在CPRD中实施OMOP和CONCEPTION共同数据模型GOLD:因使用抗凝剂而导致出血和心血管结果的风险
Nicholas B Hunt1, Patrick Souverein1, Marloes Bazelier1
1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Clinical pharmacology and therapeutics
|March 7, 2026
概括
对现实世界证据研究的共同数据模型 (CDM) 的比较揭示了结果的差异. 与Conception CDM不同的是,OMOP CDM显示了直接口服抗凝剂 (DOAC) 对心血管事件的保护作用.
科学领域:
- 药物监督 药物监督 药物监督
- 医疗信息学 医疗信息学
- 现实世界的证据研究研究.
背景情况:
- 共同数据模型 (CDM) 选择对现实世界证据 (RWE) 研究结果的影响尚未得到充分理解.
- 标准化数据对于可复制和可比的RWE研究至关重要.
研究的目的:
- 为了比较RWE研究的结果,当数据被映射到两个不同的CDM时:CONCEPTION和OMOP.
- 在CDM中识别直接口服抗凝剂 (DOAC) 与维生素K抗剂 (VKA) 的风险估计中的潜在差异.
主要方法:
- 来自单个CPRD GOLD实例的数据被映射到CONCEPTION和OMOP CDM中.
- 在非膜心肌动患者中,与DOACs和VKAs相关的出血和心血管结果的风险使用相同的编程步骤进行了分析.
- 两个CDM分析之间比较了包括基线特征,发病率和危险比率在内的关键指标.
主要成果:
- 在OMOP绘制的人群 (80,701名患者) 和ConcePTION绘制的人群 (76,726名患者) 中,对DOAC和VKA的心血管 (CVD) 风险估计有所不同.
- OMOP表明DOAC对心血管疾病具有保护作用 (HR 0.82),而ConcePTION显示没有显著差异 (HR 0.99).
- 两种CDM都表明DOACs具有类似的中风风险增加,并且没有增加严重出血的风险.
结论:
- 选择CDM可以影响RWE研究结果,特别是心血管结果.
- 在CDM之间队列构造,表型识别和变量归算的差异可能解释了观察到的差异.
- 仔细考虑CDM选择和映射过程对于强大的RWE研究至关重要.
相关概念视频
Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
2.6K
Oral anticoagulants are vital tools in preventing and treating blood clotting disorders. This diverse class of medications can be categorized as vitamin K antagonists, exemplified by warfarin, and direct thrombin inhibitors (DTIs), such as dabigatran, as well as factor Xa inhibitors, including rivaroxaban.
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
2.6K
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors
1.4K
Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
1.4K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
510
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
510
Venous Thrombosis III: Interprofessional Care
432
Venous thrombosis requires effective prevention and treatment strategies to improve patient outcomes and reduce potential complications.Prevention StrategiesHealthcare providers must prioritize preventing venous thromboembolism (VTE) for all adult patients upon admission. Interventions depend on bleeding and thrombosis risk, medical history, current medications, diagnoses, planned procedures, and patient preferences. Patients on bed rest should change positions every two hours and, if not...
432
Anticoagulant Drugs: Low-Molecular-Weight Heparins
2.2K
Hemostasis is a crucial process that prevents excessive blood loss from damaged blood vessels. It involves various mechanisms such as vasoconstriction, platelet adhesion and activation, and fibrin formation. The importance of each mechanism depends on the type of vessel injury. In contrast, thrombosis is the abnormal formation of a blood clot within the blood vessels, leading to potential complications if the clot obstructs blood flow. Thrombosis can be caused by increased coagulability of the...
2.2K
Methods of Documentation II: POMR
1.5K
The Problem-Oriented Medical Record (POMR) revolutionized medical record-keeping by introducing a systematic approach focusing on the patient's problems rather than merely listing symptoms. Dr. Lawrence Weed's introduction of this method in the 1960s marked a significant advancement in medical documentation. The POMR framework consists of four key components: the database, problem list, plan of care, and progress notes.
1.5K


