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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AR052158-06S1
Application #
8706606
Study Section
Special Emphasis Panel (ZRG1-RPHB-A (54))
Program Officer
Serrate-Sztein, Susana
Project Start
2004-09-28
Project End
2014-07-31
Budget Start
2009-09-30
Budget End
2014-07-31
Support Year
6
Fiscal Year
2013
Total Cost
$80,000
Indirect Cost
$30,000
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
Cook, Karon F; Jensen, Sally E; Schalet, Benjamin D et al. (2016) PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol 73:89-102
Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly et al. (2016) Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain. Pain 157:339-47
Dampier, Carlton; Barry, Vaughn; Gross, Heather E et al. (2016) Initial Evaluation of the Pediatric PROMIS® Health Domains in Children and Adolescents With Sickle Cell Disease. Pediatr Blood Cancer 63:1031-7
Schalet, Benjamin D; Pilkonis, Paul A; Yu, Lan et al. (2016) Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol 73:119-27
Li, Zheng; Thompson, Lindsay A; Gross, Heather E et al. (2016) Longitudinal associations among asthma control, sleep problems, and health-related quality of life in children with asthma: a report from the PROMIS(®) Pediatric Asthma Study. Sleep Med 20:41-50
Thissen, David; Liu, Yang; Magnus, Brooke et al. (2016) Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method. Qual Life Res 25:13-23
Stukenborg, George J; Blackhall, Leslie J; Harrison, James H et al. (2016) Longitudinal patterns of cancer patient reported outcomes in end of life care predict survival. Support Care Cancer 24:2217-24
Brandon, Timothy G; Becker, Brandon D; Bevans, Katherine B et al. (2016) Patient Reported Outcomes Measurement Information System® (PROMIS(®) ) Tools for Collecting Patient-Reported Outcomes in Children with Juvenile Arthritis. Arthritis Care Res (Hoboken) :
Dampier, Carlton; Jaeger, Byron; Gross, Heather E et al. (2016) Responsiveness of PROMIS® Pediatric Measures to Hospitalizations for Sickle Pain and Subsequent Recovery. Pediatr Blood Cancer 63:1038-45
Reeve, Bryce B; Thissen, David; DeWalt, Darren A et al. (2016) Linkage between the PROMIS® pediatric and adult emotional distress measures. Qual Life Res 25:823-33

Showing the most recent 10 out of 82 publications