a Market Access, Bayer Yakuhin, Ltd , Tokyo , Japan.
b Adelphi Values LLC , Boston , MA , USA.
J Med Econ. 2019 Aug;22(8):798-805. doi: 10.1080/13696998.2019.1609003. Epub 2019 May 13.
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). 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). 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 ( 0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range 0.09-0.48), but in line with the original ACTS development study. Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks). 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. NCT01598051, clinicaltrials.gov; registered April 20, 2012.
抗栓治疗量表（ACTS）和药物治疗满意度问卷第二版（TSQM-II）是经过验证的治疗满意度患者报告结局（PRO）工具。ACTS 包括两个领域：负担和获益；TSQM-II 包括四个领域：疗效、副作用、便利性和总体满意度。已经开发并验证了这两种工具的日语版本。本研究旨在评估其在日本心房颤动（AF）患者中的心理测量特性。 在一项直接口服抗凝剂利伐沙班的日本上市后监测研究中，共收集了 534 例 AF 患者的 ACTS 和 TSQM-II 数据。使用美国食品和药物管理局的最佳实践指南，采用传统心理测量方法检查了四个关键心理测量特性：可接受性、刻度假设、可靠性（即内部一致性可靠性、重测信度）和结构有效性（即收敛有效性和已知群组）。结果发现，ACTS 负担和获益以及 TSQM-II 疗效、便利性和总体满意度量表具有可接受性（例如，基线时项目水平缺失数据<4%），所有量表的内部一致性均良好（克朗巴赫α>0.80）。ACTS 负担和获益的重测信度组内相关系数分别为 0.59 和 0.65，而 TSQM-II 量表的组内相关系数在 0.54-0.61 之间。ACTS 和 TSQM-II 的已知群组有效性得到了支持，因为量表评分在阳性和阴性影响之间存在差异（ 0.05）。ACTS 和 TSQM-II 之间的相关性（收敛有效性）低于预期（范围为 0.09-0.48），但与 ACTS 的原始开发研究一致。重测信度评估受到评估期的限制，评估期（3 个月）长于推荐指南（通常不超过 2 周）。总的来说，ACTS 和 TSQM-II 量表的日语版本符合内部一致性可靠性和传统有效性标准。我们的研究支持 ACTS 和 TSQM-II 作为合适的 PRO 工具，用于衡量日本 AF 患者对抗凝治疗的满意度。NCT01598051，clinicaltrials.gov；注册于 2012 年 4 月 20 日。
