title: Cross-cultural validation of a disease-specific patient-reported outcome measure for systemic lupus erythematosus in Canada.
abstract: OBJECTIVE
  The LupusPRO, a disease-targeted patient-reported outcome measure, was developed and validated in US patients with systemic lupus erythematosus (SLE). We report the results of the cross-cultural validation study of the English version of the LupusPRO among patients in Canada with SLE.
  
  
  METHODS
  The LupusPRO was administered to English-speaking Canadian patients with SLE. Demographic, clinical, and serological characteristics were obtained, and the Medical Outcomes Study Short Form-36 (SF-36) and LupusPRO were administered. Disease activity was ascertained using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and the Lupus Foundation of America definition of flare (Yes/No). Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Physician disease activity and damage assessments were also ascertained using visual analog scales. A mail-back LupusPRO form was completed within 2-3 days of the index visit. Items tested were internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity or health status), and known-groups validity.
  
  
  RESULTS
  Participants were 123 Canadian patients with SLE (94% women); mean age was 47.7 (SD 14.8) years. The median (interquartile range) SELENA-SLEDAI and SDI were 4 (6) and 1 (3), respectively. The ICR of the LupusPRO domains ranged from 0.60 to 0.93, while the TRT range was 0.62-0.95. Measures observed were convergent and discriminant validity with corresponding domains of SF-36, criterion validity, and known-groups validity against disease activity, damage, and health status. Confirmatory factor analysis showed a good fit.
  
  
  CONCLUSIONS
  The LupusPRO has fair psychometric properties among Canadian patients with SLE, and prospective studies to establish minimally important difference are continuing.
authors.affiliation: Department of Medicine, Division of Rheumatology, McGill University Health Center, Montréal, Québec, Canada.
authors.forename: Josiane
authors.initials: J
authors.lastname: Bourré-Tessier
authors.forename: Ann E
authors.initials: AE
authors.lastname: Clarke
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Mikolaitis-Preuss
authors.forename: Mark
authors.initials: M
authors.lastname: Kosinski
authors.forename: Sasha
authors.initials: S
authors.lastname: Bernatsky
authors.forename: Joel A
authors.initials: JA
authors.lastname: Block
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Jolly
mesh_terms: D000328:Adult; D002170:Canada / Q000453:epidemiology; D003469:Culture; D005260:Female; D006801:Humans; D007802:Language; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011594:Psychometrics / Q000379:methods; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D014177:Translations
keywords: QUALITY OF LIFE; SELF-ASSESSMENT; SYSTEMIC LUPUS ERYTHEMATOSUS