Bosma Karen J, Lafreniere-Roula Myriam, Jiang Arlene, Heath Anna, Ouyang Yongdong, Wade Kaitlyn, Hu Pingzhao, Burns Karen E A, Martin Claudio M, Skrobik Yoanna, Mulligan Sorcha, Thorpe Kevin E, Brochard Laurent
Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, and London Health Sciences Centre Research Institute, London, Canada.
Applied Health Research Centre, St. Michael's Hospital, Toronto, Canada.
Trials. 2024 Dec 30;25(1):855. doi: 10.1186/s13063-024-08669-7.
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.
ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.
我们之前发表了一项关于比例辅助通气以缩短机械通气时间的随机对照试验的方案和统计分析计划：即试验中的“PROMIZING研究”（https://doi.org/10.1186/s13063-023-07163-w）。本更新总结了自原始方案和统计分析计划发表以来对该试验统计分析计划所做的更改。
方法/设计：比例辅助通气以缩短机械通气时间（PROMIZING）研究是一项多中心、开放标签、随机对照试验，旨在确定对于急性呼吸衰竭患者，与压力支持通气相比，使用具有负荷可调增益因子的比例辅助通气是否会缩短机械通气时间。该试验的统计分析计划已纳入《试验》中方案的原始出版物（https://doi.org/10.1186/s13063-023-07163-w），并基于研究方案的5.0版和统计分析计划（SAP）的1.0版，其中包括频率学派和贝叶斯分析计划。此后，我们更新了SAP，以完善贝叶斯分析计划，更新多状态模型图，并纳入聚类分析计划以确定治疗效果是否存在异质性。本更新总结了所做的更改及其原理，并根据随机对照试验SAP前瞻性报告指南，为PROMIZING试验提供了一份完善的SAP以及额外的背景信息。
ClinicalTrials.gov标识符：NCT02447692，于2015年5月19日进行前瞻性注册。
