Gwadry-Sridhar Femida, Guyatt Gordon, O'Brien Bernie, Arnold J Malcom, Walter Stephen, Vingilis Evelyn, MacKeigan Linda
Department of Medicine, University of Western Ontario, London, ON, Canada.
Contemp Clin Trials. 2008 Nov;29(6):905-18. doi: 10.1016/j.cct.2008.07.001. Epub 2008 Jul 24.
In this manuscript we outline the development of a randomized control trial.
Heart failure (HF) is one of the leading causes of hospitalization in North America. While great advances have been made in the treatment of this disease, many factors limit the effectiveness of treatment. The objective of this Trial of Education And Compliance in Heart failure patients (TEACH) was to measure in patients with heart failure who were hospitalized and then discharged into the community, the impact of a comprehensive outpatient educational intervention on: 1) a composite endpoint of mortality, readmissions and visits to the emergency room for all causes, 2) the impact of the intervention on health-related quality of life, 3) the impact of the intervention on compliance to medication and 4) the economic impact of providing such an intervention to patients.
This was a prospective cluster randomized controlled clinical trial in patients who were admitted to hospital with a diagnosis of heart failure (HF). Patients were stratified by reason for admission to hospital. Stratum 1 included patients whose primary reason for admission was HF and stratum 2 included patients whose primary reason for hospital admission was not HF.
HF patients who receive an enhanced educational intervention from their community pharmacist will 1) have an absolute risk reduction in the number of events of 20%, 2) be more compliant, 3) will demonstrate less health-related quality of life (HRQoL) impairment as measured by disease-specific and generic HRQoL instruments and 4) will lower costs/Quality Adjusted Life Years (QALY) due to fewer total events per patient.
Outcomes were collected every 3 months from baseline to the end of 1 year. Events were tracked using a comprehensive database that we developed and validated. In order to measure compliance we used electronic measures known as Track Caps (MEMS). We also used pharmacy refill data that was provided to us from all community pharmacies the patient used. This data was analyzed and interpreted using a validated formula developed by Steiner et al. (1996).
在本手稿中，我们概述了一项随机对照试验的开展情况。
心力衰竭（HF）是北美住院治疗的主要原因之一。虽然在这种疾病的治疗方面已取得了巨大进展，但许多因素限制了治疗效果。本心力衰竭患者教育与依从性试验（TEACH）的目的是，在因心力衰竭住院然后出院回到社区的患者中，衡量一项全面门诊教育干预对以下方面的影响：1）由死亡率、再入院率和因各种原因前往急诊室就诊组成的复合终点；2）干预对健康相关生活质量的影响；3）干预对药物依从性的影响；4）为患者提供这种干预的经济影响。
这是一项针对因心力衰竭（HF）入院的患者的前瞻性整群随机对照临床试验。患者按入院原因分层。第1层包括以心力衰竭为主要入院原因的患者，第2层包括以非心力衰竭为主要入院原因的患者。
从社区药剂师处接受强化教育干预的心力衰竭患者将：1）事件数量的绝对风险降低20%；2）依从性更高；3）通过疾病特异性和通用健康相关生活质量工具衡量，健康相关生活质量（HRQoL）受损程度更低；4）由于每位患者的总事件减少，成本/质量调整生命年（QALY）降低。
从基线到1年末，每3个月收集一次结果。使用我们开发并验证的综合数据库跟踪事件。为了衡量依从性，我们使用了称为跟踪帽（MEMS）的电子测量方法。我们还使用了患者使用的所有社区药房提供给我们的药房配药数据。使用Steiner等人（1996年）开发并验证的公式对这些数据进行分析和解读。
