PSYCHOMETRIC VALIDATION OF ANTI-CLOT TREATMENT SCALE IN JAPANESE PATIENTS WITH ATRIAL FIBRILLATION
Author(s)
Cano S1, Koretsune Y2, Kumagai K3, Uchiyama S4, Yamashita T5, Yasaka M6, Akiyama S7, Briere J8, Sakaguchi T9, Okayama Y9, Watanabe Fujinuma E7
1Modus Outcomes, Stotfold, UK, 2National Hospital Organization, Osaka National Hospital, Osaka, Japan, 3Fukuoka Sanno Hospital, Fukuoka, Japan, 4Sanno Hospital, Tokyo, Japan, 5The Cardiovascular Institute, Tokyo, Japan, 6Kyushu Medical Center, Fukuoka, Japan, 7Bayer Yakuhin, Ltd., Tokyo, Japan, 8Bayer Pharma AG, Berlin, Germany, 9Bayer Yakuhin, Ltd., Osaka, Japan
OBJECTIVES: The Anti-Clot Treatment Scale (ACTS) is a validated patient-reported outcome (PRO) instrument of satisfaction with anticoagulant treatment, consisting two scales: 12-item ACTS Burdens; 3-item ACTS Benefits. A Japanese-language version of the ACTS has been developed and linguistically validated. The aim of this study was to assess its psychometric properties in Japanese patients with atrial fibrillation (AF). METHODS: ACTS Burdens and Benefits data from 532 patients with AF were collected in a Japanese post-marketing surveillance study of an oral anticoagulant. Five key psychometric properties, in line with best practice guidelines from the US FDA, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reproducibility), construct validity (i.e. convergent validity and known groups), and responsiveness. RESULTS: ACTS Burdens and Benefits scales were found to be acceptable (e.g., item-level missing data at baseline <3%), and have good internal consistency (Cronbach’s alpha>0.85). Test-retest reproducibility for the ACTS Benefits and Burdens was ICC=0.59 and 0.65, respectively. However, the assessment period was longer (3 months) than recommended guidelines (usually up to 2 weeks). Convergent validity was supported by differences in scale scores by positive impact (ACTS Benefits p<0.001) and negative impact (ACTS Burdens p<0.001). Correlations with the Treatment Satisfaction Questionnaire for Medication (convergent validity) were lower than expected (range r=0.13-0.48), but these findings were in line with the original ACTS development study. Clinical change over time for patients reporting improvement was associated with moderate effect size for ACTS Burdens (0.55) and small effect sizes for ACTS Benefits (-0.25). CONCLUSIONS: Overall, findings confirm the original scale validation study. The Japanese versions of ACTS Burdens and Benefits scales satisfied traditional reliability and validity criteria. This further supports the ACTS as a clinically useful PRO instrument of satisfaction in Japanese patients with AF under anticoagulant treatment.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCV44
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Cardiovascular Disorders