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Domains selection for patient-reported outcomes: current activities and options for future methods.
Peter S Tugwell1, Ingemar F Petersson, Maarten Boers
1Faculty of Medicine, University of Ottawa, Ottawa, Canada.
Outcome Measures in Rheumatology Clinical Trials (OMERACT) emphasizes an open domain selection process for rheumatologic trials. A gold standard includes frameworks, clinical relevance, and patient-reported outcomes for comprehensive measurement.
Area of Science:
- Rheumatology clinical trials
- Outcome measurement in clinical research
Background:
- Outcome Measures in Rheumatology Clinical Trials (OMERACT) develops consensus core sets for outcome measurement in rheumatologic diseases.
- Core sets define the minimum essential domains and instruments for trial outcomes.
- Domains represent attributes of activity or function.
Framework:
- Discusses the need for an open domain selection process.
- Reviews existing frameworks for choosing domains.
- Highlights the importance of transparent methods in domain selection.
Implementation:
- Analyzed domain selection methods from three OMERACT patient-reported outcomes (PRO) groups.
- Categorized methods by comprehensiveness and examined their adherence to related issues.
- Identified a consensus for a gold standard in domain selection.
Implications:
- Agreed on the utility of a guide for developing domains meeting OMERACT Filter criteria.
- Acknowledged the need to address patient-reported outcomes beyond the International Classification of Functioning, Disability and Health (ICF).
- Recognized the value of the population/intervention/comparison/outcome (PICO) structure in domain selection and future framework development based on ICF.
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