Page 114 - SPONDYLOARTHRITIS IN COLOMBIA -

ABSTRACT
Objective: To investigate how well the ASAS/OMERACT core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions.
Methods: A systematic literature search was performed up to June 2013 looking for RCTs in patients with axial SpA (AS and non-radiographic axial SpA). The assessed domains and instruments belonging to the core sets for disease controlling anti-rheumatic therapy (DC-ART) and symptom modifying anti-rheumatic drugs (SMARD) were extracted. Results were reported separately for those trials published until 2 years after the publication of the core set (1 April 2001; ‘control trials’), and those trials published at least two years after the publication date (‘implementation trials’). Results: One hundred twenty three articles from 99 RCTs were included in the analysis, comparing 48 ‘control trials’ and 51 ‘implementation trials’. Regarding DC-ART core set, the following domains were significantly more frequently assessed in the ‘implementation group’ in comparison to the ‘control group’, ‘physical function’ (100% vs 41.7%; p0.001), ‘peripheral joints/entheses’ (100% vs 33.3%; p0.001) and ‘fatigue’ (100% vs 0%; p0.001). Three instruments were significantly more used in the ‘implementation group’: BASFI (100% vs 8.3%; p=0.001), CRP (92.3% vs 58.3%; p=0.01) and BASMI (53.8% vs 0%; p=0.001).
Regarding SMARD core set domains, physical function (92% vs 23%; p0.001) and fatigue (84% vs 17%; p0.001), as well as the instruments BASFI (88% vs 14%; p0.001) and BASMI (52% vs 0%; p0.001), increased significantly in the ‘implementation group’. Twenty percent of trials from the ‘implementation group’ but none from the ‘control group’ included all domains of the core-set. Conclusion: In conclusion, this study provides evidence for the implementation of the ASAS/OMERACT core-set in RCTs of both DC-ART and SMARD. This applies to the use of the domains and to a lesser extent to the specific instruments.
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