Outcome Reporting in Interventional Necrotizing Enterocolitis Studies: A Systematic Review

Otis C van Varsseveld; Daphne H Klerk; Ingo Jester; Martin Lacher; Elisabeth M W Kooi; Jan B F Hulscher

doi:10.1016/j.jpedsurg.2023.06.017

Outcome Reporting in Interventional Necrotizing Enterocolitis Studies: A Systematic Review

J Pediatr Surg. 2023 Nov;58(11):2105-2113. doi: 10.1016/j.jpedsurg.2023.06.017. Epub 2023 Jul 4.

Authors

Otis C van Varsseveld¹, Daphne H Klerk², Ingo Jester³, Martin Lacher⁴, Elisabeth M W Kooi², Jan B F Hulscher⁵

Affiliations

¹ Department of Surgery, Division of Pediatric Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: o.c.van.varsseveld@umcg.nl.
² Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, the Netherlands.
³ Department of Pediatric Surgery, Birmingham Children's Hospital, Birmingham, United Kingdom.
⁴ Department of Pediatric Surgery, University Hospital Leipzig, University of Leipzig, Leipzig, Germany.
⁵ Department of Surgery, Division of Pediatric Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

PMID: 37516599
DOI: 10.1016/j.jpedsurg.2023.06.017

Abstract

Background: 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.

Methods: 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).

Results: 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%).

Conclusions: 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.

Study type: Systematic Review and Meta-Analyses.

Level of evidence: III.

Keywords: Core outcome set; Intervention; Necrotizing enterocolitis; Outcome reporting; Treatment.

Publication types

Review