[Practical Diagnostic Criterion of Blood Stasis Syndrome: Introduction, Reliability, and Validity]

Abstract

Objective: To introduce practical diagnostic criterion of blood stasis syndrome (BSS), and to evaluate its reliability and validity.

Methods: By referring to three diagnostic criteria of BSS [practical diagnostic criterion of BSS (criterion A), diagnostic criterion of BSS in 1986 (criterion B), Consensus of Integrative Medicine on BSS Diagnosis in 2011 (criterion C)], 712 patients from different departments of Xiyuan Hospital were recruited. The reliability of criterion A and its consistency with the other two criteria were assessed using Kappa coefficient. A Bayesian approach was also employed to assess the sensitivity and specificity of criterion A.

Results: According to the consistency check, criterion A presented good consistency when used by different researchers (the diagnostic accordance rate was 91. 96%, Kappa =0. 82, P <0.001). Meanwhile, there was an acceptable diagnostic consistency among the three diagnostic criteria. Bayesian estimation suggested that criterion A had higher sensitivity but similar specificity, as compared with criterion B or criterion C. Compared with criterion B [the median of sensitivity and specificity were 0. 762 (95% Cl: 0. 731 -0. 790) and 0. 902 (95% Cl: 0. 858 -0. 936) respectively, the median of sensitivity and specificity of criterion A were 0. 911 (95% CI: 0. 888 - 0. 930) and 0. 875 (95% CI: 0. 826 - 0. 915) respectively. Estimating the difference between criterion A and B, the median of sensitivity and specificity were 0. 149 (95% CI: 0. 112 -0.184) and -0. 026 (95% CI:-0. 085 -0. 033) respectively. Compared with criterion C [the median of sensitivity and specificity were 0. 831 (95% Cl: 0. 804 -0. 857) and 0. 892 (95% CI: 0. 848 - 0. 926) respectively], the median of sensitivity and specificity of criterion A were 0. 912 (95% CI: 0. 889 -0. 932) and 0. 880 (95%CI: 0. 833 - 0.919) respectively. Estimating the difference between criterion A and C, the median of sensitivity and specificity were 0. 081 (95% CI: 0.047 - 0.114) and -0.011 (95%CI: -0.070 -0.046) respectively.

Conclusion: Compared with criterion B and C, criterion A not only had better reliability, but also could significantly improve the sensitivity without obviously lowering the specificity.