PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions

Karon F Cook, Sally E Jensen, Benjamin D Schalet, Jennifer L Beaumont, Dagmar Amtmann, Susan Czajkowski, Darren A Dewalt, James F Fries, Paul A Pilkonis, Bryce B Reeve, Arthur A Stone, Kevin P Weinfurt, David Cella, Karon F Cook, Sally E Jensen, Benjamin D Schalet, Jennifer L Beaumont, Dagmar Amtmann, Susan Czajkowski, Darren A Dewalt, James F Fries, Paul A Pilkonis, Bryce B Reeve, Arthur A Stone, Kevin P Weinfurt, David Cella

Abstract

Objective: To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.

Study design and setting: Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.

Results: The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.

Conclusion: The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.

Keywords: Outcomes research; Patient-reported outcomes; Psychometrics; Responsiveness; Validity.

Conflict of interest statement

K.F.C. is an unpaid officer of the PROMIS Health Organization; D.A.D. is an unpaid member of the board of directors of the PROMIS Health Organization; B.B.R. is an unpaid member of the board of directors of the PROMIS Health Organization. A.A.S. declares a potential conflict as Senior Scientist with the Gallup Organization and as a Senior Consultant with ERT, inc.; K.W. is an unpaid member of the board of directors of the PROMIS Health Organization; D.C. is an unpaid member of the board of directors and officer of the PROMIS Health Organization. All other authors declare no conflict of interest.

Copyright © 2016 Elsevier Inc. All rights reserved.

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