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RCTs evaluating DMARDs, biological drugs or systemic glucocorticoids
Domains
The usage of the domains and instruments recommended for the DC-ART scenario is shown in Table 3. The domains ‘patient global assessment’ was assessed in about 60% of the trials (61% vs 67%; p=0.8) in ‘implementation’ and ‘control group’. The domain ‘spine radiograph’ was only assessed in the implementation group (23% vs 0%; p=0.07). Three domains were substantially more frequently represented in the ‘implementation group’ as compared to the ‘control group’ and were even assessed in all trials of the implementation group: ‘physical function’ (100% vs 42%; p0.001), ‘peripheral joints/entheses’ (100% vs 33%; p0.001) and ‘fatigue’ (100% vs 0%; p0.001). Four domains also show a high level of usage in the ‘implementation group’ but were already high in the ‘control group’: ‘pain’ (100% vs 92%), ‘spinal mobility’ (81% vs 92%), ‘spinal stiffness’ (100% vs 92%) and ‘acute phase reactants’ (96% vs 83%).
Instruments
A number of instruments had a low usage in the trials of both the ‘implementation group’ and ‘control group’: ‘pain night’ (42% vs 33%) and ‘joint count’ (42% vs 33%). With respect to the instrument ‘joint count’ the number of joints assessed was very different ranging from 22 to 70 joints. Three instruments were substantially more frequently reported in the ‘implementation’ vs the ‘control group’: ‘BASFI’ (100% vs 8%), ‘BASMI’ (54% vs 0%) and ‘CRP’ (92% vs 59%). The domain ‘pain global’ was frequently used in both groups (100% vs 92%). Concerning ‘radiographic progression’, two instruments -‘mSASSS’ and ‘BASRI’- were used, but were only reported in ‘implementation trials’. The instruments ‘MASES’ and ‘Berlin’, both for the domain ‘peripheral joint/entheses’, were evaluated only after 2001. Although the most commonly selected instrument
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