Validation of Predictors for Oral Anticoagulant Medication Choice Using EMR Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140,187
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Alcohol Consumption
研究概览
简要总结
The objectives of this study are, first, to identify select clinical covariates from electronic medical records (EMR) that might be associated with initiation of oral anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based clinical characteristics and patterns of insurance claims; third, to assess the potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies based on administrative claims databases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First dispensing of warfarin or dabigatran between October 2010 and December 2014
- •Diagnosis of atrial fibrillation
- •≥ 12 months enrolment in the database preceding the date of the first dispensing
- •Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease (CHA2DS2-VASc) score ≥ 1
排除标准
- •Prior use of oral anticoagulation
- •Evidence of valvular atrial fibrillation
- •Missing or ambiguous age or sex information
- •Patients with a nursing home stay during baseline
研究组 & 干预措施
Dabigatran etexilate
NVAF patients initiating dabigatran etexilate
干预措施: Dabigatran etexilate (Drug)
Warfarin
NVAF patients initiating warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
Percentage of Patients With Alcohol Consumption
时间窗: Up to 12 months
Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Percentage of Patients With Abnormal Renal Function
时间窗: Up to 12 months
Percentage of patients with abnormal renal function; defined as "Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR)". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Percentage of Patients Smoking
时间窗: Up to 12 months
Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Percentage of Patients With Bleeding History or Predisposition
时间窗: Up to 12 months
Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Percentage of Patients With Obesity
时间窗: Up to 12 months
Percentage of patients with obesity; where obesity is defined as "obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR)". The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
EMR Characteristic: Serum Creatinine
时间窗: Up to 12 months
EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
Percentage of Patients With Abnormal Liver Function
时间窗: Up to 12 months
Percentage of patients with abnormal liver function; defined as "Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)
时间窗: Up to 12 months
EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.
次要结局
- EMR Characteristic: Duration of Atrial Fibrillation(Up to 12 months)
- Percentage of Patients With Prior Transient Ischemic Attack(Up to 12 months)
- Percentage of Patients With Hyperlipidemia(Up to 12 months)
- Percentage of Patients With Diabetes(Up to 12 months)
- EMR Characteristic: History/Duration of Hypertension(Up to 12 months)
- EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)(Up to 12 months)
- Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs(Up to 1 month)
- EMR Characteristic: History of Adherence: Non-adherent/Adherent(Up to 12 months)
- Percentage of Patients With Uncontrolled Hypertension(Up to 12 months)
- EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score(Up to 12 months)