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

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

Trials. 2024 Dec 30;25(1):855. doi: 10.1186/s13063-024-08669-7.

Authors

Karen J Bosma^#¹, Myriam Lafreniere-Roula^#², Arlene Jiang³, Anna Heath^{4

5}, Yongdong Ouyang^{4

6}, Kaitlyn Wade⁷, Pingzhao Hu⁸, Karen E A Burns⁹, Claudio M Martin¹⁰, Yoanna Skrobik¹¹, Sorcha Mulligan², Kevin E Thorpe^#¹², Laurent Brochard^#¹³; members of the Canadian Critical Care Trials Group and the REVA Network

Collaborators

members of the Canadian Critical Care Trials Group and the REVA Network:
Andre Carlos Kajdacsy-Balla Amaral, John Basmaji, Jason Shahin, Alain Mercat, François Beloncle, Gaëtan Beduneau, Armand Mekontso Dessap, Guillaume Carteaux, Alexandre Demoule, Marie Lecronier, Martin Dres, Katerina Vaporidi, Eumorfia Kondili, Vito Fanelli, Savino Spadaro, Yaseen Arabi, Jordi Mancebo Cortes, Juan Carlos Suárez Montero, Indalecio Moran Chorro, Núria Rodríguez Farre, François Lellouche, Pablo O Rodriguez, Jeff Singh, M Elizabeth Wilcox, Tommaso Maraffi, Emmanuel Charbonney, Stephanie Sibley, Ewan Goligher, Niall Ferguson, Anna Geagea, Phil Shin, Irene Telias, Chris Yarnell, Gabriela Ferreyra, Hiba Azher, Cheryl Misak

Affiliations

¹ Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and London Health Sciences Centre Research Institute, London, Canada. [email protected].
² Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
³ Child Health Evaluative Sciences, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, ON, Canada.
⁴ 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, Toronto, Canada.
⁵ Department of Statistical Science, University College London, London, UK.
⁶ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
⁷ Department of Computer Science, Western University, London, Canada.
⁸ Department of Biochemistry, Schulich School of Medicine & Dentistry and Department of Computer Science, Western University, London, ON, Canada.
⁹ Interdepartmental Division of Critical Care, University of Toronto and Division of Critical Care, Unity Health Toronto - St. Michael's Hospital, Toronto, Canada.
¹⁰ Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, and London Health Sciences Centre Research Institute, London, Canada.
¹¹ Department of Medicine, McGill University, Montreal, Canada.
¹² Dalla Lana School of Public Health, Biostatistics Division, University of Toronto, Toronto, Canada.
¹³ Department of Critical Care, Keenan Research Centre, St Michael's Hospital, and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada.

^# Contributed equally.

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.

Keywords: Bayesian; Cluster; Liberation; Proportional assist ventilation; Statistical analysis plan; Ventilator-free days; Weaning from mechanical ventilation.

Publication types

Clinical Trial Protocol

MeSH terms

Bayes Theorem*
Data Interpretation, Statistical
Duration of Therapy
Humans
Interactive Ventilatory Support / methods
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Research Design
Respiration, Artificial / methods
Respiratory Insufficiency / therapy
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02447692

Abstract

Publication types

MeSH terms

Associated data

Grants and funding