Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation.

Authors:
Benjamin F Banderas
Benjamin F Banderas
g Adelphi Values LLC
Yukihiro Koretsune
Yukihiro Koretsune
Osaka National Hospital
Japan
Koichiro Kumagai
Koichiro Kumagai
Fukuoka University Hospital
Shinichiro Uchiyama
Shinichiro Uchiyama
Tokyo Women's Medical University School of Medicine
Japan
Takeshi Yamashita
Takeshi Yamashita
The Cardiovascular Institute
Japan
Masahiro Yasaka
Masahiro Yasaka
National Hospital Organization Kyushu Medical Center
Japan
Sayako Akiyama
Sayako Akiyama
Health Economics and Outcomes Research
Ann Arbor | United States

J Med Econ 2019 Apr 17:1-8. Epub 2019 Apr 17.

i Modus Outcomes Ltd , Letchworth Garden City , UK.

Aims: The Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) are validated treatment satisfaction patient-reported outcome (PRO) instruments. The ACTS includes two domains: Burdens and Benefits; the TSQM-II includes four: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Japanese-language versions of the ACTS and TSQM-II have been developed and linguistically validated. This study aimed to assess their psychometric properties in Japanese patients with atrial fibrillation (AF).

Materials And Methods: ACTS and TSQM-II data from 534 patients with AF were collected in a Japanese post-marketing surveillance study of a direct oral-anticoagulant, rivaroxaban. Four key psychometric properties, in line with best practice guidelines from the US Food and Drug Administration, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reliability), and construct validity (i.e. convergent validity and known groups).

Results: ACTS Burdens and Benefits and TSQM-II Effectiveness, Convenience, and Global Satisfaction scales were found to be acceptable (e.g. item-level missing data at baseline <4%), with all scales having good internal consistency (Cronbach's alpha > 0.80). test-retest reproducibility intraclass correlation coefficients for the ACTS Burdens and Benefits were 0.59 and 0.65, respectively, and between 0.54-0.61 for the TSQM-II scales. Known-groups validity for the ACTS and TSQM-II was supported by differences in scale scores by positive and negative impact (p < 0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range r = 0.09-0.48), but in line with the original ACTS development study.

Limitations: Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks).

Conclusions: Overall, Japanese versions of ACTS and TSQM-II scales satisfied internal consistency reliability and traditional validity criteria. Our study supports the ACTS and TSQM-II as appropriate PRO instruments to measure satisfaction with anticoagulant treatment in Japanese patients with AF.

Trial Registration: NCT01598051, clinicaltrials.gov; registered April 20, 2012.

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http://dx.doi.org/10.1080/13696998.2019.1609003DOI Listing
April 2019
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References

(Supplied by CrossRef)
Article in Japan Med Assoc J
Takahashi S et al.
Japan Med Assoc J 2006

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