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.     

树立和落实科学发展观--以中地集团的实践为例

科学发展观的内涵极为丰富 ,涉及经济、政治、文化、社会发展各个领域 ,既有生产力和经济基础问题 ,又有生产关系和上层建筑问题 ;既管当前 ,又管长远 ;既是重大的理论问题 ,又是重大的实践问题。中地集团树立和落实科学发展观的实践 :(1)较长时间内保持高速度的、有效益的经济总量增长 ;(2 )明确企业定位 ;(3)加快体制机制改革的步伐 ;(4 )营造良好的人文环境 ;(5 )弘扬优秀的企业文化     

对科学发展观指导下的高校思想政治教育工作的探讨

科学发展观是推进我国经济社会全面发展的指导思想,也是加强和改进大学生思想政治教育的指导方针。本文通过分析高校思想政治教育存在的普遍问题,提出了在科学发展观指导下的思想政治教育工作的新思路,新途径。     

西部地方政府在西部大开发中如何落实科学发展观

坚持以人为本，树立全面、协调、可持续的发展观，是党的十六大提出的促进经济社会和人的全面发展的科学发展观。在西部大开发中，西部地方政府应把社会结构、人类发展与宏观经济作为一个整体来考虑；确立新的开发目标；整合新的扶贫思路；成为为市场服务的主体。     

毛泽东关于中国革命的科学预见及其重大意义

毛泽东具有高超的科学预见的能力。毛泽东的科学预见能力在于他掌握了社会调查的方法 ,正确地运用对立统一规律和量变到质变的规律 ,以及采取“从群众中来 ,到群众中去”的方法。学习毛泽东关于中国革命的科学预测理论与方法 ,对于处理当今国际国内的各种复杂问题有着十分重要的意义。     

债务重组的会计问题研究

本文根据新会计制度的规定,就债务重组的基本原理五种债务重组方式的会计处理事项分别作了说明,并对中外关于债务重组的处理方法进行了比较,找出了其中的差异。为了寻找更为完善的对债务重组的会计处理方法,本文对新会计制度关于债务重组的某些不足之处进行了讨论,提出了相应的意见和建议。     

2001-2002年山东省农药工业回顾

本文在广泛调查与深入分析的基础上 ,对山东省近两年的农药生产、科研、销售和应用情况进行了综述。为企业及有关部门提供了详实可靠的资料。     

科学创新的人文动源系统

创新是当今世界发展的主题,科学创新是创新链条的初环,研究科学创新的动力系统成为一种必然.科学创新的人文内涵表现在各种人文要素对其影响上,这些结构要素的系统动力学效应成为科学创新的动力源泉.这些人文要素大体包括哲学、宗教、政治制度、法律、社会道德、文学和艺术等.它们主要从诱发基本观念、规范、情感三个角度对科学创新产生影响.     

Social Scientific Explanations?

Generally valid scientific explanations of observable social phenomena are still hardly available. By applying philosophical insights generated by Quine and derived from semiotics to social research methodology three kinds of context dependencies accompanying theory formation within social science are identified. The third context dependency is mostly not attended in theory formation about social phenomena thereby producing a ``connotation fallacy', which leaves almost all social theories undetermined and fallible. These context dependencies should be taken into account in the research design and be tested for using statistical criteria comprising a new methodology presented in this article.