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

Journal article

Karen J. Bosma, M. Lafreniere-Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang, Kaitlyn E Wade, Pingzhao Hu, Karen E A Burns, Claudio M Martin, Y. Skrobik, Sorcha Mulligan, Kevin E Thorpe, L. Brochard, Andre Carlos Kajdacsy-Balla John Jason Alain François Ga Amaral Basmaji Shahin Mercat Beloncle Beduneau Des, Andre Amaral, J. Basmaji, Jason Shahin, A. Mercat, F. Beloncle, G. Béduneau, A. Dessap, G. Carteaux, Alexandre Demoule, Marie Lecronier, M. Dres, K. Vaporidi, E. Kondili, V. Fanelli, S. Spadaro, Y. Arabi, J. Mancebo Cortés, J. C. Montero, I. M. Chorro, Nuria Farré, François Lellouche, P. O. Rodriguez, Jeff M Singh, M. E. Wilcox, T. Maraffi, Emmanuel Charbonney, Stephanie Sibley, E. Goligher, Niall D. Ferguson, Anna Geagea, Phil Shin, I. Telias, Christopher J Yarnell, Gabriela Ferreyra, Hiba Azher, Cheryl Misak
Trials, 2024

Semantic Scholar DOI PubMedCentral PubMed

Cite

APA Click to copy
Bosma, K. J., Lafreniere-Roula, M., Jiang, A., Heath, A., Ouyang, Y., Wade, K. E., … Misak, C. (2024). Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial. Trials.

Chicago/Turabian Click to copy
Bosma, Karen J., M. Lafreniere-Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang, Kaitlyn E Wade, Pingzhao Hu, et al. “Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING Study): Update to the Statistical Analysis Plan for a Randomized Controlled Trial.” Trials (2024).

MLA Click to copy
Bosma, Karen J., et al. “Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING Study): Update to the Statistical Analysis Plan for a Randomized Controlled Trial.” Trials, 2024.

BibTeX Click to copy

@article{karen2024a,
  title = {Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial},
  year = {2024},
  journal = {Trials},
  author = {Bosma, Karen J. and Lafreniere-Roula, M. and Jiang, Arlene and Heath, Anna and Ouyang, Yongdong and Wade, Kaitlyn E and Hu, Pingzhao and Burns, Karen E A and Martin, Claudio M and Skrobik, Y. and Mulligan, Sorcha and Thorpe, Kevin E and Brochard, L. and Des, Andre Carlos Kajdacsy-Balla John Jason Alain François Ga Amaral Basmaji Shahin Mercat Beloncle Beduneau and Amaral, Andre and Basmaji, J. and Shahin, Jason and Mercat, A. and Beloncle, F. and Béduneau, G. and Dessap, A. and Carteaux, G. and Demoule, Alexandre and Lecronier, Marie and Dres, M. and Vaporidi, K. and Kondili, E. and Fanelli, V. and Spadaro, S. and Arabi, Y. and Cortés, J. Mancebo and Montero, J. C. and Chorro, I. M. and Farré, Nuria and Lellouche, François and Rodriguez, P. O. and Singh, Jeff M and Wilcox, M. E. and Maraffi, T. and Charbonney, Emmanuel and Sibley, Stephanie and Goligher, E. and Ferguson, Niall D. and Geagea, Anna and Shin, Phil and Telias, I. and Yarnell, Christopher J and Ferreyra, Gabriela and Azher, Hiba and Misak, Cheryl}
}

Abstract

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. 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. ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.