Background Juvenile dermatomyositis (JDM) is a rare disease associated with significant morbidity. International collaboration is essential to collect sufficient patients for research. This requires standardised data collection suitable for both clinicians and research. A provisional data set has been produced from existing clinical registries1.
Objectives To develop the provisional dataset into a consensus-approved minimum core dataset tested in a wider setting, with international agreement.
Methods A two-stage Delphi-process will engage the opinion of a large number of key stakeholders by e-mail distribution via established international paediatric rheumatology and myositis organisations. Consensus that each outcome should be included in the minimal dataset is defined by ≥70% of participants scoring “critical for decision making”, but all outcomes will be considered. This, together with a formalised patient/parent participation process will help inform a consensus meeting of international experts. Agreement of ≥80% consensus of all attendees is required for each variable to be included. The resulting proposed minimal dataset will be tested for feasibility within existing database infrastructures. The developed minimal dataset will be sent to all internationally representative collaborators for final comment.
Results The proposed minimal dataset from a consensus meeting of 17 internationally representative myositis experts in March 2015 will be available for presentation. Data from Delphi round 1 (n=171 responses) and round 2 will be used to define the opinion of clinicians representative of paediatric rheumatology/ myositis organisations. Patient and parent opinion will be collated from questionnaires to help inform the consensus process.
Conclusions An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal 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 minimum core dataset could be rapidly incorporated into national and international collaborative efforts.
McCann LJ, Arnold K, Pilkington CA, Huber AM, Ravelli A, Beard L, Beresford MW, Wedderburn LR, UK Juvenile Dermatomyositis Research Group (JDRG). Developing a provisional, international Minimal Dataset for Juvenile Dermatomyositis: for use in clinical practice to inform research. 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.
Disclosure of Interest None declared
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.