Badano L P, Gregori D, Slavich G, Gremese E, Ghidina M, Fioretti P M
Fondazione IRCAB, Az. Osp. S.M. della Misericordia, Udine.
G Ital Cardiol. 1999 Nov;29(11):1291-301.
Clinical, economical, organizative, and medico-legal issues raised by management of citizens who come to Emergency Department with acute chest pain and non diagnostic electrocardiogram are well known. Data from the Italian Health Ministry show that, in 1996, 37,444 patients had been discharged from Italian hospitals with the main diagnosis of chest pain. To obtain this "non-diagnosis", it was needed a mean hospital stay of 4.2 days with estimated costs close to $57,000,000. The ASSENCE study is a randomized, multicenter, international trial aimed at comparing three strategies of handling citizens presenting to emergency department for unexplained chest pain in terms of cost/effectiveness ratio and quality of patients' life. The three strategies that will be compared are: 1. current clinical protocols, prescribing an in-hospital observation period and discharge after several hours/days; 2. performing a dobutamine-atropine stress echocardiography between 0 and 18 hours after randomization (at 6 hours after index chest pain onset) and discharging the patients (if negative) immediately thereafter; 3. performing an electrocardiographic exercise stress test between 0 and 18 hours after randomization and discharging the patients (if negative) immediately thereafter. The main ASSENCE study end-point will be assessment of cost/effectiveness of the 3 strategies tested. Costs will be assessed taking into account: hospital stay length, performed diagnostic procedures and treatments during index admission, in-hospital and 2-month follow-up events (cardiac death, myocardial infarction, definite unstable angina, coronary angioplasty, by-pass surgery, re-admission to hospital for chest-pain). A secondary ASSENCE study end-point will be to assess the effect on patient quality of life of the use of the 3 strategies tested. Sample size estimation calculated in order to detect an absolute difference of at least 10% and based on a 30% expected rate of events, was of 186 patients for each strategy tested.
因急性胸痛前来急诊科就诊且心电图无诊断意义的患者管理所引发的临床、经济、组织和医疗法律问题广为人知。意大利卫生部的数据显示，1996年，有37444名患者从意大利医院出院，主要诊断为胸痛。为了得出这种 “无诊断结果”，平均住院时间为4.2天，估计费用接近5700万美元。ASSENCE研究是一项随机、多中心、国际试验，旨在比较针对因不明原因胸痛前往急诊科就诊的患者的三种处理策略在成本效益比和患者生活质量方面的差异。将进行比较的三种策略是：1. 当前临床方案，规定住院观察期并在数小时/数天后出院；2. 在随机分组后0至18小时（胸痛发作后6小时）进行多巴酚丁胺 - 阿托品负荷超声心动图检查，然后（如果结果为阴性）立即让患者出院；3. 在随机分组后0至18小时进行心电图运动负荷试验，然后（如果结果为阴性）立即让患者出院。ASSENCE研究的主要终点将是评估所测试的三种策略的成本效益。评估成本时将考虑：住院时间长短、首次住院期间进行的诊断程序和治疗、住院期间及2个月随访事件（心源性死亡、心肌梗死、明确的不稳定型心绞痛、冠状动脉成形术、搭桥手术、因胸痛再次入院）。ASSENCE研究的次要终点将是评估所测试的三种策略对患者生活质量的影响。为了检测至少10%的绝对差异并基于30%的预期事件发生率计算的样本量估计，每种测试策略为186名患者。
