Background & objectives:
Complex Regional Pain Syndrome (CRPS) is a severe chronic pain condition characterised by a wide range of sensory, motor and autonomic abnormalities, usually in a single limb. CRPS clinical studies have historically used a diverse range of outcome measures to capture the multi-dimensional nature of the condition, however this has hindered the meaningful comparison and pooling of data. In response, the COMPACT consortium published recommendations for a minimum core set of patient-reported outcome measures and has established an international registry to collect and manage these data. The current study aims to extend the work of the COMPACT consortium by using an electronic Delphi process to develop a complementary set of clinical outcome measures.
From a systematic literature review, and subsequent workshop with clinicians and academics, a list of clinical outcomes has been developed for potential inclusion in a core clinical outcome set. In round 1 of the e-Delphi study, CRPS clinicians and researchers internationally will be asked to rate each outcome in relation to its relevance to the question: “What is the clinical presentation and course of CRPS, and what factors influence it?” Free text comments will also be elicited. In round 2, respondents will be presented with their individual ratings, the median group ratings for each item, and anonymised free-text comments. Respondents will be asked to re-rate in the light of this information. Outcomes with a final group median score of ≥ 7, as agreed by 75% of the study group, will be considered the draft ‘core clinical outcome measurement set’. This will be discussed by members of the COMPACT consortium to determine the final core set.
Findings from the study will inform the final combined set of patient-reported and clinical outcome measures which will be advocated for use in all CRPS clinical trials.
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