Kim Hun-Sung, Lee Sue Hyun, Kim Tong Min, Kim Ju Han
1Department of Medical Informatics, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591 Republic of Korea.
2Department of Endocrinology and Metabolism, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Clin Hypertens. 2018 Dec 15;24:18. doi: 10.1186/s40885-018-0103-7. eCollection 2018.
Randomized controlled trials can be expensive and time-consuming, leading to medical researchers utilizing real-world evidence (RWE) based on already-collected data. We aimed to conduct various RWE studies on angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blocker (ARB), commonly used as first-line therapy for blood pressure, and to develop a multi-center clinical data mart (CDM) of ACEI/ARB for various clinical purposes.
Data from electronic medical records of St. Mary's Hospital and the Seoul National University Hospital were collected. We obtained blood and urine test results of patients within the 30 days prior to their first prescription of ACEI or ARB, as well as the first date of diagnosis and presence of various chronic and cardiovascular diseases using the International Classification of Diseases-10 classification. One researcher managed data quality and collation for each hospital in order to facilitate patient anonymity. When results were unclear, the responsible investigator for each hospital attempted to resolve ambiguities by direct chart review.
A total of 102,333 patients who were prescribed ACEI or ARB for the first time were included (21,481 ACEI, 80,551 ARB, and 301 both). Our ACEI/ARB-CDM included short-term studies (within 12 months) to observe changes in various blood or urinary laboratory test values after the initial prescription of ACEI or ARB and long-term studies to confirm the incidence of various diseases.
We established a CDM of RWE for ACEI/ARB prescription, which included various clinical studies. As we accumulate experience in this process, we expect that the use of RWE research will grow and develop.
随机对照试验可能成本高昂且耗时，这导致医学研究人员利用基于已收集数据的真实世界证据（RWE）。我们旨在对通常用作血压一线治疗药物的血管紧张素转换酶抑制剂（ACEI）和血管紧张素II受体阻滞剂（ARB）开展各种RWE研究，并为各种临床目的开发一个ACEI/ARB多中心临床数据集市（CDM）。
收集了圣玛丽医院和首尔国立大学医院电子病历中的数据。我们获取了患者首次开具ACEI或ARB处方前30天内的血液和尿液检测结果，以及使用国际疾病分类第10版分类法得出的首次诊断日期和各种慢性及心血管疾病的患病情况。一名研究人员负责每家医院的数据质量和整理工作，以方便对患者进行匿名处理。当结果不明确时，每家医院的责任研究者会通过直接查阅病历试图解决歧义。
共纳入102333例首次开具ACEI或ARB处方的患者（21481例使用ACEI，80551例使用ARB，301例两者都用）。我们的ACEI/ARB - CDM包括短期研究（12个月内），以观察首次开具ACEI或ARB处方后各种血液或尿液实验室检测值的变化，以及长期研究，以确认各种疾病的发病率。
我们建立了一个用于ACEI/ARB处方的RWE的CDM，其中包括各种临床研究。随着我们在这个过程中积累经验，我们预计RWE研究的应用将会不断发展。
