Evidence map›Paper›PMID 35987698›Full record

Trial reportTrials2022

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.

Sarah N Dawson, Yi-Da Chiu, Andrew A Klein, Melissa Earwaker, Sofia S Villar

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 30% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
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

5 authors at 3 institutions in 1 country.

Sarah N DawsonMRC Biostatistics Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK. snd33@cam.ac.uk.ORCID http://orcid.org/0000-0001-7401-2192
Yi-Da ChiuMRC Biostatistics Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Andrew A KleinDepartment of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, UK.
Melissa EarwakerPapworth Trials Unit Collaboration, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Sofia S VillarMRC Biostatistics Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
University of Cambridge · GBPapworth Hospital · GBPapworth Hospital NHS Foundation Trust · GB

Funding

Department of Health NIHR128351Health Technology Assessment Programme NIHR128351
6 · The paper itself

Abstract

backgroundThe NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery. METHODS/

designNOTACS is an adaptive, international, multicentre, parallel-group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1152 patients.

resultsThis manuscript provides detailed descriptions of the design of the NOTACS trial, and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery. DISCUSSION: This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the interim analysis in order to preserve scientific integrity under an adaptive design framework. The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials.

trial registrationISRCTN14092678 . Registered on 13 May 2020.

Indexed as

Cardiac Surgical ProceduresOutcome Assessment, Health CareHumansResearch DesignSample SizeStandard of CareTreatment OutcomeAdaptive designSample size re-estimationStatistical analysis plan

Identifiers

PMID35987698
PMCPMC9391633
OpenAlexW4292678935

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.