title: Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings.
abstract: The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives.
  
  
  
  A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method.
  
  
  
  Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5 (13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8 (10.8) and mental component summary 43.0 (12.3). Mean LIT score was 34.2 (22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo- R 2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P < 0.035) and absence of flares (P = 0.004). The LIT showed a strong association with SF-36 physical and social role functioning, vitality, bodily pain and mental health (P < 0.001). The LIT was well accepted by patients and physicians. It was reliable, with Cronbach α coefficients ranging from 0.89 to 0.92 among countries.
  
  
  
  The LIT is validated in the five participating European countries. The results show its reliability and cultural invariability across countries. They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction.
authors.affiliation: Policlinic of Rheumatology, Hiller Research Unit, Heinrich-Heine University, Düsseldorf, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Schneider
authors.affiliation: Department of Internal Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Mosca
authors.affiliation: Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Ourense y Pontevedra, Spain.
authors.forename: José-Maria
authors.initials: JM
authors.lastname: Pego-Reigosa
authors.affiliation: Department of Medicine, Unit of Rheumatology, Karolinska Institutet, Solna, Sweden.
authors.forename: Iva
authors.initials: I
authors.lastname: Gunnarsson
authors.affiliation: HEOR, Real-World Evidence Solutions (RWES) unit, IMS Health, Paris-La Défense, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Maurel
authors.affiliation: HEOR, Real-World Evidence Solutions (RWES) unit, IMS Health, Paris-La Défense, France.
authors.forename: Anna
authors.initials: A
authors.lastname: Garofano
authors.affiliation: Global Specialty Pharma Franchise, GlaxoSmithKline; Services Unlimited, Brentford, UK.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Perna
authors.affiliation: Immunology Medical Department, GlaxoSmithKline spa, Verona, Italy.
authors.forename: Rolando
authors.initials: R
authors.lastname: Porcasi
authors.affiliation: Department of Internal Medicine and Systemic Diseases, University Hospital of Dijon, 5bis INSERM U866 5ter INSERM CIC-EC 1432, Dijon, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Devilliers
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003431:Cross-Cultural Comparison; D003430:Cross-Sectional Studies; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Lupus Impact Tracker; cross-cultural validation; differential item functioning/Rasch method; patient-reported outcome tool; systemic lupus erythematosus