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Record W4405882638 · doi:10.1186/s13063-024-08669-7

Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial

2024· article· en· W4405882638 on OpenAlexafffund
Karen J. Bosma, Myriam Lafrenière‐Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang, Kaitlyn E Wade, Pingzhao Hu, Karen E. A. Burns, Claudio M. Martin, Yoanna Skrobik, Sorcha Mulligan, Kevin E. Thorpe, Laurent Brochard, André Carlos Kajdacsy-Balla Amaral, John Basmaji, Jason Shahin, Alain Mercat, François Beloncle, G. Béduneau, Armand Mekontso Dessap, Guillaume Carteaux, Alexandre Demoule, Marie Lecronier, Martin Dres, Katerina Vaporidi, Εumorfia Kondili, Vito Fanelli, Savino Spadaro, Yaseen M. Arabi, Jordi Mancebo Cortes, J.C. Suarez Montero, Indalecio Moran Chorro, Núria Rodríguez Farre, François Lellouche, Pablo Rodríguez, Jeffrey M. Singh, M. Elizabeth Wilcox, Tommaso Maraffi, Emmanuel Charbonney, Stephanie Sibley, Ewan C. Goligher, Niall D. Ferguson, Anna Geagea, Phil Shin, Irene Telías, Christopher J. Yarnell, Gabriela Ferreyra, Hiba Azher, Cheryl Misak

Bibliographic record

VenueTrials · 2024
Typearticle
Languageen
FieldMedicine
TopicRespiratory Support and Mechanisms
Canadian institutionsOttawa HospitalMcGill UniversityInstitute for Clinical Evaluative SciencesPublic Health OntarioHospital for Sick ChildrenWestern UniversitySt. Michael's HospitalLondon Health Sciences CentreUniversity of TorontoSickKids Foundation
FundersCanadian Institutes of Health ResearchArts and Humanities Research CouncilInstitut universitaire de cardiologie et de pneumologie de Québec, Université LavalUniversità degli Studi di FerraraSorbonne UniversitéUniversité de MontréalUniversità degli Studi di TorinoUniversity of TorontoSchulich School of Medicine and Dentistry, Western UniversityMedtronicQueen's UniversityMcGill University
KeywordsRandomized controlled trialMedicineProtocol (science)Ventilation (architecture)Statistical analysisMechanical ventilationResearch designDuration (music)Clinical trialSurgeryStatisticsAlternative medicineAnesthesiaEngineeringInternal medicinePathologyMathematics

Abstract

fetched live from OpenAlex

BACKGROUND: We previously published the protocol and statistical analysis plan for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study in Trials ( https://doi.org/10.1186/s13063-023-07163-w ). This update summarizes changes made to the statistical analysis plan for the trial since the publication of the original protocol and statistical analysis plan. METHODS/DESIGN: The Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (PROMIZING) study is a multi-center, open-label, randomized controlled trial designed to determine if ventilation with proportional assist ventilation with load-adjustable gain factors will result in a shorter duration of time spent on mechanical ventilation compared to ventilation with pressure support ventilation for patients with acute respiratory failure. The statistical analysis plan for the trial was incorporated into the original publication of the protocol in Trials ( https://doi.org/10.1186/s13063-023-07163-w ) and was based on version 5.0 of the study protocol and version 1.0 of the statistical analysis plan (SAP), which included plans for both frequentist and Bayesian analyses. We have since updated the SAP to refine the Bayesian analysis plan, update the multistate model diagram, and include plans for a cluster analysis to determine if there is heterogeneity of treatment effect. This update summarizes the changes made and their rationale and provides a refined SAP for the PROMIZING trial with additional background information, in adherence with guidelines for the prospective reporting of SAPs for randomized controlled trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.

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)0.025
metaresearch head score (Gemma)0.008
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.857
Threshold uncertainty score0.962

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0250.008
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0000.000
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 head0.109
GPT teacher head0.418
Teacher spread0.309 · 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 designRandomized trial
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
Published2024
Admission routes2
Has abstractyes

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