Cardiology, University of Pavia, Pavia, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy.
Open Heart. 2020 Dec;7(2). doi: 10.1136/openhrt-2020-001415.
Despite the availability of diverse evidence-based diagnostic and treatment options, many patients with acute coronary syndrome (ACS) still fail to receive effective, safe and timely diagnoses and therapies. The Association of Acute CardioVascular Care of the European Society of Cardiology has proposed and retrospectively validated a set of ACS-specific quality indicators. Combining these indicators with the principles of clinical governance-a holistic, patient-centred approach intended to promote continuous quality improvement-we designed the clinical governance programme in patients with ACS.
This is a multicentre quality improvement initiative exploring multiple dimensions of care, including diagnosis, therapy, patient satisfaction, centre organisation and efficiency in all comers patients with ACS.The study will enrol ≈ 5000 patients prospectively (ie, at the time of the first objective qualifying ACS criterion) with a 1-year follow-up. Consecutive inclusion will be promoted by a simplified informed consent process and quantified by the concordance with corresponding hospital administrative records using diagnosis-related group codes of ACS.Coprimary outcome measures are (1) timely reperfusion in patients with ST-elevation ACS and (2) optimal medical therapy at discharge in patients with confirmed acute myocardial infarction. Secondary outcomes broadly include multiple indicators of the process of care. Clinical endpoints (ie, death, myocardial infarction, stroke and bleeding) will be adjudicated by a clinical event committee according to predefined criteria.
The study has been approved by local ethics committee of all study sites. As a quality improvement initiative and to promote consecutive inclusion of the population of interest, a written informed consent will be requested only to patients who are discharged alive. Dissemination will be actively promoted by (1) the registration site (ClinicalTrials.Gov ID NCT04255537), (2) collaborations with investigators through open data access and sharing.
尽管有多种基于证据的诊断和治疗选择，但许多急性冠状动脉综合征（ACS）患者仍然无法获得有效、安全和及时的诊断和治疗。欧洲心脏病学会急性心血管护理协会提出并回顾性验证了一组特定于 ACS 的质量指标。我们将这些指标与临床治理原则相结合——一种旨在促进持续质量改进的整体、以患者为中心的方法——为 ACS 患者设计了临床治理计划。
这是一项多中心质量改进计划，探索了包括诊断、治疗、患者满意度、中心组织和效率在内的多个护理维度，适用于所有 ACS 患者。该研究将前瞻性纳入约 5000 名患者（即在首次符合 ACS 标准的客观标准时），并进行为期 1 年的随访。通过简化的知情同意程序促进连续纳入，并使用 ACS 的诊断相关组代码对相应的医院行政记录进行量化。主要结局指标是（1）ST 段抬高型 ACS 患者的及时再灌注和（2）确诊急性心肌梗死患者的出院时最佳药物治疗。次要结局广泛包括护理过程的多个指标。临床终点（即死亡、心肌梗死、卒中和出血）将根据预设标准由临床事件委员会进行裁决。
该研究已获得所有研究地点的当地伦理委员会的批准。作为一项质量改进计划，并为了促进有兴趣的人群的连续纳入，仅要求存活出院的患者提供书面知情同意。将通过以下方式积极传播：（1）注册网站（ClinicalTrials.Gov ID NCT04255537）；（2）通过开放数据访问和共享与研究人员合作。
