Objectives To define the instruments for the Assessment of SpondyloArthritis international Society–Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).
Methods An 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.
Results The 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.
Conclusions The 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.
Navarro-Compán V, Boel A, Boonen A, Mease PJ, Dougados M, Kiltz U, Landewé RBM, Baraliakos X, Bautista-Molano W, Chiowchanwisawakit P, Dagfinrud H, Fallon L, Garrido-Cumbrera M, Gensler L, ElZorkany BK, Haroon N, Kwan YH, Machado PM, Maksymowych W, Molto A, de Peyrecave N, Poddubnyy D, Protopopov M, Ramiro S, Song IH, van Weely S, van der Heijde D.
Disease Category: Rheumatology
Disease Name: Axial spondyloarthritis, Ankylosing spondylitis (AS)
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Drug, Physical
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- Recommendations for outcome measures (measurement/how)
- Semi structured discussion
- Systematic review
An international working group representing rheumatologists actively working in axial spondyloarthritis, patients with axial spondyloarthritis, health professionals and pharmaceutical industry will be created to update the core set. First, an extended list of outcomes through a systematic literature review will be identified. Second, this list will be reduced by mean of Delphi method and with a consensus meeting of the working group. Third, the final voting of the outcomes will take place in a plenary sesión . Finally, after the final outcomes core set will be approved, a similar process will be follow in order to select the instruments for each outcome.