Blinding Assessments in Neonatal Ventilation Meta-Analyses: A Systematic Meta-Epidemiological Review.

Neonatology Pub Date : 2024-06-11 DOI:10.1159/000539203
Ilari Kuitunen, Kati Räsänen, Maria Rosaria Gualano, Daniele De Luca
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Abstract

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.

新生儿通气元分析中的盲法评估:系统性元流行病学回顾。
引言在随机试验中,随机化和盲法一般都很重要。在新生儿科,通气策略的盲法即使不是不可能,也是不可行的,我们假设其重要性被高估了,而新生儿患者的特殊性和具体结果却未被考虑在内:为了进行这项荟萃流行病学综述,我们在 2023 年 11 月检索了 PubMed 和 Scopus 数据库。我们纳入了过去 5 年中发表的所有以通气为重点、以死亡率或支气管肺发育不良(BPD)为结果的荟萃分析。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:我们筛选了 494 篇摘要,并纳入了 40 篇荟萃分析。总体而言,40 篇综述中有 13 篇正确评估了盲法。澳大利亚和欧洲作者最有可能正确评估盲法(p = 0.03),使用 RoB 2.0 工具也与正确评估有关(p < 0.001)。在多变量回归中,使用 RoB 2.0 是唯一与正确评估相关的因素(贝塔值为 0.57 [95% 置信区间:0.29-0.99])。作者对25篇综述进行了GRADE评级,其中19篇综述因存在偏倚风险而降低了证据的确定性,这些综述中没有一篇正确进行了盲法评估:结论:在以往的新生儿证据综述中,盲法的作用大多被高估,导致证据确定性降级。客观结果(如死亡率和BPD)无需因缺乏盲法而降级,因为对所接受干预的了解不会影响结果评估。
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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