Outcome reporting in oral and maxillofacial trauma research is inconsistent and often clinician-centric, limiting evidence synthesis and overlooking patient-relevant domains. To address this, we propose the development of a Core Outcome Set (COS) for maxillofacial trauma, applicable to all AO-classified fracture types, ensuring consistent measurement of outcomes critical to patients, clinicians, and researchers. This study will use a multi-phase design, starting with a systematic scoping review which will serve as the foundation for a subsequent international Delphi consensus study and a selection of the most appropriate outcome measurement instruments, grounded in COMET and COS-STAD methodologies. The result will be an internationally agreed-upon, evidence-based Core Outcome Set for maxillofacial trauma, promoting standardized reporting and comparability across studies. This COS aims to enhance research quality and inform clinical practice and policy worldwide.
A similar project registered in the COMET database, named “Core outcome set for clinical research involving patients with facial trauma” (https://www.comet-initiative.org/Studies/Details/3667), will aim to develop a COS for clinical research involving patients with facial trauma including both soft-tissue and skeletal trauma. While very relevant, it does not seem to distinguish between specific AO-classified fracture types, and therefore did not specify to address the distinct outcome needs associated with different maxillofacial fracture patterns. Our proposed COS will provide a granular, fracture-specific framework aligned with the AO CMF classification, improving comparability across studies and supporting more precise, clinically meaningful outcome reporting. Moreover, the candidate outcomes will be organized into meaningful domains (e.g. clinical/physical, functional, aesthetic, and patient-reported domains) and outcome definitions will be refined before and during the Delphi process, ensuring clarity and non-duplication. Therefore, we believe our project can be complementary to other research, rather than duplicative.
Dr. Van der Cruyssen Fréderic (University Hospitals Leuven) - Supervisor and principal investigator
Prof. dr. van der Tas Justin (UMC Erasmus Rotterdam) - Supervisor and principal investigator
Dr. Van Kelecom Valerie (University Hospitals Ghent) - Investigator
Disease Category: Orthopaedics & trauma
Disease Name: Oral and Maxillofacial Trauma
Age Range: 16 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
First, a systematic literature review employing an iterative saturation approach will identify candidate outcomes. These will be refined and categorized into clinical, functional, aesthetic, and patient-reported domains. A two-round Delphi process with international multidisciplinary stakeholders, combined with importance performance analysis, will be used to achieve consensus on core outcomes. Outcomes rated as critically important and underrepresented will be prioritized. Subsequently, the COSMIN framework will guide selection of validated outcome measurement instruments for each core outcome. A multinational pilot study will evaluate feasibility, reliability, and stakeholder acceptance of the final COS.