Jdm definition7/25/2023 Table 1 gives the six core variables validated previously and the respective tools for their assessment. The overall methodology of this phase of the project was based on a methodological framework used successfully in previous work in rheumatoid arthritis ( 1) juvenile arthritis ( 2– 4), juvenile SLE ( 8– 10), and inflammatory myopathies ( 13). The first two phases of the project, previously published ( 8 19), led to the development of a prospectively evidence-based validated core set of six variables for the evaluation of response to therapy that is now known as the provisional PRINTO/American College of Rheumatology/European League Against Rheumatism Disease Activity Core Set for the evaluation of response to therapy in JDM (PRINTO/ACR/EULAR JDM core set) ( Table 1). National Institutes of Health, undertook in year 2000 a multinational effort to develop, and promulgate a core set of outcome variables and a definition of clinical improvement to evaluate response to therapy in patients with JDM and in juvenile SLE. To help standardize the conduct and reporting of juvenile dermatomyositis (JDM) clinical trials and enhance identification of new therapeutic agents, the Pediatric Rheumatology International Trials Organization (PRINTO) ( 18), in collaboration with the Pediatric Rheumatology Collaborative Study Group (PRCSG) and with the support of the European Union and the U.S. Therefore, all outcome measures developed for adults need to be subjected to a critical evidence-based evaluation of their measurement properties in children and adolescents. Although children/adolescents and adults with DM share many signs and symptoms of disease, they differ in the clinical features and outcome ( 15– 17), and treatment approaches should consider the peculiarities of juvenile patients as well as their longer life expectancy. However, until now these proposals have not yet been formally validated in the context of external prospective pediatric studies or clinical trials. The International Myositis Outcome Assessment and Clinical Studies (IMACS) group proposed a core set of outcome variables for inclusion in clinical trials in adult and juvenile inflammatory myopathies and defined the degree of change in each core set variables that is clinically meaningful, as well as guidelines for performing clinical trials ( 11– 14). This work led to establishment of definition of response in rheumatoid arthritis ( 1), juvenile arthritis ( 2– 4), systemic lupus erythematosus (SLE) both in adults ( 5– 7) and children ( 8– 10). The standardization of the criteria to evaluate improvement in rheumatic diseases has been a goal of numerous research groups.
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