Development and validation of the SLE Disease Activity Questionnaire (SLEDAQ)
5 affiliations
- 1Medicine, University of California San Francisco, San Francisco, California, USA
- 2UCSF, San Francisco, California, USA
- 3Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA
- 4Rheumatology, VA Medical Center, Durham, North Carolina, USA
- 5Duke University School of Medicine, Durham, North Carolina, USA
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.
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BibTeX
@article{katz2026development,
title = {{Development and validation of the SLE Disease Activity Questionnaire (SLEDAQ)}},
author = {Patricia Katz and Sarah Patterson and Maria Dall’Era and Ellen Thovmasyan and Jennifer L Rogers and David Pisetsky and Amanda M Eudy},
journal = {Lupus Science \& Medicine},
year = {2026},
month = oct,
doi = {10.1136/lupus-2026-002177},
url = {https://doi.org/10.1136/lupus-2026-002177},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Development and validation of the SLE Disease Activity Questionnaire (SLEDAQ)
AU - Patricia Katz
AU - Sarah Patterson
AU - Maria Dall’Era
AU - Ellen Thovmasyan
AU - Jennifer L Rogers
AU - David Pisetsky
AU - Amanda M Eudy
PY - 2026
DA - 2026/10/26
JO - Lupus Science & Medicine
DO - 10.1136/lupus-2026-002177
UR - https://doi.org/10.1136/lupus-2026-002177
AB - 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.
SN - 2053-8790
ER -