title: Design and validation of LupusCol, an instrument for the evaluation of health-related quality of life in Colombian adult patients with systemic lupus erythematosus.
abstract: OBJECTIVE
  The aim of this study was to design and validate LupusCol, an instrument for the evaluation of health-related quality of life (HRQoL) in Colombian adult patients with SLE.
  
  
  METHODS
  Items and domains of the initial instrument were defined. Preliminary tests were made with the participation of patients. Validity and reliability tests of the administration method were conducted. Usability tests were applied to the version obtained in the previous phases to complete the validation process.
  
  
  RESULTS
  Following preliminary tests, six items and one domain were excluded and two new items were added to the instrument, producing a form with 44 questions and 7 domains, which was submitted for validity and reliability tests. Factor analysis excluded three items, obtaining a Pearson's correlation (PC) for the criteria validity of -0, 48; a Cronbach's α coefficient for internal consistency of 0, 96; an intraclass correlation coefficient (ICC) for personal test-retest-telephone of 0.96 and an ICC personal test-retest-personal of 0.96. For interrater concordance a PC of 0.8, an ICC of 0.77 and a Lin's coefficient of 0.86 were found. Sensitivity to change was demonstrated through analysis of variance, obtaining significant indicators about the scale, demonstrating the instrument's ability to detect changes in HRQoL.
  
  
  CONCLUSIONS
  The design and validation process was completed successfully. The scale has significant values for validity, reliability and sensitivity to change in the studied population.
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia. Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia. Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia. ge_quintana@yahoo.com.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Quintana López
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Muñetón López
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia. Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: Paola
authors.initials: P
authors.lastname: Coral-Alvarado
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia. Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: Paúl
authors.initials: P
authors.lastname: Méndez Patarroyo
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: José
authors.initials: J
authors.lastname: Molina
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: Philippe
authors.initials: P
authors.lastname: Chalem
authors.affiliation: Faculty of Medicine, Internal Medicine Department, Universidad Nacional de Colombia, Faculty of Medicine, Universidad de los Andes, Rheumatology Section, Fundación Santa Fe de Bogotá, Bogotá, Faculty of Medicine, Universidad CES, Medellín, Fundación Instituto de Reumatología e Inmunología and Faculty of Sciences, Pharmacy Department, Universidad Nacional de Colombia, Bogotá, Colombia.
authors.forename: Jorge
authors.initials: J
authors.lastname: Díaz
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D003105:Colombia; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires
keywords: factor analysis; health status; health-related quality of life; scales development and validation; systemic lupus erythematosus