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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

162 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)89-102
Number of pages14
JournalJournal of Clinical Epidemiology
Volume73
DOIs
StatePublished - May 1 2016

Keywords

  • Outcomes research
  • Patient-reported outcomes
  • Psychometrics
  • Responsiveness
  • Validity

ASJC Scopus subject areas

  • Epidemiology

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