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Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

Grieve, Sharona,b,*; Perez, Roberto S.G.M.c; Birklein, Frankd; Brunner, Floriane; Bruehl, Stephenf; Harden, R. Normang; Packham, Tarah; Gobeil, Francoisi; Haigh, Richardj; Holly, Janetk; Terkelsen, Astridl; Davies, Lindsaya; Lewis, Jennifera,b; Thomassen, Ilonam; Connett, Robynn; Worth, Tinao; Vatine, Jean-Jacquesp,q; McCabe, Candida S.a,b

doi: 10.1097/j.pain.0000000000000866
Research Paper

Complex regional pain syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers, and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations. The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. “What is the clinical presentation and course of CRPS, and what factors influence it?” was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as follows: pain, disease severity, participation and physical function, emotional and psychological function, self-efficacy, catastrophizing, and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and 1 clinician-reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally.

Supplemental Digital Content is Available in the Text.An international consortium has developed a core outcome measurement set which will be advocated for all future complex regional pain syndrome clinical trials.

aCRPS Service, Royal United Hospitals NHS Foundation Trust, Bath, United Kingdom

bFaculty of Health and Applied Sciences, University of the West of England, Bristol, United Kingdom

cDepartment of Anesthesiology, VU University Medical Centre, Amsterdam, the Netherlands

dDepartment of Neurology, University Medical Centre Mainz, Mainz, Germany

eDepartment of Physical Medicine and Rheumatology, Balgrist University Hospital, Zurich, Switzerland

fDepartment of Anesthesiology, Vanderbilt University School of Medicine, Nashville, TN, USA

gPM&R and PTHMS, Northwestern University, Chicago, IL, USA

hHand Therapy Clinic, Regional Rehabilitation Program, Hamilton Health Sciences, Hamilton, ON, Canada

iCSSS Pierre Boucher, Longueuil, QC, Canada

jRheumatology Department, Royal Devon & Exeter Hospital, Exeter, United Kingdom

kOut-patient and Outreach Rehabilitation Service, Ottawa Hospital Rehabilitation Centre, Ottawa, ON, Canada

lDepartment of Neurology, Aarhus University Hospital, Aarhus, Denmark

mDutch National CRPS Patient Organization, Nijmegen, the Netherlands

nPatient Partner, Exeter, United Kingdom

oMarket Access, Grünenthal Ltd, Stokenchurch, United Kingdom

pRehabilitation Department, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

qCenter for Rehabilitation of Pain Syndromes, Reuth Rehabilitation Hospital, Tel Aviv, Israel

Corresponding author. Address: Royal National Hospital for Rheumatic Diseases, Upper Borough Walls, Bath BA1 1RL, United Kingdom. Tel.: 01225 465941; fax: 01225 473461. E-mail address: sharon.grieve1@nhs.net (S. Grieve).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.painjournalonline.com).

Received August 11, 2016

Received in revised form January 19, 2017

Accepted January 30, 2017

© 2017 International Association for the Study of Pain
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