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Design and development of case report form of stable angina pectoris with blending of phlegm and blood stasis syndrome |
Hits 1089 Download times 584 Received:November 10, 2020 |
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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 Name | Affiliation | E-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 |
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Abstract
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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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