title: Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis.
abstract: OBJECTIVE
  This analysis aimed to confirm the reliability, validity, and responsiveness of the Psoriasis Symptom Diary (PSD) using data from two Phase III studies in patients with moderate to severe chronic plaque psoriasis.
  
  
  METHODS
  Data from two randomized, double-blind, double-dummy, placebo-controlled, multicenter Phase III studies (n = 820) assessing the efficacy and safety of secukinumab were used. The PSD (24-h recall; 0-10 numeric rating scale) was electronically administered each evening. Test-retest reliability was determined using intraclass correlations. Construct validity hypotheses were evaluated via correlations with the Psoriasis Area and Severity Index (PASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), EuroQoL 5-Dimension Health Status Questionnaire, and Patient Global Impression of Change (PGIC). Discriminating ability and responsiveness were evaluated by estimating mean differences and effect sizes between known groups (using the PASI and IGA). Phase II-derived, anchor-based PGIC thresholds and cumulative distribution function (CDF) plots described meaningful change.
  
  
  RESULTS
  Items on the PSD yielded high intraclass coefficients (>0.90). Correlations were in the anticipated direction and by week 12 were moderate to strong (0.41-0.73) in magnitude, demonstrating construct validity. Average PSD item scores differed predictably and significantly between known groups. Responsiveness effect size estimates were moderate to large (0.6-1.5), and CDF plots showed the percentage of responders to be consistently higher in treatment than in placebo arms across the range of change in PSD scores.
  
  
  CONCLUSIONS
  The PSD is reliable, valid, and responsive, and represents a valid tool to enhance treatment decisions in patients with moderate to severe plaque psoriasis.
authors.affiliation: Department of Dermatology, University of Connecticut Health Center, University of Connecticut, Farmington, CT, USA.|Probity Medical Research, Waterloo, Ontario, Canada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Strober
authors.affiliation: Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals Corp., East Hanover, NJ, USA.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Global Value & Access PCSK9 Development and Launch Unit, Sanofi-Aventis US LLC, Bridgewater, NJ, USA.
authors.forename: Mary Helen
authors.initials: MH
authors.lastname: Tran
authors.affiliation: Patient Reported Outcomes Division, RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Ari
authors.initials: A
authors.lastname: Gnanasakthy
authors.affiliation: Department of US Medical, Novartis Pharmaceuticals Corp., East Hanover, NJ, USA.
authors.forename: Judit
authors.initials: J
authors.lastname: Nyirady
authors.affiliation: Department of Immunology and Dermatology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Charis
authors.initials: C
authors.lastname: Papavassilis
authors.affiliation: Patient Reported Outcomes Division, RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Nelson
authors.affiliation: Patient Reported Outcomes Division, RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Lori D
authors.initials: LD
authors.lastname: McLeod
authors.affiliation: MAOS Division, RTI Health Solutions, Ann Arbor, MI, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Mordin
authors.affiliation: Chair and Dermatologist in Chief Harvey B Ansell Professor of Dermatology, Tufts Medical Center and Tufts Univ School of Medicine, Boston, MA.
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.affiliation: Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Boni E
authors.initials: BE
authors.lastname: Elewski
authors.affiliation: Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D017326:Clinical Trials, Phase III as Topic; D003879:Dermatologic Agents / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D000071066:Patient Reported Outcome Measures; D011565:Psoriasis / Q000188:drug therapy; D011594:Psychometrics; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D057566:Self Report; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D063189:Symptom Assessment; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C555450:secukinumab