Validity of PROMIS physical function measured in diverse clinical samples

Abstract

Objectives: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function measures using longitudinal data collected in six chronic health conditions.

Study design and setting: Individuals with rheumatoid arthritis (RA), major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed the PROMIS Physical Function computerized adaptive test or fixed-length short form at baseline and at the end of clinically relevant follow-up intervals. Anchor items were also administered to assess change in physical function and general health. Linear mixed-effects models and standardized response means were estimated at baseline and follow-up.

Results: A total of 1,415 individuals participated (COPD n = 121; CHF n = 57; back pain n = 218; MDD n = 196; RA n = 521; cancer n = 302). The PROMIS Physical Function scores improved significantly for treatment of CHF and back pain patients but not for patients with MDD or COPD. Most of the patient subsamples that reported improvement or worsening on the anchors showed a corresponding positive or negative change in PROMIS Physical Function.

Conclusion: This study provides evidence that the PROMIS Physical Function measures are sensitive to change in intervention studies where physical function is expected to change and able to distinguish among different clinical samples. The results inform the estimation of meaningful change, enabling comparative effectiveness research.

Keywords: Chronic conditions; Item bank; PROMIS; Patient-reported outcome; Physical function; Validity.

Conflict of interest statement

CONFLICT OF INTEREST

Benjamin D. Schalet: None

Ron D. Hays: None

Sally E. Jensen: None

Jennifer L. Beaumont: None

James F. Fries: None

David Cella is an unpaid member of the board of directors and officer of the PROMIS Health Organization

Copyright © 2016 Elsevier Inc. All rights reserved.

Figures

Figure 1. PROMIS Physical Function Scores in Different Clinical Groups from Baseline to Follow-Up

Higher scores indicate better physical function. A T-score of 50 reflects the mean (and 10 the standard deviation) in the US general population sample that was used to center the T-scores. [35] Cancer (Group 1) and RA (Group 1) patients reported better physical function on the domain-specific global change rating. Cancer (Group 2) and RA (Group 2) reported worse physical function on the domain-specific global change rating. Abbreviations: COPD, chronic obstructive pulmonary disease.