SCORING AND RESPONSIVENESS OF THE SELF-ASSESSMENT OF TREATMENT VERSION II QUESTIONNAIRE IN PATIENTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY

Author(s)

van Nooten FE1, Trundell D2, Staniewska D3, Revicki DA3
1Astellas Pharma BV, Leiden, The Netherlands, 2Evidera, Inc., London, UK, 3Evidera, Bethesda, MD, USA

OBJECTIVES: The Self-Assessment of Treatment Version II (SAT-II) instrument has three versions: baseline; follow-up (FU); and last-visit versions. Baseline version measures pain level (one item) and impact of pain (six items). Follow-up and last-visit versions measure improvement in the impact or level of pain  due to treatment. Last-visit also includes two items about treatment preferences. This study explored scoring of the SAT-II (baseline and last-visit). Scores were also assessed for their responsiveness to change. METHODS: Data from 369 patients (42% female; mean age=63) with painful diabetic peripheral neuropathy from a randomised, double-blind placebo-controlled trial (STEP) were used to test baseline and last-visit versions. Item-to-item spearman correlations and spearman correlations between summary scores and Brief Pain Inventory-Diabetic Neuropathy pain severity score (PSS) were tested. Factor analysis was conducted on the six impact items to develop a scoring algorithm (baseline or last-visit summary score). Analysis of variance measured responsiveness to treatment responder status as defined by PSS (both ≥30% & ≥50% reduction from baseline) and Patient Global Impression of Change (PGIC; much/very much improved). RESULTS: A single-factor structure for the six impact items was demonstrated for baseline and last-visit. Item-to-item correlations (baseline: correlation (r)=0.33 to 0.75; last-visit: r=0.52 to 0.89) and correlations between a sum of the impact items and PSS were significant for baseline (r= 0.39, p=0.001) and last-visit (r=-0.46, p=0.0001). A mean summary score of the impact items discriminated (all p<0.0001) between non-responders and responders, respectively for each definition as follows: ≥30%, 0.6 (SD 0.9) vs 1.9(1.3); ≥50%, 0.8 (1.0) vs. 2.3 (1.3); and PGIC, 0.6 (0.7) vs. 2.3 (1.2). CONCLUSIONS: The six impact items of the SAT-II can be scored as a summary measure on both the baseline and last-visit versions, whilst other items should be scored individually. The last-visit version discriminates treatment response.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PRM137

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Systemic Disorders/Conditions

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