Development of a blood stasis syndrome questionnaire and its reliability and validity

IntroductionThe Korea Institute of Oriental Medicine (KIOM) has developed and validated a Blood Stasis Syndrome (BSS) questionnaire by integrating Korean, Chinese and Japanese BSS criteria with a community-based, multi-center trial, called the Convergence Research of the Diagnostic Technology for Blood Stasis (CORE-DITEC-BS). The aims of the current study were to assess the reliability and validity of the CoRe-Ditec-BS Questionnaire-I (BSQ-I).MethodsBetween May 2013 and November 2013, 607 patients from 6 traditional Korean medical hospitals were asked to complete the BSQ-I. Each patient was independently diagnosed with BSS by two traditional Korean medical physicians from the same site. We estimated the internal consistency using Cronbach's α coefficient, the inter-rater reliability in each site using the kappa coefficient, the discriminant validity using the means score of BSS, and the predictive validity using logistic regression (sensitivity and specificity).ResultsThe BSQ-I had satisfactory internal consistency (average: 0.701, expert1: α = 0.710, expert2: α = 0.700) and validity, with significant differences in the mean scores between the BSS and non-BSS groups. The overall classification accuracy of the two experts was 78.42%, and the Kappa value was 0.57 (0.50, 0.63), which was considered moderate. The area under the receiver operating curve was 85%, and the sensitivity and specificity were 77.4% and 75.9%, respectively.ConclusionThese results suggest that the CoRE-Ditec-BSQ-I is a reliable and valid instrument for estimating BSS.