title: Determination of a clinically important difference and definition of a responder threshold for the UCSD performance-based skills assessment (UPSA) in patients with major depressive disorder.
abstract: This article reports an evaluation of the psychometric properties and clinically important difference (CID) threshold of the UCSD Performance-Based Skills Assessment (UPSA) in major depressive disorder (MDD), using data from a large-scale study of the effects of vortioxetine on cognitive functioning and functional capacity in MDD patients.
  
  
  
  Adults with moderate-to-severe recurrent MDD and self-reported cognitive dysfunction were randomized to 8 weeks of double-blind treatment with vortioxetine 10/20mg QD (flexible), duloxetine 60mg QD, or placebo. Pearson correlation coefficients were calculated between UPSA composite score and demographic/disease characteristics at baseline to examine construct validity. Two methods (distribution-based and anchor-based) were used to establish a CID threshold.
  
  
  
  A total of 602 patients were randomized; 528 comprised the full analysis set. For the entire sample mean UPSA composite scores were 77.8 at baseline and 83.9 at week 8 (mean change, +6.1). As hypothesized, at baseline, the UPSA composite score correlated with cognitive functioning (Digit Symbol Substitution Test: r=0.36, P<0.001) and workplace productivity (Work Limitations Questionnaire: r=-0.17, P=0.008), but not depressive symptoms (Montgomery-Åsberg Depression Rating Scale: r=0.02, P=0.707) or subjective cognitive dysfunction (Perceived Deficits Questionnaire: r=-0.02, P=0.698).
  
  
  
  Two versions of the UPSA were used and no inclusion/exclusion criteria were based on the UPSA.
  
  
  
  These results support the construct validity of UPSA for assessing functional capacity independent of mood symptoms. The estimated CID for changes in UPSA scores was quite consistent at +6.4 points and +6.7 based on distribution-based and anchor-based methods, respectively.
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: pharvey@med.miami.edu.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Harvey
authors.affiliation: Takeda Development Center Americas, Deerfield, IL, USA.
authors.forename: William
authors.initials: W
authors.lastname: Jacobson
authors.affiliation: Takeda Development Center Americas, Deerfield, IL, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhong
authors.affiliation: Takeda Development Center Americas, Deerfield, IL, USA.
authors.forename: George G
authors.initials: GG
authors.lastname: Nomikos
authors.affiliation: H. Lundbeck A/S, Copenhagen, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Cronquist Christensen
authors.affiliation: H. Lundbeck A/S, Copenhagen, Denmark.
authors.forename: Christina
authors.initials: C
authors.lastname: Kurre Olsen
authors.affiliation: Takeda Development Center Americas, Deerfield, IL, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Merikle
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003072:Cognition Disorders / Q000150:complications / Q000175:diagnosis*; D003865:Major Depressive Disorder / Q000150:complications / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011581:Psychological Tests / Q000706:statistics & numerical data*; D011594:Psychometrics; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D055815:Young Adult
keywords: Clinically important difference; Cognitive dysfunction; Functional capacity; Major depressive disorder (MDD); UCSD Performance-Based Skills Assessment (UPSA)