Analysis of the impact of missed doses of venous thromboembolism prophylaxis

项目摘要 本申请题为《静脉血栓栓塞症错过剂量的影响分析》 《预防》是对PAR-13-009心脏、肺和血液二级数据集分析的回应 疾病和睡眠障碍(R21)计划宣布。静脉血栓栓塞症(VTE)是常见的 住院患者的并发症，影响超过75万名患者，造成超过10万人死亡 每年。大量随机对照试验(RCT)已经证明了VTE的有效性。 然而，现实世界的临床实践与随机对照试验中的结构化方案有很大的不同。尽管 我们发现，国家成功地改进了住院患者的VTE预防处方 在医院开出预防VTE的处方并不能确保它的管理。 我们已经建立了一个数据库，记录了为每个人开出的预防VTE的每一剂药理学药物 自2008年以来在约翰·霍普金斯医院住院的患者(~300万剂)，与 实施我们的电子健康记录。通过将此数据集与我们完整的住院患者登记表相关联，我们 将利用现有数据来确定不一致的VTE预防管理之间的关联 和VTE结果。我们假设，不一致的管理减少了 是预防性的，并且与VTE的高发病率相关。 我们将构建对数二项广义估计方程(GEE)模型来确定剂量- 不一致的VTE预防措施与VTE结局之间的反应关系。我们将包括所有患者 在本研究中于2008年1月1日至2016年6月30日期间在本院住院，无论是否 静脉血栓栓塞症的预防性治疗。这些模型将研究缺失单剂之间的联系， 多个连续剂量、多个间歇剂量、所有剂量以及不使用VTE预防和VTE剂量 结果。我们将控制年份、给药方案、患者人口统计和已知的静脉血栓栓塞症危险因素。 未开出预防VTE处方的患者将作为对照。我们假设不一致的 静脉血栓栓塞症预防药物的使用与医院相关疾病的发生率增加相关。 由于高凝反弹效应导致的静脉血栓栓塞症，患者因缺少剂量而受到更大的伤害 而不是接受任何预防措施。 拟议研究的成功完成将模拟VTE预防之间的关系 药物管理和医院相关的VTE。这项研究将描述以下内容的有效性： 药理学VTE预防在现实世界的临床实践中，并产生数据，将促进 优化住院患者静脉血栓栓塞症预防的新策略的开发。

Project Summary This application entitled “Analysis of the impact of missed doses of venous thromboembolism prophylaxis” is in response to the PAR-13-009 Secondary Dataset Analysis in Heart, Lung, and Blood Diseases and Sleep Disorders (R21) program announcement. Venous thromboembolism (VTE) is a common complication for hospitalized patients, affecting more than 750,000 patients and causing over 100,000 deaths each year. Numerous randomized controlled trials (RCTs) have demonstrated the effectiveness of VTE prophylaxis, however real-world clinical practice differs dramatically from structured protocols in RCTs. Despite successful national efforts to improve VTE prophylaxis prescription for hospitalized patients, we have found that prescribing VTE prophylaxis in hospitals does not ensure its administration. We have assembled a database of every dose of pharmacologic VTE prophylaxis prescribed for every patient hospitalized at the Johns Hopkins Hospital since 2008 (~3 million doses), corresponding with the implementation of our electronic health record. By linking this dataset with our complete inpatient registry, we will leverage existing data to determine the association between inconsistent VTE prophylaxis administration and VTE outcomes. We hypothesize that inconsistent administration decreases the protective benefit of prophylaxis and is associated with higher incidence of VTE. We will construct log-binomial generalized estimating equation (GEE) models to determine the dose- response relationship between inconsistent VTE prophylaxis and VTE outcomes. We will include all patients admitted to our hospital between January 1, 2008 and June 30, 2016 in this study, regardless of whether or not VTE prophylaxis was prescribed. These models will study the association between missing a single dose, multiple consecutive doses, multiple intermittent doses, all doses, and no doses of VTE prophylaxis and VTE outcomes. We will control for year, dosing regimen, patient demographics, and known VTE risk factors. Patients who were not prescribed VTE prophylaxis will serve as controls. We hypothesize that inconsistent administration of VTE prophylaxis medications is associated with an increased incidence of hospital associated VTE due to a hypercoagulable rebound effect and that patients are exposed to greater harm by missing doses than by receiving no prophylaxis at all. Successful completion of the proposed research will model the relationship between VTE prophylaxis medication administration and hospital-associated VTE. This research will describe the effectiveness of pharmacologic VTE prophylaxis in real-world clinical practice and generate data that will facilitate the development of novel strategies to optimize VTE prevention in hospitalized patients.