Discipline of Paediatrics, Trinity College Dublin, The University of Dublin & Children's Hospital Ireland (CHI) at Tallaght, Dublin, Ireland.
John Stearne Medical Library, Trinity College Dublin, St. James' Hospital, Dublin, Ireland.
Pediatr Res. 2022 Mar;91(4):735-742. doi: 10.1038/s41390-021-01883-y. Epub 2022 Jan 7.
The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.
A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.
Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.
This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.
This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
新生儿败血症缺乏共识定义和核心结局集（COS），这对影响政策和实践的研究构成了实质性障碍，这些政策和实践与关键利益相关者、患者和家长有关。
根据系统评价和荟萃分析的首选报告项目（PRISMA）指南，对文献进行了系统回顾。在纳入的研究中，根据核心结局测量在有效性试验（COMET）手册的规定提取了所描述的结局，并进行了登记。
在确定的 884 篇摘要中，纳入了 90 项随机对照试验（RCT）。仅有 30 篇手稿明确说明了主要和/或次要结局。在纳入的 90 项研究中，共记录了 88 个不同的结局。根据 COMET 倡议提出的分类 taxonomy，将这些结局分配到七个不同的领域。报告率最高的结局是存活率，74%（n=67）的研究报告了该领域的结局。
这项系统评价是制定新生儿败血症 COS 的方案的初始阶段之一。新生儿败血症中标准化结局报告的缺乏阻碍了数据的比较和综合。最后阶段将通过德尔菲调查，根据共识建议生成新生儿败血症的 COS。
这项系统评价确定了发表的关于新生儿败血症管理的 RCT 中报告的结局存在广泛差异。标准化结局报告的缺乏阻碍了数据的比较和综合，并且不太可能对新生儿败血症的管理进行具有结论性建议的未来荟萃分析。最后阶段将通过德尔菲调查，根据共识建议确定由所有相关利益相关者参与的 COS。
