Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study.
Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study.
复制标题
设计和实施一项提供高质量冠心病预防的两种策略的比较有效性研究：“心脏与健康”研究的方法和参与者特征。
DOI：
10.1016/j.cct.2013.07.013
复制
发表时间：
2013
影响因子：
2.2
通讯作者：
Keyserl
中科院分区：
文献类型：
--
作者：
Sheridan,StaceyL;Draeger,LindyB;Pignone,MichaelP;Sloane,PhilipD;Samuel-Hodge,Carmen;Finkelstein,EricA;Gizlice,Ziya;Vu,MaihanB;Gitterman,DanielP;Bangdiwala,ShrikantI;Donahue,KatrinaE;Evenson,Kelly;Ammerman,AliceS;Keyserl
背景虽然生活方式和药物治疗对降低冠心病（CHD）风险有效，但很少有研究对各种高质量降低CHD风险策略的比较有效性进行研究。在本文中，我们报告的设计和基线特征的参与者只是这样一个trial.MethodsWe进行了一项随机试验，相同的生活方式和药物干预提供两种替代格式：顾问提供或基于网络的。该试验在家庭医学研究网络的5个不同实践中进行，包括年龄35-79岁的男性和女性，他们基于10年预测的心脏病风险≥ 10%或已知的心血管疾病史而处于CHD事件的高风险中。在个体水平随机化后，两组受试者均接受了决策辅助，并在12个月内接受了4次强化干预访视和3次维持访视。主要结局是既往无心血管疾病患者10年预测CHD风险的变化。次要结果，所有参与者之间的测量，包括冠心病危险因素的变化，成本效益和可接受性在4和12个月follow-up.ResultsWe随机489名符合条件的患者：389没有和100名已知的心血管疾病史。平均年龄为62.3岁。75%是白色，25%是非洲裔美国人。45%受过大学教育。88%有医疗保险。平均10年预测冠心病风险为16.9%。结论我们成功地招募了一个多样化的实践和患者样本，这将提供一个丰富的样本来测试两种策略的比较有效性，以实施高质量的冠心病预防。
BackgroundAlthough lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial.MethodsWe conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35–79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥ 10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up.ResultsWe randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%.ConclusionWe have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.