Zhao Tianyi, Liu Jia, Li Yiming, Li Hongjiao, Wang Chao, Yang Zhuoxin, Wang Xin, Ai Yanke, Qin Yuning, Cao Xue, Yue Lihong, Ge Zhishan, Wang Shihua, Meng Xiangran, Wang Yanjun, He Liyun
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Swiviss University of Traditional Chinese Medicine, Hauptstrasse 61, Bad Zurzach 5330, Switzerland.
Evid Based Complement Alternat Med. 2022 Nov 21;2022:3860231. doi: 10.1155/2022/3860231. eCollection 2022.
The acupuncture case registry study is focusing on acupuncture therapy data from patient cases. The main objective is to collect real-world data and integrate clinically meaningful outcome evaluation indicators to uncover and evaluate real-world acupuncture efficacy and safety, explore factors affecting acupuncture efficacy, and provide real-world evidence to complement RCTs. Since the International Acupuncture Case Registry data collection system's establishment in 2017, 16 projects have been underway, including two acupuncture specialty therapies and 15 diseases. Data from 3404 patients included extensive information on the diagnosis and treatment of acupuncture and the evaluation of its efficacy. In order to serve as a guide for future studies, this article discusses the value of and rationale for establishing acupuncture case registry studies, how to distinguish them from patient registries, and crucial techniques for implementing registry studies in terms of applications, patient recruitment, costakeholder collaboration, data collection and management, study quality control, and ethics.
针灸病例登记研究聚焦于患者病例的针灸治疗数据。主要目标是收集真实世界数据，并整合具有临床意义的结局评估指标，以揭示和评估真实世界中针灸的疗效和安全性，探索影响针灸疗效的因素，并提供真实世界证据以补充随机对照试验。自2017年国际针灸病例登记数据收集系统建立以来，已有16个项目在进行中，包括两种针灸特色疗法和15种疾病。来自3404名患者的数据包含了针灸诊断和治疗以及疗效评估的广泛信息。为了为未来研究提供指导，本文讨论了建立针灸病例登记研究的价值和基本原理，如何将其与患者登记区分开来，以及在应用、患者招募、利益相关者合作、数据收集与管理、研究质量控制和伦理方面实施登记研究的关键技术。
