TY - JOUR
T1 - Instrument selection for the ASAS core outcome set for axial spondyloarthritis
AU - Navarro-Compán, Victoria
AU - Boel, Anne
AU - Boonen, Annelies
AU - Mease, Philip J.
AU - Dougados, Maxime
AU - Kiltz, Uta
AU - Landewé, Robert B. M.
AU - Baraliakos, Xenofon
AU - Bautista-Molano, Wilson
AU - Chiowchanwisawakit, Praveena
AU - Dagfinrud, Hanne
AU - Fallon, Lara
AU - Garrido-Cumbrera, Marco
AU - Gensler, Lianne
AU - Elzorkany, Bassel Kamal
AU - Haroon, Nigil
AU - Kwan, Yu Heng
AU - MacHado, Pedro M.
AU - Maksymowych, Walter
AU - Molto, Anna
AU - de Peyrecave, Natasha
AU - Poddubnyy, Denis
AU - Protopopov, Mikhail
AU - Ramiro, Sofia
AU - Song, In-Ho
AU - van Weely, Salima
AU - van der Heijde, D. sirée
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - outcome and process assessment, health care
KW - outcome assessment, health care
KW - spondylitis, ankylosing
UR - http://www.scopus.com/inward/record.url?scp=85132403417&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/annrheumdis-2022-222747
DO - https://doi.org/10.1136/annrheumdis-2022-222747
M3 - Article
C2 - 35680390
SN - 0003-4967
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
M1 - heartjnl-2022-222747
ER -