Kuitunen Ilari, Räsänen Kati, Gualano Maria Rosaria, De Luca Daniele
University of Eastern Finland, Institute of Clinical Medicine and Department of Pediatrics, Kuopio, Finland.
Kuopio University Hospital, Department of Pediatrics, Kuopio, Finland.
Neonatology. 2024;121(6):659-666. doi: 10.1159/000539203. Epub 2024 Jun 11.
INTRODUCTION: Randomization and blinding are generally important in randomized trials. In neonatology, blinding of ventilation strategies is unfeasible if not impossible and we hypothesized that its importance has been overestimated, while the peculiarities of the neonatal patient and the specific outcomes have not been considered. METHODS: For this meta-epidemiological review, we searched PubMed and Scopus databases in November 2023. We included all meta-analyses focusing on ventilation, published in past 5 years, and reporting either mortality or bronchopulmonary dysplasia (BPD) as an outcome. We extracted the information about how the authors had analyzed risk of bias and evidence certainty. RESULTS: We screened 494 abstracts and included 40 meta-analyses. Overall, 13 of the 40 reviews assessed blinding properly. Australian and European authors were most likely to perform correct assessment of the blinding (p = 0.03) and the use of RoB 2.0 tool was also associated with proper assessment (p < 0.001). In multivariate regression, the use of RoB 2.0 was the only factor associated with a proper assessment (Beta 0.57 [95% confidence interval: 0.29-0.99]). GRADE ratings were performed in 25 reviews, and the authors downgraded the evidence certainty due to risk of bias in 19 of these and none of these reviews performed the blinding assessment correctly. CONCLUSION: In past neonatal evidence syntheses, the role of blinding has been mostly overestimated, which has led to downgrading of evidence certainty. Objective outcomes (such as mortality and BPD) do not need to be downgraded due to lack of blinding, as the knowledge of the received intervention does not influence the outcome assessment.
引言:随机化和盲法在随机试验中通常很重要。在新生儿学中,对通气策略进行盲法操作即便并非不可能也是不可行的,并且我们推测其重要性被高估了,而新生儿患者的特殊性和特定结局并未得到考虑。 方法:对于这项元流行病学综述,我们于2023年11月检索了PubMed和Scopus数据库。我们纳入了过去5年发表的所有聚焦于通气的元分析,并将死亡率或支气管肺发育不良(BPD)作为结局进行报告。我们提取了有关作者如何分析偏倚风险和证据确定性的信息。 结果:我们筛选了494篇摘要,纳入了40项元分析。总体而言,40项综述中有13项对盲法进行了恰当评估。澳大利亚和欧洲的作者最有可能对盲法进行正确评估(p = 0.03),并且使用RoB 2.0工具也与恰当评估相关(p < 0.001)。在多变量回归中,使用RoB 2.0是与恰当评估相关的唯一因素(β 0.57 [95%置信区间:0.29 - 0.99])。25项综述进行了GRADE评级,其中19项综述的作者因偏倚风险而降低了证据确定性,并且这些综述中没有一项对盲法评估正确。 结论:在过去的新生儿证据综合分析中,盲法的作用大多被高估,这导致了证据确定性的降低。客观结局(如死亡率和BPD)无需因缺乏盲法而被降级,因为所接受干预的信息并不影响结局评估。
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