INTEnsive 救护车送药降低超急性期中风患者血压试验 (INTERACT4) 统计分析计划。

IF 2.2 3区 医学 Q3 CLINICAL NEUROLOGY Cerebrovascular Diseases Pub Date : 2024-05-30 DOI:10.1159/000539503
Laurent Billot, Chen Chen, Lili Song, Yapeng Lin, Feifeng Liu, Xiaoying Chen, Hisatomi Arima, Philip M Bath, Gary A Ford, Thompson G Robinson, Else Charlotte Sandset, Jeffrey L Saver, Nikola Sprigg, H Bart van der Worp, Jie Yang, Gang Li, Craig S Anderson
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引用次数: 0

摘要

简介:第四项 INTEnsive 救护车送药降低超急性期中风患者血压试验(INTERACT4)已完成招募:第四届INTEnsive救护车降压治疗超急性脑卒中试验(INTERACT4)是一项多中心、前瞻性、随机、开放标签、盲终点评估的试验,针对中国疑似急性脑卒中且血压升高的患者在救护车上启动院前降压治疗。根据已注册并公布的试验方案,并由盲法试验指导委员会和操作团队制定,本稿件概述了数据库锁定前试验的详细统计分析计划:患者被随机(1:1)分配到强化治疗组(目标收缩压[SBP] 130-140 mmHg,30 分钟内达标)或指南推荐的血压管理组(只有当 SBP >220 mmHg 时才考虑降压)。主要结果是对 90 天时改良兰金量表的全部评分进行序数分析。据估计,修改后的样本量为 2320 个,使用序数逻辑回归法,假设有 5% 的患者结果缺失,6% 的患者为中风模拟患者,则 90% 的力量可以检测到功能结果变差的几率降低了 22%(普通几率比为 0.78):该试验的统计分析计划是为确保透明、可核查和预先指定的分析而制定的,以避免试验干预评估中可能出现的偏差。
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Statistical Analysis Plan for the INTEnsive Ambulance-Delivered Blood Pressure Reduction in Hyper-ACute Stroke Trial.

Introduction: Recruitment is complete in the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4), a multicenter, prospective, randomized, open-label, blinded endpoint assessed trial of prehospital blood pressure (BP) lowering initiated in the ambulance for patients with a suspected acute stroke and elevated BP in China. According to the registered and published trial protocol and developed by the blinded trial Steering Committee and Operations team, this manuscript outlines a detailed statistical analysis plan for the trial prior to database lock.

Methods: Patients were randomized (1:1) to intensive (target systolic BP 130-140 mm Hg within 30 min) or guideline-recommended BP management (BP lowering only considered if systolic BP >220 mm Hg) group. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale at 90 days. A modified sample size of 2,320 was estimated to provide 90% power to detect a 22% reduction in the odds (common odds ratio of 0.78) of a worse functional outcome using ordinal logistic regression, on the assumption of 5% patients with missing outcome and 6% patients with a stroke mimic.

Conclusion: The statistical analysis plan for the trial has been developed to ensure transparent, verifiable, and prespecified analysis and to avoid potential bias in the evaluation of the trial intervention.

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来源期刊
Cerebrovascular Diseases
Cerebrovascular Diseases 医学-临床神经学
CiteScore
4.50
自引率
0.00%
发文量
90
审稿时长
1 months
期刊介绍: A rapidly-growing field, stroke and cerebrovascular research is unique in that it involves a variety of specialties such as neurology, internal medicine, surgery, radiology, epidemiology, cardiology, hematology, psychology and rehabilitation. ''Cerebrovascular Diseases'' is an international forum which meets the growing need for sophisticated, up-to-date scientific information on clinical data, diagnostic testing, and therapeutic issues, dealing with all aspects of stroke and cerebrovascular diseases. It contains original contributions, reviews of selected topics and clinical investigative studies, recent meeting reports and work-in-progress as well as discussions on controversial issues. All aspects related to clinical advances are considered, while purely experimental work appears if directly relevant to clinical issues.
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