Ecological validity of PROMIS instruments

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DESCRIPTION (provided by applicant): Patient Reported Outcomes (PROs) are a necessary component of medical research and practice. The NIH- sponsored Patient-Reported Outcome Measurement Information System (PROMIS) has developed item banks and scales for several domains of symptoms and functioning, and these assessments are ready for validation. Ecological validity is an emerging and innovative approach to measurement validation. It is based on the premise that assessment scale scores using reporting periods of several days or more should have a high level of correspondence with ratings of that experience that are made on a dally or more frequent basis for the same reporting period. Good cortespondence indicates that the recall measure is not seriously compromised by memory deficits or other recall biases. This application proposes three major aims: to provide evidence of ecological and known-group validity of the PROMIS scales; to provide evidence of the responsiveness of the scales to change across time; and, to test a comprehensive theoretical model of 7-day recall in PROs. Study participants will complete weekly computer-assisted (CAT) PROMIS scales of the several domains and will monitor symptoms daily (to provide ecologically valid information) across a 4-week protocol. Five samples have been selected to provide variability in mean levels of the PROMIS scales (e.g., general population vs. osteoarthritis) and to provide patterns of change in symptoms over the 28-days (e.g., symptom shifts following chemotherapy or surgery). Second, the ability of PROMIS scales to track expected patterns of within-group change that correspond to changes captured by daily ratings will comprise a strong test of PROMIS scales' responsiveness to change. A comprehensive theoretical model of factors (cognitive heuristics) that influence recall ratings will also be tested. This research will provide a unique and important form of validation of PROMIS scales. The ability to probe the "meaning" of recall ratings will also make important contributions to the science of self-report and inform clinical Interpretation of PROs. PUBLIC HEALTH RELEVANCE: Patient reported outcomes (PROs) of symptoms and functioning are central to the medical research enterprise and to clinical practice. The newly developed PROMIS instruments are a major step in improving measurement of PROs. This study will provide information about the validity of the PROMIS instruments. Improved PROs will enhance our ability to assess health in the general population and evaluate new medicines and treatments.