Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-11-06 DOI:10.1186/s13063-024-08538-3
Sarah N Dawson, Yi-Da Chiu, Andrew A Klein, Melissa Earwaker, Sofia S Villar
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Abstract

Background: The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.

Methods/design: NOTACS is an adaptive, international, multicentre, parallel group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1280 patients.

Results: This manuscript provides detailed descriptions of the design of the NOTACS trial and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery.

Discussion: This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the final analysis in order to preserve scientific integrity under an adaptive design framework. A previous version of this SAP was published prior to the interim analysis (Dawson, 2022). The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials (Gamble, 2017).

Trial registration: ISRCTN14092678 . (13 May 2020).

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高流量鼻腔疗法对心脏手术后肺部并发症高危患者以患者为中心的治疗效果的影响:NOTACS(一项多中心适应性随机对照试验)统计分析计划的更新。
背景:NOTACS 试验将评估高流量鼻腔疗法 (HFNT) 与标准氧疗 (SOT) 相比,对心脏手术后患者的疗效、安全性和成本效益:NOTACS 是一项适应性、国际性、多中心、平行分组、随机对照试验,并预先计划了中期样本量再估计 (SSR)。至少有 850 名患者将按 1:1 的比例随机接受 HFNT 或 SOT 治疗。主要结果是计划手术后前 90 天的存活天数和居家天数(DAH90),还计划进行一些辅助分析和成本效益分析。中期 SSR 将在至少对 300 名患者进行 90 天随访后进行,样本量最多可增至 1280 名患者:本手稿详细介绍了 NOTACS 试验的设计以及中期和最终分析。中期分析的主要目的是评估安全性并对样本量进行重新估计。最终分析的主要目的是检验 HFNT 与 SOT 相比对心脏手术后患者预后的安全性、有效性和成本效益:本稿件概述了NOTACS统计分析计划的主要特点,并在最终分析之前提交给了期刊,以便在适应性设计框架下保持科学完整性。该SAP的前一版本已在中期分析之前发表(Dawson,2022年)。NOTACS SAP严格遵循已发布的临床试验SAP内容指南(Gamble,2017):试验注册:ISRCTN14092678 .(2020年5月13日)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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