Background Rheumatology is embarking on a fundamental redesign of rheumatic disease care. It became mandatory not only to recognize disease activity core set data, but also the risks for other co-morbidities associated with the disease. Measurement of patient reported outcomes have become critical in both standard clinical practice and long term observational studies. Objectives to assess validity; reliability and responsiveness to change of a patient self-reported outcome measures (PROMs) questionnaire which can assess construct outcome measures of SLE patients. Methods The PROMs was conceptualized based on frameworks used by the WHO Quality of Life tool, as well as the PRO measurement information system (PROMIS). Cognitive interviews were conducted with 36 SLE patients (diagnosed according to ACR criteria), with a range of severity and disease activity to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of physicians, nurses, and health educators, in addition to clinometric and psychometric methods. The latter included Rasch and internal consistency reliability analyses. The questionnaire includes assessment for functional disability, quality of life, VAS for pain, global status, fatigue, duration of morning stiffness, SLE manifestations, lupus medications as well as review of the systems including the falls and cardiovascular risks, self-helplessness and self-reported joint pain. SLEDAI, SF-36 and Euro QoL 5D were assessed for every patient. Results The questionnaire was reliable as demonstrated by a high-standardized alpha (0.894-0.971). The questionnaire items correlated significantly (P< 0.01) with clinical parameters of disease activity. Patient reported tender joints correlated significantly with the physician’s scores (r= 0.842). Content construct assessment of the PROMs-functional disability and QoL revealed significant correlation (P< 0.01) with both SF-36 and Euro QoL respectively. Changes in parameters of disease activity, SLE systemic manifestations, functional disability, quality of life as well as self-helplessness scores showed significant (P< 0.01) variation with diseases activity status. Mean time to complete the PROMs was 7.01 + 0.92 min. The PROMs questionnaire showed also a high degree of comprehensibility (9.3). Conclusions Integrating patient reported outcome measures into standard clinical practice is feasible and applicable. This version of multidimensional SLE-PROMs questionnaire was found to be valid and reliable. It provides informative quantitative measure for the disease activity core set data, and in the meantime, facilitates assessing the patient’s disease activity, health related quality of life measure, cardiovascular and falls risks on individual basis. Disclosure of Interest: None Declared
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