Validation of PROMIS Banks With COPD Exacerbations
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
Chronic Obstructive Pulmonary Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation of PROMIS Banks With COPD Exacerbations|
|Study Start Date:||July 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Patients who are stable have not had a COPD exacerbation in the past 2 months.
Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
This is a prospective longitudinal study of adult patients with chronic obstructive pulmonary disease (COPD) who will be enrolled when their COPD is considered clinically stable or during an acute exacerbation. This design will allow both within-person and between-person comparisons by exacerbation experience. Comprehensive clinical and patient-reported assessments will be performed at baseline and at 3 months (end of study). Subsets of items will be administered by interactive voice response (IVR) over the course of the study to measure changes in key symptoms over the course of recovery from an exacerbation. A subset of patients will be interviewed at the end of the study to assess content validity of PROMIS items in this patient population.
With such a study design, we will be able to evaluate the validity of the PROMIS items in this patient population under acute and stable conditions and evaluate responsiveness of several PROMIS item banks under conditions of known change in an underlying chronic disease. We will also evaluate stability of sub-domains that are not hypothesized to change with COPD exacerbations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784342
|United States, Illinois|
|NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)|
|Evanston, Illinois, United States, 60201|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Durham, North Carolina, United States, 27701|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Pittsburgh VA Hospital|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Darren A. Dewalt, MD, MPH||University of North Carolina, Chapel Hill|