@article{fc601f5fa8d6455fbe4c6b3794daa7e6,
title = "Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior",
abstract = "Objective To evaluate clinical validity, including responsiveness, of Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PROMIS-PI) and pain behavior (PROMIS-PB) T-scores. Study Design and Setting Data were aggregated from longitudinal studies of cancer, chronic low back pain (cLBP), rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and major depressive disorder (MDD). Linear mixed-effects models were used to compare baseline score differences and score changes over time. We calculated standardized response means (SRMs) for subgroups defined by self-reported change in general health and pain. Results A total of 1,357 individuals participated at baseline and 1,225 at follow-up. Hypotheses of significant change in PROMIS-PI and PROMIS-PB scores were supported in the intervention groups (cLBP and MDD). Differences in baseline scores for COPD exacerbators compared to stable COPD patients were in the hypothesized direction but were not statistically significant. Subgroups reporting better health showed corresponding negative SRM values supporting responsiveness of T-scores to improvement. Responsiveness to decrements was supported in some but not all clinical groups and varied by anchor. More congruent values were obtained when using a pain-specific anchor. Conclusion This study provides evidence that PROMIS-PI and PROMIS-PB scores are sensitive to changes in pain in studies of interventions expected to impact pain. The results inform estimation of meaningful change and support power analyses for comparative effectiveness research.",
keywords = "Back pain, Cancer, Chronic pain, PROMIS, Pain behavior, Pain interference",
author = "Askew, {Robert L.} and Cook, {Karon Frances} and Revicki, {Dennis A.} and David Cella and Dagmar Amtmann",
note = "Funding Information: PROMIS was funded with cooperative agreements from the National Institutes of Health Common Fund Initiative (Northwestern University, PI: D.C., U54AR057951, U01AR052177, R01CA60068; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, U01AR052170; University of Washington, Seattle, PIs: Heidi M. Crane, MD, MPH, Paul K. Crane, MD, MPH, and Donald L. Patrick, PhD, U01AR057954; University of Washington, Seattle, PI: Dagmar Amtmann, PhD, U01AR052171; University of North Carolina, Chapel Hill, PI: Harry A. Guess, MD, PhD (deceased), Darren A. DeWalt, MD, MPH, U01AR052181; Children's Hospital of Philadelphia, PI: Christopher B. Forrest, MD, PhD, U01AR057956; Stanford University, PI: James F. Fries, MD, U01AR052158; Boston University, PIs: Alan Jette, PT, PhD, Stephen M. Haley, PhD (deceased), and David Scott Tulsky, PhD (University of Michigan, Ann Arbor), U01AR057929; University of California, Los Angeles, PIs: Dinesh Khanna, MD (University of Michigan, Ann Arbor) and Brennan Spiegel, MD, MSHS, U01AR057936; University of Pittsburgh, PI: Paul A. Pilkonis, PhD, U01AR052155; Georgetown University, PIs: Carol. M. Moinpour, PhD (Fred Hutchinson Cancer Research Center, Seattle) and Arnold L. Potosky, PhD, U01AR057971; Children's Hospital Medical Center, Cincinnati, PI: Esi M. Morgan DeWitt, MD, MSCE, U01AR057940; University of Maryland, Baltimore, PI: Lisa M. Shulman, MD, U01AR057967; and Duke University, PI: Kevin P. Weinfurt, PhD, U01AR052186). NIH Science Officers on this project have included Deborah Ader, PhD, Vanessa Ameen, MD (deceased), Susan Czajkowski, PhD, Basil Eldadah, MD, PhD, Lawrence Fine, MD, DrPH, Lawrence Fox, MD, PhD, Lynne Haverkos, MD, MPH, Thomas Hilton, PhD, Laura Lee Johnson, PhD, Michael Kozak, PhD, Peter Lyster, PhD, Donald Mattison, MD, Claudia Moy, PhD, Louis Quatrano, PhD, Bryce Reeve, PhD, William Riley, PhD, Peter Scheidt, MD, Ashley Wilder Smith, PhD, MPH, Susana Serrate-Sztein, MD, William Phillip Tonkins, DrPH, Ellen Werner, PhD, Tisha Wiley, PhD, and James Witter, MD, PhD. The contents of this article use data developed under PROMIS. These contents do not necessarily represent an endorsement by the US Federal Government or PROMIS. See www.nihpromis.org for additional information on the PROMIS initiative. Publisher Copyright: {\textcopyright} 2016 Elsevier Inc. All rights reserved.",
year = "2016",
month = may,
day = "1",
doi = "10.1016/j.jclinepi.2015.08.035",
language = "English (US)",
volume = "73",
pages = "103--111",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier USA",
}
