Development And Evaluation Of The Patient-Reported Outcomes Of Yin-Deficiency Syndrome

Objective:To develop the self-assessment lists of Yin-deficiency syndrome withCharacteristics of traditional Chinese medicine, which Provides clinical Yin-deficiency syndrome diagnosis and identify disease with measuring tool, and provides reference for Yin-deficiency syndrome curative effect evaluation.Methods:According to the methods of the scaledevelopment, the literature research results obtained the distribution of Yin-deficiency syndrome in all kinds of diseases, and On the basis of the syndromes, the standardization processing, formed the alternativeitem pool, which reflected the Yin-deficiency syndrome.Translating entry into various problems, and formulating the Delphi expert consultation, which was for the preliminary screening questionnaire items, to form the self-assessment lists of Yin-deficiency syndrome (draft). Then adjustment of the language, to see if the patient can understand each entry, further optimize the scale, to form the self-assessment lists of Yin-deficiency syndrome (1 edition) to enter the next step of clinical investigation.Collecting 100 outpatient and inpatient in Fujian province people’s hospital, Fujian Second People’s Hospital, Guo Yi Tang, Fujian Province-owned Hospital, The second hospital of Fuzhou, and Jinjiang hospital of traditional Chinese medicine for the Clinical preliminary investigation. Using the difficulty analysis, response characteristics analysis and related coefficient method to process the clinical data, which could further optimize the filter entries, then form the self-assessment lists of Yin-deficiency syndrome (2 edition). In the end, evaluate the 2 edition, collecting clinical data of 400 investigators, to test its reliability, validity and feasibility, to further improve the scale.Results:1. After the early literature research obtains 232 symptoms of Yin-deficiency syndrome performance, form the item pool.2. After three rounds of expert consultation, the average recovery was 100%. There were 84 items on the scale. There were 36 items onrenal dimension,29 items on liver dimension,15 items on stomach dimension,22 items on lung dimension,10 items on heart dimension, and 10 items onspleen dimension with the three round of expert questionnaire survey.3. In the clinical investigation beforehand, the difficulty of analysis, response characteristics and correlation coefficient method and other statistical methods for screening the 56 entries of 84 entries, to make the self-assessment lists of Tin-deficiency syndrome (2 edition), there were 20 items onrenal dimension,22 items on liver dimension,13 items on stomach dimension,12 items on lung dimension,10 items on heart dimension, and 10 items onspleen dimension.4. The split-half reliability of the scale was 0.920, the split-half reliability of each dimension was higher than 0.6; The Cronbach’s a coefficient of the scale was 0.872, and the Cronbach’s a coefficient of each dimension was higher than 0.6, which suggest that scale has goodreliability. The non parametric test suggest that scale has good discriminant validity, and factor analysis suggest that scale has good structure validity.Conclusion:1. Through the relevant literature research of Yin-deficiency syndrome, which summarized common diseases in Traditional Chinese Medicine and Western medicine, syndrome types of TCM, syndrome factor of Yin-deficiency syndrome.2. The literature research provided the item pool for subsequent scale development, and provided the basis for the formation of the dimension and clinical investigation of cases.3. Standard term syndrome provided a standardized way for the formation of optional item pool.4. Through the methods of the Delphi expert consultation and the clinical investigation beforehand, item selection optimization were obtained. Which formed the self-assessment lists of Yin-deficiency syndrome (2 edition), there were 56 items on the scale.5. Through the clinical investigation, to test reliability, validity and feasibility of Yin-deficiency syndrome (2 edition). As a result, the scale with good reliability, validity, and feasibility, which will provide clinical Yin-deficiency syndrome diagnosis and identify disease with measuring tool, and provide reference for Yin-deficiency syndrome curative effect evaluation.