Comparison of three methods for measuring psoriasis severity in clinical studies (Part 2 of 2): use of quality of life to assess construct validity of the Lattice System Physician's Global Assessment, Psoriasis Area and Severity Index and Static Physician's Global Assessment

J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1415-20. doi: 10.1111/jdv.12861. Epub 2015 Apr 27.

Abstract

Background: Systems for determining psoriasis severity in clinical trials have not been sufficiently validated against patients' perceived quality of life.

Objective: To validate three systems of physician-determined psoriasis severity (the Lattice System Physician's Global Assessment [LS-PGA], Psoriasis Area and Severity Index [PASI] and static Physician's Global Assessment [sPGA]).

Methods: Data were from a 24-week randomized, double-blind, placebo-controlled, multicenter trial of therapy with oral calcineurin inhibitors in 445 patients. Construct validity was measured by correlations of the three severity scores with patients' self-reported quality of life (QoL) from the Dermatology Life Quality Index (DLQI) and a DLQI item about psoriasis symptoms.

Results: All severity systems were moderately and positively correlated with QoL, indicating construct validity. QoL was most consistently related to physicians' assessments of body surface area involved with psoriasis (iBSA) followed by, in the order of consistency, plaque elevation, erythema and scale.

Conclusions: The LS-PGA weights iBSA and aspects of plaque morphology in concert with their relative effects on QoL. The LS-PGA, sPGA and PASI are validated by their relationship to QoL in a clinical trial.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Calcineurin Inhibitors / administration & dosage*
  • Clinical Competence*
  • Cyclosporine / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Male
  • Physicians / standards*
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Psoriasis / psychology
  • Quality of Life*
  • Severity of Illness Index
  • Time Factors

Substances

  • Calcineurin Inhibitors
  • Immunosuppressive Agents
  • voclosporin
  • Cyclosporine