Development of a core set of domains for data collection in cohorts of patients with ankylosing spondylitis receiving anti-tumor necrosis factor-alpha therapy.

Abstract

To create a core set of measurement concepts for use in the creation and maintenance of anti-tumor necrosis factor-alpha patient registries in ankylosing spondylitis (AS). 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. 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. This core set is a basis for data collection across AS populations.