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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

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Helen Kitchen

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Review Open access Sep 2026

Incorporating the patient perspective into clinician-reported outcome (ClinRO) content validation and meaningful within-patient change thresholds

Clinician-reported outcome measures (ClinROs) are completed by trained clinical experts, yet the signs and behaviors they capture must reflect meaningful aspects of health to patients. FDA Patient Focused Drug Development (PFDD) Guidance indicates the importance of establishing content validity for ClinROs. Patie...

Helen Kitchen, Stephanie Fairhurst, Chris Marshall et al. · 0 citations

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