First-line support for assistance in breathing in children : statistical and health economic analysis plan for the FIRST-ABC trial

Orzechowska, I ORCID: https://orcid.org/0000-0001-9711-3594, Sadique, MZ, Thomas, K, Davis, P, Morris, KP, Mouncey, PR, Peters, MJ, Richards-Belle, A, Tume, LN ORCID: https://orcid.org/0000-0002-2547-8209, Ramnarayan, P and Harrison, DA 2020, 'First-line support for assistance in breathing in children : statistical and health economic analysis plan for the FIRST-ABC trial' , Trials, 21 (1) , p. 903.

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Abstract

Background: The FIRST-ABC trial comprises of two pragmatic, multicentre, parallel groups, non-inferiority randomised clinical trials designed to evaluate the clinical non-inferiority of first-line use of high flow nasal cannula (HFNC) to continuous positive airway pressure (CPAP) in critically ill children who require non-invasive respiratory support (NRS). Objectives: To describe the pre-specified statistical and health economic analysis for the FIRST-ABC trial before completion of patient recruitment and data collection. Methods: The statistical analysis plan was designed by the chief investigators and statisticians. We define the primary and secondary outcomes, summarise methods for data collection and safety monitoring, and present a detailed description of the planned statistical and health economic analysis. Results: The primary clinical outcome is time to liberation from respiratory support. The primary effect estimate will be the adjusted hazard ratio, reported with a 95% confidence interval. As a sensitivity analysis, the primary analysis will be repeated using time to start weaning of NRS. Subgroup analyses will be performed to test for interactions between the effect of allocated treatment group and pre-specified baseline covariates. The health economic analysis will follow the intention-to-treat principle and report the mean (95% confidence interval) incremental costs, quality-adjusted life years (QALYs) and cost-effectiveness up to 6 months. All analyses will be performed separately for each of the two trials, and any results will not be combined. Conclusion: The FIRST-ABC trial will assess the non-inferiority of HFNC compared to CPAP in two parallel trials with shared infrastructure (step-up RCT and step-down RCT). We have developed a pre-specified statistical and health economics analysis plan for the FIRST-ABC study before trial completion to minimise analytical bias. Trial registration: ISRCTN ISRCTN60048867. Registered on 19 June 2019.

Item Type: Article
Additional Information: ** From Springer Nature via Jisc Publications Router ** Licence for this article: https://creativecommons.org/licenses/by/4.0/ **Journal IDs: eissn 1745-6215 **Article IDs: publisher-id: s13063-020-04818-w; manuscript: 4818 **History: collection 12-2020; published_online 31-10-2020; online 31-10-2020; accepted 16-10-2020; registration 16-10-2020; submitted 11-07-2020
Schools: Schools > School of Health and Society
Journal or Publication Title: Trials
Publisher: BioMed Central
ISSN: 1745-6215
Related URLs:
Funders: National Institute for Health Research (NIHR)
SWORD Depositor: Publications Router
Depositing User: Publications Router
Date Deposited: 03 Nov 2020 15:08
Last Modified: 03 Nov 2020 16:04
URI: http://usir.salford.ac.uk/id/eprint/58674

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