Instrument selection for the ASAS core outcome set for axial spondyloarthritis

Objectives: To define the instruments for the 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: i) Identifying candidate instruments using a sys...

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Detalles Bibliográficos
Autores: Navarro Compán, Victoria, Boel, Anne, Boonen, Annelies, Mease, Philip, Dougados, Maxime, Kiltz, Uta, Landewé, Robert, Baraliakos, Xenofon, Bautista Molano, Wilson, Chiowchanwisawakit, Praveena, Dagfinrud, Hanne, Fallon, Lara, Garrido Cumbrera, Marco, Gensler, Lianne, El-Zorkany, Bassel, Haroon, Nigil, Kwan, Yu Heng, Machado, Pedro, Maksymowych, Walter P., Molto, Anna, Peyrecave, Natasha de, Poddubnyy, Denis, Protopopov, Mikhail, Ramiro, Sofía, Song, In-Ho, Weely, Salima van, Heijde, Désirée van der
Tipo de recurso: artículo
Estado:Versión enviada para evaluación y publicación
Fecha de publicación:2023
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/159775
Acceso en línea:https://hdl.handle.net/11441/159775
https://doi.org/10.1136/annrheumdis-2022-222747
Access Level:acceso abierto
Palabra clave:Axial spondyloarthritis
Outcome
Instrument
Core outcome set
Descripción
Sumario:Objectives: To define the instruments for the 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: i) Identifying candidate instruments using a systematic literature review; ii) Reducing the list of candidate instruments by the working group, iii) Assessing the instruments’ psychometric properties following OMERACT Filter 2.2, iv) Selection of the core instruments by the working group; v) Voting and endorsement by ASAS. Results: The updated core set for axSpA includes seven instruments for six domains that are mandatory for all trials: ASDAS and NRS patient global assessment of disease activity; NRS total back pain; average NRS of duration and severity of morning stiffness; NRS fatigue; BASFI; and ASAS health index. There are 9 additional instruments considered mandatory for disease modifying drugs (DMARDs) trials: MRI activity SPARCC sacroiliac joints and SPARCC spine, uveitis, IBD and psoriasis assessed as recommended by ASAS, 44 swollen joint count, MASES, dactylitis count, and mSASSS. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for DMARD-properties. Furthermore, 11 additional instruments were also endorsed by ASAS to be used in axSpA trials on top of the core instruments. Conclusions: The previous core instrument set has been updated and endorsed for the use in all axSpA trials. The selection of the instruments for the ASAS-OMERACT core domain set complete the update of the core outcome set for axSpA.

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