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

Abstract

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.

Conflict of interest statement

Conflict of Interest Statement

Professor Bruehl reports grants from NIH, personal fees from Thar Pharmaceuticals, personal fees from Grunenthal, personal fees from Eli Lilly, grants from Reflex Sympathetic Dystrophy Syndrome Association, outside the submitted work. Professor R Perez has received government grants (Economic affairs, STW, ZonMw) and consultancy fees and has previously received research grants from Pfizer and Grünenthal. Professor C McCabe has previously received consultancy fees from GlaxoSmithKline and Grünenthal outside of this submitted work. Professor Birklein received grants from the German Research Foundation, unrestricted research support from Pfizer, Germany and Grünenthal, and consulting fees from Astellas and Eli Lilly, all outside the submitted work. Dr J Lewis has a National Institute for Health Research Clinical Lectureship. T Worth is an employee of Grunenthal Ltd.

Figures

Figure 1

Development of a core measurement set for CRPS clinical research studies