Perceived or Actual Barriers to Warfarin Use in Atrial Fibrillation Based on Electronic Medical Records
Perceived or Actual Barriers to Warfarin Use in Atrial Fibrillation Based on Electronic Medical Records
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DOI：
10.1097/mjt.0b013e3182546840
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发表时间：
2012-09-01
影响因子：
4.2
通讯作者：
Jackson, Joseph D.
中科院分区：
文献类型：
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作者：
Rosenman, Marc B.;Simon, Teresa A.;Jackson, Joseph D.
与通常的做法相比，临床试验往往会排除有相对禁忌症的患者。一项关于华法林实际使用情况的研究可能有助于为可能取代华法林的新药试验提供信息。本研究的目的是描述房颤患者使用华法林的潜在障碍。这是一项对市中心公立医院和附属初级保健诊所的电子病历（1998-2007年）进行的回顾性研究，包括18岁或以上的房颤成人。排除包括二尖瓣或主动脉瓣置换术、甲状腺功能亢进症或首次诊断后1年内无临床表现。战时暴露由电子药房或医嘱数据定义，或者在第二种定义中，国际标准化比率> 1.3。根据国际诊断分类、第9版代码或电子病历“词典”术语定义华法林潜在障碍史。3329例患者中，CHADS（2）评分为0（17%），1（2 - 6%），2-6（57%）。在1276例CHADS（2）评分>0且处方华法林的患者中，华法林的潜在障碍发生率为胃肠道或泌尿生殖系统出血（20%）、酗酒（16%）、肾功能不全（15%）、易患福尔斯（8%）、肝硬化/肝炎（5%）、颅内出血（1%）、其他出血（6%）、75岁或以上（23%）。在1475例CHADS（2）评分>0且未使用华法林的患者中，除易患福尔斯（16%）和年龄≥ 75岁（43%）外，其他患者的发生率差异不超过3%。在现实世界的实践中，许多给予华法林的患者有禁忌症，这将使他们从临床试验中排除，许多显然符合华法林的患者没有接受华法林。
Compared with usual practice, clinical trials often exclude patients with relative contraindications. A study of real-world warfarin use could help inform trials of new medications that could potentially replace warfarin. The objective of this study was to describe potential barriers to warfarin use among patients with atrial fibrillation. This was a retrospective study of electronic medical records (1998-2007) from an inner-city public hospital and affiliated primary care clinics and included adults aged 18 years or more with atrial fibrillation. Exclusions included mitral or aortic valve replacement, hyperthyroidism, or no clinical encounter within 1 year after first diagnosis. Warfarin exposure was defined by electronic pharmacy or physician order data or, in a second definition, international normalized ratio > 1.3. A history of potential barriers to warfarin was defined by International Classification of Diagnoses, 9th revision codes or electronic medical record "dictionary" terms. Among 3329 patients, CHADS(2) scores were 0 (17%), 1 (26%), 2-6 (57%). Among 1276 patients with CHADS(2) scores >0 who were prescribed warfarin, rates of potential barriers to warfarin were gastrointestinal or genitourinary hemorrhage (20%), alcohol abuse (16%), renal insufficiency (15%), predisposition to falls (8%), cirrhosis/ hepatitis (5%), intracranial hemorrhage (1%), other hemorrhage (6%), and age 75 years or more (23%). Among 1475 patients with CHADS(2) scores >0 who were not prescribed warfarin, these rates differed by not >3% except for predisposition to falls (16%) and age 75 years or more (43%). In real-world practice, many patients given warfarin have contraindications that would exclude them from clinical trials, and many patients apparently eligible for warfarin do not receive it.