Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes.
Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes.
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DOI：
10.1186/s13063-021-05324-3
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发表时间：
2021-05-26
期刊：
影响因子：
2.5
通讯作者：
Linsell L
中科院分区：
文献类型：
--
作者：
Bell JL;Gupta S;Juszczak E;Hardy P;Linsell L
Baby-OSCAR试验是一项多中心、随机、安慰剂对照、平行组试验，在极早产儿中使用布洛芬早期治疗大动脉导管未闭（PDA）。本文描述了Baby-OSCAR试验短期健康结局的统计分析计划。这是一项随机对照试验，旨在确定在极早产儿中使用肠外布洛芬早期靶向治疗大PDA是否能改善短期和长期的健康和经济结局。出生于妊娠23+0和28+6周之间的婴儿，经超声心动图证实患有大PDA（直径至少为1.5 mm，PDA血流模式不受限制），并获得父母知情同意，在出生后72小时内随机分配接受布洛芬或安慰剂。主要结局是经后36周死亡或经后36周中度或重度支气管肺发育不良（BPD）的复合终点。将按随机分组组描述基线人口统计学和临床特征。主要分析将针对修改后的意向治疗（ITT）人群。将列出二进制和分类变量的计数和百分比，将列出连续变量的平均值和标准差或中位数和四分位距。对于二元结局，将使用对数二项式或泊松回归和稳健方差估计量计算风险比和置信区间。将使用线性回归模型或分位数回归模型（如果有偏差）分析连续结局。在技术上可能的情况下，将对所有最小化因素进行分析调整，并通过将聚类嵌套为随机效应来解释多胞胎兄弟姐妹之间的相关性。将提供粗效应估计值和调整后效应估计值，主要推断基于调整后估计值。95%的置信区间将用于所有预先规定的结局比较。本文描述了试验短期健康结局的统计分析计划，包括分析原则、重要结局的定义、主要分析方法、预先指定的亚组分析和次要分析。在完成短期随访之前完成计划。ISRCTN登记研究ISRCTN 84264977。2010年9月15日登记。在线版本包含补充材料，可通过10.1186/s13063-021-05324-3获得。
The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analysis plan for the short-term health outcomes of the Baby-OSCAR trial. This is a randomised controlled trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies improves short and long-term health and economic outcomes. Infants born between 23+0 and 28+6 weeks of gestation, confirmed by echocardiography as having a large PDA (with a diameter of at least 1.5 mm and unrestricted pulsatile PDA flow pattern), with parental informed consent, were randomly allocated to receive either ibuprofen or placebo within 72 h of birth. The primary outcome is a composite of death by 36 weeks’ postmenstrual age or moderate or severe bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age. Baseline demographic and clinical characteristics will be described by randomised group. The primary analysis will be on the modified intention to treat (ITT) population. Counts and percentages will be presented for binary and categorical variables, and mean and standard deviation or median and interquartile range will be presented for continuous variables. For binary outcomes, risk ratios and confidence intervals will be calculated using log binomial or Poisson regression with a robust variance estimator. Continuous outcomes will be analysed using linear regression models, or quantile regression models if skewed. Analyses will be adjusted for all minimisation factors where technically possible, and correlation between siblings from multiple births will be accounted for by nesting the clusters as a random effect. Both crude and adjusted effect estimates will be presented, with the primary inference based on the adjusted estimates. Ninety-five per cent confidence intervals will be used for all pre-specified outcome comparisons. This paper describes the statistical analysis plan for short-term health outcomes of the trial, including the analysis principles, definitions of important outcomes, methods for primary analysis, pre-specified subgroup analysis, and secondary analysis. The plan was finalised prior to completion of short-term follow-up. ISRCTN registry ISRCTN84264977. Registered on 15 September 2010. The online version contains supplementary material available at 10.1186/s13063-021-05324-3.
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DOI：
10.1136/adc.2007.120584
发表时间：
2008-03-01
影响因子：
4.4
作者：
Su, B-H;Lin, H-C;Tsai, Y-C
通讯作者：
Tsai, Y-C
影响因子：
120.7
作者：
Gamble, Carrol;Krishan, Ashma;Loder, Elizabeth
通讯作者：
Loder, Elizabeth
影响因子：
9.3
作者：
Schulz, Kenneth F.;Altman, Douglas G.;Grp, C. O. N. S. O. R. T.
通讯作者：
Grp, C. O. N. S. O. R. T.
影响因子：
8
作者：
Noori, Shahab;Mccoy, Michael;Sekar, Kris
通讯作者：
Sekar, Kris
影响因子：
2.5
作者：
Oncel, Mehmet Yekta;Yurttutan, Sadik;Dilmen, Ugur
通讯作者：
Dilmen, Ugur