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The impact on the individual patient of specific clinical aspects of scleroderma depends on the duration and stage of illness as well as the interplay among coexisting clinical problems. Thus, as with other multisystem rheumatic diseases, it is difficult to quantify the level of illness in a specific patient with scleroderma, especially if one focuses only on end-organ damage and mortality. The true impact of scleroderma on a patient's lifestyle, functional capacity, and emotional well-being is not well measured by any of the clinical and laboratory parameters traditionally used in the assessment of patients with this disease. This article describes the work to date on the development and validation of instruments to measure these health outcomes in patients with scleroderma and their incorporation into clinical treatment trials.