Quality of life and outcome measures in vasculitis

The primary vasculitides are a life- and organ-threatening set of diseases with a course often marked by alternating periods of active vasculitis and remission. As opposed to clinical trials within the fields of cardiology and oncology, where treatment interventions have been tested in a controlled fashion using hard ‘end’ points, such as mortality and hospitalisation, surrogate ‘end’ points have to be used in randomised clinical trials (RCTs) in vasculitis. Given the multisystem nature of the vasculitides, their heterogeneous clinical presentations and rarity, outcome-measure development is a challenging task.The objective of this review is to summarise the data on how health-related quality of life is affected by vasculitis, to describe the currently used outcome measures and provide insight into future outcome-measures development. The primary focus is on anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis, where the most data exist and outcome measure development is farthest along. Data on other vasculitides will also be briefly discussed.