title: Validation of a disease-specific health-related quality of life measure in adult Italian patients with systemic lupus erythematosus: LupusQoL-IT.
abstract: OBJECTIVE
  The objective of this paper is to assess the validity of a linguistically validated version of the Lupus Quality of Life (LupusQoL(©)) in Italian patients affected by systemic lupus erythematosus (SLE).
  
  
  METHODS
  Consecutive SLE patients completed the Italian version of the LupusQoL(©) and the Short Form (SF)-36. Disease activity was evaluated by the SLE disease activity Index-2000 (SLEDAI-2 K), and chronic damage by the Systemic Lupus International Collaborating Clinics/American College Rheumatology (ACR) Damage Index score (SDI). Internal consistency and test-retest reliability, convergent and discriminant validity were examined. Factor analysis with varimax rotation was performed.
  
  
  RESULTS
  A total of 117 Italian SLE patients (M:F 13:104; mean age 40.6 ± 11.6 years, mean disease duration 127.5 ± 94.1 months) were recruited into the study. The Italian version of the LupusQoL(©) demonstrated substantial evidence of convergent validity in these patients when compared with equivalent items of the SF-36. In addition, the LupusQoL(©) discriminated between patients with different degrees of disease activity as measured by the SLEDAI-2 K. SLE patients with higher disease activity (SLEDAI-2K ≥4) showed poor QoL compared with those with lower disease activity (SLEDAI-2K <4), with significant differences in the domains of physical health, planning, burden to others and fatigue (p = 0.001, p = 0.04, p = 0.03, p = 0.04, respectively). The confirmatory factor analysis using the eight domain loadings of the 34 items showed a poor fit (χ(2)/degree of freedom (df) 2.26, χ(2 )= 1128.6 (p < 0.001), root mean square error of approximation (RMSEA) = 0.167; goodness-of-fit index (GFI) = 0.606, comparative fit index (CFI) = 0.649)). Screeplot analysis suggested a five-factor loading structure and confirmatory factor analysis result of which is similar to the eight-factor model. A good internal consistency was observed (Cronbach's α 0.89-0.91). Test-retest reliability was good to excellent between baseline and day 15 (intraclass correlation coefficient (ICC) 0.90-0.98).
  
  
  CONCLUSIONS
  The Italian version of the LupusQoL(©) is a valid tool for adult patients with SLE.
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy fabrizio.conti@uniroma1.it.
authors.forename: F
authors.initials: F
authors.lastname: Conti
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Perricone
authors.affiliation: Department of Medicine, University of Perugia, Perugia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Reboldi
authors.affiliation: Corporate Translations, Inc., East Hartford, CT, USA.
authors.forename: M
authors.initials: M
authors.lastname: Gawlicki
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Bartosiewicz
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: V A
authors.initials: VA
authors.lastname: Pacucci
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Massaro
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Miranda
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Truglia
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Alessandri
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: F R
authors.initials: FR
authors.lastname: Spinelli
authors.affiliation: Department of Rheumatology, Royal Blackburn Hospital, Blackburn, UK.
authors.forename: L-S
authors.initials: LS
authors.lastname: Teh
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Ceccarelli
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Valesini
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007558:Italy; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis; D008297:Male; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: Autoimmunity; LupusQoL; SF-36; autoantibodies; lupus; quality of life; systemic lupus erythematosus