van Varsseveld Otis C, Klerk Daphne H, Jester Ingo, Lacher Martin, Kooi Elisabeth M W, Hulscher Jan B F
Department of Surgery, Division of Pediatric Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, the Netherlands.
J Pediatr Surg. 2023 Nov;58(11):2105-2113. doi: 10.1016/j.jpedsurg.2023.06.017. Epub 2023 Jul 4.
Despite an increasing necrotizing enterocolitis (NEC) incidence, treatment strategies have failed to make major advancements towards improved NEC outcomes. Heterogeneity in outcome reporting and a lack of treatment efficacy studies potentially hamper these advancements. We aimed to analyze outcome reporting in recent interventional NEC studies.
We performed a systematic review identifying interventional studies on NEC between 1st of January 2016 and 1st of June 2023 in MEDLINE, Embase, CENTRAL and Cochrane reviews. Systematic reviews, clinical trials and change-in-practice cohort studies reporting any therapeutic intervention for NEC patients (Bell's stage ≥ IIa) were eligible. We excluded studies on NEC diagnostics or prevention and non-English publications. Outcomes were categorized into five core areas and presented descriptively. The review was registered with PROSPERO (CRD42022302712).
Out of 1.642 screened records, 65 were eligible for full-text review and 15 were finally included for data extraction. Median number of reported outcomes per article was six (range 1-19). We identified 66 unique outcomes, which were mapped to 53 outcome terms. Thirty-four out of the 53 of the outcome terms (64%) were only reported in a single article. Mortality was the most reported outcome (11/15 articles, 73%). Core area 'Adverse outcomes' contained the most outcome terms (n = 19), whereas 'Life impact' contained the least outcome terms (n = 4) and was represented in 3 articles (20%).
Considerable heterogeneity in outcome reporting and a paucity of outcomes concerning 'Life impact' exist in interventional NEC studies. Development of a NEC core outcome set may improve consistency and patient-relevance in outcome reporting.
Systematic Review and Meta-Analyses.
III.
尽管坏死性小肠结肠炎（NEC）的发病率不断上升，但治疗策略在改善NEC治疗效果方面未能取得重大进展。结果报告的异质性和缺乏治疗效果研究可能阻碍了这些进展。我们旨在分析近期NEC干预性研究中的结果报告情况。
我们进行了一项系统评价，在MEDLINE、Embase、CENTRAL和Cochrane综述中检索2016年1月1日至2023年6月1日期间关于NEC的干预性研究。报告对NEC患者（Bell分期≥IIa）进行任何治疗干预的系统评价、临床试验和实践改变队列研究均符合纳入标准。我们排除了关于NEC诊断或预防的研究以及非英文出版物。结果被分为五个核心领域并进行描述性呈现。该综述已在PROSPERO（CRD42022302712）注册。
在1642条筛选记录中，65条符合全文审查标准，最终15条被纳入数据提取。每篇文章报告的结果中位数为6个（范围1 - 19）。我们识别出66个独特结果，这些结果被映射到53个结果术语。53个结果术语中的34个（64%）仅在一篇文章中被报告。死亡率是报告最多的结果（11/15篇文章，73%）。核心领域“不良结局”包含的结果术语最多（n = 19），而“生活影响”包含的结果术语最少（n = 4），且在3篇文章中出现（20%）。
NEC干预性研究中结果报告存在相当大的异质性，且关于“生活影响”的结果较少。制定NEC核心结局集可能会提高结果报告的一致性和与患者的相关性。
系统评价和荟萃分析。
III。
