Objective To examine change in health-related quality of life in association with clinical outcomes of neuropsychiatric events in systemic lupus erythematosus (SLE).
Methods An international study evaluated newly diagnosed SLE patients for neuropsychiatric events attributed to SLE and non-SLE causes. The outcome of events was determined by a physician-completed seven-point scale and compared with patient-completed Short Form 36 (SF-36) health survey questionnaires. Statistical analysis used linear mixed-effects regression models with patient-specific random effects.
Results 274 patients (92% female; 68% Caucasian), from a cohort of 1400, had one or more neuropsychiatric event in which the interval between assessments was 12.3±2 months. The overall difference in change between visits in mental component summary (MCS) scores of the SF-36 was significant (p<0.0001) following adjustments for gender, ethnicity, centre and previous score. A consistent improvement in neuropsychiatric status (N=295) was associated with an increase in the mean (SD) adjusted MCS score of 3.66 (0.89) in SF-36 scores. Between paired visits when the neuropsychiatric status consistently deteriorated (N=30), the adjusted MCS score decreased by 4.00 (1.96). For the physical component summary scores the corresponding changes were +1.73 (0.71) and −0.62 (1.58) (p<0.05), respectively. Changes in SF-36 subscales were in the same direction (p<0.05; with the exception of role physical). Sensitivity analyses confirmed these findings. Adjustment for age, education, medications, SLE disease activity, organ damage, disease duration, attribution and characteristics of neuropsychiatric events did not substantially alter the results.
Conclusion Changes in SF-36 summary and subscale scores, in particular those related to mental health, are strongly associated with the clinical outcome of neuropsychiatric events in SLE patients.
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Funding JGH (Canadian Institutes of Health Research grant MOP-57752, Capital Health Research Fund); MBU (Canadian Institutes of Health Research grant MOP-49529, Lupus Foundation of Ontario, Ontario Lupus Association, Lupus UK, Lupus Foundation of America, Lupus Alliance Western New York, Conn Smythe Foundation, Tolfo Family (Toronto)); DJ (MRC (UK) grant U.1052.00.006.00001.01); SCB (Korea Healthcare technology R&D project, Ministry for Health, Welfare and Family Affairs, Republic of Korea (A080588)); CG (Lupus UK, arthritis research campaign, Wellcome Trust Clinical Research Facility in Birmingham, UK); AC (Fonds de la recherche en sante de Quebec National Scholar, Singer Family Fund for Lupus Research); SB (Canadian Institutes of Health Research Junior Investigator Award; Fonds de la recherche en santé du Québéc Jeune Chercheure; Canadian Arthritis Network Scholar Award; McGill University Health Centre Research Institute); GSA (University of Alabama at Birmingham, grant P60AR48095); DDG (Canadian Institutes of Health Research); PRF (Distinguished Senior Research Investigator of the Arthritis Society and Arthritis Centre of Excellence); INB (supported by the Manchester Academic Health Sciences Centre and the Manchester NIHR Biomedical Research Centre); MP (Hopkins Lupus Cohort grant AR 43727, Johns Hopkins University General Clinical Research Center grant MO1 RR00052); SM (National Institutes of Health research grants R01 AR46588, K24 AR002213 and M01 RR000056; ON (Swedish Medical Research council grant 13489)); GS (Swedish Medical Research council grant 13489); RR-G (National Institutes of Health research grants UL1RR025741; K24 AR02318; P60 AR 48098); VF (MRC (UK) grant U.1052.00.009.00001.01).
Competing interests None.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the Capital Health Research Ethics Board and the research ethics boards at each of the participating centres.
Provenance and peer review Not commissioned; externally peer reviewed.
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