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Record W4387262569 · doi:10.1186/s13063-023-07079-5

Frequency of screening and SBT Technique Trial—North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan

2023· article· en· W4387262569 on OpenAlexafffund
Karen E. A. Burns, Myriam Lafrienier-Roula, Nicholas S. Hill, Andrew Seely, Bram Rochwerg, Michaël Mayette, Frédérick D’Aragon, John W. Devlin, Peter Dodek, Maged Tanios, Audrey Gouskos, Alexis F. Turgeon, Pierre Aslanian, Ying Tung Sia, Jeremy R. Beitler, Robert C. Hyzy, Gerard J. Criner, Elias Baedorf Kassis, Jennifer Tsang, Maureen O. Meade, Janice M. Liebler, Jessica T. Y. Wong, Kevin E. Thorpe

Bibliographic record

VenueTrials · 2023
Typearticle
Languageen
FieldMedicine
TopicRespiratory Support and Mechanisms
Canadian institutionsHamilton Health SciencesNiagara Health SystemCentre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-QuébecCentre Hospitalier de l’Université de MontréalUniversité LavalUniversity of British ColumbiaCentre Hospitalier Universitaire de SherbrookeOttawa HospitalHôpital de l'Enfant-JésusUniversity of OttawaImpactMcMaster UniversityMuscular Dystrophy CanadaUniversity of TorontoCentre for Advancing Health OutcomesSt. Michael's Hospital
FundersNational Heart, Lung, and Blood InstituteCanadian Institutes of Health Research
KeywordsMedicineProtocol (science)Clinical trialRandomized controlled trialResearch designCoronavirus disease 2019 (COVID-19)Intensive careEmergency medicineIntensive care medicineSurgeryAlternative medicineDiseaseInternal medicinePathologyStatistics

Abstract

fetched live from OpenAlex

BACKGROUND: This update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial-North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidates to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American intensive care units. METHODS/DESIGN: Protocols for the pilot, factorial design trial and the full trial were previously published in J Clin Trials ( https://doi.org/10.4172/2167-0870.1000284 ) and Trials (https://doi: 10.1186/s13063-019-3641-8). As planned, participants enrolled in the FAST pilot trial will be included in the report of the full FAST-NAWC trial. In response to the onset of the coronavirus disease of 2019 (COVID-19) pandemic when approximately two thirds of enrollment was complete, we revised the protocol and consent form to include critically ill invasively ventilated patients with COVID-19. We also refined the statistical analysis plan (SAP) to reflect inclusion and reporting of participants with and without COVID-19. This update summarizes the changes made and their rationale and provides a refined SAP for the FAST-NAWC trial. These changes have been finalized before completion of trial follow-up and the commencement of data analysis. TRIAL REGISTRATION: Clinical Trials.gov NCT02399267.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.398
Threshold uncertainty score0.372

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0030.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.100
GPT teacher head0.423
Teacher spread0.323 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations1
Published2023
Admission routes2
Has abstractyes

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