Improving Outcome Reporting in Paediatric Airway Management in Clinical Trials (IMPACT): A Study Protocol for Core Outcomes and Clinical Endpoints

BACKGROUND: Although clinical trials are fundamental to advancing evidence-based practice, significant heterogeneity in outcome reporting poses a considerable challenge to the validity of systematic reviews. This inconsistency impedes the ability to compare, synthesise and interpret research findings effectively. In the field of paediatric airway management, this issue is particularly relevant because of the low incidence of critical events and the related high morbidity and mortality. The issue of inadequate and variable outcome reporting in clinical trials has been widely acknowledged, necessitating initiatives to enhance the quality of future research.

OBJECTIVE: This protocol delineates the methodology used for the development of standardised, consensus-based outcome definitions and reporting items specifically tailored to paediatric airway management trials. The goal is to create guidance that will serve as an extension to the established SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) frameworks, leading to enhanced trial reproducibility and transparency and ultimately improve pediatric airway research, systematic reviews and advance patient care and safety.

METHODS: This project will adhere to the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network's framework for guideline development. The methodology will be structured into four distinct phases: (1) a scoping review to comprehensively identify outcomes and variables currently reported in paediatric airway management trials; (2) a three-round Delphi process involving a multidisciplinary panel of experts to prioritise and refine outcomes and variables; (3) a consensus meeting to achieve agreement on the final set of reporting items, which will then be prepared for publication and (4) dissemination.

CONCLUSIONS: The finalised outcome reporting guidelines, in the form of SPIRIT and CONSORT extensions for paediatric airway management, will be disseminated through various channels to maximise their reach and impact. These include publication in peer-reviewed journals, presentation at major international conferences and submission to relevant international reporting registries, such as the EQUATOR, SPIRIT and CONSORT registries. Active engagement with key stakeholders, including journal editors, research funders, regulatory bodies and clinician networks and national and international societies, will be a crucial component of the dissemination strategy.