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Development of a Core Set of Domains for Data Collection in Cohorts of Patients with Ankylosing Spondylitis Receiving Anti-Tumor Necrosis Factor-α Therapy

JANE ZOCHLING, JOACHIM SIEPER, DÉSIRÉE van der HEIJDE, and JÜRGEN BRAUN, on behalf of the Assessment in Ankylosing Spondylitis International Working Group

ABSTRACT.

Objective.
To create a core set of measurement concepts for use in the creation and maintenance of anti-tumor necrosis factor-a patient registries in ankylosing spondylitis (AS).

Methods. A Delphi-based approach was used to identify elements that best identify a patient's clinical state, disease progression, and potential drug-related toxicities. Decision-making was based on systematic literature reviews and clinical experience and expertise.

Results. A core set of measurement domains was defined including disease activity and physical function outcomes. Comparison with domains used in existing AS registries showed excellent agreement with current practice.

Conclusion. This core set is a basis for data collection across AS populations. (J Rheumatol First Release May 1 2008)

Key Indexing Terms:

ANKYLOSING SPONDYLITIS
TUMOR NECROSIS FACTOR-a INHIBITORS
REGISTRIES


From the Menzies Research Institute, Hobart, Australia; Charité Hospital, Berlin, Germany; Leiden University Medical Center, Leiden, The Netherlands; and Ruhr University and Rheumazentrum-Ruhrgebiet, Herne, Germany.

J. Zochling, MBBS, PhD, Research Fellow, Menzies Research Institute; J. Sieper, MD, Professor of Rheumatology, Charité Hospital Berlin; D. van der Heijde, MD, Professor of Rheumatology, Leiden University Medical Center; J. Braun, MD, Professor of Rheumatology, Ruhr University, Rheumazentrum-Ruhrgebiet.

Address reprint requests to Prof. J. Braun, Rheumazentrum-Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne, Germany. E-mail: j.braun@rheumazentrum-ruhrgebiet.de

Accepted for publication January 7, 2008.



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