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.
J Affect Disord
; 213: 105-111, 2017 Apr 15.
Article
em En
| MEDLINE
| ID: mdl-28213121
ABSTRACT
BACKGROUND:
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.METHODS:
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.RESULTS:
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).LIMITATIONS:
Two versions of the UPSA were used and no inclusion/exclusion criteria were based on the UPSA.CONCLUSIONS:
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.Palavras-chave
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Testes Psicológicos
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Transtornos Cognitivos
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Transtorno Depressivo Maior
Tipo de estudo:
Clinical_trials
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Qualitative_research
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article