Julius Center for Health Sciences and Primary care, University Medical Center, Stratenum 6,131, PO box 85500, 3508AB, Utrecht, the Netherlands.
BMC Cardiovasc Disord. 2013 Sep 26;13:77. doi: 10.1186/1471-2261-13-77.
Chest pain remains a diagnostic challenge: physicians do not want to miss an acute coronary syndrome (ACS), but, they also wish to avoid unnecessary additional diagnostic procedures. In approximately 75% of the patients presenting with chest pain at the emergency department (ED) there is no underlying cardiac cause. Therefore, diagnostic strategies focus on identifying patients in whom an ACS can be safely ruled out based on findings from history, physical examination and early cardiac marker measurement. The HEART score, a clinical prediction rule, was developed to provide the clinician with a simple, early and reliable predictor of cardiac risk. We set out to quantify the impact of the use of the HEART score in daily practice on patient outcomes and costs.
METHODS/DESIGN: We designed a prospective, multi-centre, stepped wedge, cluster randomised trial. Our aim is to include a total of 6600 unselected chest pain patients presenting at the ED in 10 Dutch hospitals during an 11-month period. All clusters (i.e. hospitals) start with a period of 'usual care' and are randomised in their timing when to switch to 'intervention care'. The latter involves the calculation of the HEART score in each patient to guide clinical decision; notably reassurance and discharge of patients with low scores and intensive monitoring and early intervention in patients with high HEART scores. Primary outcome is occurrence of major adverse cardiac events (MACE), including acute myocardial infarction, revascularisation or death within 6 weeks after presentation. Secondary outcomes include occurrence of MACE in low-risk patients, quality of life, use of health care resources and costs.
Stepped wedge designs are increasingly used to evaluate the real-life effectiveness of non-pharmacological interventions because of the following potential advantages: (a) each hospital has both a usual care and an intervention period, therefore, outcomes can be compared within and across hospitals; (b) each hospital will have an intervention period which enhances participation in case of a promising intervention; (c) all hospitals generate data about potential implementation problems. This large impact trial will generate evidence whether the anticipated benefits (in terms of safety and cost-effectiveness) of using the HEART score will indeed be achieved in real-life clinical practice.
ClinicalTrials.gov 80-82310-97-12154.
胸痛仍然是一个诊断挑战：医生既不想错过急性冠状动脉综合征（ACS），又希望避免不必要的额外诊断程序。在急诊科（ED）因胸痛就诊的患者中，约有 75%的患者没有潜在的心脏原因。因此，诊断策略侧重于根据病史、体格检查和早期心脏标志物测量结果，确定可以安全排除 ACS 的患者。HEART 评分是一种临床预测规则，旨在为临床医生提供一种简单、早期和可靠的心脏风险预测指标。我们着手量化在日常实践中使用 HEART 评分对患者结局和成本的影响。
方法/设计：我们设计了一项前瞻性、多中心、阶梯式楔形、集群随机试验。我们的目标是在 11 个月内纳入来自荷兰 10 家医院的总共 6600 名未经选择的胸痛患者。所有集群（即医院）都从“常规护理”开始，并按照切换到“干预护理”的时间进行随机分组。后者涉及为每位患者计算 HEART 评分，以指导临床决策；特别是对评分低的患者给予安慰和出院，对评分高的患者进行强化监测和早期干预。主要结局是 6 周内发生主要不良心脏事件（MACE），包括急性心肌梗死、血运重建或死亡。次要结局包括低危患者发生 MACE、生活质量、卫生保健资源的使用和成本。
由于以下潜在优势，阶梯式楔形设计越来越多地用于评估非药物干预措施的实际效果：（a）每个医院都有常规护理和干预期，因此可以在医院内和医院间进行比较；（b）每个医院在有前景的干预措施时将有一个干预期，从而提高参与度；（c）所有医院都会产生关于潜在实施问题的数据。这项大型影响试验将提供证据，证明在实际临床实践中，使用 HEART 评分的预期效益（在安全性和成本效益方面）是否确实能够实现。
ClinicalTrials.gov NCT03613228。
