Givi Mahshid, Sarrafzadegan Nizal, Garakyaraghi Mohammad, Yadegarfar Ghasem, Sadeghi Masoumeh, Khosravi Alireza, Azhari Amir Hossein, Samienasab Mohammad Reza, Shafie Davood, Saadatnia Mohammad, Roohafza Hamidreza, Paydari Navid, Soleimani Azam, Hosseinzadeh Mohsen, Ahmadi Seyed Abdulah, Dehghani Leila, Najafian Jamshid, Andalib Elham, Shahabi Javad, Sabri Mohammad Reza
Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
ARYA Atheroscler. 2017 Sep;13(5):236-244.
Our aim was to create and establish a database called "Persian Registry Of cardioVascular diseasE (PROVE)" in order to be used for future research and in addition, as a tool to develop national guidelines for diagnosis, treatment, and prevention of cardiovascular disease (CVD). In this paper, the design and methodology of the PROVE pilot study will be discussed, launched in Isfahan, Iran, in 2015-2016.
Through establishing PROVE, patients' data were collected from hospitals and outpatient clinics prospectively or retrospectively and followed up for a maximum of three years based on the type of CVDs. The inclusion criteria were as patients with acute coronary syndrome (ACS), ST elevation myocardial infarction (STEMI), stroke, atrial fibrillation (AF), heart failure (HF), congenital heart disease (CHD), percutaneous coronary intervention (PCI), and chronic ischemic cardiovascular disease (CICD). Specific protocols, questionnaires, and glossaries were developed for each registry. In order to ensure the validation of the protocols, questionnaires, data collection, management, and analysis, a well-established quality control (QC) protocol was developed and implemented. Data confidentiality was considered.
In order to register patients with ACS, STEMI, stroke, HF, PCI, and CICD, the hospital recorded data were used, whereas, in case of AF and CHD registries, the data were collected from hospitals and outpatient clinics. During the pilot phase of the study in Isfahan, from March 2015 to September 2016, 9427 patients were registered as ACS including 809 as STEMI, 1195 patients with HF, 363 with AF, 761 with stroke, 1136 with CHD, 1200 with PCI, and 9 with CICD. Data collection and management were performed under the supervision of the QC group.
PROVE was developed and implemented in Isfahan as a pilot study, in order to be implemented at national level in future. It provides a valuable source of valid data that could be used for future research, re-evaluation of current CVD management and more specifically, gap analysis and as a tool for assessment of the type of CVDs, prevention, treatment, and control by health care decision makers.
我们的目标是创建并建立一个名为“波斯心血管疾病注册库（PROVE）”的数据库，以便用于未来的研究，此外，作为制定心血管疾病（CVD）诊断、治疗和预防国家指南的工具。本文将讨论2015 - 2016年在伊朗伊斯法罕开展的PROVE试点研究的设计和方法。
通过建立PROVE，前瞻性或回顾性地从医院和门诊收集患者数据，并根据心血管疾病类型进行最长三年的随访。纳入标准为急性冠状动脉综合征（ACS）、ST段抬高型心肌梗死（STEMI）、中风、心房颤动（AF）、心力衰竭（HF）、先天性心脏病（CHD）、经皮冠状动脉介入治疗（PCI）和慢性缺血性心血管疾病（CICD）患者。为每个注册库制定了特定的方案、问卷和术语表。为确保方案、问卷、数据收集、管理和分析的有效性，制定并实施了完善的质量控制（QC）方案。考虑了数据保密性。
为登记ACS、STEMI、中风、HF、PCI和CICD患者，使用了医院记录的数据，而对于AF和CHD注册库，数据则从医院和门诊收集。在伊斯法罕的研究试点阶段，从2015年3月至2016年9月，9427例患者被登记为ACS，其中809例为STEMI，1195例为HF患者，363例为AF患者，761例为中风患者，1136例为CHD患者，1200例为PCI患者，9例为CICD患者。数据收集和管理在QC小组的监督下进行。
PROVE作为一项试点研究在伊斯法罕开发并实施，以便未来在国家层面实施。它提供了有价值的有效数据来源，可用于未来研究、重新评估当前的心血管疾病管理，更具体地说，用于差距分析，以及作为医疗保健决策者评估心血管疾病类型、预防、治疗和控制的工具。
