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Table 4 Implementation of ASAS/OMERACTCore Outcome Set (SMARD) and specific instruments in each domain in trials evaluating interventions other than DMARD, biological
drugs or glucocorticoids
SMARD Control group (before 2001)
(n = 36)1
Implementation group (after 2001)
(n= 25)2
Performed
Reported separately (n, %)
-
-
-
Performed
(n, %)
23 (92.0)
Reported separately (n, %)
-
-
-
Assessment
Physical function 8 (22.9)
p value
¶
< 0.001
0.3
0.1
(n, %)
BASFI
Dougados-FI
HAQ 3(8.6)-0-
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 Fatigue*
32 (88.8)
16 (44.4) 30 (85.8) 28 (77.7) 0
2 (5.7) 5 (14.3) 21 (58.3) 3 (8.6) 2 (5.7) 1 (2.9) 12 (34.3) 24 (66.6) 25 (71.5) 18 (51.4) 6 (17.1)
30 (85.7)
-
29 (82.9) 27 (77.1) -
2 (5.7) 5 (14.3) -
3 (8.6) 2 (5.7) 1 (2.9) -
-
24 (68.6) -
4 (11.4)
24 (96.0)
5 (20.0) 24 (96.0) 23 (92.0) 13 (52.0) 13 (52.0) 14 (56.0) 5 (20.0) 18 (72.0) 14 (56.0) 14 (56.0) 7 (28.0) 17 (68.0) 22 (88.0) 9 (36.0) 21 (84.0)
15 (60.0)
-
15 (60.0) 23 (92.0) -
6 (24.0) 7 (28.0) -
10 (40.0) 7 (28.0) 6 (24.0) -
-
11 (50.0) -
6 (24.0)
0.1
0.2 0.001
5 (14.3) 3 (8.6)
22 (88.0) 2 (8.0)
¶ p values are for comparison between assessment performed in control and implementation group 1Intervention in these studies: NSAIDs (25), physical therapy (5) and miscellaneous (6)
2Intervention in these studies: NSAIDs (4), physical therapy (13), balneotherapy (5) and miscellaneous (3)
* If BASDAI was reported, we considered the following domains (fatigue, pain, stiffness and peripheral joint/enthuses) was performed although it was 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.
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