Core Outcome Measures in Effectiveness Trials: https://www.comet-initiative.org/
Core outcomes in clinical research refer to a standardized minimum set of outcomes that should be consistently measured and reported in all clinical trials for a specific health condition or intervention. These core outcome sets (COS) are developed through a rigorous consensus process involving diverse stakeholders such as patients, healthcare professionals, researchers, and policymakers to ensure the outcomes are relevant and meaningful to all parties involved1235.
Key characteristics of core outcomes include:
Minimum essential outcomes: COS represent the smallest set of outcomes that must be measured and reported to allow comparability across studies.
Standardization: They include both the domains (what to measure) and the instruments or methods (how to measure) to ensure consistency.
Consensus-based: Developed through systematic reviews, qualitative research, and consensus techniques like Delphi surveys and nominal group discussions.
Stakeholder involvement: Patients and healthcare providers are actively involved to capture outcomes that matter most to them.
Facilitate evidence synthesis: By harmonizing outcomes, COS reduce research waste, improve meta-analyses, and enhance the reliability of evidence for decision-making.
Flexibility: While COS define the minimum outcomes, researchers can measure additional outcomes relevant to their specific study question.
For instance, in Dentistry > Endodontics, an international consensus study (COSET) identified core outcomes for endodontic treatment trials including:
Pain
Signs of infection (swelling, sinus tract)
Need for further intervention or exacerbation
Tenderness to percussion/palpation
Radiographic evidence of disease progression or healing
Function
Tooth survival
Patient satisfaction
Outcomes in a Dental Clinical Trial:
Maldupa, I., Innes, N., Viduskalne, I. et al. Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial. Sci Rep 14, 8123 (2024). https://doi.org/10.1038/s41598-024-58850-w
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