title: Validation of a new tool to assess health-related quality of life in psoriasis: the PSO-LIFE questionnaire.
abstract: BACKGROUND
  Several questionnaires have been used to measure health related quality of life (HRQoL) in patients with psoriasis, few have been adapted for use in Spain; none of them was developed specifically for the Spanish population. The purpose of the study was to validate and assess the sensitivity to change of a new questionnaire to measure HRQOL in patients with psoriasis (PSO-LIFE).
  
  
  METHODS
  Observational, prospective, multicenter study performed in centers around Spain. Patients with active or inactive psoriasis completed the PSO-LIFE together with other Dermatology Quality of Life Index (DLQI) and Psoriasis Disability Index (PDI). A control group of patients with urticaria or atopic dermatitis was also included. Internal consistency and test-retest reliability of the PSO-LIFE were assessed by calculating Cronbach's alpha and Intraclass Correlation Coefficient (ICC). Validity was assessed by examining factorial structure, the capacity to discriminate between groups, and correlations with other measures. Sensitivity to change was measured using effect sizes.
  
  
  RESULTS
  The final sample included for analysis consisted of 304 patients and 56 controls. Mean (SD) age of psoriasis patients was 45.3 (14.5) years compared to 38.8 (14) years for controls (p < 0.01). Cronbach's alpha for the PSO-LIFE was 0.95 and test-retest reliability using the ICC was 0.98. Factor analysis showed the questionnaire to be unidimensional. Mean (SD) PSO-LIFE scores differed between patients with psoriasis and controls (64.9 [22.5] vs 69.4 [17.3]; p < 0.05), between those with active and inactive disease (57.4 [20.4] vs 76.4 [20.6]; p < 0.01), and between those with visible and non-visible lesions (63.0 [21.9] vs. 74.8 [23.9]; p < 0.01). The correlation between PSO-LIFE and PASI scores was moderate (r = -0.43) while correlations with DLQI and PDI dimensions ranged from moderate to high (between 0.4 and 0.8). Effect size on the PSO-LIFE in patients reporting 'much improved' health status at study completion was 1.01 (large effect size).
  
  
  CONCLUSIONS
  The present results provide substantial support for the reliability, validity, and responsiveness of the PSO-LIFE questionnaire in the population for which it was designed.
authors.affiliation: Outcomes Research, MSD, Madrid, Spain.
authors.forename: Esteban
authors.initials: E
authors.lastname: Dauden
authors.forename: Enrique
authors.initials: E
authors.lastname: Herrera
authors.forename: Lluis
authors.initials: L
authors.lastname: Puig
authors.forename: José Luis
authors.initials: JL
authors.lastname: Sánchez-Carazo
authors.forename: Jaime
authors.initials: J
authors.lastname: Toribio
authors.forename: Ma Teresa
authors.initials: MT
authors.lastname: Caloto
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Nocea
authors.forename: Montse
authors.initials: M
authors.lastname: Roset
authors.forename: Nuria
authors.initials: N
authors.lastname: Lara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D009819:Office Visits / Q000706:statistics & numerical data; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011565:Psoriasis / Q000175:diagnosis / Q000523:psychology*; D011594:Psychometrics / Q000295:instrumentation; D036301:Qualitative Research; D011788:Quality of Life; D015203:Reproducibility of Results; D012923:Social Class; D013030:Spain; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires / Q000592:standards* / Q000706:statistics & numerical data