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Design and development of case report form of stable angina pectoris with blending of phlegm and blood stasis syndrome
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DOI   10.11656/j.issn.1672-1519.2021.03.11
Key Words   syndrome differentiation and treatment;stable angina pectoris;blending of phlegm and blood stasis syndrome;CDASH;case report form
Author NameAffiliationE-mail
AO Yuhan Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China  
WU Dongning Clinical Evaluation Center, China Academy of Chinese Medical Sciences, Beijing 100700, China  
LI Han Shenyang Health Service and Administrative Law Enforcement Center, Shenyang 110000, China  
LIU Botong Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China  
ZHOU Yushi Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China  
LI Zheng First Department of Cardiology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China  
ZHANG Mingxue Second Department of Cardiology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China zhmx6228@163.com 
Abstract
    Based on the "dynamic space-time" characteristics of syndromes and the principle of "combining disease with syndrome, syndrome differentiation and treatment", combined with the current research status of data collection tools, an evidence-based optimization study case report form (CRF) of traditional Chinese medicine (TCM) treatment scheme for stable angina pectoris was developed and designed. The formed case report form takes 4 visits and 2 follow-up as the time frame, including baseline index, TCM syndrome curative effect index, western medicine curative effect index, safety index, adverse events and drug combination table. In order to obtain standardized data, CRF was designed under the guidance of the Clinical Data Acquisition Standards Harmonization (CDASH) of the Clinical Data Interchange Standards Consortium (CDISC) standard.

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