Formulate Development And Assessment Of Blood Deficiency Syndrome Patient Reported Outcome Scale

Objective:This topic is the whole concept of Chinese medicine as a guide, based on literature research results and syndrome element differentiation principle and preliminary development of a table with the amount of blood deficiency syndrome of traditional Chinese medicine (TCM), blood deficiency syndrome scale reliability, validity and responsiveness of the evaluation, provide a quantitative reference tool for the objectification of blood deficiency syndrome of TCM clinical diagnosis and Curative effect evaluation.Methods:1. According to scale development scheme, based on the literature research, screening blood deficiency related entries, selected entry after experts to discuss terms, the standardization of processing establishment of item pool of blood deficiency syndrome.2. The three rounds Delphi method:the first round of consultation, on the item pool of preliminary screening (Appendix 1), the second round of consultation, the entries again screening and classification dimensions (Appendix 2) and the three rounds of consultation, according to the importance of items for screening (Appendix 3).3. Pre-survey:1. To collect and 40 cases (normal or blood deficiency syndrome patients) in the scale pretest language debugging), forming scale version 2); Ⅱ 100 cases of blood deficiency syndrome were collected through the difficulties of analysis method,the response characteristic analysis method and correlation coefficient method and statistical method of screening items, the formation of scale (version 3).4 Evaluation:collect 300 cases of blood deficiency patients,100 cases of non blood deficiency patients, for the validity and reliability evaluation.Results:1. Through three rounds of Delphi expert consultation to form blood deficiency syndrome Checklist (Appendix 3). The volume contains 46 items, from the heart, lung, spleen, liver, gallbladder, kidney, uterus seven dimensions composition.2. Pre clinical investigation:through the difficulties of analysis method, the response characteristics analysis method and correlation coefficient method and statistical method of 46 items of screening that 43 entries, the central dimensions 17, lung dimensions 5,12 dimensions of spleen, liver dimensions 14, renal dimension 8, uterus dimension four.3. scale reliability and validity evaluation:the overall scale reliability coefficient, reliability index of each dimension of Spearman-Brown were above 0.7, so the reliability is good; the total scale is 0.860 Cronbach’s Alpha, renal dimension 0.672, the rest is greater than 0.7, that scale internal consistency reliability; factor analysis by principal component analysis the method according to the interpretation of the results of the total variance, value, factor initial feature extraction of 1 Statistics, the number of common factors is extracted to 11, the cumulative variance contribution value is 62.837%, according to the 3-6 statistics, the scale factor can explain more than 50% of the variance, andeach item from the common factor variance the value of more than 0.4, so the scale has good construct validity. The factor analysis proved validity and structure validity is better.Conclusion:Through theoretical study, the Delphi method, clinical research, the initial establishment of the has the characteristics of traditional Chinese medicine blood deficiency syndrome self-evaluation, and confirmed that the scale has good reliability and validity, for blood deficiency syndrome diagnosis and curative effect evaluation norms areestablished to provide clinical reference and quantitative tools.