Evidence map›Paper›PMID 33129360›Full record

ArticleTrials2020

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

Izabella Orzechowska, M Zia Sadique, Karen Thomas, Peter Davis, Kevin P Morris, Paul R Mouncey, Mark J Peters, Alvin Richards-Belle, Lyvonne N Tume, Padmanabhan Ramnarayan and 1 more

Open access · goldAbstract read
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Izabella OrzechowskaClinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK. izabella.orzechowska@icnarc.org.ORCID http://orcid.org/0000-0001-9711-3594
M Zia SadiqueDepartment of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Karen ThomasClinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK. Karen.Thomas@icnarc.org.
Peter DavisPaediatric Intensive Care, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Upper Maudlin Street, Bristol, BS2 8BJ, UK.
Kevin P MorrisPaediatric Intensive Care, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Steelhouse Lane, Birmingham, B4 6NH, UK.
Paul R MounceyClinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.
Mark J PetersPaediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, and NIHR Biomedical Research Centre, London, WC1N 3JH, UK.
Alvin Richards-BelleClinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.
Lyvonne N TumeSchool of Health & Society, University of Salford, Mary Seacole Building, Frederick Road Campus, Broad St, Salford, M6 6PU, UK.
Padmanabhan RamnarayanChildren's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, WC1N 3JH, UK.
David A HarrisonClinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.
Intensive Care National Audit & Research Centre · GBBirmingham Children's Hospital · GBGreat Ormond Street Hospital · GBImperial College Healthcare NHS Trust · GBLondon School of Hygiene & Tropical Medicine · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Salford · GB

Funding

National Institute for Health Research 17/94/28
6 · The paper itself

Abstract

backgroundThe 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).

objectivesTo describe the pre-specified statistical and health economic analysis for the FIRST-ABC trial before completion of patient recruitment and data collection.

methodsThe 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.

resultsThe 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.

conclusionThe 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 registrationISRCTN ISRCTN60048867 . Registered on 19 June 2019.

Indexed as

CannulaContinuous Positive Airway PressureChildCost-Benefit AnalysisHumansProportional Hazards ModelsQuality-Adjusted Life YearsIntensive careOxygen deliveryPaediatricsRespiratory medicineStatistics, epidemiology and research design

Identifiers

PMID33129360
PMCPMC7602829
OpenAlexW3095270833

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.