Instrument selection for the ASAS core outcome set for axial spondyloarthritis

Abstract

ObjectivesTo define the instruments for the Assessment of SpondyloArthritis international Society–Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).MethodsAn international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments’ psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS.ResultsThe updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments.ConclusionsThe selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials.

Exploring physical function and physical activity in axial spondyloarthritis: Beyond clinical remission or low disease activity

“…A patient-reported history of hip involvement was present in 95 (26.8%) patients. The median CRP level was 0.45 (0.18-1.27) and the median ESR level was 6 (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14). Further, the median ASDAS-CRP was 1.14 (0.75-1.61), which indicates an inactive to low DA.…”

“…In this observational cross-sectional study, 355 patients with axSpA were included in our study. The median age of patients was 32 years old (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38), 69.9% were male, and the median disease duration was 7 years (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). The positive rate of HLA-B27 was 81%.…”

“…6 HRQoL is a multidimensional evaluation index including sleep, exercise, fatigue, energy, mobility, social life, academic work, and mental health. Many HRQoL-related complex evaluation tools have been used in axSpA-related clinical trials, 6,7 thus leading to concordant results. Based on the current recommendation by the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set, the Assessment of Spondyloarthritis International Social Health Index (ASAS-HI), the Short Form 36-Item Health Survey (SF-36), and the Bath Ankylosing Spondylitis Functional Index (BASFI) were suggested as the mandatory instrument for HRQoL of axSpA.…”

“…Based on the current recommendation by the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set, the Assessment of Spondyloarthritis International Social Health Index (ASAS-HI), the Short Form 36-Item Health Survey (SF-36), and the Bath Ankylosing Spondylitis Functional Index (BASFI) were suggested as the mandatory instrument for HRQoL of axSpA. 7 The Global Physical Activity Questionnaire (GPAQ) was a simplified and easy index developed for PA and had been widely applied in axSpA worldwide. 8 In addition, various factors on disease progression and prognosis, including gender differences, 9 human leukocyte antigen B27 (HLA-B27), 10 and hip involvement, 11 which need to be considered when evaluating HRQoL and achieving comprehensive remission in axSpA patients.…”

Greetings from the editor 2023/2

“…The current issue contains a number of Recommendations and Points to Consider that have been developed by EULAR task forces17 18 and other groups of investigators 19–21. Developing such publications is a major endeavour within EULAR and the international rheumatological community and serve to advance our field by bringing together state-of-the-art information or updates to similar previous activities.…”