Cost comparison of continued anticoagulation with rivaroxaban versus placebo based on the 1-year EINSTEIN-Extension trial efficacy and safety results

Aims: The EINSTEIN-Extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (vs placebo) after 6–12 months of initial anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small non-significant increased risk of major bleeding (none fatal or in critical site). This study aimed to compare total healthcare cost between rivaroxaban and placebo, based on the EINSTEIN-EXT event rates.

Methods: Total healthcare cost was calculated as the sum of treatment and clinical event costs from a US managed care perspective. Treatment duration and event rates were obtained from the EINSTEIN-EXT study. Adjustment on treatment duration was made by assuming a 10% non-adherence rate. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e. recurrent deep vein thrombosis [DVT], recurrent pulmonary embolism, major bleeding, clinically relevant non-major bleeding) were determined from the literature. Results were examined over a ±20% range of each cost component and over 95% confidence intervals (CIs) of event rate differences in deterministic (one-way) and probabilistic sensitivity analyses (PSA).

Results: Total healthcare cost was $1,454 lower for rivaroxaban-treated (vs placebo-treated) patients in the base-case, with a lower clinical event cost fully offsetting drug cost. The cost savings of recurrent DVT alone (–$3,102) was greater than drug cost ($2,723). Total healthcare cost remained lower for rivaroxaban in the majority (73%) of PSA (cost difference [95% CI]?=?–$1,454 [–$2,396, $1,231]).

Limitations: This study was conducted over the 1-year observation period of the EINSTEIN-EXT trial, which limited “real-world” applicability and examination of long-term economic impact. Assumptions on drug and clinical event costs were US-based and, thus, not applicable to other healthcare systems.

Conclusions: Total healthcare costs were estimated to be lower for patients continuing rivaroxaban therapy compared to those receiving placebo in VTE patients who had completed 6–12 months of VTE treatment.     

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

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.     

债务重组的会计问题研究

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钢筋混凝土现浇楼板裂缝成因分析及防治措施

文章对某工业厂房现浇楼板产生裂缝进行调查,分析了裂缝的特征和产生的原因,介绍了防治裂缝的措施以及修补裂缝的方法。     

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Dominance Statistics: A Simulation Study on the d Statistic

Quality &; Quantity - Cliff (1993) has proposed the use of a measure of effect size alternative to traditionalmean differences: δ {? = Pr(xi1 &;gt; xj2) - Pr(xi1 &;lt; xj2)}which,...     

民营旅行社在中国的发展

通过民营企业东星旅行社借助汉口国旅的“壳资源”进军出境旅游业务的事例，探讨民营资本向旅行社行业扩张时，面临的各种制度壁垒和其他困难，并联系中国加入世贸带来的机遇和挑战，对民营旅行社的发展和扩张提出了系列想法和建议。     

旋转机械振动信号分析

综述了现代信号分析处理理论、方法如时域分析(包括时域参数识别、相关分析以及统计分析等)、频域分析(包括傅立叶变换、功率谱分解等),并结合转子实验台实测的振动数据,研究了它们在旋转机械振动信号分析处理中的应用,给出了具体的应用实例。     

论违约责任的归责原则

违约责任的归责原则主要有严格责任原则和过错责任原则。违约责任的归责原则应当是二元论,即过 错责任与无过错责任并存,并有各自的调整范围和适用领域。     

冠状动脉硬化性心脏病的心身医学机理与防治

从心身医学的角度，阐述冠状动脉硬化性心脏病的病因学，心理生物学机制及防治；对现代社区医疗卫生工作中的老年疾病的康复保健具有一定的指导意义。