Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial
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...
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BMC
2024-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-08669-7 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Karen J. Bosma |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-fa61166b4df644e3979b33ad90d4e0f8 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-fa61166b4df644e3979b33ad90d4e0f82025-01-05T12:45:09ZengBMCTrials1745-62152024-12-012511510.1186/s13063-024-08669-7Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trialKaren J. Bosma0Myriam Lafreniere-Roula1Arlene Jiang2Anna Heath3Yongdong Ouyang4Kaitlyn Wade5Pingzhao Hu6Karen E. A. Burns7Claudio M. Martin8Yoanna Skrobik9Sorcha Mulligan10Kevin E. Thorpe11Laurent Brochard12members of the Canadian Critical Care Trials Group and the REVA NetworkDivision of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and London Health Sciences Centre Research InstituteApplied Health Research Centre, St. Michael’s HospitalChild Health Evaluative Sciences, Peter Gilgan Centre for Research and Learning, The Hospital for Sick ChildrenChild 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 TorontoChild 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 TorontoDepartment of Computer Science, Western UniversityDepartment of Biochemistry, Schulich School of Medicine & Dentistry and Department of Computer Science, Western UniversityInterdepartmental Division of Critical Care, University of Toronto and Division of Critical Care, Unity Health Toronto - St. Michael’s HospitalDivision of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, and London Health Sciences Centre Research InstituteDepartment of Medicine, McGill UniversityApplied Health Research Centre, St. Michael’s HospitalDalla Lana School of Public Health, Biostatistics Division, University of TorontoDepartment of Critical Care, Keenan Research Centre, St Michael’s Hospital, and Interdepartmental Division of Critical Care Medicine, University of TorontoAbstract 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.https://doi.org/10.1186/s13063-024-08669-7Proportional assist ventilationWeaning from mechanical ventilationLiberationStatistical analysis planVentilator-free daysBayesian |
| spellingShingle | 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 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 Proportional assist ventilation Weaning from mechanical ventilation Liberation Statistical analysis plan Ventilator-free days Bayesian |
| 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 |
| title_full | Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial |
| title_fullStr | Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial |
| title_full_unstemmed | Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial |
| title_short | Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial |
| title_sort | proportional assist ventilation for minimizing the duration of mechanical ventilation the promizing study update to the statistical analysis plan for a randomized controlled trial |
| topic | Proportional assist ventilation Weaning from mechanical ventilation Liberation Statistical analysis plan Ventilator-free days Bayesian |
| url | https://doi.org/10.1186/s13063-024-08669-7 |
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