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

Harden, R. Norman; Grieve, Sharon; Perez, Roberto S.G.M.; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden, Mark; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terklesen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connet, Robyn; Worth, Tina; Vatine, Jean-Jaques; McCabe, Candida S.

Abstract

© 2017 by the International Association for the Study of Pain. 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.

Citation

Harden, R. N., Grieve, S., Perez, R. S., Birklein, F., Brunner, F., Bruehl, S., …McCabe, C. S. (2017). Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT). PAIN, 158(6), 1083-1090. https://doi.org/10.1097/j.pain.0000000000000866

• Journal Article Type: Article
• Acceptance Date: Jan 30, 2017
• Online Publication Date: Jun 1, 2017
• Publication Date: Jun 1, 2017
• Deposit Date: Feb 3, 2017
• Publicly Available Date: Feb 4, 2018
• Journal: Pain
• Print ISSN: 0304-3959
• Electronic ISSN: 1872-6623
• Publisher: Lippincott, Williams & Wilkins
• Peer Reviewed: Peer Reviewed
• Volume: 158
• Issue: 6
• Pages: 1083-1090
• DOI: https://doi.org/10.1097/j.pain.0000000000000866
• Keywords: outcome measures, core data set, complex regional pain syndrome
• Public URL: https://uwe-repository.worktribe.com/output/899451
• Publisher URL: http:dx.doi.org/10.1097/j.pain.0000000000000866