Development And Methodology Of Diagnostic And Evaluation Scale For Hepatic Stagnation And Heat Syndrome

BackgroundIt is the focal and difficult point in traditional Chinese medicine field that how to develop traditional Chinese medicine new drug investigation scientifically and standardized. In present, there are two main methods of how to conduct the new dug investigation. The first one is the study under the model of combination of disease and syndrome, which is based on the Chinese traditional medicine new drug clinical research guiding principle organized by state drug administration. This kind of model is widely used in traditional Chinese medicine field with general expert consensus. The other one is the study under the model of general Chinese medicine syndrome, which is full of Chinese character and in line with Chinese medicine law itself. However, lacking of the syndrome standard of Chinese medicine, new drug investigation under the general Chinese medicine syndrome model is limited. Thus it becomes the critical problem that how to develop the syndrome standard, especially the standard of the syndrome which are generally used in clinical practice and outside the certain disease.So we hope to conduct a standard study of developing the syndrome diagnosis scale and syndrome evaluation scale, taking the liver depression of the heat syndrome as an example, in order to making the foundation of Chinese medicine syndrome new drug investigation scientifically and standardized.ObjectivesWe hope to discuss how to develop the general syndrome diagnosis scale and syndrome evaluation scale, focusing on Chinese syndrome new drug investigation and taking the liver depression of the heat syndrome as an example. A system of method for developing syndrome diagnosis scale and syndrome evaluation scale is expected in Chinese medicine field.Methods1 The development ofliver depression of the heat syndrome diagnosis scaleBased on the foundation of previous group study, we clearly declare that there are several differences between syndrome diagnosis scale and syndrome evaluation scale from several aspects, such as the theory foundation, the development skills, the formation of items, and the verification methods. With the experiences accumulated, we followed the general study method of ischemic stroke syndrome elements diagnosis scale to develop liver depression of the heat syndrome diagnosis scale. The specific steps are like the following: ① clearing the objectives and forming the study group; ② forming the item pools and making sure the formation of items and options; ﹖he analysis and filtering of items;④ the development and evaluation of diagnosis model; ⑤ the confirmation of threshold;⑥the choosing of the weight and formation of the scale;⑦evaluating the diagnosis nature of the scale.2 The development of liver depression of the heat syndrome evaluation scaleBased on the foundation of previous group study, we clearly declare that there are great differences between the definition of syndrome diagnosis scale and the definition of syndrome evaluation scale. Syndrome evaluation scale is used for quantification and ordered categories. The representative example is the psychological measurement scale in psychology. We followed the steps as forming the item pools, developing the dimensionality of the scale, analysis and filtering of items, weighting the scale items and formation of the specific scale. Especially, during the core steps of we carry out the method of improving the scale evaluation outcomes such as reliability, validity, responsiveness so that the liver depression of the heat syndrome evaluation scale comes out.Results1 The completion of liver depression of the heat syndrome diagnosis scaleThe liver depression of the heat syndrome diagnosis scale is formed by 8 items and they are the dysphoric mood, bitter taste, distending pain in hypochondrium, dry eyes, poor sleep(week in the day), red tongue, yellow tongue coating and stringy pulse. The weight of each respective item is 7.5,5.0,5.0,5.5,4.0,9.0,8.0, and 5.0. The threshold is 30.0. The sensitivity is 93.91%; the specificity is 92.94%; accuracy rate is 93.50%; positive likelihood ratio is 13.30; negative likelihood ratio is 0.065.2 The completion of liver depression of the heat syndrome evaluation scaleThe liver depression of the heat syndrome evaluation scale is formed by 13 items and they are the irritation, perturbed mood, irascible mood, symptoms change along with the mental state, bitter taste, red eyes, red cheek, distending pain in hypochondrium, dry mouth and throat, yellow urine, poor sleep, yellow tongue coating and stringy pulse. The 13 items are respectively belong to 3 dimensions. The 3 dimensions are the change of mood, the disorder through the rout of the liver meridians and the constitutional symptoms. The split-half reliability is 0.643, Cronbach’s alpha is 0.749, criterion validity contrasted with doctors’judgment is 0.625, and the responsiveness is satisfactory.ConclusionThe development of liver depression of the heat syndrome diagnosis scale and liver depression of the heat syndrome evaluation scale is a certain set of general syndrome standard, which stand outside the specific disease. The syndrome diagnosis scale are evaluated with high sensitivity, specificity and accuracy rate; the syndrome evaluation scale are evaluated with satisfied reliability, validity, responsiveness.Based on the foundation of declaring that diagnosis and evaluation are totally two different things with different contents, we carry out the method of improving the diagnosis scale evaluation outcomes during the core steps of making the diagnosis scale and conduct the way of enhancing the evaluation scale evaluation outcomes during the core steps of making the evaluation scale. Evaluated by the assessment, the two scales could achieve the basic function themselves. What is more, the diagnosis scale is hardly to accomplish the evaluation function and the evaluation scale is unlikely to shoulder the diagnosis responsibility. That is what we want. There are great differences between diagnosis and evaluation, so that two different set of methods are need. At the same time, it proves to be the more suitable way to develop syndrome scales and can enhance the properties.This set of method is also meet the clinical practice, providing the references of how to develop the syndrome diagnosis scale and evaluation scale in Chinese medicine field. We hope our exploring works could make a contribution to traditional Chinese medicine new drug investigation.