Di Mascio Daniele, Buca Danilo, Rizzo Giuseppe, Khalil Asma, Timor-Tritsch Ilan E, Odibo Anthony, Mappa Ilenia, Flacco Maria Elena, Giancotti Antonella, Liberati Marco, D'Antonio Francesco
Department of Maternal and Child Health and Urological Sciences, Sapienza University of Rome, Rome, Italy,
Department of Obstetrics and Gynecology, Center for Fetal Care and High-Risk Pregnancy, University of Chieti, Chieti, Italy.
Fetal Diagn Ther. 2022;49(4):145-158. doi: 10.1159/000521421. Epub 2022 Apr 22.
Several fetal brain charts have been published in the literature and are commonly used in the daily clinical practice. However, the methodological quality of these charts has not been critically appraised.
MEDLINE, EMBASE, CINAHL, and the Web of Science databases were searched electronically up to December 31, 2020. The primary outcome was to evaluate the methodology of the studies assessing the growth of fetal brain structures throughout gestation. A list of 28 methodological quality criteria divided into three domains according to "study design," "statistical and reporting methods," and "specific relevant neurosonography aspects" was developed in order to assess the methodological appropriateness of the included studies. The overall quality score was defined as the sum of low risk of bias marks, with the range of possible scores being 0-28. This quality assessment was applied to each individual study reporting reference ranges for fetal brain structures. Furthermore, we performed a subgroup analysis according to the different brain structures (ventricular and periventricular, fore-brain and midbrain cerebral and posterior fossa).
Sixty studies were included in the systematic review. The overall mean quality score of the studies included in this review was 51.3%. When focusing on each of the assessed domains, the mean quality score was 53.7% for "study design," 54.2% for "statistical and reporting methods," and 38.6% for "specific relevant neurosonography aspects." The sample size calculation, the correlation with a postnatal imaging evaluation, and the whole fetal brain assessment were the items at the highest risk of bias for each domain assessed, respectively. The subgroup analysis according to different anatomical location showed the lowest quality score for ventricular and periventricular structures and the highest for cortical structures.
Most previously published studies reporting fetal brain charts suffer from poor methodology and are at high risk of biases, mostly when focusing on neurosonography issues. Further prospective longitudinal studies aiming at constructing specific growth charts for fetal brain structures should follow rigorous methodology to minimize the risk of biases, guarantee higher levels of reproducibility, and improve the standard of care.
文献中已发表了几份胎儿脑图谱,在日常临床实践中常用。然而,这些图谱的方法学质量尚未得到严格评估。
截至2020年12月31日,通过电子方式检索MEDLINE、EMBASE、CINAHL和科学引文索引数据库。主要结果是评估整个孕期评估胎儿脑结构生长的研究方法。制定了一份包含28条方法学质量标准的清单,根据“研究设计”“统计和报告方法”以及“特定相关神经超声方面”分为三个领域,以评估纳入研究的方法学适宜性。总体质量得分定义为低偏倚风险标记的总和,可能得分范围为0至28分。这种质量评估应用于每项报告胎儿脑结构参考范围的个体研究。此外,我们根据不同的脑结构(脑室和脑室周围、前脑和中脑、大脑和后颅窝)进行了亚组分析。
系统评价纳入了60项研究。本评价纳入研究的总体平均质量得分为51.3%。关注每个评估领域时,“研究设计”的平均质量得分为53.7%,“统计和报告方法”为54.2%,“特定相关神经超声方面”为38.6%。样本量计算、与产后影像学评估的相关性以及全胎儿脑评估分别是每个评估领域偏倚风险最高的项目。根据不同解剖位置进行的亚组分析显示,脑室和脑室周围结构的质量得分最低,皮质结构的质量得分最高。
大多数先前发表的报告胎儿脑图谱的研究方法欠佳,存在较高的偏倚风险,尤其是在关注神经超声问题时。旨在构建胎儿脑结构特定生长图谱的进一步前瞻性纵向研究应遵循严格的方法,以尽量减少偏倚风险,保证更高的可重复性水平,并提高医疗标准。