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.
Original language | English |
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Pages (from-to) | 2105-2113 |
Number of pages | 9 |
Journal | Journal of Pediatric Surgery |
Volume | 58 |
Issue number | 11 |
DOIs | |
Publication status | Published - Nov-2023 |
Keywords
- Core outcome set
- Intervention
- Necrotizing enterocolitis
- Outcome reporting
- Treatment