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Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Publication ,  Journal Article
Taylor, AM; Phillips, K; Patel, KV; Turk, DC; Dworkin, RH; Beaton, D; Clauw, DJ; Gignac, MAM; Markman, JD; Williams, DA; Bujanover, S; Goli, V ...
Published in: Pain
September 2016

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

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Published In

Pain

DOI

EISSN

1872-6623

ISSN

0304-3959

Publication Date

September 2016

Volume

157

Issue

9

Start / End Page

1836 / 1850

Related Subject Headings

  • Treatment Outcome
  • Social Participation
  • Quality of Life
  • Pain Measurement
  • Pain Management
  • Outcome Assessment, Health Care
  • Humans
  • Clinical Trials as Topic
  • Chronic Pain
  • Anesthesiology
 

Citation

APA
Chicago
ICMJE
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Taylor, A. M., Phillips, K., Patel, K. V., Turk, D. C., Dworkin, R. H., Beaton, D., … Witter, J. (2016). Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations. Pain, 157(9), 1836–1850. https://doi.org/10.1097/j.pain.0000000000000577
Taylor, Ann M., Kristine Phillips, Kushang V. Patel, Dennis C. Turk, Robert H. Dworkin, Dorcas Beaton, Daniel J. Clauw, et al. “Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.Pain 157, no. 9 (September 2016): 1836–50. https://doi.org/10.1097/j.pain.0000000000000577.
Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, et al. Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations. Pain. 2016 Sep;157(9):1836–50.
Taylor, Ann M., et al. “Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.Pain, vol. 157, no. 9, Sept. 2016, pp. 1836–50. Epmc, doi:10.1097/j.pain.0000000000000577.
Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, Clauw DJ, Gignac MAM, Markman JD, Williams DA, Bujanover S, Burke LB, Carr DB, Choy EH, Conaghan PG, Cowan P, Farrar JT, Freeman R, Gewandter J, Gilron I, Goli V, Gover TD, Haddox JD, Kerns RD, Kopecky EA, Lee DA, Malamut R, Mease P, Rappaport BA, Simon LS, Singh JA, Smith SM, Strand V, Tugwell P, Vanhove GF, Veasley C, Walco GA, Wasan AD, Witter J. Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations. Pain. 2016 Sep;157(9):1836–1850.

Published In

Pain

DOI

EISSN

1872-6623

ISSN

0304-3959

Publication Date

September 2016

Volume

157

Issue

9

Start / End Page

1836 / 1850

Related Subject Headings

  • Treatment Outcome
  • Social Participation
  • Quality of Life
  • Pain Measurement
  • Pain Management
  • Outcome Assessment, Health Care
  • Humans
  • Clinical Trials as Topic
  • Chronic Pain
  • Anesthesiology