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Three versions of the questionnaire were evaluated in over 600 outpatients.
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Factor analysis was used to examine the construct validity of the three versions of the questionnaire.
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The final version of the LupusQoL consists of eight domains: physical health (8 items), pain (3 items), planning (3 items), intimate relationships (2 items), burden to others (3 items), emotional health (6 items), body image (5 items), and fatigue (4 items).
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The instrument demonstrated good internal reliability (Cronbach's 0.88 to 0.95), good test-retest reliability (r 0.72 to 0.93), good concurrent validity with the comparable domains of the SF-36 (r 0.71 to 0.79) and good discriminant validity for different levels of disease activity, measured by the British Isles Lupus Assessment Group (BILAG) index, and damage (SLICC/ACR-DI) but not for all domains.
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The instrument has acceptable ceiling effects and minimal floor effects.
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Limitations include the lack of males in its initial development phase. In subsequent phases, approximately 6% of patients recruited were male (representative of the SLE population in the UK).
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There is currently no sensitivity to change data.