Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Juvenile dermatomyositis (JDM) is a rare disease. International collaboration is essential for scrutiny of sufficient patient numbers. We aim to develop a core set of data for all clinicians/ researchers to collect in a standardized way, with international agreement.
Methods: Comparing variables in existing clinical registries led to a provisional minimal dataset.1A two-stage e-mail Delphi-process engaged the opinion of a large number of key stakeholders via established international paediatric rheumatology/ myositis organizations. Consensus that each outcome should be included in the dataset was defined by ≥70% of participants scoring ‘critical for decision making’. This, together with a formalized patient / parent participation process (ongoing) informed a consensus meeting of internationally representative myositis experts. Nominal group technique was used, with agreement of ≥80% consensus required for each variable to be included. The resulting dataset will be tested for feasibility within existing databases and sent to all internationally representative collaborators for final comment.
Results: Delphi responses from healthcare professionals (n=181 in round 1, 146 in round 2; 12% attrition), patients (n=14) and parents (n=20) were used to inform a consensus meeting of experts. The expert group (n=18) determined the need to include a measure of improvement /worsening of disease as well as binary documentation (feature ‘present / absent’). A visual analogue scale (VAS) was thus included for each major domain. 74 variables were included in the proposed dataset (Table 1 & 2) with further damage items under consideration. ‘Optimal dataset’ replaced the term ‘minimal dataset’. The dataset will be developed further after testing accuracy of data capture in clinical practice and analyzing additional patient/parent questionnaires.
Conclusion: An internationally agreed optimal dataset has the potential to significantly enhance collaboration, provide a standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. The final approved core dataset could be rapidly incorporated into national/international collaborative efforts.
References: 1. McCann LJ et al. Pediatric Rheumatology 2014. 12: 31
Acknowledgements: We wish to thank all collaborative groups including Euromyositis, JDRG, IMACS, CARRA, PRINTO, PReS, COMET, OMERACT, NIHR Clinical Studies Group consumer representatives, BSPAR Parent Group, NIHR Young Person’s Advisory Group, UK JDM Young Person’s Group, Cure JM, Myositis UK. Funding body: Arthritis Research UK.
To cite this abstract in AMA style:McCann LJ, Wedderburn LR, Pilkington C, Huber AM, Ravelli A, Kirkham J, Williamson P, Beresford MW. Development of an Internationally Agreed Minimal Dataset for Juvenile Dermatomyositis (JDM) for Clinical and Research Use [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/development-of-an-internationally-agreed-minimal-dataset-for-juvenile-dermatomyositis-jdm-for-clinical-and-research-use/. Accessed November 22, 2019.
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