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INTRODUCTION
Spondyloarthritis (SpA) refers to a group of chronic inflammatory rheumatic disorders, and ankylosing spondylitis (AS) is considered the prototype of this group 1. In an attempt to bring more homogeneity in outcome assessment in AS and facilitate the conduct of clinical trials, the Assessment of SpondyloArthritis international Society (ASAS) has selected core sets of variables to include as standardized end points in clinical trials and clinical practice. These core sets have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group 2.
ASAS has defined three scenarios for core-sets: 1) disease controlling anti-rheumatic therapy (DC- ART); 2) symptom modifying anti-rheumatic drugs (SMARD) and physical therapy; and 3) clinical record keeping. The domains selected for all three core-sets include ‘physical function’, ‘pain’, ‘spinal mobility’, ‘stiffness’, ‘fatigue’ and ‘patient’s global assessment’. The core-sets DC-ART and clinical record keeping further include ‘peripheral joints/entheses’ and ‘acute phase reactants’ and the core-set for DC-ART includes ‘radiographs of the spine’. In addition, specific instruments to assess each of these domains were chosen 3.
It has been postulated that the definition of core-sets and the choice of appropriate instruments, which were effective in 1999 4, have importantly facilitated the development and successful registration of new treatments in AS. However, it is difficult to prove if, and to what extent, the core-sets have contributed to this. An indirect indication for the value of core-sets in the development of new treatments could be the demonstration that the usage of domains and instruments has measurably increased after the description of the core-sets (implementation). In rheumatoid arthritis, a recent study found evidence of uptake of the core set 5.
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