Improving Outcome Reporting in Paediatric Airway Management in Clinical Trials ( <scp>IMPACT</scp> ): A Study Protocol for Core Outcomes and Clinical Endpoints
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.482 | 0.507 |
| Meta-epidemiology (narrow) | 0.005 | 0.006 |
| Meta-epidemiology (broad) | 0.007 | 0.012 |
| Bibliometrics | 0.012 | 0.014 |
| Science and technology studies | 0.005 | 0.008 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.005 | 0.010 |
| Research integrity | 0.018 | 0.014 |
| Insufficient payload (model declined to judge) | 0.028 | 0.014 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".