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Data collection
The same two authors extracted the data from the included studies independently according to a predetermined and standardised outcome review matrix. Differences regarding data extraction were resolved by re-review and consensus discussion by the two primary reviewers. General data extracted included information about first-author, publication year, study start date and end date, study duration, interventions, total number of patients randomized and number of AS/SpA patients and primary outcome. The presence/absence of reported domains collected were: ‘physical function’, ‘pain’, ‘spinal mobility’, ‘stiffness’, ‘fatigue’, ‘patient global assessment’, ‘peripheral joints/entheses’, ‘acute phase reactants’ and ‘spine radiographs’.
All different instruments and outcomes described in each study were extracted and included in the analysis. The instruments that were noted for each domain were those included in the ASAS core set, as well as additional instruments that were considered belonging to the same domains. Table1 describes the domains and the instruments according to the ASAS/OMERACT core-set, as they were published originally in 1999 and with a minor modification to add additional instruments in 2009 2, 3.
If the composite measure BASDAI (Bath ankylosing spondylitis disease activity index) was reported, we considered the following domains also as performed: fatigue, pain, stiffness and peripheral joint/entheses, even though these were not separately reported. If the BASMI (Bath ankylosing spondylitis metrology index) was reported, we considered the domain spinal mobility as well as the instruments lateral spinal flexion, tragus-to-wall distance, modified Schober’s test, Intermalleolar distance and cervical rotation also as performed, regardless of whether they were separately reported. Additionally, measures for the evaluation of treatment response were
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