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Patient-Reported Outcome Measure Development and Validation: A Primer for Clinicians
Mark Kosinski1, Linda M Nelson2, Richard H Stanford3
1IQVIA, Durham, NC.
The Journal of Allergy and Clinical Immunology. in Practice
|August 24, 2024
Summary
Patient-reported outcome (PRO) instruments capture patient experiences with disease and treatment. This paper details the development and validation of standardized PRO instruments for comprehensive health assessment.
Area of Science:
- Health Outcomes Research
- Clinical Trial Methodology
- Patient-Centered Care
Background:
- Comprehensive health assessment requires evaluating patient experiences.
- Patient-reported outcome (PRO) instruments are essential for capturing these experiences.
- PROs provide patient perspectives on disease and treatment impact.
Purpose of the Study:
- To describe the process of developing standardized patient-reported outcome (PRO) instruments.
- To outline the steps from conceptual model development to instrument validation.
- To highlight the importance of PROs in clinical research and practice.
Main Methods:
- Conceptual model development for PRO instruments.
- Standardization and validation of PRO questionnaires.
- Item scaling and combination to represent health constructs.
Main Results:
- PRO instruments are validated questionnaires capturing patient perspectives.
- PROs assess physical, social, and role functioning, psychological well-being, symptoms, pain, and quality of life.
- PROs are increasingly used as endpoints in clinical trials and in clinical practice.
Conclusions:
- Standardized PRO instruments are crucial for understanding treatment benefits and patient needs.
- The described development and validation process ensures reliable patient-reported data.
- PROs enhance clinical trials and patient care by incorporating the patient's voice.
Keywords:
Health-related quality of lifeInstrument developmentInterpretationPatient-reported outcomesReliabilityResponsivenessValidityMore Related Videos
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