Xiao-Qi Liu1, Dan-Hong Peng1, Yan-Ping Wang1, Rong Xie1, Xin-Lin Chen1, Chun-Quan Yu2, Xian-Tao Li3. 1. School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China. 2. Journal Editorial Board, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. 3. School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China. lxt150@126.com.
Abstract
BACKGROUND: Phlegm and blood stasis syndrome (PBSS) is one of the main syndromes in coronary heart disease (CHD). Syndromes of Chinese medicine (CM) are lack of quantitative and easy-implementation diagnosis standards. To quantify and standardize the diagnosis of PBSS, scales are usually applied. OBJECTIVE: To evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. METHODS: Six hundred patients with stable angina pectoris of CHD, 300 in case group and 300 in control group, will be recruited from 5 hospitals across China. Diagnosis from 2 experts will be considered as the "gold standard". The study design consists of 2 phases: pilot test is used to evaluate the reliability and validity, and diagnostic test is used to assess the diagnostic accuracy of the scale, including sensitivity, specificity, likelihood ratio and area under the receiver operator characteristic (ROC) curve. DISCUSSION: This study will evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. The consensus of 2 experts may not be ideal as a "gold standard", and itself still requires further study. (No. ChiCTR-OOC-15006599).
BACKGROUND: Phlegm and blood stasis syndrome (PBSS) is one of the main syndromes in coronary heart disease (CHD). Syndromes of Chinese medicine (CM) are lack of quantitative and easy-implementation diagnosis standards. To quantify and standardize the diagnosis of PBSS, scales are usually applied. OBJECTIVE: To evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. METHODS: Six hundred patients with stable angina pectoris of CHD, 300 in case group and 300 in control group, will be recruited from 5 hospitals across China. Diagnosis from 2 experts will be considered as the "gold standard". The study design consists of 2 phases: pilot test is used to evaluate the reliability and validity, and diagnostic test is used to assess the diagnostic accuracy of the scale, including sensitivity, specificity, likelihood ratio and area under the receiver operator characteristic (ROC) curve. DISCUSSION: This study will evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. The consensus of 2 experts may not be ideal as a "gold standard", and itself still requires further study. (No. ChiCTR-OOC-15006599).
Entities:
Keywords:
composite syndrome; coronary heart disease; diagnosis scale; diagnostic accuracy; phlegm and blood stasis; study protocol; syndrome differentiation