share

Gmail Facebook X LinkedIn More