18. An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Clinical Trials

ABSTRACT: Abstract

Background

The impact of frailty on the efficacy and safety of vaccines and therapeutic interventions is increasingly recognized, yet assessment of frailty in clinical trials is often considered logistically challenging. We developed the retrospective Clinical Trial Frailty Index (CT-FI), using baseline medical history and patient reported outcomes collected via standard instruments (Short Form Survey-36 and Euro Quality of Life-5 Dimension) in two clinical trials of the adjuvanted recombinant zoster vaccine (RZV, ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]). This post-hoc analysis aimed to show that CT-FI is a robust measure that may be used in any analysis where sufficient patient data has been collected in a clinical trial.

Methods

Items included in the CT-F

SUBMITTER: Andrew M 

PROVIDER: S-EPMC8644468 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature