• Ann M Taylor, Kristine Phillips, Kushang V Patel, Dennis C Turk, Robert H Dworkin, Dorcas Beaton, Daniel J Clauw, GignacMonique A MMAMInstitute for Work and Health, University of Toronto, ON, Canada., John D Markman, David A Williams, Shay Bujanover, Laurie B Burke, Daniel B Carr, Ernest H Choy, Philip G Conaghan, Penney Cowan, John T Farrar, Roy Freeman, Jennifer Gewandter, Ian Gilron, Veeraindar Goli, Tony D Gover, J David Haddox, Robert D Kerns, Ernest A Kopecky, David A Lee, Richard Malamut, Philip Mease, Bob A Rappaport, Lee S Simon, Jasvinder A Singh, Shannon M Smith, Vibeke Strand, Peter Tugwell, Gertrude F Vanhove, Christin Veasley, Gary A Walco, Ajay D Wasan, and James Witter.
• Centre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom.
• Pain. 2016 Sep 1; 157 (9): 1836-1850.

AbstractAlthough 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.

This article appears in the collection: Chronic pain.

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