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Taxonomy of PROs Used in Clinical Trials |
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| Attribute |
Types |
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| 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) |
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research et al. Health and Quality of Life Outcomes 2006 4:79 doi:10.1186/1477-7525-4-79 |
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