冠心病强化二级预防试验。
The Enhancing Secondary Prevention in Coronary Artery Disease trial.
机构信息
Department of Medicine, University of Alberta, the Royal Alexandra Hospital, Edmonton, Alberta.
出版信息
CMAJ. 2009 Dec 8;181(12):897-904. doi: 10.1503/cmaj.090917. Epub 2009 Nov 23.
BACKGROUND
Proven efficacious therapies are sometimes underused in patients with chronic cardiac conditions, resulting in suboptimal outcomes. We evaluated whether evidence summaries, which were either unsigned or signed by local opinion leaders, improved the quality of secondary prevention care delivered by primary care physicians of patients with coronary artery disease.
METHODS
We performed a randomized trial, clustered at the level of the primary care physician, with 3 study arms: control, unsigned statements or opinion leader statements. The statements were faxed to primary care physicians of adults with coronary artery disease at the time of elective cardiac catheterization. The primary outcome was improvement in statin management (initiation or dose increase) 6 months after catheterization.
RESULTS
We enrolled 480 adults from 252 practices. Although statin use was high at baseline (n=316 [66%]), most patients were taking a low dose (mean 32% of the guideline-recommended dose), and their low-density lipoprotein (LDL) cholesterol levels were elevated (mean 3.09 mmol/L). Six months after catheterization, statin management had improved in 79 of 157 patients (50%) in the control arm, 85 of 158 (54%) patients in the unsigned statement group (adjusted odds ratio [OR] 1.18, 95% CI 0.71-1.94, p=0.52) and 99 of 165 (60%) patients in the opinion leader statement group (adjusted OR 1.51, 95% CI 0.94-2.42, p=0.09). The mean fasting LDL cholesterol levels after 6 months were similar in all 3 study arms: 2.35 (standard deviation [SD] 0.86) mmol/L in the control arm compared with 2.24 (SD 0.73) among those in the opinion leader group (p=0.48) and 2.19 (SD 0.68) in the unsigned statement group (p=0.32).
INTERPRETATION
Faxed evidence reminders for primary care physicians, even when endorsed by local opinion leaders, were insufficient to optimize the quality of care for adults with coronary artery disease. ClinicalTrials.gov trial register no. NCT00175240.
背景
在患有慢性心脏疾病的患者中，有时会未使用已证实有效的疗法，导致治疗效果欠佳。我们评估了未经签名或由当地意见领袖签名的证据总结是否会改善初级保健医生对冠状动脉疾病患者进行二级预防护理的质量。
方法
我们进行了一项随机试验，以初级保健医生为单位进行分组，共分为 3 个研究组：对照组、未经签名的陈述或意见领袖的陈述。陈述在择期进行心脏导管检查时通过传真发送给患有冠状动脉疾病的成年患者的初级保健医生。主要结局是在导管检查后 6 个月他汀类药物管理（起始或剂量增加）的改善。
结果
我们从 252 个实践中招募了 480 名成年人。尽管基线时他汀类药物的使用率很高（n=316 [66%]），但大多数患者服用的剂量较低（平均为指南推荐剂量的 32%），且低密度脂蛋白（LDL）胆固醇水平升高（平均 3.09 mmol/L）。在导管检查后 6 个月时，对照组中有 157 名患者中的 79 名（50%）、未经签名陈述组中有 158 名患者中的 85 名（54%）（调整后的优势比[OR]1.18，95%置信区间[CI]0.71-1.94，p=0.52）和意见领袖陈述组中有 165 名患者中的 99 名（60%）（调整后的 OR 1.51，95%CI0.94-2.42，p=0.09）的他汀类药物管理得到了改善。在所有 3 个研究组中，6 个月后的空腹 LDL 胆固醇水平相似：对照组为 2.35（标准差[SD]0.86）mmol/L，而意见领袖组为 2.24（SD 0.73）mmol/L（p=0.48）和未经签名陈述组为 2.19（SD 0.68）mmol/L（p=0.32）。
解释
即使有当地意见领袖背书，初级保健医生的传真证据提醒也不足以优化冠状动脉疾病成年患者的护理质量。ClinicalTrials.gov 试验注册编号 NCT00175240。
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