Protocol: An e-Delphi study to define internationally agreed core clinical outcome measures for Complex Regional Pain Syndrome clinical research studies

Llewellyn, Alison; Birklein, Frank; Brunner, Florian; Goebel, Andreas; Grieve, Sharon; Buckle, Lisa; McCabe, Candy

Abstract

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[1]. In response, the COMPACT consortium published recommendations for a minimum core set of patient-reported outcome measures[2] 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.

Method:
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[3], 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.

Conclusions
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.

References

1. Grieve, S., Jones, L., Walsh, N., and McCabe, C., 2016. What outcome measures are commonly used for Complex Regional Pain Syndrome clinical trials? A systematic review of the literature. European Journal of Pain, 20(3), pp.331-340.

2. Grieve, S., Perez, R.S., Birklein, F., Brunner, F., Bruehl, S., Harden, N., Packham, T., Gobeil, F., Haigh, R., Holly, J. and Terkelsen, A., 2017. Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT). Pain, 158(6), p.1083.

3. McMillan, S.S., King, M., Tully, M.P., 2016. How to use the Nominal Group and Delphi techniques. International Journal of Clinical Pharmacy, 38(3), pp.655–662.

• Presentation Conference Type: Poster
• Conference Name: UWE Centre for Health and Clinical Research Showcase Conference
• Start Date: Apr 5, 2019
• End Date: Apr 5, 2019
• Acceptance Date: Feb 27, 2019
• Publicly Available Date: Jun 6, 2019
• Peer Reviewed: Not Peer Reviewed
• Keywords: protocol, Delphi, clinical outcome measures, Complex Regional Pain Syndrome
• Public URL: https://uwe-repository.worktribe.com/output/851676
• Additional Information: Title of Conference or Conference Proceedings : University of the West of England Centre for Health and Clinical Research Showcase Conference