| Objective: This study aims to develop a quality of life scale which is characteristic of TCM.This quality of life scale is more suited to our National conditions,and can be used to evaluate the health status of children with chronic primary immune thrombocytopenia.Thus enrich the content of clinical efficacy evaluation of traditional Chinese medicine(TCM).Methods: The theoretical framework of TCM quality of life scale for children with chronic immune thrombocytopenia was constructed based on the basic theory of TCM,following the principles and procedures of the quality of life scale.Through a great deal of literature research,medical history system review,expert consultation survey and patient interview,a comprehensive analysis was made to determine the index pool.By using Delphi method,the entries of the scale were selected subjectively in the form of two rounds of questionnaires.Then the predicative test scale is applied in clinic,and the objective screening of the scale items is accomplished by examining its clinical applicability and feasibility.Finally,using the methods of split and half confidence,klonbach coefficient,expert investigation and correlation coefficient,we can evaluate the reliability and validity of the scale scientifically.Finally,we have formulated the quality of life scale for children with chronic primary immune thrombocytopenia,which is characteristic of Chinese medicine and can be used to evaluate the efficacy of Chinese medicine.Results: 1.Expert questionnaire survey: Through Delphi’s two rounds of expert consultation questionnaires,experts’ positive coefficients were 97% and 100%,respectively;The degree of expert opinion concentration was statistically analyzed using EXCEL worksheet and SPSS22.0 software.The boundary value was calculated and the entry was filtered.The first round of the questionnaire deleted 27 entries,combined with the expert’s supplementary opinions,and 1 item was added after the discussion and analysis of the topical group,there remaining 69 items.The second questionnaire deletes 10 items,A3 and A11 parts are duplicated,and A11 is deleted after being merged,the same as A30 and A31,and A30 is deleted.A total of 12 items are deleted at last.In the two rounds of expert consultation questionnaires,the Kendall harmony coefficient of expert opinion was 0.357 and 0.593,respectively,indicating that the degree of coordination of expert opinions was relatively high.There are 57 remaining items after the Delphi Method Master Observation.2.Clinical self-assessment survey: based on the data collected from the clinical self-assessment survey of 60 subjects,SPSS 22.0 software was used to complete the objective screening of scale items through a series of methods,such as frequency distribution method,correlation coefficient method,exploratory factor analysis method,and discrete trend method.After the objective evaluation through clinical investigation,we finally determined the four dimensions of the scale which contains 42 items:the first dimension(physiological function)contains 18 entries,the second dimension(emotional function)contains 8 entries,the third dimension(social role)contains 12 entries,the fourth dimension(environmental factor)contains 4 entries.3.Assessment of reliability and validity of the scale: In the evaluation of the characteristics of the scale,the overall reliability and reliability coefficient of the scale was 0.997,and the four dimensions were 0.988,0.964,0.986,and 0.922,respectively.It shows that regardless of the internal dimensions or the entire scale,it retains excellent internal consistency and stably reflects the same content;the Cronbach’s reliability coefficient is 0.989 for the total scale,the first dimension(physiological function)is 0.979,and the second dimension(emotion Function)0.968,the third dimension(social role)0.971,and the fourth dimension(environmental factor)0.901.It is concluded that the internal consistency and reliability of the whole scale and all fields are good,as well as the reliability and validity.Conclusion: Through rigorous and scientific evaluation,the preliminarily compiled TCM quality of life scale for chronic primary immune thrombocytopenia has proved to be of good reliability and validity.It can be used for the evaluation of the quality of life of children with chronic primary immune thrombocytopenia.And with further large-scale clinical verification,it can also be used for evaluation of clinical efficacy of Chinese medicine for children with chronic primary immune thrombocytopenia. |
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