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Oct 12, 2018

7th Congress of the European Academy of Paediatric Societies

05 - CORE OUTCOMES IN NEONATOLOGY: RESULTS OF AN INTERNATIONAL CONSENSUS PROCESS INVOLVING PATIENTS, PARENTS, HEALTHCARE PROFESSIONALS AND RESEARCHERS

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neonatology

core outcome set

outcomes

Abstract

Abstract

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Keywords

neonatology

core outcome set

outcomes

Abstract

Background: An outcome is the effect an intervention has on an individual. A ‘Core Outcomes Set’ is an agreed, standardised group of outcomes recorded by all trials. They facilitate evidence synthesis across trials and ensure outcomes relevant to patients and healthcare professionals are recorded (de Wit, 2013). Currently, no core outcomes set exists for clinical trials in neonatology. Aims: Develop a core outcomes set for neonatology. Methods: A steering group including patients, parents, healthcare professionals and researchers was formed. We systematically reviewed outcomes reported in neonatal trials and identified outcomes of importance to stakeholders through a systematic review of qualitative studies. We entered the identified outcomes identified into a three round international eDelphi survey. We recruited stakeholders online (target of 120 participants). We prospectively registered the project with COMET. Results: We identified 104 outcomes. Worldwide, 413 people registered to participate in the Delphi process (Fig. 1) and 173 participants completed all rounds (Table 1). After three rounds 15 outcomes reached pre-specified criteria for inclusion in the COS: Survival, Sepsis, Necrotising enterocolitis, Brain injury on imaging, Retinopathy of Prematurity, General gross motor ability, General cognitive ability, Visual impairment, Pain, Quality of life, Hearing impairment, Seizures, Harm due to medical treatment, Need for surgical operations and Ability to walk. Conclusions: The core outcomes set for neonatology will standardise outcome selection in clinical trials and ensure outcomes are relevant to those most affected by neonatal care. This will help research translate into improved neonatal care.

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© Copyright 2019 Morressier GmbH.
All rights reserved.