Work

Development and validation of the SLE Disease Activity Questionnaire (SLEDAQ)

Year: 2026

Type: article

Abstract: OBJECTIVES: We aimed to develop a patient-reported measure, the SLE Disease Activity Questionnaire (SLEDAQ), intended to serve as a proxy for the SLE Disease Activity Index (SLEDAI). METHODS: Items were developed to assess SLEDAI domains, reviewed for plain language, pre-tested in individual interviews and administered at two clinical sites. Prevalence-adjusted bias-adjusted kappa (PABAK), sensitivity and specificity assessed correspondence of SLEDAQ items with the SLEDAI domain scores. Associations of SLEDAQ with SLEDAI, clinical SLEDAI and physician global assessments (PGA) were examined with Spearman correlations and by examining differences in SLEDAQ scores between SLEDAI score severity groupings (0–2, 3–4 and ≥6). SLEDAQ scores were compared by sex, education, health literacy, fibromyalgia and in-person versus virtual visits to determine if bias was detected. For comparison, similar analyses were performed with the Systemic Lupus Activity Questionnaire (SLAQ), the most commonly used patient-reported disease activity measure. RESULTS: After evaluation, the SLEDAQ consisted of 31 primary items. Agreement between SLEDAQ and SLEDAI scoring was ≥63% for all domains. PABAK indicated moderate or greater agreement for all but three domains (arthritis, mucosal ulcers and alopecia). All specificity estimates were ≥0.63. Correlations between SLEDAQ and SLEDAI, clinical SLEDAI and PGA scores were 0.25, 0.37 and 0.34, respectively. SLEDAQ scores differentiated between SLEDAI severity groupings. Performance on all metrics exceeded that of the SLAQ. There were no differences in SLEDAQ by sex or education. SLEDAQ scores were significantly higher among individuals with low health literacy and fibromyalgia; differences by health literacy were attenuated after adjustment for SLEDAI. CONCLUSIONS: SLEDAQ is a novel patient-reported measure that more closely aligns with physician-assessed disease activity than previously available instruments. Findings support its potential usefulness in observational research and clinical settings where in-person disease activity assessment is limited.

Source: Lupus Science & Medicine

DOI: 10.1136/lupus-2026-002177