| ObjectiveAcute mastitis is a common disease in the clinical manifestation. Galactostasis is the main manifestation in the early stage. Through kneading and grasping the breast, early acute mastitis could be controlled effectively. According to the research of The state administration of traditional Chinese medicine of traditional Chinese medicine technological cooperation, it is important to design an objective, measureable and sensitive scale to evaluate the clinical effect of kneading and grasping the breast.The main objective of this study is to design a scale which is concerned with curing Acute mastitis in the early stage. The scale aims to evaluate the clinical effect through Kneading and grasping manipulation while treating the early Acute mastitis. And the scale’s reliability, validity and responsibility will be studied in this paper.MethodsBased on the clinical manifestation, and consulting the Kvist evaluation form the original scale is composed of several items, such as the symptom of whole body, functional situation and laboratory test. With several times of clinical trial, the first draft scale is improved by selecting the suitable item from the original one. Second draft is adjusted with the help of professional team from State Chinese Medicine Administration Bureau. After re-consulting with the expert and getting the useful opinion from the opening report discussion,3rd draft scale is confirmed.In order to improve the applicability of the scale, a cohort study is applied in this paper. Given informed consent,108 patients who treated with kneading and grasping the breast from the Guangdong Hospital of TCM were observed during February 2014 to June 2016. The Cronbach’s a and test-retest reliability was applied to study the reliability. The validity was investigated by comparing the scale with the State Administration of TCM s“Chinese disease diagnosis and efficacy standards" and factor analysis. Paired t test, effect size (ES), standard response mean(SRM) and change ratio (CR) were used to evaluate the validity and responsiveness. And from the evaluation of the clinical efficacy of the evaluation tableResults108 patients were investigated with this 7-items scale.(1)The Cronbach’s a of retest reliability were 0.878 and 0.968 respectively,0.881 after correcting.(2)The KMO 0.854, and Bartlett’s test of Sphericity was 386.524, P＜0.001;Three factors were extracted according to the factor analysis, the cumulative contribution rate of factor was 80.967%;The Spearman rank correlation coefficient between the scale of Aucate mastitis in early stage and the efficacy standards of Chinese disease d was 0.807.(3) Reaction test:Matching T with the total score before and after the scale intervention. While t=21.735, P=0.000, each item is compared and tested accordingly. P value is higher than 0.000. Comparing with The SRM and CR before and after the intervention, all the items’SRM is higher than 0.8 and CR is 50%higher excepting nursing status is 0.41,15.1%.Comparing the parallel table, all the SRM\CR value and t value was higher than the parallel table.ConelusionThe scale of Acute mastitis of early stage was based on the general international development principle of PRO. The properties of the scale were acceptable after testing. It can be applied extensively to the clinical practice of Kneading and grasping manipulation while treating early Acute mastitis in the future. |
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