| This study is from the subject of Beijing Science and Technology Plan "The Ming and Validation of Type2Diabetes Clinical Diagnosis and Treatment Regularities of Traditional Chinese Medicine"(No. D08050703020802).Objective:Patient-reported outcome(PRO) is the reporting of patients’health and the results of treatment directly from themselves,which can provide international recognized scientific basis for symptoms curative effect.So in this study,we would explore the method of developing type2diabetes PRO scale with the characteristics of traditional Chinese medicine,to provide reference for the evaluation of clinical effects.Methods:At the beginning of the study,we established the working group, and cleared the concept that the scale measures as type2diabetes patients reported outcomes.The international PRO scale development norms were followed during the research process.Under the guidance of traditional Chinese medicine theory,we constructed the scale’s expected structure framework. Literature,clinical data analysis,and patients interviews were comprehensive used to develop items,which were screened and optimized from the perspective of language and logic, and classified and reorganized according to the scale’s expected structure framework to establish the primary item pool.After the confirmation of response scale and scale format had been designed,the draft scale was formed.The draft scale had been used for a small range cognitive test,whose result was according to to revise the draft scale,before the pre-test questionnaire was formed.A sample of200type2diabetes cases was taken from endocrinology department of Guang’anmen hospital affiliated to China Academy of the Chinese Medical Sciences to have a field survey with the pre-test questionnaire,which had covered different situation on ages,sexes, complications,and treatment ways.We analyzed the data information from field survey by using different kinds of statistical methods,including discrete trend analysis,cluster analysis,Cronbach’s a coefficient,related coefficient,factor analysis,step regression,t test and discriminatory analysis to screen items,and optimize the scale structure.And then,the formal scale was formed.At last,the formal scale’s reliability, validity,and responsibility were tested.Results:The developed type2diabetes PRO scale was composed of4domains,17facets,and64items.The split-half reliability coefficient of the whole scale was0.829,while physiological domain0.840,function independence domain0.654, psychological domain0.723,social domain0.689.The Cronbach’s a coefficient of the whole scale was0.923,while physiological domain0.909,function independence domain0.762,psychological domain0.826,social domain0.697.The correlation coefficients for all domains and the whole scale were greater than0.4.AThe correlation between physiological domain and it’s items were relatively small,which were between0.130and0.627.While the correlation between other domains and their items were relatively large,which were more than0.6,except the item about economic support.The correlation coefficients for the scale’s all items and their domains were greater than those for items and domains which were not their,except the items about difficulty sleeping, constipation or diarrhea and urgency of urination.Exploratory factor analysis showed that,the12common factors extracted by scree plot had explained62.181%of the variance.Information of the scale’s all facets had been basically reflected by the12common factors’sense explanation,and there was obvious logical relationship between each factor and the scale’s inner structure.As to responsibility,the result of t test showed that the mean comparisons between outpatient and inpatient were all have statistical significance in each domain and the total scale score(P<0.05).Conclusion:The developed type2diabetes PRO scale had passed the preliminary assessment of reliability,validity,and responsibility,so that it can be used to evaluate type2diabetes clinical effects of traditional Chinese medicine. |
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