Patient reported physical function is an important component of clinical and epidemiological studies. The traditional instruments used to assess Physical Function have served us well over three decades, but the newer tools of item response theory and computerized adaptive testing now permit major improvements resulting in better power and precision. Our work with the Patient Reported Outcome Measurement Information System (PROMIS) resulted in more powerful patient reported tools. However, this work has revealed critical yet unresolved issues- issues that we address in the current application. We have four specific aims: 1. To develop, test, and extend the PROMIS physical function domain (ability to perform) to assess above normal or superior abilities ("positive health") and far below normal abilities (severely impaired, frail). We will also add the new physical function domains of Actual Performance, Satisfaction with physical function Abilities, and Physical Ability for Social Participation, as well as the referent domains of Pain and Global Health. 2. To validate these domains in rheumatoid arthritis, osteoarthritis, lupus, scleroderma, juvenile arthritis, vasculitis, and gout patients, in frailty/aging, nursing home, and positive health populations, as well as populations that may become available through other PROMIS primary research sites (e.g., COPD and Heart Failure). Validation will include responsiveness testing and exploration of differential item function (with age, gender, ethnicity, and disease duration). We will develop and validate short-forms and GAT applications for the extended and new domains. 3. To develop and validate a PRO Drug Safety domain supplemented by medical record review and National Death Index-based mortality surveillance. 4. To encourage use of PROMIS tools by academic investigators, NIH, industry, the Food and Drug Administration, Clinical Research Organizations, and other stakeholders in clinical research. Availability of these tools will result in outcome assessment tools that will not be bounded by floors and ceilings, will be appropriate endpoints for the interventions being studied, will better represent the patient's perspective, and will enable more effective and more cost- effective clinical research.
This research will enable more effective measurement of disease outcomes such as physical function, disability, pain, and drug side effects. It will focus outcomes research on endpoints of greatest importance and relevance to the patient and will help improve the infrastructure of medical research by providing better measures of results.
|Revicki, Dennis A; Cook, Karon F; Amtmann, Dagmar et al. (2014) Exploratory and confirmatory factor analysis of the PROMIS pain quality item bank. Qual Life Res 23:245-55|
|Siemons, Liseth; Krishnan, Eswar (2014) A short tutorial on item response theory in rheumatology. Clin Exp Rheumatol 32:581-6|
|Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E et al. (2014) Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res 56:112-9|
|Bjorner, Jakob B; Rose, Matthias; Gandek, Barbara et al. (2014) Difference in method of administration did not significantly impact item response: an IRT-based analysis from the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. Qual Life Res 23:217-27|
|Tucker, Carole A; Bevans, Katherine B; Teneralli, Rachel E et al. (2014) Self-reported pediatric measures of physical activity, sedentary behavior, and strength impact for PROMIS: conceptual framework. Pediatr Phys Ther 26:376-84|
|Fries, James F; Lingala, Bharathi; Siemons, Liseth et al. (2014) Extending the floor and the ceiling for assessment of physical function. Arthritis Rheumatol 66:1378-87|
|Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A et al. (2014) Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue. J Psychosom Res 76:300-6|
|Rose, Matthias; Bjorner, Jakob B; Gandek, Barbara et al. (2014) The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol 67:516-26|
|Bjorner, Jakob B; Rose, Matthias; Gandek, Barbara et al. (2014) Method of administration of PROMIS scales did not significantly impact score level, reliability, or validity. J Clin Epidemiol 67:108-13|
|Tucker, Carole A; Bevans, Katherine B; Teneralli, Rachel E et al. (2014) Self-reported pediatric measures of physical activity, sedentary behavior, and strength impact for PROMIS: item development. Pediatr Phys Ther 26:385-92|
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