OBJECTIVES: To review the evidence on the application of the new VAE surveillance definition in paediatric population and examine the potential challenges in clinical practice.
REVIEW METHODS: A systematic approach was used to locate and synthesise the relevant paediatric literature. Studies were appraised according to epidemiological appraisal instrument (EAI) and the grades of evidence in the National Health Medical Research Council (NHMRC) guidelines.
RESULTS: Seven studies met the inclusion criteria. Quality of study methods was above 50% on the EAI. The overall grade of evidence was assessed as C (satisfactory). The incidence of VAE in children ranged from 1.1 to 20.9 per 1000 ventilator days as a result of variations in surveillance criteria across included studies. There is little agreement between the new VAE and PNU/VAP surveillance definition in the identification of VAP. Challenges in the application of VAE surveillance were related to; the difference in modes of ventilation used in children versus adults, inconclusive criteria tailored to paediatric samples and a lack of data that support for automatic data extraction applied in paediatric studies.
CONCLUSION: This review demonstrated promising evidence using the new VAE surveillance definition to define the VAE in children, but the level of the evidence is low. Before the possibility of real implementation in clinical settings, challenges related to VAE paediatric specific criteria' and the value of automated data collection need to be considered.
METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.
RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.
CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
METHODS: Neonatal trials including >100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports.
RESULTS: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: "survival," "short-term neonatal complications," and "long-term developmental outcomes" depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting.
CONCLUSIONS: We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.