Cryopyrin-associated periodic syndromes : development of a patient-reported outcomes instrument to assess the pattern and severity of clinical disease activity
2008
ABSTRACTObjective: Development of an instrument for characterization of symptom patterns and severity in patients with cryopyrin-associated periodic syndromes (CAPS).Methods: Two generations of daily health assessment forms (DHAFs) were evaluated in this study. The first-generation DHAF queried 11 symptoms. Analyses of results obtained with that instrument identified five symptoms included in a revised second-generation DHAF that was tested for internal consistency and test–retest reliability. This DHAF was also assessed during the initial portion of a phase 3 clinical study of CAPS treatment.Results: Forty-eight CAPS patients provided data for the first-generation DHAFs. Five symptoms (rash, fever, joint pain, eye redness/pain, and fatigue) were included in the revised second-generation DHAF. Symptom severity was highly variable during all study phases with as many as 89% of patients reporting at least one symptom flare, and percentages of days with flares reaching 58% during evaluation of the second-gen...
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