| [Objective]According to the the requirement of scale development, we extract "elements of syndrome and pathogenesis"(ESP), build item pool and determine the weights of diagnostic elements by literature research and Delphi method, and then determine the diagnosis threshold by statistical methods and experts’ experiment. And finally finish retrospective clinical verification in order to develop the ESP diagnosis scale for acute hemorrhagic stroke. This study is aimed to explore the methods of syndromes standardization research in stroke, develop a diagnosis scale which has high clinical coincidence. We hope the scale may guide clinical practice, and improve the level of TCM clinical syndrome differentiation.[Method]1Extract ESP of acute hemorrhagic stroke based on diagnostic information combined with modern research results of stroke pathogenesis syndrome study by literature research and Delphi method.2Choose the symptoms, and signs that have the high specificity for each ESP, and then compose item pool corresponding to the each ESP, finally form epidemiology questionnaire.3According to the contribution of diagnostic elements for the ESP, assign different score that is the weights of diagnostic elements by experts’ discussion repeatedly.4Expert identify ESP of926patients combining with ROC curve in order to determine the diagnostic threshold. Finally examine clinical coincidence.[Result]1We have abstracted eight ESP of acute hemorrhagic stroke:Stasis heat, Wind, Fire, Hot phlegm, Wet phlegm, Blood stasis, Qi deficiency and Yin deficiency.2Choose diagnostic elements under eight ESP, and summarize diagnostic items.3According to the contribution of diagnostic elements for the ESP, determine the weights of diagnostic elements.4Through expert experience combining with ROC curve we determine diagnostic threshold, so as to develop the ESP diagnosis scale for acute hemorrhagic stroke eventually(appendix1).[Conclusion] 1Syndrome elements as the unit is the important way to realize the standardization of syndrome.lt not only can simplify the complexity and multidimensional nature of syndrome differentiation, also provide model for the research on TCM scale2Through the ways of iterature research, epidemiology, statistical analysis and clinical examination, comparing and analysing the result of expert experience and the computer statistics, we develop the ESP diagnosis scale for acute hemorrhagic stroke which has good accuracy and high clinical coincidence, and provide research idea and accurate method of syndrome standardization. |