Core Outcome Measures in Effectiveness Trials

Proposal for the update of the ASAS-OMERACT core set for ankylosing spondylitis

General Information

Summary:
INTRODUCTION: The current core set for ankylosing spondylitis exists for about 20 years with only very minor adaptations since then. Due to all the advances occurred in this field during the last decades, it is needed to update this core set.
OBJECTIVE: To update the ASAS-OMERACT core set for ankylosing spondylitis.
METHODS: The steering groupd already defined the scope of the update. This will be defined by: disease (axial spondyloarthritis), age (18-100 years old), type of intervention (drugs and physical intervention), scenarios: i) disease modify antirheumatic drugs (DMARDs), ii) symptom modifying antirheumatic drugs (SMARD), and iii) clinical record keeping for studies; and i) evaluation at each visit, ii) specific evaluation before and during DMARD or non-pharmacological therapy; and iii) annual systematic review for clinical practice.
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.
RESULTS: The ASAS core set for ankylosing spondylitis will be updated into
ASAS core set for axial spondyloarthritis and will be later disseminated

Contributors:
INTRODUCTION: The current core set for ankylosing spondylitis exists for about 20 years with only very minor adaptations since then. Due to all the advances occurred in this field during the last decades, it is needed to update this core set.
OBJECTIVE: To update the ASAS-OMERACT core set for ankylosing spondylitis.
METHODS: The steering groupd already defined the scope of the update. This will be defined by: disease (axial spondyloarthritis), age (18-100 years old), type of intervention (drugs and physical intervention), scenarios: i) disease modify antirheumatic drugs (DMARDs), ii) symptom modifying antirheumatic drugs (SMARD), and iii) clinical record keeping for studies; and i) evaluation at each visit, ii) specific evaluation before and during DMARD or non-pharmacological therapy; and iii) annual systematic review for clinical practice.
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.
RESULTS: The ASAS core set for ankylosing spondylitis will be updated into
ASAS core set for axial spondyloarthritis and will be later disseminated.

Chair: Désirée van der Heijde, Leiden University Hospital, Leiden, the Netherlands
Co-chair: Victoria Navarro-Compán, University Hospital La Paz, Madrid, Spain
Collaborators:
- Annelies Boonen, Maastricht University Medical Centre, The Netherlands; Caphri Research Institute, Maastricht University, Maastricht, The Netherlands.
- Maxime Dougados, Paris Descartes university, department of rheumatology, hôpital Cochin; INSERM (UU1153), clinical epidemiology and biostatistics, PRES Sorbonne, Paris, France.
- Uta Kiltz, Rheumazentrum Ruhrgebiet, Herne, Germany.
- Robert Landewé, Amsterdam Rheumatology and Immunology Center, Amsterdam; Department of Rheumatology, Zuyderland Medical Center, Heerlen, the Netherlands

Further Study Information

Current Stage:
Ongoing
Date:
February 2018 - 2021
Funding source(s):
ASAS (Assessment of SpondyloArthritis International Society) group

Health Area

Disease Category
Rheumatology

Disease Name
Ankylosing spondylitis (AS)
Axial spondyloarthritis

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Drug
Physical

Method(s)

Consensus meeting
Delphi process
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.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Regulatory agency representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice
Recommended outcome measures (measurement)

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