Guided Notes

Patient-Reported Outcomes Data

Validated PRO instruments, scoring rules and missing items, recall periods, translations and licensing, compliance and analysis implications.

What PROs measure

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Patient-reported outcomes capture how patients feel and function, directly from them: symptoms, pain, fatigue, quality of life, physical function. Examples: EQ-5D, SF-36, PROMIS measures, disease-specific questionnaires (e.g. for asthma, diabetes, cancer like EORTC QLQ-C30). Regulators use PROs for labeling claims when instruments are well-defined and reliable (FDA PRO guidance series).

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