VALIDATION OF THE SELF ASSESSMENT OF TREATMENT (SAT) QUESTIONNAIRE

Author(s)

Wyrwich KW1, Thompson C1, Holmstrom S2, Wiklund I31United BioSource Corporation, Bethesda, MD, USA, 2Astellas Pharma Global Development, Leiderdorp, Netherlands, 3United BioSource Corporation, London, United Kingdom

OBJECTIVES: The original SAT is a five-item questionnaire developed to assess treatment benefits associated with application of QUTENZA™, a novel high-dose capsaicin patch, in clinical trials among patients with neuropathic pain .  The objective of this study was to evaluate the item performance and psychometric properties of the SAT. METHODS: The SAT, Numerical Pain Rating Scale (NPRS), SF-36, Brief Pain Inventory and Patient Global Impression of Change (PGCI) scores were measured in two 12 week Phase3 clinical trials.  Descriptive statistics, exploratory and confirmatory factor analysis (EFA and CFE) were conducted to assess the item performance and to explore the underlying constructs.  Reliability and validity were also examined. RESULTS: Pooled data from 698 patients (21-91 years) completing SAT after 12 weeks of treatment were analyzed. From descriptive statistics, EFA and CFA results, a one-factor model combining 4 of the 5 items emerged as the optimal solution with 66% explained variance. The internal consistency reliability was high (Cronbach’s alpha = 0.87). Construct validity was demonstrated by moderate to high correlations with change in the NPRS (-0.55 pain now and -0.64 average pain), BPI (-0.59 worst pain, -0.35 activity limitation), SF 36v2 pain subscale (0.43) and PGIC (0.85).  SAT scores strongly discriminated patient change groups  using the PGIC; mean SAT scores were 1.7 in patients who were very much improved versus -1.0 in patients who were much worse/very much worse. CONCLUSIONS: Preliminary analyses indicate that the measurement properties of the four-item version of SAT are valid and reliable for patients self assessment of treatment with QUTENZA™  among patients with neuropathic pain. The item performance suggests that the questionnaire could be further improved with additional patient input to clarify some of the questions as well as revising the response options and recall period to better reflect treatment benefits during the course of a trial.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PND43

Disease

Neurological Disorders, Respiratory-Related Disorders

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