title: Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling.
abstract: BACKGROUND
  Assessing the consequences of chronic spontaneous/idiopathic urticaria (CSU) requires the evaluation of health-related quality of life (HRQoL) associated with the severity of CSU signs and symptoms. It is important to understand how signs, symptoms, and HRQoL change over time in CSU. Evidence is lacking on how closely changes in signs and symptoms of CSU are related to changes in HRQoL. The objective of this study was to assess the correlation between changes in patient-reported outcome measures (PROMs) of signs and symptoms, dermatologic quality of life (QoL), and urticaria-specific QoL.
  
  
  METHODS
  Latent growth models (LGMs) were applied to longitudinal data from three randomized, Phase 3 clinical trials investigating the efficacy and safety of omalizumab in CSU.
  
  
  RESULTS
  A near-perfect association between changes in signs and symptoms and changes in dermatologic and urticaria-specific QoLs was identified in each clinical trial when using LGMs (correlation coefficient range 0.88-0.92).
  
  
  CONCLUSIONS
  Evidence showed that changes in signs and symptoms are closely related to changes in HRQoL. However, analyses were performed on clinical trial results of an extremely effective treatment; a less effective treatment with much smaller changes over time may not show such close correlations. Results suggest that any of these PROMs may be used to understand changes in CSU.
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA. dstull@rti.org.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Stull
authors.affiliation: RTI Health Solutions, Didsbury, Manchester, UK. dmcbride@rti.org.
authors.forename: Doreen
authors.initials: D
authors.lastname: McBride
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Houghton
authors.affiliation: Cardiff University School of Medicine, Cardiff, UK.
authors.forename: Andrew Y
authors.initials: AY
authors.lastname: Finlay
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Ari
authors.initials: A
authors.lastname: Gnanasakthy
authors.affiliation: Novartis Pharma AG, GMA and HEOR, Basel, Switzerland.
authors.forename: Maria-Magdalena
authors.initials: MM
authors.lastname: Balp
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002908:Chronic Disease; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D000069444:Omalizumab / Q000627:therapeutic use*; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy* / Q000523:psychology*; D055815:Young Adult
chemical_list: D000069444:Omalizumab
keywords: Correlation; Health-related quality of life; Latent growth model; Quality of life; Urticaria
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