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to evaluate ‘physical function’ in the ‘implementation group’ was the ‘BASFI’, in many trials more than one instrument was used to evaluate this domain.
Table 3 Implementation of ASAS/OMERACT Core Outcome Set (DC-ART) and specific instruments in each domain in trials evaluating interventions with DMARDs, biological drugs or glucocorticoids.
DC-ART
Assessment Physical function
BASFI Dougados-FI HAQ
Pain*
Night
Global*
Spinal mobility**
BASMI
Cervical rotation** Lateral spinal flexion** Schober
Modified Schober** Intermalleolar distance** Tragus to wall distance** Occiput to wall distance Chest expansion
Spinal stiffness*
Patient global assessment Peripheral Joints/entheses*
Joint count MASES Berlin Index
Acute phase reactants
CRP
ESR
Spine radiograph
mSASSS
BASRI
Fatigue*
Control group (before 2001) (n = 12)1
Implementation group (after 2001)
(n= 26)2
Performed
(n, %)
5 (41.7)
1 (8.3) 4 (33.3) 1 (8.3) 11 (91.7) 4 (33.3) 11 (91.7) 11 (91.7) 0
2 (16.7) 0
7 (58.3) 4 (33.3) 0
0
4 (33.3) 10 (83.3) 11 (91.7) 8 (66.7) 4 (33.3)
4 (33.3) 0
0
10 (83.3) 7 (58.3) 10 (83.3) 0
0
0
0
Reported separately (n, %)
-
-
-
-
11 (91.7) -
11 (91.7) 11 (91.7) -
2 (16.7) 0
-
4 (33.3) 0
0
-
-
11 (91.7) -
4 (33.3)
- - - - - - - - - 0
Performed
(n, %)
26 (100)
26 (100) 1 (3.8) 4 (15.4) 26 (100) 11 (42.3) 26 (100) 21 (80.8) 14 (53.8) 14 (53.8) 15 (57.7) 8 (30.8) 18 (69.2) 14 (53.8) 15 (57.7) 7 (26.9) 12 (46.2) 26 (100) 16 (61.4) 26 (100)
11 (42.3) 4 (15.4) 1 (3.8) 25 (96.2) 24 (92.3) 13 (50.0) 6 (23.1) 4 (15.4) 3 (11.5) 26 (100)
Reported separately (n, %)
-
-
-
-
19 (73.1) -
19 (73.1) 21 (80.8) -
4 (15.4) 5 (19.2)
-
5 (19.2) 4 (15.4) 5 (19.2)
-
-
15 (57.7) -
14 (53.8)
-
-
-
-
-
-
-
-
-
7 (26.9)
p value
¶
< 0.001
0.3 0.4
0.1
0.8
< 0.001
0.2 0.07 < 0.001
¶ p values are for comparison between assessment performed in control and implementation group
1Intervention in these studies: DMARDs (10) and glucocorticoids (2)
2Intervention in these studies: DMARDs (3) and biological drugs (23)
* If BASDAI was reported, we considered the following domains (fatigue, pain, stiffness and peripheral joint/entheses) were performed although these were not separately reported.** If BASMI was reported, we considered this domain (spinal mobility) and the following instruments (lateral spinal flexion, tragus to wall distance, modified Schober, Intermalleolar distance and cervical rotation) were performed although these were not separately reported. DC-ART, disease controlling anti-rheumatic therapy; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, linear definition of the Bath Ankylosing Spondylitis Metrology Index, CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; mSASSS, modified Stoke Ankylosing Spondylitis Spine Score; MASES, Maastricht Ankylosing Spondylitis Enthesis; BASRI, Bath Ankylosing Spondylitis Radiology Index
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