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

Clicks: 310
ID: 262486
2020
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This article has not been analysed, so there is no overall score — reader engagement is measured and shown alongside.
AI Quality Assessment
Not analyzed
Readership in this journal
Emerging

Ranked #104 of 436 articles by views in Trials

Most read Least read

Bar heights use a square-root scale. Only the 120 most-read articles are drawn; the journal has 436 in total.

Mint this article as an NFT
Not yet minted

Create a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.

5 SUSD one-off · no wallet required
Sign in to mint
Abstract
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).To describe the pre-specified statistical and health economic analysis for the FIRST-ABC trial before completion of patient recruitment and data collection.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.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.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.ISRCTN ISRCTN60048867 . Registered on 19 June 2019.
Reference Key
orzechowska2020firstlinetrials Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Orzechowska, Izabella;Sadique, M Zia;Thomas, Karen;Davis, Peter;Morris, Kevin P;Mouncey, Paul R;Peters, Mark J;Richards-Belle, Alvin;Tume, Lyvonne N;Ramnarayan, Padmanabhan;Harrison, David A;
Journal Trials
Year 2020
DOI
10.1186/s13063-020-04818-w
URL
Keywords
intensive care paediatrics oxygen delivery respiratory medicine statistics, epidemiology and research design

Citations

No citations found. To add a citation, contact the admin at info@scimatic.org

Comments

No comments yet. Be the first to comment on this article.