COHESION: core outcomes in neonatal encephalopathy (protocol)

Abstract

Background Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. Methods We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a “Real-Time” Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). Discussion More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. Trial registration This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270.

Creatinine Trends and Patterns in Neonates Undergoing Whole Body Hypothermia: A Systematic Review

“…At least, this additional data set further confirms the fact that in future pooling efforts, postnatal age should be further extended beyond the first week of postnatal life to provide more confidence on the Scr patterns in asphyxia + WBH cases. Finally, this paper further supports other recent efforts to also assess non-neurodevelopmental aspects of the outcome (renal, cardiac) in asphyxia + WBH cases, as well suggests incorporating these aspects into the ongoing efforts to develop a core outcome set specific to neonatal encephalopathy trials [21,61].…”

Core outcomes in neonatal encephalopathy: a qualitative study with parents

“…While, the reasons for these differences in outcomes is beyond the scope of this work, all outcomes will be included in the next phase of the COS development. 6 33 …”

“…The final outcomes to include in the COS will be decided through discussion with stakeholders in online consensus meetings. 6 …”

“…This qualitative study is a part of a larger study (COHE-SION) to develop a core outcome set (COS) for the treatment of neonatal encephalopathy. 6 A COS is a standardised list of outcomes considered to be the most important to all stakeholders (parents/caregivers, healthcare providers, researchers/academics), which should be measured as a minimum in all trials for a specific condition. 7 The development of COSs involves a consensus process to prioritise outcomes for a particular condition.…”

Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol

“…We will categorise outcomes according to the predefined consensus definition described in table 2. [34][35][36] All responses, including from partially completed questionnaires will be used in analyses.…”