South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
School of Public Health, The University of Adelaide, Adelaide, SA, Australia.
BJOG. 2018 Oct;125(11):1406-1413. doi: 10.1111/1471-0528.15292. Epub 2018 Jun 25.
To estimate the magnitude of the correlation between neonatal outcomes of twins and demonstrate how this information can be used in the design of randomised controlled trials (RCTs) in women with twin pregnancies.
Secondary analysis of data from 12 RCTs.
Obstetric care in multiple countries, 2004-2012.
4504 twin pairs born to women who participated in RCTs to assess treatments given during pregnancy.
Intraclass correlation coefficients (ICCs) were estimated using log-binomial and linear models.
Perinatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, sepsis, neonatal intensive care unit admission, birthweight, low birthweight and two composite measures of adverse neonatal outcome.
ICCs for the composite measures of adverse neonatal outcome were all above 0.5, indicating moderate to strong correlation between adverse outcomes of twins. For individual neonatal outcomes, median ICCs across trials ranged from 0.13 to 0.79 depending on the outcome. An example illustrates how ICCs can be used in sample size calculations for RCTs in women with twin pregnancies.
The correlation between neonatal outcomes of twins varies considerably between outcomes and may be lower than expected. Our ICC estimates can be used for designing and analysing RCTs that recruit women with twin pregnancies and for performing meta-analyses that include such RCTs. Researchers are encouraged to report ICCs for neonatal outcomes in twins in their own RCTs.
Correlation between neonatal outcomes of twins depends on the outcome and may be lower than expected.
评估双胞胎新生儿结局的相关程度,并展示如何将此信息应用于接受双胎妊娠的女性的随机对照试验(RCT)设计中。
对 12 项 RCT 的数据进行二次分析。
多国的产科护理,2004-2012 年。
4504 对双胞胎,由参与评估妊娠期间治疗方法的 RCT 的女性所生。
使用对数二项式和线性模型估计组内相关系数(ICC)。
围产儿死亡、呼吸窘迫综合征、支气管肺发育不良、脑室内出血、坏死性小肠结肠炎、败血症、新生儿重症监护病房入院、出生体重、低出生体重和两种不良新生儿结局的复合指标。
不良新生儿结局的复合指标的 ICC 均大于 0.5,表明双胞胎不良结局之间存在中度至高度相关性。对于个别新生儿结局,根据结局的不同,试验间的 ICC 中位数范围从 0.13 到 0.79。一个示例说明了如何在接受双胎妊娠的女性的 RCT 中使用 ICC 进行样本量计算。
双胞胎新生儿结局之间的相关性因结局而异,且可能低于预期。我们的 ICC 估计值可用于设计和分析招募双胎妊娠女性的 RCT,并进行包括此类 RCT 的荟萃分析。鼓励研究人员在其自身的 RCT 中报告双胞胎新生儿结局的 ICC。
双胞胎新生儿结局的相关性取决于结局,且可能低于预期。