Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials

Chen X. Chen, Kurt Kroenke, Timothy Stump, Jacob Kean, Erin E. Krebs, Matthew J. Bair, Teresa Damush, Patrick O. Monahan

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

The Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares with legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from 3 clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n = 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n = 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale; Pain, Enjoyment, General Activity scale; 36-Item Short Form Survey (SF-36) Bodily Pain scale; and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area under the curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference and Pain, Enjoyment, General Activity scales. The 4 PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. Perspective: This article presents 1) how responsive the PROMIS-PI scales were to detect change over time in the context of 3 clinical trials and 2) how their responsiveness compared with legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.

Original languageEnglish (US)
Pages (from-to)664-675
Number of pages12
JournalJournal of Pain
Volume20
Issue number6
DOIs
StatePublished - Jun 2019

Bibliographical note

Funding Information:
This work was supported by a National Institute of Arthritis and Musculoskeletal Disorders R01 award to P.O.M. (R01 AR064081) and Department of Veterans Affairs Health Services Research and Development Merit Review awards to M.J.B. (IIR 10-128), E.E.K. (IIR 11-125), and T.D. (VA HSRD QUERI Service Directed Project SDP- 10-379). C.X.C. was supported by the National Institute of Nursing Research under award number 5T32 NR007066, the Indiana University?Purdue University Indianapolis Enhanced Mentoring Program with Opportunities for Ways to Excel in Research (EMPOWER) grant, and grant numbers KL2TR001106 and UL1TR001108 (PI: A. Shekhar) funded by the National Institutes of Health, National Center for Advancing Translational Sciences Clinical and Translational Sciences Award. J.K. was supported by the Department of Veterans Affairs Rehabilitation Research and Development Career Development Award (IK2RX000879). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veteran Affairs. This work was supported by a National Institute of Arthritis and Musculoskeletal Disorders R01 award to P.O.M. ( R01 AR064081) and Department of Veterans Affairs Health Services Research and Development Merit Review awards to M.J.B. (IIR 10-128), E.E.K. (IIR 11-125), and T.D. (VA HSRD QUERI Service Directed Project SDP- 10-379). C.X.C. was supported by the National Institute of Nursing Research under award number 5T32 NR007066, the Indiana University? Purdue University Indianapolis Enhanced Mentoring Program with Opportunities for Ways to Excel in Research (EMPOWER) grant, and grant numbers KL2TR001106 and UL1TR001108 (PI: A. Shekhar) funded by the National Institutes of Health, National Center for Advancing Translational Sciences Clinical and Translational Sciences Award. J.K. was supported by the Department of Veterans Affairs Rehabilitation Research and Development Career Development Award ( IK2RX000879). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veteran Affairs. The authors thank Dr. Janet Carpenter for helpful comments on earlier versions of this article and Ms. Lindsay Rosa for editorial support. This work was supported by a National Institute of Arthritis and Musculoskeletal Disorders R01 award to P.O.M. ( R01 AR064081) and Department of Veterans Affairs Health Services Research and Development Merit Review awards to M.J.B. (IIR 10-128), E.E.K. (IIR 11-125), and T.D. (VA HSRD QUERI Service Directed Project SDP- 10-379). C.X.C. was supported by the National Institute of Nursing Research under award number 5T32 NR007066, the Indiana University? Purdue University Indianapolis Enhanced Mentoring Program with Opportunities for Ways to Excel in Research (EMPOWER) grant, and grant numbers KL2TR001106 and UL1TR001108 (PI: A. Shekhar) funded by the National Institutes of Health, National Center for Advancing Translational Sciences Clinical and Translational Sciences Award. J.K. was supported by the Department of Veterans Affairs Rehabilitation Research and Development Career Development Award ( IK2RX000879). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veteran Affairs.

Funding Information:
This work was supported by a National Institute of Arthritis and Musculoskeletal Disorders R01 award to P.O.M. (R01 AR064081) and Department of Veterans Affairs Health Services Research and Development Merit Review awards to M.J.B. (IIR 10-128), E.E.K. (IIR 11-125), and T.D. (VA HSRD QUERI Service Directed Project SDP- 10-379). C.X.C. was supported by the National Institute of Nursing Research under award number 5T32 NR007066, the Indiana University–Purdue University Indianapolis Enhanced Mentoring Program with Opportunities for Ways to Excel in Research (EMPOWER) grant, and grant numbers KL2TR001106 and UL1TR001108 (PI: A. Shekhar) funded by the National Institutes of Health, National Center for Advancing Translational Sciences Clinical and Translational Sciences Award. J.K. was supported by the Department of Veterans Affairs Rehabilitation Research and Development Career Development Award (IK2RX000879). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veteran Affairs.

Publisher Copyright:
© 2019 the American Pain Society

Keywords

  • PROMIS
  • Pain interference
  • pain measurement
  • patient-reported outcome measures
  • responsiveness

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