Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial.

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-28 DOI:10.2196/54451
Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen Ea Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho
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Abstract

Background: Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.

Objective: Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).

Methods: CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).

Results: CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.

Conclusions: We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.

Trial registration: ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.

International registered report identifier (irrid): RR1-10.2196/54451.

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对机械通气的重症患者进行早期床上自行车负重训练:国际多中心随机临床试验 CYCLE(危重症患者骑自行车提高下肢力量)的统计分析计划。
背景:危重病幸存者在重症监护室(ICU)出院后有可能出现身体功能障碍。以重症监护室为基础的康复干预措施,如早期床内循环测力,可改善患者的短期身体功能:在解除盲法和试验数据库锁定之前,我们介绍了 CYCLE(重症监护室骑自行车提高下肢力量)随机对照试验(RCT)的预设统计分析计划(SAP):CYCLE 是一项由 360 名患者参与的国际多中心、开放标签、平行组 RCT(1:1 比例),在重症监护室出院后 3 天进行主要结果盲法评估。CYCLE 的主要研究人员和统计人员在获得指导委员会和共同研究人员的批准后编写了本 SAP。SAP 定义了主要和次要结局(包括不良事件),并描述了计划进行的主要、次要和亚组分析。CYCLE 试验的主要结果是重症监护病房出院后 3 天的身体功能重症监护病房测试评分(PFIT-s)。PFIT-s 是一种可靠有效的基于表现的测量方法。我们计划使用频数统计框架进行所有分析。我们将进行线性回归来评估主要结果,将随机化作为自变量,并对年龄(≥65 岁与结果)进行调整:CYCLE 于 2017 年获得资助,并于 2023 年 5 月完成注册。数据分析已经完成,首批结果已于 2024 年提交发表:我们为 CYCLE RCT 制定并提出了 SAP,并将在所有分析中遵循该 SAP。这项研究将为越来越多的评估基于重症监护室的康复干预措施的有效性和安全性的证据增添新的内容:ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 和 NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.International 注册报告标识符 (irrid):RR1-10.2196/54451。
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