Development of an international core outcome set for treatment trials in necrotizing enterocolitis-a study protocol.

ABSTRACT:

Aim

Necrotizing enterocolitis (NEC) is the most lethal disease of the gastrointestinal tract of preterm infants. New and existing management strategies need clinical evaluation. Large heterogeneity exists in the selection, measurement, and reporting of outcome measures in NEC intervention studies. This hampers meta-analyses and the development of evidence-based management guidelines. We aim to develop a Core Outcome Set (COS) for NEC that includes the most relevant outcomes for patients and physicians, from moment of diagnosis into adulthood. This COS is designed for use in NEC treatment trials, in infants with confirmed NEC.

Methods

This study is designed according to COS-STAD (Core Outcome Set-STAndards for Development) recommendations and the COMET (Core Outcome Measures

SUBMITTER: Klerk DH 

PROVIDER: S-EPMC10230797 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature