Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial
Karen J. Bosma,
Myriam Lafreniere-Roula,
Arlene Jiang,
Anna Heath,
Yongdong Ouyang,
Kaitlyn Wade,
Pingzhao Hu,
Karen E. A. Burns,
Claudio M. Martin,
Yoanna Skrobik,
Sorcha Mulligan,
Kevin E. Thorpe,
Laurent Brochard,
members of the Canadian Critical Care Trials Group and the REVA Network
Affiliations
Karen J. Bosma
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and London Health Sciences Centre Research Institute
Myriam Lafreniere-Roula
Applied Health Research Centre, St. Michael’s Hospital
Arlene Jiang
Child Health Evaluative Sciences, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children
Anna Heath
Child Health Evaluative Sciences, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, and Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto
Yongdong Ouyang
Child Health Evaluative Sciences, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, and Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto
Kaitlyn Wade
Department of Computer Science, Western University
Pingzhao Hu
Department of Biochemistry, Schulich School of Medicine & Dentistry and Department of Computer Science, Western University
Karen E. A. Burns
Interdepartmental Division of Critical Care, University of Toronto and Division of Critical Care, Unity Health Toronto - St. Michael’s Hospital
Claudio M. Martin
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, and London Health Sciences Centre Research Institute
Yoanna Skrobik
Department of Medicine, McGill University
Sorcha Mulligan
Applied Health Research Centre, St. Michael’s Hospital
Kevin E. Thorpe
Dalla Lana School of Public Health, Biostatistics Division, University of Toronto
Laurent Brochard
Department of Critical Care, Keenan Research Centre, St Michael’s Hospital, and Interdepartmental Division of Critical Care Medicine, University of Toronto
members of the Canadian Critical Care Trials Group and the REVA Network
Abstract 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.
