Article Text
PDF
Abstract
Objectives To develop and evaluate a self-administered questionnaire (LUPIN) to assess SLE disease activity and lupus-relevant PROs.
Methods Patient representatives from a nationwide lupus association (AFL+) and lupus experts developed a self- administered questionnaire which included several domains of SLE perceived activity (figure 1) and the SF-36 quality of life questionnaire. Prior to a medical consultation, the patient filled the questionnaire which was sealed. Subsequently, the physician evaluated the patient (blindly of the patient responses) and filled patient characteristics, a physician global assessment (PhGA) and a SLEDAI-2K. The questionnaires were distributed to 31 centers of metropolitan France and overseas territories. Correlations between patient response in individual domains and physician assessment were evaluated using Spearman’s regression and p-values were adjusted for multiple testing using the Bonferroni method.
Results 325 questionnaires were analyzed at the time of the submission. The mean age was 44 (±14.4) years and 85,2% were women. The mean duration of disease was 12.7 (±9.42) years. Most patients had history of articular and cutaneous involvements (86.6% and 72.6%, respectively) and 34.4% of lupus nephritis. The mean SLEDAI was 3 (±3.70) and 67 (20.6%) patients had a clinical SLEDAI ≥ 4. The PhGA correlated moderately with the cSLEDAI (r = 0.52). As expected, there was a weak albeit statistically significant correlation between components of the LUPIN questionnaire and the SLEDAI/cSLEDAI and PhGA (r < 0.25 for all; figure 2). However, there were very good correlations between several components of the LUPIN questionnaire and several domains of the SF-36 (r = -0.68 for pain evaluation; r = -0.65 for physical activity evaluation; r = -0.60 for fatigue evaluation; p < 0.0001 for all).
The LUPIN questionnaire (paper or electronic form)
Spearman’s correlation matrix between components of the LUPIN questionnaire, the SF-36 questionnaire and the physician’s assessment of disease activity. Each value corresponds to the spearman r value, in bold when there is a statistically significant correlation after adjusting p-value for multiple testing using the Bonferroni method.
Conclusion Several components of the LUPIN questionnaires have significant correlation with domains of the SF-36 quality of life questionnaire making LUPIN a patient-friendly tool to evaluate PROs now that it has been implemented on smartphones. As expected in a cross-sectional study, there were only weak correlations between domains of the LUPIN questionnaire and physician-assessed disease activity. However, the changes in LUPIN scores assessed prospectively may be more sensitive to detect disease activity fluctuation, which is currently evaluated in a follow-up study.
Acknowledgments All patients and physicians who participated in the study. The AFL+ patient association represented by her president Marianne Riviere.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .