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Table 1 Taxonomy of PROs Used in Clinical Trials

From: Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

Attribute Types
Intended use of the measure • To define entry criteria for study populations
• To evaluate efficacy
• To evaluate adverse events
Concepts measured • Overall health status
• Symptoms/signs, individually or as a syndrome associated with a medical condition
• Functional status (physical, psychological or social)
• Health perceptions (e.g., self-rating of health or worry about condition)
• Satisfaction with treatment or preference for treatment
• Adherence to medical treatment
Number of items • Single item for single concept
• Multiple items for single concept
• Multiple items for multiple domains within a concept
Intended measurement population or condition • Generic
• Condition-specific
• Population-specific
Mode of data collection • Interviewer-administered
• Self-administered, with or without supervision
• Computer-administered or computer-assisted
• Interactively administered (e.g., interactive voice response systems or Web-based systems)
Timing and frequency of administration • As events occur
• At regular intervals throughout a study
• Baseline and end of treatment
Types of scores • Single rating on a single concept (e.g., pain severity)
• Index – single score combining multiple ratings of related domains or independent concepts
• Profile – multiple uncombined scores of multiple-related domains
• Battery – multiple uncombined scores of independent concepts
• Composite – an index, profile, or battery
Weighting of items or concepts • All items and domains are equally weighted
• Items are assigned variable weights
• Domains are assigned variable weights
Response options • See Table 2 for examples of response options (types of PRO scales)