Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT).
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.
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.
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D002986:Clinical Trials as Topic / Q000592:standards*; D020918:Complex Regional Pain Syndromes / Q000175:diagnosis* / Q000628:therapy*; D019317:Evidence-Based Medicine / Q000592:standards; D006801:Humans; D038622:Internationality; D017063:Outcome Assessment, Health Care / Q000592:standards*; D010147:Pain Measurement / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity