Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
The Assessment of SpondyloArthritis international Society (ASAS) has selected a core set of variables to include as standardized endpoints in clinical trials and clinical practice. These core sets received endorsement by OMERACT and specific measurement instruments to assess each of these domains have been chosen. The implementation of the ASAS/OMERACT core sets, though, has so far not been evaluated. The purpose of this systematic literature review, therefore, was to compare the usage of domains and instruments of the core-sets before and after the original publication.
To investigate how well the ASAS/OMERACT core sets for the outcome of ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions.
Methods:
A systematic literature search was performed in electronic databases looking for RCTs in patients with AS. Domains of outcome, and instruments belonging to them, for disease controlling antirheumatic therapy (DC-ART) and symptom modifying antirheumatic drugs (SMARD) were extracted. Results are reported for clinical trials published before (control trials) in comparison to those published 2 years after the publication of the core set (1 April 2001, implementation trials).
Results:
One hundred eight articles reporting results from 91 RCTs, and together including 11.174 patients, fulfilled the selection criteria for this project, and were included in the analysis. Forty-seven RCTs were considered ‘control trials’ and 44 were considered ‘implementation trials’. NSAID and conventional non-biological DMARD therapies were more often tested in the ‘control’ – than in the ‘implementation trials’. Biological DMARDs and physical therapy were more often tested in the ‘implementation trials’. The domains ‘physical function’, ‘pain’, ‘stiffness’, ‘peripheral joint/entheses’, ‘acute phase reactants’ and ‘fatigue’, as well as the instruments ‘BASFI’, ‘BASMI’, ‘CRP’ and ‘spine radiograph’ were more frequently addressed in the ‘implementation trials’ (Table 1).
Conclusion:
This systematic literature review suggests that the implementation of ASAS/OMERACT core set has been partly successful. The definition and dissemination of the core set measures for clinical trials in AS has indeed resulted in an improved usage of the endorsed domains and instruments.
References:
- van der Heijde D. J Rheumatol 1999;26:951-4
- Sieper J. Ann Rheum Dis 2009;68 (Suppl 2):ii1-44
Table 1 Usage of ASAS/OMERACT DCART Core Domains and instruments in trials evaluating interventions with DMARD, biologic or corticosteroids.
|
Assessment |
Control trials before 2001 (%) |
Implementation trials after 2001 (%) |
p value |
|
Physical function |
41.7 |
100 |
< 0.001 |
|
BASFI |
8.3 |
100 |
< 0.001 |
|
Dougados FI |
33.3 |
4.5 |
0.02 |
|
HAQ |
8.3 |
13.6 |
0.6 |
|
Pain |
91.7 |
100 |
0.2 |
|
Night |
33.3 |
45.5 |
0.5 |
|
Global |
91.7 |
100 |
0.2 |
|
Spinal mobility |
91.7 |
86.4 |
0.6 |
|
BASMI |
0 |
54.5 |
0.001 |
|
Spinal stiffness |
91.7 |
100 |
0.2 |
|
Patient global assessment |
66.7 |
81.8 |
0.3 |
|
Peripheral joint/entheses |
33.3 |
100 |
< 0.001 |
|
Joint count |
33.3 |
45.5 |
0.5 |
|
MASES |
0 |
9.1 |
0.3 |
|
Berlin |
0 |
4.5 |
0.4 |
|
Acute phase reactants |
83.3 |
95.5 |
0.2 |
|
CRP |
58.3 |
90.9 |
0.03 |
|
ESR |
83.3 |
59.1 |
0.2 |
|
Spine radiograph |
0 |
27.3 |
0.046 |
|
mSASSS |
0 |
18.2 |
0.1 |
|
BASRI |
0 |
13.6 |
0.2 |
|
Fatigue |
0 |
100 |
< 0.001 |
Disclosure:
W. Bautista-Molano,
None;
V. Navarro-Compán,
None;
R. Landewé,
None;
D. van der Heijde,
None.
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