THU0037 Validation of A Disease-Specific Patient-Reported Outcome Measure for Arabic Patients with Systemic Lupus Erythematosus
Authors: Y. El Miedany, M. El Gaafary, S. Sayed, I. Ahmed
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> In comparison to the common chronic diseases, SLE has poorer outcomes with negative impact on the patient9s life. Therefore, it became mandatory not only to recognize disease activity core set data, but also health, as well as non-health, related quality of life domains in addition to other co-morbidities risks. Hence, patient reported outcome measures constitute an important facet of overall management of SLE. <h3>Objectives</h3> 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. <h3>Methods</h3> The PROMs was conceptualized based on frameworksused by the WHO Quality of Life tool, as well as the PRO measurement informationsystem (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. Disease activity was ascertained using the SLEDAI and the Lupus Foundation of America definition of flare (Yes/No). Damage was assessed using the ACR Damage Index. Items tested were internal consistency reliability, test-retest reliability, convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity or health status), <h3>Results</h3> Participants were 113 SLE patients (94% women); mean age was 42.4 ± 14.5 years. The questionnaire was reliable as demonstrated by a high-standardized alpha (0.894-0.961). The questionnaire items correlated significantly (p&lt;0.01) with clinical parameters of disease activity. Patient reported tender joints correlated significantly with the physician9s scores (r=+0.842). Content construct assessment of the PROMs-functional disability and QoL revealed significant correlation (p&lt;0.01) with both SF-36 and Euro QoL. Changes in functional disability, quality of life as well as self-helplessness scores showed significant (p&lt;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). <h3>Conclusions</h3> Integrating patient reported outcome measures into standard clinical practice is feasible and applicable. The Arabic-PROMs questionnaire had fairly good psychometric properties among SLE patients. It also provides informative quantitative measure for the disease activity core set data, and in the meantime, facilitates assessing the patient9s health related quality of life measure, co-morbidities including cardiovascular risk on individual basis. This would enable setting a treatment plan tailored to the patient9s needs. <h3>Disclosure of Interest</h3> : None declared <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.3758